Advisory Committee on Human Radiation Experiments : final report

Advisory

Committee

on

Human

Radiation

Experiments

NATIONAL IjVSTITi
NIHLIBR

JAN 2 2

BLDG 10, 10 CENTER DR
BETHESDA, MD 20892-1150

Advisory Committee

on Human Radiation

Experiments

Final Report

October 1995

Additional copies of the Final Report of the Advisory Committee on Human
Radiation Experiments (stock number 061-000-00-848-9) as well as copies of the
Executive Summary and Guide to Final Report (stock number 061-000-00849-7)
and the three supplemental volumes (061-000-00850-1, 061-000-00851-9, and
061-000-00852-7) may be purchased from the Superintendent of Documents, U.S.
Government Printing Office.

All telephone orders should be directed to:

Superintendent of Documents

U.S. Government Printing Office

Washington, D.C. 20402

(202) 512-1800

FAX (202) 512-2250

8 a.m. to 4 p.m., Eastern time, M-F

All mail orders should be directed to:

U.S. Government Printing Office
P.O. Box 371954
Pittsburgh, PA 15250-7954

An Internet site containing ACHRE information (replicating the Advisory
Committee's original gopher) will be available at George Washington University.
The site contains complete records of Advisory Committee actions as approved;
complete descriptions of the primary research materials discovered and analyzed;
complete descriptions of the print and non-print secondary resources used by the
Advisory Committee; a copy of the Interim Report of October 21, 1994, and a
copy of the Final Report; and other information. The address is
http://www.seas.gwu.edu/nsarchive/radiation. The site will be maintained by the
National Security Archive at GWU.

Printed in the United States of America

Contents

PREFACE 1

INTRODUCTION The Atomic Century 19

PART I Ethics of Human Subjects Research: A Historical Perspective

Overview 81

1 Government Standards for Human Experiments: The 1940s and 1950s 83

2 Postwar Professional Standards and Practices for Human Experiments .... 130

3 Government Standards for Human Experiments: The 1960s and 1970s .... 171

4 Ethics Standards in Retrospect 196

PART II Case Studies

Overview 227

5 Experiments with Plutonium, Uranium, and Polonium 233

6 The AEC Program of Radioisotope Distribution 283

7 Nontherapeutic Research on Children 320

8 Total-Body Irradiation: Problems When Research and Treatment Are
Intertwined 366

9 Prisoners: A Captive Research Population 42 1

10 Atomic Veterans: Human Experimentation in Connection with Bomb

Tests 454

1 1 Intentional Releases: Lifting the Veil of Secrecy 506

12 Observational Data Gathering 563

13 Secrecy, Human Radiation Experiments, and Intentional Releases 619

PART III Contemporary Projects

Overview 669

14 Current Federal Policies Governing Human Subjects Research 675

1 5 Research Proposal Review Project 694

16 Subject Interview Study 724

Discussion of Part III 758

PART IV Coming to Terms with the Past, Looking Ahead to the Future

Overview 769

1 7 Findings 777

18 Recommendations 801

Statement By Committee Member Jay Katz 847

Official Documents

Executive Order 857

Charter | 862

Appendices

Acronyms and Abbreviations 869

Glossary 878

Selected Bibliography 886

Public Comment Participants 892

A Citizen's Guide to the Nation's Archives: Where the Records Are

and How to Find Them 897

iii

advisory committee on human radiation Experiments

1726 M STREET, N.W., SUITE 600

WASHINGTON, D.C. 20036 _ . innc

October 1995

To the Members of the Human Radiation Interagency Working Group:

Secretary Hazel O'Leaiy, Department of Energy

Secretary William Perry, Department of Defense

Attorney General Janet Reno, Department of Justice

Secretary Donna Shalala, Department of Health and Human Sen-ices

Secretary Jesse Brown. Department of Veterans Affairs

Director Alice Rivlin, Office of Management and Budget

Director John Deutch, Central Intelligence Agency

Administrator Daniel Goldin, National Aeronautics and Space Administration

On behalf of the Advisory Committee on Human Radiation Experiments, it is my
privilege to transmit to you our Final Report.

Since the Committee's first meeting in April 1994 we have been able to conduct
an intensive inquiry into the history of government-sponsored human radiation
experiments and intentional environmental releases of radiation that occurred between
1944 and 1974. We have studied the ethical standards of that time and of today and have
developed a moral framework for evaluating these experiments. Finally, we have
examined the extent to which current policies and practices appear to protect the rights
and interests of today's human subjects. This report documents our findings and makes
recommendations for your consideration.

The committee listened to the testimony of more than 200 public witnesses who
appeared before us. We are deeply grateful to all these witnesses, who overcame the
obstacles of geography and emotions to assist us.

Our work and this report would not have been possible without the extraordinary
effort the President and you put forward to open the government's records to our inquiry
and thus to the nation. We are especially pleased that, through our joint efforts, the
American people now have access to the tens of thousands of documents that bear on this
important history.

None of our conclusions came easily. We endeavored, both as individuals and as
a committee, to live up to the responsibility with which we were entrusted. This report
represents the consensus of fair-minded people who gave the best they had to offer to
their fellow citizens.

We thank President Clinton for this opportunity and for his courage and
leadership in appointing the Advisory Committee.

Ruth R. Faden

Chair, Advisory Committee

on Human Radiation Experiments

®

Printed with soy ink on recycled paper

Advisory Committee on Human Radiation Experiments

Ruth R. Faden. Ph.D.. M.RH.-Chair

Philip Franklin Wagley Professor of Biomedical Ethics and Director

The Bioethics Institute

Johns Hopkins University

Baltimore, Maryland

Senior Research Scholar

Kennedy Institute of Ethics

Georgetown University

Washington, D.C.

Kenneth R. Feinberg, J.D.

Kenneth R. Feinberg & Associates
Washington, D.C.

Eli Glatstein, M.D.

Professor and Chair
Department of Radiation Oncology
The University of Texas
Southwestern Medical Center at Dallas
Dallas, Texas

Jay Katz, M.D.

Elizabeth K. Dollard Professor Emeritus

of Law, Medicine and Psychiatry
Harvey L. Karp Professorial Lecturer in Law

and Psychoanalysis
Yale Law School
New Haven, Connecticut

Patricia A. King, J.D.

Professor of Law

Georgetown University Law Center

Washington, D.C.

Susan E. Lederer, Ph.D.

Associate Professor

Department of Humanities

The Pennsylvania State University College of Medicine

Hershey, Pennsylvania

Ruth Macklin, Ph.D.

Professor of Bioethics

Department of Epidemiology & Social Medicine

Albert Einstein College of Medicine

Bronx, New York

Nancy L. Oleinick, Ph.D.

Professor of Radiation Biochemistry

Division of Radiation Biology

Case Western Reserve University School of Medicine

Cleveland, Ohio

Henry D. Royal, M.D.

Professor of Radiology

Associate Director; Division of Nuclear Medicine

Mallinckrodt Institute of Radiology

Washington University Medical Center

St. Louis, Missouri

Philip K. Russell, M.D.

Professor, Department of International Health
Johns Hopkins University
School of Hygiene and Public Health
Baltimore, Maryland

Mary Ann Stevenson, M.D., Ph.D.

Assistant Professor of Radiation Oncology
Joint Center for Radiation Therapy
Harvard Medical School
Boston, Massachusetts

Deputy Chief

New England Deaconess Hospital
Department of Radiation Oncology
Boston, Massachusetts

Duncan C. Thomas, Ph.D.

Director, Biostatistics Division

Department of Preventive Medicine

University of Southern California School of Medicine

Los Angeles, California

Lois L. Norris

Second Vice President of Omaha National Bank
and Omaha National Corporation (Retired)
Omaha, Nebraska

Reed V. Tuckson, M.D.

President

Charles Drew University of Medicine and Science

Los Angeles, California

Advisory Committee on Human Radiation Experiments

Jeffrey Kahn

Associate Director

Dan Guttman

Executive Director

Anna Mastroianni

Associate Director

Stephen Klaidman

Director of Communications
Counselor to the Committee

Sarah Flynn

Editor

Staff*

Senior Policy and Research Analysts

Barbara Berney
James David
John Harbert
Gregg Herken
Jonathan Moreno
Ronald Neumann
Gary Stem
Jeremy Sugarman
Donald Weightman
Gilbert Whittemore

Research Analysts

Jonathan Engel
Patrick Fitzgerald
Mark Goodman
Deborah Holland
Denise Holmes
Michael Jasny
Gail Javitt
Wilhelmine Miller
Patricia Perentesis
Kathy Taylor
Sandra Thomas
Faith Weiss

Research Associates

Miriam Bowling
Praveen Fernandes
Sara Chandros Hull
Valerie Hurt
John Kruger
Ellen Lee

Shobita Parthasarathy
Noel Theodosiou

Information Services

David Saumweber, Director
Robin Cochran, Librarian
Tom Wisner, Senior Technology
Consultant

Communications and Outreach

Lanny Keller
Kristin Crotty

Committee and Staff Affairs

Jerry Garcia
Jeanne Kepper

Consultants

Jeffrey Botkin
Allen Buchanan
Gwen Davis
Gail Geller
Steve Goodman
Jon Harkness
Rebecca Lowen

Suzanne White Junod
Nancy Kass
Charles McCarthy
Monica Schoch-Spana
Patricia Stewart-Henney
John Till
E.W. Webster

*includes both full-time and part-time staff

acknowledgments

Tt

he Committee's work over the past year and a half would have been
impossible without the assistance of an extraordinary number of individuals and
groups from all corners of the United States, and beyond. We wish to express the
depth of our gratitude to the many people who assisted, informed, and advised us.

Some of these people are identified by name elsewhere in this report and
its supplemental volumes. An appendix in this volume lists the more than 200
witnesses who appeared before the Committee at our public meetings in
Washington, D.C., Cincinnati, Knoxville, San Francisco, Santa Fe, and Spokane.
The supplemental volumes identify the dozens of individuals who agreed to
formal, taped interviews in connection with the Committee's oral history projects.
We thank all these people and many more:

• The hundreds of people who contacted the Committee with information
about their own experiences or the experiences of their family members.
Many of these people shared not only their personal stories but also the
information they had collected in the course of conducting their own
research into government archives.

• The representatives of many groups whose interests coincided with the
work of the Committee. These include organizations of former subjects of
biomedical radiation experiments (and their families), downwinders,
atomic veterans, uranium miners, and workers in and around atomic
energy communities. These groups, as well, shared the accumulated
information and perspective of years of experience and research.

• The numerous professionals in fields related to our research who gave of
their time and expertise to provide information or comment on the myriad
factual, technical, and policy questions before the Committee. These
experts provided help in understanding areas ranging from military and
human rights law to the laws of the atom, from the history of the
government's use of secrecy to the history of radiation science.

• The dozens of universities and independent hospitals, located in all
regions of the country, that willingly provided us with the documents we
needed to conduct our Research Proposal Review Project.

vn

A ckn o wledgm en (s

The nearly 1,900 individuals who graciously participated in our Subject
Interview Study, and the university hospitals, veterans hospitals, and
community hospitals that permitted us to conduct the study.

The numerous chairs of institutional review boards and radiation safety
committees who were kind enough to share with us their views about the
current status of human subject protections.

Archivists at public and private libraries, universities, and research
institutions, who assisted the Committee in our search for information.

The many journalists and scholars who have previously researched and
written about the subjects covered in this report, for sharing the
knowledge and wisdom embodied in their own many years of inquiry and
reflection.

A variety of state and local agencies for sharing with the Committee the
results of their own reviews of activities that we explored.

Members of Congress and congressional staff, including the staffs of the
General Accounting Office and the Office of Technology Assessment, for
sharing the product of their own prior inquiries into many of the areas
discussed in this report.

The members of the Human Radiation Interagency Working Group, who
provided invaluable assistance. We are particularly grateful to the many
employees at the Department of Energy, the Department of Defense, the
Department of Health and Human Services, the Department of Veterans
Affairs, the National Aeronautics and Space Administration, and the
Central Intelligence Agency, who aided us in the search and retrieval of
the many thousands of documents that provide the backbone for the
Committee's review of human radiation experiments that took place
between 1944 and 1974 and the history of government requirements for
the conduct of that research. We are also grateful to the staffs of the
Nuclear Regulatory Commission and the National Archives and Records
Administration for their invaluable assistance. Many of the same people,
as well as others, also provided advice and information as we undertook
our evaluation of the conduct of research involving human subjects today.

We wish to thank both the professional and administrative members of our
staff who worked so hard and showed such dedication to our task. Their talent,
energy, and commitment provided the foundation for our work. It is impossible
to overstate our gratitude and appreciation for their extraordinary efforts.

Finally, we wish to acknowledge our indebtedness to President Clinton for
the honor he bestowed upon us when he selected us to serve on the Advisory
Committee.

Vlll

Documentary Note

In fulfilling its mandate, the Advisory Committee on Human Radiation
Experiments (ACHRE) relied on several thousand separate sources: primary and
secondary published monographs, journal articles, historical records and
manuscripts, original correspondence and surveys, interviews, specially
constructed databases, searches of public and commercial databases, and
documentary films. Only a fraction of these, however, is represented in the final
report. More extensive information may be found in the supplemental volume
Sources and Documentation, which contains a full account of the ACHRE
research program, a finding aid to the complete research document collection, a
bibliography of published sources used, an index to significant documents and
identified experiments, and other auxiliary materials. Further information both
about the sources used by the Advisory Committee generally and about the
particular sources cited in this volume should be sought there.

The unpublished documents referenced in this report are identified by
their places in the ACHRE Research Document Collection. These identifiers, or
ACHRE document numbers, have four parts: originating institution, date of
receipt, order of receipt, and document number. For example, DOE-05 1094-A-
123 is the 123d document described in the first ("A") Department of Energy
("DOE") shipment (or accession) received on May 10, 1994 ("051094"). One of
the appendices, A Citizen's Guide to the Nation's Archives, provides instructions
for using references to the ACHRE collection to find documents there and in the
collections of the National Archives and at the agencies.

IX

FINAL REPORT

Preface

Un January 15, 1994, President Clinton created the Advisory Committee
on Human Radiation Experiments in response to his concern about the growing
number of reports describing possibly unethical conduct of the U.S. government,
and institutions funded by the government, in the use of, or exposure to, ionizing
radiation in human beings at the height of the Cold War. He directed us to
uncover the history of human radiation experiments and intentional environmental
releases of radiation; to identify the ethical and scientific standards for evaluating
these events; and to make recommendations to ensure that whatever wrongdoing
may have occurred in the past cannot be repeated.

The Advisory Committee is composed of fourteen members: a citizen
representative and thirteen experts in bioethics, radiation oncology and biology,
epidemiology and statistics, public health, history of science and medicine,
nuclear medicine, and law. We report to a Cabinet-level group convened by the
President (the Human Radiation Interagency Working Group), whose members
are the secretaries of defense, energy, health and human services, and veterans
affairs; the attorney general; the administrator of the National Aeronautics and
Space Administration; the director of the Central Intelligence Agency; and the
director of the Office of Management and Budget.

On April 21, 1994, at the end of the first day of our opening meeting,
President Clinton invited us to the White House to personally communicate his
commitment to the process we were about to undertake. He urged us to be fair,
thorough, and unafraid to shine the light of truth on this hidden and poorly
understood aspect of our nation's past. Our most important task, he said, was to
tell the full story to the American public. At the same time, we were also to
examine the present, to determine how the conduct of human radiation research
today compares with that of the past and to assess whether, in the light of this
inquiry, changes need to be made in the policies of the federal government to
better protect the American people. This report and the accompanying

1

Preface

supplemental volumes constitute the Committee's attempt to tell the story of the
past and to report on our inquiry into the present.

WHY THE COMMITTEE WAS CREATED

Past research with human subjects, including human radiation research,
has been a source of life-saving knowledge. Research involving human subjects
continues to be essential to the progress of medical science, since most advances
in medicine must at some point in their development be tested in human subjects.
Every one of us who has been either a patient or a loved one of a patient has
benefited from knowledge gained through research with human subjects. But
medical science, like all science, does not proceed or progress without the taking
of risks. In medical research, these risks often fall on the human subject, who
sometimes does not stand to benefit personally from the knowledge gained. This
is the source of the moral tension at the core of the enterprise of research
involving human subjects. In order to secure important collective goods-
scientific knowledge and advances in medicine-individuals are put in harm's
way. The moral challenge is how to protect the rights and interests of these
individuals while enabling and encouraging the advancement of science.

The Committee had its origins when public controversy developed
surrounding human radiation experiments that were conducted half a century
ago. In November 1993, the Albuquerque Tribune published a series of articles
that, for the first time, publicly revealed the names of Americans who had been
injected with plutonium, the man-made material that was a key ingredient of the
atom bomb. Reporter Eileen Welsome put a human face to what had previously
been anonymous data published in official reports and technical journals. As
World War II was ending, she wrote, doctors in the United States injected a
number of hospitalized patients with plutonium, very likely without their
knowledge or consent. The injections were part of a group of experiments to
determine how plutonium courses through the human body. The experiments,
and the very existence of plutonium, were shrouded in secrecy. They were
conducted at the direction of the U.S. government, with the assistance of
university researchers in Berkeley, Chicago, and Rochester (New York), with the
expectation that the information gained could be used to limit the hazards to the
thousands of workers laboring to build the bomb.

On reading the articles, Secretary of Energy Hazel O'Leary expressed
shock, first to her staff, and then in response to a question posed at a press
conference. She was particularly concerned because the Department of Energy
had its earliest origins in the agencies responsible for building the atomic bomb
and sponsoring the plutonium experiments. During the Cold War, these agencies
had continued to do much of their work in the twilight zone between openness
and secrecy. Now, the Cold War was over. The time had come, Secretary

Preface

O'Leary determined, to make public anything that remained to be told about the
plutonium experiments.

Subsequent press reports soon noted that the plutonium injections were
not the only human radiation experiments that had been conducted during the war
and the decades that followed. In Massachusetts, the press reported that members
of the "science club" at the Fernald School for the Retarded had been fed oatmeal
containing minute amounts of radioactive material. In Ohio, news articles revived
an old controversy about University of Cincinnati researchers who had been
funded by the Defense Department to gather data on the effects of "total-body
irradiation" on cancer patients. In the Northwest, the papers retold the story of
Atomic Energy Commission funding of researchers to irradiate the testicles of
inmates in Oregon and Washington prisons in order to gain knowledge for use in
government programs. The virtually forgotten 1986 report prepared by a
subcommittee headed by U.S. Representative Edward Markey, "American
Nuclear Guinea Pigs: Three Decades of Radiation Experiments on U.S.
Citizens," was also recalled to public attention.1

Coincidentally, the fact that the environment had also been used as a
secret laboratory became a subject of controversy. A November 1993
congressional report uncovered thirteen cases in which government agencies had
intentionally released radiation into the environment without notifying the
affected populations.2 At various times, tests were conducted in Tennessee, Utah,
New Mexico, and Washington state. This report had been prepared at the request
of Senator John Glenn in his capacity as chair of a committee that had undertaken
a comprehensive oversight investigation of the nuclear weapons complex. As a
young marine in 1945, the senator was in a squadron being trained for possible
deployment to Japan when the atomic bomb ended the war; as an astronaut, he
had been the subject of constant testing and medical monitoring by space
administration flight surgeons; as a senator he was at the center of the country's
efforts to understand and control nuclear weapons. Senator Glenn understood the
importance of national security, but he found it "inconceivable . . . that, even at
the height of the communist threat, some of our scientists and doctors and military
and perhaps political leaders approved some of these experiments to be conducted
on an unknowing and unwitting public."3

In the immediate aftermath of Secretary O'Leary's press conference and
the further press reports, thousands of callers flooded the Department of Energy's
phone lines to recount their own experiences and those of friends and family
members.

Underlying the outrage and concern expressed by government officials
and members of the public were many unanswered questions. How many human
radiation experiments were conducted? No one knew if the number was closer to
100 or 1,000. Were all the human radiation experiments done in secret, and were
any of them still secret? Are any secret or controversial studies still ongoing?

Preface

Scientists and science journalists pointed out that some of the highly publicized
experiments had long ago been the subject of technical journal articles, even press
accounts, and were old news; other commentators countered that, for most of the
public, articles in technical journals might as well be secret.

How, why, and from what population groups were subjects selected for
experiments? Some suspected that subjects were disproportionately chosen from
the most vulnerable populations-children, hospitalized patients, the retarded, the
poor—those too powerless to resist the government and its researchers.

Did the experiments benefit the American people through the
advancement of science and the enhancement of the ability to treat disease?

How many intentional releases took place, and how many people were
unknowingly put at risk? The answer here was sketchy; the releases identified in
the November 1993 Glenn report had all been performed in secret, and much
information about them was still secret.

How great were the risks to which people were exposed? Many pointed
out that radiation is not only present in our natural environment, but that, as a
result of biomedical research, most people routinely rely on radiation as a means
of diagnosing and treating disease. Others noted that while this is so, radiation
can be abused, and the potential dangers of low-level exposure are still not well
understood.

What did our government and the medical researchers it sponsored do to
ensure that the subjects were informed of what would be done to them and that
they were given meaningful opportunities to consent? Today, federal government
rules require the prior review of proposed experiments, to ensure that the risks
and potential benefits have been considered and that subjects will be adequately
informed and given the opportunity to consent. But the standards of today, many
historians and scholars of medical ethics noted, are not those of yesterday.
Others, however, declared that it was self-evident that no one should be
experimented upon without his or her voluntary consent. Indeed, it was pointed
out that this very principle was proclaimed aloud to the world in 1947, as the
plutonium experiments were coming to a close. It was the American judges at the
international war crimes trials in Nuremberg, Germany, who invoked the
principle in finding doctors guilty of war crimes for their vile experiments on
inmates of Nazi concentration camps. How could yesterday's standard have been
less strict than that of today? How, moreover, could the standard not have been
known by the government that sponsored the experiments and the researchers
who conducted them?

Finally, there were questions about how human experiments are
conducted today. Insofar as wrong things happened in the past, how confident
should we be that they could not happen again? Have practices changed? Do we
have the right rules, and are they implemented and enforced?

4

Preface
THE PRESIDENT'S CHARGE

The Advisory Committee was created under the Federal Advisory
Committee Act of 1972, which provides that committee meetings and basic
decision making be conducted in the open. The Committee's charter4 defined
human radiation experiments to include

(1) experiments on individuals involving intentional exposure to
ionizing radiation. This category does not include common and
routine clinical practices. . . .

(2) experiments involving intentional environmental releases of
radiation that (A) were designed to test human health effects of
ionizing radiation; or (B) were designed to test the extent of human
exposure to ionizing radiation.

The Committee was mandated to review experiments conducted between
1944 and 1974, the latter being the year that the U.S. Department of Health,
Education, and Welfare issued rules for the protection of human subjects of
federally sponsored research. The Committee was asked to determine the ethical
and scientific standards by which to evaluate the pre- 1974 experiments and the
extent to which these experiments were consistent with such standards. We were
also to "consider whether (A) there was a clear medical or scientific purpose for
the experiments; (B) appropriate medical follow-up was conducted; and (C) the
experiments' design and administration adequately met the ethical and scientific
criteria, including standards of informed consent, that prevailed at the time of the
experiments and that exists today." The charter also directed that, upon
completing our review, the Committee may recommend that subjects (or families)
be notified of potential health risks and the need for medical follow-up and also
that we "may recommend further policies, as needed, to ensure compliance with
recommended ethical and scientific standards for human radiation experiments."

In order to inform the public about the conduct of research involving
human subjects taking place today, we were authorized to sample and consider
examples of research with human subjects currently under way.

In essence, we were to answer several fundamental questions: (1) What
was the federal government's role in human radiation experiments conducted from
1944 to 1974? (2) By what standards should the ethics of these experiments be
evaluated? and (3) What lessons learned from studying past and present research
standards and practices should be applied to the future?

In addition, while the Committee was not expressly charged with
considering issues relating to remedies, including financial compensation, we
have felt obliged to address the type of remedies that we believe the government,

Preface

as an ethical matter, should provide to subjects of experiments where the
circumstances warranted such a response.

THE COMMITTEES APPROACH

When those of us selected by President Clinton to serve on the Committee
read about human radiation experiments in our hometown newspapers during the
1993 holiday season, none of us imagined that within months we would be
embarking on such an intense and challenging investigation of an important
aspect of our nation's past and present, requiring new insights and difficult
judgments about enduring ethical questions.

On April 2 1 and 22, 1 994, the Committee held its first meeting, and most
of us met each other for the first time. As we listened to opening statements by
Cabinet members and members of Congress, as well as the first witness from the
general public, it became clear how daunting a task we were undertaking. We
realized that our ability to reconstruct the story of past radiation experiments
required both the capacity to join with the agencies in the search through
thousands of boxes for documents and the intuition to recognize which documents
were important. We knew that the ability to tell that story depended on our ability
to understand the full range of technically complex, often emotionally charged
issues related to human radiation experiments. We could not understand, much
less tell, the story until we sought out all who could enhance our understanding, a
difficult job because the voices to which we had to listen spoke in the varied
languages of medicine, a multiplicity of scientific disciplines, the military,
policymakers, philosophers, patients, healthy subjects, family members of former
subjects, and individuals in a variety of other roles.

Finally, we were also convinced that an important determinant of our
success in keeping faith with the American people would be to understand not
only how human subject research was conducted in the past but also how it is
being conducted in the present.

Reaching In and Reaching Out

As we began our work, Committee members first sought to educate one
another. Early meetings included basic presentations on such topics as research
ethics, radiation, the history of human experimentation, the law of remedies, and
the debate over the effects of low levels of radiation.

Then we determined to search broadly for those who could contribute to
our understanding. We hired a staff with the expertise and experience need for
the Committee's myriad tasks. Finally, we sought to make ourselves available to
those who wanted to speak to us directly, especially people who felt they or their
loved ones were harmed, or might have been harmed, by human radiation-related

Preface

research or exposure. Each of the Committee's meetings reserved a period for
public comment. Since April 1994, the full Committee held sixteen public
meetings, each of two to three days' duration. Fifteen of those meetings were held
in Washington, D.C., and one was in San Francisco. In addition,; subsets of
Committee members presided over public forums in Cincinnati, Knoxville, Santa
Fe and Spokane. We traveled to these different cities in order to hear from
people who could not come to Washington, D.C., and lived in communities
where, or near where, experiments or intentional releases of interest to the
Committee had taken place. We further sought to reach out to those who could
not attend our meetings. By phone, mail, and personal visit, we and our staff
communicated with members of the public, researchers, attorneys, investigative
reporters, authors, and representatives of dozens of groups of interested people
who shared some aspect of the Committee's concern.

The Records of Our Past: The Search for Documents

One of the most difficult tasks before the Committee was determining how
many federally sponsored human radiation experiments occurred between 1944
and 1974 and who conducted them. When President Clinton established the
Committee, he also directed the Human Radiation Interagency Working Group to
provide us with all relevant documentary information in each of the agencies
files Teams were formed to identify the hundreds of government sites where
relevant documents might be located. We discovered there was no easy way to
identify how many experiments had been conducted, where they took place and
which government agencies had sponsored them. The location and retrieval of
documents thus required an extraordinary effort, and we appreciate the assistance

of all our collaborators. . , ...

We began with documents that were assembled during the 1980s and that
provided the basis for the Markey report. But review of those materials
confirmed that, even for this relatively well-known group of uexP^m^; basic
information was lacking. We found that the Department of Health ; an Humm
Services (DHHS), which is the primary government sponsor of research involving
human subjects, reported that, as permitted by federal records laws it had long
since discarded files on experiments performed decades ago. Furthermore, the
capsule descriptions of research that remained sometimes did not make clear
whether the subjects of research had been humans or animals To complicate
matters further, the DHHS also pointed out that much research documentation had
originated and been retained only in the files of nonfederal grantee institutions
and investigators. Other agencies did provide some lists of experiments, in many
cases however, there was no information on basic questions of concern (tor
example, who the subjects were and what, if anything, they were told).

What rules or policies, if any, existed to govern federally sponsored

Preface

experiments in the pre- 1974 period? The prevailing assumption was that, with a
few notable exceptions, it was not until the mid-1960s that federal agencies began
to develop such policies in any significant way. Most scholarship focused on
divisions of the (then) Department of Health, Education, and Welfare. Little was
known about approaches to human experimentation at the Atomic Energy
Commission and the Department of Defense. Yet it was clear from the outset of
our inquiry that these agencies, as well as the DHEW, were central to the story of
human radiation experiments and that many of the experiments of interest
predated by decades the mid-1960s' interest in human subject protections.

As we began our search into the past, we found that it was necessary to
reconstruct a vanished world. The Committee and the agencies had to collect
information scattered in warehouses throughout the country. At the same time,
we had to create and test the framework needed to ensure that there would be a
"big picture" into which all the pieces of the puzzle would fit.

After a few months, the outlines of a world that had been almost lost
began to reemerge. Working with the Defense Department, we discovered that
long-forgotten government entities had played central roles in the planning of
midcentury atomic warfare-related medical research and experimentation. These
groups, the piecing together of long-lost or forgotten records would show,
debated the ethics of human experimentation and discussed possible human
radiation experimentation: Similarly, working with the Department of Energy, we
pieced together the minutes, and even many transcripts, of the key medical
advisory committee to the Atomic Energy Commission. We sought to mine
agency histories, when th£y existed: for example, at the Committee's request, the
Defense Nuclear Agency (the heir to the part of the Manhattan Project that was
transferred to the Defense Department) made public portions of the more than 500
internal histories that chronicle its story, most of which had previously been
available only to those with security clearances.

Despite these successes, it became evident that the records of much of our
nation's recent history had been irretrievably lost or simply could not be located.
The Department of Energy told the Committee that all the records of the
Intelligence Division of its predecessor, the Atomic Energy Commission, had
been destroyed— mainly during the 1970s, but in some cases as late as 1989. The
CIA explained, as had been previously reported, that records of the program
known as MK.ULTRA, in which unwitting subjects were experimented upon with
a variety of substances, had been destroyed during the 1970s, when the program
became a widely publicized scandal. Though documents related to the program
referred to radiation, the CIA concluded that human experiments using ionizing
radiation never took place under that program, based on currently available
evidence.

We also turned to nongovernmental archives throughout the country.
Cryptic notes and fragments of correspondence located in private and university

8

Preface

archives were fitted into our growing outline. For example, a copy of an
important 1954 Army surgeon general research policy statement, referenced in
Defense Department documents, was found at Yale University among the papers

of a Nobel laureate. . ,

Bv the end of our term, the Committee had received, organized, and
reviewed hundreds of thousands of pages of documents from public and private
archives This collection will be available to individuals and scholars who wish
to pursue the great many stories that remain to be told, and we view this as one of
our most significant contributions.

The Records of Our Past: The Memories of the People

The Committee listened to the testimony of more than 200 public
witnesses who appeared before us. We heard from people or their family
members who had been subjects in controversial radiation experiments, including
the plutonium injections, total-body irradiation experimen ts and ex Penments
involving the use of radioactive tracers with institutionalized children. We heard
from "atomic veterans": soldiers who had been marched to ground zero at atomic
bomb tests, sailors who had walked the decks of ships contaminated by
radioactive mist, and pilots who had flown through radioactive mushroom clouds.
We also heard from their widows. We heard from people who lived "downwind
from nuclear weapons tests in Nevada and intentional releases of radioactive
material in Washington state. We heard from Navajo miners who had served the
Country in uranium mines filled with radioactive dust, from native Alaskans who
had been experimented upon by a military cold weather research . lab, and I from
Marshall Islanders, whose Pacific homeland had been contaminated by fallout
after a 1954 hvdrogen bomb test.

We heard from officials and researchers responsible for human t research
today and from those who were present at or near the dawn of the Cold War. We
heard from individuals who, on their own time, had long been seeking to piece
together the story of human radiation experiments and offered to share their
findings. We heard from scholars, from members of Congress, and from people
who wanted to bear witness for those who could no longer speak We heard from
a woman who, as a high-school student intern decades ago, attended at the
bedside while a terminally ill patient was injected with uranium and from a
powerfully spoken veteran of the nuclear weapons work force who told of the
"bodv snatching" of dead friends in the name of science.

Most important, we heard from many people who believed that something
involving the government and radiation happened to them or their loved ones
decades ago; most had been unable to find out exactly what had happened, or
whv and now they wanted to know the truth. These witnesses spoke eloquent y
of their pain, their frustration, and the reasons they do not trust the government.

Preface

Their very appearance before the Committee testified to a commitment to the
country and to the value of the nation's effort to understand its past. We are
deeply grateful to all of these witnesses, who overcame the obstacles of
geography and emotions to participate in this work.

We combined our public meetings with additional efforts to interview, and
record for the nation's archives, those who could shed light on Cold War human
radiation experiments and on the ethics of biomedical experimentation. Dozens
of interviews were conducted with former government officials responsible for
programs that included radiation research, as well as with radiation researchers.

In Mississippi we talked with a retired general who served as a military
assistant to secretaries of defense in the 1940s and 1950s; in Berkeley, we talked
with the chemist who was one of the discoverers of plutonium; in Rhode Island
we talked with the physicist who served as the link between the civilian health
and safety agencies and the Cold War military research efforts; in Florida we
talked with a pioneer in health physics, a discipline created to provide for the
safety of nuclear weapons workers; in San Francisco and Washington, D.C., we
talked to the lawyers who advised the Atomic Energy Commission at its postwar
creation; in New York we talked with the Navy radiation researcher who was
rousted from his Maryland laboratory to respond to the emergency created by the
exposure of the Marshall Islanders; in San Diego we talked with a researcher
whose own career and massive history of radiation research had covered much of
the Committee's territory.

We also launched a special effort, called the Ethics Oral History Project,
to learn from eminent physicians who were beginning their careers in academic
medicine in the 1940s and 1950s about how research with human subjects was
then conducted. The Ethics Oral History Project also included interviews with
two people who had been administrators of the National Institutes of Health
during the 1950s, since they were intimately involved with ethical and legal
aspects of research involving human subjects at the time.

We listened to all these people and more, and through their testimony, this
report is informed.

Bounds of Our Inquiry

In the course of listening to public testimony, it became clear to us that
confusion exists about what an experiment is and whether it can be distinguished
from other activities in which people are put at risk and information is gathered
about them. The biomedical community, for example, struggles with the
distinction between scientific research and related activities. In a medical setting,
it is sometimes hard to distinguish a formal experiment designed to test the
effectiveness of a treatment from ordinary medical care in which the same
treatment is being administered outside of a research project. The patient

10

Preface

receiving the treatment may discern no difference between the two but the
Sn is relevant to questions of ethics. The physician-investigator may face
conflicts between the obligation to do what is best for each individual patient .and
the requirements of scientific research, whereas the physician involved only in
clinical care has a responsibility solely to the patient.

Similarly, in an occupational setting in which employees are put at risk, it
is often difficult to distinguish formal scientific efforts to study effects on the
health of employees fromroutine monitoring of employees exposure to hazards
in the work place for purposes of ensuring worker safety. In the first case, the
r^les of research ethics apply; in the second they do not. And yet here too, the
worker may discern no difference between the two activities. A further
complication for the Committee to consider was the fact that research in
occupational settings rarely takes the form of a classic experiment, in which the
investigator controls the variable under study and then randomly assigns subjects
to be in the "treatment" or "control" group. Instead, most occupational research
employs observational and statistical methods, drawing most heavily from the
field of epidemiology. These distinctions were unimportant, however to Mhe
representatives of atomic veterans, uranium miners, and residents of the Marshall
Islands, who told us of their belief that they, or those they spoke for, were

subjects of research. j-„*:„„

The Committee struggled with how strictly to define human radiation
experiments for purposes of our inquiry. There is no sin gle clear definition of an
experiment that is widely subscribed to by every member of the biomedical
community. Even our description above of a classic experiment is open to
contest Today, as well as in the past, the scientific community has rarely
employed the term experiment in discussions of biomedical research; other terms,
not necessarily synonymous-such as clinical study, clinical investigation, quasi
Zeriment, and case control study--** all used. We concluded that it was not
possible to interpret our charge by stipulating an artificial definition of human
radiation experiment. Instead, in keeping with the realities of bl0™e?ical
research, we decided to interpret our charge broadly, as including both research
involving human subjects in which the research design called for exposing
subjects to ionizing radiation and research designed to study the effects of
radiation exposure resulting from nonexpenmental activities.

This latter category includes the research involving uranium miners and
Marshall Islanders. In these cases we quickly determined that it was in some
respects impossible to isolate the ethical questions raised by the research from the
ethics of the context in which the research was conducted. A centra issue was
the exposure of people to risk, regardless of whether they were clearly understood
to be subjects of research. This characterization is true, as well, of the experience
of atomic veterans. As a consequence, we considered events that might be said to
be on the boundary between research and some other activity. Our inquiry

11

Preface

underscored the importance for social policy of the need to keep focused on
questions of risk and well-being regardless of what side of that boundary the
activity producing the risk falls.

Human Experimentation Today

In tandem with the reconstruction of the past, we undertook three projects
to examine the current state of human radiation experiments.

First, we studied how each agency of the federal government that
currently conducts or funds research involving human subjects regulates this
activity and oversees it. We surveyed what the operative rules are, how they are
implemented, and how they are enforced.

Second, from among the very large number of research projects involving
human subjects currently supported by the federal government, we randomly
selected 125 research projects for scrutiny by the Committee. For each of these
projects, we reviewed all available relevant documentation to assess how well it
appeared the rights and interests of the subjects participating in these projects
were being protected. The success of this review required the cooperation of
private research institutions all over the country, on whom we were dependent for
access to important documents. We had expected that perhaps no more than half
of those asked to cooperate would agree to do so, but with little hesitation, all of
the research centers that we approached agreed to cooperate.

Third, to learn from the subjects themselves, the Committee interviewed
almost 1,900 patients receiving medical care in outpatient facilities of private and
federal hospitals throughout the country. We asked patients about their attitudes
toward medical research with human subjects and about the meaning they attach
to the different terms used to explain medical research to potential subjects. We
ascertained, and attempted to verify, how many of these patients were currently or
ever had been subjects of research. Patient-subjects were asked about their
reasons for agreeing to join research projects; patients who reported having
refused offers to enter research projects were asked why they had decided against
participating.

In all three of these projects, we focused not only on human radiation
experiments but on human research generally. In critical (but not all) respects,
the government regulations that apply to human radiation research do not differ
from those that govern other kinds of research involving human subjects.
Moreover, the underlying ethical principles that should guide the conduct of
research are identical, whether one is considering human radiation research or all
research with human subjects. Finally, the Committee hoped to learn whether, in
practice, there are any differences between the conduct of radiation and
nonradiation experiments.

12

Preface
LESSONS FROM HISTORY: LOOKING TO THE FUTURE

What we have found is a story about the government's attempt to serve
two critical purposes: safeguarding national security and advancing medical
knowledge. One-half century ago, the U.S. government and its experts in the
fields of radiation and medicine were seeking to learn more about radiation in
order to protect workers, service personnel, and the general public against
potential atomic war and individuals against the menace of disease.

Toward these laudable ends, the government used patients, workers,
soldiers, and others as experimental subjects. It acted through the experts to
whom we regularly entrust the well-being of our country and our selves: elected
officials, civil servants, generals, physicians, and medical researchers.

Moreover, the government acted with full knowledge that the use of
individuals to serve the ends of government raises basic ethical questions. If, as
we look back, there could be doubt about the importance of the matter to the
leaders of the time, we need only look to the appearance before the U.S. Senate of
David Lilienthal, who had been nominated to serve as the first chairman of the
Atomic Energy Commission, the civilian successor to the Manhattan Project and
the predecessor to today's Department of Energy. In his testimony, Lilienthal
forcefully stated:

... all Government and private institutions must be
designed to promote and protect and defend the
integrity and the dignity of the individual. . . . Any
forms of government . . . which make men means
rather than ends in themselves ... are contrary to
this conception; and therefore I am deeply opposed
to them. . . . The fundamental tenet of communism
is that the state is an end in itself, and that therefore
the powers which the state exercises over the
individual are without any ethical standards to limit
them. This I deeply disbelieve.6

What did happen when individuals were sometimes used as means to
achieve national goals? How well were the national goals of preserving the peace
and advancing medical science reconciled with the equally important end of
respect for individual dignity and health? What rules were followed to protect
people, and how well did they work? Was the public let in on the balancing of
collective and individual interest? In what sense did the public, in general, and
individuals, in particular, know what was happening and have the opportunity to
provide their meaningful consent?

In this report we try to convey our understanding of how, when only good

13

Preface

was sought, when its pursuit was entrusted to the experts on whom we most
relied, and when missions were substantially accomplished, distrust, as well as
accomplishment, remains.

We focus on the ways in which the government and its experts recognized
the interest of individual dignity and sought to strike a balance with the national
interests being pursued. We focus equally on the extent to which the public was
privy to this balancing. In particular, we try to show how individuals'
understanding and participation were limited by the conjunction of government
secrecy and expert knowledge.

All Americans should experience immense satisfaction in the strides that
have been made toward accomplishing both our national security and our medical
research goals. However, as attested to by the many thousands of letters and calls
that led to the Committee's creation, and the eloquent statements of the witnesses
who appeared before us, this pride is diluted by a bitter aftertaste-distrust by
many Americans of the federal government and those who served it.

The government has the power to create and keep secrets of immense
importance to us all. Secret keeping is a part of life. Secret keeping by the
government may be in the national interest. However, if government is to be
trusted, it is important to know, at the very least, the basic rules of secrecy and to
know that they are reasonable and that they are being followed.

Similarly, experts, by training and experience, have knowledge that
individual people must, as a practical matter, rely on. However, legitimate
questions arise when experts wear multiple hats or when they are relied on in
areas beyond their expertise.

Where official secrecy is coupled with expert authority, and both are
focused on a public that is not privy to secrets and does not speak the languages
of experts, the potential for distrust is substantial.

In telling the story, and asking the questions, we have kept our eyes open
for ways in which lost trust can be restored. It might be presumed that the past
we report on here is so different from the present that it will be of little use in
understanding research involving human subjects today. In fact, as we shall see,
basic questions posed by the story of human radiation experiments conducted
during the 1944-1974 period are no less relevant today. Then, as now, there were
standards; the question is how they worked to protect individuals and the public.
Then, as now, the ethical impulse was complexly alloyed with concerns for legal
liability and public image. Then, as now, the most difficult questions often
concerned the scope and practical meaning of ethical rules, rather than their
necessity. The country has come to recognize, from its experience of the past half
century, that tinkering with the regulations that govern publicly supported
institutions, imposing ethical codes on experts, and altering the balance between
secrecy and openness are important but not always sufficient means of reform.
The most important element is a citizenry that understands the limits of these

14

Preface

activities. That is why the purpose of this story is not simply to leam which
changes to make in rules or policies that apply to government or professionals,
but to begin to learn something more about how the Cold War world worked, as
the most important means to making the world of tomorrow work better.

HOW THIS REPORT IS ORGANIZED

Though this report is addressed largely to those who can affect future
policy in light of the information the Advisory Committee has gathered,
specifically the Human Radiation Interagency Working Group, it has been written
in such a way that it should be accessible to a wide range of interested readers.

We begin with an introduction, titled "The Atomic Century," which
describes the intersection of several developments: the birth and remarkable
growth of radiation science; the parallel changes in medicine and medical
research; and the intersection of these changes with government programs that
called on medical researchers to play important new roles beyond that involved in
the traditional doctor-patient relationship. The introduction concludes with a
section titled "The Basics of Radiation Science" for the lay reader.

The remainder of the text is divided into four parts. Each part is preceded
by an overview.

Part I, "Ethics of Human Subjects Research: A Historical Perspective,"
which contains four chapters, explores how both federal government agencies and
the medical profession approached human experimentation in the period 1944
through 1974. We begin with the story of the principles stated at midcentury at
the highest levels of the Cold War medical research bureaucracies and what we
have ascertained about whether these principles were translated into federal rules
or requirements. We then turn to the norms and practices engaged in at the time
by medical researchers themselves. It is in this chapter that we report the results
of our Ethics Oral History Project. In chapter 3, we review the development of
formal and public regulations concerning research involving human subjects in
the 1960s and 1970s. In the last chapter in part I we present our framework for
evaluating the ethics of human radiation experiments, grounded in both history
and philosophical analysis.

Part II, "Case Studies," approaches particular experiments from several
angles, each of which raises overlapping ethical questions. The chapters on the
plutonium injections and total-body irradiation consider the use of sick patients to
provide data needed to protect the health of workers engaged in the production of
nuclear weapons; the chapter on prisoners considers the use of healthy subjects
for this purpose; the chapter on children considers experimentation with
particularly vulnerable people; and the chapter on the AEC program of
radioisotope distribution considers the institutional safeguards that underlay the
conduct of thousands of human radiation experiments. The chapters on

15

Preface

intentional releases, atomic veterans, and observational studies consider, in
common, situations in which entire groups of people were exposed to risk as a
consequence of government-sponsored Cold War programs. The section
concludes with a review of the degree to which secrecy impaired, and may still
impair, our ability to understand human radiation experiments and intentional
releases conducted in the 1944-1974 period.

Part III, "Contemporary Projects," reports the findings of our three
inquiries into the present. We begin by describing what we have learned about
how the different federal agencies that sponsor human research regulate and
oversee this activity. Next, we report the results of our Research Proposal
Review Project, followed by the results of our Subject Interview Study. Part III
concludes with the Committee's synthesis of the implications of the results of all
three of these projects for the current state of human subject research.

Part IV, "Coming to Terms with the Past, Looking Ahead to the Future,"
reports the Committee's findings and recommendations.

A FINAL NOTE

The Committee's findings and recommendations represent our best efforts
to distill almost eighteen months of inquiry into, debate about, and analysis of
human radiation experiments. But what they cannot fully express is the
appreciation we developed for how much damage was done to individuals and to
the American people during the period we investigated and how this damage
endures today. The damage we speak of here is not physical injury, although this
too did occur in some cases. Rather, the damage is measured in the pain felt by
people who believe that they or their loved ones were treated with disrespect for
their dignity and disregard for their interests by a government and a profession in
which they had placed their trust. It is measured in a too-often cynical citizenry,
some of whom have lost faith in their government to be honest brokers of
information about risks to the public and the purposes of government actions.
And it is measured in the confusion among patients that remains today about the
differences between medical research and medical care— differences that can
impede the ability of patients to determine what is in their own best interest.

In the period that we examined, extraordinary advances in biomedicine
were achieved and a foundation was laid for fifty years without a world war. At
the same time, however, it was a time of arrogance and paternalism on the part of
government officials and the biomedical community that we would not under any
circumstances wish to see repeated.

As we listened to the heart-rending testimony of many public witnesses,
we came to feel great sorrow about the suffering they described. Our most
difficult task was determining what to recommend as the appropriate national
response to these emotions and the events that stimulated them. What can best

16

Preface

precipitate the healing of wounds and the restoration of trust? Appropriate
remedies for those who were wronged or harmed were of critical importance, but
remedies alone speak only to the past, not the future. It is equally important that,
the historical record having been spelled out and appropriate remedies identified,
we as a nation move forward and take action to prevent similar occurrences from
happening in the future. In the end, if trust in government is to be restored, those
in power must always act in good faith in their dealings with the citizenry. At the
same time, however, we must recognize that unless we have expectations of
honesty and fairness from our government and unless we are vigilant in holding
the government to those expectations, trust will never be restored.

Finally, we hope that this report conveys the sense of gratitude and honor
that we experienced as citizens serving on the Advisory Committee. We were
provided by the President with extraordinary access to the records of our past and
given complete liberty to deliberate on what we found. Although some of what
we report is a matter for national regret, our freedom of inquiry, and the
cooperation we received from officials and fellow citizens of all perspectives,
confirms that our nation's highest traditions are not things of the past but live very
much in the present.

17

ENDNOTES

1 . U.S. House of Representatives, Committee on Energy and Commerce,
Subcommittee on Energy Conservation and Power, November 1986, "American Nuclear
Guinea Pigs: Three Decades of Radiation Experiments on U.S. Citizens" (ACHRE No.
CON-050594-A-1).

2. U.S. Senate, Committee on Governmental Affairs, 1 1 November 1993,
"Nuclear Health and Safety: Examples of Post World War II Radiation Releases at U.S.
Nuclear Sites," GAO/RCED-94-51-FS (ACHRE No. CON-042894-A-4).

3. Advisory Committee on Human Radiation Experiments, proceedings of 21
April 1994, transcript, 112-113.

4. The full text of the Committee's charter appears at the end of this report. See
table of contents for page number.

5. For further information on access to this collection, see "A Citizen's Guide to
the Nation's Archives" at the end of this report.

6. David E. Lilienthal, The Journals of David E. Lilienthal: 1945-1950, 2 vols.
(New York: Harper and Row, 1964), as quoted in David McCullough, Truman (New
York: Simon and Schuster, 1992), 537-538.

18

INTRODUCTION

The Atomic Century

One hundred years ago, a half century before the atomic bombing of
Hiroshima and Nagasaki, the discovery of x rays spotlighted the extraordinary
promise, and peril, of the atom. From that time until 1942, atomic research was in
private hands. The Second World War and the Manhattan Project, which planned
and built the first atomic bombs, transformed a cottage industry of researchers
into the largest and one of the most secretive research projects ever undertaken.
Scientists who had once raced to publish their results learned to speak in codes
accessible only to those with a "need to know." Indeed, during the war the very
existence of the man-made element plutonium was a national secret.

After the war's end, the network of radiation researchers, government and
military officials, and physicians mobilized for the Manhattan Project did not
disband. Rather, they began working on government programs to promote both
peaceful uses of atomic energy and nuclear weapons development.

Having harnessed the atom in secret for war, the federal government
turned enthusiastically to providing governmental and nongovernmental
researchers, corporations, and farmers with new tools for peace-radioisotopes-
mass-produced with the same machinery that produced essential materials for the
nation's nuclear weapons. Radioisotopes, the newly established Atomic Energy
Commission (AEC) promised, would create new businesses, improve agricultural
production, and through "human uses" in medical research, save lives.

From its 1947 creation to the 1974 reorganization of atomic energy
activities, the AEC produced radioisotopes that were used in thousands of human
radiation experiments conducted at universities, hospitals, and government
facilities.' This research brought major advances in the understanding of the

19

Introduction

workings of the human body and the ability of doctors to diagnose, prevent, and
treat disease.

The growth of radiation research with humans after World War II was part
of the enormous expansion of the entire biomedical research enterprise following
the war. Although human experiments had long been part of medicine, there had
been relatively few subjects, the research had not been as systematic, and there
were far fewer promising interventions than there were in the late 1940s.

With so many more human beings as research subjects, and with
potentially dangerous new substances involved, certain moral questions in the
relationship between the physician-researcher and the human subject—questions
that were raised in the nineteenth century-assumed more prominence than ever:
What was there to protect people if a researcher's zeal for data gathering
conflicted with his or her commitment to the subjects' well-being? Was the age-
old ethical tradition of the doctor-patient relationship, in which the patient was to
defer to the doctor's expertise and wisdom, adequate when the doctor was also a
researcher and the procedures were experimental?

While these questions about the role of medical researchers were fresh in
the air, the Manhattan Project, and then the Cold War, presented new ethical
questions of a different order.

In March 1946, former British Prime Minister Winston Churchill told an
audience in Fulton, Missouri, that an "iron curtain" had descended between
Eastern and Western Europe—giving a name to the hostile division of the
continent that had existed since the end of World War II. By the following year.
Cold War was the term used to describe this state of affairs between the United
States and its allies on the one hand and the Soviet bloc on the other. A quick
succession of events underscored the scope of this conflict, as well as the stakes
involved: In 1948 a Soviet blockade precipitated a crisis over Berlin; in 1949, the
American nuclear monopoly ended when the Soviet Union exploded its first
atomic bomb; in 1950, the Korean War began.

The seeming likelihood that atomic bombs would be used again in war,
and that American civilians as well as soldiers would be targets, meant that the
country had to know as much as it could, as quickly as it could, about the effects
of radiation and the treatment of radiation injury.

This need for knowledge put radiation researchers, including physicians,
in the middle of new questions of risk and benefit, disclosure and consent. The
focus of these questions was, directly and indirectly, an unprecedented public
health hazard: nuclear war. In addressing these questions, medical researchers
had to define the new roles that they would play.

As advisers to the government, radiation researchers were asked to assist
military commanders, who called for human experimentation to determine the
effects of atomic weapons on their troops. But these researchers also knew that
human experimentation might not readily provide the answers the military
needed.

20

The Atomic Century

As physicians, they had a commitment to prevent disease and heal. At the
same time, as government advisers, they were called upon to participate in
making decisions to proceed with weapons development and testing programs
that they knew could put citizens, soldiers, and workers at risk. As experts they
were asked to ensure that the risks would not be excessive. And as researchers
they saw these programs as an opportunity for gathering data.

As researchers, they were often among the first to volunteer to take the
risks that were unavoidable in such research. But the risks could not always be
disclosed to members of the public who were also exposed. In keeping with the
tradition of scientific inquiry, these researchers understood that their work should
be the subject of vigorous discussion, at least among other scientists in their field.
But, as government officials and advisers, they understood that their public
statements had to be constrained by Cold War national security requirements, and
they shared in official concern that public misunderstanding could compromise
government programs and their own research.

Medical researchers, especially those expert in radiation, were not
oblivious to the importance of the special roles they were being asked to play.
"Never before in history," began the 1949 medical text Atomic Medicine, "have
the interests of the weaponeers and those who practice the healing arts been so
closely related."2 This volume, edited by Captain C. F. Behrens, the head of the
Navy's new atomic medicine division, was evidently the first treatise on the topic.
It concluded with a chapter by Dr. Shields Warren, the first chief of the AEC's
Division of Biology and Medicine, who would become a major figure in setting
policy for postwar biomedical radiation research. While the atomic bomb was not
"of medicine's contriving," the book began, it was to physicians "more than to any
other profession" that atomic energy had brought a "bewildering array of new
problems, brilliant prospects, and inescapable responsibilities." The text, a
prefatory chapter explained, treats "not of high policy, of ethics, of strategy or of
international control [of nuclear materials], as physicians these matters are not for
us."3 Yet what many readers of Atomic Medicine could not know in 1949 was
that Behrens, along with Warren and other biomedical experts, was already
engaged in vigorous but secret discussions of the ethics underlying human
radiation experiments. At the heart of these discussions lay difficult choices at
the intersection of geopolitics, science, and medicine that would have a
fundamental impact on the federal government's relationship with the American
people.

This chapter provides a brief survey of the development of radiation
research and the changing roles of the biomedical researcher, from the discovery
of x rays by a single individual to the complex world of government-sponsored
human radiation experimentation. Finally, at the end of this chapter, an aid to the
reader titled "The Basics of Radiation Science" provides information needed to
understand technical concepts in this report.

21

Introduction

BEFORE THE ATOMIC AGE: "SHADOW PICTURES,"
RADIOISOTOPES, AND THE BEGINNINGS OF HUMAN
RADIATION EXPERIMENTATION

Radiation has existed in nature from the origins of the universe, but was
unknown to man until a century ago. Its discovery came by accident. On a
Friday evening, November 8, 1895, the German physicist Wilhelm Roentgen was
studying the nature of electrical currents by using a cathode ray tube, a common
piece of scientific equipment. When he turned the tube on, he noticed to his
surprise that a glowing spot appeared on a black paper screen coated with
fluorescent material that was across the room. Intrigued, he soon determined that
invisible but highly penetrating rays were being produced at one end of the
cathode ray tube. The rays could expose photographic plates, leaving shadows of
dense objects, such as bone.

After about six weeks of experimenting with his discovery, which he
called x rays, Roentgen sent a summary and several "shadow pictures" to a local
scientific society. The society published the report in its regular journal and
wisely printed extra copies. News spread rapidly; Roentgen sent copies to
physicists throughout Europe. One Berlin physicist "could not help thinking that
I was reading a fairy tale . . . only the actual photograph proved to everyone that
this was a fact."4

Physicians immediately recognized these rays as a new tool for diagnosis,
a window into the interior of the body. The useless left arm of German Emperor
Wilhelm II was x-rayed to reveal the cause of his disability, while Queen Amelia
of Portugal used x rays of several of her court ladies to vividly display the
dangers of "tightlacing."5 Physicians began to use x rays routinely for examining
fractures and locating foreign objects, such as needles swallowed by children or
bullets shot into adults.6 During World War I, more than 1.1 million wounded
soldiers were treated with the help of diagnostic x rays.7

In 1 896, Roentgen's insight led to the discovery of natural radioactivity.
Henri Becquerel, who had been studying phosphorescence, discovered that
shadow pictures were also created when wrapped photographic plates were
exposed to crystals partly composed of uranium. Could this radioactive property
be concentrated further by extracting and purifying some as-yet-unknown
component of the uranium crystals? Marie and Pierre Curie began laborious
chemical analyses that led to the isolation of the element polonium, named after
Marie's native Poland.8 Continuing their work, they isolated the element radium.
To describe these elements' emission of energy, they coined the word radio-
activity!'

As with x rays, popular hopes and fears for natural radioactivity far
exceeded the actual applications. One 1905 headline captures it all: "Radium, as
a Substitute for Gas, Electricity, and as a Positive Cure for Every Disease."10

22

The Atomic Century

Following initial enthusiasm that radiation could, by destroying tumors, provide a
miracle cure for cancer, the reappearance of irradiated tumors led to
discouragement. Despite distressing setbacks, research into the medical uses of
radiation persisted. In the 1920s French researchers, performing experiments on
animals, discovered that radiation treatments administered in a series of
fractionated doses, instead of a single massive dose, could eliminate tumors
without causing permanent damage. With the new method of treatment, doctors
began to report impressive survival rates for patients with a variety of cancers.^
Fractionation became, and remains, an accepted approach to cancer treatment.

Along with better understanding of radiation's benefits came a better
practical appreciation of its dangers. Radiation burns were quickly apparent, but
the greater danger took longer to manifest itself. Doctors and researchers were
frequently among the victims. Radiation researchers were also slow to take steps
to protect themselves from the hidden danger. One journal opened its April 1914
issue by noting that "[w]e have to deplore once more the sacrifice of a radiologist,
the victim of his art."12

Clear and early evidence of tragic results sharpened both expert and public
concern. By 1924, a New Jersey dentist noticed an unusual rate of deterioration
of the jawbone among local women. On further investigation he learned that all
at one time had jobs painting a radium solution onto watch dials. Further studies
revealed that as they painted, they licked their brushes to maintain a sharp point.
Doing so, they absorbed radium into their bodies. The radium gradually revealed
its presence in jaw deterioration, blood disease, and eventually, a painful,
disfiguring deterioration of the jaw.13 There was no question that radium was the
culprit. The immediate outcome was a highly publicized crusade, investigation,
lawsuits, and payments to the victims. Despite the publicity surrounding the dial
painters, response to the danger remained agonizingly slow. Patent medicines
containing radium and radium therapies continued.14

The tragedy of the radium dial painters and similar cases of patients who
took radium nostrums have provided basic data for protection standards for
radioactive substances taken into the body. One prominent researcher in the new
area of radiation safety was Robley Evans. Evans was drawn into the field by the
highly publicized death in 1932 of Eben Byers, following routine consumption of
the nostrum Radiothor. Byers's death spurred Evans, then a California Institute of
Technology physics graduate student, to undertake research that led to a study of
the effects on the body of ingesting radium; this study would continue for more
than half a century.15

Evans's study and subsequent studies of the effects of radium treatments
provided the anchor in human data for our understanding of the effects of
radiation within the human body. As the dangers of the imprudent use of x rays
and internal radiation became clear, private scientific advisory committees sprang
up to develop voluntary guidelines to promote safety among those working with
radiation. When the government did enter the atomic age, it often referred to the

23

Introduction

guidelines of these private committees as it developed radiation protection
standards."'

The Miracle of Tracers

In 1913, the Hungarian chemist Georg von Hevesy began to experiment
with the use of radioactive forms of elements (radioisotopes) to trace the behavior
of the normal, nonradioactive forms of a variety of elements. Ten years later
Hevesy extended his chemical experiments to biology, using a radioisotope of
lead to trace the movement of lead from soil into bean plants. In 1943, Hevesy
won the Nobel Prize for his work on the use of radioisotopes as tracers.

Previously, those seeking to understand life processes of an organism had
to extract molecules and structures from dead cells or organisms, and then study
those molecules by arduous chemical procedures, or use traceable chemicals that
were foreign to the organism being studied but that mimicked normal body
chemicals in some important way. Foreign chemicals could alter the very
processes being measured and, in any case, were often as difficult to measure
precisely as were normal body constituents. The radioactive tracer— as Our
Friend the Atom, a book written by Dr. Heinz Haber for Walt Disney productions,
explained in 1956 to readers of all ages—was an elegant alternative: "Making a
sample of material mildly radioactive is like putting a bell on a sheep. The
shepherd traces the whole flock around by the sound of the bell. In the same way
it is possible to keep tabs on tracer-atoms with a Geiger counter or any other
radiation detector."17

By the late 1920s the tracer technique was being applied to humans in
Boston by researchers using an injection of dissolved radon to measure the rate of
blood circulation, an early example of using radioactivity to observe life
processes.18 However, research opportunities were limited by the fact that some
of the elements that are most important in living creatures do not possess
naturally occurring radioactive isotopes.

The answer to this problem came simultaneously at faculty clubs and
seminars in Berkeley and Boston in the early 1930s. Medical researchers realized
that the famed "atom smasher," the cyclotron invented by University of California
physicist Ernest Lawrence, could be used as a factory to create radioisotopes for
medical research and treatment. "Take an ordinary needle," Our Friend the Atom
explained, "put it into an atomic reactor for a short while. Some of the ions
contained in the steel will capture a neutron and be transformed into a radio-
isotope of iron. . . . Now that needle could be found in the proverbial haystack
without any trouble."19

In 1936, two of Lawrence's Berkeley colleagues, Drs. Joseph Hamilton
and Robert Stone, administered radiosodium to treat several leukemia patients. In
1937, Ernest Lawrence's brother, physician John Lawrence, became the first to
use radiophosphorus for the treatment of leukemia. This application was

24

The Atomic Century

extended the following year to the treatment of polycythemia vera, a blood
disease. This method soon became a standard treatment for that disease. In 1938,
Hamilton and Stone also began pioneering work in the use of cyclotron-produced
neutrons for the treatment of cancer. The following year, not long before the war
in Europe began, Ernest Lawrence unveiled a larger atom smasher, to be used to
create additional radioisotopes and hence dubbed the "medical cyclotron."20 The
discovery that some radioisotopes deposited selectively in different parts of the
body—the thyroid, for example-inspired a spirited search for a radioactive "magic
bullet" that might treat, or even cure, cancer and other diseases.

In Cambridge, the age of "nuclear medicine" is said to have begun in
November 1936 with a lunchtime seminar at Harvard, at which MIT President
Karl Compton talked on "What Physics Can Do for Biology and Medicine."
Robley Evans, by that time at MIT, is reported to have helped prepare the portion
of the talk from which medical researchers at the Massachusetts General
Hospital's thyroid clinic came to realize that MIT's atom smasher could produce a
great research tool for their work—radioisotopes. Soon, doctors at the thyroid
clinic began a series of experiments, including some involving humans, that
would lead to the development of radioiodine as a standard tool for diagnosing
and treating thyroid disease.21

In late 1938, the discovery of atomic fission in Germany prompted
concern among physicists in England and the United States that Nazi Germany
might be the first to harness the power of the atom— as a propulsion method for
submarines, as radioactive poison, or most worrisome of all, as a bomb capable of
unimagined destruction. In the United States, a world-famous physicist, Albert
Einstein, and a recent emigre from Hungary, Leo Szilard, alerted President
Franklin D. Roosevelt to the military implications of the German discovery in an
August 1939 letter.

Assigning his own science adviser, Vannevar Bush, to the task of
determining the feasibility of an atomic bomb, Roosevelt's simple "O.K.,"
scrawled on a piece of paper, set in motion the chain of events that would lead to
the largest and most expensive engineering project in history. Soon, Ernest
Lawrence's Radiation Laboratory and its medical cyclotron were mobilized to aid
in the nationwide effort to build the world's first atomic bomb. In a related effort,
Drs. Stone and Hamilton, and others, would turn their talents to the medical
research needed to ensure the safety of those working on the bomb.

THE MANHATTAN PROJECT: A NEW AND SECRET
WORLD OF HUMAN EXPERIMENTATION

In August 1942, the Manhattan Engineer District was created by the
government to meet the goal of producing an atomic weapon under the pressure
of ongoing global war. Its central mission became known as the Manhattan
Project. Under the direction of Brigadier General Leslie Groves of the Army

25

Introduction

Corps of Engineers, who recently had supervised the construction of the
Pentagon, secret atomic energy communities were created almost overnight in
Oak Ridge, Tennessee, at Los Alamos, New Mexico, and in Hanford,
Washington, to house the workers and gigantic new machinery needed to produce
the bomb. The weapon itself would be built at the Los Alamos laboratory, under
the direction of physicist J. Robert Oppenheimer.

Plucked from campuses around the country, medical researchers came
face to face with the need to understand and control the effect upon the thousands
of people, doctors included, of radioactive materials being produced in previously
unimaginable quantities.

In November 1942 General Groves, through the intermediation of an
Eastman Kodak official, paid a call on University of Rochester radiologist
Stafford Warren. Rochester, like MIT and Berkeley, was another locale where
radiation research had brought together physicists and physicians. "They wanted
to know what I was doing in radiation. So I discussed the cancer work and some
of the other things," Warren told an interviewer in the 1960s. Then "[w]e got
upstairs and they looked in the closet and they closed the transom and they looked
out the window. . . . Then they closed and locked the door and said, 'Sit down.'"22

Soon thereafter, Dr. Warren was made a colonel in the U.S. Army and the
medical director of the Manhattan Project. As his deputy, Warren called on Dr.
Hymer Friedell, a radiologist who had worked with Dr. Stone in California. Dr.
Stone himself had meanwhile moved to the University of Chicago, where he
would play a key role in Manhattan Project-related medical research.

Initially, researchers knew little or nothing about the health effects of the
basic bomb components, uranium, plutonium, and polonium.23 But, as a secret
history written in 1946 stated, they knew the tale of the radium dial painters:

The memory of this tragedy was very vivid in the
minds of people, and the thoughts of potential
dangers of working in areas where radiation hazards
existed were intensified because the deleterious
effects of radiation could not be seen or felt and the
results of over-exposure might not become apparent
for long periods after such exposure.24

The need for secrecy, Stafford Warren later recalled, compounded the
urgency of understanding and controlling risk. Word of death or toxic hazard
could leak out to the surrounding community and blow the project's cover.25

The need to protect the Manhattan Project workers soon gave rise to a new
discipline, called health physics, which sought to understand radiation effects and
monitor and protect nuclear worker health and safety. The Project was soon
inundated with data from radiation-detection instruments, blood and urine
samples, and physical exams. The "clinical study of the personnel," Robert Stone

26

The Atomic Century

wrote in 1943, "is one vast experiment. Never before has so large a collection of
individuals been exposed to so much radiation."26 Along with these data-
gathering efforts came ethical issues.

Would disclosure of potential or actual harm to the workers, much less the
public, impair the program? For example, a July 1945 Manhattan Project memo
discussed whether to inform a worker that her case of nephritis (a kidney disease)
may have been due to her work on the Project. The issue was of special import
because, the memo indicated, the illness might well be a precursor of more cases.
The worker, the memo explained, "is unaware of her condition which now shows
up on routine physical check and urinalysis."27

As this memo showed, there was an urgent need for decisions on how to
protect the workers, while at the same time safeguard the security of the project:
"The employees must necessarily be rotated out, and not permitted to resume
further exposure. In frequent instances no other type of employment is available.
Claims and litigation will necessarily flow from the circumstances outlined."
There were also, the memo concluded, "Ethical considerations":

The feelings of the medical officers are keenly
appreciated. Are they in accordance with their
canons of ethics to be permitted to advise the
patient of his true condition, its cause, effect, and
probable prognosis? If not on ethical grounds, are
they to be permitted to fulfill their moral obligations
to the individual employees in so advising him? If
not on moral grounds, are those civilian medical
doctors employed here bound to make full
disclosure to patients under penalty of liability for
malpractice or proceeding for revocation of license
for their failure to do so?28

It is not clear what was decided in this case. However, the potential
conflict between the government doctors' duty to those working on government
projects and the same doctors' obligations to the government would not disappear.
Following the war, as we see in chapter 12, this conflict would be sharply posed
as medical researchers studied miners at work producing uranium for the nation's
nuclear weapons.

Another basic question was the extent to which human beings could or
should be studied to obtain the data needed to protect them. The radium dial
painter data served as a baseline to determine how the effects of exposures in the
body could be measured. But this left the question of whether plutonium,
uranium, and polonium behaved more or less like radium. Research was needed
to understand how these elements worked in the body and to establish safety
levels. A large number of animal studies were conducted at laboratories in

27

Introduction

Chicago, Berkeley, Rochester, and elsewhere; but the relevance of the data to
humans remained in doubt.

The Manhattan Project contracted with the University of Rochester to
receive the data on physical exams and other tests from Project sites and to
prepare statistical analyses. While boxes of these raw data have been retrieved, it
is not clear what use was made of them.29 Accidents, while remarkably few and
far between, became a key source of the data used in constructing an
understanding of radiation risk. But accidents were not predictable, and their
occurrence only enhanced the immediacy of the need to gain better data.

In 1944, the Manhattan Project medical team, under Stafford Warren and
with the evident concurrence of Robert Oppenheimer, made plans to inject
polonium, plutonium, uranium, and possibly other radioactive elements into
human beings. As discussed in chapter 5, the researchers turned to patients, not
workers, as the source of experimental data needed to protect workers. By the
time the program was abandoned by the government, experimentation with
plutonium had taken place in hospitals at the Universities of California, Chicago,
and Rochester, and at the Army hospital in Oak Ridge, and further
experimentation with polonium and uranium had taken place at Rochester.

The surviving documentation provides little indication that the medical
officials and researchers who planned this program considered the ethical
implications of using patients for a purpose that no one claimed would benefit
them, under circumstances where the existence of the substances injected was a
wartime secret. Following the war, however, the ethical questions raised by these
experiments would be revisited in debates that themselves were long kept secret.

In addition to experimentation with internally administered radioisotopes,
external radiation was administered in human experiments directed by Dr. Stone
at Chicago and San Francisco and by others at Memorial Hospital in New York
City. Once again, the primary subjects were patients, although some healthy
subjects were also involved. In these cases, the researchers may have felt that the
treatment was of therapeutic value to the patients. But, in addition to the question
of whether the patients were informed of the government's interest, this research
raised the question of whether the government's interest affected the patients'
treatment. As discussed in chapter 8, these questions would recur when,
beginning in 1 95 1 , and for two decades thereafter, the Defense Department would
fund the collection of data from irradiated patients.

Ensuring safety required more, however, than simply studying how
radioactive substances moved through and affected the human body. It also
involved studying how these substances moved through the environment. While
undetectable to the human senses, radiation in the environment is easily
measurable by instruments. When General Groves chose Hanford, on the
Columbia River in Washington state, as a site for the plutonium production
facility, a secret research program was mounted to understand the fate of
radioactive pollution in the water, the air, and wildlife.30

28

The Atomic Century

Outdoor research was at times improvisational. Years after the fact,
Stafford Warren would recall how Manhattan Project researchers had deliberately
"contaminated the alfalfa field" next to the University of Rochester medical
school with radiosodium, to determine the shielding requirements for radiation-
measuring equipment. Warren's associate Dr. Harold Hodge recalled that a
shipment of radiosodium was received by plane from Robley Evans at MIT,
mixed with water in a barrel, and poured into garden sprinklers:

We walked along and sprinkled the driveway. This
was after dark. . . . The next thing, we went out and
sprayed a considerable part of the field. ... It was
sprayed and then after a while sprayed again, so
there was a second and third application. We were
all in rubber, so we didn't get wet with the stuff . . .
then Staff [Warren] said that one of the things we
needed was to see what would be the effect on the
inside of a wooden building. So we took the end of
the parking garage, and we sprinkled that up about
as high as our shoulders, and somebody went inside
and made measurements, and we sprinkled it again.
Then we wanted to know about the inside of a brick
building, and so we sprinkled the side of the animal
house. ... I had no idea what the readings were. . . I
hadn't the foggiest idea of what we were doing,
except that obviously it was something
radioactive.31

Outdoor releases would put at risk unsuspecting citizens, even
communities, as well as workers. There were no clear policies and no history of
practice to guide how these releases should be conducted. As we explore in
chapter 1 1, this would be worked out by experts and officials in secret, on behalf
of the workers and citizens who might be affected.

THE ATOMIC ENERGY COMMISSION AND POSTWAR
BIOMEDICAL RADIATION RESEARCH

On August 6, 1945, when the atomic bomb was dropped on Hiroshima,
the most sensitive of secrets became a symbol for the ages. A week later, the
bomb was the subject of a government report that revealed to the public the uses
of plutonium and uranium.32 Immediately, debate began over the future of atomic
energy. Could it be controlled at the international level? Should it remain
entirely under control of the military? What role would industry have in
developing its potential? Although American policymakers failed to establish

29

Introduction

international control of the bomb, they succeeded in creating a national agency
with responsibility for the domestic control of atomic energy.

The most divisive question in the creation of the new agency that would
hold sway over the atom was the role of the military. Following congressional
hearings, the Atomic Energy Commission was established by the 1946 McMahon
Act, to be headed by five civilian commissioners. President Truman appointed
David Lilienthal, former head of the Tennessee Valley Authority, as the first
chairman of the AEC, which took over responsibilities of the Manhattan Engineer
District in January 1947.

Also in 1947, under the National Security Act, the armed services were
put under the authority of the newly created National Military Establishment
(NME), to be headed by the secretary of defense. In 1949 the National Security
Act was amended, and the NME was transformed into an executive department—
the Department of Defense.33 The Armed Forces Special Weapons Project, which
would coordinate the Defense Department's responsibilities in the area of nuclear
weapons, became the military heir to the Manhattan Engineer District. The
Military Liaison Committee was also established as an intermediary between the
Atomic Energy Commission and the Defense Department; it was also to help set
military requirements for the number and type of nuclear weapons needed by the
armed services.

Even before the AEC officially assumed responsibility for the bomb from
the Manhattan Project, the Interim Medical Advisory Committee, chaired by
former Manhattan Project medical director Stafford Warren, began meeting to
map out an ambitious postwar biomedical research program. Former Manhattan
Project contractors proposed to resume the research that had been interrupted by
the war and to continue wartime radiation effects studies upon human subjects.34

In May 1947, Lilienthal commissioned a blue-ribbon panel, the Medical
Board of Review, that reported the following month on the agency's biomedical
program. In strongly recommending a broad research and training program, the
board found the need for research "both urgent and extensive." The need was
"urgent because of the extraordinary danger of exposing living creatures to
radioactivity. It is urgent because effective defensive measures (in the military
sense) against radiant energy are not yet known." The board, pointing to the
AEC's "absolute monopoly of new and important tools for research and important
knowledge," noted the commensurate responsibilities-both to employees and
others who could suffer from "its negligence or ignorance" and to the scientific
world, with which it was obliged to "share its acquisitions . . . whenever security
considerations permit."35 In the fall of 1947, as recommended by the Medical
Board of Review, the AEC created a Division of Biology and Medicine (DBM) to
coordinate biomedical research involving atomic energy and an Advisory
Committee for Biology and Medicine (ACBM), which reported directly to the
AEC's chairman.36

Not surprisingly, the DBM and ACBM became gathering places for the

30

The Atomic Century

luminaries of radiation science. The ACBM was headed by a Rockefeller
Foundation official, Dr. Alan Gregg. It settled on Dr. Shields Warren, a Harvard-
trained pathologist, to serve as the first chief of the DBM. Warren, as we shall
see, would play a central role in developments related to radiation research and
human experimentation. In the 1930s, focusing on cancer research, and
influenced by the work of Hevesy and the pioneering radioisotope work being
done in Berkeley and Boston, Warren turned to the question of the effects of
radiation on animals and the treatment of acute leukemia, the "most hopeless . . .
of tumors at that time." As the war neared, Warren enlisted in the Naval Reserve.
He continued medical work for the Navy, turning down an invitation to join
Stafford Warren (no relation) on "a project . . . that he couldn't tell me anything
about [the Manhattan Project].""

While most of the AEC's budget would be devoted to highly secret
weapons development and related activities, the biomedical research program
represented the commission's proud public face. Even before the AEC opened its
doors, Manhattan Project officials and experts had laid the groundwork for a bold
program to encourage the use of radioisotopes for scientific research, especially in
medicine. This program was first presented to the broad public in a September
1946 article in the New York Times Magazine. The article began dramatically by
describing the use of "radioactive salt" to measure circulation in a crushed leg, so
that a decision on whether to amputate below or above the knee could be made.

By November 1946, the isotope distribution program was well under way,
with more than 200 requests approved, about half of which were designated for
"human uses." From the beginning, the AEC's Isotope Division at Oak Ridge had
in its program director, Paul Aebersold, a veritable Johnny Appleseed for
radioelements.39 In presentations before the public and to researchers, Aebersold,
dubbed "Mr. Isotope," touted the simplicity and low cost with which scientists
would be provided with radioisotopes: "The materials and services are made
available . . . with a minimum of red tape and under conditions which encourage
their use."40 At an international cancer conference in St. Louis in 1947, the AEC
announced that it would make radioisotopes available without cost for cancer
research and experimental cancer treatment. This, Shields Warren later recalled,
had a "tremendous effect" and "led to a revolution in the type of work done in this

field."41 c . .__,

To AEC administrators, Aebersold emphasized the benefits to the AhC s
public image: "Much of the Commission's success is judged by the public and
scientists ... on its willingness to carry out a wide and liberal policy on the
distribution of materials, information, and services," he wrote in a memo to the
AEC's general manager.42

The AEC biomedical program as a whole also provided for funding ot
cancer research centers, research equipment, and numerous other research
projects. Here, too, were advances that would save many lives. Before the war,
radiotherapy had reached a plateau, limited by the cost of radium and the inability

31

Introduction

of the machines of the time to focus radiation precisely on tumors to the exclusion
of surrounding healthy tissue. AEC facilities inherited from the Manhattan
Project could produce radioactive cobalt, a cheaper substitute for radium. As
well, the AEC's "teletherapy" program funded the development of new equipment
capable of producing precisely focused high-energy beams.43

The AEC's highly publicized peacetime medical program was not immune
to the pressures of the Cold War political climate. Even the lives of young
researchers in the AEC Fellowship Program conducting nonclassified research
were subject to Federal Bureau of Investigation review despite protests from
commission members. Congressionally mandated Cold War requirements such as
loyalty oaths and noncommunist affidavits, Chairman Lilienthal declared, would
have a chilling effect on scientific discussion and could damage the AEC's ability
to recruit a new generation of scientists.44 The reach of the law, the Advisory
Committee for Biology and Medicine agreed, was like a "blighting hand; for
thoughtful men now know how political domination can distort free inquiry into a
malignant servant of expediency and authoritarian abstraction."45 Nonetheless,
the AEC accepted the congressional conditions for its fellowship program and
determined to seek the program's expansion.46

The AEC's direct promotional efforts were multiplied by the success of
Aebersold and his colleagues in carrying the message to other government
agencies, as well as to industry and private researchers. This success led, in turn,
to new programs.

In August 1947, General Groves urged Major General Paul Hawley, the
director of the medical programs of the Veterans Administration, to address
medical problems related to the military's use of atomic energy. Soon thereafter,
Hawley appointed an advisory committee, manned by Stafford Warren and other
medical researchers. The advisers recommended that the VA create both a
"publicized" program to promote the use of radioisotopes in research and a
"confidential" program to deal with potential liability claims from veterans
exposed to radiation hazards.47 The "publicized" program soon mushroomed,
with Stafford Warren, Shields Warren, and Hymer Friedell among the key
advisers. By 1974, according to VA reports, more than 2,000 human radiation
experiments would be performed at VA facilities,48 many of which would work in
tandem with neighboring medical schools, such as the relationship between the
UCLA medical school, where Stafford Warren was now dean, and the Wadsworth
(West Los Angeles) VA Hospital.

While the AEC's weapons-related work would continue to be cloaked in
secrecy, the isotope program was used by researchers in all corners of the land to
achieve new scientific understanding and help create new diagnostic and
therapeutic tools. It was, however, only a small part of an enormous institution.
By 1951 the AEC would employ 60,000 people, all but 5,000 through contractors.
Its land would encompass 2,800 square miles, an area equal to Rhode Island and
Delaware combined. In addition to research centers throughout the United States,

32

The Atomic Century

its operations "extended] from the ore fields of the Belgian Congo and the Arctic
region of Canada to the weapons proving ground at Enewetak Atoll in the Pacific
and the medical projects studying the after-effects of atomic bombing in . . .
Japan "49 The Isotope Division, however, would employ only about fifty people
and, when reactor production time was accounted for, occupy only a fraction of
its budget and resources.50

THE TRANSFORMATION IN GOVERNMENT-SPONSORED
RESEARCH

The AEC's decision to proceed with a biomedical research program was
part of an even greater transformation, in which government continued and
expanded wartime support for research in industry and at universities. Before
World War II, biomedical research was a small enterprise in which the federal
government played a minor role. During the war, however, large numbers of
American biomedical researchers were mobilized by the armed forces. These
researchers played an important role in advancing military medicine in a wide
range of areas, including blood substitutes, antimalarial drugs and, as noted
above in nurturing the infant science of nuclear medicine.

' As the war was drawing to a close, President Roosevelt asked for advice
from his Office of Scientific Research and Development (OSRD) on how to
convert the nation's military research effort to a peacetime footing, and whether
the government should take an activist role in promoting research. The OSRD,
under Vannevar Bush, responded in July 1945, after Roosevelt's death, with a
report called "Science, the Endless Frontier." Bush and his colleagues
recommended among other things the establishment of a National Science
Foundation (NSF) to support basic research in all areas including the biomedical
sciences. While the principle that the federal government should fund medical
research came to seem self-evident, this was hardly the case at the time. In a
personal reminiscence published in 1970, Bush wrote:

To persuade the Congress of these pragmatically
inclined United States to establish a strong
organization to support fundamental research would
seem to be one of the minor miracles. We in this
country have supported well those pioneers who
have created new gadgetry for our use or our
amusement. But we have not had during our
formative years the respect for scientific endeavors,
for scholarship generally, to the extent it had been
present in Europe.51

Congress worked Bush's small miracle and passed relevant legislation, but

33

Introduction

President Harry Truman vetoed the bill. When the bill passed again, however,
Bush persuaded Truman to sign it.52

At the new AEC, and elsewhere, a key element of the support for science
was the determination to fund extramural research, that is, research outside the
agency. Prior to the war, federal support for private researchers was limited. The
Manhattan Project was only one of several wartime efforts that drew private
researchers into government service and that provided federal funds for those who
remained in private research centers. Following the war, as researchers returned
to universities, laboratories, and hospitals, the continued federal support of their
efforts transformed the relationship between government and science and the
dimensions of the scientific effort.53

During the war, the Committee on Medical Research (CMR) of the OSRD
operated entirely by funding external research. In 1 944, Congress empowered the
surgeon general of the Public Health Service to make grants to universities,
hospitals, laboratories, and individuals, which provided the legislative basis for
the postwar National Institute of Health (NIH) extramural program.54 In 1948,
Congress authorized the National Heart Institute to join the decade-old National
Cancer Institute, and NIH became the National Institutes of Health.

By the late 1960s, the annual appropriations of NIH exceeded $1 billion.55
Research involving medical uses of radioisotopes and external radiation was
among the newer fields benefiting from the increased funding. As discussed in
more detail in chapter 6, government-supported radioisotope research has proved
profoundly important in the development of techniques for medical diagnosis and
treatment.

Federal research funding has also continued to be essential to the
development of the use of external sources of radiation. For example, the crude
images made possible by Roentgen's discovery of x rays have been replaced by
higher resolution, three-dimensional pictures, such as those produced by
computerized tomographic (CT) scanning and magnetic resonance imaging
(MRI).

Today, the benefits of federally sponsored medical research are often
taken for granted. To many of those in the midst of the postwar planning and
advocacy, however, the result was not foreordained. "Fortunately," Shields
Warren recalled years later, postwar "momentum" kept AEC research budgets on
track until, in 1957, the Soviet launch of Sputnik (the first space satellite) jolted
the American people into a renewed commitment to the support of scientific
research.56

34

The Atomic Century

THE AFTERMATH OF HIROSHIMA AND NAGASAKI: THE
EMERGENCE OF THE COLD WAR RADIATION RESEARCH
BUREAUCRACY

While promoting the beneficial uses of radiation, the government also
wished to continue and expand research on its harmful effects. Three days after
the destruction of Hiroshima, Robert Stone wrote two letters to Stafford Warren's
deputy, and Stone's former student, Hymer Friedell. The first expressed hope that
the contribution of medical researchers could now be made public, so that people
would know what they had done during the war.57 The second letter described
Stone's "mixed feelings" at the success that had been achieved and his fear that
the lingering effects of radiation from the bomb had been underestimated: "I
could hardly believe my eyes," Stone wrote, "when I saw a series of news releases
said to be quoting Oppenheimer, and giving the impression that there is no
radioactive hazard. Apparently all things are relative."58

Friedell and other researchers, including Stafford Warren and Shields
Warren, soon traveled to Hiroshima and Nagasaki to begin what became an
extensive research program on survivors. The data from that project quickly
became and still remain the essential source of information on the long-term
effects of radiation on populations of human beings. It was not long, however,
before there were additional real-life data on the bomb, from postwar atomic tests.
In 1946, the United States undertook the first peacetime nuclear weapons tests at
Bikini Atoll in the Marshall Islands. Operation Crossroads, conducted before
journalists and VIPs from around the world, was intended to test the ability of a
flotilla of unmanned ships to withstand the blast. Since most of the ships
remained afloat, the Navy declared Crossroads a triumph.59

Behind the scenes, however, Crossroads medical director Stafford Warren
expressed horror at the level of contamination on the ships due to the underwater
atomic blast.60 When the ships returned to the West Coast from the Pacific, they
were extensively studied to assess the damage and contamination from the atomic
bombs. The government created the Naval Radiological Defense Laboratory
(NRDL) to study the effects of atomic bombs on ships and to design ways to
protect them. "Crossroads," according to an NRDL history, "left no doubt that
man was faced with the necessity for coping with strange and unprecedented
problems for which no solutions were available."6'

Hiroshima and Nagasaki, it now seemed, were only the beginning, not the
end, of human exposure to bomb-produced radiation. As Crossroads confirmed
with the lingering problem of contaminated ships, what the bomb did not
obliterate it might still damage by radiation over the course of days or years. It
was no longer enough to know about the effects of radioactive materials on
American nuclear weapons workers; now there was the urgent need to understand
the effects on American soldiers, sailors, and even citizens as well.

Largely invisible to the public, an ad hoc bureaucracy sprang up to

35

Introduction

address the medical and radiation research problems of atomic warfare. This
bureaucracy brought together former wartime radiation researchers, who were
joined by junior colleagues, to advise, and participate in, the government's
growing radiation research program. Other, already established groups-such as
the AEC's Division of Biology and Medicine and its advisory committee-also
had important places in the new network.

Beyond considering fallout from the testing of atomic bombs, these groups
also looked at how radiation itself might be used as a weapon. During the war,
scientists like J. Robert Oppenheimer had speculated on the possibility that fission
products (radioactive materials produced by the bomb or by reactors) could be
dispersed in the air and on the ground to kill or incapacitate the enemy. In 1946,
the widespread contamination of ships at Crossroads by radioactive mist gave
dramatic evidence of the potential of so-called radiological warfare, or RW. In
1947, the military created a committee of experts to study the problem. The
following year, a blue-ribbon panel of physicians and physicists looked at the
prospects, both offensive and defensive, of what the Pentagon termed "Rad War."
The work of these panels would lead to dozens of intentional releases of radiation
into the environment at the Army's Dugway, Utah, testing grounds from the late
1940s to the early 1950s. The very fact that the government was engaged in RW
tests was a secret. Indeed, the records of the RW program-including, as we shall
see in chapter 1 1, the debate on what the public should be told about the
program-would remain largely secret for almost fifty years.

In 1 949, a military program to build a nuclear-powered airplane led to a
set of proposed human radiation experiments. The NEPA (Nuclear Energy for the
Propulsion of Aircraft) program had its origins in 1946 as a venture that included
the Manhattan Project's Oak Ridge site, the military, and private aircraft
manufacturers. Robert Stone, as we shall see in chapter 8, was a leading
proponent of experiments involving healthy volunteers, as a key to answering
questions about the radiation hazard faced by the crew of the proposed airplane.

The NEPA and RW groups considered important, but still discrete,
projects. Where did the "big picture" discussions take place? The Advisory
Committee has pieced together the records of the Armed Forces Medical Policy
Council, the Committee on Medical Sciences, and the Joint Panel on the Medical
Aspects of Atomic Warfare." These three Defense Department groups, all
chaired by civilian doctors, guided the government on both the broad subject of
military-related biomedical research and the new and special problems posed by
atomic warfare.

If the surviving records are an indication, from its creation in 1949 to its
evident demise with the reorganization of the Defense Department in 1953, the
Joint Panel quickly became the hub of atomic warfare-related biomedical
research. The Joint Panel gathered information about relevant research from all
corners of the government, provided guidance for Defense Department programs,

36

The Atomic Century

and reviewed and coordinated policy in the matter of human experimentation
using atomic energy.

By charter, the group was to be headed by a civilian. Harvard's Dr. Joseph
Aub, a long-standing member of the Boston-based medical research community
who had worked with Robley Evans on the study of the radium dial painters and
had also studied lead toxicity, served as chair. Those who served with Aub
included Evans, Hymer Friedell, and Louis Hempelmann, Oppenheimer's
Manhattan Project medical aide. Other government participants came from the
AEC, the Public Health Service, the National Institutes of Health, the Veterans
Administration, and the CIA. (The charter provided that the Joint Panel should
collect information on relevant research conducted abroad, which the CIA
evidently provided.)63

This bureaucracy provided the venue for secret discussions that linked the
arts of healing and war in ways that had little precedent. At one and the same
time, for example, doctors counseled the military about the radiation risk to troops
at the site of atomic bomb tests, advised on the need for research on the
"psychology of panic" at such bomb tests, and debated the need for rules to
govern atomic warfare-related experimentation. (See chapter 10.)

The records of the Joint Panel show that, during the height of the Cold
War, the resources of civilian agencies were part of the mobilization of resources
to serve national security interests. For example, Dr. Howard Andrews, trained as
a physicist, was the National Institutes of Health's representative to the Joint
Panel, and in the 1950s he worked with the DOD and the AEC in monitoring
safety measures and measuring fallout from nuclear tests.64

In 1950 President Truman ordered federal agencies, including the Public
Health Service and NIH, to focus their resources on activities that would benefit
national security needs. On paper, at least, PHS and NIH policymakers sought to
direct resources to questions of radiation injury, civil defense, and worker health
and safety.65 For example, a 1952 internal planning memo explained that NIH
"will not wait for formal requests by the armed forces ... to undertake research
which NIH staff knows to be of urgent military and civilian defense significance.
Limited selective conversion of research to work directly related to biological
warfare, shock, radiation injury and thermal burns will begin immediately. . . ."66
The fragmentary surviving documentation, however, does not show the extent to
which PHS- and NIH-funded researchers actually redirected their investigations
or merely recast the purpose of ongoing work.

NEW ETHICAL QUESTIONS FOR MEDICAL
RESEARCHERS

As medical researchers became fixtures in the Cold War research
bureaucracy, they assumed roles that, if not entirely new, raised ethical questions
with which they had rarely dealt before. The surviving records of the period

37

Introduction

reveal that frank and remarkable discussions took place among military and
civilian officials and researchers, all of whom had to balance the benefits of
gaining knowledge needed to fight and survive an atomic war with the risks that
had to be taken to gain this knowledge. They had to consider, and even debated,
whether human radiation experimentation was justified, what kinds of risks entire
populations could be exposed to, and what the public could and should be told.

Whether to Experiment with Humans: The Debate Is Joined

Spurred by proposals for human radiation experiments connected with the
nuclear-powered airplane (NEPA) project, AEC and DOD medical experts in
1949 and 1950 engaged in debate on the need for human experimentation. The
transcript of a 1950 meeting among AEC biomedical officials and advisers and
military representatives provides unique insight into the mix of moral principles
and practical concerns.67

The participants in the debate included many of the key medical figures in
the Manhattan Project and the postwar radiation research bureaucracy. For the
Navy, for example, Captain Behrens, the editor of Atomic Medicine, made the
point that an atomic bomb might contaminate, but not sink, ships. The Navy
would need to know the risk of sending rescue or salvage parties into the
contaminated area. There were questions of "calculated risk which all of the
services are interested in, and not only the services but probably the civilians as
well."68 Brigadier General William H. Powell, Jr., of the Office of the Air Force
Surgeon General, added further questions: How does radiation injure tissue? Can
equipment protect against the bomb's effects? Is there a way to treat radiation
injury? How should mass casualties be handled?69

These questions were hardly abstract. Operation Crossroads had
demonstrated that postblast contamination of Navy ships was a serious hazard.
The use of the atomic bomb as a tactical weapon, declared Brigadier General
James Cooney of the AEC's Division of Military Applications, "has now gone
beyond the realm of possibility and into the realm of probability."70 This meant
that "we have a responsibility that is tremendous," Cooney added. "If this weapon
is used tactically on a corps or division, and we have, say, 5,000 troops who have
received 100 Roentgens] radiation, the Commander is going to want from me, 'Is
it all right for me to reassemble these men and take them into combat?' I don't
know the answer to that question."71 Commanders needed to know "How much
radiation can a man take?"72

Cooney argued that human experimentation was necessary. He invoked
the military's tradition of experimentation with healthy volunteers, dating back to
Walter Reed's famous work on yellow fever at the turn of the century. Cooney
urged that the military seek volunteers within its ranks--"both officer and
enlisted"--to be exposed to as much as 150 R of whole-body radiation.73

The AEC's Shields Warren took the other side in this debate. Warren

38

The Atomic Century

raised two basic points in response to Cooney. First, human experimentation was
not essential because animal research would be adequate to find the answers.
Second, data from human experimentation would likely be scientifically useless.
"We have," Warren declared, "learned enough from animals and from humans at
Hiroshima and Nagasaki to be quite certain that there are extraordinary variables
in this picture. There are species variables, genetics variables within species,
variations in condition of the individual within that species." The danger of
failing to provide data had to be weighed against the danger of providing
misleading data: "It might be almost more dangerous or misleading to give an
artificial accuracy to an answer that is of necessity an answer that spreads over a
broad range in light of these variables."74

There were, moreover, political obstacles to the program Cooney had
proposed. Satisfactory answers, Warren concluded, would require "going to tens
of thousands of individuals." But America was not the Soviet Union: "If we were
considering things in the Kremlin, undoubtedly it would be practicable. I doubt
that it is practicable here."75

At the heart of Warren's objections to Cooney's proposal was a concern
about employing "human experimentation when it isn't for the good of the
individual concerned and when there is no way of solving the problem."76 To
Cooney's invocation of Walter Reed, Warren responded that, in the case of yellow
fever, humans were needed as subjects because there was no nonhuman host to

Cooney did not disagree with Warren "that statistically we will prove

nothing." But, he pointed out, "[G]enerals are hard people to deal with If we

had 200 cases whereby we could say that these men did or did not get sick up to
150 R, it would certainly be a great help to us."77

Even then, Warren rejoined, the data might not be of great use: "I can
think in terms of times when even if everybody on a ship was sea-sick, you would
still have to keep the ship operating."78

The 1950 debate over NEPA provides clear evidence that midcentury
medical experts gave thought before engaging in human experimentation that
involved significant risk and was not intended to benefit the subject. On paper,
the debate was decided in Shields Warren's favor. Following Warren's and
DBM's opposition, Cooney and the military agreed that "human experimentation"
on healthy volunteers would not be approved. However, even as this policy was
declared, the Defense Department, with Warren's apparent acquiescence,
proceeded to contract with private hospitals to gather data on sick patients who
were being treated with radiation. The government's use of sick patients for
research, as we shall see in chapter 8, raised difficult ethical questions of its own.

Whether to Put Populations at Risk: The Debate Continues

As the medical experts debated the issue of whether to put individual

39

Introduction

human subjects at risk in radiation experiments on behalf of NEPA, they were
also engaged in secret discussions about whether to proceed with the testing of
nuclear weapons, which might put whole populations at risk.

It was also in 1950 that the decision was made to carry out atomic bomb
testing at a site in the continental United States. President Truman chose the
Nevada desert as the location for the test site. Shields Warren's Division of
Biology and Medicine was assigned the job of considering the safety of early
tests. Like the earlier transcript, an account of a May 1951 meeting at Los
Alamos, convened by Warren, provides a window onto the balancing of risks and
benefits by medical researchers.

The meeting focused on the radiological hazards to populations downwind
from underground testing planned at the Nevada Test Site. Those in attendance
realized that the testing could be risky. "I would almost say from the discussion
this far," Warren summarized, "that in light of the size and activity of some of
these particles, their unpredictability of fallout, the possibility of external beta
burns is quite real."79 Committee members considered the testing a "calculated
risk" for populations downwind, but they thought that the information they could
gain made the risk worthwhile. According to the record of the meeting, Warren
summarized the view of Dr. Gioacchino Failla, a Columbia University
radiological physicist: "[T]he time has come when we should take some risk and
get some information ... we are faced with a war in which atomic weapons will
undoubtedly be used, and we have to have some information about these
things ... if we look for perfect safety we will never make these tests."80 Worried
about the potential consequences of miscalculation, the AEC's Carrol Tyler
observed, "We have lost a continental site no matter where we put it." Still, Tyler
argued, "If we are going to gamble it might as well be done where it is
operationally convenient."1" A proposed deep underground test did not take place,
and a test evidently considered less risky was substituted. Ultimately, in a
summary prepared at the end of the 1951 test series, the Health Division leader of
the AEC's Los Alamos Laboratory recorded that perhaps only good fortune had
averted significant contamination: "Thanks to the kindness of the winds, no
significant activity was deposited in any populated localities. It was certainly
shown however," he wrote, "that significant exposures at considerable distances
could be acquired by individuals who actually were in the fallout while it was in
progress."82

The NEPA debate and the advent of nuclear testing confronted biomedical
experts with a set of conflicting, and even contradictory, objectives. First, they
were called upon to offer advice on decisions that might inevitably put people at
some risk. The risk had to be balanced against the benefit, which in most
instances was defined as connected with the nation's security. In many cases, the
experts agreed, it was better to bear the lesser risk now, in order to avoid a greater
risk later. Second, these experts were also called upon, as in the 1951 Nevada
test, to provide advice on minimizing risk. Third, as in the Nevada test, these

40

The Atomic Century

same experts saw the tests as opportunities to gather data that might ultimately be
used to reduce risk for all.

Whether and What the Public Should Be Told About Government-Created
Radiation Risk

Scientific research had a long and celebrated tradition of open publication
in the scientific literature. But several factors caused Cold War researchers to
limit their public disclosures. These included, preeminently, concern with
national security, which necessarily required secrecy. But they also included the
concern that the release of research information would undermine needed
programs because the public could not understand radiation or because the
information would embarrass the government.

The tension between the publicizing of information and the limits on
disclosure was a constant theme in Cold War research. When, in June 1 947, the
Medical Board of Review appointed by David Lilienthal reported on the AEC's
biomedical program, it declared that secrecy in scientific research is "distasteful
and in the long run contrary to the best interests of scientific progress."83 As
shown by its organization of the medical isotope program, the AEC acted quickly
to make sure that the great preponderance of biomedical research done under its
auspices would be published in the open literature.

However, recently retrieved documents show that the need for secrecy was
also invoked where national security was not endangered. At the same time that
biomedical officials, such as those on the Medical Board of Review, spoke openly
of the need to limit national security restrictions, internally they sometimes sided
with those who would restrict information from the public even where release
admittedly would not directly endanger national security. Thus, as we shall see in
chapter 13, Shields Warren and other AEC medical officials agreed to withhold
data on human experiments from the public on the grounds that disclosure would
embarrass the government or could be a source of legal liability.

A further important qualification to what the public could know related to
research connected with the atomic bomb-including the creation of a worldwide
network to gather data on the effects of fallout from nuclear tests. In 1949, the
AEC undertook Project Gabriel, a secret effort to study the question of whether
the tests could threaten the viability of life on earth. In 1953, Gabriel led to
Project Sunshine, a loose confederation of fallout research projects whose human
data-gathering efforts, as we see in chapter 13, operated in the twilight between
openness and secrecy.

Finally, while documents show that medical experts and officials shared
an acute awareness of the importance of public support to the success of Cold
War programs, this awareness was coupled with concern about the American
public's ability to understand the risks that had to be borne to win the Cold War.
The concern that citizens could not understand radiation risk is illustrated by a

41

Introduction

recently recovered NEPA transcript. In July 1949, the nuclear airplane project
gathered radiation experts and psychologists to consider psychological problems
connected to radiation hazard. To the assembled experts the greatest unknown
was not radiation itself, but the basis for public fear and misunderstanding of
radiation.

"I believe," General Cooney proposed, "that the general public is under
the opinion that we don't know very much about this condition [radiation]. . . . We
know," he ventured, "just about as much about it as we do about many other
diseases that people take for granted . . . even tuberculosis."84

Yet, said the Navy's Captain Behrens, "there are some peculiar ideas
relative to radiation that are related to primitive concepts of hysteria and things in
that category. . . . There is such a unique element in it; for some it begins to
border on the mystical."85 A good deal of the public's fear of radiation, declared
Berkeley's Dr. Karl M. Bowman, a NEPA medical adviser, "is essentially the fear
of the unknown. The dangers have been enormously magnified." As Dr.
Bowman and others noted, the public's perception was not without reason, for "we
have emphasized for purposes of getting funds for research how little we know."86

The perspective expressed in the NEPA transcript would lead, as shown in
chapter 10, to the use of atomic bomb tests to perform human research on the
psychology of panic and, as shown in other case studies, to decisions to hold
information closely out of concern that its release could create public
misunderstanding that would imperil important government programs.

CONCLUSION

In the atomic age, Captain Behrens's Atomic Medicine pointed out,
radiation research was both the agent and the beneficiary of dramatic
developments at the intersection of government and medicine. When ethical
questions were raised by these developments, radiation researchers would be on
the front line in having to deal with them. The burgeoning government- funded
biomedical research, including human radiation research, required a
reexamination of the traditional doctor-patient relationship. At the same time, the
evolving role of medical researchers as government officials and advisers also
posed questions about the place of doctors, and more generally of scientists, in
service to government.

42

The Atomic Century

The Basics of Radiation Science

The ethical and historical issues of human radiation experiments cannot be
understood without a basic grasp of the underlying science. This requires more
than a glossary defining technical terms. At least an intuitive understanding of
the natural laws and scientific techniques of radiation science is necessary.
Obviously, acquiring a professional level of knowledge would require far more
time than most readers can afford; indeed, entire careers are devoted to studying
just one aspect of the field. To serve the interests of democracy in a technological
world, however, we must provide sufficient technical background for all citizens
to become active participants in considering the ethical and political dimensions
of scientific research.

What follows is an attempt to provide such a background for the events
and issues discussed in this report, directed toward those readers less familiar
with "the basics" of radiation science. This task was deemed important enough to
deserve a distinct section of this Introduction.

What Is Ionizing Radiation?

What is radiation!

Radiation is a very general term, used to describe any process that
transmits energy through space or a material away from a source. Light, sound,
and radio waves are all examples of radiation. When most people think of
radiation, however, they are thinking of ionizing ra<//arto«--radiation that can
disrupt the atoms and molecules within the body. While scientists think of these
emissions in highly mathematical terms, they can be visualized either as
subatomic particles or as rays. Radiation's effects on humans can best be
understood by first examining the effect of radiation on atoms, the basic building
blocks of matter.

What is ionization!

Atoms consist of comparatively large particles (protons and neutrons)
sitting in a central nucleus, orbited by smaller particles (electrons): a miniature
solar system. Normally, the number of protons in the center of the atom equals
the number of electrons in orbit. An ion is any atom or molecule that does not
have the normal number of electrons. Ionizing radiation is any form of radiation
that has enough energy to knock electrons out of atoms or molecules, creating
ions.

How is ionizing radiation measured?

Measurement lies at the heart of modern science, but a number by itself
conveys no information. Useful measurement requires both an instrument for
measurement (such as a stick to mark off length) and an agreement on the units to

43

Introduction

be used (such as inches, meters, or miles). The units chosen will vary with the
purpose of the measurement. For example, a cook will measure butter in terms of
tablespoons to ensure the meal tastes good, while a nutritionist may be more
concerned with measuring calories, to determine the effect on the diner's health.

The variety of units used to measure radiation and radioactivity at times
confuses even scientists, if they do not use them every day. It may be helpful to
keep in mind the purpose of various units. There are two basic reasons to
measure radiation: the study of physics and the study of the biological effects of
radiation. What creates the complexity is that our instruments measure physical
effects, while what is of interest to some are biological effects. A further
complication is that units, as with words in any language, may fade from use and
be replaced by new units.

Radiation is not a series of distinct events, like radioactive decays, which
can be counted individually. Measuring radiation in bulk is like measuring the
movement of sand in an hourglass; it is more useful to think of it as a continuous
flow, rather than a series of separate events. The intensity of a beam of ionizing
radiation is measured by counting up how many ions (how much electrical
charge) it creates in air. The roentgen (named after Wilhelm Roentgen, the
discoverer of x rays) is the unit that measures the ability of x rays to ionize air; it
is a unit of exposure that can be measured directly. Shortly after World War II, a
common unit of measurement was the roentgen equivalent physical (rep), which
denoted an ability of other forms of radiation to create as many ions in air as a
roentgen of x rays. It is no longer used, but appears in many of the documents
examined by the Advisory Committee.

What are the basic types of ionizing radiation?

There are many types of ionizing radiation, but the most familiar are
alpha, beta, and gamma/x-ray radiation. Neutrons, when expelled from atomic
nuclei and traveling as a form of radiation, can also be a significant health
concern.

Alpha particles are clusters of two neutrons and two protons each. They
are identical to the nuclei of atoms of helium, the second lightest and second most
common element in the universe, after hydrogen. Compared with other forms of
radiation, though, these are very heavy particles—about 7,300 times the mass of
an electron. As they travel along, these large and heavy particles frequently
interact with the electrons of atoms, rapidly losing their energy. They cannot even
penetrate a piece of paper or the layer of dead cells at the surface of our skin. But
if released within the body from a radioactive atom inside or near a cell, alpha
particles can do great damage as they ionize atoms, disrupting living cells.
Radium and plutonium are two examples of alpha emitters.

Beta particles are electrons traveling at very high energies. If alpha
particles can be thought of as large and slow bowling balls, beta particles can be
visualized as golf balls on the driving range. They travel farther than alpha

44

The Atomic Century

particles and, depending on their energy, may do as much damage. For example,
beta particles in fallout can cause severe burns to the skin, known as beta burns.
Radiosotopes that emit beta particles are present in fission products produced in
nuclear reactors and nuclear explosions. Some beta-emitting radioisotopes, such
as iodine 131, are administered internally to patients to diagnose and treat disease.

Gamma and x-ray radiation consists of packets of energy known as
photons. Photons have no mass or charge, and they travel in straight lines. The
visible light seen by our eyes is also made up of photons, but at lower energies.
The energy of a gamma ray is typically greater than 100 kiloelectron volts (keV—
"k" is the abbreviation for kilo, a prefix that multiplies a basic unit by 1 ,000) per
photon, more than 200,000 times the energy of visible light (0.5 eV). If alpha
particles are visualized as bowling balls and beta particles as golf balls, photons
of gamma and x-radiation are like weightless bullets moving at the speed of light.
Photons are classified according to their origin. Gamma rays originate from
events within an atomic nucleus; their energy and rate of production depend on
the radioactive decay process of the radionuclide that is their source. X rays are
photons that usually originate from energy transitions of the electrons of an atom.
These can be artificially generated by bombarding appropriate atoms with high-
energy electrons, as in the classic x-ray tube. Because x rays are produced
artificially by a stream of electrons, their rate of output and energy can be
controlled by adjusting the energy and amount of the electrons themselves. Both
x rays and gamma rays can penetrate deeply into the human body. How deeply
they penetrate depends on their energy; higher energy results in deeper
penetration into the body. A 1 MeV ("M" is the abbreviation for mega, a prefix
that multiplies a basic unit by 1,000,000) gamma ray, with an energy 2,000,000
times that of visible light, can pass completely through the body, creating tens of
thousands of ions as it does.

A final form of radiation of concern is neutron radiation. Neutrons, along
with protons, are one of the components of the atomic nucleus. Like protons, they
have a large mass; unlike protons, they have no electric charge, allowing them to
slip more easily between atoms. Like a Stealth fighter, high-energy neutrons can
travel farther into the body, past the protective outer layer of the skin, before
delivering their energy and causing ionization.

Several other types of high-energy particles are also ionizing radiation.
Cosmic radiation that penetrates the Earth's atmosphere from space consists
mainly of protons, alpha particles, and heavier atomic nuclei. Positrons, mesons,
pions, and other exotic particles can also be ionizing radiation.

What Is Radioactivity?

What causes radioactivity?

As its name implies, radioactivity is the act of emitting radiation
spontaneously. This is done by an atomic nucleus that, for some reason, is

45

Introduction

unstable; it "wants" to give up some energy in order to shift to a more stable
configuration. During the first half of the twentieth century, much of modern
physics was devoted to exploring why this happens, with the result that nuclear
decay was fairly well understood by 1 960. Too many neutrons in a nucleus lead
it to emit a negative beta particle, which changes one of the neutrons into a
proton. Too many protons in a nucleus lead it to emit a positron (positively
charged electron), changing a proton into a neutron. Too much energy leads a
nucleus to emit a gamma ray, which discards great energy without changing any
of the particles in the nucleus. Too much mass leads a nucleus to emit an alpha
particle, discarding four heavy particles (two protons and two neutrons).

How is radioactivity measured?

Radioactivity is a physical, not a biological, phenomenon. Simply stated,
the radioactivity of a sample can be measured by counting how many atoms are
spontaneously decaying each second. This can be done with instruments
designed to detect the particular type of radiation emitted with each "decay" or
disintegration. The actual number of disintegrations per second may be quite
large. Scientists have agreed upon common units to use as a form of shorthand.
Thus, a curie (abbreviated "Ci" and named after Pierre and Marie Curie, the
discoverers of radium87) is simply a shorthand way of writing "37,000,000,000
disintegrations per second," the rate of disintegration occurring in 1 gram of
radium. The more modern International System of Measurements (SI) unit for the
same type of measurement is the becquerel ( abbreviated "Bq" and named after
Henri Becquerel, the discoverer of radioactivity), which is simply a shorthand for
"1 disintegration per second."

What is radioactive half-life"!

Being unstable does not lead an atomic nucleus to emit radiation
immediately. Instead, the probability of an atom disintegrating is constant, as if
unstable nuclei continuously participate in a sort of lottery, with random drawings
to decide which atom will next emit radiation and disintegrate to a more stable
state. The time it takes for half of the atoms in a given mass to "win the lottery"--
that is, emit radiation and change to a more stable state—is called the half-life.
Half-lives vary greatly among types of atoms, from less than a second to billions
of years. For example, it will take about 4.5 billion years for half of the atoms in
a mass of uranium 238 to spontaneously disintegrate, but only 24,000 years for
half of the atoms in a mass of plutonium 239 to spontaneously disintegrate.
Iodine 131, commonly used in medicine, has a half-life of only eight days.

What is a radioactive decay chain?

Stability may be achieved in a single decay, or a nucleus may decay
through a series of states before it reaches a truly stable configuration, a bit like a
Slinky toy stepping down a set of stairs. Each state or step will have its own

46

The Atomic Century

unique characteristics of half-life and type of radiation to be emitted as the move
is made to the next state. Much scientific effort has been devoted to unraveling
these decay chains, not only to achieve a basic understanding of nature, but also
to design nuclear weapons and nuclear reactors. The unusually complicated
decay of uranium 238, for example— the primary source of natural radioactivity on
earth— proceeds as follows:"8

U-238 emits an alpha

I

Thorium 234 emits a beta

I

Protactinium 234 emits a beta

I
Uranium 234 emits an alpha

1
Thorium 230 emits an alpha

1
Radium 226 emits an alpha

I

Radon 222 emits an alpha

!

Polonium 2 1 8 emits an alpha

1

Lead 214 emits a beta

1

Bismuth 214 emits a beta

I

Polonium 214 emits an alpha

I

Lead 210 emits a beta

1

Bismuth 210 emits a beta

1

Polonium 210 emits an alpha

I

Lead 206, which is stable

How can radioactivity be caused artificially?

Radioactivity can occur both naturally and through human intervention.
An example of artificially induced radioactivity is neutron activation. A neutron
fired into a nucleus can cause nuclear fission (the splitting of atoms). This is the
basic concept behind the atomic bomb. Neutron activation is also the underlying

47

Introduction

principle of boron-neutron capture therapy for certain brain cancers. A solution
containing boron is injected into a patient and is absorbed more by the cancer than
by other cells. Neutrons fired at the area of the brain cancer are readily absorbed
(captured) by the boron nuclei. These nuclei then become unstable and emit
radiation that attacks the cancer cells. Simple in its basic physics, the treatment
has been complex and controversial in practice and after half a century is still
regarded as highly experimental.

What Are Atomic Number and Atomic Weight?

What is an element?

Chemical behavior is what originally led scientists to classify matter into
various elements. Chemical behavior is the ability of an atom to combine with
other atoms. In more technical terms, chemical behavior depends upon the type
and number of the chemical bonds an atom can form with other atoms. In
classroom kits for building models of molecules, atoms are usually represented by
colored spheres with small holes for pegs and the bonds are represented by the
small pegs that can connect the spheres. The number of peg holes signifies the
maximum number of bonds an atom can form; different types of bonds may be
represented by different types of pegs. Atoms that have the same number of peg
holes may have similar chemical behavior. Thus, atoms that have identical
chemical behavior are regarded as atoms of the same element. For example, an
atom is labeled a "carbon atom" if it can form the same number, types, and
configurations of bonds as other carbon atoms. Although the basics are simple to
explain, how atoms bind to each other becomes very complex when studied in
detail; new discoveries are still being made as new types of materials are formed.

What is atomic number?

An atom may be visualized as a miniature solar system, with a large
central nucleus orbited by small electrons. The bonding capacity of an atom is
determined by the electrons. For example, atoms that in their normal state have
one electron are hydrogen atoms and will readily (and sometimes violently) bond
with oxygen. This bonding capacity of hydrogen was the cause of the explosion
of the airship Hindenburg in 1937. Atoms that in their normal state have two
electrons are helium atoms, which will not bond with oxygen and would have
been a better choice for filling the Hindenburg.

We can pursue the question back one step further: What determines the
number of electrons? The number of protons in the nucleus of the atom. Here,
the analogy between an atom and the solar system breaks down. The force that
holds the planets in their orbits is the gravitational attraction between the planets
and the sun. However, in an atom what holds the electrons in their orbit is the
electrical attraction between the electrons and the protons in the nucleus. The

48

The Atomic Century

basic rule is that like charges repel and opposite charges attract. Although a
proton has more mass than an electron, they both have the samf amount of
electrical charge, but opposite in kind. Scientists have designated electrons as
having a negative charge and protons as having a positive charge. One positive
proton can hold one negative electron in orbit. Thus, an atom with one proton in
its nucleus normally will have one electron in orbit (and be labeled a hydrogen
atom); an atom with ninety-four protons in its nucleus will normally have ninety-
four electrons orbiting it (and be labeled a plutonium atom).

The number of protons in a nucleus is called the atomic number and
always equals the number of electrons in orbit about that nucleus (in a nonionized
atom). Thus, all atoms that have the same number of protons~the atomic
number— are atoms of the same element.

What is atomic weight?

The nuclei of atoms also contain neutrons, which help hold the nucleus
together. A neutron has no electrical charge and is slightly more massive than a
proton. Because a neutron can decay into a proton plus an electron (the essence
of beta decay), it is sometimes helpful to think of a neutron as an electron and a
proton blended together, although this is at best an oversimplification. Because a
neutron has no charge, a neutron has no effect on the number of electrons orbiting
the nucleus. However, because it is even more massive than a proton, a neutron
can add significantly to the weight of an atom. The total weight of an atom is
called the atomic weight. It is approximately equal to the number of protons and
neutrons, with a little extra added by the electrons. The stability of the nucleus,
and hence the atom's radioactivity, is heavily dependent upon the number of
neutrons it contains.

What notations are used to represent atomic number and weight?

Each atom, therefore, can be assigned both an atomic number (the number
of protons equals the number of electrons) and an atomic weight (approximately
equaling the number of protons plus the number of neutrons). A normal helium
atom, for example, has two protons and two neutrons in its nucleus, with two
electrons in orbit. Its chemical behavior is determined by the atomic number 2
(the number of protons), which equals the normal number of electrons; the
stability of its nucleus (that is, its radioactivity) varies with its atomic weight
(approximately equal to the number of protons and neutrons). The most well-
known form of plutonium, for example, has an atomic number of 94, since it has
94 protons, and with the 145 neutrons in its nucleus, an atomic weight of 239 (94
protons plus 145 neutrons). In World War II, its very existence was highly
classified. A code number was developed: the last digit of the atomic number
(94) and the last digit of the atomic weight (239). Thus, in some of the early
documents examined by the Advisory Committee, the term 49 refers to
plutonium.

49

Introduction

Styles of notation vary, but usually isotopes are written as:

atcic number Chemical abbreviation at™8ht

or as
atomic weight chemical abbreviation

Thus, the isotope of plutonium just discussed would be written as:

94

Pu239 or as 239Pu

Since the atomic weight is what is often the only item of interest, it might also be
written simply as Pu-239, plutonium 239, or Pu239.

Radioisotopes: What Are They and How Are They Made?

What are isotopes?

The isotopes of an element are all the atoms that have in their nucleus the
number of protons (atomic number) corresponding to the chemical behavior of
that element. However, the isotopes of a single element vary in the number of
neutrons in their nuclei. Since they still have the same number of protons, all
these isotopes of an element have identical chemical behavior. But since they
have different numbers of neutrons, these isotopes of the same element may have
different radioactivity. An isotope that is radioactive is called a radioisotope or
radionuclide. Two examples may help clarify this.

The most stable isotope of uranium, U-238, has an atomic number of 92
(protons) and an atomic weight of 238 (92 protons plus 146 neutrons). The
isotope of uranium of greatest importance in atomic bombs, U-235, though, has
three fewer neutrons. Thus, it also has an atomic number of 92 (since the number
of protons has not changed) but an atomic weight of 235 (92 protons plus only
143 neutrons). The chemical behavior of U-235 is identical to all other forms of
uranium, but its nucleus is less stable, giving it higher radioactivity and greater
susceptibility to the chain reactions that power both atomic bombs and nuclear
fission reactors.

Another example is iodine, an element essential for health; insufficient
iodine in one's diet can lead to a goiter. Iodine also is one of the earliest elements
whose radioisotopes were used in what is now called nuclear medicine. The most
common, stable form of iodine has an atomic number of 53 (protons) and an
atomic weight of 127 (53 protons plus 74 neutrons). Because its nucleus has the
"correct" number of neutrons, it is stable and is not radioactive. A less stable
form of iodine also has 53 protons (this is what makes it behave chemically as

50

The Atomic Century

iodine) but four extra neutrons, for a total atomic weight of 131 (53 protons and
78 neutrons). With "too many" neutrons in its nucleus, it is unstable and
radioactive, with a half-life of eight days. Because it behaves chemically as
iodine, it travels throughout the body and localizes in the thyroid gland just like
the stable form of iodine. But, because it is radioactive, its presence can be
detected. Iodine 131 thus became one of the earliest radioactive tracers.

How can different isotopes of an element be produced?

How can isotopes be produced-especially radioisotopes, which can serve
many useful purposes? There are two basic methods: separation and synthesis.

Some isotopes occur in nature. If radioactive, these usually are
radioisotopes with very long half-lives. Uranium 235, for example, makes up
about 0.7 percent of the naturally occurring uranium on the earth.*9 The challenge
is to separate this very small amount from the much larger bulk of other forms of
uranium. The difficulty is that all these forms of uranium, because they all have
the same number of electrons, will have identical chemical behavior: they will
bind in identical fashion to other atoms. Chemical separation, developing a
chemical reaction that will bind only uranium atoms, will separate out uranium
atoms, but not distinguish among different isotopes of uranium. The only
difference among the uranium isotopes is their atomic weight. A method had to
be developed that would sort atoms according to weight.

One initial proposal was to use a centrifuge. The basic idea is simple:
spin the uranium atoms as if they were on a very fast merry-go-round. The
heavier ones will drift toward the outside faster and can be drawn off. In practice
the technique was an enormous challenge: the goal was to draw off that very
small portion of uranium atoms that were lighter than their brethren. The
difficulties were so enormous the plan was abandoned in 1942.90 Instead, the
technique of gaseous diffusion was developed. Again, the basic idea was very
simple: the rate at which gas passed {diffused) through a filter depended on the
weight of the gas molecules: lighter molecules diffused more quickly. Gas
molecules that contained U-235 would diffuse slightly faster than gas molecules
containing the more common but also heavier U-238. This method also presented
formidable technical challenges, but was eventually implemented in the gigantic
gas diffusion plant at Oak Ridge, Tennessee. In this process, the uranium was
chemically combined with fluorine to form a hexafluoride gas prior to separation
by diffusion. This is not a practical method for extracting radioisotopes for
scientific and medical use. It was extremely expensive and could only supply
naturally occurring isotopes.

A more efficient approach is to artificially manufacture radioisotopes.
This can be done by firing high-speed particles into the nucleus of an atom.
When struck, the nucleus may absorb the particle or become unstable and emit a
particle. In either case, the number of particles in the nucleus would be altered,
creating an isotope. One source of high-speed particles could be a cyclotron. A

51

Introduction

cyclotron accelerates particles around a circular race track with periodic pushes of
an electric field. The particles gather speed with each push, just as a child swings
higher with each push on a swing. When traveling fast enough, the particles are
directed off the race track and into the target.

A cyclotron works only with charged particles, however. Another source
of bullets are the neutrons already shooting about inside a nuclear reactor. The
neutrons normally strike the nuclei of the fuel, making them unstable and causing
the nuclei to split (fission) into two large fragments and two to three "free"
neutrons. These free neutrons in turn make additional nuclei unstable, causing
further fission. The result is a chain reaction. Too many neutrons can lead to an
uncontrolled chain reaction, releasing too much heat and perhaps causing a
"meltdown." Therefore, "surplus" neutrons are usually absorbed by "control
rods." However, these surplus neutrons can also be absorbed by targets of
carefully selected material placed in the reactor. In this way the surplus neutrons
are used to create radioactive isotopes of the materials placed in the targets.

With practice, scientists using both cyclotrons and reactors have learned
the proper mix of target atoms and shooting particles to "cook up" a wide variety
of useful radioisotopes.

How Does Radiation Affect Humans?

Radiation may come from either an external source, such as an x-ray
machine, or an internal source, such as an injected radioisotope. The impact of
radiation on living tissue is complicated by the type of radiation and the variety of
tissues. In addition, the effects of radiation are not always easy to separate from
other factors, making it a challenge at times for scientists to isolate them. An
overview may help explain not only the effects of radiation but also the
motivation for studying them, which led to much of the research examined by the
Advisory Committee.

What effect can ionizing radiation have on chemical bonds?

The functions of living tissue are carried out by molecules, that is,
combinations of different types of atoms united by chemical bonds. Some of
these molecules can be quite large. The proper functioning of these molecules
depends upon their composition and also their structure (shape). Altering
chemical bonds may change composition or structure. Ionizing radiation is
powerful enough to do this. For example, a typical ionization releases six to
seven times the energy needed to break the chemical bond between two carbon
atoms.91 This ability to disrupt chemical bonds means that ionizing radiation
focuses its impact in a very small but crucial area, a bit like a karate master
focusing energy to break a brick. The same amount of raw energy, distributed
more broadly in nonionizing form, would have much less effect. For example, the
amount of energy in a lethal dose of ionizing radiation is roughly equal to the

52

The Atomic Century

amount of thermal energy in a single sip of hot coffee.92 The crucial difference is
that the coffee's energy is broadly distributed in the form of nonionizing heat,
while the radiation's energy is concentrated in a form that can ionize.

What is DNA?

Of all the molecules in the body, the most crucial is DNA (deoxyribose
nucleic acid), the fundamental blueprint for all of the body's structures. The DNA
blueprint is encoded in each cell as a long sequence of small molecules, linked
together into a chain, much like the letters in a telegram. DNA molecules are
enormously long chains of atoms wound around proteins and packed into
structures called chromosomes within the cell nucleus. When unwound, the DNA
in a single human cell would be more than 2 meters long. It normally exists as
twenty-three pairs of chromosomes packed within the cell nucleus, which itself
has a diameter of only 10 micrometers (0.00001 meter).93 Only a small part of
this DNA needs to be read at any one time to build a specific molecule. Each cell
is continually reading various parts of its own DNA as it constructs fresh
molecules to perform a variety of tasks. It is worth remembering that the
structure of DNA was not solved until 1953, nine years after the beginning of the
period studied by the Advisory Committee. We now have a much clearer picture
of what happens within a cell than did the scientists of 1944.

What effect can ionizing radiation have on DNA?

Ionizing radiation, by definition, "ionizes," that is, it pushes an electron
out of its orbit around an atomic nucleus, causing the formation of electrical
charges on atoms or molecules. If this electron comes from the DNA itself or
from a neighboring molecule and directly strikes and disrupts the DNA molecule,
the effect is called direct action. This initial ionization takes place very quickly,
in about 0.000000000000001 of a second. However, today it is estimated that
about two-thirds of the damage caused by x rays is due to indirect action. This
occurs when the liberated electron does not directly strike the DNA, but instead
strikes an ordinary water molecule. This ionizes the water molecule, eventually
producing what is known as zfree radical. A free radical reacts very strongly
with other molecules as it seeks to restore a stable configuration of electrons. A
free radical may drift about up to 10,000,000,000 times longer than the time
needed for the initial ionization (this is still a very short time, about 0.00001 of a
second), increasing the chance of it disrupting the crucial DNA molecule. This
also increases the possibility that other substances could be introduced that would
neutralize free radicals before they do damage.94

Neutrons act quite differently. A fast neutron will bypass orbiting
electrons and occasionally crash directly into an atomic nucleus, knocking out
large particles such as alpha particles, protons, or larger fragments of the nucleus.
The most common collisions are with carbon or oxygen nuclei. The particles
created will themselves then set about ionizing nearby electrons. A slow neutron

53

Introduction

will not have the energy to knock out large particles when it strikes a nucleus.
Instead, the neutron and the nucleus will bounce off each other, like billiard balls.
In so doing, the neutron will slow down, and the nucleus will gain speed. The
most common collision is with a hydrogen nucleus, a proton that can excite or
ionize electrons in nearby atoms.95

What immediate effects can ionizing radiation have on living cells?

All of these collisions and ionizations take place very quickly, in less than
a second. It takes much longer for the biological effects to become apparent. If
the damage is sufficient to kill the cell, the effect may become noticeable in hours
or days. Cell "death" can be of two types. First, the cell may no longer perform
its function due to internal ionization; this requires a dose to the cell of about 100
gray (10,000 rad). (For a definition of gray and rad, see the section below titled
"How Do We Measure the Biological Effects of Radiation?") Second,
"reproductive death" (mitotic inhibition) may occur when a cell can no longer
reproduce, but still performs its other functions. This requires a dose of 2 gray
(200 rad), which will cause reproductive death in half the cells irradiated (hence
such a quantity is called a "mean lethal dose.")96 Today we still lack enough
information to choose among the various models proposed to explain cell death in
terms of what happens at the level of atoms and molecules inside a cell.97 If
enough crucial cells within the body totally cease to function, the effect is fatal.
Death may also result if cell reproduction ceases in parts of the body where cells
are continuously being replaced at a high rate (such as the blood cell-forming
tissues and the lining of the intestinal tract). A very high dose of 100 gray
( 1 0,000 rad) to the entire body causes death within twenty-four to forty-eight
hours; a whole-body dose of 2.5 to 5 gray (250 to 500 rad) may produce death
within several weeks.98 At lower or more localized doses, the effect will not be
death, but specific symptoms due to the loss of a large number of cells. These
effects were once called nonstochastic; they are now called deterministic.™ A
beta burn is an example of a deterministic effect.

What long-term effects can radiation have?

The effect of the radiation may not be to kill the cell, but to alter its DNA
code in a way that leaves the cell alive but with an error in the DNA blueprint.
The effect of this mutation will depend on the nature of the error and when it is
read. Since this is a random process, such effects are now called stochastic.™0
Two important stochastic effects of radiation are cancer, which results from
mutations in nongerm cells (termed somatic cells), and heritable changes, which
result from mutations in germ cells (eggs and sperm).

How can ionizing radiation cause cancer?

Cancer is produced if radiation does not kill the cell but creates an error in
the DNA blueprint that contributes to eventual loss of control of cell division, and

54

The Atomic Century

the cell begins dividing uncontrollably. This effect might not appear for many
years. Cancers induced by radiation do not differ from cancers due to other
causes, so there is no simple way to measure the rate of cancer due to radiation.
During the period studied by the Advisory Committee, great effort was devoted to
studies of irradiated animals and exposed groups of people to develop better
estimates of the risk of cancer due to radiation. This type of research is
complicated by the variety of cancers, which vary in radiosensitivity. For
example, bone marrow is more sensitive than skin cells to radiation-induced
cancer.101

Large doses of radiation to large numbers of people are needed in order to
cause measurable increases in the number of cancers and thus determine the
differences in the sensitivity of different organs to radiation. Because the cancers
can occur anytime in the exposed person's lifetime, these studies can take seventy
years or more to complete. For example, the largest and scientifically most
valuable epidemiologic study of radiation effects has been the ongoing study of
the Japanese atomic bomb survivors. Other important studies include studies of
large groups exposed to radiation as a consequence of their occupation (such as
uranium miners) or as a consequence of medical treatment. These types of
studies are discussed in greater detail in the section titled "How Do Scientists
Determine the Long-Term Risks from Radiation?"

How can ionizing radiation produce genetic mutations?

Radiation may alter the DNA within any cell. Cell damage and death that
result from mutations in somatic cells occur only in the organism in which the
mutation occurred and are therefore termed somatic or nonheritable effects.
Cancer is the most notable long-term somatic effect. In contrast, mutations that
occur in germ cells (sperm and ova) can be transmitted to future generations and
are therefore called genetic or heritable effects. Genetic effects may not appear
until many generations later. The genetic effects of radiation were first
demonstrated in fruit flies in the 1920s. Genetic mutation due to radiation does
not produce the visible monstrosities of science fiction; it simply produces a
greater frequency of the same mutations that occur continuously and
spontaneously in nature.

Like cancers, the genetic effects of radiation are impossible to distinguish
from mutations due to other causes. Today at least 1,300 diseases are known to
be caused by a mutation.102 Some mutations may be beneficial; random mutation
is the driving force in evolution. During the period studied by the Advisory
Committee, there was considerable debate among the scientific community over
both the extent and the consequences of radiation-induced mutations. In contrast
to estimates of cancer risk, which are based in part on studies of human
populations, estimates of heritable risk are based for the most part upon animal
studies plus studies of Japanese survivors of the atomic bombs.

The risk of genetic mutation is expressed in terms of the doubling dose:

55

Introduction

the amount of radiation that would cause additional mutations equal in number to
those that already occur naturally from all causes, thereby doubling the naturally
occurring rate of mutation.

It is generally believed that mutation rates depend linearly on dose and
that there is no threshold below which mutation rates would not be increased.
Spontaneous mutation (unrelated to radiation) occurs naturally at a rate of
approximately 1/10,000 to 1/1,000,000 cell divisions per gene, with wide
variation from one gene to another.

Attempts have been made to estimate the contribution of ionizing
radiation to human mutation rates by studying offspring of both exposed and
nonexposed Japanese atomic bomb survivors. These estimates are based on
comparisons of the rate of various congenital defects and cancer between exposed
and nonexposed survivors, as well as on direct counting of mutations at a small
number of genes. For all these endpoints, no excess has been observed among
descendants of the exposed survivors.

Given this lack of direct evidence of any increase in human heritable
(genetic) effects resulting from radiation exposure, the estimates of genetic risks
in humans have been compared with experimental data obtained with laboratory
animals. However, estimates of human genetic risks vary greatly from animal
data. For example, fruit flies have very large chromosomes that appear to be
uniquely susceptible to radiation. Humans may be less vulnerable than previously
thought. Statistical lower limits on the doubling dose have been calculated that
are compatible with the observed human data. Based on our inability to
demonstrate an effect in humans, the lower limit for the genetic doubling dose is
thought to be less than 100 rem.103

How Do We Measure the Biological Effects of External Radiation?

The methods of measuring radiation and radioactivity, purely physical
events, were discussed earlier. In studying the effect of radiation on living
organisms, a biological event, the crucial data are the amount of energy absorbed
by a specific amount and type of tissue. This requires first measuring the amount
of energy left behind by the radiation in the tissue and, second, the amount and
type of tissue.

What is an absorbed dose of radiation?

The risk posed to a human being by any radiation exposure depends partly
upon the absorbed dose, the amount of energy absorbed per gram of tissue.
Absorbed dose is expressed in rad. A rad is equal to 100 ergs of energy
absorbed by 1 gram of tissue. The more modern, internationally adopted unit is
the gray (named for the English medical physicist L. H. Gray); one gray equals
100 rad. Almost all the documents from the time period studied by the Advisory
Committee use the term rad rather than gray. It is important to realize that

56

The Atomic Centwy

absorbed dose refers to energy per gram of absorbing tissue, not total energy.
Someone absorbing 1 gray (100 rad) in a small amount of tissue, such as a thyroid
gland, will absorb much less total energy than someone absorbing 1 gray (100
rad) throughout his or her entire body. Thus, when speaking of absorbed dose, it
is crucial to know the amount of tissue being exposed, not simply the number of
gray or rad.

What is an equivalent dose of radiation?

Even the rad or gray, though, are still units that measure a purely physical
event: the amount of energy left behind in a gram of tissue. It does not directly
measure the biological effect of that radiation. The biological effect of the same
amount of absorbed energy may vary according to the type of radiation involved.
This biological effect can be computed by multiplying the absorbed dose (in rad
or gray) by a number indicating the quality factor of the particular type of
radiation. For photons and electrons the quality factor is defined to be 1; for
neutrons it ranges from 5 to 20 depending on the energy of the neutron; for alpha
particles it is 20. m Thus, 1 gray (100 rad) of alpha particles is currently judged to
have an effect on living tissue that is twenty times more than 1 gray ( 1 00 rad) of x
rays. Multiplying the absorbed dose (in rad or gray) by the quality factor (also
known as the radiation weighting factor) produces what is called the equivalent
dose. For the period studied by the Advisory Committee, this was expressed in
terms of a unit called the rem, an acronym for roentgen equivalent man.105 (The
term equivalent simply meant that an absorbed dose expressed in rem would have
equivalent biological effects, regardless of the type of radiation. Thus, 10 rem of
x rays should have the same biological effect as 10 rem of neutrons absorbed by
the same part of the body.) The modern unit is the sievert (abbreviated Sv and
named for the prominent Swedish radiologist, Rolf Sievert), which is equal to 100
rem. Thus, an equivalent dose of 200 rem would today be expressed as 2 sievert.

What is an effective dose of radiation?

Finally, the biological effect of radiation depends on the type of tissue
being irradiated. As with different types of radiation, a weighting or quality
factor is introduced depending on the type of tissue. The more sensitive the tissue
is to radiation, the higher the factor. The effective dose is the sum of the
equivalent doses of the various types of irradiated tissue, each properly weighted
for its sensitivity to radiation. Tissue weighting factors are determined from the
relative incidence of cancers in different tissues in the Japanese survivors of the
atomic bombs.

Calculating the effective dose makes it possible to readily compare
different exposures, as illustrated by the accompanying graphs.

57

Experimental and Nonexperimental Doses*

Thyroid Studies with lodine-131

Effective Dose Equivalant (millirems, thyroid excluded)
350

Study 1 Study 2 Study 3 Study 4 Background

Largest Dose

Smallest Dose

Thyroid Studies with lodine-131

Dose to Thyroid Gland (rads)
600

Study 1 Study 2 Study 3
■ Largest Thyroid Dose H

Study 4 Medical Scan
Smallest Thyroid Dose

*The experiments themselves are discussed in chapter 7. These graphs are reproduced with permission
from Task Force on Human Subject Research, Commonwealth of Massachusetts Department of Mental
Retardation, April 1994, "A Report on the Use of Radioactive Materials in Human Subject Research that
Involved Residents of State-Operated Facilities within the Commonwealth of Massachusetts from 1942-
1973" (ACHRENo. MASS-072194-A), 17, and the Working Group on Human Subject Research,
Commonwealth of Massachusetts Department of Mental Retardation, June 1994, "The Thyriod Studies:
A Follow-up Report on the Use of Radioactive Materials in Human Subject Research that Involved
Residents of State-Operated Facilities within the Commonwealth of Massachusetts from 1942-1973"
(ACHRENo. MASS-072194-A), 14.

Fernald School Nutrition Study: Ca Tracer

Effective Dose Equivalent (millirems)
500

Smallest Dose Largest Dose

|H Annual Natural Background |

Denver Resident
Study

Fernald School Nutrition Study: Fe Tracer

Effective Dose Equivalent (millirems)
500

Smallest Dose Largest Dose Denver Resident

MB Annual Natural Background H] Study

Common Medical Procedures

Whole Body Effective Dose Equivalent (millirems)
1000

Chest X-Ray BackX-Ray Colon X-Ray Brain Scan
H| Annual Natural Background HH Procedure

Introduction

How Do We Measure the Biological Effects of Internal Emitters?

The general principles just described require further refinement when
applied to doses from internal emitters.

What information is needed to calculate absorbed dose of a
radionuclide inside the body?

Calculating the absorbed dose from a radionuclide inside the body is
complex since it involves both the physics of radioactive decay and the biology of
the body's metabolism. Six important factors that must be considered are these:

1. The amount of the radionuclide administered.

2. The type of radiation emitted during the decay process.

3. The physical half-life of the radionuclide.

4. The chemical form of the radionuclide.

5. The fraction of the radionuclide that accumulates in each organ.

6. The length of time that the radionuclide remains in the organ (the
biological half-life).

How varied are the types of radiation that different radionuclides
emit?

Radionuclides can emit several types of radiation (e.g., gamma rays, beta
or alpha particles). Each radionuclide emits its own unique mixture of radiations;
indeed, scientists identify radioactive materials by using these unique mixtures as
if they were fingerprints. The mix of radiations for a specific radionuclide is
always the same, regardless of whether the radionuclide is located on a bench in a
physicist's laboratory or inside the human body. This means that the type of
radiation of each radionuclide can be measured outside the body with great
precision by laboratory instruments. A quality factor, discussed earlier, is used to
adjust for the difference in the biological effects of different types of radiation.

What determines how long a radionuclide will irradiate the body?

The combination of the physical and biological half-life (the effective
half-life) determines how long a radionuclide will continue to pump out energy
into surrounding tissue. If the physical and biological half-lives of a particular
chemical form of a radionuclide are very long, the radionuclide will continue to
expose an individual to radiation over his or her lifetime. The total lifetime
radiation exposure, expressed in rem, is called the committed dose equivalent.

The physical half-life is the length of time it will take for half of the atoms
in a sample to decay to a more stable form. The physical half-life of each
radionuclide can be measured precisely in the laboratory. A shorter half-life
means that the miniature power source will "run down" sooner. Sometimes,
however, a radionuclide will not decay immediately to a stable form, but to a

60

The Atomic Century

second, still unstable, form. A full calculation, therefore, must also include the
types of radiation and physical half-lives of any decay products.

The biological half-life does not depend on the radionuclide but rather on
the chemical form of the radionuclide. One chemical form of the radionuclide
might be rapidly eliminated from the body whereas other chemical forms may be
slowly eliminated.

To measure the biological half-life of a particular chemical form of a
radionuclide, that chemical form needs to be studied in animals. Since the
biological processes of different animals vary considerably, an accurate
determination of the biological half-life requires that each chemical form of the
radionuclide be studied in each animal of interest. Prior to studying a chemical
form of a radionuclide in a human being, animal studies are performed to get
some idea of what to expect.

Once the results of animal studies are available, scientists are able to
predict what amount of that chemical form of the radionuclide can be safely
injected into humans. An accurate determination of what fraction of each
chemical form of the radionuclide accumulates in each organ and how long it
stays in each organ in humans can only be determined by studying humans.
These type of studies are called biodistribution studies.

What is the tissue weighting factor?

Some chemical forms of radionuclides are highly concentrated in one
small organ (e.g., iodine in the thyroid gland). When this happens, that organ will
absorb most of the radiated energy, and little energy will be deposited in the
remainder of the body. Thus, for each chemical form of a radionuclide, there is
an organ that will receive the highest dose from that radionuclide. Since organs
also vary greatly in their sensitivity to radiation, the biological consequences of
the radiation dose differ depending on the organ. This difference in sensitivity to
radiation is represented by what is called a tissue weighting factor.

What is the difference between committed equivalent dose and
committed effective dose?

An estimate of the risk posed by a radionuclide in the body depends on its
chemical form, its biodistribution, its physical properties (how it decays), and the
sensitivity of the organs exposed. When all these factors are considered in the
calculation of risk for a single radionuclide, the total lifetime exposure is called
the committed equivalent dose. If more than one radioisotope is present, the sum
of all the committed equivalent doses is called the committed effective dose. Both
are expressed in rem or the more modern units sieverts.m These calculations
provide a basis for comparing the risk posed by different isotopes.

How do radiation risks compare with chemical risks?

It should be noted that radiation is not the only possible hazard resulting

61

Introduction

from the medical use of radionuclides. Few radioisotopes, whether intentionally
or accidentally introduced into the body, enter in a chemically pure form. The
radioactive atoms are usually part of a larger chemical compound. The chemical
form of the radioisotope may pose its own hazards of chemical toxicity. Chemical
toxicity depends upon the chemical effect of the compound on the body, quite
independent of any effects of radiation. Determining chemical toxicity is an
entire field of science on its own.

How Do Scientists Determine the Long-Term Risks from Radiation?

Where did the risk estimates in this report come from?

Throughout this report, the reader will find numerous statements
estimating the risks of cancer and other outcomes to individuals exposed to
various types of radiation. These estimates were obtained from various scientific
advisory committees that have considered these questions in depth.107 Their
estimates in turn are based on syntheses of the scientific data on observed effects
in humans and animals.

How are risk estimates expressed?

Epidemiologists usually express the risk of disease in terms of the number
of new cases {incidence rate) or deaths (mortality rate) in a population in some
period of time. For example, an incidence rate might be 100 new cases per
100,000 people per year; a mortality rate might be 15 deaths per 100,000 people
per year. These rates vary widely by age, conditions of exposure, and various
other factors. To summarize this complex set of rates, government regulatory
bodies often consider the lifetime risk of a particular outcome like cancer. When
relating a disease, such as cancer, to one of its several causes, a more useful
concept is the excess lifetime risk expected from one particular pattern of
exposure, such as continuous exposure to 1 rad per year.

It is well established that cancer rates begin to rise above the normal
background rate only some time after exposure, the latent period, which varies
with the type of cancer and other factors such as age. Even after the latent period
has passed and radiation effects begin to appear, not all effects are due to
radiation. The excess rate may still vary by age, latency, or other factors, but for
many cancers it tends to be roughly proportional to the rate in the general
population. This is known as the constant relative risk model, and the ratio of
rates at any given age between exposed and unexposed groups is called the
relative risk. Many advisory committees have based their risk estimates on
models for the relative risk as a function of dose and perhaps other factors. Other
committees, however, have based their estimates on the difference in rates
between exposed and unexposed groups, a quantity known as the absolute risk.
This quantity also varies with dose and other factors, but when this variation is
appropriately accounted for, either approach can be used to estimate lifetime risk.

62

The Atomic Century

What are the types of data on which such estimates are based?

Human data are one important source, discussed below. Two other
important sources of scientific data are experiments on animals and on cell
cultures. Because both types of research are done in laboratories, scientists can
carefully control the conditions and many of the variables. For the same reason,
the experiment can be repeated to confirm the results. Such research has
contributed in important ways to our understanding of basic radiobiological
principles. It also has provided quantitative estimates of such parameters as the
relative effectiveness of different types of radiation and the effects of dose and
dose rate. In some circumstances, where human data are limited or nonexistent,
such laboratory studies may provide the only basis on which risks can be
estimated.

Why are human data preferable to data on animals or tissue cultures
for most purposes?

Most scientists prefer to base risk estimates for humans on human data
wherever possible. This is because in order to apply animal or tissue culture data
to humans, scientists must extrapolate from one species to another or from simple
cellular systems to the complexities of human physiology. This requires adjusting
the data for differences among species in life span, body size, metabolic rates, and
other characteristics. Without actual human data, extrapolation provides no
guarantee that there are no unknown factors also at work. It is not surprising that
there is no clear consensus as to how to extrapolate risk estimates from one
species to another. This problem is not unique to radiation effects; there are
countless examples of chemicals having very different effects in different species,
and humans can differ quite significantly from animals in their reaction to toxic
agents.

How have human data been obtained?

There are serious ethical issues with conducting experiments on humans,
as discussed elsewhere in the report. However, most of the human data that are
used to estimate risks, not just risk from radiation, come from epidemiologic
studies on populations that already have been exposed in various ways. For
radiation effects, the most important human data come from studies of the
Japanese atomic bomb survivors carried out by the Radiation Effects Research
Foundation (formerly the Atomic Bomb Casualty Commission) in Hiroshima.
Other valuable sources of data include various groups of medically exposed
patients (such as radiotherapy patients) and occupationally exposed workers (such
as the uranium miners, discussed in chapter 12). I08

63

Introduction

Why is it necessary to compare exposed populations with unexposed
populations?

Unlike a disease caused by identifiable bacteria, no "signature" has yet
been found in cancerous tissue that would link it definitively to prior radiation
exposure. Radiogenic cancers are identical in properties, such as appearance
under a microscope, growth rate, and potential to metastasize, to cancers
occurring in the general population. Finding cancers in an exposed population is
not enough to prove they are due to radiation; the same number of cancers might
have occurred due to the natural frequency of the disease. The challenge is to
separate out the effects of radiation from what would otherwise have occurred. A
major step in this direction is to develop follow-up (or cohort) studies, in which
an exposed group is followed over time to observe their disease rates, and these
rates are then compared with the rates for the general population or an unexposed
control group.109

Why is the analysis of epidemiologic data so complicated?

Simply collecting data on disease rates in exposed and control populations
is not enough; indeed, casual analysis may lead to serious errors in understanding.
Sophisticated data-collection techniques and mathematical models are needed to
develop useful risk estimates for several reasons:

1 . Random variation due to sample size.

2. Multiple variables.

3. Limited time span of most studies.

4. Problems of extrapolation.

In addition, individual studies may also be biased in their design or
implementation.

What is random variation?

The observed proportion of subjects developing disease in any randomly
selected subgroup (sample) of individuals with similar exposures is subject to the
vagaries of random variation.

A simple-minded example of this is the classic puzzle of determining, in a
drawer of 100 socks, how many are white and how many are black, by pulling out
one sock at a time. Obviously, if we pull out all the socks, we know for certain.
In most areas of study, though, "pulling out all the socks" is far too expensive and
time-consuming. But if we pull only 10, with what degree of confidence can we
predict the color of the others? If we pull 20, we will have more confidence. In
other words, the larger the sample, the greater our confidence. Using statistical
techniques, our degree of confidence can be calculated from the size of the entire
population (in this case 100 socks) and the size of the actual sample. The result is
popularly called the margin of error.

64

The Atomic Century

The most common examples of this in everyday life are the public opinion
polls continually quoted in the news media. As can be seen in the simple example
of the drawer of socks, the highest degree of confidence can be achieved simply
by pulling all the socks out of the drawer. For public opinion polls, this would be
far too expensive; instead, a small sample is selected at random from the
population. Nowadays it is common to report not only the actual results, but also
the sample size and the margin of error. The margin of error depends not only on
the sample size, but also on how high a degree of confidence we desire. The
degree of confidence is the probability that our sample has provided a true picture
of the entire population. For example, the margin of error will be smaller for 80
percent degree of confidence than for 95 percent. Even where a study covers an
entire exposed population, such as the atomic bomb survivors, the issue of
random variation remains when we wish to generalize the findings to other
populations.

What are multiple variables'!

The effects of radiation will depend upon, or vary, with the dose of
radiation received. However, these effects also may vary with other factors-
other variables-thai are not dependent upon the radiation dose itself. Examples
of such variables are age, gender, latency (time since exposure), and smoking.
Data on these other variables must be collected as well as data on the basic
elements of radiation dose and disease. The challenge is to then distinguish
between disease rates due to radiation and those due to other factors. For
example, if the population studied were all heavy smokers, this might explain in
part a higher rate of lung cancer. Much of the science of epidemiology is devoted
to choosing what factors to collect data on and then developing the multivariate
mathematical models needed to separate out the effect of each variable.
Radiation effects vary considerably across subgroups and over time or age.
Because of this, direct estimates of risk for particular subgroups would be very
unstable. Mathematical models must be used. These models allow all the data to
be used to develop risk estimates that, while based on sufficiently large estimates
to be stable, will be applicable to particular subgroups.

A more subtle problem is mis specification of the model finally chosen to
calculate risks. The model may weigh selected factors in a manner that best fits
the data from a statistical viewpoint. This model, while fitting the data, may not
actually be a "correct" view of nature; another model that does not fit the data
quite as well may actually better describe the as-yet-unknown underlying
mechanisms.

Why does a limited time span reduce the value of a study?

The most pronounced effects of large exposures to radiation manifest
themselves quickly in symptoms loosely termed radiation sickness.

However, another concern is understanding the effects of much lower

65

Introduction

levels of radiation. Unlike the more acute effects of large exposures, these may
not appear for some time. Some cancers, for example, do not appear until many
years after the initial exposure. These latent effects may continue to appear in a
population throughout their entire lifetimes. Calculating the lifetime risk of an
exposure requires following the entire sample until all its members have died.
Thus far, none of the exposed populations have yet been followed to the ends of
their lives, although the radium dial painter study for the group painting before
1930 essentially has been completed, and the follow-up has been closed out."0

Why does extrapolation among human populations pose problems?

As discussed earlier, extrapolating results from one species to another is
problematic due to differences in how species respond to radiation.

Even though humans are all members of the same species, there are
similar problems when extrapolating results from one group of humans to another
group. Within the human species, different groups can have different rates of
disease. For example, stomach cancer is much more common and breast cancer
much rarer among Japanese than among U.S. residents.

How then should estimates of the radiation-induced excess of cancer
among the atomic bomb survivors be applied to the U.S. population?
Assumptions are needed to "transport" risk estimates from one human population
to another human population that may have very different "normal" risks.

Why does extrapolation from high to low doses pose problems?

Acquiring high-quality human data on low-dose exposure is difficult. Past
studies indicate that the effects of low doses are small enough to be lost in the
"noise" of random variation. In other words, the random variation due to sample
size may be greater than the effects of the radiation. Thus, to estimate the risks of
low doses, it is necessary to extrapolate from the effects of high doses down to
the lower range of interest. As with extrapolation among species or among
human populations, assumptions must be made.

The basic assumption concerns the dose effect. Is the effect of a dose
linear? This would mean that half the dose would produce half the effect; one-
tenth of the dose would produce one-tenth of the effect, and so forth. Nature is
not always so reasonable, however. There are many instances in nature of
nonlinear relationships. A nonlinear dose effect, for example, could mean that
half the dose would produce 75 percent of the effects. Or, going in the other
direction, a nonlinear dose effect could mean that half the dose would produce
only 10 percent of the effect. Reliable data are too sparse to settle the issue
empirically. Much of the ongoing controversy over low-dose effects concerns
which dose effect relationship to assume. Concerning dose response, most
radiation advisory committees assume that radiation risks are linear in doses at
low levels, although these risks may involve nonlinear terms at higher doses.

Another assumption concerns the effect of dose rate. It is generally

66

The Atomic Century

agreed that the effect of high-dose x rays is reduced if the radiation is received
over a period of time instead of all at once. (This reduction in acute effects, due
to the cell's ability to repair itself in between exposures, is one of the reasons that
modern protocols for radiotherapy use several fractionated doses.) The degree to
which this also happens at low doses is less clear. There are few human data on
the effect of dose rate on cancer induction. Most estimates of the effect come
from animal or cell culture experiments. There is also evidence of quite different
dose-rate effects for alpha radiation and neutrons.

How can a specific study be biased?

When applied to an epidemiologic study, the term bias does not refer to
the personal beliefs of the investigators, but to aspects of the study design and
implementation. There are several possible sources of bias in any study.

What is called a confounding bias may result if factors other than radiation
have affected disease rates. Such factors, as mentioned earlier, might be a rate of
smoking higher than the general population.

A selection bias may result if the sample was not truly a random selection
from the population under study. For example, the results of a study that includes
only employed subjects might not be applicable to the general population, since
employed people as a group are healthier than the entire population.

An information bias may result from unreliability in a source of basic
data. For example, basing the amount of exposure on the memory of the subjects
may bias the study, since sick people may recall differently than healthy people.
Dose, in particular, can be difficult to determine when studies are conducted on
populations exposed prior to the study, since there usually was no accurate
measurement at the time of exposure. Sometimes when dose measurements were
taken, as in the case of the atomic veterans, the data are not adequate by today's
standards."1

Finally, any study is subject to the random variation discussed earlier,
which depends on how large the sample is. This is more important for low-dose
than for high-dose studies, since the low-dose effects themselves are small
enough to be lost amid random variations if the sample is too small.

To summarize, multiple studies may produce somewhat different results
because there is an actual difference in the response between populations or
because studies contain spurious results due to their own inadequacies. In
addition, it must be recognized that the entire body of scientific literature is itself
subject to a form of bias known as publication bias, meaning an overreporting of
findings of excess risk. This is because studies that demonstrate an excess risk
may be more likely to be published than those that do not.

67

Introduction

In view of all these uncertainties, what risk estimates did the
Committee choose?

Despite all these uncertainties, it must be pointed out that more is known
about the effects of ionizing radiation than any other carcinogen.

The BEIR V Committee of the National Academy of Sciences estimated
in 1990 that the lifetime risk from a single exposure to 10 rem of whole-body
external radiation was about 8 excess cancers (of any type) per 1,000 people.
(This number is actually an average over all possible ages at which an individual
might be exposed, weighted by population and age distribution.) For continuous
exposure to 0.1 rem per year throughout a lifetime, the corresponding estimate
was 5.6 excess cancers (that is, over and above the rate expected in a similar, but
nonexposed population) per 1 ,000 people. It is widely agreed that for x rays and
gamma rays, this latter figure should be reduced by some factor to allow for a
cell's ability to repair DNA, but there is considerable uncertainty as to what figure
to use; a figure of about 2 or 3 is often suggested."2

The estimates of lifetime risk from the BEIR V report have a range of
uncertainty due to random variation of about 1.4-fold. The additional
uncertainties, due to the factors discussed earlier, are likely to be larger than the
random variation.

In comparison, for most chemical carcinogens, the uncertainties are often
a factor of 10 or more. This agreement among studies of radiation effects is quite
remarkable and reflects the enormous amount of scientific research that has been
devoted to the subject, as well as the large number of people who have been
exposed to doses large enough to show effects.

68

ENDNOTES

1 . In 1974 the AEC's regulatory activities for civilian nuclear power and the use
(including medical research) of radioisotopes produced in nuclear reactors were
transferred to the Nuclear Regulatory Commission and its research and weapons-
development activities to the Energy Research and Development Administration
(ERDA) In 1 977 ERDA was incorporated into the new Department of Energy.

2. Captain C. F. Behrens, ed., Atomic Medicine (New York: Thomas Nelson and
Sons, 1949), 3.

3. Ibid., 7.

4 Otto Glasser, William Conrad Roentgen and the Early History oj the
Roentgen Rays (Springfield, 111., and Baltimore: Charles C. Thomas, 1934), 29; Glasser is
quoting O. Lummer of Berlin.

5. Ibid., 271.

6. Ibid., 244-282.

7. Robert Reid, Marie Curie (New York: E. P. Dutton, 1974), 241.

8. Ibid., 86-87.

9. P. Curie and M. S. Curie, "Radium: A New Body, Strongly Radio-Active,
Contained in Pitchblende," Scientific American (28 January 1899): 60. The term
hyperphosphorescence was suggested by Silvanus Thompson. Reid, Marie Curie, 87.
See also Susan Quinn, Marie Curie: A Life (New York: Simon and Schuster, 1995).

10. New York Journal, 21 June 1905, reproduced in David J. DiSantis, M.D.,
and Denise M. DiSantis, "Radiologic History Exhibit: Wrong Turns on Radiology's Road
of Progress," Radiographics (1991): 1 121-1 138, figure 17.

11. Henry S. Kaplan, "Historic Milestones in Radiobiology and Radiation
Therapy," Seminars in Oncology 6, no. 4 (December 1979): 480.

12. "Autopsy of a Radiologist," Archives of the Roentgen Ray 18

(April 1914): 393. .

13 Reid, Marie Curie, 274; Barton C. Hacker, The Dragon's Tail: Radiation
Safety in the Manhattan Project, 1942-1946 (Berkeley, Calif: University of California

Press, 1987), 22-23.

14. The marketing of one nostrum containing radium, Radiothor, was not
officially shut down by the Federal Trade Commission until 1932. "With the institution
of regulations, the radioactive patent medicine industry collapsed overnight." Roger M.
Macklis, "The Great Radium Scandal," Scientific American 269 (March 1993): 94-99.
In the 1920s, the use of capsules containing radium inserted into the nose was introduced
as a means of shrinking lymphoid tissue in children to treat middle ear obstructions and
infections. During World War II this procedure was used on submariners and Air Force
personnel as treatment and, in the case of several hundred submariners, on an
experimental basis to test the effectiveness of nasopharyngeal irradiation in shrinking
lymphoid tissue and equalizing external and middle ear pressure. In the late 1940s, the
observation that no controlled study had ever been conducted to test the treatment's
effectiveness in preventing deafness in children led Johns Hopkins researchers to begin
the experimental treatment of several hundred children. As the Advisory Committee
began its work in 1994, controversy over the long-term effects of this treatment still
swirled. Samuel Crane, "Irradiation of Nasopharynx," Annals of Otology, Rhinology, and
Laryngology 55 (1946): 779-788; H. L. Holmes and J. D. Harris, "Aerotitis Media in

69

Submariners," Annals of Otology, Rhinology, and Laryngology 55 (1946): 347-371. See
chapter 7 and ACHRE Briefing Book, vol. 13, tab E, April 1995, for fuller discussion.

15. Macklis, "The Great Radium Scandal," 94-99.

16. The National Council on Radiation Protection began as the American
Committee on X Ray and Radium Protection in 1928, under the aegis of the International
Congress of Radiology. A private organization, its members were physicians, physicists,
and representatives of the equipment manufacturers. Prior to World War II its main
function was to issue recommendations on radiological safety, which were published by
the National Bureau of Standards (a federal agency). At times this arrangement created
confusion, leading people to believe the publications were official recommendations.
After the war, the private group was revived as the National Committee on Radiation
Protection. In 1956 it was renamed the National Committee on Radiation Protection and
Measurements. In the early 1 960s, it received a congressional charter and was renamed
the National Council on Radiation Protection and Measurements. Throughout its history
it has coordinated its activities with other groups, such as the International Commission
on Radiological Protection' and committees of the National Academy of Sciences (known
as the BEAR and BEIR Committees). The most complete record of the NCRP's activities
is Lauriston S. Taylor, Organization for Radiation Protection: The Operations of the
ICRPandNCRP, 1928-1974 (Washington, D.C.: Office of Technical Information, U.S.
Department of Energy.) Lauriston Taylor, a physicist at the National Bureau of
Standards, served as the executive director of the organization from its founding in 1 928
to 1974. For further background on the history of radiation protection, see Daniel P.
Serwer, The Rise of Radiation Protection: Science, Medicine and Technology in Society,
1896-1935 (Ph.D. diss, in the History of Science, Princeton University, 1976) (Ann
Arbor: University Microfilms 77-14242, 1977); Gilbert F. Whittemore, The National
Committee on Radiation Protection, 1928-1960: From Professional Guidelines to
Government Regulation (Ph.D. diss, in the History of Science, Harvard University, 1986)
(Ann Arbor: University Microfilms 87-04465, 1987); J. Samuel Walker, "The
Controversy Over Radiation Safety: A Historical Overview," Journal of the American
Medical Association 262 (1989): 664-668; D. C. Kocher, "Perspective on the Historical
Development of Radiation Standards," Health Physics 61, no. 4 (October 1994).

17. Heinz Haber, The Walt Disney Story of Our Friend the Atom (New York:
Simon and Schuster, 1956), 152. The German-born Dr. Haber had come to the United
States in 1947 to work for the Air Force School of Aviation Medicine and was a
cofounder of the field of space medicine. In the early 1950s he joined the faculty of the
University of California at Los Angeles. As Spencer Weart, a historian of the images of
the atomic age has recorded, the accompanying Walt Disney movie Our Friend the Atom,
which was shown on television and in schools beginning in 1957, was probably the most
effective of educational films on the perils and potential of atomic energy. "The great
storyteller introduced the subject as something 'like a fairy tale,' indeed the tale of a genie
released from a bottle. The cartoon genie began as a menacing giant. . . . But scientists
turned the golem into an obedient servant, who wielded the 'magic power' of
radioactivity. . . ." Spencer R. Weart, Nuclear Fear: A History of Images (Cambridge,
Mass.: Harvard University Press, 1988), 169.

18. Marshall Brucer, Chronology of Nuclear Medicine (St. Louis: Heritage
Publications, 1990), 199-200. Radon is a gas at room temperature. Doctors developed
an innovative system for capturing radon from used cancer therapy vials and dissolving
it in a saline solution, which was then injected.

70

19. Haber, Our Friend the Atom, 152.

20. J. L. Heilbron and Robert W. Seidel, Lawrence and His Laboratory: A
History of the Lawrence Berkeley Laboratoiy, vol. 1 (Los Angeles: University of
California Press, 1989). The birth and development of nuclear medicine at the University
of California's Berkeley and San Francisco branches is the subject of a case study in a
supplemental volume to this report.

21. John Stanbury, A Constant Ferment (Ipswich, N.Y.: Ipswich Press, 1991),
57-67.

22. Stafford Warren, interview by Adelaide Tusler (Los Angeles: University of
California), 23 June 1966 in An Exceptional Man for Exceptional Challenges, Vol. 2
(Los Angeles: University of California, 1983) (ACHRE No. UCLA-101794-A-1), 421-
422.

23. Manhattan Project researchers focused on polonium in the development of
the initiator for the bomb. See Richard Rhodes, The Making of the Atomic Bomb (New
York: Simon and Schuster, 1986), 578-580.

24. Manhattan District Program, 31 December 1946 (book 1, "General," volume
7, "Medical Program") (ACHRE No. NARA-052495-A-1), 2.2.

25. Stafford Warren in Radiology in World War II, ed. Arnold Lorentz Ahnfeldt
(Washington, D.C.: GPO, 1966), 847.

26. Robert Stone, 10 May 1943 ("Health Radiation and Protection") (ACHRE
No. DOE-011195-B-1).

27. Philip J. Close, Second Lieutenant, JAGD, to Major C. A. Taney, Jr., 26
July 1945 ("Determination of Policy on Cases of Exposure to Occupational Disease")
(ACHRE No. DOE-120894-E-96), 1.

28. Ibid., 3.

29. Response to ACHRE Request No. 012795-B, Oak Ridge Associated
Universities, D. M. Robie to A. ("Tony") P. Polendak, 15 June 1979 ("Storage of records-
-Shipment 1161").

30. The story of this early Hanford research is told in Neal D. Hines, Proving
Ground: An Account of the Radiobiological Studies in the Pacific 1946-61 (Seattle:
University of Washington Press, 1962). As Hines explains, the initial study of the effect
of radioactivity on aquatic organisms was undertaken by a University of Washington
researcher. The program could not be identified with the Columbia River, and the
research was to be conducted in a normal campus setting. The project's name ("Applied
Fisheries Laboratory") was selected to disguise its work. The primary researcher initially
did not know the true purpose, and the university accepted the work for undisclosed
purpose on the assurance that national security required it.

3 1 . Harold Hodge, interview by J. Newell Stannard, transcript of audio
recording, 22 October 1980 (ACHRE No. DOE-061794-A-4), 21-22. Stafford Warren,
interview by J. Newell Stannard, transcript of audio recording, 7 February 1979 (ACHRE
No. DOE-061794-A), 3.

32. Henry DeWolf Smyth, Atomic Energy for Military Purposes: The Official
Report on the Development of the Atomic Bomb under the Auspices of the United States
Government, 1940-45 (Princeton, N.J.: Princeton University Press, 1945).

33. The organizational history of the Department of Defense is chronicled in
The Department of Defense: Documents on Establishment and Organization 1944-1978,
eds. Alice C. Cole, Alfred Goldberg, Samuel A. Tucker, Rudolf A. Winnacker
(Washington, D.C.: Office of the Secretary of Defense, Historical Office, 1978).

71

34. The program expanded from the base of Manhattan Project research sites
such as Oak Ridge, Hanford, Chicago, and the Universities of California, Chicago, and
Rochester to take in a growing portion of the university research establishment. The
minutes of the January 1947 meeting record an ambitious program to focus on the
physical measurement of radiation, the biological effects of radiation, methods for the
detection of radiation damage, methods for the prevention of radiation injury, and
protective measures. There followed an itemized list of the work to be done at Argonne
National Laboratory, Los Alamos, Monsanto, Columbia University, and the Universities
of Michigan, Rochester, Tennessee, California, and Virginia.

The University of Rochester was to be the largest university contractor, receiving
more than $1 million, followed by the University of California (about one-half million
for UCLA, where Stafford Warren was dean of the new medical school, and Berkeley, to
which Stone had returned to join Hamilton), Western Reserve (to which Warren's deputy
Hymer Friedell was headed), and Columbia (more than $100,000). Argonne received an
amount comparable to Rochester; other labs, including Los Alamos National Laboratory
and Clinton Laboratories (now Oak Ridge National Laboratory), were scheduled for
$200,000 or less. Stafford Warren, Interim Medical Committee, proceedings of 23-24
January 1947 (ACHRE No. UCLA-1 1 1094-A-26). See also ACHRE Briefing Book, vol.
3, tab F, document H.

35. "Report of the Board of Review," 20 June 1947, attached to letter from
David Lilienthal, Chairman, AEC, to Dr. Robert F. Loeb, Chairman, AEC Medical Board
of Review, 27 June 1947 ("At the conclusion of the deliberations . . .") (ACHRE No.
DOE-051094-A-191), 3-4.

36. The Advisory Committee has assembled the minutes of the meetings, and
such transcripts as have been retrieved.

37. Shields Warren, interview by Dr. Peter Olch, National Library of Medicine,
transcript of audio recording, 10-11 October 1972, 59.

38. Harry H. Davis, "The Atom Goes to Work for Medicine," New York Times
Magazine, 26 September 1946 (ACHRE No. DOE-051094-A-408).

39. Marshall Brucer, M.D., Chairman, Medical Division, Oak Ridge Institute
for Nuclear Studies, wrote:

Paul Aebersold's isotopes division was the only safely nonsecret part of
AEC. Aebersold had unlimited funds, unlimited radioisotopes, and
seemingly unlimited energy to promote the unlimited cures that had been
held back from the American public for too long. The liberal
establishment was in the depths of shame for having ended the war by
killing people. Radioisotopes didn't kill people; they cured cancer.

Aebersold spoke at every meeting of one person or more that had one
minute or more available on its program. No matter what the meeting's
subject, Aebersold's topic was always the same. He sold isotopes.

Marshall Brucer, "Nuclear Medicine Begins with a Boa Constrictor," Journal of Nuclear

Medicine 19, no. 6 (1978): 595.

40. Isotopes Division, prepared for discussion with general manager, "Present
and Future Scope of Isotope Distribution," 4 March 1949 (ACHRE No. DOE-01 1895-B-
1).

41. Interview with Shields Warren, 10-11 October 1972, 76.

72

42. Isotopes Division, 4 March 1949, 2.

43. See Kaplan, "Historic Milestones," 480.

44. "Summary of Congressional Hearings on Fellowship Issue," 16 May 1949
(ACHRE No. DOE-061395-D-1).

45. Advisory Committee for Biology and Medicine, proceedings of 10
September 1949 (ACHRE No. DOE-072694-A), 18.

46. Ibid, 19.

47. For a further discussion of the contemplated secret record keeping by the
VA, see chapter 10. As noted there, a VA investigation concluded that the "confidential"
division was never activated.

48. The VA provided the Advisory Committee with capsule descriptions of
experiments, which appeared in periodic VA reports of the time. In fact, the number of
descriptions exceeded 3,000 for the portion of the 1944-74 period the reports covered.
However, further information on the vast majority of the experiments was typically
unavailable, and the VA noted that some of the descriptions may be redundant (or reflect
refunding of a single experiment), and some may not have involved humans. Therefore,
the "more than 2,000" reflects a very rough estimate adjusted for these considerations.

49. Paul C. Aebersold, address before Rocky Mountain Radiological Society, 9
August 1951 ("The United States Atomic Energy Program: Part I-Overall Progress")
(ACHRE No. TEX- 101294- A- 1), 6.

50. By 1955 the program was receiving 8,000 applications a year, including
hundreds from abroad. A July 1955 Aebersold summary of accomplishments pronounced
that, as a result of the program, there were now 1 00 companies in the radiation instrument
business, two dozen suppliers of commercially labeled compounds, pharmaceutical
companies, hundreds of isotope specialists, a half-dozen waste disposal firms, and ten
safety monitoring companies. Also, 2,693 U.S. institutions had received isotope
authorization, including 1,126 industrial firms, 1,019 hospitals and private physicians,
220 colleges and universities, 244 federal and state laboratories, and 47 foundations.
"Capsule Summary of Isotopes Distribution Program," July 1955 (ACHRE No. TEX-
101294-A-2).

5 1 . Vannevar Bush, Pieces of the Action (New York: William Morrow and
Company, 1970), 65.

52. Ibid.

53. In addition to direct grants to private institutions the AEC pioneered the
creation of research consortia. In 1946, for example, the University of Tennessee and a
consortium of southeastern universities urged the Manhattan Project to establish the Oak
Ridge Institute of Nuclear Studies (ORINS). Following the creation of the AEC, ORINS
operated under AEC contract to train researchers and to operate a clinical research facility
focused on cancer. In 1966 ORINS became known by the name of its operating
contractor, the Oak Ridge Associated Universities, and the research facility is now known
as the Oak Ridge Institute for Science and Education (ORISE).

54. Donald C. Swain, "The Rise of a Research Empire: NIH, 1930 to 1950,"
Science 138, no. 3546 (14 December 1962): 1235. The National Institutes of Health
began as the Laboratory of Hygiene in 1887. It was renamed the National Institutes of
Health in 1948.

55. Assistant Director, Office of Extramural Research, National Institutes of
Health, to Anna Mastroianni, Advisory Committee, 16 July 1995 ("Comments on Draft
Chapters of ACHRE Final Report").

73

56. Interview with Shields Warren, 10-1 1 October 1972, 78.

57. Robert S. Stone, M.D., to Lieutenant Colonel H. L. Friedell, U.S. Engineer
Corps, Manhattan District, 9 August 1945 ("In reading through the releases . . .")
(ACHRE No. DOE-121494-D-2).

58. Robert S. Stone, M.D., to Lieutenant Colonel H. L. Friedell, U.S. Engineer
Corps, Manhattan District, 9 August 1945 ("As you and many others are aware, a great
many of the people . . .") (ACHRE No. DOE-121494-D-1).

59. Jonathan M. Weisgall, Operation Crossroads: The Atomic Tests at Bikini
Atoll (Annapolis, Md.: Naval Institute Press, 1994). For a contemporary account by a
doctor who served as a radiation monitor, see David Bradley, No Place to Hide (Boston:
Little, Brown and Co., 1948).

60. Weisgall, Operation Crossroads, 266-270.

61. "History of the U.S. Naval Radiological Defense Laboratory, 1946-58"
(ACHRE No. DOD-071494-A-1), 1.

62. The Joint Panel was the child of the Committee on Medical Science and
Committee on Atomic Energy (hence the term Joint), both of which, in turn, were
committees of the Defense Department's Research and Development Board. That board
served as the secretary of defense-level coordinator of departmentwide R&D.

63. The Committee has assembled the charter, agenda, reports, and available
minutes of the Joint Panel. ACHRE Research Collection Series, Library File,
Compilation of the Minutes of the Joint Panel on Medical Aspects of Atomic Warfare,
1948-1953(1994).

64. Howard Andrews, interview by Gilbert Whittemore (ACHRE staff),
transcript of audio recording, 3 December 1994 (ACHRE Reseach Project, Interview
Series, Targeted Interview Project).

65. In a February 1950 paper, the Public Health Service explained its role in
national defense:

During and since WW II, science and technology have
introduced new weapons and whole new industries
whose effects on human health have not been precisely
determined and effective methods against these hazards
have not yet been developed.

If, for example, an atomic bomb were to burst over a
large city in this country, tens of thousands of burned and
injured people could not be given effective treatment
because science has not yet found the practical means. . . .
The operation of atomic piles and related facilities also
presents a variety of problems as to human tolerance of
radiation and the disposition of radioactive substances.

"The U.S. Public Health Service and National Defense," February 1950 (ACHRE No.

HHS-071394-A-2), 1.

66. National Institutes of Health, 2 August 1952 ("Assumptions Underlying
NIH Defense Planning") (ACHRE No. HHS-071394-A-1).

67. Advisory Committee for Biology and Medicine, transcript (partial) of
proceedings of 10 November 1950 (ACHRE No. DOE-012795-C-1). While the
document is undated, discussion of the meeting appears in the November 1950 ACBM

74

minutes (12); a letter from Alan Gregg, Chairman, ACBM, to Gordon Dean, Chairman,
AEC, 30 November 1950 ("The Advisory Committee for Biology and Medicine held
their twenty-fourth . . .") (ACHRE No. DOE-072694-A); and a letter from Marion W.
Boyer, AEC General Manager, to Honorable Robert LeBaron, Chairman, Military
Liaison Committee, 10 January 1951 ("As you know, one of the important problems . .
.") (ACHRE No. DOE-040395-A-1).

68. Behrens, transcript, proceedings of 10 November 1950, 2.

69. Powell, transcript, proceedings of 10 November 1950, 8-10.

70. Cooney, transcript, proceedings of 10 November 1950, 6.

71. Ibid., 7.

72. Ibid., 6.

73. Ibid., 7-8.

74. Warren, transcript, proceedings of 10 November 1950, 13.

75. Ibid., 14.

76. Ibid., 15.

77. Cooney, transcript, proceedings of 10 November 1950, 15.

78. Ibid., 16.

79. "Notes on the Meeting of a Committee to Consider the Feasibility and
Conditions for a Preliminary Radiological Safety Shot for Operation 'Windsquall,'" 2 1 -
22 May 1951 (ACHRE No. DOE-030195-A-1), 41.

80. Ibid., 40.

81. Ibid., 19.

82. T. L. Shipman, Health Division Leader, to Alvin Graves, J-Division Leader,
27 December 1951 ("Summary Report Rad Safe and Health Activities at Buster- Jangle")
(ACHRE No. DOE-033195-B-1).

83. [AEC] Board of Review to the Atomic Energy Commission, 20 June 1947
("Report of the Board of Review") (ACHRE No. DOE-071494-A-4), 10.

84. NEPA Medical Advisory Panel, Subcommittee No. IX, "An Evaluation of
Psychological Problem of Crew Selection Relative to the Special Hazards of Irradiation
Exposure," 22 July 1949 (ACHRE No. DOD-121494-A-2), 20.

85. Ibid., 27.

86. Ibid., 22.

87. Definition of "curie," The Compact Edition of the Oxford English Dictionaiy
(Oxford, England: Oxford University Press, 1971), 3937.

88. J. Newell Stannard, Radioactivity and Health: A History (Oak Ridge, Tenn.:
Office of Scientific and Technical Information, 1988), 9.

89. Hanson Blatz, ed., Radiation Hygiene Handbook (New York: McGraw-Hill
Book Co., 1959), 6-185.

90. Richard G. Hewlett and Oscar E. Anderson, The New World: A Histo>y of
the Atomic Energy Commission, Vol. I: 1939-1946 (Berkeley: University of California
Press, 1990), reprint of 1962 edition, 107-108.

91. Eric Hall, Radiobiology for the Radiologist, 4th ed. (Philadelphia: J. B.
Lippincott, 1994), 3.

92. Ibid., 5.

93. The DNA strand would be about 5 centimeters (cm) long; the average cell
diameter is about 20 microns (0.002 cm). Bruce Alberts et al., eds., Molecular Biology of
the Cell (New York: Garland, 1983), 385-388.

94. Hall, Radiobiology for the Radiologist, 4th ed., 9-10.

75

95.

Ibid.

96.

Ibid.,

30.

97.

Ibid.,

32-33.

98.

Ibid.,

312.

99.

Ibid.,

324.

100

. Ibid

101. International Commission on Radiological Protection, Recommendations:
ICRP Publication No. 60 (New York: Pergamon Press, 1991), cited in Hall,
Radiobiology for the Radiologist, 4th ed., 456.

102. Hall, Radiobiology for the Radiobiologist, 4th ed., 355.

103. Committee on the Biological Effects of Ionizing Radiation, National
Research Council, Health Effects of Exposure to Low Levels of Ionizing Radiation: BEIR
V (Washington, D.C.: National Academy Press, 1990), 2-4.

104. International Commission on Radiological Protection, Recommendations:
ICRP Publication No. 60, quoted in Hall, Radiobiology for the Radiologist, 4th ed., 455.

105. ". . . roentgen equivalent man, or mammal (rem). The dose of any ionizing
radiation that will produce the same biological effect as that produced by one roentgen of
high-voltage x-radiation." Blatz, ed., Radiation Hygiene Handbook, 2-19.

106. Hall, Radiobiology for the Radiobiologist, 4th ed., 458.

107. These include the National Council on Radiation Protection and
Measurement (NCRP), the International Commission on Radiation Protection (ICRP), the
United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR),
the Committee on the Biological Effects of Ionizing Radiation (BEIR) of the National
Research Council, and the Environmental Protection Agency (EPA).

108. In addition, there have been a number of studies of people exposed to low
levels of radiation, including military personnel and residents subject to fallout from
nuclear weapons testing, workers at and residents near nuclear facilities, patients given
diagnostic x rays, and regions with high natural background radiation. Most of these
either have not produced convincing positive results or are unsuitable for risk assessment
because of the statistical instability of their estimates.

109. Some indirect estimates have been based on "case control" studies, in which
diseased cases are compared with unaffected controls to look for differences in their past
exposures that could account for their different outcomes.

General reference works include D. G. Kleinbaum, W. Kupper, and H.
Morgenstern, Epidemiologic Research: Principles and Quantitative Methods (Belmont,
Calif.: Lifetime Learning Publications, 1982), and J. D. Boice, Jr., and J. E. Fraumeni, Jr.,
Radiation Carcinogenesis: Epidemiology and Biological Significance (New York: Raven
Press, 1984).

110. Dr. Shirley Fry to Bill LeFurgy, 31 August 1995 ("HRE Draft Final
Report"), 8, contained in Ellyn Weiss, Special Counsel and Director, Office of Human
Radiation Experiments, DOE, to Anna Mastroianni, ACHRE, 1 1 September 1995.

111. "[T]he NTPR dose data are not suitable for dose-response analysis."
Institute of Medicine, "A Review of the Dosimetry Data Available in the Nuclear Test
Personnel Review (NTPR) Program, An Interim Letter Report of the Committee to Study
the Mortality of Military Personnel Present at Atmospheric Tests of Nuclear Weapons to
the Defense Nuclear Agency" (Washington, D.C.: Institute of Medicine, May 15, 1995),
2.

76

1 12. Committee on the Biological Effects of Ionizing Radiation, National
Research Council, Health Effects of Exposure to Low Levels of Ionizing Radiation: BEIR
V (Washington, D.C.: National Academy Press, 1990), 22, 162.

77

Part I

ETHICS OF HUMAN SUBJECTS

RESEARCH: A HISTORICAL

PERSPECTIVE

PartI
Overview

W hen the Advisory Committee began work in April 1994 we were
charged with determining whether "the [radiation] experiments' design and
administration adequately met the ethical and scientific standards, including
standards of informed consent, that prevailed at the time of the experiments and
that exist today" and also to "determine the ethical and scientific standards and
criteria by which it shall evaluate human radiation experiments."

Although this charge seems straightforward, it is in fact difficult to
determine what the appropriate standards should be for evaluating the conduct
and policies of thirty or fifty years ago. First, we needed to determine the extent
to which the standards of that time are similar to the standards of today. To the
extent that there were differences we needed to determine the relative roles of
each in making moral evaluations.

In chapter 1 we report what we have been able to reconstruct about
government rules and policies in the 1940s and 1950s regarding human
experiments. We focus primarily on the Atomic Energy Commission and the
Department of Defense, because their history with respect to human subjects
research policy is less well known than that of the Department of Health,
Education, and Welfare (now the Department of Health and Human Services).
Drawing on records that were previously obscure, or only recently declassified,
we reveal the perhaps surprising finding that officials and experts in the highest
reaches of the AEC and DOD discussed requirements for human experiments in
the first years of the Cold War. We also briefly discuss the research policies of
DHEW and the Veterans Administration during these years.

In chapter 2 we turn from a consideration of government standards to an
exploration of the norms and practices of physicians and medical scientists who
conducted research with human subjects during this period. We include here an

81

Part I

analysis of the significance of the Nuremberg Code, which arose out of the
international war crimes trial of German physicians in 1947. Using the results of
our Ethics Oral History Project, and other sources, we also examine how
scientists of the time viewed their moral responsibilities to human subjects as well
as how this translated into the manner in which they conducted their research. Of
particular interest are the differences in professional norms and practices between
research in which patients are used as subjects and research involving so-called
healthy volunteers.

In chapter 3 we return to the question of government standards, focusing
now on the 1960s and 1970s. In the first part of this chapter, we review the well-
documented developments that influenced and led up to two landmark events in
the history of government policy on research involving human subjects: the
promulgation by DHEW of comprehensive regulations for oversight of human
subjects research and passage by Congress of the National Research Act. In the
latter part of the chapter we, review developments and policies governing human
research in agencies other than DHEW, a history that has received comparatively
little scholarly attention. We also discuss scandals in human research conducted
by the DOD and the CIA that came to light in the 1970s and that influenced
subsequent agency policies.

With the historical context established in chapters 1 through 3, we turn in
chapter 4 to the core of our charge. Here we put forward and defend three kinds
of ethical standards for evaluating human radiation experiments conducted from
1944 to 1974. We embed these standards in a moral framework intended to
clarify and facilitate the difficult task of making judgments about the past.

82

Government Standards for

Human Experiments:

The 1940s and 1950s

W hen the Advisory Committee began its work, a central task was the
reconstruction of the federal government's rules and policies on human
experiments from 1944 through 1974. The history of research rules at the
Department of Health, Education, and Welfare (DHEW) was well known, at least
from 1953 on, when DHEW's National Institutes of Health (NIH) adopted a
policy on human subjects research for its newly opened research hospital, the
Clinical Center. In the 1960s, the DHEW and some other executive branch
agencies undertook regulation of research involving human subjects. These were
early steps of a process that culminated, in 1991, in the comprehensive federal
policy known as the "Common Rule."' The historical background of this process,
including a well-publicized series of incidents and scandals that motivated it, was
also widely known and much discussed (see chapter 3).2

By contrast to DHEW, much less was known about the history of research
rules for other agencies also involved in research with human subjects during this
period, including the Department of Defense (DOD), the Atomic Energy
Commission (AEC), and the Veterans Administration (VA). From the
perspective of the charge to the Advisory Committee, these agencies were at least
as important as DHEW. It was known that in 1953 the secretary of defense
issued, in Top Secret, a memorandum on human subjects based on the Nuremberg
Code.3 In 1947 an international tribunal had declared the Nuremberg Code the
standard by which a group of doctors in Nazi Germany should be judged for their

83

Parti

horrific wartime experiments on concentration camp inmates. However, the
actual impact of the Nuremberg Code on the biomedical community in the United
States, both inside and outside of government, is a matter of some disagreement
(see chapter 2). The general view was that, despite some developments in the
1940s and 1950s, there was little activity within the federal government on issues
of human subjects research before the 1960s.

But while scholars have known of the 1953 secretary of defense
memorandum, which was declassified in 1975, other relevant Department of
Defense documents remained classified or had lain buried in archives. Moreover,
relevant records of the Atomic Energy Commission were largely unexplored and
in some cases still classified. These records are important because, from its
creation in 1947, the AEC distributed radioisotopes that would be used in
thousands of human radiation experiments, and it was a funding source for many
other experiments (see Introduction). Along with the DOD, also created in 1 947,
the AEC was searching for biomedical information needed to understand the
effects of radiation as it prepared for the possibility of atomic warfare. Although
the AEC was thus the catalyst for a considerable amount of human
experimentation after World War II, there has been literally no scholarship on the
AEC's position on the use of human beings in radiation-related research.

Now that previously obscure, even classified, records are being made
public, it appears that in the first years of the Cold War, officials and experts in
the AEC and DOD did discuss the requirements for human experiments. In this
chapter we tell what we have learned about those discussions.

We begin by telling the story of the AEC general manager's early
declarations on human research, which included a requirement that consent be
obtained from patient-subjects. This story requires a careful look at a series of
letters and memorandums exchanged in the late 1940s. Together these documents
paint a clearly important but nonetheless confusing picture of a new agency's
attempts to come to grips with the complexities of human experimentation. We
consider not only what these documents say, but what we can piece together
about what they meant in the context of the times. Central questions include the
precise scope of the activities covered by the requirements and whether and how
these 1 947 statements were communicated and put into effect in the AEC's
burgeoning contract research and radioisotope distribution programs.

We turn next to the Department of Defense, where we trace the history of
rules on the use of healthy "normal volunteer" subjects in military research from
the time of Walter Reed through the secretary of defense's 1953 memorandum,
and beyond. This memorandum is the earliest known instance in which a federal
agency that sponsored human experiments adopted the Nuremberg Code. What is
known about how the memorandum was interpreted and implemented by the
military establishment takes up much of the rest of this chapter. Here, as in the
case of the AEC, key questions concern the scope of the activities covered by
requirements and the extent to which they were put into effect.

84

Chapter 1

Finally, we briefly discuss how research involving human subjects was
addressed at the National Institutes of Health and the Veterans Administration in
the 1950s. The evolution of policies governing human research at DHEW has
been well documented and is only summarized here.4 We now know that NIH's
1953 policy was not the earliest federal requirement that consent be obtained from
patients as well as healthy subjects. However, in contrast with the 1940s
declarations by the AEC, it was a far more visible statement issued by an agency
that was emerging as the leading sponsor of human subjects research. In contrast
with what is known about NIH, the extent to which there were research rules at
the VA in the 1940s and 1950s remains unclear.

A recurring theme in this chapter is the uncertainty about the significance
within government agencies of many of the official statements that are discussed.
While these statements emanated from high and responsible officials and
committees, often they cannot be linked to fuller expressions of commitment by
the agencies. Some of these statements were not widely disseminated, and there
were no implementing guidelines or regulations and no sanctions for failures to
abide by them. Thus, it is sometimes unclear what formal, legal significance
these statements had. We are no less interested, however, in what these
statements can tell us about how government officials and advisers saw human
research at the time and how they understood the obligations surrounding it.

THE ATOMIC ENERGY COMMISSION: A REQUIREMENT
FOR "CONSENT" IS DECLARED AT THE CREATION

Even before the AEC came into existence on January 1, 1947, Manhattan
Project researchers and officials had begun to lay the groundwork for the
expansion of the government's support of biomedical radiation research
conducted under federal contract. By the time the AEC began operations, the
parallel program to distribute federally produced radioisotopes to research
institutions throughout the country was already well under way.

The planning for these undertakings required both reflection on high-level
matters of policy and attention to matters of small but critical legal and
bureaucratic detail. Both legal rules and administrative processes were uncharted.
For example, who would be responsible if things went awry and subjects were
injured? When could the government tell private doctors or researchers how to
conduct treatment or research? The need for rules seemed obvious, but the
particular rules that would be arrived at were not.

In April 1947 and again in November, Carroll Wilson, the general
manager of the new agency, wrote letters first to Stafford Warren and then to
Robert Stone, both of whom played prominent roles in Manhattan Project medical
research, Warren as medical director, and Stone as a key member of the Chicago
branch of the project. In these letters, Wilson maintained that "clinical testing"
with patients could go forward only where there was a prospect that the patient

85

Part I

could benefit medically and only after that patient had been informed about the
testing and there was documentation that the patient had consented. What was the
origin of this position, and what was its reach? It appears that these letters were
the products of an agency that was not only seeking to devise rules for new
programs but also was trying to glean lessons from the experience with the secret
research that had been conducted during the Manhattan Project. In the course of
setting rules for the future, the AEC and its research community had to confront
whether and how to proceed with human experimentation in the face of human
experiments, including plutonium injections, conducted under the auspices of the
Manhattan Project, experiments that were conducted in secret and that had the
potential for both negative public reaction and litigation.

The First Wilson Letter

General Manager Wilson's first 1947 letter on human research, dated April
30, was, at least in part, a straightforward effort to define the rules according to
which the AEC would provide contractors with research funding. The need for
such rules had been discussed by the AEC's Interim Medical Advisory
Committee, chaired by Stafford Warren, in January 1 947 when it met to consider
whether "clinical testing" should be part of the AEC contract research program.
The report of the meeting records projects involving human subjects at the
University of Rochester and the University of California at Berkeley, and perhaps
others.5 In a January 30 letter to General Manager Wilson, Stafford Warren
reported the committee's conclusion that in the study of health hazards and the use
of fissionable and radioactive materials, "final investigations by clinical testing of
these materials" would be needed. Warren therefore requested that the AEC legal
department determine the "financial and legal responsibility" of the AEC when
such "clinical investigations" are carried out under AEC-approved and -financed
programs.6 (The term experiment was not used, and the precise meaning of
clinical testing is not clear.)

A month later, in early March, Warren met with Major Birchard M.
Brundage, chief of the AEC's Medical Division, and two AEC lawyers to consider
the terms for the resumption of "clinical testing." In a memorandum for the
record, the lawyers summarized the meeting. In the case of "clinical testing" the
lawyers

expressed the view that it was most important that it
be susceptible of proof that any individual patient,
prior to treatment, was in an understanding state of
mind and that the nature of the treatment and
possible risk involved be explained very clearly and
that the patient express his willingness to receive
the treatment.7

86

Chapter 1

Initially, the lawyers had proposed that researchers obtain a "written
release" from patients. However, "on Dr. Warren's recommendation," the lawyers
agreed that it would be sufficient if "at least two doctors certify in writing to the
patient's state of mind to the explanation furnished him and to the acceptance of

the treatment.""

In his April 30 letter to Stafford Warren, Wilson announced that the AEC
had approved Warren's committee's recommendations for a "program for
obtaining medical data of interest to the Commission in the course of treatment of
patients, which may involve clinical testing."9 Wilson's letter spelled out ground
rules that were agreed upon. The commission understood that "treatment (which
may involve clinical testing) will be administered to a patient only when there is
expectation that it may have therapeutic effect." In addition, the commission
adopted the requirement for documentation of consent agreed upon in Warren's
meeting with the lawyers:

[I]t should be susceptible of proof from official
records that, prior to treatment, each individual
patient, being in an understanding state of mind,
was clearly informed of the nature of the treatment
and its possible effects, and expressed his
willingness to receive the treatment.10

The commission deferred to Warren's request that written releases from
the patient not be required. However,

it does request that in every case at least two
doctors should certify in writing (made part of an
official record) to the patient's understanding state
of mind, to the explanation furnished him, and to
his willingness to accept the treatment."

Carroll Wilson's April letter was sent to Stafford Warren as head of the
Interim Medical Advisory Committee, which was responsible for advising the
AEC on its contract research program, and forwarded to Major Brundage at the
Oak Ridge office.12 Stafford Warren was at this point dean of the medical school
at the University of California at Los Angeles, one of the dozen research
institutions involved in the AEC contract research program. With one exception
the Advisory Committee on Human Radiation Experiments did not locate
documentation that the letter or its contents were communicated to any other
research institutions involved with the AEC's contract research program. The
exception is the University of California at San Francisco, where there is indirect
evidence that someone at that institution had been apprised of Wilson's April
letter. Of the eighteen plutonium injections, only the last one, that involving

87

Parti

Elmer Allen, or "CAL-3," took place after the April letter. In Mr. Allen's
medical chart, there is a notation signed by two physicians indicating that the
"experimental nature" of the procedure was explained and that the patient
"agreed."13 Although the note in Mr. Allen's chart suggests an effort on the part
of the researchers to comply with Wilson's April letter, the researchers did not
comply with the other provision of the Wilson letter, that "treatment (which may
involve clinical testing) will be administered to a patient only when there is
expectation that it may have therapeutic effect."14 As is discussed in more detail
in chapter 5, there was no expectation at the time that Mr. Allen would benefit
medically from an injection of plutonium.15

The Second Wilson Letter

The context of the second Wilson letter, as well as its precise terms, further
indicates that the April 1947 letter was given little distribution and effect. In the
fall of 1947, the AEC laboratory at Oak Ridge requested advice from Carroll
Wilson's office on the rules for experiments involving human subjects. Just as the
AEC's Washington headquarters had embarked on the funding of a new research
program, Oak Ridge was also in the midst of considering the rules governing the
expansion of its own medical research program and the distribution of isotopes,
which was then headquartered at Oak Ridge. In September 1 947, the manager of
Oak Ridge Operations wrote to Wilson, asking, "What responsibilities does the
AEC bear for human administration of isotopes (a) by private physicians and
medical institutions outside the Project, and (b) by physicians within the project. . .
What are the criteria for future human use?"16

Two weeks later. Oak Ridge sent a memorandum to the Advisory
Committee for Biology and Medicine (ACBM). The ACBM had succeeded both
Stafford Warren's Interim Medical Advisory Committee and the Medical Board of
Review, a group appointed by AEC Chairman David Lilienthal to review the
AEC's medical program. The memorandum emphasized the need for "medico-
legal criteria" for "future human tracer research" because some of that research
would be "of no immediate therapeutic value to the patient." The memorandum
outlined the pros and cons of "tracer studies":

Pro-

( 1 ) Tracer research is fundamental to toxicity
studies.

(2) The adequacy of the health protection which we
afford our present employees may in a large
measure depend upon information obtained using
tracer techniques.

(3) New and improved medical applications can

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Chapter 1

only be developed through careful experimentation
and clinical trial.

(4) Tracer techniques are inherent in the
radioisotope distribution program.

Con-

(1) Moral, ethical and medico-legal objections to
the administration of radioactive material without
the patient's knowledge or consent.

(2) There is perhaps a greater responsibility if a
federal agency condones human guinea pig
experimentation.

(3) Publication of such researches in some
instances will compromise the best interests of the
Atomic Energy Commission.

(4) Publication of experiments done by Atomic
Energy Commission contractor's personnel may
frequently be the source of litigation and be
prejudicial to the proper functioning of the Atomic
Energy Commission Insurance Branch.17

The questions raised by Oak Ridge were discussed by the ACBM at its
October 11, 1947, meeting, which decided to give the "matter more study."18 The
minutes of the October 1 1 meeting record that "human experimentation" was then
discussed in the context of a request by Dr. Robert Stone to release "classified
papers containing certain information on human experimentation with
radioisotopes conducted within the AEC research program."19 The request was
part of a continuing effort by Stone and other scientists to obtain permission to
publish the research, including the plutonium experiments, that they had
conducted in secret during the Manhattan Project. Earlier in 1947, the AEC had
reversed a decision to declassify a report on the plutonium injections, citing the
potential for public embarrassment and legal liability (see chapter 5). The
question of what to do with these requests continued to fester.

The minutes explain that the "problem" raised by Stone had been dealt
with by Chairman Lilienthal's Medical Board of Review in June. In a cryptic
statement, the minutes record the ACBM's agreement that papers on human
experiments "should remain classified unless the stipulated conditions laid down
by the Board of Review were complied with."20

The "stipulated conditions" referred to are contained in General Manager

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Wilson's November 5, 1947, letter to Stone. According to Wilson's letter, at a
June meeting the Medical Board of Review concluded that "the matter of human
experimentation" would remain classified where certain "conditions" were not
satisfied. Wilson then quoted from the "preliminary unpublished and restricted
draft of the [Medical Board] report read to the Commissioners" as follows:

The atmosphere of secrecy and suppression makes
one aspect of the medical work of the Commission
especially vulnerable to criticism. We therefore
wish to record our approval of the position taken by
the medical staff of the AEC in point of their
studies of the substances dangerous to human life.
We [the Medical Board of Review] believe that no
substances known to be, or suspected of being,
poisonous or harmful should be given to human
beings unless all of the following conditions are
fully met: (a) that a reasonable hope exists that the
administration of such a substance will improve the
condition of the patient, (b) that the patient give his
complete and informed consent in writing, and (c)
that the responsible next of kin give in writing a
similarly complete and informed consent, revocable
at any time during the course of such treatment
[emphasis added].21

In other words, the opinion of the Medical Board of Review was presented
by Wilson in his November letter as both a prescription for the future conduct of
human experiments and a presentation of the criteria that must be met for the
declassification of past research. Wilson again referenced these conditions in a
letter to ACBM Chairman Alan Gregg, also on November 5. "I am sure," Wilson
wrote Gregg, "that this information will assist Dr. Stone in evaluating the present
problem and inform him as to the conditions that must be met in future
experiments."22 Thus, as discussed in more detail in chapters 5 and 13, the
requirement that research proceed only with consent appears to have been
coupled with the decision to withhold from the public information about
experiments that failed to meet that standard.

Two points should be made about the term informed consent, which
appears in the November letter from Wilson to Stone. First, it is not clear what
meaning Wilson and the members of the Medical Board of Review attributed to
the term. No further explanation was given. Second, it is nevertheless a matter of
some historical interest that this term is used at all. Previous scholarship had
attributed its first official usage to a landmark legal opinion in a medical
malpractice case that was issued a decade later.23-

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Chapter 1

The April and November 1947 Wilson letters have some common
elements, in spite of their differences in detail. They both provided that research
with humans proceed (1) only where there is reasonable hope of therapeutic effect;
and (2) with documentary proof that the patient-subject was informed of the
treatment and its possible effects and had consented to its administration.

But there are many remaining mysteries about the AEC's 1947 statements.
In interviews with Advisory Committee staff, Joseph Volpe, who served as an
AEC attorney in its early days and became general counsel in 1949, explained
that a letter authored by General Manager Wilson could state AEC policy and
confidently recollected that informed consent from research subjects would have
been required by the first AEC general counsel. This requirement, Volpe
maintained, should be reflected in the commission's minutes.24 However,
Committee and DOE review of the commission's minutes did not reveal evidence
that the "consent" policy was expressly addressed.

Even more troubling is that both Wilson letters precluded research that did
not offer patient-subjects a prospect of direct medical benefit. In the context of
the concern about the plutonium injections and the other "nontherapeutic"
research conducted during the Manhattan Project experiments, this provision
readily makes sense. Yet, as Oak Ridge's inquiry to Washington noted,
nontherapeutic research in the form of tracer studies had been, and would
continue to be, a mainstay of AEC-sponsored isotope research. How could it be
that the Wilson letters were intended to ban exactly the kind of research that at the
same time the AEC was so actively promoting? It is conceivable that the
requirement of the isotope distribution program for risk review prior to the human
use of radioisotopes was a means of addressing this notion. However, if the
equation between that risk review procedure and the provision in the November
Wilson letter seems implicit, the documentary evidence does not provide an
express link between the requirement stated in the Wilson letter and the rules of
the isotope distribution program.

From Statements to Policy: A Failure of Translation

Despite the fact that they were developed in response to a need for clarity
in the way that human research should be conducted, we have found little
evidence of efforts to communicate or implement the rules stated by Wilson in
coordination with the AEC's biomedical advisory groups and other AEC officials.
In some cases the evidence described in the following paragraphs suggests that
policies for consent from subjects were established and implemented, while in
other cases it suggests that, if there were any such policies, they were unknown or
lost. Taken together, however, this evidence further supports the view that the
ideas present in General Manager Wilson's 1947 statements were available to
those working in the field during this time, albeit perhaps in a primitive form.

Consider, for example, a 1951 exchange between the AEC's Division of

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Parti

Biology and Medicine (DBM), which directed the AEC's medical research
program, and the commission's Los Alamos Laboratory, which was in routine
contact with Washington. An information officer at Los Alamos, Leslie Redman,
who was charged to review papers that involved human experimentation, asked
the DBM for a "definite AEC policy" on "human experimentation." In the course
of his work, Redman wrote, he had been advised by "various persons" at Los
Alamos that "regulations or policies of the AEC" on human experimentation were
available, but he had been unable to locate more than general information about
these regulations. According to his letter, his understanding was that

these regulations are comparable to those of the
American Medical Association: that an experiment
be performed under the supervision of an M.D.,
with the permission of the patient, and for the
purpose of seeking a cure.25

Redman's characterization of the American Medical Association's guidelines, as
we shall see in chapter 2, is partly incorrect. The requirement of a therapeutic
intent is absent from the AM A guidelines. The possibility of direct therapeutic
benefit for the patient was, however, a condition of research according to both of
General Manager Wilson's 1947 letters.

Shields Warren, the DBM chief, responded to Redman by citing Wilson's
November 5, 1947, letter to Stone and by excerpting the conditions quoted
above.26 But Warren did not term these conditions "standards" or "requirements."
Rather, Warren's response to Los Alamos "urges" compliance with these "guiding
principles."27

Though Los Alamos was provided with the criteria stated by Wilson in
November 1947, General Manager Wilson's statements were not routinely
communicated in response to requests for guidance from non-AEC researchers.
In an April 1948 letter to the DBM, a university researcher explained that the
Isotopes Division had approved his request to use phosphorus 32 for
"experimental procedures in the human . . . simply for investigational purposes
and not for treatment of disease." What, the researcher wanted to know, should
be done about "medical-legal aspects" and "permission forms"?28 The request
could have been answered by referring to Wilson's 1 947 statements about
consent. Instead, the DBM simply referred the researcher to the Isotopes Division
at Oak Ridge.29 In its response, the Isotopes Division did not indicate that consent
should be solicited, as Wilson had stipulated. The Isotopes Division, stating it
could be "of little assistance," declined to provide "legal advice," save to note that
"we understand that most hospitals do require patients to sign general releases
before entering into treatment."30

From 1947 onward, the AEC had ample opportunity to disseminate a
research policy. The AEC routinely provided educational and administrative

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Chapter 1

materials to applicants for AEC funding and to the far greater number of
ZlTcan s foTAEC-produced radioisotopes. The isotopes distribution program,
np Sat included a sophisticated structure of regulation, repkte with ; review
oSmttees, training courses, and informational brochures (see chapter -t ) At the
federal level this included the Subcommittee on Human Applications of the
Cotmi ^ilitopc Distribution, whose very purpose was "to review all initial
« for radioisotopes to be used experimentally or otherwise in human beings
remohasis added]."31 The AEC Subcommittee on Human Applications was
supplemented by similar committees at the research institutions where the work

WaS C°fnUpCnnciple, there does not seem to be any reason these local committees
could not have been instructed by the Isotopes Division on consent
eautemenL- Some evidence suggests that in March 1948 the Subcommittee on
Human Applications discussed consent requirements for healthy subjects and
"Sheets. In a document dated March 29, 1948, the Subcommittee on
Human Applications appeared to resolve that

1 Radioactive materials should be used in experiments
involving human subjects when information obtained will
have diagnostic value, therapeutic significance, or will
contribute to knowledge on radiation protection.

2. Radioactive materials may be used in normal human
subjects provided

a. The subject has full knowledge of
the act and has given his consent to
the procedure.

b. Animal studies have established
the assimilation, distribution,
selective localization and excretion
of the radioisotope or derivative in
question.

3. Radioactive materials may be used in patients
suffering from diseased conditions of such nature
that there is no reasonable probability of the
radioactivity employed producing manifest injury
provided:

a. Animal studies have established the
assimilation, distribution, selective

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Part I

localization and excretion of the
radioisotope or derivative in
question.

b. The subject is of sound mind, has
full knowledge of the act and has
given his consent to the procedure. . . .

4. Investigations are approved ( 1 ) by medical
director or his equivalent at the installation
responsible for the investigation, (2) by the
Director, Division of Biology and Medicine, and (3)
full written descriptions of experimental procedures
and calculated estimates of radiation to be received
by body structure and organs must be submitted.31

We were unable to locate any further references to this document and do not
know whether it represented a policy that was adopted. Perhaps it represents the
consensus of the Subcommittee on Human Applications, as it had met shortly
before that, or perhaps it is simply a draft document prepared by staff.

Whatever the ultimate disposition of this document, it provides some idea
of the problems that were under consideration at the time and indicates that views
on human use were unsettled. The first numbered item, for example, appears to
recommend human radiation experiments when they will offer diagnostic value
and therapeutic significance or knowledge about radiation protection. If the
document had in fact been adopted, the recognition that isotope experimentation
could be undertaken to "contribute to knowledge" (item 1) would appear to revise
the Wilson letters' prohibition of nontherapeutic experimentation. The third item
also addresses consent and risk of injury to patient-subjects without indicating
that there should be any potential benefit. Another peculiarity is found in the
second item, which refers to consent from normal human subjects but does not
rule out experiments that present risk to the subject.

In any event, at a 1948 meeting the Subcommittee on Human Applications
articulated a consent requirement as part of a decision to permit patients suffering
from serious diseases to receive "larger doses for investigative purposes."34 This
requirement was disseminated to all radioisotope purchasers in 1949.35 The
subcommittee allowed investigators to administer "larger doses" to seriously ill
patients but only with the patient's consent. While it is possible that the basis for
permitting larger doses was an assumption that smaller ones would be of no
potential benefit to subjects, item 3 of the just-quoted March 1948 document
suggests the assumption was rather that in seriously ill patients other disease
processes would be more likely to take their course before radiation injury was
manifested.

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Chapter 1

There is evidence that at least one AEC-funded entity did routinely
provide some form of disclosure and consent in the early 1950s. From its opening
in 1950 the AEC-sponsored Oak Ridge Institute for Nuclear Studies (ORINS), a
research hospital, advised incoming patients that procedures were experimental.
Additionally, patients were given written information that advised them that
"probable benefit, if any, cannot always be predicted in advance."36 Patients were
also asked to sign a form that indicated that they were "fully advised" about the
"character and kind of treatment and care," which would be "for the most part
experiments with no definite promise of improvement in my physical
condition."37 Thus, at least in the case of ORINS, and perhaps at other AEC
facilities, a local process was instituted apart from any known communication of
the statements by AEC officials.

Nonetheless, there is other evidence that the AEC did not communicate
the requirements detailed in General Manager Wilson's 1 947 letters to its own
contract research organizations, which, as in the cases of Argonne, Los Alamos,
Brookhaven, and Oak Ridge, ;had significant biomedical programs and were
engaged in human research. When the Division of Biological and Medical
Research at Argonne National Laboratory met in January 1951 to discuss
beginning a program of human experimentation in cancer research, one of its
members asserted that the ACBM had not established a "general policy
concerning human experimentation." The minutes of the meeting at Argonne
record that the ACBM "has been approached several times in the past for a
general policy and has refused to formulate one."38

In 1956, Los Alamos asked the DBM to "restate its position on the
experimental use of human volunteer subjects" for tracer experiments.39 The
DBM responded by stating that tracer doses might be administered under certain
conditions, which included the provision that subjects be volunteers who were
fully informed. The focus of this position seems to have been research with
healthy people and not patients, and no reference was made to the provisions of
the Wilson letters.40 The DBM's 1956 formulation was given "staff distribution"
by Los Alamos and restated in 1962.4'

Also in 1956, the Isotopes Division did state a requirement for healthy
subjects. All subjects were to be informed volunteers. As part of its
"Recommendations and Requirements" guidebook for the medical uses of
radioisotopes, which was distributed to all medical users of radioisotopes, the
Isotopes Division stated:

Uses of radioisotopes in normal subjects for
experimental purposes shall be limited to:

a. Tracer doses which do not exceed the
permissible total body burden for the radioisotope

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Part I

in question. In all instances the dose should be kept
as low as possible.

b. Volunteers to whom the intent of the study and
the effects of radiation have been outlined.

c. Volunteers who are unlikely to be exposed to
significant additional amounts of radiation.42

These requirements apparently applied to all uses of AEC radioisotopes, whether
government or private researchers were involved. The "experimental or
nonroutine" use of radioisotopes in any human subjects was limited to
institutional programs where local review committees existed to oversee the risk
to which subjects were exposed. In stating these requirements, the AEC reiterated
that "patients" in whom "there is no reasonable probability of producing manifest
injury" may be used in some experiments not normally permitted, but did not
reiterate the requirement that consent should be obtained from these patients, as
was stated in 1948.

What, then, can be said about the rules and policies of the AEC in the
1940s and 1950s? General Manager Wilson's 1947 letters clearly stipulate a
requirement of "informed consent" from patient-subjects, at least where
potentially "poisonous or harmful" substances are involved. But with the
exception of ORINS there is little indication that this requirement was imposed as
binding policy on any AEC facility, contractor, or recipient of radioisotopes. By
contrast, later requirements that healthy subjects be informed volunteers and that
seriously ill patients be permitted to receive higher doses only with their consent
appear to have been more broadly communicated and enforced. The only
evidence of general attention to matters of consent from patient-subjects comes
from ORINS, whose policies and practices show a striking similarity to those that,
as we shall see, were being contemporaneously employed at another facility
essentially devoted to experimental work, the NIH's Clinical Center. At the same
time, there is evidence of considerable attention in both policy and practice to
issues of safety and acceptable risk (see chapter 6). Questions of subject
selection, as in the case of seriously ill patients, emerge only in this context of
safety; there is no evidence that issues of fairness or concerns about exploitation
in the selection of subjects figured in AEC policies or rules of the period.

THE DEPARTMENT OF DEFENSE: CONSENT IS
FORMALIZED

The story of research involving human subjects in the U.S. military began
at least a century ago. Well before 1944, the beginning of the period of special
interest to the Advisory Committee, the military needed healthy subjects to test

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Chapter 1

means to prevent and treat infectious diseases to which military personnel might
be exposed. The notion that consent should be obtained from human subjects was
clearly part of this tradition; less clear is how consistently this was applied and
what consent actually meant to those in authority.

The most famous example of the early use of subject consent in the
military took place at the turn of the century. Walter Reed's successful research
on yellow fever, the mosquito-borne disease that bedeviled Panama Canal
construction efforts, employed healthy subjects who signed forms indicating their
agreement. Whether the practice was required by the Army or self-imposed by
Reed is unknown. In 1925 an Army regulation to promote infectious disease
research noted that "volunteers" should be used in "experimental" research.43

The Navy also provided early requirements for human subject research.
In 1932, the secretary of the Navy granted permission for the conduct of an
experiment involving divers on condition that the subjects were "informed
volunteers."44 In 1943 the secretary of the Navy also required that all
investigators seeking to conduct research with service personnel obtain prior
approval from the secretary.45

As we have noted in the Introduction, during World War II, federally
funded biomedical research related to the war effort (outside the Manhattan
Project) was coordinated by the Committee on Medical Research (CMR) of the
Office of Scientific Research and Development, which was part of the Executive
Office of the President. The CMR supported a program of human research,
during which the question of the rules for the conduct of human research was
addressed. In 1942 a University of Rochester researcher, seeking to "work out a
human experiment on the chemical prophylaxis of gonorrhea," asked the CMR for
"an opinion that such human experimentation is desirable."46 In an October 9,
1942, response, the CMR's chairman offered the following general statement,
which was endorsed by the full committee:

[HJuman experimentation is not only desirable, but
necessary in the study of many of the problems of
war medicine which confront us. When any risks
are involved, volunteers only should be utilized as
subjects, and these only after the risks have been
fully explained and after signed statements have
been obtained which shall prove that the volunteer
offered his services with full knowledge and that
claims for damage will be waived. An accurate
record should be kept of the terms in which the
risks involved were described.47

In spite of the CMR's statement in response to this researcher's query, it supported
other experiments that involved subjects whose capacity to give valid consent to

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Part I

participation was doubtful, including institutionalized people with cognitive
disabilities.4*

During the war, the Navy used consent forms in wartime experiments
using prisoners and conscientious objectors, as a proposal for research on an
influenza vaccine with prisoners at San Quentin in 1943 shows.49 The form used
in this case indicates that the subject is "acting freely and voluntarily without any
coercion on the part of any person whomever."50 To be sure, the forms located by
the Advisory Committee were called "waiver" or "release" rather than "consent"
forms. Thus, the attestation to voluntary participation was punctuated by the
release of experimenters from liability. However, at a time when free young men
were routinely conscripted into the military, the requirement that subjects,
including prisoners and conscientious objectors, must be volunteers seems
remarkable.

In sharp contrast with these procedures, the Navy, too, sometimes
functioned in a manner inconsistent with a voluntary consent policy for healthy
subjects. Surviving subjects have reported that harmful mustard gas experiments
on naval personnel at the Naval Research Laboratory in Washington, D.C., during
World War II failed to adequately inform subjects and seem to have involved
manipulation or coercion of "volunteers."51 The lack of medical follow-up on the
subjects of these experiments was sharply criticized in a 1993 report by the
Institute of Medicine of the National Academy of Sciences.52

The NEPA Debate on the Ethics of Prisoner Experiments

Many of the researchers and officials who had been involved in Manhattan
Project human experiments during the war and then in the 1947 AEC
deliberations about human research policy also were engaged in 1949 and 1950 in
discussions of the ground rules for research with human subjects in the
development of new military technology. This time the forum was the joint AEC-
DOD project on Nuclear Energy for the Propulsion of Aircraft (NEPA). The
DOD convened an advisory panel of private and public officials to determine how
to obtain data needed to answer questions such as whether the air crew would be
put at undue risk by the nuclear-powered engine. The participants in the
discussion included university researchers Hymer Friedell, Stafford Warren,
Robert Stone, and Joseph Hamilton, and AEC officials Shields Warren and Alan
Gregg. Shields Warren argued that human experimentation was not appropriate
because the research could be done on animals and human data was not likely to
produce scientifically valid results (see Introduction).

Robert Stone, the recipient of the November 1947 letter in which AEC
General Manager Wilson called for "informed consent," emerged as the primary
proponent of human experiments. In a January 1950 discussion paper, he focused
on the "ethics of human experimentation."53 After a recitation of a tradition that
included Walter Reed's experience and the historical use of prisoners and medical

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Chapter 1

students as research subjects, Stone cited requirements that had been publicized
by the American Medical Association in 1946. These rules provided that subjects
must give voluntary consent, that animal experimentation must precede human
experimentation, and that human experiments should be "performed under proper
medical protection and management."54 (See chapter 2.) Stone argued that it
would be possible to conduct NEPA-related experiments with prisoners in
compliance with all three of these requirements.

Stone's proposal generated considerable discussion among DOD and AEC
experts and officials. In April 1950, the DOD's Joint Panel on the Medical
Aspects of Atomic Warfare endorsed the use of prisoners of "true volunteer
status" as meeting "the requirements of accepted American standards for the use
of human subjects for research purposes."55

However, AEC officials were less than enthusiastic. "Doesn't the prisoner
proposal," ACBM Chairman Alan Gregg asked a military official in the course of
one discussion, "fall in the category of cruel and unusual punishment?"5 "Not,"

the official replied, "if they would carry out the work as they proposed It

would be on an absolutely voluntary basis, and under every safety precaution that
could be built up around it ... it didn't strike me as being cruel and unusual." To
which Shields Warren retorted: "It's not very long since we got through trying
Germans for doing exactly the same thing."57

In December 1950 the AEC convened a panel to discuss what was known
about potential radiation effects on service personnel and whether human research
was needed. Joseph Hamilton, Robert Stone's colleague at the University of
California, was unable to attend the meeting, and in his regrets he offered his
thoughts on the matter. In a letter to Shields Warren, he noted that the proposal to
use prisoner volunteers "would have a little of the Buchenwald touch" and
reported that he had no "very constructive ideas as to where one would turn for
such volunteers should this plan be put into effect."58 He suggested using large
primates, even though, from a purely scientific viewpoint, the data collected
would not be as useful as data from humans.59

Apparently Stone lost the debate. A decision was made not to conduct
experiments with prisoners or other healthy subjects in connection with the NEPA
project. However, as will be discussed in more detail in chapter 8, the military
contracted with a private hospital to study patients who were being irradiated for
cancer treatment, in the hopes of answering the same kinds of questions that
would have been addressed if NEPA research with prisoners had gone forward.

Congress Provides for DOD Contractor Indemnification in the Case of
Injury

In the aftermath of World War II, the military continued its long-standing
program of infectious disease research using human subjects. During the late
1940s and early 1950s the Army Epidemiological Board (AEB) and its 1949

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Parti

successor, the Armed Forces Epidemiological Board (AFEB), which was
established to advise on medical research funded by the DOD and to direct some
research undertaken with Army funds, sponsored studies with healthy subjects
that focused on hepatitis, dengue fever, and other infectious diseases. Consistent
with military tradition, at least some AEB-sponsored researchers were using
written permission forms. The forms, frequently referred to as an "Agreement
with Volunteer," or a "release," outlined the study and the risks to the subject and
protected the DOD from liability.60

In the late 1 940s, some university researchers expressed concern that they
were not adequately protected from liability in the case of injury or death of their
prisoner-subjects. The ensuing dialogue provides a window on the role of the
written releases and the understanding of the rules governing human subject
research. In response to a researcher's request to be reimbursed by the Army for a
disability policy for the subjects, the Army lawyers replied that the Army could
not provide indemnification in the absence of clear congressional authority.
Army legal advisers recommended that the researcher "protect himself, the State
of New Jersey [the research locale], and the Government by means of the usual
waiver."61

In a February 1948 letter, the AEB director, John R. Paul, explained that
the "world situation" had placed the rules for human experimentation up for
grabs.62

At this stage in the world situation one should
proceed cautiously, until standards are set by what
ever body is in 'authority.' I am not sure just what
the rules are but I understand that . . . some type of
vigilance committee has laid down certain
principles about volunteers in order to protect this
country from the criticisms brought up in Germany
during the Nuremberg trials. . . . During the war we
more or less made our own policies on this, but I
am not sure that this is possible today. . . ,63

The allusion to a "vigilance committee" is unclear. It may be a reference to a
committee established by the governor of Illinois to examine the use of prisoners
as research subjects in that state and chaired by Andrew Ivy, the principal expert
witness for the prosecution at the Nuremberg Medical Trial (see chapter 2).
Given the date of the letter, February 18, 1948, it seems likely that Paul had just
skimmed through his new copy of the Journal of the American Medical
Association— the report of Ivy's committee was published in the February 14,
1948, issue.64

In April 1948, an AEB official made it plain to the researchers that the fact
that state authorities or the prison warden gave permission for the experiment

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Chapter 1

should be of little comfort to them. In case of a lawsuit, responsibility "would
devolve entirely upon the individual experimenter."65 Only Congress could
provide a solution, but it would be a "dangerous course" to raise the matter
publicly. "I have," the AEB official wrote,

given considerable thought to the matter of whether
it would be advisable to approach individuals or
groups in Congress with the idea of having laws
passed relating to payment of compensation for
disability or release of the experimenter from
liability. I am afraid that this would be a dangerous
course, and that it might in fact injure clinical
investigations generally. There is a very real
possibility that unfavorable publicity would quickly
result.66

It appears that the relief sought by researchers was provided by Congress
in 1952, however, under the umbrella of a law that provided indemnification for
DOD research and development activities as a whole. In October 1952, following
the death of a prisoner-subject in an AFEB-sponsored hepatitis study67 and
questions raised by the Army Chemical Corps about release forms for "human
'guinea pigs,'"68 the AFEB administrator queried the DOD Legal Office about a
recently passed federal law. The law provided authority for the military to
indemnify contractors for risks undertaken in "research and development
situations." Did the new law "afford relief to the immediate dependents of

prison volunteers when as [a] result of these experiments they should die[?]"6
The answer was yes, but only by providing relief to the researchers first. "From
the wording of the law, and from ... the legislative history," the Legal Office
replied, "it is a direct indemnification to the contractor and not to the individual

human guinea pig."70

Thus, what appears to have been the first Cold War congressional
enactment to deal with human subjects of research addressed the government's
obligation to its contractors, not the government's and its researchers' obligations
to the subjects. Moreover, the record indicates that a more direct approach was
not sought by the DOD because of concerns about public relations. At the same
time Congress was acting, however, the DOD itself was secretly debating a new
policy for human experiments.

The Secretary of Defense Issues the Nuremberg Code in Top Secret

As the Korean War began in mid- 1950, the military's interest in human
experimentation-in connection with chemical and biological as well as atomic
and radiation warfare-intensified. The need for a DOD-wide policy on the use of

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human subjects in research was noted by Colonel George Underwood, the
director of the Office of the Secretary of Defense, in a February 1953
memorandum to the incoming administration of Dwight D. Eisenhower: "There
is no DOD policy on the books which permits this type of research [human
experiments in the field of atomic, biological, and chemical warfare]."71

From 1950 to 1953 discussions about human research and human research
policy were held in several high-level DOD panels, including the Armed Forces
Medical Policy Council (AFMPC), the Committee on Medical Sciences (CMS),
and the Joint Panel on the Medical Aspects of Atomic Warfare. These groups
were headed by civilian researchers, and, in at least the latter two cases, included
representatives of the AEC, CIA, NIH, VA, and Public Health Service.

At its September 8, 1952, meeting, the AFMPC heard a presentation from
the chief of preventive medicine of the Army Surgeon General's Office on the
topic of biological warfare research:

It was pointed out that the research had reached a
point beyond which essential data could not be
obtained unless human volunteers were utilized for
such experimentation. . . . Following detailed
discussion, it was unanimously agreed that the use
of human volunteers in this type of research be
approved.72

At its October 13, 1952, meeting the AFMPC again took up the question
of human experimentation. "It was resolved," the chairman wrote to the secretary
of defense, "that the ten rules promulgated at the Nuremberg trials be adopted as
the guiding principles to be followed. An eleventh rule [barring experiments with
prisoners of war] was added by the legal advisor to the Council, Mr. Stephen S.
Jackson."73

DOD attorney Jackson evidently was responsible for the inclusion of the
Nuremberg Code in the AFMPC's proposed policy. In an October 13, 1952,
memo to the chairman of the AFMPC, Jackson

recommended: that the attached principles and
conditions for human experimentation, which were
laid down by the Tribunal in the Nuremberg Trials,
be adopted instead of those previously submitted by
me.74

As an addendum to the Nuremberg Code, Jackson proposed a requirement
that "consent be expressed in writing before at least one witness." This
recommendation followed from the suggestion of Anna Rosenberg, assistant

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The Nuremberg Code

1. The voluntary consent of the human subject is absolutely essential.

This means that the person involved should have legal capacity to give consent; should be so
situated as to be able to exercise free power of choice, without the intervention of any element of
force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and
should have sufficient knowledge and comprehension of the elements of the subject matter
involved as to enable him to make an understanding and enlightened decision. The latter element
requires that before the acceptance of an affirmative decision by the experimental subject there
should be made known to him the nature, duration, and purpose of the experiment; the method and
means by which it is to be conducted; all inconveniences and hazards reasonably to be expected;
and the effects upon his health or person which may possibly come from his participation in the
experiment. The duty and responsibility for ascertaining the quality of the consent rest upon each
individual who initiates, directs or engages in the experiment. It is a personal duty and
responsibility which may not be delegated to another with impunity.

2. The experiment should be such as to yield fruitful results for the good of society,
unprocurable by other methods or means of study, and not random and unnecessary in nature.

3. The experiment should be so designed and based on the results of animal
experimentation and a knowledge of the natural history of the disease or other problem under
study that the anticipated results will justify the performance of the experiment.

4. The experiment should be so conducted as to avoid all unnecessary physical and
mental suffering and injury.

5. No experiment should be conducted where there is an a priori reason to believe that
death or disabling injury will occur; except, perhaps, in those experiments where the experimental
physicians also serve as subjects.

6. The degree of risk to be taken should never exceed that determined by the
humanitarian importance of the problem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities provided to protect the
experimental subject against even remote possibilities of injury, disability, or death.

8. The experiment should be conducted only by scientifically qualified persons. The
highest degree of skill and care should be required through all stages of the experiment of those
who conduct or engage in the experiment.

9. During the course of the experiment the human subject should be at liberty to bring the
experiment to an end if he has reached the physical or mental state where continuation of the
experiment seems to him to be impossible.

10. During the course of the experiment the scientist in charge must be prepared to
terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the
good faith, superior skill, and careful judgment required of him, that a continuation of the
experiment is likely to result in injury, disability, or death to the experimental subject.

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secretary of defense for manpower and personnel, who was an expert on labor
relations.75

A letter written by the administrator of the Armed Forces Epidemiological
Board documents Mr. Jackson's role and motivation:

It was on Mr. Jackson's insistence that the
'Nuremberg Principles' were used in toto in the
document, since he stated, these already had
international judicial sanction, and to modify them
would open us to severe criticism along the line—
"see they use only that which suits them."76

Thus, the DOD's counsel cited the 1947 Nuremberg military tribunal
ruling as establishing an international legal precedent to which American
researchers should be held.

It appears that in succeeding months the AFMPC proposal was received
unenthusiastically by other DOD committees that reviewed it. In a November 12,
1952, memorandum, the executive director of the Committee on Medical Sciences
pointed out that "human experimentation has been carried on for many years." He
contended that

to issue a policy statement on human
experimentation at this time would probably do the
cause more harm than good; for such a statement
would have to be "watered down" to suit the
capabilities of the average investigator.77

"Human experimentation," the CMS executive director asserted, "has, in
years past, and is at present governed by an unwritten code of ethics," which is
"administered informally by fellow workers in the field [and] is considered to be
satisfactory. ... To commit to writing a policy on human experimentation would
focus unnecessary attention on the legal aspects of the subject."78

Notwithstanding the reservations of the CMS and others,79 the Nuremberg
Code proposal had the support of President Truman's secretary of defense, Robert
A. Lovett.80 However, the secretary's aide, George V. Underwood, wrote in
January 1953, "Since consequences of this policy will fall upon Mr. Wilson
[President Eisenhower's nominee for secretary of defense, Charles Wilson], it
might be wise to pass to him as a unanimous recommendation from the
'alumni.'"81

In a January 13, 1953, memorandum for the new secretary, the AFMPC
"strongly recommended that a policy be established for the use of human
volunteers (military and civilian employees) in experimental research at Armed

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Chapter 1

Forces facilities." The policy would render the research "subject to the principles
and conditions laid down as a result of the Nuremberg trials."82

The Wilson Memorandum

26 Feb 1953

Memorandum for the Secretary of the Army

Secretary of the Navy
Secretary of the Air Force

Subject: Use of Human Volunteers in Experimental Research

1. Based upon a recommendation of the Armed Forces Medical Policy Council, that
human subjects be employed, under recognized safeguards, as the only feasible means for realistic
evaluation and/or development of effective preventive measures of defense against atomic,
biological or chemical agents, the policy set forth below will govern the use of human volunteers
by the Department of Defense in experimental research in the fields of atomic, biological and/or
chemical warfare.

2. By reason of the basic medical responsibility in connection with the development of
defense of all types against atomic, biological and/or chemical warfare agents. Armed Services
personnel and/or civilians on duty at installations engaged in such research shall be permitted to
actively participate in all phases of the program, such participation shall be subject to the
following conditions:

a. The voluntary consent of the human subject is absolutely essential.

( 1 ) This means that the person involved should have legal capacity to
give consent; should be so situated as to be able to exercise free power of choice,
without the intervention of any element offeree, fraud, deceit, duress, over-
reaching, or other ulterior form of constraint or coercion; and should have
sufficient knowledge and comprehension of the elements of the subject matter
involved as to enable him to make an understanding and enlightened decision.
This latter element requires that before the acceptance of an affirmative decision
by the experimental subject there should be made known to him the nature,
duration, and purpose of the experiment; the method and means by which it is to
be conducted; all inconveniences and hazards reasonably to be expected; and the
effects upon his health or person which may possibly come from his
participation in the experiment.

(2) The concept [sic] of the human subject shall be in writing; his
signature shall be affixed to a written instrument setting forth substantially the
aforementioned requirements and shall be signed in the presence of at least one
witness who shall attest to such signature in writing.

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(a) In experiments where personnel from more than one
Service are involved the Secretary of the Service which is exercising
primary responsibility for conducting the experiment is designated to
prepare such an instrument and coordinate it for use by all the Services
having human volunteers involved in the experiment.
(3) The duty and responsibility for ascertaining the quality of the
consent rests upon each individual who initiates, directs or engages in the
experiment. It is a personal duty and responsibility which may not be delegated
to another with impunity.

b. The experiment should be such as to yield fruitful results for the good of
society, unprocurable by other methods or means of study, and not random and
unnecessary in nature.

c. The number of volunteers used shall be kept at a minimum consistent with
item b., above.

d. The experiment should be so designed and based on the results of animal
experimentation and a knowledge of the natural history of the disease or other problem
under study that the anticipated results will justify the performance of the experiment.

e. The experiment should be so conducted as to avoid all unnecessary physical
and mental suffering and injury.

f. No experiment should be conducted where there is an a priori reason to
believe that death or disabling injury will occur.

g. The degree of risk to be taken should never exceed that determined by the
humanitarian importance of the problem to be solved by the experiment.

h. Proper preparation should be made and adequate facilities provided to protect
the experimental subject against even remote possibilities of injury, disability, or death.

i. The experiment should be conducted only by scientifically qualified persons.
The highest degree of skill and care should be required through all stages of the
experiment of those who conduct or engage in the experiment.

j. During the course of the experiment the human subject should be at liberty to
bring the experiment to an end if he has reached the physical or mental state where
continuation of the experiment seems to him to be impossible.

k. During the course of the experiment the scientist in charge must be prepared
to terminate the experiment at any stage, if he has probable cause to believe, in the
exercise of the good faith, superior skill and careful judgment required of him that a
continuation of the experiment is likely to result in injury, disability, or death to the
experimental subject.

1. The established policy, which prohibits the use of prisoners of war in human
experimentation, is continued and they will not be used under any circumstances.
3. The Secretaries of the Army, Navy and Air Force are authorized to conduct
experiments in connection with the development of defenses of all types against atomic, biological
and/or chemical warfare agents involving the use of human subjects within the limits prescribed
above.

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4. In each instance in which an experiment is proposed pursuant to this memorandum,
the nature and purpose of the proposed experiment and the name of the person who will be in
charge of such experiment shall be submitted for approval to the Secretary of the military
department in which the proposed experiment is to be conducted. No such experiment shall be
undertaken until such Secretary has approved in writing the experiment proposed, the person who
will be in charge of conducting it, as well as informing the Secretary of Defense.

5. The addresses will be responsible for insuring compliance with the provisions of this
memorandum within their respective Services.

/signed/
C. E. Wilson
copies furnished:

Joint Chiefs of Staff

Research and Development Board

Downgraded to
UNCLASSIFIED
22 Aug 75
TOP SECRET

On February 26, 1953, Secretary of Defense Wilson signed off on the
AFMPC policy. It was issued in a Top Secret memorandum to the secretaries of
the Army, Navy, and Air Force. The Wilson memorandum reiterates the
principles of the Nuremberg Code, requires written and witnessed informed
consent of research subjects, and prohibits the use of prisoners of war. The policy
was to "govern the use of human volunteers by the Department of Defense in
experimental research in the fields of atomic, biological, and/or chemical warfare
for defensive purposes."83

The basis for the classification of the 1953 memorandum is not clear.
Since the memorandum dealt with atomic and other unconventional forms of
warfare, its classification may have been routine. There is evidence that the DOD
had a general desire to keep hidden from public view any indication that it was
involved in biological and chemical warfare-related research; the Wilson
memorandum, of course, was just such an indication. In September 1952, the
Joint Chiefs of Staff advised the services to "[e]nsure, insofar as practicable, that
all published articles stemming from BW [biological warfare] and CW [chemical
warfare] research and development programs are disassociated from anything
which might connect them with U.S. military endeavor."84

In one sense the memorandum is a landmark in its official recognition of
the Nuremberg Code, but in another sense it also generates important questions.
Having determined to recognize international principles of human rights, why, or
how, could the secretary have limited their application to some, but not all, human

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Parti

experiments? Why was the policy directed exclusively to experiments related to
"atomic, biological, and chemical warfare"? Moreover, was the policy intended
to govern such research wherever it was conducted; for example, when it was
performed by private contractors, as well as by intramural researchers? How was
a directive issued in secret implemented?

Communicating the 1953 Wilson Memorandum

That there were problems in the dissemination of Secretary Wilson's Top
Secret memorandum is evidenced in a memorandum containing queries by
officials of the Armed Forces Special Weapons Project (AFSWP), within a year
of the Wilson memorandum's issuance. The AFSWP, now the Defense Nuclear
Agency (DNA), was at the hub of DOD nuclear weapons research. In the course
of a routine review of research reports, an AFSWP official learned that
"volunteers were injured as a consequence of taking part in [a] field experiment"
of flashblindness conducted at an atomic bomb test before the Wilson
memorandum was issued (see chapter 10). The AFSWP reviewer immediately
concluded that a "definite need exists for guidance in the use of human volunteers
as experimental subjects."85

On further inquiry, the AFSWP reviewer found that a policy already
existed, but had not been disseminated to investigators. A follow-up
memorandum, evidently written in early 1954, records:

In November 53 it was learned that there existed a
T/S [Top Secret] document signed by the Secretary
of Defense which listed various requirements and
criteria which had to be met by individuals
contemplating the use of human volunteers in Bio-
medical or other types of experimentation. ... It
was learned that although this document details
very definite and specific steps which must be taken
before volunteers may be used in experimentation,
no serious attempt has been made to disseminate the
information to those experimenters who have a
definite need-to-know.86

"The lowest level at which it had been circulated," the AFSWP reviewer
learned, "was that of the three Secretaries of the Services." Efforts by an assistant
secretary to "downgrade" the document had "not been able to obtain
concurrence." The reviewer hoped that "this letter shall point up the need for
some relaxation of the grip in which this document is now held, at least on a
definite need-to-know basis."87 (The application of the Wilson memorandum to
further experiments conducted at atomic bomb tests is discussed in chapter 10.)

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Chapter 1
Implementation in the Army

The Army did take substantial steps to put into effect the Wilson
memorandum. In June 1953 the Army chief of staff, John C. Oakes, issued a
memorandum implementing the secretary of defense's policy in toto. Referred to
in the Army as CS:385, this memorandum was initially classified Top Secret, but
was declassified the following year. In addition to the provisions of the Wilson
memorandum, the Army document required the prior review and approval of both
the surgeon general and the secretary of the Army. The Army's memorandum
also contained legal analysis that explained the source of the Army's authority to
perform human experiments in the first place and the limits that this authority put
on the selection of subjects.81* Even in the midst of the Korean War, the Army
did not view it as self-evident that the DOD could engage in human experiments
or choose any subjects it wished. The memorandum explained that the authority
to experiment on humans came from congressional enactments, including
provisions for research and development.1*9

Interestingly, choice of subjects was to be governed by the Army's ability
to ensure compensation in the case of death or disability.90 This could be
provided, the lawyers declared, only upon express congressional action. In the
case of military personnel and contractor employees there was such provision.
But there was no such authority in the case of private citizens who offered their
services. The Army lawyers recommended, and the CS:385 policy provided, that
private citizens not employed by Army contractors could not serve as research
subjects.91

On March 12, 1954, the Army Office of the Surgeon General (OSG)
issued an unclassified statement entitled "Use of Human Volunteers in Medical
Research: Principles, Policies, and Rules."92 This document too restated the
Nuremberg principles. In contrast with the Wilson and Oakes memorandums, it
was not restricted to research related to atomic, biological, or chemical warfare.
Instead, the OSG statement was directed to "medical research" with human
volunteers generally.93

Moreover, while CS:385 did not state directly whether it applied to
contract researchers, the 1954 OSG statement was transmitted to at least some
university researchers with the prefatory note, "To be used as far as applicable as
a non-mandatory guide for planning and conducting contract research."94 There is
evidence that the OSG's requirements were sometimes more than "non-mandatory
guides." For example, in a June 27, 1956, letter to the the Armed Forces
Epidemiological Board, a Tulane University public health researcher agreed that
his vaccine experiments with prisoner subjects would be conducted only after
written consent was obtained from the subjects.95 The Tulane researcher
indicated that, with respect to his application for funding, "I have held it up since
Dr. Dingle indicated I be familiar with the statement of the Office of the Surgeon
General re the use of human volunteers I have read it and believe that our

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Parti

past and future work have [sic] and will comply with the rules stipulated."96
Moreover, this researcher provided a written statement to supplement his original
proposal that explained how the OSG requirements would be met. In another
case, a proposal involving measles and normal children, an AFEB official advised
the researcher to "take [the OSG policy] into consideration in writing the
proposal."97

As discussed earlier, in 1952 the Army obtained congressional authority to
indemnify contract researchers in the event that an experiment caused injury or
death. There is evidence that the Army sought to link the grant of an
indemnification clause (ASPR 7.203.22, "Insurance-Liability to Third Persons")
to contractor acceptance of the principles stated by the Army surgeon general. In
a March 1957 letter to the University of Pittsburgh, which was proposing to use
medical student-volunteers in a (nonradiation) experiment, the Army told
Pittsburgh that the provision of the clause was "contingent upon your adhering to
the following [March 1954 Office of the Surgeon General] principles, policies,
and rules for the use of human volunteers in performing subject medical research
contracts."98

While the evidence clearly shows that Army officials sought to apply the
Nuremberg Code policy to contractors, it did not meet with complete success, and
the full extent of its efforts remains unclear. As we see in chapter 2, in the early
1960s Harvard successfully resisted the inclusion of the Nuremberg Code
language in its medical research contracts with the Army. As we see in chapter 8,
which discusses DOD funding of research on the effects of total-body irradiation,
the indemnification language was included in at least some contracts in which the
surgeon general's policy was not mentioned. By 1969, however, the policy may
have become standard in Army contracts under the authority of the Medical
Research and Development Command.99

There are several possible explanations for the seeming absence of
widespread inclusion of the surgeon general's memo as a contractual requirement,
at least where indemnification was provided for. First, as discussed below, it is
possible that the 1954 policy was meant to apply to research with healthy
subjects, and not sick patients. (However, even if that were generally the case,
the provision of indemnification might be expected to have triggered reflection on
this limitation.) Second, as a related matter, the evidence we are reviewing shows
a tension between the government's declaration of a principle and its readiness to
actively insist that the principle be honored within the privacy of the doctor-
patient relationship.

Finally, Army imposition of the surgeon general's principles may also
have depended on the nature of its interest in the research being done. An April
3, 1957, memo distinguished cases where the institution "because of its primary
interest, would conduct the research even without support of the OSG," from
cases where "the study is conducted at the insistence of OSG." In the former case
the strategy would be to seek cost-sharing contracts, in which the institution

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would "assume all responsibility for any possible effects resulting from the
experimentation." In the latter case, the indemnification clause would be
provided, but the March 1954 policy would also be required and included in the
contract directly or by reference. ino

It is not clear that the 1954 OSG policy on human volunteers was intended
to apply to research with patients. The term volunteer is ambiguous but at the
time was commonly used to refer to healthy subjects. Nonetheless, a 1 962 Army
memorandum that declared that since World War II "by and large research has
been conducted in strict accordance with the Nuremberg Code" mentions
patients. I0' The memo reported that a recent survey of contract research found
that the volunteers treated in accord with the Nuremberg Code included "3,000
students, 250 patients, and 300 prisoners." It is not known what kind of research
these 250 patients were involved in, nor is it known what proportion of the
patients who had been subjects of research supported or conducted by the Army
since World War II were represented by these 250.

Unfortunately, the 1962 review's confident declaration that Army research
complied with the Nuremberg Code was too sanguine. In 1975, following public
revelations that the Army and the CIA had conducted LSD experiments on
unwitting subjects, the Army inspector general reviewed the application of the
June 1953 policy to drug testing. The inspector general's review led to the
declassification of the 1953 Wilson memorandum. The inspector general found
that the Army had, with one or two exceptions, used only "volunteers" for its
drug-testing program. However, the "volunteers were not fully informed, as
required, prior to their participation, and the methods of procuring their services
in many cases appeared not to have been in accord with the intent of Department
of the Army policies governing use of volunteers in research."102

Additional DOD Research Requirements

While the Navy is not known to have taken specific action in response to
the 1953 Wilson memorandum, we have already noted that the Navy had long
since provided for prior review and voluntary participation in some cases. The
1951 Navy "Manual of the Medical Department" required secretarial approval of
human experimentation and the use of volunteers. These requirements applied to
"experimental studies of a medical nature" involving "personnel of the Naval
Establishment (military and civilian)."103 Participation was to be "on a voluntary
basis only."104 The manual also mandated prior review for research with patient-
subjects. "Clinical research," including "research projects and therapeutic trials,"
was to be "authorized by" the Bureau of Medicine and Surgery.105

At least for research with radioisotopes, the requirement for voluntary
participation may have applied to patient-subjects as well as healthy subjects. In
1951 the Navy debated adoption of a permission form for the use of radioisotopes
for patients at naval hospitals.106 This form, to be signed by either the patient or

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Parti

the responsible next of kin, authorized the use of "tracer-therapeutic" doses
"obtained from the Atomic Energy Commission for research purposes."107

Although it is not clear that the Army rules implementing the 1953 Wilson
memorandum applied to patient-subjects, there is some evidence that consent
forms that were usually used for surgical procedures were used in patient-related
experimental settings involving radioisotopes. In 1955 an official from the
Letterman Army Hospital in San Francisco asked the Walter Reed Hospital about
the need for written "permission" forms for "test doses" of radioisotopes.108 In
response, the Army indicated that a standard form used for operations and
anesthesia should also be employed, at the physician's discretion, when
"authorization for administration of radioisotope therapy is desired."109

In the Air Force, a 1952 regulation on clinical research mandated safety
and administrative procedures for the use of humans in experiments at Air Force
medical facilities."0 This regulation required prior group review but did not
mention consent provisions or refer to the subjects as volunteers. In 1958 a letter
from the Air Force's Air Research and Development Command describes the
policy for the use of humans in "hazardous research and development tests." This
policy reiterated the requirement for prior review discussed in the 1952
regulation. In this context, however, subjects were to be "volunteers]" who
"understood] the degree of risk involved in the experiment.""1

What, then, were the operative rules in the Department of Defense for
research involving human subjects in the 1940s and 1950s? By the mid-1950s,
for the entire DOD for research related to atomic, biological, and chemical
warfare, and for all research involving "human volunteers" in the Army, the
formal rules were the ten principles of the Nuremberg Code and the additions
included in the secretary of defense's 1953 policy. According to the 1975
testimony of the surgeon general of the Army before the U.S. Senate and the
internal review conducted by the Army inspector general, these principles were
Army "policy.""2 At the same time, as the inspector general reported in 1975 and
as we discuss further in chapter 10, these requirements were not always known or
followed. While there were attempts to implement the Army surgeon general's
1954 policy, it is not known how the policy's provisions, including the
requirement to obtain voluntary consent, were interpreted. The Navy's 1951
requirements for prior review and voluntariness applied to all research involving
Navy personnel.

The extent to which research rules applied to patient-subjects in the
clinical setting is less clear. There is some indication that in some cases standard
consent forms, akin to the surgical permits in use at the time, were employed with
patients at military hospitals who were administered "test doses" of radioisotopes.

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THE NATIONAL INSTITUTES OF HEALTH AND THE
VETERANS ADMINISTRATION

During the late 1940s and 1950s, the AEC and DOD were by no means
the only agencies sponsoring research involving human subjects. The Department
of Health, Education, and Welfare (DHEW), through two of its components, the
Public Health Service and the NIH, was emerging during this period as the
dominant government agency sponsoring human biomedical research. The
Veterans Administration (VA) as well conducted a large medical research
program that involved the use of radioisotopes in numerous human experiments.

In the early 1950s NIH participated in some of the discussions preceding
the issuance of the 1953 secretary of defense memorandum. At the request of a
DOD official for information on NIH's approach to the use of human subjects,
NIH responded with an April 1952 letter that included a draft statement on the
"Ethical Principles Underlying Investigations Involving Human Beings." Among
its other provisions, the April 28, 1952, draft states that

[t]he person who is competent to give consent to an
investigative procedure must do so. He must have legal
capacity to give consent and be able to exercise free choice,
without the intervention of any element of force, fraud,
deceit, duress, constraint or coercion. He must have
sufficient knowledge and comprehension of the nature of
the investigation to enable him to make an understanding
and enlightened decision. He must therefore be told the
nature, duration, and purpose of the experiment; the
method and means by which it is to be conducted; the
inconveniences and hazards reasonably to be expected; and
the effects upon his health or person which can reasonably
be expected to come from his participation in the
investigation. He should understand, furthermore, that by
his participation he becomes a co-investigator with the
physician."3

Although it is not known what became of this draft statement, around this
time NIH had good reason to develop a policy on the use of human subjects. In
1953 NIH opened the Clinical Center, a state-of-the-science research hospital.
The center adopted a policy requiring "voluntary agreement based on informed
understanding" from all research subjects and written consent from some patient-
subjects involved in research that the physician believed to be unusually
hazardous."4 Written consent was required from all healthy, "normal" subjects of
research beginning in 1954."5 Additionally, NIH began a system of group review
of proposed research that became a model for today's institutional review boards

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(IRBs)."6 Thus, the NIH policy appears to be the first instance of a single policy
that expressly provides for consent from all subjects, be they healthy or sick.
Even so, the policy was still limited to research at the Clinical Center and did not
apply to the considerable amount of NIH-funded research being undertaken by
grantees (extramural research).

The question of whether "patients," as well as healthy, "normal"
volunteers, should give written consent arose in the development of the NIH
policy. Legal counsel at NIH advised that, "from a legal point of view," there
should be a "written statement . . . indicating the patient's awareness of the nature
of the particular investigation in which he was to participate and acceptance of
any particular inconvenience or risk inherent in his participation.""7 A signed
form offered the best proof that a "policy" of "informed consent" was followed for
all subjects enrolled in studies at the center.

The NIH attorney wrote that while the Clinical Center's Medical Advisory
Board did not disagree with the principle, it did disagree with the need for a
written statement:

[0]f the members that expressed their views, and
most did so, all rejected such a proposal. The
rejection was due, as I understand it, not to any
particular detail but rather a more basic objection to
written, as opposed to oral, statements. There was
apparently, therefore, no objection to providing the
patient with enough information to permit him to
exercise an informed choice of participation or
refusal as long as not reduced to writing for his
signature."8

Nonetheless, the principle that all research subjects, including healthy subjects in
the "normal volunteer" program and patient-subjects, should make an informed
choice seems to be acknowledged in the Medical Advisory Board's position.

The NIH Clinical Center approach adopted by the mid-1950s-written
consent from healthy subjects and from only certain patient-subjects— persisted
through the early 1960s and was paralleled in policies of the DOD and the AEC.
The view that written consent from patients might unnecessarily interfere with
doctor-patient relationships prevailed.

Within the NIH, dialogue continued throughout the 1950s, setting the
stage for the leading role DHEW was to take in formulating human research
regulations in the 1960s (see chapter 3)."9

Although the NIH was by far the dominant agency in research involving
human subjects, a significant amount of radioisotope research occurred at the VA.
The VA research program employing radioisotopes at VA medical centers began
in 1948.120 This program was limited to VA hospitals affiliated with medical

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Chapter 1

schools. From its inception, this program involved a system of prior group review
by local radioisotope committees, normally composed of non-VA-affiliated
teaching staff of the affiliated medical school.121 These committees reviewed all
research proposals and approved all research conducted at VA radioisotope units.

In its formative years, the advisers to the new VA program included
Stafford Warren, Shields Warren, and others who were likely to be familiar with
the consent principles articulated by the AEC. Nonetheless, the earliest evidence
of a consent policy at the VA comes in the form of a 1958 general counsel's
opinion on whether the VA could participate in certain research. The general
counsel asserted that

persons who participate [in human subject research]
must voluntarily consent to the experiment on
themselves. Such consent must rest upon an
understanding of the hazards involved. The
volunteer may withdraw from the experiment at any
time. Moreover, before the experiment, steps to
reduce the hazard, as for example, indicated
research on animals, must be made.122

This opinion was written in response to two proposed research projects, and it is
not known if it was implemented in the projects or applied to others.

CONCLUSION

Records now available show that at the highest reaches of Cold War
bureaucracies officials discussed conditions under which human experimentation
could take place. These discussions took place earlier and in greater, although by
today's standards uncritical and less searching, detail than might have been
assumed. Nonetheless, the stated positions that resulted were often developed in
isolation from one another, were neither uniform nor comprehensive in their
coverage, and were often limited in their effectuation. Several interrelated factors
seem to have been prominent in causing these discussions to take place and in
determining the scope of the requirements that were declared and the efforts that
were undertaken to implement them. We summarize these key factors below.

Administrative and Legal Circumstance

The creation of new programs, or the qualitative expansion of old ones,
impelled officials, lawyers, and researchers to reflect on the rules to govern them.
While these rules were sometimes cast as "legal" or "financial" requirements, they
often included provisions, such as a requirement for written consent, that appear
similar to statements in requirements that govern the conduct of research today.

115

Parti

The language used to describe these rules was often that of law or administration,
such as "waiver" or "release" forms, or it may have had particular meaning to
researchers at the time, such as "clinical testing." As a result, it is often hard to
compare these rules to current requirements, which have benefited from
intervening decades of linguistic and conceptual refinement.

Professional Cultures

Differing professions brought their own tools and perspectives to
discussions of conditions under which human subjects research could proceed.
For example, lawyers were likely to insist on obtaining documented evidence of
patient consent, while medical professionals emphasized the importance of the
trust that underlay the relationship between doctor and patient; they sometimes
objected to the use and implications of written consent forms.

If consent procedures were a source of disagreement, the need to minimize
risk to subjects was not. In creating and administering the AEC's radioisotope
distribution program, physician investigators and other researchers placed a
premium on controlling and minimizing risk in the "human use" of radioisotopes.
This emphasis on the establishment of administrative and educational procedures
to control risk, the details of which are discussed in chapter 6, embodied an
essential principle of ethical research.

The requirement for prior review included in the isotope distribution
program was, as we have seen, also present elsewhere. Even before 1944,
approval of the secretary of the Navy was required for research with human
subjects. The secretary of the Army required prior approval of research related to
atomic, biological, and chemical warfare in 1953. In the Air Force, secretarial
approval of human experiments was codified in 1952. At NIH, prior group
review was employed as a policy from 1953 on. The VA, whose program
developed under the eye of AEC experts and advisers, relied on local isotope
committees.

The Nature of the Subjects

While voluntary consent was acknowledged as a condition of human
research by some government agencies well before 1944, it was not as broadly
applied as it is today. Requirements of voluntary consent were asserted most
clearly and consistently where the subjects were healthy. As a practical matter,
healthy subjects are not likely to participate in experiments without specific
request, and as a legal matter the invasion of a person's body in the absence of a
prior relationship that might justify it has long been unacceptable. Still more
important, the arbitrary use of people in experiments is incompatible with respect
for human dignity.

116

Chapter 1

The use of patients in medical research appeared in a different historical
context from that of healthy subjects, and the agencies appear to have responded
accordingly. From the perspective of the medical profession, the age-old tradition
of the doctor-patient relationship, as we shall see in the next chapter, provided a
justification for research with the potential to benefit patients, but not, of course,
for healthy subjects who were not under medical care. There is little evidence
that the agencies questioned whether research with patients that did not offer a
prospect of benefit warranted a different response. An exception is the position
articulated by the AEC's general manager in 1947, which made the possibility of
benefit to the patient-subject a condition of permissible research, at least where
the research involved "poisonous or harmful" substances. However, there is little
indication that this provision was ever implemented.

The period we reviewed in this chapter led to considerable public disquiet
about the use of healthy subjects and about the use of ill and institutionalized
people in research from which they could not possibly benefit. It was this
disquiet, in the wake of several well-publicized incidents, that formed the basis of
the mid-1960s reforms of federal policy governing research with human subjects
(see chapter 3). The focus on the way that patient-subjects were used in clinical
research that offered some prospect of benefit, and particularly on consent issues,
came much later. The latter discussion is one that continues today, as is evident
from the Advisory Committee's work on current research regulation that is
described in part III.

The Degree of Risk

To the extent that there was discussion in the 1940s and the 1950s of
consent for patient-subjects, it seemed to arise mainly in circumstances in which
those who were ill would be put at unusual risk from the research.

As we have seen, the AEC's radioisotope distribution division concluded
that consent was required where patients were being subjected to "larger doses for
investigative purposes" that apparently posed unusually hazardous or unknown
risks. Similarly, from its establishment at midcentury, the AEC's hospital at Oak
Ridge, which focused on new and potentially risky experimental cancer treatment,
did have routine requirements for consent. Likewise, from its 1953 birth, the
NIH's Clinical Center established a policy that recognized that patient choice was
important for all kinds of research with patients, and written consent was required
when an experiment involved' an unusual hazard.

Formal Policies and Public Morality

It is important not to get lost in the details of the various documents we
have cited in this chapter. What is most significant about the discussions that
took place in federal agencies from the mid- 1940s through the 1950s is the fact

117

Part I

that so many of the ideas and values with which we are familiar were apparent
then. That does not mean that the same words were used or that when they were
used they had the same meaning as they do for us today. But it does mean that
there were certainly more or less rough ideas about voluntary consent and
minimization of risk. As we have seen in this chapter, these ideas were very
much in play in the culture of the time.

118

ENDNOTES

1. The "Common Rule" applies requirements for voluntary consent, prior
review, and risk analysis to all federally sponsored research. This rule is discussed in
chapter 14.

2. David Rothman, Strangers at the Bedside: A History of How Law and
Bioethics Transformed Medical Decision Making (New York: Basic Books, 1991), and
Ruth Faden and Tom Beauchamp, A History and Theoiy of Informed Consent (New
York: Oxford University Press, 1986).

3. George J. Annas and Michael A. Grodin, eds.. The Nazi Doctors and the
Nuremberg Code; Human Rights in Human Experimentation (New York: Oxford
University Press, 1992). 343-345.

4. See Faden and Beauchamp, A Histoiy and Theory of Informed Consent, and
Mark S. Frankel, "Public Policymaking for Biomedical Research: The Case of Human
Experimentation" (Ph.D. diss., George Washington University, 9 May 1976).

5. Stafford L. Warren, Chairman, Interim Medical Advisory Board ("Report of
the 23-24 January 1947 Meeting of the Interim Medical Committee of the United States
Atomic Energy Commission") (ACHRE No. UCLA-1 1 1094-A-26). The report
summarized "specific projects" at twelve institutions. The projects at the University of
Rochester included "Study of the Metabolism of Plutonium, polonium, radium, etc. in
human subjects" (p. 8). In the case of Berkeley, the projects identified to Dr. Stone were

(1 ) Studies in whole-body radiation of human subjects by external and internal
radiation.

(2) Studies on the metabolism of radioactive iodine in animals and man.

(3) Joint studies with Dr. Joseph G. Hamilton to evaluate the therapeutic
applications '

of the fission products and the fissionable elements.

(4) Exploration and therapeutic application of other radioactive elements and
compounds (p. 1 1).

A 14 March 1947 memorandum from Austin Brues, director of the Biology Division of
the Argonne National Laboratory, records that "clinical testing programs" had only been
authorized, at least for the time being, at Berkeley and Rochester. However, Brues urged
that Argonne also be included. On behalf of this request he cited the University of
Chicago's "work using human subjects" with specific reference to a report on plutonium
injections. He further noted that human subject work also included the Argonne project
list provided at the January meeting. A. M. Brues, Director, Biology Division, to N.
Hilberry, Associate Laboratory Director, 14 March 1947 ("Clinical Testing") (ACHRE
No. DOE-050195-B).

6. Stafford Warren, Chairman, Interim Medical Advisory Committee, to Carroll
Wilson, General Manager, AEC, 30 January 1947 ("The opinion on Clinical Testing . . .")
(ACHRE No. DOE-051094-A-439), 1.

19

7. John L. Burling, Deputy General Counsel's Office, AEC, to Edwin
Huddleson, Jr., Deputy General Counsel, AEC, 7 March 1947 ("Clinical Testing")
(ACHRE No. DOE-051094-A-468), 2-3.

8. Ibid., 3.

9. Carroll L. Wilson, General Manager of the AEC, to Stafford Warren, the
University of California at Los Angeles, 30 April 1947 ("This is to inform you that the
Commission is going ahead with its plans . . .") (ACHRE No. DOE-051094-A-439), 2.

10. Ibid.

11. Ibid.

12. Robert J. Buettner, Assistant to Chairman, Interim Medical Advisory
Committee, AEC, to B. M. Brundage, Chief, Medical Division, AEC, 12 May 1947
("Transmitted herewith for your information . . .") (ACHRE No. DOE-05 1 094-A-439),
1.

13. Note in medical chart of Cal-3, dated 18 July 1947 ("Elmer Allen chart")
(ACHRE No. DOE-05 1 094- A-6 1 5). For more information on this case, see chapter 5.

14. Wilson to Warren, 30 April 1947.

15. University of California at San Francisco, February 1995 ("Report of the
UCSF Ad Hoc Fact Finding Committee ") (ACHRE No. UCSF-022495-A-6), 27.

16. J. C. Franklin, Manager, Oak Ridge Operations, to Carroll Wilson, General
Manager, AEC, 26 September 1947 ("Medical Policy") (ACHRE No. DOE-1 13094-B-
3), 2. Although the motivation for Oak Ridge's inquiry is not entirely clear, it seems to
have come in part from concerns of Albert Holland, M.D., who became the acting
medical adviser at Oak Ridge after Major Brundage retired. Holland served on the
committee that oversaw the use of radioisotopes in human research, discussed in chapter
6. In November 1947 Holland wrote, in regard to the isotopes distribution program:
"How far does the AEC's moral responsibility extend in this program?" Albert Holland,
Jr., Medical Adviser, Oak Ridge, to J. C. Franklin, Manager of Oak Ridge Operations, 7
November 1947 ("Medical and Operational Decisions") (ACHRE No. DOE-1 13095-B-
10), 2.

1 7. Unknown author to the Advisory Committee for Biology and Medicine, 8
October 1947 ("It is the desire of the Medical Advisor's Office . . .") (ACHRE No. DOE-
05 1094-A-502).

18. Atomic Energy Commission, Advisory Committee for Biology and
Medicine, minutes of 1 1 October 1947 (ACHRE No. DOE-072694-A-1), 10.

19. Ibid.

20. Ibid.

21 . Carroll Wilson, General Manager, AEC, to Robert Stone, University of
California, 5 November 1947 ("Your letter of September 18 regarding the
declassification of biological and medical papers was read at the October 1 1 meeting of
the Advisory Committee for Biology and Medicine.") (ACHRE No. DOE-052295-A-1).

22. Carroll Wilson, General Manager, AEC, to Alan Gregg, Chairman of the
AEC Advisory Committee for Biology and Medicine, 5 November 1947 ("I want to
thank you for your letter of October 14 concerning the questions raised by Dr. Stone in
his letter to me of September 18 regarding declassification of biological and medical
papers containing information on the experimental use of radioisotopes in human beings
conducted under AEC sponsorship.") (ACHRE No. DOE-052295-A-I).

23. Salgo v. Leland Stanford Jr. University Board of Trustees, 317 P. 2d 170
(1957).

120

24. Joseph Volpe, interview by Gregg Herken, Dan Guttman, and Debra Holland
(ACHRE), transcript of audio recording, 6 October 1994 (ACHRE Research Project
Series, Interview Program Files, Targeted Interview Project), 24-42.

In a May 1995 interview, Volpe agreed that a letter written by the general
manager constituted a "policy." The transcript of the interview records:

Interviewer: . . . today there are regular procedures for getting

something recognized as a policy, including publication
and so forth. In 1947, when the general manager writes
a letter, is that a policy?

Mr. Volpe: Yes, Yes.

Mr. Volpe noted that while the question of the precise authority of the general manager
was not without controversy. Chairman Lilienthal "believed in delegation of authority
and so always took measures to strengthen the general manager's hand on these things."
Joseph Volpe, interview by Barbara Berney, Steve Klaidman, Dan Guttman, Lanny
Keller, Jonathan Moreno, Patrick Fitzgerald, and Gilbert Whittemore (ACHRE),
transcript of audio recording, 18 May 1995 (ACHRE Research Project Series, Interview
Program Files, Targeted Interview Project), 37-38.

25. Leslie M. Redman, Los Alamos Laboratory, to Dr. Alberto F. Thompson,
Chief, Technical Information Service, DBM, 22 January 1951 ("I find myself concerned
in the course of duty with the review of papers relating to human experimentation.")
(ACHRE No. DOE-051094-A-609).

26. Warren did not cite the context for Wilson's discussion of these conditions,
that is, the need for criteria for declassification.

27. Shields Warren, Director, DBM, to Leslie Redman, "D" Division, Los
Alamos National Laboratory, 5 March 1951 (". . . to reply to your letter of January 22,
1951, concerning policies on human experimentation.") (ACHRE No. DOE-051094-A-
603).

28. Everett Idris Evans, M.D., Medical College of Virginia, to John Z. Bowers,
M.D., Assistant to the Director, DBM, AEC, 8 April 1948 ("We have recently obtained
approval from the Isotopes Division for human use of P32. . .") (ACHRE No. DOE-
051094-A-64).

29. John Z. Bowers, Assistant to Director, DBM, AEC, to Everett Idris Evans,
M.D., Medical College of Virginia, 27 April 1948 ("Thank you for recent letter
requesting information regarding isotopes.") (ACHRE No. DOE-050194-A-480).

30. Nathan H. Woodruff, Chief Technical Division, Isotopes Division, to Everett
I. Evans, M.D., Medical College of Virginia, 14 May 1948 ("Your letter of April 8 to Dr.
Bowers has been referred to me for answer.") (ACHRE No. NARA-082294-A-10).

3 1 . U.S. Atomic Energy Commission, Advisory Committee for Biology and
Medicine, agenda of 14 February 1948 (ACHRE No. DOE-072694-A), 2.

32. In addition to the document discussed above, there is some indication that
the AEC Isotopes Division was charged with ensuring that consent was obtained. In the
early 1970s, when the AEC conducted an investigation into the plutonium experiments.
Shields Warren told the investigators that his recollection was that ethical issues were
addressed at the time by the issuance of prospective policies. Warren stated:

I think the way it [concern about the plutonium

121

injections] was handled was that Alan Gregg and 1
agreed the best way to do [it] was to see that the rules
were properly drawn up by the . . . Human Applications
Isotope Committee, which had then come into being, so
that use without full safeguards could not occur, and that
we saw no point in bringing this up after the fact as long
as we were sure that nothing of this sort could happen in
the future.

Shields Warren, interview by L. A. Miazga, Sidney Marks, Walter Weyzen (AEC),
transcript of audio recording, 9 April 1974, 10-11 (ACHRE No. DOE-121294-D-14).

33. Unknown author, unpublished draft, 29 March 1948 ("The Experimental
Use of Radioactive Materials in Human Subjects at AEC Establishments") (ACHRE No.
DOE-050194-A-267).

34. Subcommittee on Human Applications, minutes of 22-23 March 1948, as
discussed in the minutes of the 13 March 1949 meeting. S. Allan Lough, Chief,
Radioisotopes Branch, to H. L. Friedell, G. Failla, J. G. Hamilton, and A. H. Holland, 19
July 1949 ("Revised Tentative Minutes of March 13, 1949 Meeting of the Subcommittee
on Human Applications of Committee of U.S. Atomic Energy Commission, AEC
Building, Washington, DC") (ACHRE No. DOE-101 194-A-13), 5.

35. The subcommittee was not definitive about when larger doses were
permitted, however. The policy was to apply in "instances in which the disease from
which a patient is suffering permits the administration of larger doses for investigative
purposes." U.S. Atomic Energy Commission, Isotopes Division, September 1949
("Supplement No. 1 to Catalogue and Price List No. 3, July 1949") (ACHRE No. DOD-
122794-A-l), 3-4.

36. While these statements were perhaps more than was told to patient-subjects
in other institutions, they did not necessarily provide details about the research. In the
application for admission, the applicant agreed to "such operations and biopsies as are
deemed necessary and advisable by the hospital." Oak Ridge Institute of Nuclear
Studies, 1950 ("Application for Admission to the Medical Division Hospital") (ACHRE
No. DOE-121494-C-1), 1.

Upon admission, the applicant was required to sign a "Waiver and Release" that
did not describe the treatment, but included a lengthy release from the patient, the
patient's "heirs, executors, administrators, and assigns," for any "causes of action, claims,
demands, damages, loss, costs, and expenses, whether direct or consequential," associated
with or resulting from the care of the hospital. This form notes that the hospital has
described the "character and kind of treatment." Oak Ridge Institute of Nuclear Studies,
1950 ("Waiver and Release") (ACHRE No. DOE-121494-C-3), 1.

37. Oak Ridge Institute for Nuclear Studies, 1950 ("Waiver and Release")
(ACHRE No. DOE-121494-C-3).

38. Program Committee of the Division of Biological and Medical Research of
the Argonne National Laboratory, minutes of 22 January 1951 (ACHRE No. DOE-
051095-B), 3.

39. Thomas Shipman, M.D., Health Division Leader, Los Alamos Laboratory,
AEC, to Dr. Charles Dunham, Director, DBM, AEC, 18 June 1956 ("Two questions have
recently arisen— one of them specific, the other general— wherein we need an opinion
from you.") (ACHRE No. DOE-091994-B-1).

122

40. Charles Dunham, Director, DBM, AEC, to Thomas Shipman, Health
Division Leader, Los Alamos Laboratory, 5 July 1956 ("This is in response to your letter
of June 18.") (ACHRE No. DOE-091994-B-2). In addition to consent, Dunham indicated
that the research should proceed so long as (a) the doses were small, "true tracer doses";
(b) the proposal was approved by a senior medical officer; and (c) the work was
supervised by a licensed physician.

41. T. L. Shipman, Health Division Leader, Los Alamos Laboratory, to Staff
Distribution, 12 July 1956 ("Administration of Tracer Doses to Humans") (ACHRE No.
DOE-091994-B-3), 1. Also, T. L. Shipman, Health Division Leader, Los Alamos
Laboratory, to "Distribution," 3 September 1963 ("Administration of Tracer Doses to
Humans For Experimental Purposes") (ACHRE No. DOE-091994-B-4), 1.

42. Isotopes Extension, Division of Civilian Application, U.S. AEC, "The
Medical Uses of Radioisotopes, Recommendations and Requirements of the Atomic
Energy Commission" (Oak Ridge, Tenn.: AEC, Februaiy 1956), 15.

43. U.S. Department of the Army, AR 40-210, The Prevention of Communicable
Diseases of Man— General (21 April 1925).

44. Charles W. Shilling, Medical Corps, USN. Retired, undated paper ("History
of the Research Division, Bureau of Medicine and Surgery, USN") (ACHRE No. DOD-
080295-A), 74.

45. The Secretary of the Navy to All Ships and Stations, 7 April 1943
("Unauthorized Medical Experimentation on Service Personnel") (ACHRE No. DOD-
091494-A-2).

46. J. E. Moore, M.D., to Dr. A. N. Richards, excerpt of letter dated 6 October
1942 ("I have recently received an inquiry from Dr. Charles M. Carpenter of the
University of Rochester School of Medicine who believes that he may be able to work
out a human experiment on the chemical prophylaxis of gonorrhea.") (ACHRE No.
NARA-060794-A-1).

47. A. N. Richards to J. E. Moore, 31 October 1942 (" Revision of Dr. Richards'
letter of October 9, 1942") (ACHRE No. NARA-060794-A-1 ). Stafford Warren, the
Manhattan Project medical director, also came from the University of Rochester. It is not
clear how, if at all, the CMR's views on human experiments were accounted for in
Manhattan Project research.

48. Rothman, Strangers at the Bedside, 30-50.

49. The Chief of the Bureau of Medicine and Surgery to the Officer-in-Charge,
Naval Laboratory Research Unit No. 1, University of California, Berkeley, California, 6
March 1943 ("Proposed Clinical Evaluation of Influenza Antiserum, and Messages
concerning Influenza Virus Specimens") (ACHRE No. DOD-062194-C-1).

50. Ibid., 2.

51. Institute of Medicine, National Academy of Sciences, Veterans at Risk: The
Health Effects of Mustard Gas and Lewisite (Washington, D.C.: National Academy
Press, 1993), 66-69.

52. Ibid., 214.

53. Robert S. Stone, unpublished paper, "Irradiation of Human Subjects as a
Medical Experiment," 31 January 1950 (ACHRE No. NARA-070794-A).

54. American Medical Association, Judicial Council, "Supplementary Report of
the Judicial Council," Journal of the American Medical Association 132 (1946): 1090.

55. The Under Secretary of the Navy to the Secretary of Defense, 24 April 1950
("Recommendation that the Armed Service conduct experiments on human subjects to

123

determine effects of radiation exposure") (ACHRE No. NARA-070794-A).

56. Atomic Energy Commission, Advisory Committee for Biology and
Medicine, transcript (partial) of meeting, 10 November 1950 (ACHRE No. DOE-0 12795-
C-l), 28.

57. Ibid., 28-29.

58. J. G. Hamilton, University of California, to Shields Warren, DBM, AEC, 28
November 1950 ("Unfortunately, it will not be possible for me to be at the meeting on
December 8 . . .") (ACHRE No. DOE-072694-B-45), 1.

59. Ibid.

60. Adam J. Rapalski, Administrator, the Armed Forces Epidemiological Board,
DOD, to Chief, Legal Office, 5 January 1952 ("Draft of 'Agreement with Volunteer'")
(ACHRE No. DOD-040895-A).

61. Lieutenant Colonel Robert J. O'Connor, Chief, Legal Officer, JAGD, to
Colonel Frank L. Baier, Army Medical Research and Development, 23 October 1947
("Protection of Research Project Volunteers") (ACHRE No. NARA-012395-A-4).

62. John R. Paul, Director, AEB, DOD, to Dr. Joseph Stokes, Jr., Children's
Hospital, Philadelphia, Pennsylvania, 18 February 1948 ("This is in reply to your hand
written request for a comment [from] me re your letter to Dr. Macleod dated 1 1 February
on the subject of funds for the reimbursement of volunteer prisoners . . .") (ACHRE No.
NARA-012395-A-1).

63. Ibid.

64. Committee Appointed by Governor Dwight H. Green of Illinois, "Ethics
Governing the Service of Prisoners As Subjects In Medical Experiments," Journal of the
American Medical Association 136, no. 7 (1948): 457-458.

65. C. J. Watson, M.D., Commission on Liver Disease, Army Epidemiological
Board, to Colin MacLeod, President of the Board, AEB, 5 April 1948 ("I have given
considerations in the past few weeks to the matter of using volunteers in penal
institutions for experimentation . . .") (ACHRE No. NARA-012395-A-2).

66. Ibid.

67. "Prisoner Dies After Injection in Disease Study," Washington Post, 6 May
1952,3.

68. L. M. Harff, Contract Insurance Branch, to File, 25 April 1952 ("Research
and Development Contracts-Medical Investigations) (ACHRE No. DOD-012295-A).

69. Adam J. Rapalski, Administrator, AEB, to Chief Legal Office, 14 October
1952 ("Applicability of Section 5, Public Law 557-82d Congress") (ACHRE No. NARA-
012395-A).

70. Adam J. Rapalski, Administrator, AEB, to Members of the AEB, undated
memorandum ("Applicability of Section 5, Public Law 557-82nd Congress") (ACHRE
No. NARA-012395-A). In congressional hearings, the activities used to illustrate the
purpose of the indemnification provision included test piloting, damage that might be
caused by cloud modification research, and cataracts caused by the operation of a
cyclotron. In addition, however, biomedical human experimentation was specifically
addressed in the following exchange between Representative Edward Hebert and Colonel
W. S. Triplet, from the Army Research and Development Division:

Mr. Hebert. Colonel, would you expand on the proposal to make
the Government liable for losses and damages? . . .

124

Colonel Triplet. There have been some experiments or types of
research in the past which would have come under section 5 [the
indemnification provision]. There are more coming up in the
future. One of the early cases, long before the time of the bill, I
would cite as an example is Dr. Reed in Cuba in 1900 utilized
the services of 21 volunteers to study yellow fever, an extremely
dangerous experiment. Two of these volunteers died. Eighteen
of the others became seriously ill. As a result a special medal
was awarded these people by Congress. That is an example of
the type of experiment that at the present time is going on in the
medical service.
Subcommittee Hearings on H. R. 1 1 80 to Facilitate the Performance of Research and
Development Work by and on Behalf of the Departments of the Army, the Navy, and the
Air Force, and for Other Purposes; House of Representatives, Committee on Armed
Services, Subcommittee no. 3, 6 June 1952, 621 (ACHRE No. NARA-10495-D).

71. Colonel George V. Underwood, Director, Executive Office, Office of the
Secretary of Defense, to Mr. Kyes, Deputy Secretary of Defense, 5 February 1953 ("Use
of Human Volunteers in Experimental Research") (ACHRE No. DOD-062194-A).

72. Melvin Casberg, Chairman, AFMPC, to the Secretary of Defense, 24
December 1952 ("Human Volunteers in Experimental Research") (ACHRE No. NARA-
101294-A-3).

73. Ibid.

74. Jackson recommended changes to the Nuremberg Code: the elimination of
the Nuremberg Code exception for self-experimentation by physicians and the express
provision that prisoners, but not prisoners of war, could be used. We do not know what
Jackson had "previously submitted." See Stephen Jackson, Assistant General Counsel in
the Office of the Secretary of Defense and Counsel for the AFMPC, to Melvin Casberg,
undated memorandum ("The standards and requirements to be followed in human
experimentation") (ACHRE No. NARA-101294-A-3).

75. Ms. Rosenberg, a high-ranking official in the DOD, was an expert in labor
relations and a New Dealer. Her role was recorded in Stephen Jackson to Melvin
Casberg, Chairman, AFMPC, 22 October 1952 ("I discussed the attached with Mrs.
Rosenberg . . .") (ACHRE No. NARA-101294-A-3).

76. Colonel Adam J. Rapalski, Administrator, Armed Forces Epidemiological
Board, DOD, to Colin MacCleod, President, Armed Forces Epidemiological Board,
DOD, 2 March 1953 ("The attached copy of letter I believe is self-explanatory.")
(ACHRE No. NARA-012395-A-5).

77. F. Lloyd Mussells, Executive Director, Committee on Medical Sciences,
RDB, DOD, to Floyd L. Miller, Vice Chairman, Research and Development Board,
DOD, 12 November 1952 ("Human Experimentation") (ACHRE No. NARA-071 194-A-
2).

78. Ibid.

79. In a 10 November 1952 meeting the Committee on Chemical Warfare was
read a draft of the AFMPC policy. One member remarked to general laughter: "If they
can get any volunteers after that I'm all in favor of it." Committee on Chemical Warfare,
RDB, DOD, transcript of the meeting of 10 November 1952 (ACHRE No. NARA-
102594-A), 128. H. N. Worthley, Executive Director, Committee on Chemical Warfare,
RDB, DOD, to the Director of Administration, Office of the Secretary of Defense, 9

125

December 1952 ("Use of Volunteers in Experimental Research") (ACHRE No. NARA-
101 294- A), 1.

80. This, at least, was the 1994 recollection of Lovett's military assistant.
General Carey Randall, who served in the same role for Lovett's predecessor and
successor. General Carey Randall, interview by Lanny Keller (ACHRE), transcript of
audio recording, 20 September 1994 (ACHRE Research Project Series, Interview
Program File, Targeted Interview Project), 17.

81 . George V. Underwood, Director of the Executive Office of the Secretary of
Defense, to Deputy Secretary of Defense Foster, 4 January 1953 ("I believe that Mr.
Lovett has a considerable awareness of this proposed policy.") (ACHRE No. NARA-
101294-A-l), 1.

82. Melvin A. Casberg, Chairman, Armed Forces Medical Policy Council, DOD,
to the Secretary of Defense, 13 January 1953 ("Digest 'Use of Human Volunteers in
Experimental Research"') (ACHRE No. DOD-042595-A), 1.

83. Secretary of Defense to the Secretary of the Army, Secretary of the Navy,
Secretary of the Air Force, 26 February 1953 ("Use of Human Volunteers in
Experimental Research") (ACHRE No. DOD-082394-A). The second paragraph of the
memorandum stipulates its application to "Armed Services personnel and/or civilians on
duty at installations engaged in such research. . . ." The Advisory Committee takes this
stipulation to be in recognition of the separate authority of the medical services, as
distinct from research and development commands.

84. W. G. Lalor. Secretary, Joint Chiefs of Staff, to Chief of Staff, U.S. Army,
Chief of Naval Operations, Chief of Staff, U.S. Air Force, 3 September 1952 ("Security
Measures on Chemical Warfare and Biological Warfare") (ACHRE No. NARA-0 12495-
A-l).

85. Irving L. Branch, Colonel, USAF, Acting Chief of Staff, to the Assistant
Secretary of Defense (Health and Medicine), 3 March 1954 ("Status of Human
Volunteers in Bio-medical Experimentation") (ACHRE No. DOD-090994-C), 2.

86. Ibid.. 3.

87. Ibid.

88. Brigadier General John C. Oakes, GS, Secretary of the General Staff,
Department of the Army, to the Chief Chemical Officer and the Surgeon General, 30
June 1953 ("CS:385-Use of Volunteers in Research") (ACHRE No. DOD-022295-B-1)
(CS385). This document was originally classified as Top Secret then downgraded to
Confidential and declassified in June 1954. "Research Report Concerning the Use of
Volunteers in Chemical Agent Research." Inspector General and Auditor General, 1975
(Army IG report), 77.

89. Oakes, sec. 3(a).

90. A series of memorandums from the Office of the Judge Advocate General
preceded and shed light on the 30 June 1953 memorandum:

Colonel Robert H. McCaw, JAGC, Chief, Military Affairs Division, to the Chief,
Research and Development, Office of the Chief of Staff, 6 April 1953 ("Volunteers for
Biological Warfare Research") (ACHRE No. DOD-082294-B).

Colonel Robert H. McCaw, JAGC, Chief, Military Affairs Division, to the Chief,
Research and Development, Office of the Chief of Staff, 10 April 1953 ("Volunteers for
Biological Warfare Research") (ACHRE No. DOD-082294-B).

126

Colonel A. W. Betts, GS, Executive for the Chief of Research and Development, to
Mr. J. N. Davis, Office of the Under Secretary of the Army, 15 April 1953 ("Use of
Volunteers in Experimental Research") (ACHRE No. DOD-082294-B).

91. CS:385, sec. 3(d).

92. Army Office of the Surgeon General, 12 March 1954 ("Use of Volunteers in
Medical Research, Principles, Policies, and Rules of the Office of the Surgeon General")
(ACHRE No. DOD-1 20694- A-4).

93. Ibid., 1 . A copy of this document was found in the files of John Enders,
Ph.D., Nobel Laureate in Medicine and Physiology, 1954, Yale University.

94. Ibid.

95. John Fox, M.D., Professor of Epidemiology, Tulane University School of
Medicine, to Captain R. W. Babione, Executive Secretary, AFEB, 27 June 1956 ("Finally
I am able to complete and send to you the application for a research contract to study . . .
") (ACHRE No. NARA-012395-A).

96. Ibid.

97. W. McD. Hammon, M.D., Director, Commission on Viral Infections, AFEB,
to John Enders, Children's Medical Center, 20 November 1958 ("This is to confirm our
telephone call this morning, November 20th, regarding approval of the AFEB for the
protocol of the experiment which you propose to carry out . . .") (ACHRE No. NARA-
032495-B), 1.

98. Max H. Brown, Contracting Officer, to Vice Chancellor, Schools of the
Health Professions, University of Pittsburgh, 12 March 1957 ("This is in reply to letter . .
.") (ACHRE No. DOD NARA-012395-A-6) The DOD has not located the Pittsburgh
contract itself, which may have been long since routinely destroyed; therefore, it cannot
be said for certain that the 1 954 surgeon general provisions were made a contract
requirement.

99. Herbert L. Ley to Colonel Howie, 8 January 1969 ("Review of Department
of the Army Policy on Use of Human Subjects in Research") (ACHRE No. DOD-
063094-A).

100. Max H. Brown to Contracting Officer, OTSG, 5 August 1957 ("The Use of
Human Test Subjects in Medical Research Supported by the Office of the Surgeon
General") (ACHRE No. NARA-012395-A).

101. Donald L. Howie, Assistant Chief, Medical Research, 10 July 1962
("Memorandum for the Record, Use of Volunteers for Army Medical Research")
(ACHRE No. DOD-1 20694- A-3). It is worth noting that prior to this memorandum, in
March 1 962, the Army promulgated its first regulation specifically directed to the
conduct of clinical research. This regulation (AR 70-25, 26 March 1962) specifically
exempted "clinical research," which apparently included research conducted on patients.
See chapter 3.

102. Army IG report, 1975.

103. Department of the Navy, Bureau of Medicine and Surgery, "Manual of the
Medical Department," sec. IV, research article 1-17 (26 September 1951).

104. On the question of written documentation, interestingly, the manual
stipulated: "[Vjolunteers" should not "execute a release for future liability for negligence
attributable to the Navy," but the manual required that a statement be "entered into the
Individual's Health Record" indicating the project number and the physical and
psychological effects, or lack of same, resulting from the investigation. "Manual of the
Medical Department," sec. IV, art. 1-17.

127

105. Ibid.

106. Loren B. Poush, Code 1 1, USN, to Code 74, USN (Bureau of Medicine and
Surgery), 18 October 1951 ("Legal comments relative to proposed means of proper
authorization and safeguard in use of radioisotopes") (ACHRE No. NARA-070794-A-4).

107. Code 74, USN, to Code 1 1, USN, 18 September 1951 ("Proposed Means
of Proper Authorization and Use of Radioisotopes") (ACHRE No. NARA-070794-A-4)
2.

108. Paul O. Wells, Chief, Radiological Service, Letterman Army Hospital, to
Elmer A. Lodmell, Chief, Radiological Service, Walter Reed Army Hospital, 14 January
1955 ("I am writing this letter at the suggestion of General Gillespie after having
discussed with him the matter of requiring patients to sign a permit for radioisotope
therapy.") (ACHRE No. DOD-012295-A).

109. Standard Form 522 (SF-522), "Clinical Record-Authorization for
Administration of Anesthesia and Performance of Operations and Other Procedures," was
proposed for use "in those instances when authorization for administration of
radioisotope therapy is desired." Eugene L. Hamilton, Chief, Medical Statistics Division,
to the Chiefs of the Medical Plans and Operations Division and the Legal Office, 3
August 1955 ("Permit for Radioisotope Therapy") (ACHRE No. DOD-012295-A).

In response to an inquiry from Walter Reed Army Hospital concerning the use of
consent forms for patients, the Medical Statistics Division, recommending the use of SF-
522, indicated that consent should be obtained when a procedure "carries an unusual
risk." Additionally, the Medical Statistics Division recommended that patients should be
"counselled as to the nature, expected results of, and risks involved in procedures."
Eugene L. Hamilton, Chief, Medical Statistics Division, to the Chiefs of the Professional
Division, Medical Plans and Operations Division, and the Legal Office, undated
memorandum (probably November 1956) ("Forms for Authorization of Radiation
Therapy") (ACHRE No. DOD-012295-A).

110. U.S. Air Force, Research and Development, "Clinical Research," AFR 80-
22(11 July 1952).

111. The Deputy Commander for Research and Development of the Air Force
R&D Command to RADC, WADC, APGC, AFCRC, AFSWC, AFMTC, AFMDC,
AFFTC, AFBMD (ARDC), AFOSR, 12 September 1958 ("Conduct of Hazardous
Human Experiments") (ACHRE No. HHS-090794-A).

112. Richard R. Taylor, Surgeon General of the Department of the Army,
testimony before the Subcommittee on Administrative Practice and Procedure of the
Judiciary Committee and the Subcommittee on Health of the Labor and Public Welfare
Committee, U.S. Senate, 94th Cong., 1st Sess., 10 September 1975 (ACHRE No. DOD-
063094-A), 1.

See also, U.S. Army Inspector General, Use of Volunteers in Chemical Agent
Research (Washington D.C.: GPO, 1975), 77.

1 13. Charles V. Kidd, Director, Research and Planning Division, NIH, to Rear
Admiral Winfred Dana, Medical Corps, USN, 30 April 1952 ("In accordance with our
telephone conversation of this afternoon I am enclosing a copy of draft statement which
we have developed.") (ACHRE No. DOD-1 1 1594-A), 2-3. The context of this statement
is not known. Perhaps it was formulated in response to an inquiry from the DOD about
the NIH's research requirements during the discussions that led to the drafting of the
Wilson memorandum.

128

1 14. National Institutes of Health, 17 November 1953 ("Group Consideration of
Clinical Research Procedures Deviating from Accepted Medical Practice or Involving
Unusual Hazard") (ACHRE No. HHS-090794-A), 4.

115. Director, N1H, to Institute Directors, 15 November 1954 ("Participation by
NIH Employees as Normal Controls in Clinical Research Projects") (ACHRE No. HHS-
090794-A), 1. Although this memorandum referred only to NIH employees, Advisory
Committee' staff and NIH staff have concluded it applied to all healthy volunteer subjects.

116. National Institutes of Health, policy statement of 17 November 1953
("Group Consideration of Clinical Research Procedures Deviating From Accepted
Medical Practice Or Involving Unusual Hazard") (ACHRE No. HHS-090794-A).

117. Edward J. Rourke, Legal Adviser, NIH, to Mr. John A. Trautman, Director,
Clinical Center, 5 December 1952 ("At your invitation, I presented to the Medical Board
of the Clinical Center on December 2 a proposal that, in view of several factors in some
degree peculiar to the Clinical Center, it would be advisable from the legal point of view
among others to accept certain procedures relating to patient admission that are more
formal than might otherwise be considered necessary") (ACHRE No. DOD-1 1 1 594- A),
1.

118. Ibid.

119. For a more detailed review of this history see Faden and Beauchamp, A
Histoiy and Theoiy of Informed Consent, and Frankel, "Public Policymaking for
Biomedical Research: The Case of Human Experimentation."

120. George M. Lyon, M.D., Assistant Chief Medical Director for Research and
Education, presentation to the Committee on Veterans Medical Problems, National
Research Council, 8 December 1952 ("Appendix II, Medical Research Programs of the
Veterans Administration") (ACHRE No. VA-052595-A).

121. Ibid., 558.

122. Guy H. Birdsall, General Counsel, Veterans Administration, to Chief
Medical Director, 25 June 1958, ("Op. G.C. 28-58, Legal Aspects of Medical Research")
(ACHRE No. VA-052595-A).

129

Postwar Professional

Standards and Practices for

Human Experiments

In chapter 1, we explored government discussions of research involving
human subjects in the 1940s and 1950s. We found that, at several junctures,
government officials exhibited an awareness of the Nuremberg Code, the product
of an international war crimes tribunal in 1947. If a requirement of voluntary
consent of the subject was endorsed by the Nuremberg judges and was recognized
at the highest reaches of the new Cold War bureaucracy, then how, a citizen
might now ask, could there be any question about the use of this standard to judge
experiments conducted during this time in the United States? And yet precisely
this question has been raised in connection with human radiation experiments.
Did American medical scientists routinely obtain consent from their subjects in
the 1940s and 1950s, including those who were patients, and if not, how did these
scientists square their conduct with the demands of the Nuremberg Code?

This chapter describes the Advisory Committee's efforts to answer these
questions and what we learned. We begin with an examination of what, in fact,
was argued at Nuremberg. We focus particularly on the testimony of Andrew
Ivy, the American Medical Association's (AMA) official consultant to the
Nuremberg prosecutors, and on the AMA's response to the report Dr. Ivy
prepared about the trial for the organization.

We turn next to an analysis of the actual practices of American medical
scientists during this period. In addition to reviewing contemporary
documentation and present-day scholarship, the Advisory Committee conducted

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interviews with leading medical scientists and physicians who were engaged in
research with human subjects in the 1940s and 1950s. These sources suggest a
different, more nuanced picture of the principles and practices of human research
than that presented at Nuremberg.

Of particular importance in this picture are the practical and moral
distinctions that many researchers made between investigations with healthy
subjects and those with sick patients. Those working with healthy subjects could
cite a tradition of consent that dated, at least, to Walter Reed's turn-of-the-century
experiments; those working with sick patients were in a clinical context that was
conditioned by a tradition of faith in the wisdom and beneficence of physicians, a
tradition that was dominant until at least the 1 970s. Closely related to these
distinctions was the tension between being a scientist and being a physician. This
tension confronted members of a new, and rapidly growing, breed of medical
professionals in the United States working to make careers in clinical research.
The chapter goes on to explore whether these distinctions and tensions were
reflected in the Nuremberg Code and why the trial may not have had much impact
on the treatment of patient-subjects.

The rest of the chapter explores the emerging awareness of the moral
complexities of research at the bedside and the limitations of the Nuremberg Code
to address them. We close with a brief discussion of the Declaration of Helsinki,
the international medical community's attempt to produce a code of conduct
compatible with the realities of medical research.

THE AMERICAN EXPERT, THE AMERICAN MEDICAL
ASSOCIATION, AND THE NUREMBERG MEDICAL TRIAL

In the fall of 1943, the United States, Great Britain, and the Soviet Union
agreed that, once victorious, they would prosecute individuals among the enemy
who might have violated international law during the war. On August 8, 1945--
exactly three months after V.E. Day and two days after the bombing of
Hiroshima-representatives of the American, British, French, and Soviet
governments officially established the International Military Tribunal in
Nuremberg, Germany. An assemblage of Allied prosecutors presented cases
against twenty-four high-ranking German government and military officials,
including Hermann Goering and Rudolph Hess, before this international panel of
judges. Quite early in the course of these initial Nuremberg trials, which ran from
October 1945 to October 1946, "it became apparent," according to the recent
recollections of American prosecutor Telford Taylor, "that the evidence had
disclosed numerous important Nazis, military leaders, and others" who should
also be tried.' In January 1946, President Harry Truman approved a
supplementary series of war crimes trials. These trials were to take place in the
same Nuremberg courtroom, and international law would continue to be the

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standard by which guilt or innocence would be determined. America's wartime
allies would not, however, participate; responsibility for prosecuting and judging
defendants in the second set of Nuremberg trials was left exclusively to the
United States.

The first of twelve cases that would eventually make up this second series
of trials in Nuremberg is technically called United States v. Karl Brandt et al.
More popularly, this trial is known by a variety of other names such as "The
Doctors' Trial" and "The Medical Case." For the sake of convenience and
consistency we will refer to the trial by another common name: the Nuremberg
Medical Trial. This case began on December 9, 1946, when U.S. Chief of
Counsel for War Crimes Telford Taylor delivered the prosecution's opening
statement against the twenty-three defendants (twenty of whom were physicians).
To one degree or another, Taylor charged the defendants with "murders, tortures,
and other atrocities committed in the name of medical science." The trial ended in
late August 1947 when the judges handed down a ruling that included the so-
called Nuremberg Code and seven death sentences.2

In the spring of 1946, the American prosecution team preparing for the
Medical Trial, which was made up of lawyers commissioned in the Army, cabled
Secretary of War Robert P. Patterson with a request for a medical expert.
Patterson consulted with Army Surgeon General Norman T. Kirk, who suggested
turning to the American Medical Association. Kirk contacted the AMA, and,
after some internal consultation, the association's Board of Trustees voted in May
1946 to appoint Dr. Andrew C. Ivy as the AMA's official consultant to the
Nuremberg prosecutors.3 Dr. Ivy was one of America's leading medical
researchers at the time. Early in the war, Ivy was the civilian scientific director of
the Naval Medical Research Institute in Bethesda, Maryland.4 During the
summer of 1946, he was in the process of moving from a position as head of the
Division of Physiology and Pharmacology at Northwestern University Medical
School to the University of Illinois, where he would serve as a vice president with
responsibility for the university's professional schools in Chicago.

The precise rationale behind Ivy's selection as the AMA's adviser to the
Nuremberg prosecutors remains unclear, but it is likely that the AMA turned to
Ivy for at least two reasons. First, his wartime research interests corresponded in
topic, though not in style, to some of the most shocking experiments that had
taken place in the Nazi concentration camps. Ivy supervised and carried out
experiments in seawater desalination, sometimes using human subjects, with the
intent of developing techniques to aid Allied pilots and sailors lost at sea. He also
conducted some pioneering human experiments in aviation medicine dealing with
the physiological challenges posed by high altitudes. These are two of the areas
in which Nazi researchers had conducted especially gruesome human
experiments. Second, Ivy was well known for his energetic defense of animal
experimentation against American antivivisectionists. For example, he served for

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eight years as the founding secretary-treasurer of the National Society for Medical
Research, an organization formed by scientists in 1946 to ward off challenges to
medical research posed by antivivisectionists. It seems likely that the AMA
Board of Trustees would have recognized Ivy as someone who possessed an
unusual combination of familiarity with the scientific aspects of experiments
carried out in the concentration camps and broad understanding of the moral
issues at stake in medical research, whether the experimental subjects were
animals or humans. Also, Ivy was almost certainly perceived as someone who
could be trusted to look out for the interests of the American medical research
community during the Nuremberg Medical Trial. The AMA Board of Trustees
probably realized that the entire enterprise of medical research would, to some
degree, be on trial in Germany.

In July or early August of 1946, Ivy went to Germany to meet with the
Nuremberg prosecution team. Ivy offered technical assistance to the lawyers
struggling with the scientific details of the experiments, but he also recognized, as
he put it, that the prosecutors "appeared somewhat confused regarding the ethical
and legal aspects" of human experimentation.5

After returning from his initial trip to Europe in aid of the Nuremberg
prosecutors, Ivy offered a preliminary oral report to the Board of Trustees of the
American Medical Association at the board's August 1946 meeting. After his
presentation, the trustees asked Ivy to provide a written summary of his findings,
so that the AMA's Judicial Council (a committee of five whose duties included
deliberating on matters of medical ethics) could "make a report as to the manner
in which these [Nazi] experiments [were] infringements of medical ethics."6

In mid-September, Ivy submitted a written report to the AMA as he had
been directed.7 At roughly the same time, he also turned over a copy of the
twenty-two-page typescript to the Nuremberg prosecution team. In this piece, Ivy
laid out "the rules" of human experimentation. He stated without equivocation
that these standards had been "well established by custom, social usage and the
ethics of medical conduct." Ivy's rules read as follows:

1 . Consent of the human subject must be obtained.
All subjects must have been volunteers in the
absence of coercion in any form. Before
volunteering the subjects have been informed of the
hazards, if any. (In the U.S.A. during War, accident
insurance against the remote chance of injury,
disability and death was provided. [This was not
true in all cases.])

2. The experiment to be performed must be so
designed and based on the results of animal

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Parti

experimentation and a knowledge of the natural
history of the disease under study that the
anticipated results will justify the performance of
the experiment. That is, the experiment must be
such as to yield results for the good of society
unprocurable by other methods of study and must
not be random and unnecessary in nature.

3. The experiment must be conducted

(a) only by scientifically qualified persons, and

(b) so as to avoid all unnecessary physical and mental
suffering and injury, and

(c) so, that, on the basis of the results of previous
adequate animal experimentation, there is no a priori
reason to believe that death or disabling injury will occur,
except in such experiments as those on Yellow Fever where
the experimenters serve as subjects along with non-
scientific personnel.8

A comparison of these rules with the Nuremberg Code, which the
Nuremberg Tribunal issued as part of its judgment on August 19, 1947, reveals
that the three judges extracted important elements of clause 1 from Ivy's first rule
and clauses 2, 3, 4, 5, and 8 almost verbatim from the rest of Ivy's formulation.
Significantly, the judges also reiterated Ivy's assertion that these rules were
already widely understood and followed by medical researchers.9

It is possible that the Nuremberg judges never read Ivy's report directly.
During his testimony at the trial, Ivy essentially read his set of rules into the court
record.10 Also, the judges could have gained exposure to Ivy's thinking through
two additional indirect sources. First, another medical expert who aided the
prosecution, an American Army psychiatrist named Leo Alexander, submitted on
April 15, 1947, a memorandum to the prosecutors entitled "Ethical and Non-
Ethical Experimentation on Human Beings." In this memorandum, which would
have been passed to the judges, Alexander repeated in very similar language
significant portions of Ivy's rules as outlined in the September 1946 report."
Second, American prosecutor James McHaney closely followed the text of Ivy's
rules when setting before the judges the "prerequisites to a permissible medical
experiment on human beings" during the prosecution's closing statement on July
14, 1947.12

But Ivy's standards for human experimentation served as even more than
the primary textual foundation for the Nuremberg Code; his set of rules also
undergirded the AMA's first formal statement on human experimentation. As the
Board of Trustees had directed when asking Ivy to prepare his written report, the

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finished document was immediately forwarded to the AMA Judicial Council.
The board gave the Judicial Council three months to prepare a presentation for the
House of Delegates, the large policy-making body of the AMA that was
scheduled to hold an annual meeting in early December 1946.13 Unfortunately,
records of the Judicial Council's consideration of Ivy's report have not survived,
but published proceedings of the House of Delegates meeting reveal the results of
the council's deliberations.14 Dr. E. R. Cunniffe, chair of the Judicial Council,
summarized his panel's response to Ivy's report at an executive session of the
House of Delegates on December 10, 1946 (the day immediately following the
prosecution's opening statement in the Nuremberg Medical Trial). Cunniffe
condemned the Nazi experiments described in Ivy's report as gross violations of
standards that were already inherent in the existing "Principles of Medical Ethics
of the American Medical Association," which had undergone only minor revision
since the AMA adopted them in 1847, the first year of the association's existence.
But in recognition of the fact that guidelines for human experimentation were not
explicitly laid out in these "Principles," the Judicial Council offered the following
distillation of Ivy's rules:

In order to conform to the ethics of the American
Medical Association, three requirements must be
satisfied: (1) the voluntary consent of the person on
whom the experiment is to be performed [must be
obtained]; (2) the danger of each experiment must
be previously investigated by animal
experimentation, and (3) the experiment must be
performed under proper medical protection and
management.15

These three rules became the official policy of the AMA when the House
of Delegates voted its approval "section by section and as a whole" on the
morning of December 1 1, 1946. The AMA's official governing body also added a
general admonition: "This House of Delegates condemns any other manner of
experimentation on human beings than that mentioned herein."16 It is worth
noting that in 1946 roughly 70 percent of American physicians belonged to the
AMA. In absolute terms, 126,835 physicians belonged to the association, but it
must be acknowledged that membership in the national association came
automatically with membership in county and state medical societies, which was
often necessary for professional privileges at local hospitals.17 Each member of
the AMA would have received a regular subscription to the Journal of the
American Medical Association, and all of these subscribers would have had an
opportunity to read the three rules for human experimentation approved by the
House of Delegates. At the same time, however, these rules were not published

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prominently; they were set in small type along with a variety of other
miscellaneous business items in the lengthy published minutes of the meeting.
Only an exceptionally diligent member, or one with a special interest in medical
ethics, is likely to have located this item.

In mid-June 1947, Ivy took the stand late in the Nuremberg Medical Trial
as a rebuttal witness for the prosecution to counter the claims of the defense that
standards for proper conduct in human experimentation had not been clearly
established before the initiation of the trial. The contents of Ivy's September 1946
report, and the AMA standards that arose from it, played a major role during his
three days of testimony. At one point, prosecution associate counsel Alexander
G. Hardy carefully walked Ivy through a verbatim oral recitation of the rules for
human experimentation contained in Ivy's report and the condensed version of his
rules as approved by the AMA. After a reading of the AMA principles, Hardy
and Ivy had the following exchange:

Q. . . . Now, [do these rules] purport to be the principles
upon which all physicians and scientists guide themselves
before they resort to medical experimentation on human
beings in the United States?

A. Yes, they represent the basic principles approved by the
American Medical Association for the use of human beings
as subjects in medical experiments.18

Hearing this specific, and obviously important, claim about research with
human subjects in the United States, Judge Harold E. Sebring interjected with a
broad question about the international significance of Ivy's assertion: "How do the
principles which you have just enunciated comport with the principles of the
medical profession over the civilized world generally?" Ivy responded: "They
are identical, according to my information."19

Later in his testimony, Ivy faced cross-examination by Fritz Sauter,
counsel for two of the German medical defendants. Sauter pushed Ivy to
acknowledge that the AMA guidelines had come into formal existence only as the
Nuremberg Medical Trial was getting under way. In response to this attempt to
diminish the legal force of the AMA standards with the obvious suggestion that
the rules had been made up too recently to be of relevance, Ivy made an explicit
claim in court that the ideas inherent in the AMA standards significantly predated
their official formulation:

Q. You told us that ... an association had made a
compilation regarding the ethics of medical experiments on
human beings. . . . Can you recall what I am referring to?
A. Yes.

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Q. That was in December 1946, 1 believe.

A. Yes, I remember. . . .

Q. Did that take place in consideration of this trial?

A. Well, that took place as a result of my relations

to the trial, yes.

Q. Before December of 1946 were such instructions

in printed form in existence in America?

A. No. They were understood only as a matter of

common practice.20

Thus, if Ivy is to be taken literally, the standards he forcefully articulated
during the Nuremberg Medical Trial, which were affirmed by the AMA House of
Delegates as the trial was just beginning and codified by three American judges
as the trial came to an end, were the standards of practice at the time.

THE "REAL WORLD" OF HUMAN EXPERIMENTATION

It would be historically irresponsible, however, to rely solely on records
related directly to the Nuremberg Medical Trial in evaluating the postwar scene in
American medical research. The panorama of American thought and practice in
human experimentation was considerably more complex than Ivy acknowledged
on the witness stand in Nuremberg. In general, it does seem that most American
medical scientists probably sought to approximate the practices suggested in the
Nuremberg Code and the AMA principles when working with "healthy
volunteers." Indeed, a subtle, yet pervasive, indication of the recognition during
this period that consent should be obtained from healthy subjects was the
widespread use of the term volunteer to describe such research participants. Yet,
as Advisory Committee member Susan Lederer has recently pointed out, the use
of the word volunteer cannot always be taken as an indication that researchers
intended to use subjects who had knowingly and freely agreed to participate in an
experiment; it seems that researchers sometimes used volunteer as a synonym for
research subject, with no special meaning intended regarding the decision of the
participants to join in an experiment.21

Even with this ambiguity it is, however, quite clear that a strong tradition
of consent has existed in research with healthy subjects, research that generally
offered no prospect of medical benefit to the participant. In the United States
much of this tradition has rested on the well-known example of Walter Reed's
turn-of-the-century experiments, when he employed informed volunteers to
establish the mosquito as the vector of transmission for yellow fever.22 Indeed, it
seems that a tradition of research with consenting subjects has been particularly
strong among Reed's military descendants in the field of infectious disease
research (which has frequently required the use of healthy subjects). For

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example, Dr. Theodore Woodward, a physician-researcher commissioned in the
Army, conducted vaccine research during the 1950s with healthy subjects under
the auspices of the Armed Forces Epidemiological Board. In a recent interview
conducted by the Advisory Committee, Woodward recalled that the risks of
exposure to diseases such as typhus were always fully disclosed to potential
healthy subjects and that their consent was obtained. Since some of these studies
were conducted in other countries with non-English-speakers, the disclosure was
given in the volunteer's language.23 Of his own values during this time,
Woodward stated: "If I gave someone something that could make them sick or kill
them and hadn't told them, I'm a murderer."24 Similarly, Dr. John Arnold, a
physician who conducted Army-sponsored malaria research on prisoners from the
late 1940s through the mid-1950s, recalled that he always obtained written
permission from his subjects.25

Not all the evidence on consent and healthy subjects comes from the
military tradition. A particularly compelling general characterization of research
with "normal volunteers" during this period comes from the "Analytic Summary"
of a conference on the "Concept of Consent in Clinical Research," which the
Law-Medicine Research Institute (LMRI) of Boston University convened on
April 29, 1961. At this conference, twenty-one researchers from universities,
hospitals, and pharmaceutical companies across the country were brought
together "to explore problems arising from the legal and ethical requirements of
informed consent of research subjects."26 The LMRI project was what one might
now call a fact-finding mission; the LMRI staff was attempting "to define and to
analyze the actual patterns of administrative practice governing the conduct of
clinical research in the United States" during the early 1960s.27 Anne S. Harris,
an LMRI staff member and author of the conference's final report, offered a
simple but significant assessment of the handling of healthy participants in
nontherapeutic research as expressed by the researchers at the meeting, whose
careers included the decade and a half since the end of World War II: "The
conferees indicated that normal subjects are usually fully informed."28

Even so, researchers who almost certainly knew better sometimes
employed unconsenting healthy subjects in research that offered them no medical
benefits. For example, Dr. Louis Lasagna, who has since become a respected
authority on bioethics, stated in an interview conducted by the Advisory
Committee that between 1952 and 1954, when he was a research fellow at
Harvard Medical School, he helped carry out secret, Army-sponsored experiments
in which hallucinogens were administered to healthy subjects without their full
knowledge or consent:

The idea was that we were supposed to give
hallucinogens or possible hallucinogens to healthy
volunteers and see if we could worm out of them

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secret information. And it went like this: a
volunteer would be told, 'Now we're going to ask
you a lot of questions, but under no circumstances
tell us your mother's maiden name or your social
security number,' I forget what. I refused to
participate in this because it was so mindless that a
psychologist did the interviewing and then we'd
give them a drug and ask them a number of
questions and sure enough, one of the questions was
'What is you mother's maiden name?' Well, it was
laughable in retrospect . . . [The subjects] weren 't
informed about anything [emphasis added].29

Lasagna, reflecting "not with pride" on the episode, offered the following
explanation: "It wasn't that we were Nazis and said, 'If we ask for consent we lose
our subjects,' it was just that we were so ethically insensitive that it never
occurred to us that you ought to level with people that they were in an
experiment."30 This might have been true for Lasagna the young research fellow,
but the explanation is harder to understand for the director of the research project,
Henry Beecher. Beecher was a Harvard anesthesiologist who, as we will see later
in this chapter and in chapter 3, would emerge as an important figure in
biomedical research and ethics during the mid-1960s.31

If American researchers experimenting on healthy subjects sometimes did
not strive to follow the standards enunciated at Nuremberg, research practices
with sick patients seem even more problematic in retrospect. Advisory
Committee member Jay Katz has recently argued that this type of research still
gives rise to ethical difficulties for physicians engaged in research with patients,
and he has offered an explanation: "In conflating clinical trials and therapy, as
well as patients and subjects, as if both were one and the same, physician-
investigators unwittingly become double agents with conflicting loyalties."

It is likely that such confusion and conflict would have been as
troublesome several decades ago, if not more troublesome, than it is today. The
immediate postwar period was a time of vast expansion and change in American
medical science (see Introduction). Clinical research was emerging as a new and
prestigious career possibility for a growing number of medical school graduates.
Most of these young clinical researchers almost certainly would have absorbed in
their early training a paternalistic approach to medical practice that was not
seriously challenged until the 1970s. This approach encouraged physicians to
take the responsibility for determining what was in the best interest of their
patients and to act accordingly. The general public allowed physicians to act with
great authority in assuming this responsibility because of an implicit trust that
doctors were guided in their actions by a desire to help their patients.

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This paternalistic approach to medical practice can be traced to the
Hippocratic admonition: "to help, or at least do no harm."33 Another long-
standing medical tradition that can be found in Hippocratic medicine is the belief
that each patient poses a unique medical problem calling for creative solution.
Creativity in the treatment of individuals, which was not commonly thought of as
requiring consent, could be— and often was—called experimentation. This tradition
of medical tinkering without explicit and informed consent from a patient was
intended to achieve proper treatment for an individual's ailments; but it seems also
to have served (often unconsciously) as a justification for some researchers who
engaged in large-scale clinical research projects without particular concern for
consent from patients.

Members of the medical profession and the American public have today
come to better understand the intellectual and institutional distinctions between
organized medical research and standard medical practice. There were significant
differences between research and practice in the 1950s, but these differences were
harder to recognize because they were relatively new. For example, randomized,
controlled, double-blind trials of drugs, which have brought so much benefit to
medical practice by greatly decreasing bias in the testing of new medicines, were
introduced in the 1950s. The postwar period also brought an unprecedented
expansion of universities and research institutes. Many more physicians than ever
before were no longer solely concerned, or even primarily concerned, with aiding
individual patients. These medical scientists instead set their sights on goals they
deemed more important: expanding basic knowledge of the natural world, curing
a dread disease (for the benefit of many, not one), and in some cases, helping to
defend the nation against foreign aggressors. At the same time, this new breed of
clinical researchers was motivated by more pragmatic concerns, such as getting
published and moving up the academic career ladder. But these differences
between medical practice and medical science, which seem relatively clear in
retrospect, were not necessarily easy to recognize at the time. And coming to
terms with these differences was not especially convenient for researchers; using
readily available patients as "clinical material" was an expedient solution to a
need for human subjects.

As difficult and inconvenient as it might have been for researchers in the
boom years of American medical science following World War II to confront the
fundamental differences between therapeutic and nontherapeutic relationships
with other human beings, it was not impossible. Otto E. Guttentag, a physician at
the University of California School of Medicine in San Francisco, directly
addressed these issues in a 1953 Science magazine article. Guttentag's article, and
three others that appeared with it, originated as presentations in a symposium held
in 1951 on "The Problem of Experimentation on Human Beings" at Guttentag's
home institution. Guttentag constructed his paper around a comparison between
the traditional role of the physician as healer and the relatively new role of

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physician as medical researcher. Guttentag referred to the former as "physician-
friend" and the latter as "physician-experimenter." He explicitly laid out the
manner in which medical research could conflict with the traditional doctor-
patient relationship:

Historically, . . . one human being is in distress, in
need, crying for help; and another fellow human
being is concerned and wants to help and the desire
for it precipitates the relationship. Here both the
healthy and the sick persons are . . . fellow-
companions, partners to conquer a common enemy
who has overwhelmed one of them. . . . Objective
experimentation to confirm or disprove some
doubtful or suggested biological generalization is
foreign to this relationship ... for it would involve
taking advantage of the patient's cry for help, and of
his insecurity.34

Guttentag worried that a "physician-experimenter" could not resist the
temptation to "tak[e] advantage of the patient's cry for help."35 To prevent the
experimental exploitation of the sick that he envisioned (or knew about),
Guttentag suggested the following arrangement:

Research and care would not be pursued by the
same doctor for the same person, but would be kept
distinct. The physician-friend and the physician-
experimenter would be two different persons as far
as a single patient is concerned. . . . The
responsibility for the patient as patient would rest,
during the experimental period, with the physician-
friend, unless the patient decided differently.

Retaining his original physician as personal adviser,
the patient would at least be under less conflict than
he is at present when the question of
experimentation arises.36

Among physicians, Guttentag was nearly unique in medicine in those days
in raising such problems in print. Another example of concern about the moral
issues raised by research at the bedside comes from what might be an unexpected
source: a Catholic theologian writing in 1945. In the course of a general review
of issues in moral theology, John C. Ford, a prominent Jesuit scholar, devoted

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several pages to the matter of experimentation with human subjects. Ford was not
a physician, but his thoughts on this topic-published a year before the beginning
of the Nuremberg Medical Trial-suggest that a thoughtful observer could
recognize, even decades ago, serious problems with conducting medical research
on unconsenting hospital patients:

The point of getting the patient's consent [before
conducting an experiment] is increasingly
important, I believe, because of reports which
occasionally reach me of grave abuses in this
matter. In some cases, especially charity cases,
patients are not provided with a sure, well-tried, and
effective remedy that is at hand, but instead are
subjected to other treatment. The purpose of
delaying the well-tried remedy is, not to cure this
patient, but to discover experimentally what the
effects of the new treatment will be, in the hope, of
course, that a new discovery will benefit later
generations, and that the delay in administering the
well-tried remedy will not harm the patient too
much. . . . This sort of thing is not only immoral,
but unethical from the physician's own standpoint,
and is illegal as well.37

The transcripts and reports produced in the Law-Medicine Research
Institute's effort during the early 1 960s to gather information on ethical and
administrative practices in research in medical settings suggest that by this time
more researchers had come to recognize the troubling issues associated with using
sick patients as subjects in research that could not benefit them. The body of
evidence from the LMRI project also suggests that problems with this type of
human experimentation had been widespread before the early 1960s and remained
common at that time. The transcript of a May 1, 1961, closed-door meeting of
medical researchers organized by LMRI to explore issues in pediatric research
shows a medical scientist from the University of Iowa offering a revealing
generalization from which none of his colleagues dissented. In order to
understand this transcript excerpt one must know that item "Al" on the meeting
agenda related to research "primarily directed toward the advancement of medical
science" and item "A2" referred to "clinical investigation . . . primarily directed
toward diagnostic, therapeutic and/or prophylactic benefit to patients."

We have done a thousand things with an implied
feeling [of consent]. . . . We wear two hats. Item

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A2 allows us to do A 1 but we feel uncomfortable
about it. The responsibility of the physician
includes responsibility to advance in knowledge.
Things are different now and this problem of a
secondary role [i.e., to advance knowledge] is
increasingly in front stage [emphasis added].38

This researcher acknowledged that many physicians during the period let
themselves slide into nontherapeutic research with patients. He provided the
additional, and significant, assessment that he and his colleagues felt guilty about
this behavior, even though it was quite common.

An even more probing analysis of these issues had taken place two days
earlier at the April 29, 1961, LMRI conference on "The Concept of Consent,"
referred to above in our discussion of research with healthy subjects. The
participants at this meeting recognized that research with sick patients could be
both therapeutic and nontherapeutic. Interestingly, they suggested that patients
employed for research in which "there was the possibility of therapeutic benefit
with minimal or moderate risk" were "usually informed" of the proposed study.
The author of the conference report offered the plausible explanation that
informing subjects in potentially beneficial research "is psychologically more
comfortable for investigators [because] the [therapeutic] expectations of potential
subjects coincide with the purpose and expected results of the experiment."39 The
conferees identified research in which "patients are used for studies unrelated to
their own disease, or in studies in which therapeutic benefits are unlikely" as the
most problematic. Those at the meeting "indicated that it is most often subjects in
this category to whom disclosure is not made."40 The conference report outlined
an approach employed by many researchers (including some at the meeting), in
which, rather than seeking consent from patients for research that offers them no
benefit,

[t]he therapeutic illusion is maintained, and the
patient is often not even told he is participating in
research. Instead, he is told he is "just going to
have a test." If the experimental procedure involves
minimal risk, but some discomfort, such as hourly
urine collection, "All you do is tell the patient: 'We
want you to urinate every hour.' We merely let them
assume that it is part of the hospital work that is
being done."41

Again, it is important to note that the conference participants displayed
some moral discomfort with this pattern of behavior, as can be seen from the

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following exchange:

Dr. X: There is a matter here of whether the patient
is not informed because the risk is too trivial, or
because it's too serious.

Dr. Y: I think you're getting right at it. There's a
great difference in not telling the patient because
you're afraid he won't participate and not telling him
because you don't think there is a conceivable risk,
and it's so trivial you don't bother to inform him.
Dr. Z: On the question of whether it's [acceptable]
not to tell, we would say that it is not permissible on
the grounds of refusal potential.42

It is also important to draw out of this transcript excerpt the general point
that most researchers in this period appear not to have had great ethical qualms
about enrolling an uninformed patient in a research project if the risk was deemed
low or nonexistent. Of course, the varying definitions of "low risk" could lead to
problems with this approach. Indeed, the participants at the "Concept of Consent"
conference grappled at length with this very issue without ever reaching
consensus. A minority steadfastly asserted that participants in an experiment
should be asked for consent even if the risk would be extremely low, such as in
only taking a small clipping of hair.

The Advisory Committee's Ethics Oral History Project43 has provided
extensive additional evidence that medical researchers sometimes (perhaps even
often) took liberties with sick patients during the decades immediately following
World War II. The element of opportunism was recounted in several interviews.
Dr. Lasagna, who was involved in pain-management studies in postoperative
patients at Harvard in the 1950s, explained rather bluntly:

[Mjostly, I'm ashamed to say, it was as if, and I'm
putting this very crudely purposely, as if you'd
ordered a bunch of rats from a laboratory and you
had experimental subjects available to you. They
were never asked by anybody. They might have
guessed they were involved in something because a
young woman would come around every hour and
ask them how they were and quantified their pain.
We never made any efforts to find out if they
guessed that they were part of it.44

Other researchers told similar tales, with a similar mixture of matter-of-

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fact reporting and regretful recollection. Dr. Paul Beeson remembered a study he
conducted in the 1940s, while a professor at Emory University, on patients with
bacterial endocarditis, an invariably fatal disease at the time. He recalled that he
thought it would be interesting to use the new technique of cardiac catheterization
to compare the number of bacteria in the blood at different points in circulation:

[This is] something I wouldn't dare do now. It
would do no good for the patient. They had to
come to the lab and lie on a fluoroscopic table for a
couple of hours, a catheter was put into the heart, a
femoral needle was put in so we could get femoral
arterial blood and so on. . . . All I could say at the
end was that these poor people were lying there and
we had nothing to offer them and it might have
given them some comfort that a lot of people were
paying attention to them for this one study. I don't
remember ever asking their permission to do it. I
did go around and see them, of course, and said,
"We want to do a study on you in the X-ray
department, we'll do it tomorrow morning," and
they said yes. There was never any question. Such
a thing as informed consent, that term didn't even
exist at that time. . . . [I]f I were ever on a hospital
ethics committee today, I wouldn't ever pass on that
particular study.45

Radiologist Leonard Sagan recalled an experiment in which he assisted
during his training on a metabolic unit at Moffett Hospital in San Francisco in
1956-1957.

At the time, the adrenal gland was hot stuff. ACTH
[adrenocorticotropic hormone] had just become
available and it was an important tool for exploring the
function of the adrenal gland. . . . This was the project
I was involved in during that year, the study of adrenal
function in patients with thyroid disease, both hypo-
and hyperthyroid disease. So what did we do? I'd find
some patients in the hospital and I'd add a little ACTH
to their infusion and collect urines and measure output
of urinary corticoids. ... I didn't consider it dangerous.
But I didn't consider it necessary to inform them
either. So far as they were concerned, this was part of

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their treatment. They didn't know, and no one had
asked me to tell them. As far as I know, informed
consent was not practiced anyplace in that hospital at
the time.46

Sagan viewed the above experiment as conforming not only with the
practices of the particular hospital but also in accord with the high degree of
professional autonomy and respect that was granted to physicians in this era:

In 1945, '50, the doctor . . . was king or queen. It
never occurred to a doctor to ask for consent for
anything. . . . People say, oh, injection with
plutonium, why didn't the doctor tell the patient?
Doctors weren't in the habit of telling the patients
anything. They were in charge and nobody
questioned their authority. Now that seems
egregious. But at the time, that's the way the world

47

was.

Another investigator, Dr. Stuart Finch, who was a professor of medicine at
Yale during the 1950s and 1960s, recalled instances when oncologists there were
overly aggressive in pursuing experimental therapies with terminal patients.

[I]t's very easy to talk a terminal patient into taking
that medication or to try that compound or whatever
the substance is. . . . Sometimes the oncologists
[got] way overenthused using it. It's very easy
when you have a dying patient to say, "Look, you're
going

to die. Why don't you let me try this substance on
you?" I don't think if they have informed consent or
not it makes much difference at that point.48

Economically disadvantaged patients seem to have been perceived by
some physicians as particularly appropriate subjects for medical experimentation.
Dr. Beeson offered a frank description of a quid pro quo rationale that was
probably quite common in justifying the use of poor patients in medical research:
"We were taking care of them, and felt we had a right to get some return from
them, since it wouldn't be in professional fees and since our taxes were paying
their hospital bills."49

Another investigator, Dr. Thomas Chalmers, who began his career in
medical research during the 1940s, identified sick patients as the most vulnerable

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type of experimental subjects-more vulnerable even than prisoners:

One of the real ludicrous aspects of talking about a
prisoner being a captive, and therefore needing
more protection than others, is, there's nobody more
captive than a sick patient. You've got pain. You
feel awful. You've got this one person who's going
to help you. You do anything he says. You're a
captive. You can't, especially if you're sick and
dying, discharge the doctor and get another one
without a great deal of trauma and possible loss of
lifesaving measures.50

Thus, as compared with prisoners, who are now generally viewed to be
vulnerable to coercion, those who are sick may be even more compromised in
their ability to withstand subtle pressure to be research subjects. Appropriate
protection for the sick who might be candidates for medical research has proved
to be an especially troublesome issue in the era following Nuremberg.

NUREMBERG AND RESEARCH WITH PATIENTS

The record of conducting nontherapeutic research with unconsenting sick
patients during the postwar period discussed above seems to stand in particularly
sharp contrast with the claims about the conduct of research involving human
subjects in the United States that Andrew Ivy made during his testimony in
Nuremberg. We have seen how some observers, even before Nuremberg,
recognized that employing uninformed, vulnerable sick patients solely as a means
to a scientific end was simply wrong. We must, however, also acknowledge that
the particulars of the Nuremberg Medical Trial did not call for careful attention to
the issues surrounding research with sick patients. None of the German
physicians at Nuremberg stood accused of exploiting patients for experimental
purposes.

Nonetheless, it is likely that Andrew Ivy would have argued that consent
was appropriate in virtually all instances of medical research. Dr. Herman
Wigodsky, who worked closely under Ivy at Northwestern in the late 1930s and
early 1940s, explicitly commented during an Ethics Oral History Project
interview that he did not believe that his mentor drew any sort of ethical line
between various types of clinical research: "I don't think he made any distinction
[between research with sick patients and research with healthy subjects].
Research was research. It didn't make any difference."51

Additional evidence that Ivy would have supported standards of consent
for research with ill as well as with healthy subjects comes from his response to a

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set of rules for human experimentation put forth by the German Ministry of
Interior in 1931, presented to him after he had prepared his written report for the
AM A in the fall of 1946. These rules appear to be considerably more
comprehensive and sophisticated than the Nuremberg Code itself.52 Most
significantly, the 1931 German standards cover both therapeutic and
nontherapeutic research, calling for consent in both types of medical
investigation. For reasons that are not clear, the prosecution team at Nuremberg
did not choose to place much emphasis on these German standards in constructing
the case. Ivy did, however, attempt (without much help from the prosecution) to
initiate a discussion of the 1931 standards during his testimony. It is clear from
the trial transcript that Ivy saw a rough equivalence between the more detailed and
extensive German rules and those formulated by the AMA, with his assistance.
Shortly after discussing the AMA principles on the witness stand, Ivy had the
following exchange with prosecutor Alexander G. Hardy:

Q. Do you have any further statements to make
concerning rules of medical ethics concerning
experimentation in human beings?
A. Well, I find that since making [my] report to the
American Medical Association that a decree of the
Minister of Public Welfare [Ivy should have said
"the Minister of the Interior"] of Germany in 1931
on the subject of "Regulations for Modern Therapy
for the Performance of Scientific Experiments on
Human Beings" contains all the [AMA] principles
which I have read.53

Hardy did not take what now seems an obvious opportunity to allow Ivy to
expand further on these rules. However, a few minutes later, Ivy brought up the
German standards again on his own (and again Hardy did not pursue the topic
further). At this point, Ivy stated his general agreement with the German
standards of 1931 even more firmly:

I cited the principles . . . from the Reich Minister of
the Interior dated February 28, 193 1 to indicate that
the ethical principles for the use of human beings as
subjects in medical experiments in Germany in
1931 were similar to these which I have enunciated
and which have been approved by the House of
Delegates of the American Medical Association.54

Ivy's assertion of "similarity" between the AMA principles and those in the 1931

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German document may not meet with agreement among those who compare the
two. Though they may be viewed as similar in philosophy and intent, the German
interior ministry document is, far more detailed and comprehensive than that of

theAMA.

Contrary to Ivy's claims at Nuremberg, and the positioning of Ivy by the
prosecution, he cannot in any full sense be taken as the embodiment of the entire
American medical profession in the years immediately following World War II.
Again, Dr. Wigodsky spoke to this point in his recent interview:

Well, I've always felt that that stuff that Ivy wrote
up during the time of the trials was pretty much an
expression of his personal philosophy about
research. And ... it was the kind of understanding
that we had in working with him about how he felt.
Voluntariness being number one--you had to
volunteer and had to be in a situation where you
could volunteer. And consent in the sense that you
didn't do anything to anybody that they didn't know
what you were doing. That you explained to people
what it was you were going to do and why you were
going to do it and that sort of thing [emphasis
added].55

Even if it is true that Andrew Ivy would have wholeheartedly endorsed the
notion of obtaining consent from any research subject- whether an experiment
held the possibility of personal benefit or not; whether the subjects were sick or
healthy-it seems likely that the AMA House of Delegates would have been
hesitant to endorse a condensation of Ivy's principles of research ethics if they had
been explicitly extended to cover all categories of clinical investigation.
Obtaining consent from patients within the normal clinical relationship was not a
common practice in late 1946. At that time, and for many years to come, patient
trust and medical beneficence were viewed as the unshakable moral foundations
on which meaningful interactions between professional healers and the sick
should be built. In fact, it was not until 1981 that the AMA's Judicial Council
specifically endorsed "informed consent" as an appropriate part of the therapeutic
doctor-patient relationship.56

But, in the end, it must be acknowledged that the facts of the Nuremberg
Medical Trial did not force Andrew Ivy, the AMA House of Delegates, the
Nuremberg prosecutors, or the judges to grapple with the distinctions between
research with sick patients and research with healthy subjects, or therapeutic and
nontherapeutic research. The Nuremberg defendants stood accused of ghastly
experimental acts that were absolutely without therapeutic intent, and their

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unfortunate subjects were never under any illusion that they were receiving
medical treatment. To rebut the claims of some of the medical defendants that
obtaining consent from research subjects was not a clearly established principle,
Ivy could, and did, offer a variety of examples on the witness stand from a long
tradition of human experimentation on consenting healthy subjects.57 Ivy and the
members of the prosecution team were not faced with what might have been a
more troubling process: finding examples of well-organized nontherapeutic
experiments on sick patients in which the subjects had clearly offered consent.
Simply put, the Nuremberg Medical Trial did not demand it.

AMERICAN MEDICAL RESEARCHERS' REACTIONS TO
NEWS OF THE NUREMBERG MEDICAL TRIAL

It is important to have some understanding of the extent to which
American medical scientists paid attention to the events of the Nuremberg
Medical Trial and made connnections with the messages that emanated from the
courtroom in Germany. The Nuremberg Medical Trial received coverage in the
American popular press, but it would almost certainly be an exaggeration to refer
to this attention as exhaustive. Historian David Rothman has provided the
following summary of the trial's coverage in the New York Times:

Over 1945 and 1946 fewer than a dozen articles
appeared in the New York Times on the Nazi
[medical] research; the indictment of forty-two
doctors in the fall of 1946 was a page-five story and
the opening of the trial, a page-nine story. (The
announcement of the guilty verdict in August 1 947
was a front-page story, but the execution of seven
of the defendants a year later was again relegated to
the back pages.)58

The Advisory Committee's Ethics Oral History Project suggests that
American medical researchers, perhaps like the American public generally, were
not carefully following the daily developments in Nuremberg. For example, Dr.
John Arnold, a researcher who, during the Medical Trial, was involved in malaria
experiments on prisoners at Stateville Prison in Illinois, offered a particularly
vivid (if somewhat anachronistic) recollection of the scant attention paid to the
Nuremberg Medical Trial among American medical scientists: "We were dimly
aware of it. And as you ask me now, I'm astonished that we [were not] hanging
on the TV at the time, watching for each twist and turn of the argument to
develop. But we weren't."59 It might have been expected that the researchers at
Stateville would have been particularly concerned with the events at Nuremberg

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because some of the medical defendants claimed during the trial that the wartime
malaria experiments at the Illinois prison were analogous to the experiments
carried out in the Nazi concentration camps.

The strongest statement of awareness came from Dr. Herbert Abrams, a
radiologist who was in his residency at Montefiore Hospital in the Bronx
throughout most of the trial:

[The Nuremberg Medical Trial] was part of the
history of the day. And there was extensive
reportage ... so that the manner of human
experimentation as it had been done by the Nazis
was very much in the news. We were all aware of
it. I think that people experienced this kind of
revulsion about it that you might anticipate. ... It
was surely something, at least in the environment I
was in, we were aware of and that affected the
thinking of everyone who was involved in clinical
investigation.60

It seems likely, however, that the "environment" this young physician was in
would have caused a heightened awareness of a trial dealing with Nazi medical
professionals. Montefiore is a traditionally Jewish hospital that was home to
many Jewish refugee physicians who had fled the terror and oppression of the
Nazi regime.61 A trial of German physicians almost certainly would have been of
particular interest in this setting.

Even among American medical researchers who might have been aware of
events at Nuremberg, it seems that many did not perceive specific personal
implications in the Medical Trial. Rothman has enunciated this historical view
most fully. He asserts that "the prevailing view was that [the Nuremberg medical
defendants] were Nazis first and last; by definition nothing they did, and no code
drawn up in response to them, was relevant to the United States."62 Jay Katz has
offered a similar summation of the immediate response of the medical community
to the Nuremberg Code: "It was a good code for barbarians but an unnecessary
code for ordinary physicians."63

Several participants in the Ethics Oral History Project affirmed the
interpretations of Rothman and Katz, using similar language. Said one physician:
"There was a disconnect [between the Nuremberg Code and its application to
American researchers]. . . . The interpretation of these codes [by American
physicians] was that they were necessary for barbarians, but [not for] fine
upstanding people."64 This same physician later acknowledged that, in a sense,
some American researchers did not pay attention to the lessons of the Nuremberg
Medical Trial because it was not convenient to do so:

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The connection between those horrendous acts
[carried out by German medical scientists in the
concentration camps] and our everyday
investigations was not made [by American medical
researchers] for reasons of self-interest, to be
perfectly frank. As I see it now, I'm saddened that
we didn't see the connection, but that's what was
done. . . . It's hard to tell you now . . . how we
rationalized, but the fact is we did/'5

The popular press mirrored the view that human experimentation as
practiced in the United States was not a morally troubling enterprise—it was as
American as apple pie. Between 1948 and 1960 magazines such as the Saturday
Evening Post, Reader's Digest, and the American Mercury ran "human interest"
stories on "human guinea pigs." These stories generally focused on specific
groups of healthy subjects— prisoners, conscientious objectors, medical students,
soldiers— and described them as "volunteers." The articles explained the ordeals
to which the volunteers had submitted themselves. "Among these men and
women," the New York Times informed its Sunday readership in 1958, "you will
find those who will take shots of the new vaccines, who will swallow radioactive
drugs, who will fly higher than anyone else, who will watch malaria infected
mosquitos feed on their bare arms."6'1 The articles assured the public that the
volunteers had plausible, often noble, reasons for volunteering for such seemingly
gruesome treatment. The explanations included social redemption (especially in
the case of prisoners), religious or other beliefs (particularly for conscientious
objectors), the advancement of science, service to society, and thrill-seeking.67 In
sum, most articles in the popular press were uncritical toward experimentation on
humans and assumed that those involved had freely volunteered to participate.

However, a smaller number of press reports in the late 1940s and 1950s
did suggest some tension between the words at Nuremberg and the practices in
America. As early as 1948, for example, Science News reported the Soviet claim
that Americans were using "Nazi methods" in the conduct of prisoner
experiments.68 Concern also began to be voiced about the dangers to volunteer
"guinea pigs." In October 1954, for another example, the magazine Christian
Century called on the Army to halt, at the first sign of danger, experiments at the
Fitzsimmons Hospital in Denver, where soldiers were called upon to eat foods
exposed to cobalt radiation.69

It is also possible that press accounts of experiments with patients rather
than healthy subjects were more inclined to be critical, even in the late 1940s. A
Saturday Evening Post article from the January 15, 1949, issue describes how a
VA physician kept quiet about streptomycin trials involving the medical
departments of the Army, Navy, and VA

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because of the risk of congressional chastisement
from publicity-conscious members of the House and
Senate who might have screamed: 'You can't
experiment on our heroes,' if it had been known that
Army and Navy veterans of former wars were being
used in the medical investigation. This was a real
worry of the doctors who formulated the clinical
program.™

Evidence suggests that some American researchers were genuinely and
deeply concerned with the issues surrounding human experimentation during the
years immediately following World War II. One source of insight into the
thinking of American physicians engaged in clinical research during the 1950s is
found in the ground-breaking work of medical sociologist Renee C. Fox. For two
five-month periods between September 1951 and January 1953, Fox spent long
days "in continuous, direct, and intimate contact with the physicians and patients"
in a metabolic research ward that she pseudonymously called "Ward F-Second."
In 1959 Fox reported with remarkable sensitivity and eloquence on the ethical
dilemmas faced by the physicians conducting research on this ward. She did not
suggest that the scientists under her observation were unaware of the Nuremberg
Code; instead she offered a point-by-point paraphrasing of the Code, which she
identified as "the basic principles governing research on human subjects which
the physicians of the Metabolic Group [her collective term for the researchers
whom she studied] were required to observe." Rather than being unconscious or
contemptuous of a set of principles intended for barbarians, Fox reported that the
researchers on "Ward F-Second" were sometimes troubled by their inability to
apply the high, but essentially unquestioned, standards enunciated at the
Nuremberg Medical Trial:

The physicians of the Metabolic Group were deeply
committed to these principles and conscientiously
tried to live up to them in the research they carried
out on patients. However like most norms, the
"basic principles of human experimentation" are
formulated on such an abstract level that they only
provide general guides to actual behavior. Partly as
a consequence, the physicians of the Metabolic
Group often found it difficult to judge whether or
not a particular experiment in which they were
engaged "kept within the bounds" delineated by
these principles.71

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Sometimes private discussions among researchers about the ethical
aspects of human experimentation led to public events. A good example from the
early 1950s is the symposium held on October 10, 1951, at the University of
California School of Medicine in San Francisco at which Otto Guttentag made the
presentation discussed earlier. One of Guttentag's colleagues, Dr. Michael B.
Shimkin, organized the symposium in response to some confidential criticism that
he had received for research carried out under his direction with patients at the
University of California's Laboratory of Experimental Oncology. The exact
nature of this criticism is unclear from the records that remain of the episode, but
Shimkin reported in a memoir that "remedial steps" were taken, including
"written protocols for all new departures in clinical research, which we asked the
cancer board of the medical school to review."72 In his memoirs Shimkin also
recalls that patients were screened carefully before they were admitted to the
Laboratory of Experimental Oncology:

They had to understand the experimental nature of
our work, and every procedure was again explained
to them; the initial release form even included
agreement to an autopsy. The understanding did
not absolve us of negligence, nor deprive patients of
recourse to legal actions, but did set the tone and
nature of our relationships. In all our 5 years of
operations, not a single threat or implied threat of
action against us was voiced. Two patients did
instruct us to terminate our attempts at therapy.73

The criticism Shimkin experienced also demonstrated to him that a more open
discussion of clinical research might be of benefit to his colleagues. According
to his recollection, "There was an almost visible thawing of attitude by the airing
of the problem" at the symposium.74

Less than a year after Shimkin's 1 95 1 San Francisco symposium, the
organizers of the "First International Congress of the Histopathology of the
Nervous System," which was held in Rome, were sufficiently concerned with
ethical issues that they invited Pope Pius XII to address "The Moral Limits of
Medical Methods of Research and Treatment." In a speech before 427 medical
researchers from around the world (including 62 Americans), the pope firmly
endorsed the principle of obtaining consent from research subjects— whether sick
or healthy. He also pointed his audience to the relatively recent lessons of the
Nuremberg Medical Trial, which he summed up as teaching that "man should not
exist for the use of society; on the contrary, the community exists for the good of
man."75 In an interview in 1961, Dr. Thomas Rivers, a prominent American virus
researcher, recalled that the pope's words had been influential among medical

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scientists working during the 1950s:

[I]n September 1952, Pope Pius XII had given a
speech at the First International Congress on the
Histopathology of the Nervous System in which he
outlined the Roman Catholic Church's position on
the moral limits of human experimentation for
purposes of medical research. That speech had a
very broad impact on medical scientists both here
and abroad.76

The growing influence of the Nuremberg Medical Trial can be seen by
looking at two editions of the best-known textbook of American medical
jurisprudence in the midtwentieth century. In the 1949 edition of Doctor and
Patient and the Law, Louis J. Regan, a physician and lawyer, offered very little
under the heading "Experimentation," and what he did offer made no reference to
Nuremberg:

The physician must keep abreast of medical
progress, but he is responsible if he goes beyond
usual and standard procedures to the point of
experimentation. If such treatment is considered
indicated, it should not be undertaken until
consultation has been had and until the patient has
signed a paper acknowledging and assuming the
risk.77

However, in Regan's next edition of the same text, published in 1956, his few
lines on human experimentation had been expanded to three pages. He presented
a lengthy paraphrasing of the Nuremberg Code, and he repeated verbatim
(without quotation marks) the judges' preamble to the Code, stating that "all
agree" about these principles. Regan characterized the standards enunciated by
the judges at Nuremberg as "the most carefully developed set of precepts
specifically drawn to meet the problem of human experimentation." Immediately
following his discussion of Nuremberg, Regan laid out the 1946 standards of the
American Medical Association, which, as he put it, researchers needed to meet
"in order to conform with the ethics of the American Medical Association."78

NEW TIMES, NEW CODES

In the spring of 1959 the National Society for Medical Research (NSMR),
an organization that Andrew Ivy had helped to found in 1946, sponsored a

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"National Conference on the Legal Environment of Medicine" at the University of
Chicago. Human experimentation was one of the major topics presented for
discussion by the 148 conference participants, primarily medical researchers,
from around the country. The published report of this conference reveals that the
many researchers who gathered in Chicago understood the Nuremberg Code well
enough to use it as a point of departure for discussion. As a group, the conferees
acknowledged that "[t]he ten principles [of the Nuremberg Code] have become
the principal guideposts to the ethics of clinical research in the western world."
Not all those in attendance, however, seemed to have been entirely pleased with
this state of affairs. A "Committee on the Re-Evaluation of the Nuremberg
Experimental Principles" reported general agreement with "the spirit of these
precautions" but discomfort with a number of "particulars." For example, they
suggested that the absolute requirement for consent in the Code's first principle
might be softened by inserting "either explicit or reasonably presumed" before the
word "consent." They also added a clause that would allow for third-party
permission for "those not capable of personal consent."79

The 1959 NSMR conference strongly suggests that by the late 1950s many
and perhaps even most American medical researchers had come to recognize the
Nuremberg Code as the most authoritative single answer to an important question:
What are the rules for human experimentation? The same conference also
provides compelling evidence that many researchers who were giving the ethical
issues surrounding human experimentation serious attention at this time were not
entirely happy with the prospect of living by the letter of the Code. The sources
of discomfort with the Nuremberg Code can be grouped, retrospectively, into
three broad categories. First, some recognized the discrepancies between what
they had come to know as real practices in research on patient-subjects and what
they read in the lofty, idealized language of the Code. Others simply disagreed
with some elements of the Code. Still others disliked the very idea of a single,
concrete set of standards to guide behavior in such a complex matter as human
experimentation.

Henry Beecher, the Harvard-based medical researcher who was Louis
Lasagna's mentor in the early 1950s, published a paper, "Experimentation in
Man," in the Journal of the American Medical Association only a few months
before the NSMR conference in Chicago. In this lengthy piece, Beecher
addressed a mixture of all three sources of discomfort with the Nuremberg Code.
Beecher offered the assertion that "it is unethical and immoral to carry out
potentially dangerous experiments without the subject's knowledge and consent"
as the "central conclusion" of his paper.80 But, even with this strong statement, he
was not entirely happy with the first clause of the Code; he viewed the
Nuremberg consent clause as too extreme and not squaring with the realities of
clinical research:

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It is easy enough to say, as point one [of the
Nuremberg Code] does, that the subject "should
have sufficient knowledge and comprehension of
the elements of the subject matter involved as to
enable him to make an understanding and
enlightened decision." Practically, this is often
quite impossible ... for the complexities of
essential medical research have reached the point
where the full implications and possible hazards
cannot always be known to anyone and are often
communicable only to a few informed investigators
and sometimes not even to them. Certainly the full
implications of work to be done are often not really
communicable to lay subjects. . . . [P]oint one states
a requirement very often impossible of fulfillment
[emphasis added].81

Beecher's second form of difficulty with the Code can be found in his
opinion of another Nuremberg clause, which states, in part, that a human
experiment should not be "random and unnecessary in nature." Beecher cited
"anesthesia, x-rays, radium, and penicillin" as important medical breakthroughs
that had resulted from "random" experimentation. He further stated that he
"would not know how to define experiments 'unnecessary in nature. ",82 Finally,
Beecher expressed skepticism in general that any code could provide effective
moral guidance for researchers working with human subjects. Near the beginning
of his paper he wrote that "the problems of human experimentation do not lend
themselves to a series of rigid rules."83 Later in the piece, he expanded on this
thought:

[I]t is not my view that many rules can be laid down
to govern experimentation in man. In most cases,
these are more likely to do harm than good. Rules
are not going to curb the unscrupulous. Such abuses
as have occurred are usually due to ignorance and
inexperience. The most effective protection for all
concerned depends upon a recognition and an
understanding of the various aspects of the
problem.84

Another episode involving Henry Beecher further clarifies the medical
profession's dissatisfaction with the construction of the Nuremberg Code. In the
fall of 1961, Beecher and other members of the Harvard Medical School's

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Administrative Board, the school's governing body, were presented with a set of
"rigid rules" that had begun to appear in Army medical research contracts. The
members of the board quickly recognized the "Principles, Policies and Rules of
the Surgeon General, Department of the Army, Relating to the Use of Human
Volunteers in Medical Research" awarded by the Army as little more than a
restatement of the Nuremberg Code. The Army Office of the Surgeon General's
provisions, as we discussed in chapter 1, originally appeared in 1954. Given what
we have just read of Beecher, it is not surprising that he was uncomfortable with
the prospect of working in strict accordance with the Nuremberg Code if he were
to receive funding from the Army, nor, as we see from the minutes of the
Administrative Board meetings in which this matter came up for discussion, was
Beecher alone in his opposition. At the October 6, 1961, meeting of the board,
when the Army contract insertion was first mentioned, "some members . . . felt
that with the minor changes the regulations were acceptable, while others
described the regulations as vague, ambiguous and, in many instances, impossible
to fulfill.""5

One of Beecher's fellow board members, Assistant Medical School Dean
Joseph W. Gardella, M.D., produced a thoroughgoing written critique of the
"Principles, Policies, and Rules of the Surgeon General" (and, thus, of the
Nuremberg Code) following the October 1961 meeting for the consideration of
the other board members. Gardella opened his analysis with some general
comments on the intended meaning of the Nuremberg Code:

The Nuremberg Code was conceived in reference to
Nazi atrocities and was written for the specific
purpose of preventing brutal excesses from being
committed or excused in the name of science. The
code, however admirable in its intent, and however
suitable for the purpose for which it was conceived,
is in our opinion not necessarily pertinent to or
adequate for the conduct of medical research in the
United States.86

After questioning the pertinence of the Nuremberg Medical Trial to American
medical science, Gardella went on to raise a general question about the scope of
the Nuremberg Code; he strongly suggested that the code was not meant to cover
what he perceived as the morally distinct enterprise of conducting potentially
therapeutic research with sick patients:

Does it refer only to healthy volunteers who have
nothing to gain in terms of their health by
participating as research subjects? Or does it

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include the sick, whose physicians foresee for them
the possibility of personal benefit through their
participation? The distinction is important in that
we believe that it would be difficult and might
prove to be impossible to devise one set of guiding
principles that would apply satisfactorily to both of
these two different categories.87

Gardella offered a variety of specific objections to the Army surgeon
general's "Principles," but several of these points related directly to the general
questions raised above. The first rule of the Army "Principles" stated (in a clear
example of borrowing from the Nuremberg Code) that "the voluntary consent of
the human subject is absolutely essential." Gardella, like Beecher, did not
question the general spirit of this stricture; he worried about the practical
application of this seemingly simple idea. Some of Gardella's worries arose
specifically in the context of research with sick patients:

The concept of "voluntary consent" is of central
importance in any code relating to experimentation
on humans. . . . And yet the concept of "consent" is
not satisfactorily defined [in the Army
"Principles"]. . . . The quality of the subject's
consent depends . . . upon an interpretation ... of a
factual situation which will frequently be complex.
Could the subject comprehend what he was told?
Did he in fact comprehend? How far was his
consent influenced by his condition or by his trust
in his physician? These questions may be easily
answered in the case of the [healthy] volunteer.
They may be more difficult for the sick [emphasis
added].88

Perhaps the most significant addition to the Nuremberg Code found in the
Army "Principles" was the requirement for written consent from research
subjects. Gardella objected to this requirement in research on patients in a firm,
and revealing, fashion:

This condition is . . . inappropriate except in
connection with healthy normal volunteers. The
legal overtones and implications attendant to such a
requirement have no place in [a] patient-physician
relationship based on trust. Here such faith and

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trust serve as the primary basis of the subject's
consent. Moreover being asked to sign a somewhat
formal paper is likely to provoke anxiety in the
subject [i.e., patient] who can but wonder at the
need for so much protocol.89

Dr. Gardella presented his analysis of the Army "Principles" to the other
members of the Harvard Medical School Administrative Board on March 23,
1962. The minutes of that meeting document that Gardella's views were not
extreme or exceptional among leading medical scientists in the early 1960s, at
least at Harvard University: "The members of the Board were in general
agreement with the objections and criticisms expressed in [Gardella's] critique."90
At this same meeting, Henry Beecher "agreed, in an expansive moment, to
attempt to capture in a paragraph or so the broad philosophical and moral
principles that underlie the conduct of research on human beings at the Harvard
Medical School."91 The members of the board hoped that such a statement might
satisfy the Army and that it would allow Harvard, as Gardella put it, "to avert the
catastrophic impact of the Surgeon General's regulation."92

A few months later, Beecher had completed a two-and-a-half-page
"Statement Outlining the Philosophy and Ethical Principles Governing the
Conduct of Research on Human Beings at Harvard Medical School." At the June
8, 1962, board meeting, Beecher's colleagues "commended" and "reaffirmed" the
views expressed in Beecher's document.93 In this statement, as in his 1959
published paper, Beecher emphasized the significance of consent, but he also
asserted that "it is folly to overlook the fact that valid, informed consent may be
difficult to the point of impossible to obtain in some cases." More than consent,
Beecher believed in the significance of "a special relationship of trust between
subject or patient and the investigator." In the end, Beecher concluded that the
only reliable foundation for this relationship was a virtuous medical researcher,
with virtuous peers:

It is this writer's point of view that the best
approach [to research with human subjects]
concerns the character, wisdom, experience,
honesty, imaginativeness and sense of responsibility
of the investigator who in all cases of doubt or
where serious consequences might remotely occur,
will call in his peers and get the benefit of their
counsel. Rigid rules will jeopardize the research
establishments of this country where
experimentation in man is essential.94

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Available evidence suggests that, by offering Henry Beecher's
replacement for the Nuremberg Code, representatives of Harvard Medical School
were able to extract a clarification during a meeting with Army Surgeon General
Leonard D. Heaton, on July 12, 1962, that the "Principles" being inserted into
Harvard's research contracts with the Army were "guidelines" rather than "rigid
rules."95

While the Harvard Medical School discussion of the Army's "Principles"
took place behind closed doors and involved a policy of limited applicability, the
leaders of the international medical community were simultaneously engaged in a
far more visible and global attempt to bring the standards enunciated in the
Nuremberg Code into line with the realities of medical research. The 1964
statement by the World Medical Association (WMA), commonly known as the
Declaration of Helsinki, created two separate categories in laying out rules for
human experimentation: "Clinical Research Combined with Professional Care"
and "Non-therapeutic Clinical Research."96 In the former category, physicians
were required to obtain consent from patient-subjects only when "consistent with
patient psychology." In the latter type of research, the consent requirements were
more absolute: "Clinical research on a human being cannot be undertaken
without his free consent, after he has been fully informed." Another noteworthy
deviation from the Nuremberg Code is Helsinki's allowance (in both therapeutic
and nontherapeutic research) for third-party permission from a legal guardian.97

As one might predict from the similarity between the changes introduced
by the Declaration of Helsinki and the changes to the Nuremberg Code suggested
by the American participants at the NSMR conference in 1959, the WMA
document met with widespread approval among researchers in this country.
Organizations including the American Society for Clinical Investigation, the
American Federation for Clinical Research, and the American Medical
Association offered their quick and enthusiastic endorsements.98 Compared with
the lofty, idealized language of the Nuremberg Code, the Helsinki Declaration
may have seemed more sensible to many researchers in the early 1 960s because it
offered rules that more closely resembled research practice in the clinical setting.

CONCLUSION

In the late 1940s American medical researchers seldom recognized that
research with patient-subjects ought to follow the same principles as those applied
to healthy subjects. Yet, as we have seen in this chapter, some of those few who
asked themselves hard questions about their research work with patients
concluded that people who are ill are entitled to the same consideration as those
who are not. That some did in fact reach this conclusion is evidence that it was
not beyond the horizon of moral insight at that time. Nevertheless, they were a
minority of the community of physician researchers, and the organized medical

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profession did not exhibit a willingness to reconsider its responsibilities to
patients in the burgeoning world of postwar clinical research.

While a slowly increasing number of investigators reflected on the ethical
treatment of human subjects during the 1950s, it was not until the 1960s and a
series of highly publicized events with names like "Thalidomide,"
"Willowbrook," and "Tuskegee" that it became apparent that a professional code,
whether it originated in Nuremberg or Helsinki, did not provide sufficient
protection against exploitation and abuse of human subjects of research. In the
next chapter we examine how the federal government became intimately,
extensively, and visibly involved in the regulation of research with human
subjects.

162

ENDNOTES

1 . A detailed recounting of the first series of Nuremberg Trials can be found in
Telford Taylor, The Anatomy of the Nuremberg Trials: A Personal Memoir (New York:
Alfred A. Knopf, 1992). Taylor describes the motivation for the second series of
Nuremberg Trials in the introduction to this book (p. xii). He also mentions that he
"hope[s] later to write a description of these subsequent trials" (p. xii). Taylor served as
an assistant to chief American prosecutor Robert H. Jackson at the first series of trials; he
was the chief prosecutor for the second series, which eventually included twelve separate

trials.

2. United States v. Karl Brandt et al, "The Medical Case, Trials of War
Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10"
(Washington, D.C.: U.S. Government Printing Office, 1949). This two-volume set
contains an abridged set of transcripts from the Nuremberg Medical Trial. A general
timeline for the trial can be found on p. 3 of volume 1 ; the quotation of Taylor's charges
can be found in the reproduction of his opening statement in volume 1, p. 27. The
published trial transcripts provide extensive detail on the experiments carried out by
German medical scientists on inmates at Nazi concentration camps. These experiments
included a long list of brutalities carried out in the name of medical science. Some of
these were specifically related to the Nazi war effort. German investigators conducted
high-altitude tolerance tests for the Luftwaffe using a low-pressure chamber. Scientists
forced prisoners to enter the chamber and subjected them to extreme pressure changes
that resulted in excruciating pain and, sometimes, death. Among these experiments were
human twin studies related to genetics and germ warfare. For example, a series of
experiments involved injecting one twin with a potential germ warfare agent to test the
effects of that agent. If the twin injected with the germ died, the other twin was
immediately killed to compare the the organs between the healthy and the sick twin.
Another series of experiments related to downed airman and shipwrecked sailors who
were faced with deprivation of potable water. In these tests, prisoners were divided into
four groups: the first received no water; a second set was forced to drink ordinary
seawater; the third would drink seawater processed to remove the salty taste (but not the
actual salt); and fourth group could drink desalinated seawater. Many of the subjects in
the first three groups died. German researchers also compelled prisoners to engage in a
variety of other cruel experiments, many of which were concerned with infectious
diseases such as malaria, epidemic jaundice, and typhus. More information can be
found on the Nazi prison camp experiments in several sources including Robert Jay
Lifton, The Nazi Doctors: Medical Killing and the Psychology of Genocide (New York:
Basic Books, 1986); Robert N. Proctor, Racial Hygiene: Medicine under the Nazis
(Cambridge, Mass.: Harvard University Press, 1988); and George J. Annas and Michael
A. Grodin, eds., The Nazi Doctors and the Nuremberg Code: Human Rights in Human
Experimentation (New York: Oxford University Press, 1992).

Japanese medical scientists, especially those associated with a biological warfare
(BW) research corps known as Unit 731, also conducted many cruel medical experiments
during the war. Until recently, these experiments were virtually unknown because
American military and medical officials struck a postwar deal with leading Japanese
scientists associated with Unit 73 1 : immunity from war crimes prosecution in exchange
for exclusive American access to the results of the Japanese BW experiments. The

163

Japanese experiments and the American cover-up have recently received coverage in
Sheldon Harris's Factories of Death: Japanese Biological Warfare, 1932-1945, and the
American Cover Up (London/New York: Routledge, 1994). See also Peter Williams and
David Wallace, Unit 731: The Japanese Army's Secret of Secrets (London: Hodder and
Stoughton, 1989); and John W. Powell, Jr., "Japan's Biological Weapons, 1930-1945,"
Bulletin of the Atomic Scientists 37 (October 1981): 44-53.

3. American Medical Association, Board of Trustees, minutes of the May 1946
meeting, AMA Archive, Chicago, Illinois (ACHRE No. IND-072595-A), 156-157.

4. A full-blown biography of Ivy remains to be written, but some biographical
information can be found in the following brief notices: Carl A. Dragstedt, "Andrew
Conway Ivy," Quarterly Bulletin of the Northwestern University Medical School 1 8
(Summer 1944): 139-140; Morton I. Grossman, "Andrew Conway Ivy (1893-1978),"
Physiologist 21 (April 1978): 1 1-12; D. B. Bill, "A. C. Ivy-Reminiscences,"
Physiologist 22 (October 1979): 21-22.

5. The quotation is taken from Andrew C. Ivy, "Nazi War Crimes of a Medical
Nature," Federation Bulletin 33 (May 1947): 133. Ivy first publicly offered this view of
the Nuremberg prosecutors' confusion about the ethics and legality of human
experimentation when he presented this paper at an annual meeting of the Federation of
State Medical Boards of the United States on 10 February 1947-just a few months after
the start of the Medical Trial. In this presentation Ivy said that he traveled to Germany
in August 1946. In a similar description of his experiences with the Nuremberg
prosecution team published a few years later Ivy reiterates a similar story except that the
date of his initial travel is given as July 1946: A. C. Ivy, "Nazi War Crimes of a Medical
Nature," Journal of the American Medical Association 139(15 January 1 949): 131. An
editorial in JAMA confirms some of the essential elements of Ivy's early work with the
Nuremberg prosecutors (his selection by the AMA Board of Trustees at the request of the
federal government and his travel to Germany "a few months" before November 1946):
"The Brutalities of Nazi Physicians," JAMA 132 (23 November 1946): 714. The basic
narrative of Ivy's selection by the Board of Trustees and his travel to Europe can also be
found in R. L. Sensenich, "Supplementary Report of the Board of Trustees," JAMA 132
(21 December 1946): 1006.

6. American Medical Association, Board of Trustees, minutes of the 16 August
1946 meeting, AMA Archive, Chicago, Illinois (ACHRE No. IND-072595-A), 8-9.

7. American Medical Association, Board of Trustees, minutes of the 19
September 1946 meeting, AMA Archive, Chicago, Illinois (ACHRE No. IND-072595-
A), 51-52.

8. A. C. Ivy, "Report on War Crimes of a Medical Nature Committed in
Germany and Elsewhere on German Nationals and the Nationals of Occupied Countries
by the Nazi Regime during World War II," 1946. This report was not published, but it is
available at the National Library of Medicine. A copy also exists in the AMA Archive
(ACHRE No. DOD-063094-A).

9. United States v. Karl Brandt et ah, "The Medical Case, Trials of War
Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10"
(Washington, D.C.: U.S. Government Printing Office, 1949), 2: 181-182. The judges'
preamble to the Code states that "[a]ll agree . . . that certain basic principles must be
observed in order to satisfy the moral, ethical and legal" aspects of human
experimentation.

164

10. Ivy's recitation of his own set of rules does not appear in the published
abridged transcripts of the trial. See the complete transcripts of the trial, which are
available on microfilm at the National Archives (National Archives Microfilm, M887,
reel 9, 13 June 1947, pp. 9141-9142). Throughout this chapter, we cite the abridged
transcripts wherever possible and the full transcripts only if necessary.

11. Leo Alexander later reproduced his 1 5 April 1 947 memo in two
publications: "Limitations in Experimental Research on Human Beings," Lex et Scientia
3 (January-March 1966): 20-22, and "Ethics of Human Experimentation," Psychiatric
Journal of the University of Ottawa 1 (1976): 42-44. In the 1976 article, Alexander made
a seemingly exaggerated claim to be "the original author of the Nuremberg Code" (p. 40).
Side-by-side comparison of Ivy's rules, Alexander's memo, and the Nuremberg Code
does, however, suggest that the judges drew two original contributions from Alexander's
memo: clauses 6 and 7 of the Nuremberg Code are embedded in the 15 April memo (they
do not appear in Ivy's rules).

12. McHaney's closing statement can be found in the complete microfilm
transcripts of the trial available through the National Archives. McHaney's closing
statement and Alexander's memorandum (and Alexander's claim to authorship of the
Code) are also reproduced in Michael A. Grodin's "Historical Origins of the Nuremberg
Code," in The Nazi Doctors and the Nuremberg Code: Human Rights in Human
Experimentation, 134-137.

13. American Medical Association, Board of Trustees, minutes of the 19
September 1946 meeting, AM A Archive, Chicago, Illinois (ACHRE No. IND-072595-

A).

14. The AM A reports that the records of the Judicial Council for all of the 1940s
have been lost. Personal communication between Marilyn Douros, of the AM A
Archives, and Jon M. Harkness (ACHRE), 19 January 1995.

15. "Supplementary Report of the Judicial Council," proceedings of the House
of Delegates Annual Meeting, 9-1 1 December 1946, JAMA 132 (28 December 1946):
1090. The bracketed addition to rule 1 was added in the final version of statement, which
was approved by the House of Delegates on 1 1 December 1946.

16. William A. Coventry, "Report of the Reference Committee on
Miscellaneous Business," proceedings of the House of Delegates Meeting, 9-1 1
December 1946, JAMA 133 (4 January 1947): 35.

17. Robert Williamson, an AMA archivist, reports that in 1942, 65 percent of
American physicians were members of the AMA, and in 1949, 75 percent of American
physicians were members; he did not have percentage figures available for 1946.
Williamson also provided the absolute number of members for 1946. Personal
communication between Jon M. Harkness (ACHRE) and Robert Williamson, 4 January
1995.

1 8. United States v. Karl Brandt et al. , "The Medical Case, Trials of War
Criminals before the Nuremberg Military Tribunal under Control Council Law No. 10,"
voi. 2, 83.

19. Ibid.

20. Complete transcripts of the Nuremberg Medical Trial, National Archives
Microfilm, M887, reel 9, 13 June 1947, pp. 9168-9170.

2 1 . Susan E. Lederer, Subjected to Science: Experimentation in America before
the Second World War (Baltimore: Johns Hopkins University Press, 1995), 105.

165

22. Lederer recounts the historical details of the yellow fever experiment (pp.
19-23) and explores Reed's powerful legacy (pp. 132-134) in Subjected to Science.

23. Theodore Woodward, interview by Gail Javitt and Suzanne White-Junod
(ACHRE), transcript of audio recording, 14 December 1994 (ACHRE Research Project
Series, Interview Program File, Ethics Oral History Project), 6.

24. Interview with Woodward, 14 December 1994, 10.

25. John D. Arnold, interview by Jon M. Harkness (ACHRE), transcript of
audio recording, 6 December 1994 (ACHRE Research Project Series, Interview Program
File, Ethics Oral History Project), 18.

26. The list of participants exists in the extant records of the LMRI project
available at the Center for Law and Health Sciences, School of Law, Boston University.
The quotation explaining the goal of the meeting is taken from the first page of a
summary of the conference prepared for the project's final report, which was not
published: Anne S. Harris, "The Concept of Consent in Clinical Research: Analytic
Summary of a Conference," chapter 6 in A Study of the Legal, Ethical, and
Administrative Aspects of Clinical Research Involving Human Subjects: Final Report of
Administrative Practices in Clinical Research, fNIHJ Research Grant No. 7039 Law-
Medicine Research Institute, Boston University, 1963 (ACHRE No. BU-053194-A).

27. The National Institutes of Health awarded LMRI almost $100,000 on 1
January 1960 to begin this project, which concluded 31 March 1963. The general
statement of the project's purpose appears in LMRI final report, chapter 1 ("Focus of the
Inquiry"), 1.

28. LMRI final report, chapter 6, 48.

29. Louis Lasagna, interview by Jon M. Harkness and Suzanne White-Junod
(ACHRE), transcript of audio recording, 13 December 1994 (ACHRE Research Project
Series, Interview Program File, Ethics Oral History Project), 5.

30. Ibid., 11.

31. Extensive newspaper clippings related to the Nuremberg Medical Trial exist
in Beecher's personal papers in the Special Collections Department, Countway Library,
Harvard University. Beecher's first major publication on research ethics appeared in early
1959: Henry K. Beecher, "Experimentation in Man," JAMA 169 (31 January 1959): 461-
478. Of course, he is best known for a 1966 article: Henry K. Beecher, "Ethics and
Clinical Research," New England Journal of Medicine 274 (16 June 1966): 1354-1360.
Significantly, Beecher acknowledged in a manuscript copy of the original version of the
NEJM paper, which he presented at a conference for science journalists on 22 March
1965, that "in years gone by work in my laboratory could have been criticized." Beecher,
"Ethics and the Explosion of Human Experimentation," 2a, Beecher Papers, Countway
Library (ACHRE No. IND-072595-A).

32. Jay Katz, "Human Experimentation and Human Rights," St. Louis University
Law Journal 38 (1993): 28.

33. Stanley Joel Reiser, Arthur J. Dyck, and William J. Curran, eds., Ethics in
Medicine: Historical Perspectives and Contemporarv Concerns (Cambridge, Mass.: The
MIT Press, 1977), 7.

34. Otto E. Guttentag, "The Physician's Point of View," Science 1 17 (1953):
207-210; the quotation is from 208. Guttentag's article appeared in Science with three
others that had been presented at the 1951 symposium: Michael B. Shimkin, "The
Researcher Worker's Point of View," 205-207; Alexander M. Kidd, "Limits of the Right

166

of a Person to Consent to Experimentation on Himself," 211-212; and W. H. Johnson,
"Civil Rights of Military Personnel Regarding Medical Care and Experimental
Procedures," 212-215.

35. Guttentag, "The Physician's Point of View," 208.

36. Ibid., 210.

37. John C. Ford, "Notes on Moral Theology," Theological Studies 6 (December
1945): 534-535. Ford's discussion of human experimentation arose in a lengthy and
discursive review of issues and ideas in moral theology. For several years, he contributed
a similar review to each volume of Theological Studies.

38. Transcripts of "Social Responsibility in Pediatric Research" conference, 1
May 1961, 7. LMRI records, Center for Law and Health Sciences, School of Law, Boston
University (ACHRE No. BU-053194-A).

39. "LMRI Final Report," chapter 6, 43.

40. Ibid., 43-44.

41. Ibid., 44.

42. Ibid., 46-47.

43. Committee member and historian Susan Lederer took principal
responsibility for organizing the Ethics Oral History Project, with assistance from several
members of the staff including two historians experienced in the techniques of oral
history. The Committee also drew on advice from several outside experts, including
historians and ethicists, to create a list of potential interviewees and to refine the list of
questions that we wanted to explore during interviews. In total, the Committee
conducted twenty-two interviews in the Ethics Oral History Project. Most of the subjects
were medical researchers whose careers began in the late 1940s or early 1950s, but we
also spoke with some research administrators. In general, we chose to interview
researchers who had exhibited some particular interest in research ethics during their
careers. But this does not mean that we held interviews only with researchers who
viewed recent developments in research ethics in a positive fashion. The interviews were
all recorded on audio tape and professionally transcribed. Interview subjects had an
opportunity to review the transcripts. Complete sets of all transcripts can be found in the
archival records of the Advisory Committee.

44. Interview with Lasagna, 13 December 1994, 13.

45. Paul Beeson, interview by Susan E. Lederer (ACHRE), transcript of audio
recording, 20 November 1994 (ACHRE Research Project Series, Interview Program
File, Ethics Oral History Project), 16-17.

46. Leonard Sagan, interview by Gail Javitt, Suzanne White-Junod, Sandra
Thomas, and John Kruger (ACHRE), transcript of audio recording, 17 November 1994
(ACHRE Research Project Series, Interview Program File, Ethics Oral History Project),
13-14.

47. Ibid., 19-20.

48. Stuart Finch, interview by Gail Javitt, Suzanne White-Junod, and Valerie
Hurt (ACHRE), transcript of audio recording, 6 December 1994 (ACHRE Research
Project Series, Interview Program File, Ethics Oral History Project), 52.

49. Interview with Paul Beeson, 20 November 1994, 39.

50. Thomas Chalmers, interview by Jon Harkness (ACHRE), transcript of audio
recording, 9 December 1994 (ACHRE Research Project Series, Interview Program File,
Ethics Oral History Project), 75.

167

5 1 . Herman Wigodsky, interview by Gail Javitt and Suzanne White-Junod
(ACHRE), transcript of audio recording, 17 January 1995 (ACHRE Research Project
Series, Interview Program File, Ethics Oral History Project), 14.

52. For an analysis and translation of the 1931 German rules see Hans-Martin
Sass, "Reichsrundschreiben 1931: Pre-Nuremberg German Regulations Concerning New
Therapy and Human Experimentation," Journal of Medicine and Philosophy 8 ( 1 983):
99-1 1 1 . A similar analysis and translation of the same set of rules appears in Grodin,
"Historical Origins of the Nuremberg Code," 129-132.

53. Full trial transcripts, 9142.

54. Abridged trial transcripts, 83.

55. Interview with Dr. Herman Wigodsky, 17 January 1995, 16-17.

56. Ruth Faden and Tom Beauchamp, A History and Theory of Informed
Consent (New York: Oxford University Press, 1986), 96.

57. Ivy's several examples ranged from Walter Reed's turn-of-the-century
experiments with yellow fever to wartime malaria experiments in American state and
federal prisons. See page 91 19 of the full trial transcripts for Ivy's discussion of the
Reed experiments and pages 9125-9129 for his description of the malaria experiments
that had taken place in the United States during the war.

58. David J. Rothman, Strangers at the Bedside: A Histoiy of How Law and
Bioethics Transformed Medical Decision Making (New York: Basic Books, 1994), 62.

59. Interview with John Arnold, 6 December 1 994, 9- 1 0.

60. Herbert Abrams, interview by Jon Harkness (ACHRE), transcript of audio
recording, 12 January 1995 (ACHRE Research Project Series, Interview Program File,
Ethics Oral History Project), 25.

61. Dorothy Levenson, Montefwre: The Hospital as Social Instrument, 1884-
1984 (New York: Farrar, Straus & Giroux, 1984). For information on the presence of
Jewish refugee physicians at Montefiore, see pages 154-155.

62. Rothman, Strangers at the Bedside, 62-63.

63. Katz, "The Consent Principle of the Nuremberg Code," 228.

64. William Silverman, interview by Gail Javitt (ACHRE), transcript of audio
recording 14 February 1995 (ACHRE Research Project Series, Interview Program File,
Ethics Oral History Project), 61-62.

65. Ibid., 87-88.

66. "Why Human 'Guinea Pigs' Volunteer," New York Times Magazine, 13
April 1958,62.

67. See, for example, John L. O'Hara, "The Most Unforgettable Character I've
Met," Reader's Digest, May 1948, 30-35; Thomas Koritz, "I Was a Human Guinea Pig,"
Saturday Evening Post, 25 July 1953, 27, 79-80, 82; Don Wharton, "A Treasure in the
Heart of Every Man,'" Reader's Digest, December 1954, 49-53 (condensed from
"Prisoners Who Volunteer, Blood, Flesh-and Their Lives," American Mercuiy,
December 1954, 51-55); Howard Simons, "They Volunteer to Suffer," Saturday Evening
Post, 26 March 1960, 33, 87-88.

68. "Experiments on Prisoners," Science Newsletter (also Science News), 2 1
February 1948,53, 117.

69. "C.O.'s Offer Selves for Atomic Experiments," Christian Century, 20
October 1954, 1260.

168

70. Robert D. Potter, "Are We Winning the War Against TB?" Saturday
Evening Post, 15 January 1949. Cited in Marcel C. LaFollette, Making Science Our
Own: Public Images of Science 1910-1955 (Chicago: University of Chicago Press, 1990),
138-140.

71 . Renee C. Fox, Experiment Perilous: Physicians and Patients Facing the
Unknown (Philadelphia: University of Pennsylvania Press, 1974, first published 1959).
Fox describes her long days of observation on page 15; she discusses the Nuremberg
Code at 46-47.

72. Michael B. Shimkin, As Memory Serves: Six Essays on a Personal
Involvement with the National Cancer Institute, 1938-1978 (Bethesda, Md.: U.S.
Department of Health and Human Services, 1983), 127.

73. Ibid., 128.

74. Ibid., 127.

75. The quotation is a translation from the French in which Pius XII delivered
the address: "II faut remarquer que l'homme dans son etre personnel n'est pas ordonne en
fin de compte a l'utilite de la societe, mais au contraire, la communaute est la pour
rhomme." The French text can be found in the Atti del Primo Congresso Internazionale
di Istopatologia del Sistema Nervosa/Proceedings of the First International Congress of
Neuropathology, Rome, 8-13 September 1952. English translations of the pope's address
appear in a variety of publications including The Linacre Quarterly: Official Journal of
the Federation of Catholic Physicians' Guilds 19 (November 1952): 98-107 and The
Irish Ecclesiastical Record 86 (1954): 222-230.

76. Saul Benison, Tom Rivers: Reflections on a Life in Medicine and Science
(Cambridge, Mass.: MIT Press, 1967), 498.

77. Louis J. Regan, Doctor and Patient and the Law, 2d ed. (St. Louis: C. V.
Mosby, 1949), 398.

78. Louis J. Regan, Doctor and Patient and the Law, 3d ed. (St. Louis: C. V.
Mosby, 1956), 370-372.

79. Report on the National Conference on the Legal Environment of
Medicine,27-28 May 1959 (Chicago: National Society for Medical Research, 1959); the
quotations are from pages 91 and 88, respectively.

80. Henry K. Beecher, "Experimentation in Man," Journal of the American
Medical Association 169(1959): 118/470.

81. Ibid., 121/473.

82. Ibid., 122/474.

83. Ibid., 109/461.

84. Ibid., 119/471.

85. Harvard Medical School, Harvard Medical School Administrative Board,
proceedings of the 6 October 1961 meeting (ACHRE No. HAR-062394-A-3).

86. Memorandum to "GPB" [Harvard Medical School Dean Berry] from "JWG"
[Assistant Dean Gardella] ("Criticisms of 'Principles, Policies and Rules of the Surgeon
General, Department of the Army, relating to the use of Human Volunteers in Medical
Research Contracts awarded by the Army'") (ACHRE No. IND-072595-A), 1.

87. Ibid., 2.

88. Ibid.

89. Ibid., 3.

169

90. Harvard Medical School, Harvard Medical School Administrative Board,
proceedings of 23 March 1962 (ACHRE No. HAR-062394-A-3).

91. Joseph W. Gardella, Assistant Dean, Harvard Medical School to Henry K.
Beecher, Massachusetts General Hospital, 27 March 1962 ("I write to confirm my
impression . . .") (ACHRE No. HAR-062394-A-4).

92. Ibid.

93. Harvard Medical School, Harvard Medical School Administrative Board,
proceedings of 8 June 1962 (ACHRE No. HAR-062394-A-3).

94. Henry Beecher, undated ("Statement Outlining the Philosophy and Ethical
Principles Governing the Conduct of Research on Human Beings at the Harvard Medical
School") (ACHRE No. IND-072595-A).

95. Henry K. Beecher to Lieutenant General Leonard D. Heaton, 12 July 1962
("I have just returned to Boston . . .") (ACHRE No. HAR-062394-A-2).

96. World Medical Association, "Declaration of Helsinki: Recommendations
Guiding Medical Doctors in Biomedical Research Involving Human Subjects," adopted
by the Eighteenth World Medical Assembly, Helsinki, Finland, 1964.

97. "Draft Code of Ethics on Human Experimentation," British Medical Journal
2 (1962): 1119; "Human Experimentation: Code of Ethics of the World Medical
Association," British Medical Journal 2 (1964): 177.

98. Faden and Beauchamp, A History and Theory of Informed Consent, 1 56- 1 57,
and Paul M. McNeill, The Ethics and Politics of Human Experimentation (Cambridge,
U.K.: Press Syndicate of the University of Cambridge, 1993), 44-47. For a more detailed
comparison between the Nuremberg Code and the Declaration of Helsinki, see Jay Katz,
"The Consent Principle of the Nuremberg Code," 231-234.

170

Government Standards for

Human Experiments:

The 1960s and 1970s

1 he year 1974 marks the upper bound for the period of the Advisory
Committee's historical investigation. That year two landmark events in the
history of government policy on research involving human subjects took place:
the promulgation by the Department of Health, Education, and Welfare (DHEW)
of comprehensive regulations for oversight of human subject research and
passage by Congress of the National Research Act. The DHEW regulations set
rules for oversight of human subject research supported by the single largest
funding source for such research, and the National Research Act authorized the
establishment of the National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research (also known as the National
Commission), which was charged with examining the conduct of research
involving human subjects. In the years following 1974, many of the rules
promulgated by DHEW were subsequently adopted by various other government
agencies, culminating in governmentwide regulations under the Common Rule in
1991.'

In the first part of this chapter, we trace the developments in the 1960s and
early 1970s that influenced and led up to the DHEW regulations and the National
Research Act. These developments included congressional hearings on the
practices of the drug industry and the thalidomide tragedy, critical scholarly
writings, interim policies at DHEW, public outcry over controversial cases of
medical research, and the congressional hearings these cases occasioned. People

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were surprised and shocked to learn about practices and behaviors they knew to
be wrong. While the ethical principles such practices violated may not have been
well articulated specific to the enterprise of human research, they were part of
individuals' moral consciousness. The history of these events has been well told
before, and we only summarize it here, drawing heavily on the previous work of
other authors.2

The 1974 regulations were promulgated by DHEW and applied only to
that agency. Likewise, the National Research Act authorized the establishment of
the National Commission and directed it to make recommendations to the
secretary of DHEW. In the latter part of this chapter, we review developments in
policies governing human research during this period in agencies other than
DHEW. This is a history that has received comparatively little scholarly
attention.

In the 1970s, just as DHEW was moving ahead with broad new
regulations, scandal rocked the Department of Defense and the CIA. It was
revealed that, with cooperation from university researchers, these agencies had
engaged in secret experimentation on military and civilian subjects without their
knowledge, sometimes with tragic results.3 The discovery of the existence of
these secret programs led to further congressional investigations and to a 1975
Department of the Army review of the effectiveness of the 1953 Secretary of
Defense Wilson memorandum adopting the Nuremberg Code. This Army review
led to the eventual declassification of the Wilson memorandum, which had been
Top Secret upon its issuance and remained classified until 1975. It also led, much
later, to litigation in which justices of the U.S. Supreme Court for the first time
commented on the applicability of the Nuremberg Code to actions undertaken by
the U.S. government.4 The chapter concludes with a discussion of these
important events.

THE DEVELOPMENT OF HUMAN SUBJECT RESEARCH
POLICY AT DHEW

As the largest funding source in the federal government for human subject
research, DHEW led the way in developing regulations aimed at protecting the
rights and welfare of subjects. The evolution of the regulations, which would
eventually be adopted on a government wide basis, was influenced by revelations
of unethical research, congressional reaction to the revelations, and concern over
public perception of such research. That regulations were eventually adopted at
all by DHEW was influenced by the political realities of the time and the lack of
congressional support for a standing regulatory body to oversee human subject
research, as had been recommended by an influential federally appointed panel,
the Tuskegee Syphilis Study Ad Hoc Panel. In a trade-off that would have major
influence on the future of human subject research oversight, the proposed bill
creating the standing regulatory body was withdrawn in exchange for the National

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Research Act, establishing the National Commission, and an understanding that
DHEW would promulgate the aforementioned regulations. This historical
backdrop is outlined in the rerhainder of this chapter.

The Thalidomide Tragedy and the Congressional Requirement for Patient
Consent

In 1959 a Senate subcommittee chaired by Senator Estes Kefauver of
Tennessee began hearings into the conduct of pharmaceutical companies.
Testimony revealed that it was common practice for drug companies to provide
samples of experimental drugs, whose safety and efficacy had not been
established, to physicians, who were then paid to collect data on their patients
taking these drugs. Physicians throughout the country prescribed these drugs to
patients without their knowledge or consent as part of this loosely controlled
research. These practices and others prompted calls by Kefauver and other
senators for an amendment to the Food, Drug, and Cosmetic Act of 1938 to
address the injuriousness and ineffectiveness of certain drugs. In 1961 the
dangers of new drug uses were vividly exemplified by the thalidomide disaster in
Europe, Canada, and to a lesser degree, the United States.5 Starting in late 1957,
the sedative thalidomide was given to countless pregnant women and caused
thousands of birth defects in newborn infants (most commonly, missing or
deformed limbs). The thalidomide disaster was widely covered by the television
networks, and the visual impact of these babies stunned viewers and caused
Americans to question the protections afforded those receiving investigational
agents.

It is in large measure because of the thalidomide episode that the 1962
Kefauver-Harris amendments to the Food, Drug, and Cosmetic Act were passed,6
requiring that informed consent be obtained in the testing of investigational
drugs.7 While such testing occurred mainly with patients, Congress carefully
avoided interfering in the doctor-patient relationship and in the process severely
reduced the effectiveness of the requirement. Consent was not required when it
was "not feasible" or was deemed not to be in the best interests of the patient—
both judgments made "according to the best judgment of the doctors involved."8
Despite their being limited in scope, the Kefauver-Harris amendments were
influential in advancing considerations of protections of research subjects first
within the DHEW and later throughout the rest of the government.

NIH and PHS Develop a Uniform Policy to Protect Human Subjects

In late 1963, concerns were raised within NIH by Director James Shannon
after disturbing revelations about two research projects funded in part by the
Public Health Service and NIH. One was the unsuccessful transplantation of a
chimpanzee kidney into a human being at Tulane University, a procedure that

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promised neither benefit to the recipient nor new scientific information. The
transplant was reportedly done with the consent of the patient, but without
consultation or review by anyone other than the medical team involved."

The second was research undertaken in mid- 1963 at the Brooklyn Jewish
Chronic Disease Hospital. There, investigators (the chief investigator, Dr.
Chester M. Southam was a physician at the Sloan-Kettering Cancer Research
Institute, and he received permission to proceed with the work from the hospital's
medical director, Dr. Emmanuel E. Mandel) had undertaken a research project in
which they injected live cancer cells into indigent elderly patients without their
consent. The research went forward without review by the hospital's research
committee and over the objections of three physicians consulted, who argued that
the proposed subjects were incapable of giving adequate consent to participate.10
The disclosure of the experiment served to make both PHS officials like Shannon
and the Board of Regents of the University of the State of New York, which had
jurisdiction over licensure of physicians, aware of the shortcomings of procedures
in place to protect human subjects. They were further concerned over the public's
reaction to disclosure of the research and the impact it would have on research
generally and the institutions in particular. After a review, the Board of Regents
censured the researchers. They suspended the licenses of Drs. Mandel and
Southam, but subsequently stayed the suspension and placed the physicians on
probation for one year." There were no immediate repercussions for the hospital,
Sloan-Kettering, the university, or PHS, but the case nonetheless profoundly
affected the subsequent development of federal guidelines to protect research
subjects.

To add to the ferment, NIH officials had closely followed the work of the
Law-Medicine Research Institute at Boston University, which issued survey
findings in 1 962 showing that few institutions had procedural guidelines covering
clinical research.12 And in the year after both the above-mentioned cases came to
light, the World Medical Association issued its Declaration of Helsinki, which set
standards for clinical research and required that subjects give informed consent
prior to enrolling in an experiment.13 Thus national and world opinion on matters
related to the ethics of human subject research created a climate ripe for changes
in policies and approaches toward research ethics.

Concern over disturbing cases and the growing attention paid to research
ethics prompted NIH director James Shannon to create a committee in late 1 963
under the direction of the NIH associate chief for program development, Robert
B. Livingston, whose office supported centers at which NIH-funded research took
place. The internal committee was charged with studying problems of inadequate
consent and the standards of self-scrutiny involving research protocols and
procedures. The committee was also to recommend a suitable set of controls for
the protection of human subjects in NIH-sponsored research. The Livingston
Committee recognized that ethically questionable research—exemplified by the
research at the Jewish Chronic Disease Hospitals-could wreak havoc on public

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perception, increase the likelihood of liability, and inhibit research.14 These
problems made it worthwhile to reconsider central oversight~or lack thereof-for
research contracted out. However, the committee expressed concern over NIH
taking too authoritarian a posture toward research oversight and so argued that it
would be difficult for the agency to assume responsibility for ethics and research
practices. When it issued its report in late 1964, the committee did not
recommend any changes in the current NIH policies and, moreover, cautioned
that "whatever NIH might do by way of designating a code or stipulating
standards for acceptable clinical research would be likely to inhibit, delay, or
distort the carrying out of clinical research. . . ."'5 In deference to physician
autonomy and traditional regard for the sanctity of the doctor-patient relationship,
the report concluded that NIH was "not in a position to shape the educational
foundations of medical ethics. . . ."16

Director Shannon did not think the conclusions of the Livingston
Committee went far enough, feeling as he did that NIH should take a position of
increased responsibility for research ethics.17 Especially in light of the Jewish
Chronic Disease Hospital case and its implications for the NIH, both internally
and in terms of public perception, he felt that a stronger reaction was needed.
Thus, despite the committee's limited conclusions, Shannon and Surgeon General
Luther Terry together decided in 1965 to propose to the National Advisory Health
Council (NAHC), an advisory committee to the surgeon general of the Public
Health Service, 1S that in light of recent problems, the NIH should assume
responsibility for formal controls on individual investigators.19 At the NAHC
meeting, Shannon argued for impartial prior peer review of the risks research
posed to subjects and questioned the adequacy of the protections of the rights of
subjects.20

The council's members mostly agreed with Shannon's concerns and three
months later issued a "resolution concerning research on humans" following
Shannon's broad recommendations and endorsing the importance of obtaining
informed consent from subjects:

Be it resolved that the National Advisory Health
Council believes that Public Health Service support
of clinical research and investigation involving
human beings should be provided only if the
judgment of the investigator is subject to prior
review by his institutional associates to assure an
independent determination of the protection of the
rights and welfare of the individual or individuals
involved, of the appropriateness of the methods
used to secure informed consent, and of the risks
and potential medical benefits of the investigation.21

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What this statement did not do, however, was explain what would count as
informed consent. The NAHC recommendations were accepted by the new
surgeon general, William H. Stewart, and in February 1966 he issued a policy
statement requiring PHS grantee institutions to address three topics by committee
prior review for all proposed research involving human subjects:

This review should assure an independent
determination (1) of the rights and welfare of the
individual or individuals involved, (2) of the
appropriateness of the methods used to secure
informed consent, and (3) of the risks and potential
medical benefits of the investigation.22

The 1966 PHS policy required that institutions give the funding agency a
written "assurance" of compliance, but like the NAHC recommendations, the
policy spoke strictly to the procedural aspects of informed consent and not to its
meaning and criteria. Substantive informed consent criteria were established for
research at the NIH Clinical Center shortly after the PHS policy was issued, but
this new policy applied only to intramural research, that is, to research undertaken
at the Clinical Center. The Clinical Center policy was important as the first
federal research policy with a specific definition of what constituted informed
consent requirements in the research context. The inclusion of specific consent
requirements in policies applying to extramural research would not occur,
however, until the mid-1970s.

The 1966 PHS policy is significant both for its recognition that patient-
subjects, like healthy subjects, should be included in the consent provisions for
federally sponsored human experimentation and for its attempt to strike a balance
between federal regulation and local control, which continues to this day. Such a
balancing continued the work begun by the AEC, in its provision for local human
use committees as a condition for the use of AEC-supplied isotopes, and the
DOD, in the provision for high-level review of proposed experimentation.
Although a landmark in the government regulation of biomedical research, the
1966 policy was to be revised and changed throughout the decade as biomedical
research drew greater attention and informed consent grew in importance.

While, from the outset, the PHS policy was revised periodically,23 site
visits by PHS employees to randomly selected institutions revealed a wide range
of compliance.24 These site visits found widespread confusion about how to
assess risks and benefits, refusal by some researchers to cooperate with the policy,
and in many cases, indifference by those charged with administering research and
its rules at local institutions. Complaints of overworked review committees and
requests for clarification and guidance came from research institutions all over the
country.25

In response to continued questions about the scope and meaning of the

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policy, DHEW in 1971 produced The Institutional Guide to DHEW Policy on
Protection of Human Subjects.2* Better known as the "Yellow Book" because of
its cover's color, this substantial guide contained both the requirements and
commentary on how the requirements were to be understood and implemented.
The guide provided that informed consent was to be obtained from anyone who
"may be at risk as a consequence of participation" in research-including both
patients and healthy volunteers.27

As the 1960s progressed, increased discussion of research practices
appeared in both professional literature and the popular press. One person who
advanced the debate in both arenas was Henry Beecher of Harvard Medical
School.

Henry Beecher: The Medical Insider Speaks Out

Henry Beecher, as noted in chapter 2, was an active participant in
professional discussions of ethics in research during the late 1950s and early
1960s. In March 1965, Beecher focused attention on the issues at a conference
for science journalists sponsored by the Upjohn pharmaceutical company. There
Beecher presented a paper discussing twenty-two examples of potentially serious
ethical violations in experiments that he had found in recent issues of medical
journals.28 (Among them was the Brooklyn Jewish Chronic Disease Hospital
study.) He explained this research had not taken place "in a remote corner, but
[in] . . . leading medical schools, university hospitals, top governmental military
departments, governmental institutes and industry."29 He also acknowledged that
his own conscience was not entirely clear: "Lest I seem to stand aside from these
matters I am obliged to say that in years gone by work in my laboratory could
have been criticized."30 Beecher also explained the consciousness-raising purpose
of these revelations with stark clarity: "It is hoped that blunt presentation of these
examples will attract the attention of the uninformed or the thoughtless and
careless, the great majority of offenders."31

In making this presentation to a group of journalists, Beecher was clearly
breaking with a professional expectation that such matters should be addressed
within the biomedical community. After some reservations on the part of medical
journals, the March 1965 paper having been rejected by at least the Journal of the
American Medical Association (JAMA), Beecher published a revised version in
the New England Journal of Medicine in June 1966.32 That article, like his
presentation at the conference, indicted the entire biomedical research community
and the journals that published biomedical research results.

Beecher's efforts to focus professional, press, and therefore public
awareness on the conduct of research involving human subjects met with some
success. A July 1965 article in the New York Times Magazine was headlined
"Doctors Must Experiment on Humans~But What Are the Patient's Rights?"33 In
February 1966, as the PHS issued its first uniform policy for biomedical research,

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more headlines, this time in the Saturday Review, asked, "Do We Need New
Rules for Experimentation on People?"34 In July 1966, following Beecher's
article in the New England Journal of Medicine and an editorial in JAMA,35
another article declared "Experiments on People— The Growing Debate."36 Thus,
by the mid- to late 1960s, professional, governmental, and public attention was all
being drawn to issues of research on human subjects. Revelations of purportedly
unethical treatment of research subjects would not be over by this time, but
changes in policy largely driven by attention from so many corners were
beginning to move toward a more comprehensive approach to research oversight.

Public Attention Is Galvanized: Willowbrook and Tuskegee

From 1956 to 1972 Dr. Saul Krugman of New York University led a study
team at the Willowbrook State School for the Retarded, on Staten Island, New
York. The study was not secret or hidden. (It was one of the twenty-two projects
Beecher discussed as ethically troublesome in his 1966 article.) The
Willowbrook study was discovered by the media beginning in the late 1 960s37 and
was the subject of further discussion of the case in separate places by Beecher,38
theologian Paul Ramsey,39 and physician Stephen Goldby.40 Noting the high
incidence of hepatitis among the residents of the school, nearly all of whom were
profoundly mentally impaired children and adolescents, Krugman and his
colleagues injected some of them with a mild form of hepatitis serum. The
researchers justified their work on the grounds that the subjects probably would
have become infected anyway, and they hoped to find a prophylaxis for the virus
by studying it from the earliest stages of infection. Before beginning the work,
Krugman discussed it with many physician colleagues and sought approval from
the Armed Forces Epidemiological Board, which approved and funded the
research,41 and the executive faculty of the New York University School of
Medicine, who approved the research. A review committee for human
experimentation did not exist in 1955,42 but later, when such a committee was
formed, it too approved the research.

According to Krugman, the parents of each subject signed a consent form
after receiving a detailed explanation of the research, without any pressure to
enroll their child.43 Some critics argued that the content of the consent form was
itself deceiving, since it seemed to say that children were to receive a vaccine
against the virus. Moreover, charges of coercion arose. It is alleged that parents
who enrolled their children in the study were initially offered more rapid
admission to the school through the hepatitis unit and later found, due to
overcrowding, that the only route for admission of new patients was through the
hepatitis unit.44 Commentators further argued that the fault in the doctors' study
lay in their deliberate attempt to infect the children, with or without parental
consent, as opposed to studying the course of disease in children who naturally
became sick.

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Soon after Willowbrook, another research project, the Tuskegee syphilis
study, provoked widespread public outcry when it was revealed the study had
exposed people to unnecessary and serious harm with no prospect of direct
benefit to them. Beginning in 1 932, PHS physicians sought to trace the natural
history of syphilis by observing some 400 African- American men affected by the
disease and another group of approximately 200 African- American men without
syphilis serving as controls. All the subjects lived in or around Tuskegee,
Alabama. Originally designed to be a short-term study in the range of six to eight
months, some investigators successfully argued that the potential scientific value
of longer-term study was so great that the research ought to go on indefinitely.
The subjects were enticed into the study with offers of free medical examinations.
Many of those who came from around the area to be tested by "government
doctors" had never had a blood test before and had no idea what one was.45 Once
selected to be subjects in the study, the men were not informed as to the nature of
their disease or of the fact that the research held no therapeutic benefit for them.
Subjects were asked to appear for "special free treatments," which included
purely diagnostic procedures such as lumbar punctures.46

By the mid- 1940s it was becoming clear that the death rate for the infected
men in the study was twice as high as for those in the control group. This was the
period in which penicillin was discovered and soon after began to be used to treat
syphilis, at least in its primary stage. The study was reviewed by PHS officials
and medical societies and reported by a number of journals from the early 1930s
to 1970. In the 1960s a growing number of criticisms began to appear, although
the study was not stopped until 1973.

Thus, men with a confirmed disease were not told of their diagnosis and
were deceived into participating in the study under the guise of its being
therapeutic for unspecified maladies. In addition to exposing the subjects to the
additional harms of participation in the study, the false belief that treatment was
being administered prevented subjects from otherwise seeking medical care for
their disease. As at Willowbrook, a justification given after the fact for the
research was that the disease had appeared in a way that was natural and
inevitable and that the study would be of immense benefit to future patients.47
Over this forty-year history, at least 28 participants died and approximately 100
more suffered blindness and insanity from untreated syphilis before the study was
stopped.

In 1972, an account of the study was published on the front page of the
New York Times.4* In response, DHEW appointed the Tuskegee Syphilis Study
Ad Hoc Panel to review the Tuskegee study as well as the department's policies
and procedures for the protection of human subjects. The work of the ad hoc
panel-which consisted of physicians, a university president, a theologian, an
attorney, and a labor representative-contributed in large measure to the passage
of the first comprehensive regulations for federally sponsored human subjects
research. One member of the ad hoc panel who is also a member of the Advisory

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Committee, Jay Katz, expressed his dismay over the unwillingness or incapacity
of society to mobilize the necessary resources for "treatment" at the beginning of
the study and the deliberate efforts of the investigators to "obstruct the
opportunity for treatment."49

Despite the fact that the PHS Policy for the Protection of Human Subjects
had been in place for six years by the time the Tuskegee study was revealed, it
was exposed by a journalist rather than by a review committee. Although an
institutional committee had allegedly reviewed the Tuskegee study, the study was
not discontinued until after the recommendation of the ad hoc panel.50 The human
rights abuses of the Tuskegee study demonstrated the need for both prior and
ongoing review, in that the study was undertaken before prior review
requirements were in place, and the prevailing review policies during the period
of the study were so flawed that the study was allowed to continue.

As a result of their deliberations, the ad hoc panel found that neither
DHEW nor any other agency in the government had adequate policies for
oversight of human subjects research. The panel recommended that the Tuskegee
study be stopped immediately and that remaining subjects be given necessary
medical care resulting from their participation.51 The panel also recommended
that Congress establish "a permanent body with the authority to regulate at least
all federally supported research involving human subjects."52 In summary, the
panel concluded that despite the lessons of Nuremberg, the Jewish Chronic
Disease Hospital case, and the Declaration of Helsinki, human subject research
oversight and mechanisms to ensure informed consent were still inadequate and
new approaches were needed to adequately protect the rights and welfare of
human subjects.

Congressional Response to Abuses of Human Subjects: The National
Research Act

Public attention to abuses such as those inflicted on the subjects of the
Tuskegee study increased during the late 1960s and early 1970s. Following the
initial revelations about the Tuskegee syphilis study, several bills were introduced
in Congress to regulate the conduct of human experimentation. In February 1973
Senator Edward Kennedy held hearings on these bills;53 the Tuskegee study;
experimentation with prisoners, children, and poor women; and a variety of other
issues related to biomedical research and the need for a national body to consider
the ethics of research and advancing medical technology.54 After the hearings,
Senator Kennedy introduced an unsuccessful bill to create a National Human
Experimentation Board, as recommended by the Tuskegee Syphilis Study Ad Hoc
Panel. When it became clear, however, that the bill would not be successful,
Senator Kennedy introduced the bill that would become the National Research
Act, endorsing the regulations about to be promulgated by DHEW and
establishing the National Commission for the Protection of Human Subjects of

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Biomedical and Behavioral Research, in return for DHEW's issuance of human
subject research regulations.55 The trade-off was clear: no national regulatory
body in return for regulations applying to the research funded or performed by the
government agency responsible for the greatest proportion of human subject
research. This meant that the goal of oversight of all federally funded research
would not be achieved and that whatever oversight did exist was left to the
funding agencies rather than an independent body.

On May 30, 1974, DHEW published regulations for the use of human
subjects in the Federal Register.5" These regulations required that each grantee
institution form a committee (what became known as an institutional review
board, or IRB) to approve all research proposals before they were passed to
DHEW for funding consideration. These committees were charged with
reviewing the safety of the proposals brought to them as well as the adequacy of
the informed consent obtained from each subject prior to participation in the
research. Additionally, the regulations defined not only the procedure for
obtaining informed consent but substantive criteria for it as well. Shortly after the
announcement of the DHEW regulations, in July 1974, the National Research Act
was passed, and with it came the establishment of the National Commission.57

The National Commission-charged with advising the secretary of DHEW
(though the National Research Act did not require the secretary to follow the
commission's recommendations)--existed over the next four years and published
seventeen reports and appendix volumes. During its tenure, the commission did
pioneering work as it addressed issues of autonomy, informed consent, and third-
party permission, particularly in relation to research involving vulnerable subjects
such as prisoners, children, and people with cognitive disabilities. It was also
charged with examining the IRB system and procedures for informed consent, as
background for proposing guidelines that would ensure that basic ethical
principles were instituted in the research oversight system and in research
involving vulnerable populations.

In the course of its deliberations, the commission identified three general
moral principles-respect for persons, beneficence, and justice-as the appropriate
framework for guiding the ethics of research involving human subjects. These
three are known as the Belmont principles because they appeared in The Belmont
Report, one of the commission's major publications.58

The National Commission was required to examine the "nature and
definition" of informed consent as well as the "adequacy" of current practices. In
its reports, the commission decisively argued that the basic justification for
obligations to obtain informed consent is the moral principle of respect for
persons. This emphasis on respect for persons meant a great premium was put on
autonomous decision making by the research subject, an emphasis that continues
to the current day.

While it may not have been the intent of those who sponsored it, the
National Research Act-because it was limited to DHEW-funded research-did

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not ensure that all federally sponsored research would be subject to requirements
for informed consent and prior review. Nonetheless, by this time, as described
below, published policies within the DOD, the AEC, the VA, and NASA did meet
these requirements.

The passage of the National Research Act and the promulgation of
DHEW's regulations were important milestones in the development of federal
standards for the protection of human subjects of research. They represented the
first national recognition of the need to protect human subjects. Moreover, they
attempted to provide for that protection through the IRB requirement and
establishment of the National Commission. The Advisory Committee's charter
requires that it examine the standards for research between 1944 and 1974. These
two landmark events in 1974 ushered in a new era in which the conduct and
oversight of biomedical experimentation with humans remained a topic of
national scrutiny and debate. Eventually, the approaches required by the 1974
DHEW regulations would be applied to nearly all federally sponsored human
research, as described in chapter 14.

THE DEVELOPMENT OF REQUIREMENTS FOR HUMAN
SUBJECT RESEARCH IN OTHER FEDERAL AGENCIES

The history and evolution of human subject research policy in the federal
government is well documented for DHEW. However, many other agencies,
most notably the military services, have important but less well-documented and
less well-studied histories. Some of this history is described in chapter 1 of this
report. Here we continue with a brief treatment of that history in the context of
the evolution of human subject research policy.

Army Policy

In 1962 the Army, for the first time, issued as a formal regulation, Army
Regulation (AR) 70-25, the 1953 policy embodied in the Wilson memorandum.
The regulation made explicit, as the 1953 DOD and Army policies had only left
implicit, basic issues about the scope of the DOD's rules. Unlike the Wilson
memorandum, the new regulation applied to all types of research, not simply that
related to atomic, biological, and chemical warfare. However, the regulation
specifically excluded clinical research, that is, the research likely to be performed
with patients at the Army's many hospitals. In 1963, an ad hoc committee of
Army and civilian personnel concluded that the rule applied where research was
done by contractors; however, tracer research (which arguably posed minimal
risk) was excluded.59 Despite the committee's recommendations, no immediate
changes were made to the regulation. In 1963, however, the Army issued a
regulation for radioisotope use that required local institutions to convene review
committees and obtain approval from the secretary of the Army pursuant to AR

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70-25 when radioisotopes were to be used with "volunteer" experimental
subjects.60

The regulatory void apparently persisted until 1973, when another rule
(AR 40-38, "Medical Services-Clinical Investigation Program") closed the gap.
That rule clearly applied to "any person who may be at risk because of
participation . . . [in] clinical investigation," including "patients" and "normal
individuals."61 It required that subjects of research be given an explanation of the
proposal in understandable language and sign a "volunteer agreement."62
Moreover, clinical research with patients, as well as healthy people, was to be
reviewed by a "Human Use Committee."63

Navy Policy

As we saw in chapter 1 , the Navy had required oral consent from research
volunteers since at least 195 1. Some evidence suggests that written consent was
required in the mid-1960s; in a 1964 proposal to study the effects of hypoxia on
service personnel it is indicated that a "signed Consent to Voluntarily Participate
in Research Experiment (NMRI Form 3)" would be used.64 In 1967 a clear
requirement for written consent appeared in the Navy's Medical Department
manual.65 It is unclear whether the policy drew a distinction between research on
patients and research on healthy subjects. In 1969, in any event, the secretary of
the Navy issued a comprehensive policy requiring written informed consent of
research subjects, which appeared to cover both groups.66

Air Force Policy

In 1965 the Air Force promulgated AFR 169-8, "Medical Education and
Research— Use of Volunteers in Aerospace Research," which required voluntary
and written informed consent from all subjects in any "research, development,
test, and evaluation" that may involve "distress, pain, damage to health, physical
injury, or death."67 As such, it seems inclusive of both healthy and patient-
subjects.68 Updating the language of the Nuremberg Code's first principle, the
policy was based on the idea that the "voluntary informed consent of the human
subject is absolutely essential."69 Additionally, the regulation provided for the
appointment of a committee to review all human research proposals at each
originating facility.

NASA Policy

The National Aeronautics and Space Administration (NASA), created in
1958, inherited staff and research expertise from the DOD and other federal
agencies. Before 1968, local centers at which research using radioisotopes was
conducted-notably the Ames Research Center and the Manned Spacecraft Center

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(MSC)-were essentially autonomous. Each center established medical use
subcommittees, as required by AEC rules.™ Reorganization within NASA in
1 968 combined the medical operations functions and the medical research
functions at MSC into one medical research and operations directorate headed by
Dr. Charles A. Berry.

By 1968, Ames had a policy requiring informed consent.71 By definition,
of course, the work of astronauts is frequently risky and experimental. The
question of the proper boundary between experimental and occupational activities
was one that could not be drawn easily. Consequently, the policy authorized the
director of Ames to waive the consent requirement in several instances, including
when obtaining consent would seriously hamper the research or when test pilots
or astronauts were involved.72

Between 1968 and 1970, prior review for risk and subject consent was
adopted at Ames in the form of the Human Research Experiments Review Board
and indirectly at the MSC in accordance with the AEC requirements for a medical
use committee.73 In 1972 the prior review provisions and consent requirements of
Ames and the MSC were reformulated in a NASA-wide policy.74 This policy
required voluntary and written informed consent from subjects prior to
participation. The policy continued to provide waivers for "exceptional cases," as
in the Ames policy, and did not apply to research conducted by NASA contractors
or grantees.

The development of NASA's polices, like those at the PHS, NIH, and the
DOD, appeared at a time when the public was becoming increasingly interested in
biomedical research. In contrast with the 1940s and 1950s, bureaucratic
developments during the 1960s and 1970s were mirrored by growing public
debate about the adequacy of protections for human subjects.

SUPREME COURT DISSENTS INVOKE THE NUREMBERG
CODE: CIA AND DOD HUMAN SUBJECTS RESEARCH
SCANDALS

As we have seen, the development of federal legislation for government-
sponsored research with human subjects arose in part because of institutional and
governmental concern and public reaction to perceived abuses and failures by the
government. Around the same time that the 1974 National Research Act was
enacted, a scandal arose surrounding the discovery of secret Cold War chemical
experiments conducted by the CIA and DOD. The review of these experiments
led to the rediscovery of the previously secret 1953 Wilson memorandum and
later to the first Supreme Court decision in which comment was made, in dissent,
on the application of the Nuremberg Code to the conduct of the U.S. government.

In December 1974, the New York Times reported that the CIA had
conducted illegal domestic activities, including experiments on U.S. citizens,
during the 1 960s. That report prompted investigations by both Congress (in the

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form of the Church Committee) and a presidential commission (known as the
Rockefeller Commission) into the domestic activities of the CIA, the FBI, and
intelligence-related agencies of the military. In the summer of 1975,
congressional hearings and the Rockefeller Commission report revealed to the
public for the first time that the CIA and the DOD had conducted experiments on
both cognizant and unwitting human subjects as part of an extensive program to
influence and control human behavior through the use of psychoactive drugs
(such as LSD and mescaline) and other chemical, biological, and psychological
means. They also revealed that at least one subject had died after administration
of LSD. Frank Olson, an Army scientist, was given LSD without his knowledge
or consent in 1953 as part of a CIA experiment and apparently committed suicide
a week later.75 Subsequent reports would show that another person, Harold
Blauer, a professional tennis player in New York City, died as a result of a secret
Army experiment involving mescaline.76

The CIA program, known principally by the codename MKULTRA,
began in 1950 and was motivated largely in response to alleged Soviet, Chinese,
and North Korean uses of mind-control techniques on U.S. prisoners of war in
Korea. Because most of the MKULTRA records were deliberately destroyed in
1973 by order of then-Director of Central Intelligence Richard Helms, it is
impossible to have a complete understanding of the more than 150 individually
funded research projects sponsored by MKULTRA and the related CIA
programs.77 Central Intelligence Agency documents suggest that radiation was
part of the MKULTRA program and that the agency considered and explored uses
of radiation for these purposes.78 However, the documents that remain from
MKULTRA, at least as currently brought to light, do not show that the CIA itself
carried out any of these proposals on human subjects.

The congressional committee investigating the CIA research, chaired by
Senator Frank Church, concluded that "[p]rior consent was obviously not
obtained from any of the subjects."7" The committee noted that the "experiments
sponsored by these researchers . . . call into question the decision by the agencies
not to fix guidelines for experiments."80 (Documents show that the CIA
participated in at least two of the DOD committees whose discussions, in 1952,
led up to the issuance of the Wilson memorandum.) Following the
recommendations of the Church Committee, President Gerald Ford in 1976 issued
the first Executive Order on Intelligence Activities, which, among other things,
prohibited "experimentation with drugs on human subjects, except with the
informed consent, in writing and witnessed by a disinterested party, of each such
human subject" and in accordance with the guidelines issued by the National
Commission.81 Subsequent orders by Presidents Carter and Reagan expanded the
directive to apply to any human experimentation.82

Following on the heels of the revelations about CIA experiments were
similar stories about the Army. In response, in 1975 the secretary of the Army
instructed the Army inspector general to conduct an investigation.83 Among the

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findings of the inspector general was the existence of the then-still-classified 1953
Secretary of Defense Wilson memorandum. In response to the inspector general's
investigation, the Wilson memorandum was declassified in August 1975. The
inspector general also found that the requirements of the 1953 memorandum had.
at least in regard to Army drug testing, been essentially followed as written. The
Army used only "volunteers" for its drug-testing program, with one or two
exceptions."4 However, the inspector general concluded that the "volunteers were
not fully informed, as required, prior to their participation; and the methods of
procuring their services, in many cases, appeared not to have been in accord with
the intent of Department of the Army policies governing use of volunteers in
research."85 The inspector general also noted that "the evidence clearly reflected
that every possible medical consideration was observed by the professional
investigators at the Medical Research Laboratories."86 This conclusion, if
accurate, is in striking contrast to what took place at the CIA.

The revelations about the CIA and the Army prompted a number of
subjects or their survivors to file lawsuits against the federal government for
conducting illegal experiments. Although the government aggressively, and
sometimes successfully, sought to avoid legal liability, several plaintiffs did
receive compensation through court order, out-of-court settlement, or acts of
Congress. Previously, the CIA and the Army had actively, and successfully,
sought to withhold incriminating information, even as they secretly provided
compensation to the families.87 One subject of Army drug experimentation,
James Stanley, an Army sergeant, brought an important, albeit unsuccessful, suit.
The government argued that Stanley was barred from suing it under a legal
doctrine—known as the Feres doctrine, after a 1950 Supreme Court case, Feres v.
United States—that prohibits members of the Armed Forces from suing the
government for any harms that were inflicted "incident to service."88

In 1987, the Supreme Court affirmed this defense in a 5-4 decision that
dismissed Stanley's case.89 The majority argued that "a test for liability that
depends on the extent to which particular suits would call into question military
discipline and decision making would itself require judicial inquiry into, and
hence intrusion upon, military matters."90 In dissent, Justice William Brennan
argued that the need to preserve military discipline should not protect the
government from liability and punishment for serious violations of constitutional
rights:

The medical trials at Nuremberg in 1947 deeply
impressed upon the world that experimentation with
unknowing human subjects is morally and legally
unacceptable. The United States Military Tribunal
established the Nuremberg Code as a standard
against which to judge German scientists who
experimented with human subjects. . . . [I]n

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defiance of this principle, military intelligence
officials . . . began surreptitiously testing chemical
and biological materials, including LSD.91

Justice Sandra Day O'Connor, writing a separate dissent, stated:

No judicially crafted rule should insulate from
liability the involuntary and unknowing human
experimentation alleged to have occurred in this
case. Indeed, as Justice Brennan observes, the
United States played an instrumental role in the
criminal prosecution of Nazi officials who
experimented with human subjects during the
Second World War, and the standards that the
Nuremberg Military Tribunals developed to judge
the behavior of the defendants stated that the
'voluntary consent of the human subject is
absolutely essential ... to satisfy moral, ethical, and
legal concepts.' If this principle is violated, the very
least that society can do is to see that the victims are
compensated, as best they can be, by the
perpetrators.92

This is the only Supreme Court case to address the application of the
Nuremberg Code to experimentation sponsored by the U.S. government.93 And
while the suit was unsuccessful, dissenting opinions put the Army-and by
association the entire government-on notice that use of individuals without their
consent is unacceptable. The limited application of the Nuremberg Code in U.S.
courts does not detract from the power of the principles it espouses, especially in
light of stories of failure to follow these principles that appeared in the media and
professional literature during the 1960s and 1970s and the policies eventually
adopted in the mid-1970s.

CONCLUSION

The 1960s and early 1970s witnessed an extraordinary growth in
government, institutional, and public awareness of issues in the use of human
subjects, fueled by scandals and an increasing emphasis on individual expression.
The branches of the military had articulated policies during this period, in spite of
numerous problems in implementation. By 1974 the DHEW had established a set
of regulations and a system of local review, and Congress had established a
commission to issue recommendations for further change to the DHEW.
Together, these advances created a model and laid the groundwork for human

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subjects protections for all federal agencies.

Many conditions coalesced into the framework for the regulation of the
use of human subjects in federally funded research that is the basis for today's
system. Described further in chapter 14, this framework is undergirded by the
three Belmont principles that were identified by the National Commission as
governing the ethics of research with human subjects: respect for persons,
beneficence, and justice. The federal regulations and the conceptual framework
built on the Belmont principles became so widely adopted and cited that it might
be argued that their establishment marked the end of serious shortcomings in
federal research ethics policies. Whether this position is well supported is
evaluated in light of the Advisory Committee's contemporary studies in part III.

By 1974, DHEW had extensive policies to protect human subjects within
its purview. Policies were more variable among other government agencies. By
1975, the branches of the military set about developing their own more
comprehensive policies for human subject research, and the CIA was required by
executive order to comply with consent requirements in human subject research in
light of scandalous practices in the past. In order to evaluate the adequacy of the
efforts taken to protect people before these policies were established, we must
take into account both the government's policies and rules and the norms and
practices of medicine reviewed in chapters 1 through 3. The Advisory
Committee's framework for the consideration of these factors is presented in the
next chapter.

188

ENDNOTES

1 For a discussion of the development of the Common Rule, see chapter 1 4.

2 We relied particularly on Ruth R. Faden and Tom L. Beauchamp, A History
and Theory of Informed Consent (New York: Oxford University Press, 1986). Other
excellent sources include Jay Katz, Experimentation with Human Beings (New York:
Russell Sage Foundation, 1972), and Robert Levine, Ethics and Regulation of Clinical
Research (Baltimore: Urban and Schwarzenberg, 1981).

3 U S. Congress, The Select Committee to Study Governmental Operations
with Respect to Intelligence Activities, Foreign and Military Intelligence [Church
Committee report], report no. 94-755, 94th Cong., 2d Sess. (Washington, D.C.: GPO,
1976). Also, U.S. Army Inspector General, Use of Volunteers in Chemical Agent
Research [Army IG report] (Washington, D.C.: 1975).

4 In dissenting opinions, four justices of the U.S. Supreme Court (Brennan,
Marshall, Stevens, and O'Connor) cited the Nuremberg Code. United States et al. v.

Stanley, 483 U.S. 669, 687, 710 (1987). u,,-^t t tW

" 5. Thalidomide was only available in clinical trials in the United States at that
time but was approved for use in a number of other countries.

6 Louis Lasagna, interview by Susan White-Junod and Jon Harkness
(ACHRE) transcript of audio recording, 13 December 1994 (ACHRE Research Project
Series Interview Program Files, Ethics Oral History Project), 37-38. See also, Louis
Lasagna "1938-1968: The FDA, the Drug Industry, the Medical Profession, and the
Public," in Safeguarding the Public: Historical Aspects of Medicinal Drug Control, ed.
John B. Blake (Baltimore: The Johns Hopkins Press, 1970), 173.

7 Food Drug and Cosmetic Act amendments, 21 U.S.C. § 355 (1962).

8* Congressional Record, 87th Cong, 2d Sess., 22042, as cited in an attached
memorandum, C. Joseph Stetler, Pharmaceutical Manufacturers Association, to James L.
Goddard M.D., Commissioner of Food and Drugs, DHEW, 1 1 October 1966
("Regarding Statement Appearing in August 30, 1966 Federal Register Concerning
Clinical Investigation of Drugs") (ACHRE No. HHS-090794-A).

9 Keith Reemtsma et al., "Reversal of Early Graft Rejection after Renal
Heterotransplantation in Man," Journal of the American Medical Association 1 87

(1964): 691-696.

1 0 This research, conducted by Dr. Chester Southam of Sloan-Kettenng
Institute and Dr. Emmanuel Mandel of the Jewish Chronic Disease Hospital in 1963 and
funded by the U.S. Public Health Service and the American Cancer Society, raised
concern within PHS and brought about an investigation by the hospital. Drs. Mandel and
Southam were subject to a disciplinary hearing before the Board of Regents of the
University of the State of New York. The hospital's internal review and a suit against
the hospital prompted concern and debate at the NIH. Edward J. Rourke, Assistant
General Counsel, NIH, to Dr. Luther L. Terry, Surgeon General, 16 September 1965
("Research Grants-Clinical-PHS responsibility-Fin* v. Jewish Chronic Disease
Hospital [New York Supreme Court, Kings County]") (ACHRE No. HHS-090794-A).

For a more thorough discussion of this case, see Katz, Experimentation with

Human Beings, 9-65.

11. In 1967 Dr. Southam was elected vice president of the American
Association for Cancer Research and became president the following year. Katz,

189

Experimentation with Human Beings, 63 and 65.

12. For a fuller discussion of the Law-Medicine Research Institute, see chapter
2.

13. The development of the Declaration of Helsinki is discussed briefly in
chapter 2.

14. Robert B. Livingston, Associate Chief for Program Development,
Memorandum to the Director, NIH, 4 November 1964 ("Progress Report on Survey of
Moral and Ethical Aspects of Clinical Investigation" [the Livingston report]) (ACHRE
No. HHS-090795-A), 3.

15. Ibid., 7.

16. Ibid.

17. Mark S. Frankel, "Public Policymaking for Biomedical Research: The Case
of Human Experimentation" (Ph.D. diss., George Washington University, 9 May 1976),
50-51.

1 8. The NAHC discussed the "general question of the ethical, moral, and legal
aspects of clinical investigation" at its meetings of September and December 1965.
Terry's interest in this was motivated in part by the concern of Senator Jacob K. Javits
that the informed consent provisions of the 1962 Drug Amendments were not applicable
to nondrug-related research. See (a) draft letter to Senator Javits from the Surgeon
General, 15 October 1965; (b) Senator Javits to Luther L. Terry, Surgeon General, 15
June 1965; and (c) Edward J. Rourke, Assistant General Counsel, to William H. Stewart,
Surgeon General, 26 October 1965. All in ACHRE No. HHS-090794-A.

19. Transcript of the NAHC meeting, Washington, D.C., 28 September 1965.
See Faden and Beauchamp, A History and Theory of Informed Consent, 208.

20. Ibid.

21 . Dr. S. John Reisman, the Executive Secretary, NAHC, to Dr. James A.
Shannon, 6 December 1965 ("Resolution of Council") (ACHRE No. HHS-090794-A).

22. Surgeon General, Public Health Service to the Heads of the Institutions
Conducting Research with Public Health Service Grants, 8 February 1966 ("Clinical
research and investigation involving human beings") (ACHRE No. HHS-090794-A).
This policy was distributed through Bureau of Medical Services Circular no. 38, 23 June
1966 ("Clinical Investigations Using Human Beings As Subjects") (ACHRE No. HHS-
090794-A).

23. In December 1966 the policy was expanded to include behavioral as well
as medical research. William H. Stewart, Surgeon General, Public Health Service, to
Heads of Institutions Receiving Public Health Service Grants, 12 December 1966
("Clarification of procedure on clinical research and investigation involving human
subjects") (ACHRE No. HHS-072894-B), 2.

In 1967 the Public Health Service required that intramural research, including
that conducted at NIH, abide by similar requirements. William H. Stewart, Surgeon
General of the Public Health Service, to List, 30 October 1967 ("PHS policy for
intramural programs and for contracts when investigations involving human subjects are
included") (ACHRE No. HHS-072894-B), 2.

24. Frankel, "Public Policymaking for Biomedical Research: The Case of
Human Experimentation," 161.

25. Ibid., 161-162.

26. U.S. Department of Health, Education, and Welfare, The Institutional
Guide to DHEW Policy on Protection of Human Subjects (Washington, D.C.: GPO,

190

1971) (ACHRE No. HHS-090794-A).

27. Ibid., 1-2.

28. Beecher's criticism involved many aspects of the research, including the
risk assessment, usefulness of the research, and the question of informed consent. On
this last point, Beecher argued that while consent was important, he disputed the belief
that it was easily obtainable. In his talk at Brook Lodge, Beecher questioned the "naive
assumption implicit in the Nuremberg Code," that consent was readily obtainable.
Beecher indicated the difficulty of obtaining truly informed consent may have led many
researchers to treat the provision cavalierly and often to ignore it. Henry K. Beecher,
"Ethics and the Explosion of Human Experimentation," unpublished manuscript of paper
presented 22 March 1965, "a," Beecher Papers, Countway Library (ACHRE No. IND-
072595-A).

29. lbid.,"a" and "b."

30. Ibid., 2a.

31. Ibid., 2.

32. H. K. Beecher, "Ethics and Clinical Research," New England Journal of
Medicine 274(1966): 3354-1360.

33. W. Goodman, "Doctors Must Experiment on Humans~But What are
Patients Rights?" New York Times Magazine, 2 July 1965, 12-13, 29-33, as cited in
Faden and Beauchamp, A History and Theory of Informed Consent, 1 88.

34. J. Lear, "Do We Need New Rules for Experimentation on People?"
Saturday Review, 5 February 1966, 61-70.

35. Henry K. Beecher, "Consent in Clinical Experimentation: Myth and
Reality," Journal of the American Medical Association 1 95 ( 1 966): 34-35.

36. J. Lear, "Experiments on People-The Growing Debate," Saturday Review,
2 July 1966,41-43.

37. Both the New York Times and the Wall Street Journal ran stories on 24
March 1971. See Medical World News, 15 October 1971, "Was Dr. Krugman Justified
in Giving Children Hepatitis?"

38. Beecher, Research and the Individual: Human Studies (Boston: Little,
Brown, and Company, 1970), 122-127.

39. Paul Ramsey, The Patient as Person: Explorations in Medical Ethics (New
Haven: Yale University Press, 1970), 51-55.

40. In a letter to the Lancet, Dr. Stephen Goldby called the work "unjustifiable"
and asked, "Is it right to perform an experiment on a normal or mentally retarded child
when no benefit can result to the individual?" (S. Goldby, "Letters to the Editor," Lancet
7702 [1971]: 749). The Lancet editors agreed with Goldby. On this side of the Atlantic,
however, the editors of NEJM and JAMA, among others, defended Krugman's work.

41. Armed Forces Epidemiological Board, minutes of 24 May 1957 (ACHRE
No. NARA-032495-B).

42. S. Krugman, "Ethical Practices in Human Experimentation," text of lecture
presented at the Fifth Annual Midwest Student Medical Research Forum, 1 March 1974
(ACHRE No. IND-072895-A).

43. Ibid., 3-4.

44. Louis Goldman, "The Willowbrook Debate," World Medicine (September
1971 and November 1971): 23, 25.

45. James H. Jones, Bad Blood (New York: Free Press, 1993 edition), 1 14.

191

46. Jones, Bad Blood (1981), 69-7 1 ; Levine, Ethics and Regulation of Clinical
Research, 70.

47. Charles J. McDonald, "The Contribution of the Tuskegee Study to Medical
Knowledge," Journal of the National Medical Association (January 1 974): 1 - 1 1 , as cited
in Faden and Beauchamp, A History and Theory of Informed Consent, 194-195.

48. Jean Heller, "Syphilis Victims in U.S. Study Went Untreated for 40
Years," New York Times (26 July 1972) 1, 8, as cited in Faden and Beauchamp, A
History and Theory of Informed Consent, 195.

49. U.S. Department of Health, Education, and Welfare, Final Report of the
Tuskegee Syphilis Study Ad Hoc Panel (Washington, D.C.: GPO, 1 973), Jay Katz
Concurring Opinion, 14.

50. Ibid.

51. Ibid., 21-32.

52. Ibid., 23.

53. Senator Jacob Javits introduced legislation that would have made the
DHEW policy a regulation backed by federal law. S. 878 and S. 974, 93d Cong., 1st
Sess. (1973).

Senator Hubert Humphrey introduced a bill to create a National Human
Experimentation Standards Board~a separate federal agency with authority over research
similar to the Security and Exchange Commission's authority over securities transactions.
S. 934, 93d Cong., 1 st Sess. ( 1 973).

Also, Senator Walter Mondale introduced a resolution to provide for a "study
and evaluation of the ethical, social, and legal" aspects of biomedical research. S.J. Res.
71, 93d Cong., 1st Sess. (1973).

54. It is worth noting here that Senator Kennedy had convened similar hearings
two years previously, in 1971, to consider the establishment of a national commission to
examine "ethical, social, and legal implications of advances in biomedical research."
Among the topics mentioned in this hearing was the total-body irradiation research
sponsored by the Department of Defense at the University of Cincinnati, which we
discuss in chapter 8.

55. Jay Katz, "Human Experimentation: A Personal Odyssey," IRB 9, no. 1
(January/February 1987): 1-6.

56. Protection of Human Subjects, 39 Fed. Reg. 105, 18914-1 8920 (1974) (to
be codified at 45 C.F.R. §46).

57. National Research Act of 1974. P.L. 348, 93d Cong., 2d Sess. (12 July
1974).

58. U.S. Department of Health, Education, and Welfare, Office for Protection
from Research Risks, 18 April 1979, OPPR Reports [The Belmont Report] (ACHRE No.
HHS-011795-A-2), 4-20.

59. Interestingly, this committee included Henry Beecher, who, as was
discussed in part I, chapter 3, had objected to the imposition of these requirements to
contract research in 1961 . Beecher's presence on the committee testifies to the common
relationship between military and private research during this time. Like many of the
AFEB members and commissioners, many of the members of the ad hoc panel were
nonmilitary consultants to the DOD.

60. Department of the Army, Army Regulation 40-37, 12 August 1963
("Radioisotope License Program [Human Use]").

192

61. Department of the Army, AR 40-38, 23 February 1973 ("Medical Services-
Clinical Investigation Program").

62. Ibid.

63. Ibid.

64. Commanding Officer, Naval Medical Research Institute, National Naval
Medical Center, to Secretary of the Navy, 30 November 1964 ("Authorization to use
human volunteers as subjects for study of effects of hypoxia on the visual field; request
for") (ACHRE No. DOD-091494-A), 2.

65. Department of the Navy, "Manual of the Medical Department," 20-8,
Change 36, 7 March 1967 ("Use of Volunteers in Medical or Other Hazardous
Experiments") (ACHRE No. DOD-091494-A).

66. Department of the Navy, SecNav Instruction 3900.39, 28 April 1969 ("Use
of volunteers as subjects of research, development, tests, and evaluation").

67. Department of the Air Force, AFR 169-8, 8 October 1965 ("Medical
Education and Research—Use of Volunteers in Aerospace Research").

68. Ibid.

69. Ibid.

70. National Aeronautics and Space Administration, Manned Spacecraft
Center, MSCI 1860.2, 12 May 1966 ("Establishment of MSC Radiological Control
Manual and Radiological Control Committee") (ACHRE No. NASA-022895-A), 3.

National Aeronautics and Space Administration, "Ames Management Manual
7170-1," 15 January 1968 ("Human Research Planning and Approval") (ACHRE No.
NASA- 120894- A), 3.

71 . Ames required the voluntary, written informed consent of the subject and
stipulated that consent be informed by an

explanation to the subject in language understandable to
him . . . [including] the nature, duration, and purpose of
the human research; the manner in which it will be
conducted; and all foreseeable risks, inconveniences and
discomforts.
"Ames Management Manual 7170-1," 15 January 1968, 3.

72. The Ames director was authorized to waive the consent requirements (a)
when the requirements would "not be necessary to protect the subject"; (b) when the
research uses "classes of trained persons who knowingly follow a specialized calling or
occupation which is generally recognized as hazardous," including "test pilots and
astronauts"; and (c) when the research "would be seriously hampered" by compliance.
"Ames Management Manual 7170-1," 15 January 1968, 3.

73. For example, one review from this group recommended changes in a
consent form to include

[T]he part of the procedure you are consenting to which
principally benefits the research program and is not part
of your treatment is known as arterial puncture. . . .
These risks will be explained to you in detail if you so
desire. The entire procedure, including the diagnostic
radioscan, takes about an hour.

193

Although this proposed consent form does not delineate the medical risks posed by the
procedure, its statement that the patient's participation is incidental to treatment may
provide a greater opportunity for the patient to make an informed decision about
participation. George A. Rathert, Jr., Chairman, Human Research Experiments Review
Board, ARC, to Director, 20 January 1969 ("Proposed Investigation entitled
'Measurement of Cerebral Blood Flow in Man by an Isotopic Technique Employing
External Counting,' by Dr. Leo Sapierstein, Stanford University") (ACHRE No. NASA-
022895-A), 4.

At MSC, the instruction establishing the Medical Uses Subcommittee was
rescinded in 1968. In 1969, formal combination of the medical operations and medical
research functions at MSC led to the reestablishment of the instruction as the Medical
Isotopes Subcommittee at MSC. No evidence suggests what factors, other than risk,
were considered in this form of prior review is available currently. National Aeronautics
and Space Administration, Manned Spacecraft Center, MSCI 1860.2, 12 May 1966
("Establishment of MSC Radiological Control Manual and Radiological Control
Committee"); and National Aeronautics and Space Administration, NMI 1 156.19, 28
August 1969 ("Medical Isotopes Subcommittee of the MSC Radiation Safety
Committee") (ACHRE No. NASA-022895-A).

74. National Aeronautics and Space Administration, NMI 71008.9, 2 February
1972 ("Human Research Policy and Procedures") (ACHRE No. NASA-022895-A). See
also, National Aeronautics and Space Administration, NMI 7100.9 ("Power and
Authority - To Authorize Human Research and to Grant Certain Related Exceptions and
Waivers") (ACHRE No. NASA-022895-A).

75. Commission on CIA Activities within the United States, Report to the
President, (Washington, D.C.: GPO, 1975).

76. U.S. Congress, The Select Committee to Study Governmental Operations
with Respect to Intelligence Activities, Foreign and Military Intelligence [Church
Committee report], report no. 94-755, 94th Cong., 2d Sess. (Washington, D.C.: GPO,
1976), 394.

77. For general information on the CIA program, see the Church Committee
report, 385-422, and J. Marks, The Search for the "Manchurian Candidate": The CIA
and Mind Control (New York: Times Books, 1978).

78. Church Committee report, book 1, 389.

79. Church Committee report, book 1, 400, 402. In 1963 the CIA inspector
general (IG) recommended that unwitting testing be terminated, but Deputy Director for
Plans Richard Helms (who later became director of Central Intelligence) continued to
advocate covert testing on the ground that "positive operational capability to use drugs is
diminishing, owing to a lack of realistic testing. With increasing knowledge of the state
of the art, we are less capable of staying up with the Soviet advances in this field." The
Church Committee noted that "Helms attributed the cessation of the unwitting testing to
the high risk of embarrassment to the Agency as well as the 'moral problem.' He noted
that no better covert situation had been devised than that which had been used, and that
'we have no answer to the moral issue.'"

80. Ibid., 402.

8 1 . Executive Order 11905(19 February 1 976).

82. Executive Order 12036, section 2-301 (26 January 1978) and Executive
Order 12333, section 2.10 (4 December 1981).

194

83. U.S. Army Inspector General, Use of Volunteers in Chemical Agent
Research [Army IG report] (Washington, D.C.: GPO, 1975), 2.

84. One noted exception involved using LSD as an interrogation devise on ten
foreign intelligence agents, and one U.S. citizen suspected of stealing classified
documents. Army IG report, 143.

85. Army IG report, 87.

86. Ibid.

87. The CIA paid death benefits to the Olson family after Frank Olson's death,
and the Army secretly paid half of an $18,000 settlement that the Blauer family
negotiated with the state of New York in 1955. The state ran the psychiatric institute
that administered the drugs, but which never disclosed the Army's involvement. Both
agencies feared that the resulting embarrassment and adverse publicity might undermine
their ability to continue their secret research programs. Barrett v. United States, 6660 F.
Supp. 1291 (E. D. N.Y., 1987).

88. Feres v. United States, 340 U.S. 1 46 ( 1 950).

89. United States v. Stanley, 483 U.S. 669 ( 1 987).

90. 483 U.S. 669, 682.

91. 483 U.S. 669, 687-88.

92. 483 U.S. 669, 709-10.

93. George Annas, a scholar of human experimentation and biomedical ethics,
has traced the history of the Nuremberg Code in the U.S. courts. The first express
reference in a majority opinion, Annas found, was in a 1973 decision in the Circuit Court
in Wayne County, Michigan. The decisions in which the Code has since been cited,
Annas concluded, reflect the proposition that the Nuremberg Code is a "document
fundamentally about nontherapeutic experimentation." Thus, the "types of experiments
that U.S. judges have found the Nuremberg Code useful for setting standards have
involved nontherapeutic experiments often conducted without consent. . . . Many of
these experiments were justified by national security considerations and the cold war."
George J. Annas, "The Nuremberg Code in U.S. Courts: Ethics versus Expediency," in
George J. Annas and Michael A. Grodin, eds.. The Nazi Doctors and the Nuremberg
Code: Human Rights in Human Experimentation (New York: Oxford University Press,
1992), 218.

195

4

Ethics Standards
in Retrospect

/\ccording to the mission set out in our charter, the Advisory Committee
is in essence a national ethics commission. In this capacity we were obliged to
develop an ethical framework forjudging the human radiation experiments. This
proved to be one of our most difficult tasks, for we were not only dealing with
complex events that occurred decades ago, but also with some of the most
controversial issues in moral philosophy. This chapter sets out the standards that
we believe are appropriate for evaluating human radiation experiments and offers
reasons for relying on them. It then applies these standards to the results of the
historical research we have conducted and draws ethical conclusions.*

Fulfilling our charge to "determine the ethical and scientific standards and
criteria" to evaluate human radiation experiments that took place between 1 944
and 1974 requires consideration of a complex question: Is it correct to evaluate
the events, policies, and practices of the past, and the agents responsible for them,
against ethical standards and values that we accept as valid today but that may not

"Some of the features of the moral framework presented in this chapter pertain to
biomedical experiments only and not to intentional releases. A moral analysis of
intentional releases involves somewhat different elements than a moral analysis of
biomedical experiments, because they engage different ethical issues. For example, a
requirement of individual informed consent is not applicable to the intentional releases,
and the concepts of risk and benefit and national security have different implications for
them. Ethical and policy issues specific to intentional releases are discussed in chapter
11.

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have been widely accepted then? Or must we limit our ethical evaluation of the
past to those standards and values that were widely accepted at the time? This is
the problem of retrospective moral judgment.

Quite apart from the issue of the validity of projecting current standards
onto the past, there is another question that this chapter must address: In a
pluralistic society such as ours, is there at present a sufficiently broad consensus
on ethical standards to make possible a public evaluation that is not simply the
arbitrary imposition of one particular moral point of view among several or even
many? This is the problem of value pluralism. The ethical framework the
Advisory Committee employs takes both these issues into account.

This chapter is divided into two parts. In the first part we present and
defend the ethical framework adopted by the Committee for the evaluation of
human radiation experiments conducted from 1944 to 1974 and the agents
responsible for them. We begin by identifying the types of moral judgments with
which the Committee is concerned and the different kinds of ethical standards
against which these judgments can be made. We next address two challenges to
the position that the Advisory Committee can use these, or any other, standards to
make valid ethical judgments. These challenges are (1) that the diversity of views
about ethics in American society invalidates any effort by a public body such as
the Advisory Committee to make moral judgments and (2) that the diversity of
views about ethics across time similarly invalidates our making defensible moral
judgments about the past. Although the Committee does not accept these
challenges as definitive, we discuss these as well as other factors that influence or
limit ethical evaluation. We include here a discussion of an issue of particular
relevance to our charge: what role, if any, considerations of national security
should play in the Committee's ethical framework. We also consider factors that
can mitigate the blame we would otherwise place on agents (whether individuals
or collective entities) for having conducted morally wrong actions.

In the second part of the chapter, we explore how the Committee's ethical
framework can be used to evaluate both experiments conducted in the past and the
people and institutions that sponsored and conducted them. Drawing on the
history presented in chapters 1 through 3, we illustrate how, when applied, the
framework is specified by context and detail. This specification of the framework
continues in part II of the report, when the framework is used to evaluate specific
cases.

AN ETHICAL FRAMEWORK
Two Types of Moral Judgment

For purposes of the Committee's charge, there are two main types of moral
judgment: judgments about the moral quality of actions, policies, practices,
institutions, and organizations; and judgments about the praiseworthiness or

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Parti

blameworthiness of individual agents and in some cases entities such as
professions and governments (insofar as these can be viewed as collective agents
with powers and responsibilities). The first type contains several kinds of
judgments. Actions may be judged to be obligatory, wrong, or permissible.
Institutions, policies, and practices can be characterized as just or unjust,
equitable or inequitable, humane or inhumane. Organizations can be said to be
responsible or negligent, fair-dealing or exploitative.

The second type of judgment about the praiseworthiness or
blameworthiness of agents also contains a diversity of determinations. Agents,
whether individual or collective, can be judged to be culpable or praiseworthy for
this or that action or policy, to be generous or mean-spirited, responsible or
negligent, to respect the moral equality of people or to discriminate against
certain individuals or groups, and so on.

Three Kinds of Ethical Standards

A recognized way to make moral judgments is to evaluate the facts of a
case in the context of ethical standards. The Committee identified three kinds of
ethical standards as relevant to the evaluation of the human radiation
experiments:1

1 . Basic ethical principles that are widely accepted and generally
regarded as so fundamental as to be applicable to the past as
well as the present;

2. The policies of government departments and agencies at the
time; and

3. Rules of professional ethics that were widely accepted at the
time.

Basic Ethical Principles

Basic ethical principles are general standards or rules that all morally
serious individuals accept. The Advisory Committee has identified six basic
ethical principles as particularly relevant to our work: "One ought not to treat
people as mere means to the ends of others"; "One ought not to deceive others";
"One ought not to inflict harm or risk of harm"; "One ought to promote welfare
and prevent harm": "One ought to treat people fairly and with equal respect"; and
"One ought to respect the self-determination of others." These principles state
moral requirements; they are principles of obligation telling us what we ought to
do.2

Every principle on this list has exceptions, because all moral principles

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can justifiably be overridden by other basic principles in circumstances when they
conflict. To give priority to one principle over another is not a moral mistake; it
is a reality of moral judgment. The justifiability of such judgments depends on
many factors in the circumstance; it is not possible to assign priorities to these
principles in the abstract.

Far more social consensus exists about the acceptability of these basic
principles than exists about any philosophical, religious, or political theory of
ethics. This is not surprising, given the central social importance of morality and
the fact that its precepts are embraced in some form by virtually all major ethical
theories and traditions. These principles are at the deepest level of any person's
commitment to a moral way of life.

It is important to emphasize that the validity of these basic principles is
not typically thought of as limited by time: we commonly judge agents in the past
by these standards. For example, the passing of fifty years in no way changes the
fact that Hitler's extermination of millions of people was wrong, nor does it erase
or even diminish his culpability. Nor would the passing of a hundred years or a
thousand do so.

This is not to deny that it might be inappropriate to apply to the distant
past some ethical principles to which we now subscribe. It is only to note that
there are some principles so basic that we ordinarily assume, with good reason,
that they are applicable to the past as well as the present (and will be applicable in
the future as well). We regard these principles as basic because any minimally
acceptable ethical standpoint must include them.

Policies of Government Departments and Agencies

The policies of departments and agencies of the government can be
understood as statements of commitment on the part of those governmental
organizations, and hence of individuals in them, to conduct their affairs according
to the rules and procedures that constitute those policies. In this sense, policies
create ethical obligations. When a department or agency adopts a particular
policy, it in effect promises to make reasonable efforts to abide by it.3

At least where participation in the organization is voluntary, and where the
organization's defining purpose is morally legitimate (it is not, for example, a
criminal organization), to assume a role in the organization is to assume the
obligations that attach to that role. Depending upon their roles in the
organization, particular individuals may have a greater or lesser responsibility for
helping to ensure that the policy commitments of the organization are honored.
For example, high-level managers who formulate organizational policies have an
obligation to take reasonable steps to ensure that these policies are effectively
implemented. If they fail to discharge these obligations, they have done wrong
and are blameworthy, unless some extenuating circumstance absolves them of
responsibility. One sort of extenuating circumstance is that the policy in question

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Parti

is unethical. In that case, we would hold an individual blameless for not
attempting to implement it (at least if the individual did so because of a
recognition that the policy was unethical). Moreover, we might praise the
individual for attempting an institutional reform at some professional or personal
risk.

Different types of organizations have different defining purposes, and
these differences determine the character of the department's or agency's role-
derived obligations. All government organizations have special responsibilities to
act impartially and to fairly protect all citizens, including the most vulnerable
ones. These special obligations constitute a standard for evaluating the conduct
of government officials.

Rules of Professional Ethics

Professions traditionally assume responsibilities for self-regulation,
including the promulgation of certain standards to which all members are
supposed to adhere. These standards are of two kinds: technical standards that
establish the minimum conditions for competent practice, and ethical principles
that are intended to govern the conduct of members in their practice. In exchange
for exercising this responsibility, society implicitly grants professions a degree of
autonomy. The privilege of this autonomy in turn creates certain special
obligations for the profession's members.

These obligations function as constraints on professionals to reduce the
risk that they will use their special power and knowledge to the detriment of those
whom they are supposed to serve. Thus, physicians, whose special knowledge
gives them opportunities for exploiting patients or breaching confidentiality, are
obligated to act in the patient's best interest in general and to follow various
prescriptions for minimizing conflicts of interest.

Unlike basic ethical principles that speak to the whole of moral life, rules
of professional ethics are particularized to the practices, social functions, and
relationships that characterize a profession. Rules of professional ethics are often
justified by appeal to basic ethical principles. For example, as we discuss later in
this chapter, the obligation to obtain informed consent, which is a rule of research
and medical ethics, is grounded in principles of respect for self-determination, the
promotion of others' welfare, and the noninfliction of harm.

In one respect, rules of professional ethics are like the policies of
institutions and organizations: they express commitments to which their members
may be rightly held by others. That is, rules of professional ethics express the
obligations that collective entities impose on their members and constitute a
commitment to the public that the members will abide by them. Absent some
special justification, failure to honor the commitment to fulfill these obligations
constitutes a wrong. To the extent that the profession as a collective entity has

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obligations of self-regulation, failure to fulfill these obligations can lead to
judgments of collective blame.

Ethical Pluralism and the Convergence of Moral Positions

Although we have argued that there is broad agreement about and
acceptance of basic ethical principles in the United States, such as principles that
enjoin us to promote the welfare of others and to respect self-determination,
people nevertheless disagree about the relative priority or importance of these
principles in the moral life. For example, although any minimally acceptable
ethical standpoint must include both these principles, some approaches to
morality emphasize the importance of respecting self-determination while others
place a higher priority on duties to promote welfare. These differences in
approaches to morality pose a problem for public moral discourse. How can a
public body, such as the Advisory Committee, purport to speak on behalf of
society as a whole and at the same time respect this diversity of views about
ethics? The key to understanding how this is possible is to appreciate that
different ethical approaches can and often do converge on the same ethical
conclusions. People can agree about what ought to be done without necessarily
appealing to the same moral arguments to defend their common position.

This phenomenon of convergence has been observed in the work of other
public bodies whose charge was to make ethical evaluations on research
involving human subjects, including the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research and the President's
Commission for the Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research.4 For example, both those who take the viewpoint that
emphasizes obligations to promote welfare and to refrain from inflicting harm and
those who accord priority to self-determination can agree that law and medical
and research practice should recognize a right to informed consent for competent
individuals. The argument for a requirement of informed consent based on
promoting welfare and refraining from inflicting harm assumes that individuals
are generally most interested in and knowledgeable about their own well-being.
Individuals are thus in the best position to discern what will promote their welfare
when deciding about participation in research or medical care. Allowing
physicians or others to decide for them runs too great a risk of harm or loss of
benefits. By contrast, an approach based on self-determination assumes that, at
least for competent individuals, being able to make important decisions
concerning one's own life and health is intrinsically valuable, independent of its
contribution to promoting one's well-being. The most compelling case for
recognizing a right of informed consent for competent subjects and patients draws
upon both lines of justification, emphasizing that this requirement is necessary
from the perspective of self-determination considered as valuable in itself and
from the standpoint of promoting welfare and refraining from doing harm.

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Part I

Therefore, although people may have different approaches to the moral
life, which reflect different priorities among basic moral principles, these
differences need not result in a lack of consensus on social policy or even on
particular moral rules such as the rule that competent individuals ought to be
allowed to accept or refuse participation in experiments. On the contrary, the fact
that the same moral rules or social policies can be grounded in different basic
moral principles and points of view greatly strengthens the case for their public
endorsement by official bodies charged to speak for society as a whole.

The three kinds of ethical standards upon which the Committee relies for
our ethical evaluations-the basic moral principles, government policies, and rules
of professional ethics—also enjoy a broad consensus. They are not idiosyncratic
to a particular ethical value system. Thus it would be a mistake to think that in
order to fulfill our charge of ethical evaluation, the Advisory Committee must
assume that there is only one uniquely correct ethical standpoint. A broad range
of views can acknowledge that the medical profession should be held accountable
for moral rules it publicly professes and that individual physicians can be held
responsible for abiding by these rules of professional ethics. Likewise, regardless
of whether one believes that the ultimate justification for government policies is
the goal of promoting welfare and minimizing harms or respect for self-
determination, one can agree that policies represent commitments to action and
hence generate obligations. Moreover, any plausible ethical viewpoint will
recognize that when individuals assume roles in organizations they thereby
undertake role-derived obligations.

We have already argued that the basic ethical principles that we employ in
evaluating experiments are widely accepted and command significant allegiance
not only from our contemporaries but also from reflective and morally sensitive
individuals and ethical traditions in the past. It would be very implausible to
construe any of them as parochial or controversial.

Retrospective Moral Judgment and the Challenge of Relativism

Some may still have reservations about the project of evaluating the ethics
of decisions and actions that occurred several decades ago. The worry is that it is
somehow inappropriate, if not muddled, to apply currently accepted standards to
earlier periods when they were not accepted, recognized, or viewed as matters of
obligation. This is an important worry, though one that does not apply to our
framework.

The position that the values and principles of today cannot be validly
applied to past situations in which they may not have been accepted is called
historical ethical relativism. This is the thesis that moral judgments across time
are invalid because moral judgments can be justified only by reference to a set of
shared values, and the values of a society change over time. According to this
view, one historical period differs from another by virtue of lacking the relevant

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values contained in the other historical period, namely, those that support or
justify the particular moral judgments in question. Understood in this way,
historical ethical relativism, if true, would explain why some retrospective moral
judgments are invalid, namely, where the past society about which the judgments
are made lacked the values that, in our time, support our judgments. In other
words, the claim is that moral judgments made about actions and agents in one
period of history cannot be made from the perspective of the values of another
historical period.

The question of whether historical ethical relativism limits the validity of
retrospective moral judgment is not a mere theoretical puzzle for moral
philosophers. It is an eminently practical question, since how we answer it has
direct and profound implications for what we ought to do now. Most obviously,
the position we adopt on the validity of retrospective moral judgment will
determine whether we should honor claims that people now make for remedies for
historical injustices allegedly perpetrated against themselves or their ancestors.
Similarly, we must know whether there is any special circumstance resulting from
the historical context in which the responsible parties acted that mitigates
whatever blame would be appropriate. We return to this question later in the
chapter.

In addition, something even more fundamental is at stake in the debate
over retrospective moral judgment: the possibility of moral progress. The idea of
moral progress makes sense only if it is possible to make moral judgments about
the past and to make them by appealing to some of the same moral standards that
we apply to the present. Unless we can apply the same moral yardstick to the past
and the present, we cannot meaningfully say either that there has been moral
progress or that there has not. For example, unless some retrospective moral
judgments are valid, we cannot say that the abolition of slavery is a case of moral
progress, moral regression, or either one. More specifically, unless we can say
that slavery was wrong, we cannot say that the abolition of slavery was a moral
improvement.

For these and other reasons, the acceptance of historical ethical relativism
has troubling implications. But even if we were to accept historical ethical
relativism as the correct position, it would not follow from this alone that there is
anything improper about making judgments about radiation experiments
conducted decades ago based on the three kinds of ethical standards the
Committee has identified. Two of these kinds of standards-government policies
and rules of professional ethics-are standards used at the time the experiments
were conducted. Neither of these kinds of standards involves projecting current
cultural values onto a different cultural milieu.

We have already argued that basic ethical principles, the third kind of
standard adopted by the Committee, are not temporally limited. Although there
have been changes in ethical values in the United States between the mid- 1940s
and the present, it is implausible that these changes involved the rejection or

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affirmation of principles so basic as that it is wrong to treat people as mere means,
wrong to inflict harm, or wrong to deceive people. Thus, the Advisory
Committee's evaluations of the human radiation experiments in light of these
basic principles is based on a simple and we think reasonable assumption that,
even fifty years ago, these principles were pervasive features of moral life in the
United States that were widely recognized and accepted, much as we recognize
and accept them today.5

Factors That Influence or Limit Ethical Evaluation

Several considerations influence and can limit the ability to reach ethical
conclusions about Tightness and wrongness and praise and blame. Some of these
may be more likely to be present in efforts to evaluate the past, but all can arise
when attempts are made to evaluate contemporary events as well. The most
important such limitations relevant to the Advisory Committee's evaluations are
these:

( 1 ) Lack of evidence as to whether ethical
standards were followed or violated and if so,
by whom, and

(2) The presence of conflicting obligations.

The three kinds of ethical standards adopted by the Committee can yield
the conclusion that an individual or collective agent had or has a particular
obligation. But this conclusion is not by itself sufficient to determine in any
particular case whether anything wrong was done or whether any individual or
collective agent deserves blame.

Lack of Evidence

Sound evaluations cannot be made without sufficient evidence.
Sometimes it cannot be determined if anything wrong was done because key facts
about a case are missing or unclear. Other times there may be sufficient evidence
that a wrong was done, but insufficient evidence to determine who performed the
action that was wrong or who authorized the policy that was wrong or who was
responsible for a practice that was wrong. This is why the Advisory Committee
strove during our tenure to reconstruct the details of the circumstances under
which the human radiation experiments themselves took place. However, these
records are incomplete, and even the copious documentation we have gathered
does not tell as complete a story as sometimes was needed to make ethical
evaluations.

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Conflicting Obligations

Because we all have more than one obligation, because they can conflict
with one another, and because some obligations are weightier than others, a
particular obligation that is otherwise morally binding may not be binding in a
particular circumstance, all things considered. For example, a government
official might be obligated to follow certain routine procedures, but in a time of
dire emergency he or she might have a weightier obligation to avert great harm to
many people by taking direct action that disregards the procedures. Similarly, a
physician is obligated to keep his patient's condition confidential, but in some
cases it is permissible and even obligatory to breach this confidence (for example,
in order to prevent the spread of deadly infectious diseases). In such cases, the
agent has done nothing wrong in failing to do what he or she would ordinarily be
morally obligated to do; that obligation has been validly overridden by what is in
the particular circumstances a weightier obligation.

The presence of conflicting obligations may limit our ability to make
moral judgments when, for example, it is difficult to determine, in a particular
case, which obligation should take precedence. At the same time, however, if it
can be determined which obligation is weightier, then the presence of this factor
does not serve as an impediment to evaluation; rather, it can lead to the
conclusion that nothing morally wrong was done and that no one should be
blamed.

An example of a potentially overriding obligation that is especially
important for the Advisory Committee's work is the possibility that, during the
period of the radiation experiments, obligations to protect national security were
sometimes more morally weighty than obligations to comply with standards for
human subjects research. If the threat were great enough, considerations of
national security grounded in the basic ethical principle that one ought to promote
welfare and prevent harm could justifiably override the basic ethical principle of
not using people as mere means to the ends of others, as well as the more specific
rule of research ethics requiring the voluntary consent of human subjects. Had
such an overriding obligation to protect national security existed during the period
we studied, it also would have relieved responsible individuals of any blame
otherwise attributable to them for using individuals in experiments that were
crucial to the national defense.

Especially during the late 1940s and early 1950s, and then again in the
first years of the early 1960s, our country was engaged in an intense competition
with the Soviet Union. A high premium was placed upon military superiority, not
only in "conventional" warfare but also in atomic, biological, and chemical
warfare. The DOD's Wilson memorandum, when originally promulgated in 1953,
declared that it was directed toward the need to pursue atomic, biological, and
chemical warfare experiments "for defensive purposes" in these fields.

It would not be surprising, therefore, to discover that, in the government's

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policies and rules for human subject research, provisions had been made for the
possibility that obligations to protect national security might conflict with and
take priority over obligations to protect human subjects, and thus that such
policies would have included exceptions for national security needs. The moral
justification would also not be surprising: that, in order to preserve the American
way of life with its precious freedoms, some sacrifices of individual rights and
interests would have to be made for the greater good. The very phrase Cold War
expressed the conviction that we already were engaged in a life-or-death struggle
and that in war actions may be permissible that would be impermissible in
peacetime. Survival in the treacherous and heavily armed post-World War II era
might demand no less, repugnant as those actions otherwise might be to many
Americans.

The Advisory Committee did not undertake an inquiry to determine
whether during either World War II or the Cold War there were ever
circumstances in which considerations of national security might have justified
infringements of the rights and protections that would otherwise be enjoyed by
American citizens in the context of human experimentation. Our sources for
answering this question were limited to materials pertinent to specific human
radiation experiments and declassified defense-related memorandums and
transcripts. With regard to the experiments, particular cases are reviewed in part
II of this report. In those experiments that took place under circumstances most
closely tied to national security considerations, such as the plutonium injections
(see chapter 5), it does not appear that such considerations would have barred
satisfying the basic elements of voluntary consent. Thus, for instance, although
the word plutonium was classified until the end of World War II, subjects could
still have been asked their permission after having been told that subjects in the
experiment would be injected with a radioactive substance with which medical
science had had little experience and which might be dangerous and that would
not help them personally, but that the experiment was important to protecting the
health of people involved in the war effort or safeguarding the national defense.

With regard to defense-related documents, in none of the memorandums
or transcripts of various agencies did we encounter a. formal national security
exception to conditions under which human subjects may be used. In none of
these materials does any official, military or civilian, argue for the position that
individual rights may be justifiably overridden owing to the needs of the nation in
the Cold War. In none of them is an official position expressed that the
Nuremberg Code or other conventions concerning human subjects could be
overridden because of national security needs.

Some government officials, military and civilian, may have personally
advocated the view that obligations to protect national security were more
important than obligations to protect the rights and interests of human subjects.
It is, of course, possible that the priority placed on national security was so great
in some circles of government that the ability of security interests to override

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other national interests was implicitly assumed, rather than explicitly articulated.
It is a matter of historical record that some initiatives undertaken by government
officials at some agencies during this period adopted the view that greater
national purposes justified the exploitation of individuals. Notorious examples
are the CIA's MKULTRA project and the Army's psychochemical experiments,
which subjected unsuspecting people to experiments with LSD and other
substances (see chapter 3).A However, even the internal investigation of the
Department of Defense into these incidents in the 1970s concluded that these
incidents were violations of government policy, not recognized legitimate
exceptions to it.7

During the era of the Manhattan Project, the United States and its allies
were engaged in a declared and just war against the Axis powers. Regarding the
possibility of a wartime exception, it is well documented that during World War II
the Committee on Medical Research (CMR) of the Executive Office of the
President funded research on various problems confronting U.S. troops in the
field, including dysentery, malaria, and influenza. This research involved the use
of many subjects whose capacity to consent to be a volunteer was questionable at
best, including children, the mentally retarded, and prisoners. K However, when
the CMR considered proposed gonorrhea experiments that would have involved
deliberately exposing prisoners to infection, the resulting discussion about the
ethics of research exhibited a cautious attitude. The conclusion was that only
"volunteers" could be used and that they had to be carefully informed about the
risks and benefits of participation. In these and other classified conversations, the
CMR took the position that care is to be taken with human subjects, including
conscientious objectors and military personnel.9

It is difficult to reconcile these deliberations with the fact that many
subjects of CMR-funded research were not true volunteers. Whether the CMR
believed that the needs of a country at war justified the use of people who could
not be true volunteers as research subjects is not known.

It would, however, be an error to conclude that, even in contexts where
important national security interests are at stake, such as during wartime, a
conflict between obligations to protect national defense and obligations to protect
human subjects ought always to be resolved in favor of national security. The
question of whether any and all means are morally acceptable for the sake of
national security and the national defense is a complex one. Even in the case of a
representative democracy that is not an aggressor, it would be wrong to assume
that there are no moral constraints in time of war. All of the major religious and
secular traditions concerning the morality of warfare recognize that there are
substantial limitations upon the manner in which even a just war is conducted.10
The issue of the morality of "total warfare" for a just cause, including the use of
medical science, was beyond the scope of the Advisory Committee's charter,
deliberations, and expertise.

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Distinguishing Between the Wrongness of Actions and Policies and the
Blameworthiness of Agents

Factors That Influence or Limit Judgments About Blame

The factors we have just discussed—lack of evidence and the presence of
conflicting obligations-place limits on our ability to make judgments about both
the Tightness and wrongness of actions and the blameworthiness of the agents
responsible for them. Some factors, however, place limits only on our ability to
make judgments about the blameworthiness of agents. Even in cases where
actions or policies are clearly morally wrong, it may be uncertain how
blameworthy the agents who conducted or promulgated them are, or in fact,
whether they are blameworthy at all. Some factors make it difficult to affix
blame; other factors can mitigate or lessen the blame actors deserve. Four such
factors are of particular concern to the Committee: ' '

(1) Factual ignorance;

(2) Culturally induced ignorance about relevant moral considerations;

(3) Evolution in the interpretations and specification of moral principles;
and

(4) Indeterminacy in an organization's division of labor, with the result
that it is unclear who has responsibility for implementing the
commitments of the organization.

Factual Ignorance

Factual ignorance refers to circumstances in which some information
relevant to the moral assessment of a situation is not available to the agent. There
are many reasons that this may be so, including that the information in question is
beyond the scope of human knowledge at the time or that there was no good
reason to think that a particular item of information was relevant or significant.
However, just because an agent's ignorance of morally relevant information leads
him or her to commit a morally wrong act, it does not follow that the person is not
blameworthy for that act. The agent is blameworthy if a reasonably prudent
person in that agent's position should have been aware that some information was
required prior to action, and the information could have been obtained without
undue effort or cost on his or her part. Some people are in positions that obligate
them to make special efforts to acquire knowledge, such as those who are directly
responsible for the well-being of others. Determinations of culpable and
nonculpable factual ignorance often turn on whether the competent person in the

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field at that time had that knowledge or had the means to acquire it without undue
burdens.

Culturally Induced Moral Ignorance

Sometimes cultural factors can prevent individuals from discerning what
they are morally required to do and can therefore mitigate the blame we would
otherwise place on individuals for failing to do what they ought to do. In some
cases these factors may have been at work in the past but are no longer operative
in the present, because of changes in culture over time.

An individual may, like other members of the culture, be morally
ignorant. Because of features of his or her deeply enculturated beliefs, the
individual may be unable to recognize, for example, that certain people (such as
members of another race) deserve equal respect or even that they are people with
rights. Moral ignorance can impair moral judgment and hence may result in a
failure to act morally.

In extreme cases, a culture may instill a moral ignorance so profound that
we may speak of cultural moral blindness. In some societies the dominant culture
may recognize that it is wrong to exploit people but fail to recognize certain
classes of individuals as being people. Some of those committed to the ideology
of slavery may have been morally blind in just this way, and their culture may
have induced this blindness.

Here it is crucial to distinguish between culpable and nonculpable moral
ignorance. The fact that one's moral ignorance is instilled by one's culture does
not by itself mean that one is not responsible for being ignorant; nor does it
necessarily render one blameless for actions or omissions that result from that
ignorance. What matters is not whether the erroneous belief that constitutes the
moral ignorance was instilled by one's culture. What matters is the extent to
which the individual can be held responsible for maintaining this belief, as
opposed to correcting it. Where opportunities for remedying culturally induced
moral ignorance are available, a person may rightly be held responsible for
remaining in ignorance and for the wrongful behavior that issues from his or her
mistaken beliefs.

People who maintain their culturally induced moral ignorance in the face
of repeated opportunities for correction typically do so by indulging in
unjustifiable rationalizations, such as those associated with racist attitudes. They
show an excessive partiality to their own opinions and interests, a willful rejection
of facts that they find inconvenient or disturbing, an inflated sense of their own
self-worth relative to others, a lack of sensitivity to the predicament of others, and
the like. These moral failings are widely recognized as such across a broad
spectrum of cultural values and ethical traditions, both religious and secular.

Only if an agent could not be reasonably expected to remedy his or her
culturally induced moral ignorance would such ignorance exculpate his conduct.

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But even in cases in which the individual could not be blamed for persisting in
ignorance, this would do nothing to show that the actions or omissions resulting
from his or her ignorance were not wrong. Nonculpable moral ignorance only
exculpates the agent; it does not make wrong acts right.

Evolution in Interpretations of Ethical Principles

There is another respect in which the dependence of our perceptions of
right and wrong on our cultural context has a bearing on the Advisory
Committee's evaluations. While basic ethical principles do not change,
interpretations and applications of basic ethical principles as they are expressed in
more specific rules of conduct do evolve over time through processes of cultural
change.

Recognizing that more specific moral rules do change has implications for
how we judge the past. For example, the current requirement of informed consent
is the result of evolution. Acceptance of the simple idea that medical treatment
requires the consent of the patient (at least in the case of competent adults) seems
to have preceded by a considerable interval the more complex notion that
informed consent is required.12 Furthermore, the notion of informed consent itself
has undergone refinement and development through common law rulings, through
analyses and explanations of these rulings in the scholarly legal literature, through
philosophical treatments of the key concepts emerging from legal analyses, and
through guidelines in reports by government and professional bodies.13 For
example, as early as 1914, the duty to obtain consent to medical treatment was
established in American law: "Every human being of adult years and sound mind
has a right to determine what shall be done with his own body; and a surgeon who
performs an operation without his patient's consent commits an assault."14
However, it was not until 1957 that the courts decreed that consent must be
informed,15 and this 1957 ruling was only the beginning of a long debate about
what it means for a consent to be informed. Thus it is probably fair to say that the
current understanding of informed consent is more sophisticated, and what is
required of physicians and scientists more demanding, than both the preceding
requirement of consent and earlier interpretations of what counts as informed
consent. As the content of the concept has evolved, so has the scope of the
corresponding obligation on the part of these professionals. For this reason it
would be inappropriate to blame clinicians or researchers of the 1940s and 1950s
for not adhering to the details of a standard that emerged through a complex
process of cultural change that was to span decades. At the same time, however,
it remains appropriate to hold them to the general requirements of the basic moral
principles that underlie informed consent—not treating others as mere means,
promoting the welfare of others, and respecting self-determination.

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Inferring Bureaucratic Responsibilities

It is often unclear in complex organizations such as government agencies
who has responsibility for implementing the organization's policies and rules.
This is particularly common in new and changing organizations, where it is more
likely than in stable organizations that there will be interconnecting lines of
authority among employees and officials, and job descriptions that are not explicit
with respect to responsibility for implementation of policies and initiatives. When
policies are not properly implemented in organizations that fit this description, it
often is difficult to assign blame to particular individuals. An employee or
official of an agency cannot fairly be blamed for a failed or poorly executed
policy unless it can be determined with confidence that the person had
responsibility for implementing that policy and should have known that he or she
had this responsibility.

The Importance of Distinguishing Wrongdoing from
Blameworthiness

Judgments of wrongdoing and judgments of blameworthiness have very
different implications. Even where a wrong was done, it does not follow that
anyone should be blamed for the wrong. This is because there are factors,
including the four we have just described, that can lessen or remove blame from
an agent for a morally wrong act but that cannot in any way make the wrong act
right. If experiments violated basic ethical principles, institutional or
organizational policies, or rules of professional ethics, then they were and will
always be wrong. Whether and how much anyone should be blamed for these
wrongs are separate questions.16

The distinction between the moral status of experiments and that of the
individuals who were involved with conducting, funding, or sponsoring them also
has important implications for our own time. For a society to make moral
progress, individuals must be able to exercise moral judgment about their actions.
It is important for social actors to be critical about their activities, even those in
which they have been engaged for some time. It is important for them to be able
to step back and analyze their actions as right or wrong. If we did not distinguish
between actions and agents, then people may feel that, once they have perceived
their moral error, it is "too late" for them to change their ways, to object to the
ongoing activity, and to try to rally others in support of reform.

For any generation to initiate morally indicated reforms, it must be able to
take this critical stance. As we see in part III of this report, even now there are
aspects of our society's use of human subjects that should be critically examined.
The actions we ourselves have performed do not condemn us as moral agents
unless we refuse to open ourselves to the possibility that we have in some ways
been in error. As we have said, even if we are exculpated by our own culturally

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induced moral ignorance, that does not make our wrong acts right. Even if we
must accept a measure of blame for our actions, we are free to achieve a critical
assessment and to initiate and participate in needed change.

The Significance of Judgments About Blameworthiness

The Committee believes that its first task is to evaluate the Tightness or
wrongness of the actions, practices, and policies involved in the human radiation
experiments that occurred from 1944 to 1974. However, it is also important to
consider whether judgments ascribing blame to individuals or groups or
organizations can responsibly be made and whether they ought to be made.

There are three main reasons forjudging culpability as well as wrongness..
First, a crucial part of the Committee's task is to make recommendations that will
reduce the risk of errors and abuses in human experimentation in the future, on
the basis of its diagnoses of what went wrong in the past. A complete and
accurate diagnosis requires not only stating what wrongs were done, but also
explaining who was responsible for the wrongs occurring. To do this is likely to
yield the judgment that some individuals were morally blameworthy. Second,
unless judgments of culpability are made about particular individuals, one
important means of deterring future wrongs will be precluded. People
contemplating unethical behavior will presumably be more likely to refrain from
it, other things being equal, if they believe that they, as individuals, may be held
accountable for wrongdoing than if they can assure themselves that at most their
government or their particular government agency or their profession may be
subject to blame. Third, ethical evaluation generally involves both evaluation of
the Tightness or wrongness of actions and the praiseworthiness or
blameworthiness of agents. In the absence of any explicit exemption of the latter
sorts of judgment in our mandate, the Committee believes it would be arbitrary to
exclude them.

Having made a case for judgments of culpability as well as wrongness, the
Committee believes it is very important to distinguish carefully between judging
that an individual was culpable for a particular action and judging that he or she is
a person of bad moral character. Justifiable judgments of character must be based
on accurate information about long-standing and stable patterns of action in a
number of areas of a person's life, under a variety of different situations. Such
patterns cannot usually be inferred from information about a few isolated actions
a person performs in one particular department of his or her life, unless the
actions are so extreme as to be on the order of heinous crimes.

APPLYING THE ETHICAL FRAMEWORK

The three kinds of standards presented in this chapter provide a general
framework for evaluating the ethics of human radiation experiments. In this

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section of the chapter, we revisit those standards in the specific context of human
radiation experiments conducted between 1944 and 1974 and what we have
learned about the policies and practices involving human subjects during that
period.

Basic Ethical Principles

Earlier in this chapter we identified six basic ethical principles as
particularly relevant to our work: "One ought not to treat people as mere means to
the ends of others"; "One ought not to deceive others"; "One ought not to inflict
harm or risk of harm"; "One ought to promote welfare and prevent harm"; "One
ought to treat people fairly and with equal respect"; and "One ought to respect the
self-determination of others."

These principles are central to our analysis of the cases we present in part
II of the report, although not every case we evaluate engages every principle.
Two of the principles, however, recur repeatedly as we consider the ethics of past
experiments. These are "One ought not to treat people as mere means to the ends
of others" and "One ought not to inflict harm or risk of harm." Whether an
experiment involving human subjects violates the principle not to use people as
mere means generally depends on two factors-consent and therapeutic intent. An
individual may give his or her consent to being treated as a means to the ends of
others. If a person freely consents, then he or she is no longer being used as a
mere means, that is, as a means only. Thus, if a person is used as a subject in an
experiment from which the person cannot possibly benefit directly, but the
person's consent to that use is obtained, the person is not being used as a mere
means to the ends of others. By contrast, if a person is used as a subject in such
an experiment but the person's consent is not obtained for that use, the person is
being used as a mere means to the ends of the investigator conducting the
experiment and the institutions funding or sponsoring the experiment.

If an action that involves the use of a person is undertaken in whole or in
part for that person's benefit, then the person is not being used as a mere means
toward the ends of others. Thus, if a person is used as a subject in an experiment
that is intended to offer the subject a prospect of direct benefit, then, even if the
subject's consent has not been obtained, the subject is not being used as a mere
means to the ends of others. This is because the experiment is intended to serve
the subject's interests as well as the interests of the investigator and funding
agency. It may be wrong not to obtain the subject's consent in this case, but the
wrong does not stem from a violation of the principle not to use people as mere
means. Instead, the wrong reflects the violation of other basic principles such as
the principles enjoining us to respect self-determination and to promote welfare
and prevent harm.

These two factors-the obtaining of consent and an intention to benefit-
also can transform the moral quality of an act that involves the imposition of harm

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or risk of harm. One important way to make the imposition of a risk of harm
justifiable is to obtain the person's permission for the imposition. The imposition
of risk on a person also is more justifiable when the risk is imposed to secure a
benefit for that person, although even in the presence of a prospect of offsetting
benefit, the imposition of risk on another without that person's consent is morally
questionable because it appears to violate the principle of respect for self-
determination.17

Consider the following example of how the factors of therapeutic intent
and consent can transform a morally questionable action into a morally acceptable
one. Patients are enrolled in an experiment in which they are given a new drug
that is unproven in humans, induces substantial discomfort or even suffering, and
may produce irreversible damage to vital organs. There is, however, no effective
treatment for the condition from which these patient-subjects suffer, and the
condition is life threatening. The drug is theoretically promising compared with
related drugs used in similar diseases, and it has proven effective in animals.
Further, the opportunity to participate in the experiment is offered to patients
while they are lucid, comfortable, and at ease. Under these circumstances the
imposition of harm may be transformed into a caring and respectful act.

Policies of Government Agencies

Where agencies of the government had policies on the conduct of research
involving human subjects, and where these policies included requirements or
rules that are morally sound, these policies constitute standards against which the
conduct of the agencies and the people who worked there, as well as the
experiments the agencies sponsored or conducted, can be evaluated. Government
agencies must be held responsible for failures to implement their own policies.
To do otherwise is to break faith with the American people, who have a
reasonable expectation that an agency will conduct its affairs in accord with the
agency's stated policies. As we noted in chapter 1 , it is not always clear,
however, whether statements made in letters or memorandums constitute agency
policy. When there is little evidence that a statement by a government official
was ever implemented, it is often difficult to determine whether this was an
instance of an agency failing to implement its own policies or an instance where a
statement by a government official was not perceived as agency policy in the first
place.

Among the general conclusions that can be drawn from the discussions
about policies during the late 1940s and early 1950s is that the AEC, DOD, and
NIH required investigators to obtain the consent of the healthy or "normal"
subject, and prior group review was required for risk in research using
radioisotopes for all private and publicly financed research (and, in the NIH, for
all hazardous procedures). Also, in 1953, the Department of Defense adopted the
Nuremberg Code as the policy for research related to atomic, biological, and

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chemical warfare, and the NIH Clinical Center articulated a consent requirement
for patient-subjects in intramural research (see chapter 1).

Two questions that arise at this juncture are whether an experiment was
wrong if it violated one of these policies but took place at another government
agency, and whether an experiment was wrong if it took place under the auspices
of an agency before it promulgated the policy. The answer to both questions is
the same: Even if such an experiment was not wrong according to the policy of
the agency sponsoring the experiment at the time, the experiment may
nevertheless have been unethical based on one or more basic ethical principles or
rules of professional ethics.

As is the case today, decades ago government officials had obligations to
take reasonable steps to see that policies were adequately implemented.18 Policies
constitute organizational commitments, and organizational commitments generate
obligations on the part of the organization and its members. In some cases,
however, it is not clear that conditions stated by individual officials rise to a level
that all would be comfortable calling "policies." Accordingly, it is not clear
whether corresponding obligations to implement can be inferred. The two letters
signed by AEC General Manager Carroll Wilson in April and November 1947 are
the best examples of this problem. Nevertheless, if it is correct to say that high
officials have an obligation to exert due efforts to implement and communicate
the rules they are empowered to establish, then they may reasonably be blamed
for failures in this regard. Further, if they do not even attempt to articulate rules
that are indicated by basic ethical principles and that are clearly relevant to
organizational activities that fall under their authority, they are also subject to
moral blame.

The mitigating condition of culturally induced moral ignorance does not
apply to government officials who failed to exercise their responsibilities to
implement or communicate requirements that clearly fell within the ambit of their
office and of which they were aware. The very fact that these requirements were
articulated by the agencies in which they worked is evidence that officials could
not have been morally ignorant of them.

We have observed, however, that, especially with regard to research
involving patients, policies were frequently unclear. When this research offered
patient-subjects a chance to benefit medically, the widespread discretion granted
physicians to make decisions on behalf of their patients is a mitigating factor in
judging the blameworthiness of government officials for failing to impose consent
requirements on physician-investigators. This failure could be attributed to a
cultural moral ignorance concerning the proper limits to the authority of
physicians over their patients.

The same cannot be said of government officials for failing to impose
consent requirements on physician-investigators who used patient-subjects in
research from which the patients could not benefit medically. This use of human
subjects took place outside of the therapeutic context that defines the doctor-

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patient relationship and therefore also was outside of the authority then ceded to
physicians. In this case responsible agency officials had a ready analogy to
healthy subjects for whom there was a lengthy tradition of policies and rules
requiring the use of "volunteers" and the obtaining of consent. Government
officials could and should have perceived the morally identical nature of these
cases— that, without consent, both cases involved violation of the principle not to
use people as mere means to the ends of others. Those who were ill should have
been granted the same protections as those who were well.

In contrast to requirements for consent, requirements intended to ensure
that risks to experimental subjects were acceptable were far more clearly stated.
Government officials are blameworthy if they permitted research to continue that
was known to entail unusual risks to the subjects, in direct violation of agency
policy.

Finally, some lessons that can be drawn from the experience of the human
radiation experiments we considered speak to the conduct of government itself as
a collective agent, rather than simply to individual government officials. In too
many instances, as we saw in chapter 1, we found a lack of clarity about the status
within an agency of specific declarations by responsible officials. Particularly
when agencies are engaged in activities that may compromise the rights or
interests of citizens, it is critically important that agencies be clear about their
commitments and policies and that they not remain passive in the face of
questionable practices for which they may bear some responsibility. In chapter 3
we saw an effective response to such a situation in the 1960s by the PHS. This
example attests to the fact that institutional clarity and active reform measures can
succeed and that when they do they can be great forward strides.

Rules of Professional Ethics

Even if the federal government had adopted no formal human research
ethics policy whatsoever, the medical profession and its members would still have
moral obligations to those who entrust themselves to their care. The successes of
modern medical research, regardless of its funding source, are ultimately due to
the efforts of talented and dedicated medical scientists. These investigators bear a
profound ethical burden in their work with human subjects. Society entrusts them
with the privilege of using other human beings to advance their important work.
Although society must not discourage them from the pursuit of new information,
it also must diligently pursue signs that medical scientists have not exercised their
ethical responsibility with the care and sensitivity that society has good reason to
expect from them.

Without reference to the policies adopted by federal agencies, what rules
of professional ethics were seen by the medical profession during the 1944-1974
period as relevant to the conduct of its members engaged in human subjects
research? The answer to this question depends upon which kind of experimental

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Chapter 4

situation is under discussion: an experiment on a healthy subject; an experiment
on a patient-subject without a scientific or clinical basis for an expectation of
benefit to the patient-subject; or an experiment on a patient-subject with a
scientific or clinical basis for an expectation of benefit to the patient-subject.

Experiments on Healthy Subjects: By the mid- 1 940s it was common to
obtain the voluntary consent of healthy subjects who were to participate in
biomedical experiments that offered no prospect of medical benefit to them.
Sophisticated philosophical analysis is not required to reach the conclusion that
using a human being in a medical experiment that offers the person no prospect of
personal benefits without that person's consent is wrong. As we have already
noted, such conduct violates the basic ethical principle that one ought not use
people as mere means to the ends of others.

Experiments on Patient-Subjects Without a Scientific or Clinical Basis for
an Expectation of Benefit to the Patient-Subject: The Hippocratic tradition of
medical ethics inherited by physicians in the 1940s holds that, unless the
physician is reasonably sure that his or her treatment is, on balance, likely to do
the patient more good than harm, the treatment should not be introduced. The
heart of the Hippocratic ethic is the physician's commitment to putting the
interests of the patient first. Subjecting one's patient to experimentation that
offers no prospect of benefit to the patient without his or her consent is a direct
repudiation of this commitment. (If the patient consents to this use, the moral
warrant for proceeding with the experiment comes from the patient's permission,
not from the Hippocratic ethic.)

Experiments on Patient-Subjects with a Scientific or Clinical Basis for an
Expectation of Benefit to the Patient-Subject: Even in Hippocratic medicine it is
recognized that physicians should attempt to use unproven or experimental
methods to benefit the patient, whether through efforts at cure or palliation, but
only so long as there is no efficacious standard therapy available and innovative
measures are compatible with the obligation to avoid doing harm without the
prospect of offsetting benefit. Interventions in this category should be based on
scientific reasoning and conservative clinical judgment. Arguably, so long as
these conditions prevailed, it was not thought morally necessary within the
medical profession to obtain the patient's consent to such experimentation prior to
the 1960s. But the physician assumed a corresponding obligation to base his or
her deviation from standard practice on the reasonable likelihood of patient
benefit, sufficient to outweigh the risks associated with being in the experiment.
This type of reasoning, too, has been available to and accepted by physicians for
many years, even though the ability to assess and calculate risks has developed
greatly.

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Part I

Although the professional ethics of the period thus had relevant moral
rules for each of these three experimental situations, compliance with these rules
is a separate matter. There may be many reasons for specific failures by
physicians to adhere to the requirements of their ethical tradition, some of which
may render them nonculpable, and there are various limitations on our ability to
assign blame for particular cases of a physician's failure to adhere to professional
ethics. However, any use of human subjects that did not proceed in accordance
with these rules of professional ethics was wrong in the sense that it was a
violation of sound professional ethical standards. Moreover, even if there was
then or is now a lack of clarity about the rules of professional ethics, recognition
by morally serious individuals of basic ethical principles is enough to identify
certain sorts of human experiments as morally unacceptable.

The special moral responsibilities of the medical profession as a whole,
whether decades ago or in our own time, deserve careful consideration, especially
insofar as previous experience can help formulate lessons for the future. Like the
government, the medical profession as a whole must be held to a higher standard
than individuals in society. Confidence in the medical profession is important
because individuals put their very lives, and the lives of their loved ones, in the
hands of those whom the profession has certified as competent to practice.
Unlike government officials, members of the medical profession are explicitly
bound to a moral tradition in their professional relations, based on which society
grants the medical profession the privilege of largely policing itself. This
authority is part of what constitutes the medical profession as a profession, but the
authority is granted by society on the condition that the profession will adhere to
the high moral rules it professes and that, if necessary, the medical profession will
reform or encourage the reform of relevant institutions to ensure that those rules
will be honored in practice.

Moreover, many of the privileges that devolve on the medical profession
are granted on the condition that it is sufficiently well organized to police itself,
with minimal intervention by the government and the legal system. Therefore,
members of the medical profession are further legitimately expected to engage in
organizational conduct that constitutes sound moral practices. Implicit in this
arrangement is also the assumption that it will be self-critical even about its
relatively well-entrenched attitudes and beliefs, so that it will be prepared to
undertake reforms. Without this commitment to self-criticism, self-regulation
cannot be effective and the public's trust in the professional's ability to self-
regulate would be unwarranted.

Today we regard subjects of biomedical research whose consent was not
obtained to have been wronged; under conditions of significant risk, the wrong is
greater, and in the absence of the potential for offsetting medical benefit, greater
still. The historical silence of the medical profession with respect to
nontherapeutic experiments was perhaps based on the rationale that those who are
ill and perhaps dying may be used in experiments because they will not be

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harmed even though they will not benefit. But this rationale overlooks both the
principle that people should never be used as mere means and the principle of
respect for self-determination; it may also provide insufficient protection against
harm, given the position of conflict of interest in which the physician-researcher
may find him-or herself. Nevertheless, until the mid-1960s medical conventions
were silent on experiments with patient-subjects that offered no direct benefit but
which physicians believed to pose acceptable risk. This silence was a failure of
the profession.

One defense of the profession in this regard is that it was as subject to the
phenomenon we have called cultural moral ignorance as any other group in
society at the time, including the arguably excessive deference to physician
authority on the part of the government and possibly the public at large.
However, the medical profession was in a wholly different position from the
others, in several respects. First, it insisted upon and was given the privilege of
policing its own behavior. Second, the profession was the direct beneficiary of
the deference paid to it. Third, there were already examples of experiments that
had involved subject consent that could have served as models of reform. Under
these conditions the profession had an obligation to be self-critical concerning the
norms and rules it thought appropriate to govern its members' conduct.

The medical profession could and should have seen that healthy subjects
and patient-subjects in nontherapeutic experiments were in similar moral
positions—neither was expected to benefit medically. Just as physicians had no
moral license to determine an "acceptable risk" for healthy subjects without their
voluntary consent, they had no moral license to do so in the case of other subjects
who also could not benefit from being in research, even if they were patients. The
prevailing standards for healthy subject groups could easily have been applied to
patient-subjects for whom there was no expectation of medical benefit. The moral
equivalence of the use of healthy people and ill people as subjects of experiments
from which no subject could possibly benefit directly was perceptible at the time.

This moral equivalence would have made it clear that no one, well or sick,
should be used as a mere means to advance medical science without voluntary
consent. Thus, this moral ignorance could have and should have been remedied at
the time. Indeed, it is arguably the case that physicians could and should have
seen that using patients in this way was morally worse than using healthy people,
for in so doing one was violating not only the basic ethical principle not to use
people as a mere means but also the basic ethical principle to treat people fairly
and with equal respect.

American physicians are members of a society that places a high value on
these basic moral principles, still more vital than the advancement of medical
science. These principles are as easily known to physicians as to anyone else, and
it is unacceptable to single oneself out as an exception to these principles simply
because one is a member of an esteemed profession. Someone who is ill deserves
to be treated with the same respect as someone who is well. Accordingly, a

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physician who failed to tell a patient that what was proposed was an experiment
with no therapeutic intent was and is blameworthy. To the extent that the
experiment entailed significant risk, the physician is more blameworthy; where it
was reasonable to assume that the experiment imposed no risk or minimal risk or
inconvenience, the blame is less.

We argue here that the use of patients in nontherapeutic experiments
without their consent was not only a violation of these basic moral principles but
also a violation of the Hippocratic principle that was the cornerstone of
professional medical ethics at that time. That principle enjoins physicians to act
in the best interests of their patients and thus would seem to prohibit subjecting
patients to experiments from which they could not benefit. It might be argued
that a widespread practice that is not in conformity with a principle of
professional ethics invalidates the principle, since the practice shows that the
profession was not really committed to the principle in the first place. This is a
misunderstanding, however, of what it means for a profession to adopt and
espouse a moral principle. Even if many or most physicians sometimes fail or
even often fail to comply with the principle, it is still coherent to say that the
principle is accepted by the profession, if the principle has been publicly
pronounced and affirmed by the profession, as was clearly the case with respect to
the Hippocratic ethic.

To characterize a great profession as having engaged over many years in
unethical conduct-years in which massive progress was being made in curbing
some of mankind's greatest ills-may strike some as arrogant and unreasonable.
However, fair assessment indicates that the circumstance was one of those times
in history in which wrongs were committed by very decent people who were in a
position to know that a specific aspect of their interactions with others should be
improved. Wrongs are not less egregious because they were committed by a
member of a certain profession or by people who are very decent in their
relationships with other parties. It is common for us to look back at such conduct
in amazement that so many otherwise good and decent people could have
engaged in it without a high level of self-awareness. Moral consistency requires
the Advisory Committee to conclude that, if the use of healthy subjects without
consent was understood to be wrong at the time, then the use of patients without
consent in nontherapeutic experiments should also have been discerned as wrong
at the time, no matter how widespread the practice.

It should be emphasized, however, that often these nontherapeutic
experiments on unconsenting patients constituted only minor wrongs. Often there
was little or no risk to patient-subjects and no inconvenience. Although it is
always morally offensive to use a person as a means only, as the burden on the
patient-subject decreased, so too did the seriousness of the wrong.

Much the same can be said of experiments that were conducted on
patient-subjects without their consent but that offered a prospect of medical
benefit. To the extent that such experiments were conducted within the moral

220

environment of the doctor-patient relationship, that is, based on the physician's
considered and informed judgment that it was in the patient's best interests to be
enrolled in the research, then the less blameworthy the physician was for failing
to obtain consent. However, where the risks were great or where there were
viable alternatives to participation in research, then the physician was more
blameworthy for failing to obtain consent.

It is often difficult to establish standards and make judgments about right
and wrong, and about blame and exculpation. Our charge was all the more
difficult because the context of the actions and agents we were asked to evaluate
differs from our own. In arriving at this moral framework for evaluating human
radiation experiments, we have tried to be fair to history, to considerations of
ethics, and above all, to the people affected by our analysis-former subjects,
physician-investigators, and government officials.

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ENDNOTES

1 . International declarations of human rights that would otherwise be relevant
to an evaluation of human experimentation, such as the Covenant on Civil and Political
Rights (1966), were articulated after the human radiation experiments with which we are
mainly concerned, with the significant exception of the Nuremberg Code, as discussed in
chapter 2.

2. The Advisory Committee is aware that questions such as precisely what
ethical principles should be considered "basic," how they are related to those less basic,
and how the basic ethical principles are known are among the most controversial and
difficult in moral philosophy. For the Advisory Committee's limited purposes, a
comprehensive and systematic moral theory is not required and is, in any case, far
beyond the scope of this report. We have rather settled on a list of immediately
recognizable and widely accepted ethical principles that are not usually thought to
require justification themselves and that should be included in any adequate moral
theory.

3. Some view promise keeping as a basic ethical principle on a par with the
prohibition against deception. It may also be seen as grounded in one or more of the
basic ethical principles on our list of six, such as those concerning deception and treating
people as mere means.

4. The President's Commission functioned from 1978 to 1983, under the Carter
and Reagan administrations, and produced a number of influential reports and
recommendations concerning medical ethics and health care policy.

5. It may be argued that historical ethical relativism reduces to cultural ethical
relativism. On this position, the notion that even basic ethical principles vary by era is
part of a more general claim that what is really at stake is different "world views," and
these different world views may exist at the same time but in cultures that are different
from one another in certain crucial respects. On this analysis, in other words, the
temporal factor is not the essential one. However, some find it easier to reject historical
ethical relativism than cultural ethical relativism, for they find it plausible that essentially
the same values operative in, say, the United States in the 1990s were operative in the
1950s, but not that essentially the same values that are operative in the United States in
the 1990s are also operative in China in the 1990s.

6. In its report on the CIA and Army psychochemical experiments, the U.S.
Senate found that

[i]n the Army's tests, as with those of the CIA, individual

rights were . . . subordinated to national security

considerations; informed consent and follow-up

examinations of subjects were neglected in efforts to

maintain the secrecy of the tests.
U.S. Congress, The Select Committee to Study Governmental Operations with Respect
to Intelligence Activities, Foreign and Military Intelligence [Church Committee report],
report no. 94-755, 94th Cong., 2d Sess. (Washington, D.C.: GPO, 1976), book 1,4111.
However, even in the light of the Army's own analysis of its LSD experiments, presented
in a 1959 staff study by the U.S. Army Intelligence Corps (USAINTC), the operative
legal principles should not have permitted the resulting practices to take place:

222

It was always a tenet of Army intelligence that the basic
American principle of dignity and welfare of the
individual will not be violated ... In intelligence, the
stakes involved and the interests of national security
may permit a more tolerant interpretation of moral-
ethical values, but not legal limits, through necessity . . .
[emphasis added].
USAINTC Staff Study, Material Testing Program EA 1 729 ( 1 5 October, 1959), 26. The
staff study's distinction between the flexibility of "moral-ethical values" and "legal

limits" is puzzling.

7. U.S. Army Inspector General, Use of Volunteers in Chemical Agent Research

(Army IG report) (Washington D.C.: GPO, 1975).

8. David J. Rothman, Strangers at the Bedside: A History of How Law and
Bioethics Transformed Medical Decision Making (New York: Basic Books, 1991), 32-

9. Rothman writes of the CMR's deliberations on the gonorrhea proposal: It
[the CMR] conducted a remarkably thorough and sensitive discussion of the ethics of
research and adopted procedures that satisfied the principles of voluntary and informed
consent. Indeed, the gonorrhea protocols contradict blanket assertions that in the 1940s
and 1950s investigators were working in an ethical vacuum." Ibid., 42-43.

10. Michael Walzer, Just and Unjust Wars (New York: Basic Books, 1977).

11. Another factor often important in assessments of blame is duress. All
systems of ethics recognize that people cannot be blamed for actions that violate basic
ethical principles if they acted under duress. Duress includes manipulation, blackmail,
or threats of physical harm. There is no evidence that any particular individual involved
in the human radiation experiments functioned under conditions of duress.

12. Ruth Faden and Tom Beauchamp, A History and Theory of Informed
Consent (New York: Oxford University Press, 1986).

13. For example, the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research published ten reports. Many of these
recommendations were enacted into federal regulation. U.S. Congress, Office of
Technology Assessment, Biomedical Ethics in U.S. Public Policy-Background Paper,
OTA-BP-BBS-105 (Washington, D.C.: GPO, June 1993), 10.

14. Scholendorffv. Society of New York Hospital, 2 1 1 N.Y. 2d ( 1 9 1 4).

1 5. Salgo v. Leland Stanford, Jr., University Board of Trustees. 3 1 7 P.2d 1 70

(1957).

1 6. In each case we assume that the principles or policies in question were
morally sound; if not, anyone who refused to take part in unethical experiments
performed in accordance with them acted, in retrospect, in a praiseworthy manner.

1 7. Again, with regard to the elements of an ethical framework suited to the
intentional releases, we note that different justifications are used to evaluate the risks to
collectives or communities as against those used to evaluate risks to individuals.

18. Note, however, that the intended scope of the policy was not always clear.
Also, if the government or an agency had no policy at all concerning the use of human
subjects but did conduct such research, then the absence of a policy would itself be
objectionable.

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PART II

CASE STUDIES

Part II
Overview

W hen we began our work, the Advisory Committee was aware of
several dozen human radiation experiments and the thirteen intentional releases in
our charter. Soon, however, we found that these represented a fraction of the
several thousand government-sponsored human radiation experiments and
hundreds of intentional releases conducted from 1944 to 1974.

It was clear that the Committee would have to decide how to proceed in
examining the experiments. Our ability to review all of the experiments and
releases in detail was limited not only by time and resources, but even more so by
the information available. For the majority of experiments identified, only the
barest descriptions remained. It appeared that the vast majority of experiments
involved trace amounts of radioisotopes, as are routinely used today for the study
of bodily processes and the diagnosis of disease. However, where reports or other
data were available, they did not routinely provide information needed to assess
the precise risks to which subjects were exposed. These reports were even less
likely to identify what kinds of people were chosen as subjects and why and how
they were selected.

Since the Committee could not review all experiments, we decided to
prepare a series of case studies focused on groups of experiments. We quickly
found that there was no one right way to organize the experiments for purpose of
case study. For example, the case studies could have been defined by the type of
radiation to which subjects were exposed. This would likely have yielded
groupings of experiments with differing purposes, differing populations, and
differing risks and benefits. Likewise, grouping all experiments according to the
characteristics of the people who were the subjects of the research would have
lumped together experiments with differing purposes, risks, and scientific
procedures.

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Part II

The ACHRE Experiments Database

By Cabinet directive on January 19, 1994, federal agencies were ordered to "establish
forthwith an initial procedure for locating records of human radiation experiments conducted by
the Agency or under a contract or grant of the Agency." The agencies most closely associated
with these activities-the DOD, DOE, DHHS, NASA, CIA, and VA (and later the NRC)--in
cooperation with Advisory Committee staff, identified record collections of importance and
provided ACHRE with copies of documents potentially containing information on human radiation
experiments. The documents were analyzed to identify individual experiments, which were then
described according to a protocol developed by ACHRE members and staff, given unique
identifiers, and recorded in an electronic database. Experiments were also identified by Advisory
Committee staff in the published literature, discovered through a search of the National Library of
Medicine databases and bibliographies, and documented by individuals who came forward with
information for the Advisory Committee.

The database contains records for approximately 4,000 human radiation experiments.
Information was collected, to the extent it was available, on the identity of the experiment
(including investigators, location, dates, title, and documentation); funding, program approval and
classification; the type and dose of radiation used; various characteristics of the experimental
subjects; and the nature of the consent obtained. The experiments were in addition categorized by
various themes and characteristics developed by Advisory Committee members and staff to reflect
ACHRE research interests.

Documentation for individual experiments varies widely, sometimes including significant
primary protocol documentation, often including only a journal article or abstract and, for the
greatest number, just an investigator's name, a location, a date, and a title. As a result, although
the database and the records it abstracts constitute an impressive and unique collection of
information on human radiation experiments, that collection is not a comprehensive information
resource on human radiation experiments but really just the best place to start to look for
information.

The supplemental volume titled Sources and Documentation contains a more extensive
and detailed description of the database and its sources.

After extensive deliberation, the Committee settled on eight case studies,
which together address the charges to and priorities of the Committee. For
example, we were charged to consider both intentional releases of radiation into
the environment and the question of whether any former subjects of human
radiation experiments would benefit medically from notification of their
involvement. In addition, the Committee saw a responsibility to address those
experiments that had received significant public attention at the time of the
Committee's creation as well as those brought to our attention by members of the
public. These experiments either offered no prospect of medical benefit to
subjects or they involved interventions alleged to be controversial at the time. We

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Overview

also, however, recognized the importance of considering the far larger group of
experiments that received no such attention but that also may have involved no
prospect of benefit to subjects. We also placed a priority on experiments that
were conducted on behalf of secret programs and for national security reasons;
experiments that posed the greatest risk of harm; and experiments in which the
subjects selected for experimentation were particularly powerless to resist or
exercise independent judgment about participation. Together, these
considerations formed the basis for the selection of the case studies.

In chapter 5, we look at the Manhattan Project plutonium-injection
experiments and related experimentation. Sick patients were used in sometimes
secret experimentation to develop data needed to protect the health and safety of
nuclear weapons workers. The experiments raise questions of the use of sick
patients for purposes that are not of benefit to them, the role of national security
in permitting conduct that might not otherwise be justified, and the use of secrecy
for the purpose of protecting the government from embarrassment and potential

liability.

In contrast to the plutonium injections, the vast majority of human
radiation experiments were not conducted in secret. Indeed, the use of
radioisotopes in biomedical research was publicly and actively promoted by the
Atomic Energy Commission. Among the several thousand experiments about
which little information is currently available, most fall into this category. The
Committee adopted a two-pronged strategy to study this phenomenon. In chapter
6, we describe the system the AEC developed for the distribution of isotopes to be
used in human research. This system was the primary provider of the source
material for human experimentation in the postwar period. In studying the
operation of the radioisotope distribution system, and the related "human use"
committees at local institutions, we sought to learn the ground rules that governed
the conduct of the majority of human radiation experiments, most of which have
received little or no public attention. Also in this chapter we review how research
with radioisotopes has contributed to advances in medicine.

The Committee then selected for particular consideration, in chapter 7,
radioisotope research that used children as subjects. We determined to focus on
children for several reasons. First, at low levels of radiation exposure, children
are at greater risk of harm than adults. Second, children were the most
appropriate group in which to pursue the Committee's mandate with respect to
notification of former subjects for medical reasons. They are the group most
likely to have been harmed by their participation in research, and they are more
likely than other former subjects still to be alive. Third, when the Committee
considered how best to study subject populations that were most likely to be
exploited because of their relative dependency or powerlessness, children were
the only subjects who could readily be identified in the meager documentation
available. By contrast, characteristics such as gender, ethnicity, and social class
were rarely noted in research reports of the day.

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Part II

Moving from case studies focused on the injection or ingestion of
radioisotopes, chapter 8 shifts to experimentation in which sick patients were
subjected to externally administered total-body irradiation (TBI). The Committee
discovered that the highly publicized TBI experiments conducted at the
University of Cincinnati were only the last of a series in which the government
sought to use data from patients undergoing TBI treatment to gain information for
nuclear weapons development and use. This experimentation spanned the period
from World War II to the early 1970s, during which the ethics of experimentation
became increasingly subject to public debate and government regulation. In
contrast with the experiments that flowed from the AEC's radioisotope program,
the use of external radiation such as TBI did not in its earlier years involve a
government requirement of prior review for risk. The TBI experimentation raises
basic questions about the responsibility of the government when it seeks to gather
research data in conjunction with medical interventions of debatable benefit to
sick patients.

In chapter 9 we examine experimentation on healthy subjects, specifically
prisoners, for the purpose of learning the effects of external irradiation on the
testes, such as might be experienced by astronauts in space. The prisoner
experiments were studied because they received significant public attention and
because a literally captive population was chosen to bear risks to which no other
group of experimental subjects had been exposed or has been exposed since. This
research took place during a period in which the once-commonly accepted
practice of nontherapeutic experimentation on prisoners was increasingly subject
to public criticism and moral outrage.

Chapter 10 also explores research involving healthy subjects: human
experimentation conducted in conjunction with atomic bomb tests. More than
200,000 service personnel—now known as atomic veterans— participated at atomic
bomb test sites, mostly for training and test-management purposes. A small
number also were used as subjects of experimentation. The Committee heard
from many atomic veterans and their family members who were concerned about
both the long-term health effects of these exposures and the government's
conduct. This case study provided the opportunity to examine the meaning of
human experimentation in an occupational setting where risk is the norm.

In chapter 1 1 we address the thirteen intentional releases of radiation into
the environment specified in the Committee's charter, as well as additional
releases identified during the life of the Committee. In contrast with biomedical
experimentation, individuals and communities were not typically the subject of
study in these intentional releases. Rather, the releases were to test intelligence
equipment, the potential of radiological warfare, and the mechanism of the atomic
bomb. While the risk posed by intentional releases was relatively small, the
releases often took place in secret and remained secret for years.

The final case study, in chapter 1 2, looks at two groups that were put at
risk by nuclear weapons development and testing programs and as a consequence

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Overview

became the subjects of observational research: workers who mined uranium for
the Atomic Energy Commission in the western United States from the 1 940s to
1960s and residents of the Marshall Islands, whose Pacific homeland was
irradiated as a consequence of a hydrogen bomb test in 1954. While these
observational studies do not fit the classic definition of an experiment, in which
the investigator controls the variable under study (in this case radiation exposure),
they are instances of research involving human subjects. The Committee elected
to examine the experiences of the uranium miners and Marshallese because they
raise important issues in the ethics of human research not illustrated in the
previous case studies and because numerous public witnesses impressed on the
Committee the significance of the lessons to be learned from their histories.

Part II concludes with an exploration of an important theme common to
many of the case studies-openness and secrecy in the government's conduct
concerning human radiation research and intentional releases. In chapter 13 we
step back and look at what rules governed what the public was told about the
topics under the Committee's purview, whether these rules were publicly known,
and whether they were followed.

231

Experiments with Plutonium,
Uranium, and Polonium

In August 1944, at the secret Los Alamos Laboratory in New Mexico, a
twenty-three-year-old chemist was trying to learn what he could about the
properties of a radioactive metal. One year later, the new "product"-one of
several code words for this three-year-old element with a classified name-would
power the bomb dropped on Nagasaki. That day the young scientist, Don
Mastick, was working with the entire Los Alamos supply of the material, 10
milligrams. It was sealed in a glass vial several inches long and about a quarter
inch in diameter. Unknown to Mastick, a chemical reaction was causing pressure
to build up inside the vial. Suddenly it burst, firing an acidic solution against the
wall from where it splattered into Mastick's face, some of it entering his mouth.'

Realizing the importance to the war effort of the plutonium he had just
ingested, Mastick hurried directly to the office of Louis Hempelmann, the health
director at Los Alamos. Hempelmann pumped Mastick's stomach and instructed
the young scientist to retrieve the plutonium from the expelled contents.
Hempelmann expressed a concern related to worker safety: there was no way
available to determine how much plutonium remained in Mastick's body. He
immediately pressed the lab's director, J. Robert Oppenheimer, for authorization
to conduct studies to develop ways of detecting plutonium in the lungs, and in
urine and feces, and of estimating the level of plutonium in the body from the
amount found in excreta.2

Looming over Mastick's accident was the well-known tragedy of the
radium dial workers more than a decade earlier. Like Mastick, they had ingested
radioactive material through their mouths, as they licked the brushes they used to

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apply radium paint to watch dials. As time passed, many suffered from a
gruesome bone disease localized in the jaw, and some bone cancers developed.
Could plutonium cause a similar tragedy? If so, how much plutonium needed to
be ingested before harmful effects might arise? How could one tell how much
plutonium a person had already ingested? The answers to these questions were
crucial, not only in the case of accidents such as Mastick's, but also, in the long
run, to establish occupational health standards for the hundreds of workers who
would soon be mass-producing plutonium for atomic bombs. Several pounds of
radium, handled without recognition of the dangers, had led to dozens of deaths;
what might plutonium cause?

A starting point was to examine the available data on radium poisoning,
compare the characteristics of the radiation emitted by radium and plutonium, and
try to extrapolate from radium to plutonium. However, plutonium had already
revealed unexpected physical properties, which were posing problems for the
bomb designers. Could plutonium also have unexpected biochemical properties?
Extrapolation from radium was a good starting point, but could never be as
reliable as data on plutonium itself.

Oppenheimer agreed that this research was critical. In an August 16,
1944, memorandum to Hempelmann, Oppenheimer authorized separate programs
to develop methods to detect plutonium in the excreta and in the lung. With
respect to biological studies, which Oppenheimer speculated might involve
human experimentation, he wrote: "I feel that it is desirable if these can in any
way be handled elsewhere not to undertake them here."3 The reason
Oppenheimer did not want these experiments conducted at Los Alamos remains
obscure. Nine days later, Hempelmann met with Colonel Stafford L. Warren,
medical director of the Manhattan Project, and others. They agreed to conduct a
research program using both animal and human subjects.4

Mastick, who reported no ill effects from the accident when Advisory
Committee staff interviewed him in 1995,5 was not the first alert to the potential
hazards of plutonium. Human experiments to study the metabolism and retention
of plutonium in the body had been contemplated from the earliest days of the
Manhattan Project. On January 5, 1944, Glenn Seaborg, who in 1941 was the
first to recognize that plutonium had been created in the cyclotron at the
University of California at Berkeley, wrote to Dr. Robert Stone, health director of
the Metallurgical Laboratory in Chicago (a Manhattan Project contractor) and a
central figure in efforts to understand the health effects of plutonium:

It has occurred to me that the physiological hazards
of working with plutonium and its compounds may
be very great. Due to its alpha radiation and long
life it may be that the permanent location in the
body of even very small amounts, say one
milligram or less, may be very harmful. The

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ingestion of such extraordinarily small amounts as
some few tens of micrograms might be unpleasant,
if it locates itself in a permanent position.6

Seaborg urged that a safety program be set up. In addition, "I would like
to suggest that a program to trace the course of plutonium in the body be initiated
as soon as possible. In my opinion such a program should have the very highest
priority."7 Stone reassured Seaborg that human tracer studies "have long since
been planned. . . . although never mentioned in official descriptions of the
program."8 The work began at Berkeley with studies on rats conducted by Dr.
Joseph Hamilton.9

Even as these studies on the biological effects of plutonium were
beginning, the amount of plutonium being produced was dramatically increasing.
Most of the effort at Oak Ridge was devoted to the separation of isotopes of
uranium. However, the X- 10 plant at Oak Ridge was a larger version of the very
small plutonium-producing reactor developed at the University of Chicago. The
X-10 plant began operating on November 4, 1943, and by the summer of 1944
was sending small amounts of plutonium to Los Alamos.10 By December 1944
large-scale production of plutonium began at the Hanford, Washington, reactor
complex. ' '

By late 1944, in the wake of the Mastick accident, the need to devise a
means of estimating the amount of plutonium in the body became acute. It
seemed that the only way to estimate how much plutonium remained in a worker's
body would be to measure over time the amount excreted after a known dose and,
from this, estimate the relationship between the amount excreted and the amount
retained in the body.12

Maximum Permissible Body Burden (MPBB) for Plutonium

The plutonium injections were part of a larger research project intended to provide data
for an occupational safety program riddled with uncertainty. Not only was there a need for ways to
monitor the exposure of personnel-the driving force behind the plutonium injections-but the
maximum permissible body burden (MPBB) for plutonium, the maximum amount of plutonium
that would be permitted in the bodies of workers, was still under debate.

The concept of "maximum permissible body burden" had begun to develop before the
war in light of the known hazards of radium. Just prior to the war, primarily at the request of the
Navy, a committee of experts was formed to establish occupational health standards for the
factories producing dials illuminated by radium paint. After examining the data on radium dial
painters, this committee agreed that 0. 1 microgram fixed in the body should be the "tolerance
level" for radium: an amount that, in the words of the committee chairman, Robley Evans, would

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be "at such a level that we would feel comfortable if our own wife or daughter were the subject."8
After the war the term maximum permissible body burden was adopted and defined more precisely
as the amount of a radioisotope that, when continuously present inside the body, would produce a
dose equivalent to the allowable occupational exposure (the maximum permissible dose). For
radioisotopes that, like radium, primarily reside in bone, biological data and mathematical models
were used to determine how much of another bone seeker would produce the same dose as the
original 0. 1 -microgram radium standard.

Between 1943 and the spring of 1945, based on the body burden for radium and
preliminary results of animal experiments, a tentative MPBB for plutonium of 5 micrograms was
adopted by the Manhattan District.b This level was derived by direct comparison of the relative
energies of plutonium and radium.

By the spring of 1945, differences between the deposition of radium and plutonium in the
body were becoming clearer. Animal data indicated that plutonium deposited in what was called at
the time the "organic matrix" of the bone-the part of the bone most associated with bone growth.
This was different from radium, which seemed to deposit instead in the mineralized bone. Wright
Langham wrote to Hymer Friedell supporting the choice of 1 microgram as an operating limit in
lieu of a more formal policy. Langham wrote that with the adoption of this lower limit "the
medico-legal aspect will have been taken care of and of still greater importance, we will have
taken a relatively small chance of poisoning someone in case the material proves to be more toxic
than one would normally expect."" This level was adopted and held until the Tripartite Permissible
Dose Conference at Chalk River, Canada, in September 1 949.

At this conference, representatives from the United States, United Kingdom, and Canada
agreed on tolerance doses for many radioactive isotopes, including a maximum body burden of 0. 1
microgram for plutonium. This reduced by a factor of 10 the value under which Los Alamos
production had been operating. This reduction was based on the results of acute toxicological
experiments with animals, which indicated that plutonium was as much as fifteen times more toxic
than radium.

On January 20, 1950, Wright Langham wrote to Shields Warren, then the director of the
AEC's Division of Biology and Medicine, alerting him to the problems caused by the Chalk River
Conference's new "extremely conservative tolerances [which] may have a drastic effect on the
efficiency and productivity of the Los Alamos Laboratory. Their official adoption will
undoubtedly force major alteration in both present and future laboratory facilities and may add
millions of dollars to the cost of construction of the permanent building program now in the

a. Robley Evans, "Inception of Standards for Internal Emitters, Radon and Radium," Health
Physics 41 (September 1981): 437-448.

b. W. H. Langham et al., "The Los Alamos Scientific Laboratory's Experience with Plutonium in
Man," Health Physics 8 (1962): 753.

C. Wright Langham, Los Alamos Scientific Laboratory Health Division, to Hymer Friedell, 21
May 1945 ("Since the Chicago Meeting, 1 am somewhat lost as to what our program should be in the
future . . .") (ACHRE No. DOE-1 13094-B-7), 1.

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planning phases.'"1 Langham continued with reasons for regarding the Chalk River value of 0.1
micrograms of plutonium as "unnecessarily low." He cited, among other things, differences
between acute and chronic toxicity and new analysis of data from the radium watch dial painters.

On January 24, 1950, Shields Warren, Austin Brues of Argonne National Laboratory,
Robley Evans, Karl Morgan, and Wright Langham met in Washington. Langham wrote later: "As
a result of this meeting, Dr. Shields Warren of the Division of Biology and Medicine authorized
0.5 ug (0.033 uc) of Pu2" as the AEC's official operating maximum permissible body burden."0
There were no minutes or transcripts taken of this meeting. The calculation of this level was again
based on the body burden for radium, this time modified by the 1/15 toxicity factor (since
experiments had indicated that plutonium was up to fifteen times more toxic than radium), by the
relative retention of plutonium and radium in rodents, and by the energy ratios modified by radon
retention.

Thus far, the entire debate had occurred behind the closed doors of the AEC.
Consideration of all the complex issues applied in setting a permissible body burden had been
within a small circle of scientists and administrators. While the MPBB for plutonium accepted at
the January 1950 meeting has held until today, its derivation has changed over the years.

By March 1945, there was disturbing news that urine samples from Los
Alamos workers were indicating, based on models developed from animal
experimentation, that some might be approaching or had exceeded a body burden
of 1 microgram.13 A March 25 meeting led to Hempelmann's recommendation
that the Project "help make arrangements for a human tracer experiment to
determine the percentage of plutonium excreted daily in the urine and feces. It is
suggested that a hospital patient at either Rochester or Chicago be chosen for
injection of from one to ten micrograms of material and that the excreta be sent to
the laboratory for analysis."14 The overall program, as it was envisioned by Dr.
Hymer Friedell, deputy medical director of the Manhattan Engineer District,
Oppenheimer, and Hempelmann, consisted of three parts: improvement of
methods to protect personnel from exposure to plutonium; development of
methods for diagnosing overexposure of personnel; and study of methods of
treatment for overexposed personnel. On March 29, Oppenheimer forwarded the
recommendation to Stafford Warren, with his "personal endorsement."15

d. The letter went on to say that "operations of the Los Alamos Laboratory would be curtailed or
stopped if such action were necessary to the reasonable and sensible protection of the personnel. The
seriousness of this action, however, seems to be adequate reason for requesting that official adoption of the
tolerances by the AEC be postponed until they have been carefully reviewed in order to make certain that the
values are not unnecessarily conservative." Wright Langham, Los Alamos Laboratory Health Division, to
Shields Warren, Director of AEC Division of Biology and Medicine, 20 January 1950 ("Radiation
Tolerances Proposed by the Chalk River Permissible Dose Conference of September 29-30, 1949") (ACHRE
No. DOE-020795-D-6), 1.

e. W. H. Langham et al„ "The Los Alamos Scientific Laboratory's Experience with Plutonium in
Man," Health Physics 8 (1962): 754.

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Part II

The accident at Los Alamos was part of the prelude to experiments
conducted between 1945 and 1947 in which eighteen hospital patients were
injected with plutonium to determine how excreta (urine and feces) could be used
to estimate the amount of plutonium that remained in an exposed worker's body.
One patient was injected at Oak Ridge Hospital in Oak Ridge, Tennessee; eleven
were injected at the University of Rochester, three at the University of Chicago,
and three at the University of California.

The results of these experiments contributed to the development of a
monitoring method that, with small changes, is still used today. The experimental
data were used to develop a model relating body burden to short-term excretion
rate. Known as the "Langham model," it was based on short-term excretion data,
long-term excretion data that were collected in 1950 from two injection subjects,
and worker excretion data. This model has been used almost universally to
monitor plutonium workers since 1950, although it has been modified over the
years as longer-term and more extensive data were accumulated. While now, fifty
years later, not every question concerning the quality of the science or the basis
for estimating risk can be answered with precision, there is general agreement
among radiation scientists that the experiments were useful.

Although this would be the first time that plutonium would be injected
into human beings, the plutonium experiments were not viewed at the time as
being extremely risky, and for good reason. Based on experience with other
bone-seeking radioisotopes such as radium, the investigators had firm basis for
believing, even in the 1940s, that the amount of material to be injected was likely
too small to produce any immediate side effects or reactions. No one was
expected to feel ill or have any negative reaction to the injection, and apparently
no one did. Because acute effects were not expected, the plutonium injections
were viewed as posing no short-term risks to human subjects. There was concern,
however, about long-term risk. A draft report, written by one of the primary
investigators within a few years of the injections, records that "acute toxic effects
from the small dose of pu [plutonium] administered were neither expected nor
observed." The document also recognized that "with regard to ultimate effects, it
is too early to predict what may occur."16 Based largely on the experience of the
radium dial painters, it was recognized that exposure to plutonium could result,
perhaps ten or twenty years later, in the development of cancer in a human
subject. This was viewed as a significant risk but also as a risk that could be
minimized by the use of small doses and wholly avoided if the subjects were
expected to die well before a cancer had a chance to materialize.

Even if the plutonium injections had been entirely risk free, an
impossibility in human experimentation, they could still be morally problematic.
As we discussed in chapter 2, it was not uncommon in the 1940s for physicians
to use patients as subjects in experiments without their knowledge or consent.
This occurred frequently in research involving potential new therapies, where
there was at least a chance that the patient-subjects might benefit medically from

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being in an experiment. But it also occurred even in experiments-like the
plutonium injections- where there was never any expectation and no chance that
the experiment might be of benefit to the subjects.

The conduct of the plutonium experiments raises a number of difficult
ethics and policy questions: Who should have been the subjects of an experiment
designed to protect workers vital to bomb production in wartime? What should
the subjects have been told about the risks of the secret substance with which they
were being injected? What should they have been told about the purpose of the
experiment? What were the subjects told? Did they know they were part of an
experiment in which there was no expectation that they would benefit medically?

An inquiry initiated by the AEC commissioners in 1974 investigated some
of these questions. That inquiry focused on whether consent was obtained from
the subjects, either at the time of the plutonium injections or during 1973 follow-
up studies funded by the AEC's Argonne National Laboratory in Chicago,
designed to determine the long-term effects of the injections. Sixteen patient
charts were examined for evidence of consent at the time of injection; the other
two charts had been either lost or destroyed. Of the sixteen charts examined, only
one chart-that of the only subject injected after the April 1947 directive of AEC
General Manager Carroll Wilson (discussed in chapter 1) that required
documented consent-contained evidence of some form of consent. The other
fifteen contained no record of consent.17 According to AEC investigators, oral
testimony pointed to failure to obtain consent in the case of the Oak Ridge
injection and to some form of disclosure to patients for the California and
Chicago experiments. The AEC concluded that testimony was inconclusive for
the Rochester experiments.11* With regard to the follow-up studies conducted with
three surviving subjects in 1973, the investigation concluded that two subjects had
deliberately not been informed of the purpose of the follow-up and that one
subject had actually been misled about the purpose.19

As we will see later in this chapter, the AEC's conclusion that consent was
not obtained from the surviving subjects for the 1973 follow-up studies was
correct. Moreover, additional documentary evidence and testimony suggests that
patient-subjects at the Universities of Rochester and California were never told
that the injections were part of a medical experiment for which there was no
expectation that they would benefit, and they never consented to this use of their
bodies.

The rest of this chapter provides a chronological account of the plutonium
injection experiments and follow-up studies conducted over the course of many
years, assesses the influence of secrecy on the conduct of the experiments, and
examines the motivating factors behind the prolonged secrecy of the experiments
and the continued deception of surviving subjects. We also consider the conduct
of experimentation with uranium and polonium. Finally, we render judgments
where we can about the ethical conduct of these experiments.

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Part II

THE MANHATTAN DISTRICT EXPERIMENTS

The First Injection

A few days after Hempelmann's March 26, 1945, recommendation that a
hospital patient be injected with plutonium, Wright Langham, of the Los Alamos
Laboratory's Health Division, sent 5 micrograms of plutonium to Dr. Friedell,
with instructions for their use on a human subject.20 The subject, as it turned out,
was already in the Oak Ridge Army hospital, a victim of an auto accident that had
occurred on March 24, 1945. 2I He was a fifty-three-year-old "colored male"22
named Ebb Cade,23 who was employed by an Oak Ridge construction company as
a cement mixer. The subject had serious fractures in his arm and leg, but was
otherwise "well developed [and] well nourished."24 The patient was able to tell
his doctors that he had always been in good health.25

Mr. Cade had been hospitalized since his accident, but the plutonium
injection did not take place until April 10. On this date, "HP- 12" (the code name
HP— "human product"26--was later assigned to this patient and to patients at the
University of Rochester) was reportedly injected with 4.7 micrograms of
plutonium. (It is important here to distinguish between administered dose and
retained dose; not all of the injected dose would remain fixed in the body. It was
not known with certainty, however, how much of the 4.7 micrograms of
plutonium would remain in his body.)

The small amount of material injected into Mr. Cade would not be
expected to produce any acute effects, and there is no indication that any were
experienced. However, except for his fractures, Mr. Cade was apparently in good
health and at age fifty-three could reasonably have been expected to live for
another ten to twenty years. Thus, in Mr. Cade's case, the risk of a plutonium-
induced cancer could not be ruled out.

Dr. Joseph Howland, an Army doctor stationed at Oak Ridge, told AEC
investigators in 1974 that he had administered the injection. There was, he
recalled, no consent from the patient. He acted, he testified, only after his
objections were met with a written order to proceed from his superior, Dr.
Friedell.27 Dr. Friedell told Advisory Committee staff in an interview that he did
not order the injection and that it was administered by a physician named Dwight
Clark, not Dr. Howland.28 The Committee has not been able to resolve this
contradiction.

Measurements were to be taken from samples of Mr. Cade's blood after
four hours, his bone tissue after ninety-six hours, and his bodily excretions for
forty to sixty days thereafter.29 His broken bones were not set until April 1 5— five
days after the injection~when bone samples were taken in a biopsy.30 Although
this was several weeks after his injury, during this era when antibiotics were only
beginning to become available, it was common practice to delay surgery if there
was any sign of possible infection. One document records that Mr. Cade had

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"marked" tooth decay and gum inflammation/1 and fifteen of his teeth were
extracted and sampled for plutonium. The Committee has not been able to
determine whether the teeth were extracted primarily for medical reasons or for
the purpose of sampling for plutonium. In a September 1945 letter, Captain
David Goldring at Oak Ridge informed Langham that "more bone specimens and
extracted teeth will be shipped to you very soon for analysis."32 It remains
unclear whether these additional bone specimens were extracted at the time of the
April 15 operation or later.

According to one account, Mr. Cade departed suddenly from the hospital
on his own initiative; one morning the nurse opened his door, and he was gone."
Later it was learned that he moved out of state and died of heart failure on April
13, 1953, in Greensboro, North Carolina.34

The experiment at Oak Ridge did not proceed as planned. "Before" and
"after" urine samples were mistakenly commingled, so no baseline data on kidney
function was available.35 Thus, the subject's kidney function would be difficult to
assess. In May 1945,36 Dr. Stone convened a "Conference on Plutonium" in
Chicago to discuss health issues related to plutonium, including the relationship
between dose and excretion rate, the permissible body burden, and potential
therapy and protective measures.37 Wright Langham spoke about the Oak Ridge
injection at the conference, carefully qualifying the reliability of the excretion
data obtained from Mr. Cade. Langham observed that "the patient might not have
been an ideal subject in that his kidney function may not have been completely
normal at the time of injection"38 as indicated by protein tests of his urine.

The Chicago Experiments

On April 1 1, the day after the Oak Ridge injection, Hymer Friedell
transmitted the protocol describing the experiment on Mr. Cade to Louis
Hempelmann at Los Alamos. "Everything went very smoothly," he wrote, "and I
think that we will have some very valuable information for you."39 He then went
on to discuss the injection of more patients: "I think that we will have access to
considerable clinical material here, and we hope to do a number of subjects. At
such time as we line up several patients I think we will make an effort to have Mr.
Langham here to review our setup."40

Subsequently, between late April and late December of 1945, three cancer
patients, code-named CHI-1, 2, and 3, were injected with plutonium. At least two
and possibly all three were injected at the Billings Hospital of the University of
Chicago. The doses to subjects CHI-2 and CHI-3 were the highest doses
administered to any of the eighteen injection subjects-approximately 95
micrograms.41 However, the amount of material injected was still below what
would be expected to produce acute effects. Moreover, unlike Mr. Cade, all three
of these patients were seriously ill and at least two of them died within ten months
of receiving the injection. That the selection of seriously ill patients was an

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intentional strategy to contain risk is indicated in a 1946 report on CHI-1 and
CHI-2: "Some human studies were needed to see how to apply the animal data to
the human problems. Hence, two people were selected whose life expectancy
was such that they could not be endangered by injections of plutonium."42 It
remains a mystery why CHI-3 was not included in this report.

On April 26, 1945, CHI-1, a sixty-eight-year-old man who had been
admitted to Billings Hospital in March, was injected with 6.5 micrograms of
plutonium. At the time of injection he was suffering from cancer of the mouth
and lung. The patient reportedly "remained in fair condition until August 1945,
when he complained of pain in the chest."4'1 His lung cancer had apparently
spread, and he died on October 3, 1945.44

The next injection took place eight months later. CHI-2 was a fifty-five-
year-old woman with breast cancer who had been admitted to Billings Hospital in
December 1945 after the cancer had already spread throughout her body. The
1 946 report recorded that "the patient's general condition was poor at the time of
admission and deteriorated steadily throughout the period of hospitalization."45
She was injected with 95 micrograms of plutonium on December 27 and died on
January 13, 1946.46

There is little known about the condition of CHI-3, the other subject who
was injected with approximately 95 micrograms. He was a young man suffering
from Hodgkin's disease, reportedly injected on the same date as CHI-2.47 His
condition at the time of injection remains unknown, as does his date of death.
There is some question whether he was injected at Billings hospital or at another
hospital in the Chicago area.4*

There was no discussion of consent in the original reports on the Chicago
experiments. However, a draft report on an interview conducted with E. R.
Russell for the 1974 AEC investigation into the experiments (Russell was
coauthor of the 1946 report on the Chicago experiments) summarized Russell's
description of consent as follows: "[H]e prepared the plutonium solutions for
injection and acted together with a nurse as witness to the fact that the patient was
or had been informed that a radioactive substance was going to be injected. The
administration of this substance, according to what was said in obtaining consent,
was not necessarily for the benefit of the patients but might help other people."49
To say that the injection was "not necessarily" for the benefit of the patient
implies that there was some chance these patients might benefit; in fact, there was
no expectation that this would occur.

Russell's account was obtained in the context of an official inquiry into his
conduct and the conduct of the other investigators and officials involved in the
plutonium injections, an inquiry that focused on whether consent was obtained
from the subjects. We have no way of corroborating this account or of assessing
what Dr. Russell's motivations were in explaining the plutonium injections to the
subjects in the way claimed.

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The Rochester Experiments

By the time the war began, the University of Rochester, which had a
cyclotron, had assembled a group of first-rate physicists and medical researchers
who were pioneering the new radiation research. Following the selection of the
university's Stafford Warren to head its medical division, the Manhattan Project
turned to Rochester for an increasing share of its biomedical research-including,
in particular, research needed to set standards for worker safety.50

The university's metabolism ward, at what is now the Strong Memorial
Hospital, became the central Manhattan District site for the administration of
isotopes to human subjects. The two-bed ward, headed by Dr. Samuel Bassett,
was part of the Manhattan District's "Special Problems Division," which worked
on the health monitoring of production plants, the development of monitoring
instruments, and research on the metabolism and toxicology of long-lived
radioactive elements.51 An experimental plan called for fifty subjects altogether,
in five groups often subjects each. Each group would receive plutonium, radium,
polonium, uranium, or lead.52 Although the exact number of subjects remains
unknown, at least twenty-two patients were administered long-lived isotopes in
experiments with plutonium (eleven subjects), polonium (five subjects), and
uranium (six subjects).

At the time the experiment was being designed, the main selection
criterion for the subjects chosen at Rochester for the plutonium experiment was
that they have a metabolism similar to healthy Manhattan Engineer District
workers. In a work plan for the plutonium study based on a September 1 945
meeting with a representative of Colonel Warren's office and the Rochester
doctors, Langham wrote:

The selection of subjects is entirely up to the
Rochester group. At the meeting it seemed to be
more or less agreed that the subjects might be
chronic arthritics [patients with serious collagen
vascular diseases, such as scleroderma] or
carcinoma patients without primary involvement of
bone, liver, blood or kidneys.

It is of primary importance that the subjects have
relatively normal kidney and liver function, as it is
desirable to obtain a metabolic picture comparable
to that of an active worker.

Undoubtedly the selection of subjects will be
greatly influenced by what is available. The above
points, however, should be kept in mind.53

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Although this protocol specifies cancer patients as potential subjects,
evidently the deliberate choice was made later by the experimenters to select
patients without malignant diseases in the hope of ensuring normal metabolism.54
Thus no cancer patients were included among the plutonium subjects at
Rochester. Preference appears to have been given to patients the doctors believed
would benefit from additional time in the hospital.55

An additional perspective on the selection of subjects for the plutonium
experiments is provided in three retrospective reports written by Wright
Langham. In a 1950 report on the plutonium project, including the experiments
conducted at Rochester, Langham wrote that "as a rule, the subjects chosen were
past forty- five years of age and suffering from chronic disorders such that
survival for ten years was highly improbable."56 In subsequent reports, Langham
refers to the plutonium subjects as having been "hopelessly sick"57 and
"terminal."58

Documents retrieved for the Advisory Committee show that all but one of
the plutonium subjects at Rochester suffered from chronic disorders such as
severe hemorrhaging secondary to duodenal ulcers, heart disease, Addison's
disease, cirrhosis, and scleroderma.59 One subject, Eda Schultz Charlton, did not
have any such condition. According to the draft of the 1950 report, she was
misdiagnosed: "a woman aged 49 years may have a greater life expectancy than
originally anticipated due to an error in the provisional diagnosis."60

Most of the subjects at Rochester were not terminally ill, and at least some
of them had the potential to live more than ten years. Three of the Rochester
subjects were known to still be living at the time of the 1974 AEC investigation
into the plutonium experiments. Whether the inclusion of subjects at Rochester
with the potential to live more than ten years is an indication that the investigators
were not using Langham's criterion to select subjects or that they erred in their
predictions is unclear. Judgments about the life expectancy of the chronically ill
are difficult to make and often in error, even today.

The likelihood that long-term risks can be altogether eliminated does
exist, however, if the subject is in the terminal stages of an illness and death is
imminent. This was recognized by the plutonium investigators, and it led to the
observation that the use of a terminal patient permitted a larger dose, which would
make analysis easier. The first terminal patient at Rochester was injected toward
the end of that series, and the possibility of further injections into terminal
patients was discussed explicitly. In a March 1946 letter, Wright Langham wrote
to Dr. Bassett, the primary physician-investigator at Rochester:

In case you should decide to do another terminal
case, I suggest you do 50 micrograms instead of 5.
This would permit the analysis of much smaller
samples and would make my work considerably
easier. ... I feel reasonably certain there would be

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no harm in using larger amounts of material if you
are sure the case is a terminal one [as was done in
two of the three Chicago injections].61

As was the case at Oak Ridge and Chicago, there was no expectation that
the patient-subjects at Rochester would benefit medically from the plutonium
injections. The Advisory Committee found no documents that bear directly on
what, if anything, the subjects were told about the injections and whether they
consented. The recollections of at least some of those intimately involved have
survived, however, and these recollections all suggest that the patients did not
know they had been injected with radioactive material or even that they were
subjects of an experiment.

Milton Stadt, the son of a Rochester subject, told the Advisory Committee
the following at a meeting in Santa Fe, New Mexico, on January 30, 1995:

My mother, Jan Stadt, had a number, HP-8. She
was injected with plutonium on March 9th, 1946.
She was forty-one years old, and I was eleven years
old at the time. My mother and father were never
told or asked for any kind of consent to have this
done to them.

My mother went in [to the hospital] for scleroderma
. . . and a duodenal ulcer, and somehow she got
pushed over into this lab where these monsters
were.

Dr. Hempelmann, in an interview for the 1974 AEC investigation, said he
believed that the patients injected with plutonium were deliberately not informed
about the contents of the injections.62 Dr. Patricia Durbin, a University of
California researcher who in 1968 undertook a scientific reanalysis of the
experiments, reported on a visit with Dr. Christine Waterhouse in 1971 . Dr.
Waterhouse was a medical resident at Rochester at the time of the plutonium
injections. Durbin wrote the following regarding the Rochester subjects who
were still alive:

She [Dr. Waterhouse] believes that all three persons
would be agreeable to providing excretion samples
and perhaps blood samples, but they are all quite
old~in their middle or late 70's and cannot travel
far. More important, they do not know that they
received any radioactive material.63

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In notes on a 1971 telephone conversation with Wright Langham, Dr.
Durbin wrote: "He is, I believe, distressed by . . . the fact that the injected people
in the HP series were unaware that they were the subjects of an experiment."64
This recollection is even more troubling than the recollections of Drs. Waterhouse
and Hempelmann, as it indicates not only that the subjects did not know that they
were being injected with plutonium or a radioactive substance, but also that they
did not know even that they were subjects of an experiment.

Even the doctors in charge of some of the injections at Rochester may not
have known what they were injecting into patients. In 1974, Dr. Hempelmann
suggested that the physician who actually injected the solution quite possibly did
not know of its contents.65

Further evidence suggesting that the patient-subjects were never told what
was done to them comes from 1 950 correspondence between Langham and the
physicians at Rochester. These physician-investigators were looking for signs of
long-term skeletal effects in follow-up studies with two of the subjects at
Rochester. Langham wrote to Rochester that he was "very glad to hear that you
will manage to get follow-ups on the two subjects. The x-rays seem to be the all-
important thing, but please get them in a completely routine manner. Do not
make the examination look unusual in any way."66

Moreover, a letter from Langham to Dr. Bassett discussed the
undesirability of recording plutonium data in the Rochester subjects' hospital
records:

I talked to Col. [Stafford] Warren on the phone
yesterday and he recommended that I send copies of
all my data to Dr. [Andrew] Dowdy where it would
be available to you and Dr. [Robert M.] Fink to
observe. He thought it best that I not send it to you
because he wanted it to remain in the Manhattan
Project files, instead of taking a chance on it finding
its way into the hospital records. I think this is
probably a sensible suggestion.

67

Uranium Injections at Rochester

Under the Manhattan Engineer District program, physicians at the
Rochester metabolism ward also injected six patients with uranium (in the form of
uranyl nitrate enriched in the isotopes uranium 234 and uranium 235) to establish
the minimum dose that would produce detectable kidney damage due to the
chemical toxicity of uranium metal, and to measure the rate at which uranium was
excreted from the body. To achieve the first objective, the experimenters used a
higher dose with each new subject until the first sign of minimal kidney damage
occurred. Damage occurred in the sixth and last subject (at a calculated amount

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of radioactivity of 0.03 microcuries), indicated by protein tests of his urine.
Unlike the plutonium injections, this was an experiment that evidently was
designed not only to obtain excretion data but to cause actual physical harm,
however minimal. Thus, although the investigators could reasonably view the
plutonium injections as an experiment that was extremely unlikely to produce
acute effects, this was not true of the uranium experiment, which was intended to
produce acute effects. As with the plutonium injections, the uranium injections
also posed a long-term risk of the development of cancer. The Committee does
not know in this case how long subjects survived after injection; there is no
documentation of follow-up with these subjects as there is for some of the
subjects of the plutonium injections.

The subjects of this experiment, like some of the plutonium-injection
subjects, were not at risk of imminent death, but did suffer from chronic medical
conditions such as rheumatoid arthritis, alcoholism, malnutrition, cirrhosis, and
tuberculosis. According to Dr. Bassett, again the primary investigator, the
subjects "were chosen from a large group of hospital patients. Criteria of
importance in making the selection were reasonably good kidney function with
urine free from protein and with a normal sediment on clinical examination. The
probability that the patient would benefit from continued hospitalization and
medical care was also a factor in the choice."68

The 1948 report on the experiment did not discuss the question of consent.
We were not able to locate any documents that bear on what, if anything, the
subjects were told about the uranium injections, nor have any relevant
recollections about the experiment survived. Two 1946 documents, however,
discussing whether Dr. Bassett should be permitted to give a departmental
seminar on the excretion rate of uranium in humans, illustrate the secrecy that
surrounded these injections and suggest that the subjects were not informed of the
experiment. By the time of this correspondence, the uranium research with
animals at Rochester had been declassified. The first document, a letter written by
Andrew Dowdy, the director of the Manhattan Department at the University of
Rochester, to a Manhattan District Area engineer requesting permission for
Bassett to give the seminar, included the following: "I feel that there is no reason
why he should not discuss this matter, and I believe that the fact that this
information was actually obtained on his own patients is of more concern to
himself than to the District."69 In the second document, an intraoffice
memorandum, the area engineer discussed this point, and more:

Dr. Dowdy states that the patients were Dr.
Bassett's, but it should be borne in mind that all the
work performed by Dr. Bassett was performed at
the request of the Manhattan District Medical
Section. This seminar is to be conducted for persons
who are all Doctors of Medicine and it is doubtful if

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this information would get out to any of the families
of the patients or the patients on whom the
experiments were performed. . . .

At the time these experiments were started, this
office was given strict orders that the information
should not be released to any but authorized
persons. Almost all the correspondence and result
of experiments were exchanged between Dr. Wright
Langham at Santa Fe and Dr. Bassett of the
University of Rochester. This rule is still in effect
on some of the material that Dr. Bassett is using and
knowledge of the experiments is kept from
personnel at the Rochester Area.70

Polonium Injections at Rochester

In addition to the subjects injected with plutonium and uranium at
Rochester, five subjects were chosen for an experiment with polonium. The
purpose of the experiment was to determine the excretion rate of polonium after a
known dose, as well as to analyze the uptake of polonium in various tissues. The
primary investigator for these experiments was Dr. Robert M. Fink, assistant
professor of radiology and biophysics at the University of Rochester. Four
patients were injected with the element, and one ingested it.71 All five patients
selected for this study were suffering from terminal forms of cancer:
lymphosarcoma, acute lymphatic leukemia, or chronic myeloid leukemia. It is
unclear why patients with malignant diseases were chosen as subjects in this
experiment but excluded from the subject pools for the plutonium and uranium
experiments. There is no discussion in the 1950 final report on the polonium
experiments of the possibility that patients with malignant diseases might have
abnormal metabolism, and the excretion data were employed right away in the
establishment of occupational safety standards.72

The final report, unlike other reports on the Manhattan District
metabolism studies, briefly discusses the question of consent: "the general
problem was outlined to a number of hospital patients with no previous or
probable future contact with polonium. Of the group that volunteered as subjects,
four men and one woman were selected for the excretion studies outlined
below."73 This statement leaves no clear impression of what the subjects actually
were told; like the experiments with plutonium and uranium, the human polonium
experiment was a classified component of the metabolism program. Still, this
report provides a contrast to the contemporaneous reports on the Manhattan
District plutonium and uranium experiments, which make no mention of consent
and which do not refer to the patient-subjects as "volunteers."

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The California Experiments

While the University of Rochester had been conducting experiments for
the Manhattan Engineer District, a related effort was under way at the University
of California at Berkeley.74 Before the war, Drs. Joseph Hamilton and Robert
Stone had been exploring medical applications of radioisotopes with the aid of the
University of California's cyclotron. Hamilton and his colleagues had pioneered
in using radioisotopes to treat cancer, in particular iodine 131 in the 1930s. At the
time the United States entered the war, they were investigating another isotope for
cancer therapy, strontium 89. Indeed, it was this area of Hamilton's expertise that
attracted the: interest of the Manhattan Project. While Stone moved to the Chicago
Metallurgical Laboratory during the war, Hamilton remained at the University of
California's Radiation Laboratory, or "Rad Lab," at Berkeley. A colleague of both
men, Dr. Earl Miller, a radiologist at the University of California, reported
regularly to Stone on the progress of the Berkeley plutonium project.

Under the Manhattan District contract, Hamilton's studies originally had
involved exposing rats to plutonium in an effort to determine its metabolic fate
and thereby project the risk to workers at atomic plants. Toward the end of the
war, Hamilton began to conduct plutonium studies on humans for the
government.75 Experiments with humans could be handled expeditiously,
Hamilton wrote, because of the close relationship between the Rad Lab and the
medical school at the University of California at San Francisco.76 In January
1945, Hamilton confirmed to the Manhattan District that he planned "to
undertake, on a limited scale, a series of metabolic studies with [plutonium] using
human subjects."77 The purpose of this work, Hamilton wrote, "was to evaluate
the possible hazards ... to humans who might be exposed to them, either in the
course of the operation of the [Chicago] pile, or in the event of possible enemy
action against the military and civilian population."78

Subsequently, three subjects, two adults and one child (known as CAL-1,
2, and 3), were injected with plutonium. In addition, in April 1947 a teenage boy
(CAL-A) was injected with americium, and in January 1948 a fifty-five-year-old
female cancer patient (CAL-Z) was injected with zirconium.79

On May 10, 1945, Hamilton reported he was awaiting "a suitable patient"
for the plutonium experiment.80 Four days later, fifty-eight-year-old Albert
Stevens, designated CAL-1, was injected with plutonium, becoming the first
human subject in the California portion of the project.81 Albert Stevens was
chosen in the belief that he was suffering from advanced stomach cancer.82
Shortly after the injection, however, a biopsy revealed a benign gastric ulcer
instead of the suspected cancer. The researchers collected excreta daily for almost
one year, analyzing them for plutonium content.83 Evidently, by two months after
the injection, Mr. Stevens was considering moving out of the Berkeley area; this
would have prevented further collection of excretion specimens. Dr. Hamilton
proposed to Drs. Stone and Stafford Warren that he be permitted to "pay the man

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fifty dollars per month" in order to keep Mr. Stevens in the area. Hamilton
recognized, however, that there were "possible legal and security situations which
may present insurmountable obstacles."84 In response to this request, Dr. Joe
Howland (who was reportedly involved with the Oak Ridge plutonium injection)
wrote the following to the California area engineer:

Possible solutions to this problem could be:

a. Pay for his care in a hospital or nursing home as
a service.

b. Place this individual on Dr. Hamilton's payroll in
some minor capacity without release of any
classified information.

It is not recommended that he be paid as an
experimental subject only."5

According to a 1979 oral history of Kenneth Scott, an investigator at
Berkeley who evidently was responsible for the analysis of Mr. Stevens's
excretion specimens, the patient was paid some amount each month to keep him
in the area. However, Dr. Scott also recalled that he never told Mr. Stevens what
had happened to him: "His sister was a nurse and she was very suspicious of me.
But to my knowledge he never found out."86

In addition, an April 1946 report on the experiment records that "several
highly important tissue samples were secured including bone."87 It appears that
these tissue specimens, which included specimens of rib and spleen, were
removed four days after the injection in an operation for the patient's suspected
stomach cancer.88

Four months after Mr. Stevens was injected, Dr. Hamilton told the
Manhattan District that the next subject would be injected "along with Pu238
[plutonium], small quantities of radio-yttrium, radio-strontium, and radio-
cerium." The purpose of this experiment was to "compare in man the behavior of
these three representative long-lived Fission Products with their metabolic
properties in the rat, and second, a comparison can be made of the differences in
their behavior from that of Plutonium."89 This research would provide data to
improve extrapolation from higher-dose animal experiments.

Despite Hamilton's hope to have a second patient by the fall, CAL-2 was
not selected until April 1946. Simeon Shaw was a four-year-old Australian boy
suffering from osteogenic sarcoma, a rare form of bone cancer, who was flown
from Australia to the University of California for treatment. According to
newspaper articles at the time, Simeon's family had been advised by an Australian
physician to seek treatment at the University of California.90 Arrangements then
were made by the Red Cross and the U.S. Army for Simeon and his mother to fly
by Army aircraft to San Francisco. Within days, he had been injected with a

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solution containing plutonium, yttrium, and cerium by physicians at the
university.91

Following his discharge on May 25, about a month after his injection, the
boy returned to Australia, and no follow-up was conducted. He died in January
1947. In February 1995 an ad hoc committee at the University of California at
San Francisco (UCSF) concluded that probably at least part of the motivation for
this experiment was to gather scientific data on the disposition of bone-seeking
radionuclides with bone cancers.92

One piece of evidence indicating that there was a secondary research
purpose for the injection of CAL-2 was a handwritten note in the boy's medical
record saying that the surgeons removed a section of the bone tumor for
pathology and for "studies to determine the rate of uptake of radioactive materials
that had been injected prior to surgery, in comparison to normal tissues."93

It is likely that the CAL-2 experiment was designed both to acquire data
for the Manhattan District and also to further the physicians' own search for
radioisotopes that might treat cancer in future patients. The California researchers
themselves noted the dual purpose of their research at the time. Hamilton wrote in
a report to the Army in the fall of 1945 that there were "military considerations
which can be significantly aided by the results of properly planned tracer
research."94

As the February 1995 UCSF report on the experiments concluded,
however, the "injections of plutonium were not expected to be, nor were they,
therapeutic or of medical benefit to the patients."95 This corresponds with the
evidence of a letter, written by Hamilton in July 1946, three months after the
injection of CAL-2, to the author of an article on the peacetime implications of
wartime medical discoveries:

To date no fission products, aside from radioactive
iodine, have been employed for any therapeutic
purposes. There is a possibility that one or more of
the long list of radioactive elements produced by
uranium fission may be of practical therapeutic
value. At the present time, however, we can do no
more than speculate.96

Documentary evidence suggests that consent for the injections likely was
not obtained from at least some of the subjects at the University of California. A
1946 letter from T. S. Chapman, with the Manhattan District's Research Division,
said the following regarding preparations for injections:

. . . preparations were being made for injection in
humans by Drs. [Robert] Stone and [Earl] Miller.
These doctors state that the injections would

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probably be made without the knowledge of the
patient and that the physicians assumed full
responsibility. Such injections were not divergent
from the normal experimental method in the
hospital and the patient signed no release. A release
was held to be invalid.

The Medical Division of the District Office has
referred "P" reports for project 48A to Colonel
Cooney for review and approval is withheld
pending his opinion.97

Chapman does not specify whether the "injections" referred to in this letter
were injections of plutonium or of some other substance. It is unclear whether "'P'
reports" refers to Hamilton's overall progress reports on his tracer research, which
had reported mostly on research with plutonium (but also on research with cerium
and yttrium), or whether "P" referred specifically to reports on work with
plutonium. As we noted at the outset of this chapter, Chapman's claim that it was
commonplace at the time to use patients in experiments without their knowledge
and without asking them to sign a "release" is correct.

In the case of Albert Stevens (CAL-1), no documentary evidence that
bears on disclosure or consent has been found. Simeon Shaw's (CAL-2's) medical
file contains a standard form "Consent for Operation and/or Administration of
Anaesthetic." This form, however, was signed by a witness attesting to consent of
Simeon's mother one week after the injection and therefore probably applies to a
biopsy done a week after the injection, not to the injection itself.98

On December 24, 1946, at the prompting of Major Birchard M. Brundage,
who was chief of the Manhattan District's Medical Division, Colonel K. D.
Nichols, commander of the Manhattan District, ordered a halt to injections of
"certain radioactive substances'' into human subjects at the University of
California.99 "Such work," Nichols wrote, "does not come under the scope of the
Manhattan District Programs and should not be made a part of its research plan. It
is therefore deemed advisable by this office not only to recommend against work
on human subjects but also to deny authority for such work under the terms of the
Manhattan contract." The following week, the civilian AEC took over
responsibility for all Manhattan District research and temporarily reaffirmed the
Manhattan District's suspension of human experimentation at the University of
California.100 It is unclear why this action was taken.

THE AEC'S REACTION: PRESERVING SECRECY WHILE
REQUIRING DISCLOSURE

When the civilian Atomic Energy Commission took over for the

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Manhattan District on January 1, 1947, the plutonium injections provoked a
strong reaction at the highest levels. One immediate result was the decision to
keep information on the plutonium injections secret, evidently for reasons not
directly related to national security, but because of public relations and legal
liability concerns. The other immediate result, as we saw in chapter 1, was the
issuing of requirements for future human subjects research as articulated in letters
by the AEC's general manager, Carroll Wilson.

In December 1946, as the civilian AEC was about to open its doors,
Hymer Friedell, who had been deputy medical director of the Manhattan Engineer
District, recommended the declassification of one of the plutonium reports, "CH
[Chicago]-3607--The Distribution and Excretion of Plutonium in Two Human
Subjects." The report, Friedell argued, "will not in my opinion result in the release
of information beyond that authorized for disclosure by the current
Declassification Guide."101

Friedell's recommendation was soon reversed. Officials with the new AEC
had learned of the human injection experiments, and on February 28, 1947, an
AEC declassification officer concluded that declassification was out of the
question. The reasons are revealed in a previously classified document recently
found at Oak Ridge:

The document [CH-3607] appears to be the most
dangerous since it describes experiments performed
on human subjects, including the actual injection of
the metal plutonium into the body. The locations of
these experiments are given and the results, even to
the autopsy findings in the two cases. It is unlikely
that these tests were made without the consent of
the subjects, but no statement is made to that effect
and the coldly scientific manner in which the results
are tabulated and discussed would have a very poor
effect on the public. Unless, of course, the legal
aspects were covered by the necessary documents,
the experimenters and the employing agencies,
including the U.S., have been laid open to a
devastating lawsuit which would, through its
attendant publicity, have far reaching results.102

It is not clear to the Advisory Committee on what basis the
declassification officer who wrote this comment concluded that it was unlikely
that consent was not obtained from the Chicago subjects. This statement could be
read as careful bureaucratic language, intended to leave an appropriate paper trail
in the event of subsequent legal problems. On the other hand, the statement does

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support the claim, noted earlier, made by one of the Chicago doctors in 1974 that
some form of oral consent for the injections had been obtained from the Chicago
subjects. It is clear that there was no documentation of disclosure or consent on
which the AEC could rely. As a consequence, secrecy was to be maintained, not
as a defense against foreign powers, but to avoid a "devastating lawsuit" and
"attendant publicity." Upon further review the report was "reclassified
'Restricted' on 3/31/47."103 In a March 19, 1947, memorandum, Major Brundage,
by that time chief of the AEC's Medical Division, explained:

The Medical Division also agrees with Public
Relations that it would be unwise to release the
paper 'Distribution and Excretion of Plutonium'
primarily because of medical legal aspects in the
use of plutonium in human beings and secondly
because of the objections of Dr. Warren and
Colonel Cooney that plutonium is not available for
extra Commission experimental work, and thus this
paper's distribution is not essential to off Project104
experimental procedures.105

In July 1947, Argonne National Laboratory's declassification officer,
Hoylande D. Young, inquired about possible declassification of this report as well
as Hamilton's report on the CAL-1 injection. She stated that the directors of
Argonne's Biology and Health Divisions (including J. J. Nickson, one of the
authors of the Chicago report on the injections) believed that declassification of
these reports would not be "prejudicial to the national interests."106 The AEC
continued to withhold declassification of these reports, however, on the grounds
that they involved "experimentation on human subjects where the material was
not given for therapeutic reasons."107 Thus, there was clearly no expectation at
the time that the plutonium injections would benefit the patient-subjects but some
expectation that the general public might be disturbed by human experimentation
in the absence of a prospect of offsetting benefit.

In 1950, Wright Langham and the Rochester doctors undertook to prepare
a "Plutonium Report"101* that would be "the last word on the plutonium
situation."109 It would be the "last word" to only a select few. In 1947, Rochester's
Andrew Dowdy had urged Los Alamos to give advance notice of declassification
of the Rochester part of the experiment "because of possible unfavorable public
relations and in an attempt to protect Dr. [Samuel] Bassett from any possible legal
entanglements."110 This is likely a reference to the same concern raised in the
discussion of Dr. Bassett's seminar about his having experimented upon his own
patients, except in this case the context is the plutonium rather than the uranium
injections. "We think," Langham wrote to Stafford Warren, "the classification will
be 'Secret,' and the circulation limited, depending on Dr. Shields Warren's [the

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head of AEC's Division of Biology and Medicine] wishes.""1 In August, Shields
Warren approved the report for "CONFIDENTIAL classification and limited
circulation as [Dr. Langham] requested.""2

Even though its data and analysis were the basis for widespread plutonium
safety procedures, the report remained unavailable to the public until 1971 when,
at the urging of Dr. Patricia Durbin, it was downgraded to "Official Use Only.""3
(This categorization means that while the document was not likely to be released
to the public absent specific request, it could be disclosed.)

What was it that was so potentially embarrassing about the plutonium
experiments? The answer appears to lie in the 1947 letters from General Manager
Wilson, discussed in detail in chapter 1 . These letters state rules for both the
conduct of human experiments and the declassification of previously conducted
secret experiments."4

In his April 1947 letter, Wilson stated the requirements that there be
expectation that research "may have therapeutic effect" and that at least two
doctors "certify in writing (made part of an official record) to the patient's
understanding state of mind, to the explanation furnished him, and to his
willingness to accept the treatment."""' In his November 1947 letter, Wilson
reiterated these terms for human experiments, again calling for "reasonable
hope . . . that the administration of such a substance will improve the condition of
patient" and this time calling for "informed consent in writing" by the patient."6
All of the seventeen plutonium injections conducted prior to the letters violated
both these terms. As a consequence, they would have to stay secret. The only
secret experiments that could be declassified were those that satisfied these
requirements; to do otherwise was to risk adverse public reaction. Thus, the
decision to keep the plutonium reports secret was itself an example of the way in
which the AEC's assertion of conditions for human experimentation was coupled
with the decision to keep secret those experiments that evidently did not adhere to
these conditions (see chapter 13).

HUMAN EXPERIMENTATION CONTINUES

In March 1947, just as he was declaring that "public relations" required
the reclassification of plutonium data. Medical Division chief Major Brundage
approved a 1947-48 "Research Program and Budget" for Rochester that provided
for metabolism studies with polonium, plutonium, uranium, thorium, radiolead,
and radium."7 The program was put on hold by the AEC soon after."8

The future of the metabolism work at Rochester apparently was decided
when Shields Warren was named the first chief of the AEC's Division of Biology
and Medicine in fall 1947. In his private diary for December 30, 1947, Warren
tersely noted: "Ordered abandonment of human isotope program at Rochester.""'
The program at the University of California at Berkeley, however, continued. On
December 4, 1947, Shields Warren had met with Hamilton and Stone;120 the

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decision to allow the program to continue clearly was not a hasty one. A 1 974
recollection of Shields Warren indicates that his decision to allow the program to
continue may have been due to Hamilton's assertion in December 1947 that it had
been the University of California's practice to obtain some form of
(undocumented) consent.121

According to Warren, Hamilton had said that subjects were told "they
would receive an injection of a new substance that was too new to say what it
might do but that it had some properties like other substances that had been used
to control growth processes in patients, or something of that general sort."122
Warren went on to observe that "you could not call it informed consent because
they did not know what it was, but they knew that it was a new and to them
unknown substance."123 Warren's observation does not go far enough, however. If
Warren's secondhand account is accurate and this is indeed what the patient-
subjects at the University of California were told, then they were more misled
than informed. Analogizing plutonium to substances that "control growth
processes in patients," even in prospect, might reasonably lead patients to believe
that they would be receiving a substance with some hope of treating their cancer.
Certainly such a remark would not communicate to patients that the experiment to
be performed was not for their own benefit. It would have been appropriate that
these patients be told that their participation might benefit future patients with the
same conditions. It would have been crucial to distinguish, however, between
this legitimate explanation of potential benefit to future cancer patients and
misleading the patient into believing the experiment might benefit him or her.

Human Experimentation Continues at the University of California

By the summer of 1947, human experimentation had resumed at the
University of California under AEC contract. In June, "CAL-A," a teenage Asian-
American bone cancer patient at Chinese Hospital in San Francisco, was injected
with americium. An instruction in the patient's file by one of Hamilton's assistants
specifies that "we will use the same procedure as with Mr. S,"'24 evidently a
reference to Albert Stevens. Dr. Durbin, Hamilton's associate, believes that CAL-
A's guardian was informed of the procedure followed in that case.125 The
Advisory Committee received incomplete records for CAL-A that contained no
evidence of disclosure or consent; UCSF has told the Committee that records at
Chinese Hospital from the 1950s and earlier have been destroyed. I2(1

A thirty-six-year-old African-American railroad porter named Elmer
Allen, code-named CAL-3, was believed to be suffering from bone cancer and
was injected with plutonium at the University of California in July 1947. His left
leg was amputated shortly thereafter. There is a note in his medical chart signed
by two physicians, stating that the experimental nature was "explained to the
patient, who agreed to the procedure" and that "the patient was in fully oriented
and in sane mind."127 It is likely that this note was intended to fulfill one of the

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April 1947 conditions for human experimentation, which allowed for such a
procedure as documentation of having obtained the patient-subject's consent. It is
not clear from the note, however, whether in explaining about the experimental
nature of the procedure the physicians told the patient about the potential effects
of the injection, as required by the Wilson letter, or that the injection was not
intended to be of medical benefit to the patient. On this second point, the
injection was in violation of the Wilson letter, which also required that there be an
"expectation that it may have therapeutic effect."128 As acknowledged by the
February 1995 UCSF report, there was never any expectation on the part of the
experimenters that the injection would be of therapeutic benefit to Mr. Allen.

Mr. Allen lived until 1991. According to UCSF's 1995 review of patient-
subjects' medical charts, upon biopsy of his tumor a pathologic diagnosis was
made of chondrosarcoma, a type of malignant bone tumor. UCSF reported that
patients with this type of tumor "frequently surviv[e] many years beyond
diagnosis if there is complete excision of the primary tumor."'29 This pathology
finding suggests that Mr. Allen was a long-term cancer survivor. A note in his
patient chart recorded that the tumor was "malignant but slow growing and late to
metastasize. Prognosis therefore moderately good."130

On March 15, 1995, Elmerine Whitfield Bell, the daughter of Elmer Allen,
told the Advisory Committee in Washington, D.C., that she

continue[s] to be appalled by the apparent attempts
at cover-ups, the inferences that the nature of the
times, the 1940s, allowed scientists to conduct
experiments without getting a patient's consent or
without mentioning risks. We contend that my
father was not an informed participant in the
plutonium experiment.

He was asked to sign his name several times while a
patient at the University of California hospital in
San Francisco. Why was he not asked to sign his
name permitting scientists to inject him with
plutonium? Why was his wife, who was college
trained, not consulted in this matter?

On January 5, 1948, a fifty-five-year-old woman with cancer was injected
with zirconium at the University of California. '■" The patient record for this case
has not yet been located, nor have any other documents that might bear on
whether this experiment was conducted in compliance with the consent
requirements of the Wilson letters. We do know that the injection of zirconium
was not expected to benefit the subject herself.132

A secret report on the zirconium injection was reviewed by the AEC in

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light of public relations and liability concerns. In August of that year, the report
was denied declassification with the approval of Shields Warren, who wrote,
"This document should not be declassified for general medical publication [and] it
would be very difficult to rewrite it in an acceptable manner."113 Warren was
responding to a memorandum from Albert H. Holland, Jr., medical adviser at Oak
Ridge, which specified that the concern about rewriting had to do with public
relations and the fact that the report "specifically involves experimental human
therapeutics."134

Follow-up of the Patient-Subjects at Rochester

The investigators at Rochester and the AEC were interested in obtaining
long-term data from surviving subjects on excretion levels and the distribution of
plutonium in various tissues. Follow-up studies at Rochester continued at least
through 1953 with two of the subjects in the HP series, Eda Charlton and John
Mousso. We have already noted Wright Langham's 1950 instruction to the
physicians at Rochester suggesting that they were not to give these patients any
indication of the true purpose of the follow-up studies.135 In addition, Langham
sought help in early 1950 to locate Ebb Cade (the man injected at Oak Ridge
Hospital) for follow-up excretion studies. Langham asked Dr. Albert Holland at
Oak Ridge to try to locate Mr. Cade and to keep his "eyes open for a possible
autopsy."136 It is unclear to the Committee whether follow-up of any kind was
ever done with Mr. Cade.

On June 8, 1953, Eda Charlton's rib was removed during exploratory
surgery for cancer and analyzed for plutonium. Louis Hempelmann, who by that
time had moved from Los Alamos to Strong Memorial Hospital at Rochester,
wrote to Charles Dunham of the AEC's Division of Biology and Medicine in
advance of the procedure:

The patient in question was brought in for a skeletal
survey, and turned out to have a 'coin-like' lesion
inside the chest wall. ... It is undoubtedly an
incidental finding, but she must be explored by the
chest surgeon here at Strong. In the course of the
operation, he will remove a rib which we can
analyze. Her films show the same type of minimal
indefinite change in the bone that the others have
had.137

It was standard practice at the time to remove a section of rib incidental to
lung surgery. It is clear that the patient was still being followed for long-term
effects of plutonium and that some subclinical bone changes of unclear
significance had already been observed by this time. Therefore, the examination

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of this rib segment would have included special tests to determine whether
plutonium was present.

On August 31, 1950, an internal DBM memorandum recorded the
understanding of some AEC officials that Wright Langham and Rochester doctors
were engaged in follow-up studies.13" In a 1974 interview, however, Shields
Warren recalled that he had no knowledge that the patients were the subjects of
follow-up studies: "I did not learn of this continuing contact while I was in office

at AEC I had assumed because I had been told that they were incurable

patients that they all had died by the time we talked."139

Additional Follow-up Studies and the Argonne Exhumation Project

In 1968 Dr. Patricia Durbin undertook an investigation of the plutonium-
injection subjects, which included a reevaluation of the original plutonium data.
Her goal was to pursue "some elusive information on Pu in man and the
information or assumptions about physiology needed to create a believable Pu
model for man." She "decided to look at all the old Pu patients as individuals

rather than in a lump "14° Durbin was surprised to find in her search for the

original experimental data that the University of California data were drawn from
three subjects who received plutonium and one who received americium; the data
from only one plutonium subject from California had previously been reported in
the open scientific literature.141 Durbin asked the original researchers why these
data had not been analyzed. She wrote: "I understand from Wright Langham that
this problem has been discussed before and discarded as too messy."14

In 1972, after the classified report on the experiments had been
downgraded to "Official Use Only," she went on to publish "Plutonium in Man:
A New Look at the Old Data," a landmark paper in the plutonium story.143 This
was the first review in the open literature to analyze Langham's results in light of
the actual medical conditions of the patient-subjects. Because of the prolonged
secrecy surrounding the experiments, it was generally not known that two of the
three University of California cases had been omitted from the 1950 analysis.
The report also revealed in retrospect that all the patients were not hopelessly or
terminally ill, as had been suggested in Langham's later public references, that
some were still alive, and that some had been misdiagnosed.

In December 1972, Argonne National Laboratory's Center for Human
Radiobiology (CHR), to whom Durbin had provided the names of surviving
subjects, began a review of the data from all eighteen people who were injected
with plutonium between 1945 and 1947. CHR was the national center designated
by the AEC to do long-term follow-up of individuals with internally deposited
radionuclides, primarily the radium dial painters. Argonne's follow-up plan for the
plutonium experiments was to uncover the postinjection medical histories of all
the subjects, obtain biological material from those still living, and exhume and
study the bodies of those deceased in order to "provide data on the organ contents

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at long times after acquisition of plutonium."144

In 1973, three patients--Eda Charlton, John Mousso, and Elmer Allen-
were admitted to the University of Rochester's metabolic ward for more excretion
studies paid for by CHR. Elmer Allen had first been brought to Argonne, where
an unsuccessful attempt had been made to detect plutonium by external counting
techniques. In the course of his examination, however, CHR found subclinical
bone "changes" that an Argonne radiologist characterized as "suggestive of
damage due to radiation."145

Again there was no disclosure to the subjects that they were now being
followed because they had been subjects of an experiment that had been unrelated
to their medical care, an experiment in which there was continuing scientific
interest. The 1974 AEC investigation concluded that, in the case of the surviving
Rochester subjects, Dr. Waterhouse, who conducted the follow-up studies with
these patients for Argonne, had not told them the purpose of the studies in 1973
because she believed "that disclosure might be harmful to them in view of their
advanced age and ill health."146 This suggests that Dr. Waterhouse had well-
intentioned motivations for not being straightforward with the Rochester subjects.
It also suggests that these subjects had not been told the truth about the
experiments at the time the injections occurred, or that they had forgotten.
According to Dr. Waterhouse, the studies were feasible without the subjects'
knowledge of the true purpose of the research since these two patients "were
accustomed to participating in clinical studies, unrelated to this matter, involving
the collection of excretion specimens."147 Elmer Allen's physician was told by
CHR that the purpose of bringing Mr. Allen to Argonne's CHR and the University
of Rochester for follow-up was interest in the treatment he received at the
University of California in 1947 for his cancer.148 This use of the term treatment
in the information provided Mr. Allen's physician, which he presumably relayed
to Mr. Allen and his family, was deceptive and manipulative; it implied that the
injection Mr. Allen received had been given as therapy for his benefit.

The second component of this follow-up study was research on the
exhumed bodies of deceased subjects. The 1974 AEC investigation concluded
that the families were not informed that plutonium had been injected. Instead,
they were told that "the purpose of exhumation was to examine the remains in
order to determine the microscopic distribution of residual radioactivity from past
medical treatment" and that the subjects had received an "unknown" mixture of
radioactive isotopes.149 The investigation concluded that such disclosure "could be
judged misleading in that the radioactive isotopes were represented as having
been injected as an experimental treatment for the patient's disease."150 Thus, the
families of the deceased subjects as well as those subjects still surviving were
deceived by officials of the AEC.

A December 1972 intralaboratory memorandum, written by an Argonne
investigator, instructs that "outside of CHR we will never use the word plutonium
in regard to these cases. 'These individuals are of interest to us because they may

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have received a radioactive material at some time' is the kind of statement to be
made, if we need to say anything at all."151 Robert E. Rowland, the author of this
memorandum, told Advisory Committee staff in 1995 that he had written this
after he had been instructed earlier that month by Dr. James Liverman, director of
the AEC's Division of Biomedical and Environmental Research, that "I could not
tell the individuals that they were given plutonium. I protested that they must be
given a reason for our interest in them, and I was told to tell them that they had
received an unknown mixture of radioisotopes in the past, and that we wanted to
determine if it was still in their bodies. Further, we were not to divulge the names
of the institutions where they received this unknown mixture."152 Dr. Rowland
said he had received these instructions during a trip to Washington, D.C., to
obtain approval and funding for the study.153 Dr. Liverman told Advisory
Committee staff that he has "no recollection of discussions with anyone in which
some stricture would have been placed on what could be discussed with the
patients. That is a medical ethics issue which would have been left to the
physicians."154

This study was not brought to the attention of the Argonne Human Use
Committee until November 1973, even though it had been established in January
1973. (See chapter 6 for a discussion of human use committees.) In a briefing for
the 1974 AEC investigation, Dr. Liverman attributed this failure to bring the
study before the Human Use Committee to the following factors: "( 1 ) [Argonne's]
opinion that the studies came under the scope of a protocol approved by that
Committee in 1971. (2) The nature of the studies was to be suppressed to avoid
embarrassing publicity for AEC."155

In 1974 the AEC informed at least two of the four living subjects— Eda
Charlton and John Mousso— of the plutonium injections and had them sign
documents to this effect. These documents did not provide any information on
possible effects of the injections, although they did describe the purpose as having
been "to determine how plutonium, a man-made radioactive material, is deposited
and excreted in the human body."156 One living patient, Jan Stadt, was not told,
because it was her attending physician's opinion that her condition was precarious
and that disclosure in this case would be "medically indefensible."157 This
judgment, like that of Dr. Waterhouse's, exemplifies how physicians of the time
commonly managed the information they shared with their patients. Physicians
typically told patients only what they thought it was helpful for them to know; if
in the physician's judgment information might cause the patient to become upset
or distressed, this was often considered reason enough to withhold it.15X The
judgment also suggests that Ms. Stadt, like Ms. Charlton and Mr. Mousso, had not
been told the truth about the experiments at the time the injections occurred or
that she had forgotten.

The AEC recommended that exhumations continue, but only with full
disclosure to the subjects' next of kin.

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The Boston Project Uranium Injections

Human experiments conducted to measure the excretion and distribution
of atomic weapons materials did not stop with the last of the injections at the
University of California. The Boston Project human uranium-injection
experiments were conducted from 1953 to 1957 at Massachusetts General
Hospital (MGH) as part of a cooperative project between the hospital and the
Health Physics Division of Oak Ridge National Laboratory. Eleven patients with
terminal conditions were injected with uranium, although data obtained from
three of these subjects were never published.159 The ORNL and the AEC
undertook the Boston Project to obtain better data for the development of worker
safety standards. One of the investigators wrote that the Boston Project would
provide "a wonderful opportunity to secure 'human data' for the analysis and
interpretation of industrial exposures."160 The occupational standards for uranium
at the time were based on animal data and on the experiment conducted at
Rochester in the 1940s. No autopsy data were obtained from this earlier
experiment at Rochester, however, since none of the patients had terminal
diseases. Thus, wrote a Boston Project investigator, "the uncertainty, in so far as
the distribution of uranium was concerned, was not reduced [by the Rochester
experiment] or could not even be determined."161

The Boston Project involved a second purpose—the search for a
radioisotope that would localize in a certain type of brain tumor—called
glioblastomas— and destroy them when activated by a beam of neutrons. This had
long been the research interest of Dr. William Sweet at MGH; at the time, these
tumors were clearly diagnosable and 100 percent fatal, and there was no effective
treatment. This research involved many radioisotopes over the years, most
notably isotopes of boron and phosphorus. It is unclear whether Dr. Sweet would
have tested uranium without ORNL's involvement— or whether it would have been
made available to him by the AEC. Dr. Sweet has indicated to the Committee that
he was interested in the potential of uranium as a therapeutic agent prior to being
approached by the AEC about the possibility of conducting a joint project.162

The Boston Project produced data on the distribution of uranium in the
human body that the earlier Manhattan District uranium studies had not provided.
The data obtained indicated that uranium, at least at the dose levels used in the
Boston Project, localized in the human kidney at higher concentrations than small
animal data had predicted and that therefore the maximum permissible levels for
uranium in water and air might be unsafe. Recommendations made by the
investigators of the Boston Project for more conservative occupational standards
were apparently not heeded, however. The accepted occupational levels for
uranium became less rather than more conservative over the years, despite the
findings of the Boston Project.163

Hopes that uranium would localize sufficiently in brain tumors to be of
potential therapeutic use were unfulfilled. In a 1979 interview, Robert Bernard,

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one of the health physicists at ORNL most intimately involved with the study,
was asked if during the experiment uranium was showing any promise as a
treatment. "No, it concentrated in the kidney just like Rochester said back in the
'40's. . . . They got brain tumor samples. There was very little uranium present,
but Sweet was still wondering: maybe [it was] not a high enough dose."164

In a 1995 interview, Karl Morgan, head of the Health Physics Division of
ORNL at the time of the Boston Project, indicated that the project was ultimately
discontinued in 1957165 because of the concerns of an ORNL health physicist:

He felt that the patients were given very large doses
of uranium which our data had indicated— that is,
the data we collected [at ORNL] in setting
permissible doses—would be very harmful. ... I
immediately cancelled our participation in the
program. Apparently, they were given doses that
were many times the . . . permissible body
burden.166

In their application to their radioisotope committee, MGH investigators clearly
recorded that the proposed dose of 2.12 rem per week "exceeds maximum
permissible exposure rate of 0.3 rem/week but [patients] are terminal."16

At least one of the subjects was selected for the distribution part of the
study only. Reports describe the patients as "virtually all" having malignant brain
tumors; newly available documents indicate that at least one patient injected with
uranium did not have a brain tumor at all. An unidentified male, identity and age
still unknown at the time of his death, became Boston Project subject VI when he
"was brought to the Emergency Ward after being found unconscious. ... No other
information was obtainable." I6X According to his autopsy report, this patient was
suffering from a subdural hematoma~a severe hemorrhage— on his brain. There
was clearly no benefit intended for this patient from the injection of uranium, but
there is evidence of harm attributable to the injection. His autopsy report records
clinical evidence of mild kidney failure169 and pathological evidence of kidney
nephrosis (damage to the kidney tubules) from the chemical toxicity of uranium
metal.170 The report also records that "the liver, spleen, kidneys and bone marrow
showed evidence of radiation."171

Even for the patient-subjects with brain cancer, there was no expectation
on the part of investigators that the experiment would benefit the subjects
themselves. The object of the experiment was to test whether uranium would
localize sufficiently in brain tumors to be of therapeutic value in the future. In
order for uranium to have had therapeutic potential for patient-subjects, exposure
to a reactor's neutron beam would have been necessary to then activate the
uranium, if it had localized sufficiently in the tumors, which it did not. There was,
however, no plan to expose these particular patient-subjects to a neutron beam;

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the goal was to see whether the concentration would justify further research that
would involve exposure to a neutron beam. Most of the subjects were already
comatose and "in the terminal phase of severe irreversible central nervous system
disease."172

The doses used in the Boston Project were high; the lowest dose was
comparable to the highest used in the earlier Rochester uranium experiment— a
dose that had caused detectable kidney damage in one of the Rochester subjects.
One document records that at least two Boston Project subjects, in addition to
subject VI, had kidney damage at the time of death, although this document does
not directly link this damage to the uranium injections.'73

There is no discussion of consent in any of the Boston Project reports. It
appears that ORNL left such considerations to Dr. Sweet and MGH. In an interim
report, ORNL discusses the division of responsibility in the experiment: "It was
agreed that the Y-12 Health Physics Department [at Oak Ridge] would prepare
injection solutions and perform the analytical work associated with this joint
effort. Massachusetts General Hospital agreed to select the patients, perform the
injections, and care for the patients during the period of study."174

Dr. Sweet told the Advisory Committee in 1995 that it was his practice to
obtain consent from patients or from their families and "scrupulously to give a
patient all the information we had ourselves."175 The Committee has not been
able to locate any documents that bear on questions of disclosure or consent for
this experiment. I7A The case of the Boston Project subject who was brought into
the hospital after being found unconscious, and who, according to his autopsy
report, was never identified and never regained consciousness, indicates that this
rule was not applied universally.

CONCLUSION

From 1945 through 1947 Manhattan Project researchers injected eighteen
human subjects with plutonium, five human subjects with polonium, and six
human subjects with uranium to obtain metabolic data related to the safety of
those working on the production of nuclear weapons. All of these subjects were
patients hospitalized at facilities affiliated with the Universities of Rochester,
California, and Chicago or at Oak Ridge. Another set of experiments took place
between 1953 and 1957 at Massachusetts General Hospital, in which human
subjects were injected with uranium. In no case was there any expectation that
these patient-subjects would benefit medically from the injections.

At fifty years' remove, it is in some respects remarkable that so much
information has survived that bears on the question of what the patient-subjects
and their families were told. Particularly for the Manhattan Project plutonium
experiments information is available, in large part because of the 1974 AEC
inquiry in which interviews with principals of these experiments were conducted
and records of these interviews maintained. At the same time, however, there are

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significant gaps in the record for all the experiments. Particularly where the
evidence is skimpy, it is possible that some of the patient-subjects agreed to be
used in nontherapeutic experiments., But the picture that emerges suggests
otherwise. This picture is bolstered by the historical context. As we discussed in
chapter 2, it was not uncommon in the 1940s and 1950s for physician-
investigators to experiment on patients without their knowledge or consent, even
where the patients could not benefit medically from the experimental procedures.
This context is referenced in a 1946 letter about the University of California
injections: "These doctors state that the injections would probably be made

without the knowledge of the patient Such injections were not divergent from

the normal experimental method in the hospital. . . ."'77

Here we present our conclusions about the ethics of these experiments,
first for the set of experiments conducted between 1945 and 1947 and then for the
experiment conducted from 1953 to 1957. Because the facts appear to be
different in the different institutions at which these experiments took place, we
summarize what we have learned about risk, disclosure, and consent at each
location. We also analyze the ethical issues the experiments raise in common. In
our analysis, we focus on whether the subjects consented to being used in
experiments from which they could not benefit medically, and the extent to which
the subjects were exposed to risk of harm. We also focus on the particular ethical
considerations raised when research is conducted on patients at the end of their
lives. All but one member of the Advisory Committee believe that what follows
is the most plausible interpretation of the available evidence in light of the
historical context.

With one exception, the historical record suggests that these patients-
subjects were not told that they were to be used in experiments for which there
was no expectation they would benefit medically, and as a consequence, it is
unlikely they consented to this use of their person.

In the case of the plutonium experiments, there was no reason to think that
the injections would cause any acute effects in the subjects. This was not true,
however, in the case of the Rochester uranium experiments. Both the plutonium
and the Rochester uranium experiments put the subjects at risk of developing
cancer in ten or twenty years' time. In some cases, this risk was eliminated by the
selection of subjects who were likely to die in the near future. The selection of
subjects with chronic illnesses was also an apparent strategy to contain this long-
term risk of cancer. However, some of these subjects lived for far longer than ten
years, and some were misdiagnosed altogether. On the basis of available
evidence, we could not conclude that any individual was or was not physically
harmed as a result of the plutonium injections. There is some evidence that there
were observable, subclinical bone changes of unclear significance in at least two
surviving subjects who were followed up in 1953 and 1973 and in one deceased
subject who was exhumed in 1973. The uranium injections at Rochester were
designed to produce minimal detectable harm-that was the endpoint of the

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experiment. Such minimal damage is reported to have occurred in the sixth
patient of the series.

In the case of Mr. Cade at Oak Ridge, a physician claiming to have
injected Mr. Cade reported that his consent was not obtained. An apparently
healthy man in his early fifties, Mr. Cade was put at some (probably small) risk of
cancer by the plutonium injection.

At the University of Chicago, the only evidence that bears on disclosure
and consent comes from an interview with a Chicago investigator conducted as
part of the AEC's 1974 inquiry. The investigator was recorded as saying that in
obtaining consent patients were told that the radioactive substance to be injected
"was not necessarily for the benefit of the patients but might help other people."178
This statement is misleading. It suggests that there was some chance these
patient-subjects might benefit when there was no such expectation. At the same
time, however, this statement suggests that the subjects at Chicago were told
something. These subjects also were all apparently terminally ill and thus at no
risk of developing plutonium-induced cancer; at least two of the three were
known to have died within one year of the injection.

Misleading language was purportedly also used with subjects at the
University of California, where a secondhand account suggests that subjects were
told they were to be injected with a new substance that "had some properties like
other substances that had been used to control growth processes in patients."179
Language in a 1946 letter suggests that at least some of the injections at the
University of California may have occurred altogether without the knowledge of
the patients. In the case of Mr. Allen, one of the California subjects, two
physicians attested that the experimental nature of the procedure had been
explained to Mr. Allen and that he had consented. And yet Mr. Allen's physician
was subsequently informed that the follow-up studies were in relation to
treatment Mr. Allen had received at the University of California. This suggests
that, while Mr. Allen may have been told the procedure was experimental, it is
not likely that he was told that the procedure was part of an experiment in which
there was no expectation that he would benefit medically. Both Mr. Allen and
Mr. Stevens survived long enough after injection to be at risk of plutonium-
induced cancer.

All the available evidence suggests that none of the subjects injected with
either plutonium or uranium at Rochester knew or consented to their being used
as subjects in experiments from which they could not benefit. This evidence
comes from recollections of some of the individuals who were involved with the
plutonium injections, as well as documents about seminars and follow-up studies
in the early 1950s suggesting that information about the experiments should be
concealed from the subjects. Most of the subjects at Rochester had serious
chronic illnesses. It is unclear how likely it was at the time that these patients
would not survive more than ten years. A few of these subjects were still alive
more than twenty years after the injections. None of the plutonium subjects but all

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of the uranium subjects were put at risk of acute effects from the experiment.

The purpose of the 1973 follow-up studies was withheld from two
surviving subjects. Also, both Elmer Allen's physician and family members of
deceased subjects were misled by AEC officials about the purpose of the follow-
up studies. They were told that the follow-up was in relation to past medical
treatment, which was not true.

It is unlikely that AEC officials would have lied about or otherwise
attempted to conceal the purpose of the follow-up studies if at the outset the
subjects had known and agreed to their being used as subjects in nontherapeutic
experiments. It is also relevant that when the Atomic Energy Commission
succeeded the Manhattan Project on January 1, 1947, officials decided to keep the
plutonium injections secret. It appears that this decision was based on concerns
about legal liability and adverse public reaction, not national security. The
documents show that the AEC responded to the possibility that consent was not
obtained in the plutonium experiments, as well as their lack of therapeutic benefit,
by stating requirements for informed consent and therapeutic benefit for future
research, while still keeping the experiments secret. As a result of the decision to
keep the injections secret, the subjects and their families, as well as the general
public, were denied information about these experiments until the 1970s.

The one likely exception to this picture of patients not knowing that they
were used as subjects in experiments that would not benefit them is the polonium
experiment conducted at Rochester. This is the one instance in which the patient-
subjects are said to have volunteered after being told about "the general problem."
Although there is no direct evidence that these subjects were told that the
experiment was not for their benefit, the language of volunteering suggests a more
forthright disclosure was made, more in keeping with the conventions in
nontherapeutic research with healthy subjects than in research with patients (see
chapter 2). We cannot reconcile the account of the polonium experiment with the
historical record on the other injections.

The Advisory Committee is persuaded that these experiments were
motivated by a concern for national security and worker safety and that,
particularly in the case of the plutonium injections, they produced results that
continue to benefit workers in the nuclear industry today.180 However, with the
possible exception of the polonium experiments, we believe that these
experiments were unethical. In the conduct of these experiments, two basic moral
principles were violated-that one ought not to use people as a mere means to the
ends of others and that one ought not to deceive others-in the absence of any
morally acceptable justification for such conduct. National security
considerations may have required keeping secret the names of classified
substances, but they would not have required using people as subjects in
experiments without their knowledge or giving people the false impression that
they or their family members had been given treatment when instead they had
been given a substance that was not intended to be of benefit.

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The egregiousness of the disrespectful way in which the subjects of the
injection experiments and their families were treated is heightened by the fact that
the subjects were hospitalized patients. Their being ill and institutionalized left
them vulnerable to exploitation. As patients, it would have been reasonable for
them to assume that their physicians were acting in their best interests, even if
they were being given "experimental" interventions. Instead, the physicians
violated their fiduciary responsibilities by giving the patients substances from
which there was no expectation they would benefit and whose effects were
uncertain. This is clearest at Rochester where at least the uranium subjects, and
perhaps the plutonium subjects, were apparently the personal patients of the
principal investigator.

Concern for minimizing risk of harm to subjects is evident in several of
the planning documents relating to the experiments, an obligation that many of
those involved apparently took seriously. At Chicago, for example, where the
highest doses of plutonium were used, care was taken to ensure that all the
subjects had terminal illnesses. In those cases where this concern for risk was
less evident and subjects were exposed to more troubling risks, the moral wrong
done in the experiments was greater. Where it was not reasonable to assume that
subjects would be dead before a cancer risk had a chance to materialize, or in the
case of the uranium injections at Rochester where acute effects were sought, the
experiments are more morally offensive.

Consideration for the basic moral principle that people not be put at risk of
harm is apparently what animated the decision to give higher doses to only
"terminal" patients who could not survive long enough for harms to materialize.
A person who is dying may have fewer interests in the future than a person who is
not. This does not mean, however, that a dying person is owed less respect and
may be used, like an object, as a mere means to the ends of others. There are
many moral questions about research on patients who are dying; the desperation
of their circumstances leaves them vulnerable to exploitation. At a minimum,
nontherapeutic research on a dying patient without the patient's consent or the
authorization of an appropriate family member is clearly unethical.

Uranium was also injected in eleven patients with terminal conditions at
Massachusetts General Hospital in an experiment conducted jointly by the
hospital and Oak Ridge National Laboratory from 1953 to 1957. ORNL's purpose
was to obtain data for setting nuclear worker safety standards. A second purpose
was to identify a radioisotope that would localize in brain tumors and destroy
them when activated by a neutron beam. Although all but one of the patient-
subjects had brain cancer, the limited purpose of the experiment— to establish
whether uranium would localize sufficiently—meant that there was no expectation
that patient-subjects might benefit medically from the uranium injections.

The uranium doses in the Boston experiment were comparable to or higher
than the one that caused measurable physical harm in the Rochester subject.
Boston subjects were apparently subjected to brain biopsies, presumably solely

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for scientific purposes. At least three Boston subjects showed kidney damage at
the time of death. In one of these cases, a trauma victim who was found
unconscious, the autopsy report recorded clinical evidence of some amount of
kidney failure and pathological evidence of kidney damage due to the chemical
toxicity of uranium.

The only evidence available about what the Boston subjects were told
comes from 1995 testimony of one of the investigators, Dr. William Sweet, who
said it was his practice to "give a patient all the information we had ourselves."
Presumably this would have included that the injections had no prospect of
benefiting the patient. The Boston Project was an instance in which high doses
were given to dying patients. Some of these patients were comatose or otherwise
suffering from severe, irreversible central nervous system disease. Unless these
patients, or the families of comatose or incompetent patients, understood that the
injections were not for their benefit and still agreed to the injections, this
experiment also was unethical. There was no justification for using dying
patients as mere means to the ends of the investigators and the AEC. In at least
one case, this disrespectful treatment clearly occurred. The trauma victim who
arrived at the hospital unconscious was used as a subject despite the fact that his
identity was never known. Presumably he was not accompanied by any family or
friends who might have authorized such a use of his body.

Only extraordinary circumstances can justify deception and the use of
people as mere means by government officials and physicians in the conduct of
research involving human subjects. In the case of the injection experiments, we
see no reason that the laudable goals of the research could not have been pursued
in a morally acceptable fashion. There is no reason to think that people would not
have been willing to serve as subjects of radiation research for altruistic reasons,
and indeed there is evidence of people writing to the AEC to volunteer
themselves for just such efforts (see chapter 13).

That people are not likely to live long enough to be harmed does not
justify failing to respect them as people. Concerns about adverse public relations
and legal liability do not justify deceiving subjects, their families, and the public.
Insofar as basic moral principles were violated in the conduct of the injection
experiments, the Manhattan Engineer District, the AEC, the responsible officials
of these agencies, and the medical professionals responsible for the injections are
accountable for the moral wrongs that were done.

269

ENDNOTES

1. Don Mastick, telephone interview with Steve Klaidman (ACHRE), 23 July 1995
(ACHRENo. IND-072395-F), 1.

2. L. H. Hempelmann, Los Alamos Laboratory Health Division Leader, to J. R.
Oppenheimer, Director, Los Alamos Laboratory, 16 August 1944 ("Health Hazards
Related to Plutonium") (ACHRE No. DOE-051094-A-17), 1.

3. J. R. Oppenheimer, Director, Los Alamos Laboratory, to L. H. Hempelmann,
Los Alamos Laboratory Health Division Leader, 16 August 1944 ("Your memorandum
of August 16, 1944") (ACHRE No. DOE-051094-A-17), 1.

4. L. H. Hempelmann, Los Alamos Laboratory Health Division Leader, to J. R.
Oppenheimer, Director of the Los Alamos Laboratory, 29 August 1944 ("Medical
Research Program") (ACHRE No. DOE-051094-A-17), 1.

5. Interview with Mastick, 23 July 1995, 1.

6. Glenn Seaborg, head of Chemistry Section C-l of the Metallurgical
Laboratory, to Robert Stone, Health Director of the Metallurgical Laboratory, 5 January
1944 ("Physiological Hazards of Working with Plutonium") (ACHRE No. DOE-070194-
A-3), 1.

7. Ibid.

8. Robert Stone, Health Director of the Metallurgical Laboratory, to Glenn
Seaborg, Head of the Chemistry Section C-l of the Metallurgical Laboratory, 8 January
1944 ("Hazards of Working with Plutonium") (ACHRE No. DOE-070194-A-4), 1.

9. Seaborg suggested that several milligrams of the first shipment of plutonium
from Oak Ridge be sent on to Dr. Hamilton at Berkeley. A minute amount of plutonium
was sent to Hamilton, who began his studies on rats in February 1944. Next came more
animal work at Chicago, focusing on the toxic effects of plutonium, as well as its
distribution in various tissues. These studies showed that plutonium, like radium, was a
"bone-seeking" element, the potential deadly consequences of which radium had already
demonstrated. Furthermore, these studies demonstrated that in rats, plutonium distributed
itself in bone in a potentially more hazardous way than radium. J. Newell Stannard,
Radioactivity and Health: A History (Oak Ridge, Tenn.: Office of Scientific and
Technical Information, 1988), 1424.

10. Richard Rhodes, The Making of the Atomic Bomb (New York: Simon and
Schuster, 1986), 547-548.

11. Ibid., 560.

12. The most likely route of worker exposure to plutonium would be inhalation.
Hempelmann and others wrote to Oppenheimer in March 1945 that "the very important
and difficult problem of detection of alpha active material in the lungs has been studied
only at this project and here only on a very limited scale. This problem should be given
much higher priority here and at other projects." L. H. Hempelmann, Los Alamos
Laboratory Health Division Leader et al., to J. R. Oppenheimer, Director of the Los
Alamos Laboratory, 15 March 1945 ("Medical Research of Manhattan District concerned
with Plutonium") (ACHRE No. DOE-051094-A-17), 1. Inhalation experiments with
rodents were undertaken, starting in 1944, at the University of California's Radiation
Laboratory and the University of Chicago's Metallurgical Laboratory, although these
studies did not result in extensive analysis of data until the latter half of the 1940s. W. H.

270

Langham and J. W. Healy, "Maximum Permissible Body Burdens and Concentrations of
Plutonium: Biological Basis and History of Development," in Uranium - Plutonium -
Transplutonic Elements, eds. H. C. Hodge et al. (New York: Springer- Verlag, 1973),
576. Wright Langham wrote in 1945 that "if a limited amount of human tracer data are to
form the basis of a method of diagnosing internal body contamination," it would be
necessary "to assume that [plutonium] is metabolized in the same way regardless of the
route of absorption or administration." Wright Langham, Los Alamos Laboratory Health
Division, 28 July 1945 ("Report of Conference on Plutonium-May 14th and 15th")
(ACHRE No. DOE-05 1 094-A-427), 29. Since the time of the experiments, it has become
clearer that the deposition of plutonium in the body can differ in cases of chronic
inhalation exposure versus other types of exposures.

13. Langham and Healy, "Maximum Permissible Body Burdens and
Concentrations of Plutonium," 576.

14. L. H. Hempelmann, Los Alamos Laboratory Health Division Leader, to J.
R. Oppenheimer, Director of the Los Alamos National Laboratory, 26 March 1945
("Meeting of Chemistry Division and Medical Group") (ACHRE No. DOE-05 1094-A-
17), 1.

15. J. R. Oppenheimer, Director, Los Alamos Laboratory, to Colonel S. L.
Warren, 29 March 1945 ("We are enclosing a record of discussions . . .") (ACHRE No.
DOE-05 1094-A- 17), 1.

16. Samuel Bassett [attr.], undated ("Excretion of Plutonium Administered
Intravenously to Man. Rate of Excretion in Urine and Feces with Two Observations of
Distribution in Tissues") (ACHRE No. DOE-121294-D-10), 29.

17. Division of Biomedical and Environmental Research and Division of
Inspection, AEC, 13 August 1974 ("Disclosure to Patients Injected with Plutonium")
(ACHRE No. DOE-05 1094-A-586), 11.

18. Ibid.

19. Ibid., 10.

20. Wright Langham, Los Alamos Laboratory Health Division, to Hymer
Friedell, Executive Officer of the Manhattan District's Medical Section, 6 April 1945
("Although we sent you directions for the 49 experiment along with the material . . .")
(ACHRE No. DOE-120894-E-1), 1.

2 1 . Wilson O. Edmonds, AEC Resident Investigator, to Jon D. Anderson,
Director, Division of Inspection, 15 July 1974 ("Division of Biomedical and
Environmental Research, Headquarters-Request to Locate Mr. Ebb Cade") (ACHRE
No. DOE-05 1 094- A-6 11), 2.

22. Undated document ("Experiment I on P. 49+4") (ACHRE No. DOE-
113094-B-5), 1.

23. The Committee uses names of subjects in this chapter only where the names
were already a matter of public record.

24. "Experiment I on P. 49+4," 1.

25. Ibid.

26. Hannah E. Silberstein, University of Rochester, to Wright Langham, Los
Alamos Laboratory Health Division, 25 October 1945 ("This letter is to report the
injection on the second human product subject, HP-2 . . .") (ACHRE No. DOE-121294-
D-19), 1.

271

27. W. H. Weyzen, 25 April 1974 ("Visit with Dr. Joe Howland, Chapel Hill
Holiday Inn, April 24, 1974") (ACHRE No. DOE-121294-D-18), 1.

28. Hymer Friedell, interviewed by Steve Klaidman and Ron Neumann
(ACHRE), transcript of audio recording, 23 August 1994 (ACHRE Research Project
Series, Interview Program File, Targeted Interview Project), 49-50.

29. "Experiment I on P. 49+4," 3.

30. Ibid.

31. Ibid., 2.

32. Captain David Goldring, Medical Corps, to Wright Langham, Los Alamos
Laboratory Health Division, 19 September 1945 ("Enclosed is a brief resume of E. C.'s
medical history . . .") (ACHRE No. NARA-082294-A-47), 1.

33. Karl Morgan, interviewed by Gil Whittemore and Miriam Bowling
(ACHRE), transcript of audio recording, 6 January 1995 (ACHRE Research Project
Series, Interview Program File, Targeted Interview Project), 147.

34. Edmonds to Anderson, 15 July 1974, 3.

35. "Experiment I on p. 49+4," 3.

36. On 7 May 1945 Germany had surrendered to the Allied forces. The
Manhattan Engineer District continued on with the building and testing of the first
atomic bomb (the first test was scheduled for July of that year).

37. Robert Stone, Health Director of the Metallurgical Laboratory, to Stafford
Warren, Hymer Friedell et al., undated ("On Monday, May 14th, we plan to have an all
day meeting dealing with plutonium . . .") (ACHRE No. N ARA-082294-A-5 1 ), 1 .

38. Wright Langham, Los Alamos Laboratory Health Division, 28 July 1945
("Report of Conference on Plutonium-May 14th and 15th") (ACHRE No. DOE-051094-
A-427), 29.

39. Colonel Hymer Friedell, Executive Officer of the Manhattan District's
Medical Section, to L. H. Hempelmann, 1 1 April 1945 ("Enclosed is a protocol of the
clinical experiment as we intend to carry it out . . .") (ACHRE No. DOE-121294-D-1), 1.

40. Ibid.

41. J. J. Nickson to R. S. Stone, 23 January 1946 ("Abstract of Monthly Report
for January, 1946") (ACHRE No. DOE-051094-A), 1.

42. E. R. Russell and J. J. Nickson, 2 October 1946 ("The Distribution and
Excretion of Plutonium in Two Human Subjects") (ACHRE No. DOE-051094-A-370),
1.

43. Ibid.

44. Ibid.

45. Ibid., 2.

46. Ibid.

47. Nickson to Stone, 23 January 1946, 1.

48. Sidney Marks, 3 May 1974 ("Interview with Dr. Leon Jacobson ... by
Marks and Miazga at about 1:30 p.m. on 4/16/74") (ACHRE No. DOE-121294-D-15), 2.

49. W. H. Weyzen, 25 April 1974 ("Visit with Edwin R. Russell, Savannah
River Plant, April 23, 1974") (ACHRE No. 121294-D-17), 1.

50. Andrew H. Dowdy, Director of AEC Rochester Project ("Proposed Research
Program and Budget: July 1, 1947 - July 1, 1948") (ACHRE No. DOE-061794-B-16).

272

51. William F. Bale, Head of Special Problems Division, undated
("Contributions of the Division of Special Problems to the Manhattan Project") (ACHRE
No. DOE-113094-B), 1.

52. L. H. Hempelmann and Wright H. Langham, undated ("Detailed Plan of
'Product' Part of Rochester Experiment") (ACHRE No. 121294-D-2), 5.

53. W. H. Langham. undated ("Revised Plan of 'Product' Part of Rochester
Experiment") (ACHRE No. DOE-121294-D-3), 2.

54. The choice not to use subjects suffering from malignant conditions is
discussed retrospectively in a partial draft version of the 1950 report (probably written
by Dr. Bassett). This discussion was not included in the final version of the report:

The individuals chosen as subjects for the experiment
were a miscellaneous group of male and female hospital
patients for the most part with well established
diagnoses. Preference was given to those who might
reasonably gain from continued residence in the hospital
for a month or more. . . . Patients with malignant disease
were also omitted from the group on the grounds that
their metabolism might be affected in an unknown
manner.
Bassett, "Excretion of Plutonium Administered Intravenously to Man," 2.

55. Ibid.

56. Wright Langham et al., 20 September 1950 ("Distribution and Excretion of
Plutonium Administered Intravenously to Man") (ACHRE No. DOE-070194-A-18). 10.

57. Wright Langham. 27 September 1957 ("Proceedings of the Second Annual
Meeting on Bio- Assay and Analytical Chemistry: October 1 1 and 12, 1956 ~ Panel
Discussion of Plutonium") (ACHRE No. DOE-120894-C-1), 80.

58. W. H. Langham et al.. "The Los Alamos Scientific Laboratory's Experience
with Plutonium in Man," Health Physics 8 (1962): 755.

59. Addison's disease is an endocrine disease produced by adrenal gland failure.
Today this disease is treated with steroid therapy that was developed in the 1940s and
that was extremely expensive at the time of the experiments. HP-6, diagnosed with
Addison's, was given steroid treatment as part of his care at the University of Rochester;
he lived until 1984.

Scleroderma is a collagen-vascular disease that can produce extreme pain,
especially in the hands; can affect eating and swallowing if the esophagus is involved;
and eventually leads to organ failure and death. Steroids are the treatment of choice
today, but if this disease is not well controlled it can still be fatal. HP-8, who was
diagnosed with scleroderma, lived until 1975.

60. Bassett, "Excretion of Plutonium Administered Intravenously to Man," 2.
Her provisional diagnosis according to this report was mild hepatitis and malnutrition.
Ibid, 18. Her medical records indicate, however, that she had symptoms related to
nutritional deficiencies, which appear to have been alleviated with proper diet and rest.
Strong Memorial Hospital, 20 December 1945 ("Discharge Summary Form") (ACHRE
No. DOE-051094-A-612), 1.

61 . Wright Langham, Los Alamos Laboratory Health Division, to Samuel
Bassett, Head of Metabolism Ward of Strong Memorial Hospital, 13 March 1946 ("Your

273

letter of February 27 regarding Hp 1 1 was startling, to say the least . . .") (ACHRE No.
DOE-121294-D-4), 1.

62. Document dated 17 April 1974 ("Comments on Meeting with Dr.
Hempelmann on April 17, 1974") (ACHRE No. DOE-121294-D-16), 1.

A 1955 letter from Dr. Hempelmann to the AEC's Division of Biology and
Medicine (discussed in more detail in chapter 13) indicates Hempelmann's belief that, in
general, patients could be easily deceived about the true research purpose of a medical
intervention. In this letter, Hempelmann (who was by then professor of experimental
radiology at Rochester) is proposing that researchers present themselves as life insurance
agents to AEC workers as a ruse, in order to conceal the true purpose of follow-up
medical examinations. He observes that it would be more difficult to deceive workers
than it would be to mislead patients in a hospital:

If you feel that the physical examinations are vital to the
survey, then, perhaps, you could offer to pay the people
to compensate them for the time and effort that they will
spend on the part of your alleged survey for the
insurance company. They would think they were getting
something for nothing and might not feel that you were
worried or they were seriously ill. I don't know if these
ideas are helpful at all. It is more difficult to find an
excuse for these individual workers than it is in the case
of patients who were treated for something or other at a
hospital.
Louis Hempelmann, University of Rochester, to Charles Dunham, Director, AEC
Division of Biology and Medicine, 2 June 1955 ("I did not have an opportunity . . ." )
(ACHRE No. DOE-092694-A), 1.

63. Patricia Durbin, 9 December 1971 ("Report on Visit to Rochester")
(ACHRE No. DOE-121294-D-I2), 1.

64. Patricia Durbin, 10 December 1971 ("Dr. Wright Langham, of the Los
Alamos Scientific Laboratory, was the biochemist who performed the Pu analyses . . .")
(ACHRE No. DOE-121294-D-13), 1.

65. "Comments on Meeting with Dr. Hempelmann on April 17, 1974," 1.

66. Langham further instructed Rochester to look for the following longer-term
"symptoms" in the examination of the patients: "Judging from the recent observations
that Robley Evans has made, a generalized osteitis with rarefaction of the bones of the
feet, the jaw and the heads of the long bones with coarsening of the trabeculae are the
most likely symptoms." Wright Langham, Los Alamos Health Division, to Dr. Joe
Howland, Chief of University of Rochester's Division of Medical Services, 2 October
1950 ("I am very glad to hear that you will manage to get follow-ups on the two subjects
. . .") (ACHRE No. DOE- 1 2 1 294-D- 1 1 ), 1 .

67. Wright Langham, Los Alamos Laboratory Health Division, to Samuel
Bassett, Head of Metabolism Ward of Strong Memorial Hospital, 25 October 1946 ("I
just received a shipment of samples which I am sure are the ones you collected on HP-3 .
. .") (ACHRE No. DOE-121294-D-5), 1.

68. Samuel Bassett et al., 19 July 1948 ("The Excretion of Hexavalent Uranium
Following Intravenous Administration II. Studies on Human Subjects") (ACHRE No.
CON-030795-A-1), 8.

274

69. Andrew H. Dowdy, Director, Manhattan Department, University of
Rochester, to the Area Engineer, Rochester Area, 22 October 1946 ("Clearance of
Material for Seminar") (ACHRE No. DOE-120994-A-4), 1.

70. Madison Square Area Engineer, 24 October 1946 ("Uranium Studies in
Humans") (ACHRE No. DOE 120994-A-4), 1.

71. Robert M. Fink ("Biological Studies with Polonium, Radium, and
Plutonium") (ACHRE No. CON-030795-A-2), 122.

72. K. Z. Morgan, Oak Ridge National Laboratory Health Physics Division, to
R. S. Stone, Health Director of the Metallurgical Laboratory, 5 May 1945 ("Tolerance
Values for Polonium Used at Clinton Laboratories") (ACHRE No. DOE-1 13094-B-6), 2.

73. Fink, "Biological Studies with Polonium, Radium, and Plutonium," 122.

74. A supplemental volume contains a chapter on the development of human
subject research at the University of California at Berkeley and San Francisco.

75. Hamilton's work with plutonium had begun in 1 942 with support from the
Office of Scientific Research and Development; it was later supported by the Manhattan
Engineer District.

76. Joseph Hamilton, Radiation Laboratory of University of California at
Berkeley, to Colonel E. B. Kelly, 28 August 1946 ("Summary of Research Program for
Contract #W-7405-eng-48-A") (ACHRE No. DOE-1 13094-B-8), 2.

77. Joseph Hamilton, 1 1 January 1945 ("Proposed Biochemical Program at
University of California") (ACHRE No. IND-071395-A-14), 2.

78. Ibid.

79. At least eleven patients were injected with columbium (later renamed
niobium) or zirconium between 1 948 and 1 950. These experiments appear to have been
outside the federal effort.

80. Joseph Hamilton, 10 May 1945 ("Progress Report for Month of May 1945")
(ACHRE No. DOE-072694-B-65), 4.

81. Joseph Hamilton, 14 June 1945 ("Progress Report for Month of June 1945")
(ACHRE No. DOE-072694-B-66), 4.

82. Ibid.

83. Joseph G. Hamilton, Radiation Laboratory, University of California,
Berkeley, to Captain Joe W. Howland, 23 April 1946 ("The problems of the research
program . . .") (ACHRE No. DOE-120894-E-40), 2.

84. Joseph G. Hamilton, Radiation Laboratory, University of California,
Berkeley, to Robert Stone, Metallurgical Laboratory, 7 July 1945 ("I am writing
concerning our experimental subject . . .") (ACHRE No. IND-071395-A), 1.

85. Joe W. Howland, First Lieutenant. Medical Corps, to the Area Engineer,
California Area, 12 July 1945 ("Status of Experimental Subject") (ACHRE No. IND-
071395-A), 1.

86. Kenneth Scott, interviewed by Sally Hughes (University of California Oral
History Project), transcript of audio recording, 17 December 1979, 49-50.

87. Ibid.

88. Hamilton, "Progress Report for Month of June 1945," 4.

89. Joseph Hamilton, 14 September 1945 ("Progress Report for Month of
September 1945") (ACHRE No. DOE-072694-B-67), 5.

275

90. "Mercy Flight Brings Aussie Boy Here: Suffering From Rare Bone Ailment,
He Seeks U.S. Treatment," San Francisco Examiner, 16 April 1946, 1.

91. In addition to this injection, which was not performed for his benefit, the
child also received superficial external radiation (five doses of 250 rad over five days)
for palliation of his pain. A 1995 report written by an ad hoc committee at the University
of California at San Francisco (UCSF) described the child's prognosis as having been
"grave with palliation the only option." With that in mind, superficial irradiation was
performed to reduce the patient's pain, not to destroy the sarcoma of the right leg.
University of California at San Francisco, February 1995 ("Report of the USCF Ad Hoc
Fact Finding Committee on World War II Human Radiation Experiments, February 1995,
Appendix 19: Summary of the medical record of CAL-2") (ACHRE No. UCSF-022495-
A-6), 3.

92. UCSF, "Report of the USCF Ad Hoc Fact Finding Committee," 27.

93. Loren J. Larson, Assistant in Orthopedic Surgery, University of California
Hospital, 1 1 June 1946 ("To Whom It May Concern . . .") (ACHRE No. DOE-05I094-A-
605), 2.

94. Joseph Hamilton, Radiation Laboratory of the University of California at
Berkeley, to Samuel K. Allison, 1 1 September 1945 ("Plans for Future Biological
Research") (ACHRE No. IND-071395-A-2), 3.

95. UCSF, "Report of the USCF Ad Hoc Fact Finding Committee," 27.

96. Joseph Hamilton, Radiation Laboratory of the University of California at
Berkeley, to John Fulton, Historical Library, Yale University Medical Center, 19 July
1946 ("Inasmuch as both the Lawrence brothers are away at the moment, I thought it
best that I answer your letter of July 16, 1946, to John . . .") (ACHRE No. DOE-122294-
A-3), 1.

97. T. S. Chapman, Chief of Operations Branch, Research Division, to Area
Engineer, Berkeley Area, 30 December 1946 ("Human Experiments") (ACHRE No.
DOE-112194-D-3), 1.

98. Form dated 2 May 1946 ("Consent for Operation and/or Administration of
Anaesthetic") (ACHRE No. DOE-051094-A-604), 1.

99. Colonel K. D. Nichols, Corps of Engineers, to the Area Engineer, California
Area, 24 December 1946 ("Administration of Radioactive Substances to Human
Subjects") (ACHRE No. DOE-1 I3094-B-2), 1. This order followed a renewed request to
the Army by Hamilton for additional plutonium, "to be used for certain human studies,"
and a further progress report on the injection of Albert Stevens.

100. John L. Burling, AEC Legal Division, to Edwin E. Huddleson, AEC
Deputy General Counsel, 7 March 1947 ("Clinical Testing.") (ACHRE No. DOE-
051094-A-468), 1.

101. Undated document ("CH-3607 . . . Excerpts from statements of reviewers")
(ACHRE No. 113094-B-9), I.

102. Ibid.

103. Ibid. For discussion of classification levels, see chapter 13.

104. "Off Project" probably refers to work not sponsored by the AEC.

105. Major B. M. Brundage, Chief, Medical Division, to Declassification
Section, 19 March 1947 ("Clearance of Technical Documents") (ACHRE No. DOE-
113094-B-4), 1.

276

106. Hoylande D. Young, Argonne National Laboratory, to Charles A. Keller,
25 July 1947 ("Declassification has been refused for the following reports . . .") (ACHRE
No. NARA-050995-A-6), 1.

107. Carroll Wilson, AEC General Manager, to Robert Stone, University of
California Medical Center, 12 August 1947 ("Declassification of Biological and Medical
Papers") (ACHRE No. DOE-061394-A-1 11), 1.

108. Wright Langham, Los Alamos Laboratory Health Division, to Stafford
Warren, University of California, 1 July 1950 ("Dr. Bassett has been here and helped me
finish the semi-final draft of the Plutonium Report . . .") (ACHRE No. DOE-082294-B-
72), 1.

109. Wright Langham, Los Alamos Laboratory Health Division, to Joe W.
Howland, Chief, Division of Medical Services, University of Rochester School of
Medicine and Dentistry, 15 April 1950 ("1 am curious to hear your reaction to the names
that I sent you . . .") (ACHRE No. DOE-082294-B-73), 1 .

1 10. Andrew H. Dowdy, Director of the Manhattan Department, University of
Rochester, to Norris E. Bradbarry [sic], Director of the Los Alamos Laboratory, 18
February 1947 ("Dr. Wright Langham and Dr. Samuel Bassett were discussing with me
today the technical details relative to writing the report . . .") (ACHRE No. DOE-121294-
D-6), 1.

111. Langham to Warren, 1 July 1950, 1.

112. Walter D. Claus, Acting Chief, Biophysics Branch, AEC Division of
Biology and Medicine, to Wright Langham, Los Alamos Laboratory Health Division, 30
August 1950 ("You will be pleased to learn that Dr. Shields Warren has approved your
report for CONFIDENTIAL classification . . .") (ACHRE No. DOE-082294-B-2), 1 .

113. It is not clear when CH-3607, the report Dr. Friedell recommended for
declassification in December 1946, was declassified. The copy retrieved by the
Committee bears a 31 December 1946 declassification date and no indication of
subsequent reclassification. Russell and Nickson, "The Distribution and Excretion of
Plutonium in Two Human Subjects," 1 . In 1956 Dr. Langham made a brief reference to
fifteen experimental subjects at an unclassified technical conference. Langham,
"Proceedings of the Second Annual Meeting on Bio-Assay and Analytical Chemistry,"
80. In 1951, a report, based on Metallurgical Laboratory Memorandum MUC-ERR-209
("Distribution and Excretion of Plutonium") appeared in a volume of the public
Manhattan District research history.

1 14. While the Wilson letters do not expressly reference the plutonium
experiments, the context seems to leave little question that the policies stated in the
letters were arrived at with the plutonium experiments in mind. In 1974, when asked
what steps had been taken when the plutonium injections had been brought to the
attention of the AEC, Shields Warren, who became director of the AEC's Division of
Biology and Medicine in late 1947, said that it had been decided "that the rules [should
be] properly drawn up by the ... Human Applications Isotope Committee ... so that
use without full safeguards could not occur, and that . . . nothing of the sort could
happen in the future." Shields Warren, interviewed by L. A. Miazga, Sidney Marks, and
Walter Weyzen (AEC), transcript of audio recording, 9 April 1974 (ACHRE No. DOE-
121294-D-14), 10.

115. Carroll Wilson, AEC General Manager, to Stafford Warren, University of
California, 30 April 1947 ("This is to inform you that the Commission is going ahead

277

with its plans to extend the medical research contracts . . .") (ACHRE No. DOE-051094-
A-439), 2.

1 16. Carroll Wilson, AEC General Manager, to Robert Stone, University of
California Medical School, 5 November 1947 ("Your letter of September 18 regarding
the declassification of biological and medical papers was read . . .") (ACHRE No. DOE-
061395-A-112), 1.

1 17. Dowdy, "Proposed Research Program and Budget: July 1, 1947-July 1,
1948," 25.

1 18. A December 1947 memorandum from Dr. Bassett recorded:

In the autumn of 1 945 the Section on Human
Metabolism was activated under your direction at the
request of the Manhattan Engineer District to carry out
certain tracer studies with long-lived isotopes. As you
know, this program was discontinued in the spring of
1 947 under a directive from the Atomic Energy
Commission although we were instructed to keep the
personnel of the section intact. When this directive was
received, it was anticipated that follow-up studies on the
several subjects of the original investigation would
provide occupation for the employees of the section.
Samuel H. Bassett, Section on Human Metabolism, University of Rochester, to William
F. Bale, Head of Special Problems Division, University of Rochester, 2 December 1947
("Proposal of Work for Metabolism Section") (ACHRE No. DOE-121294-D-7), 1.
Dr. Bassett proposed an interim activity for the employees of the section— a
study of certain aspects of radiation injury. This was approved by Bale until "the project
research program of the Metabolism Section . . . with regard to tracer studies with heavy
elements is clarified." William F. Bale, Head of Special Problems Division, University
of Rochester, to Andrew H. Dowdy, Director of AEC's Rochester Project, 3 December
1947 ("Program of Work for Metabolism Section") (ACHRE No. DOE-121294-D-8), 1.

1 19. Gilbert Whittemore, 3 March 1995 ("Shields Warren Papers: A Cumulative
Update of Excerpts") (ACHRE No. BU-030395-A-1), 3.

120. Ibid.

121. Interview with Warren, 9 April 1 974, 1 1 .

122. Ibid.

123. Ibid. According to Dr. Durbin, it is likely that the "other substances"
referred to were probably phophorus 32 and strontium 89, which were used at the
University of California between 1941 and 1944 as experimental tracers or for palliation
of pain. Dr. Patricia Durbin, telephone interview with Miriam Bowling (ACHRE), 2
August 1995 (ACHRE No. ACHRE-081095-A), 1.

124. Undated note in medical record of CAL-A from "K..G.S." (Ken G. Scott
[attr.]) ("The day after solution is injected . . .") (ACHRE No. UCLA-1 1 1094-A-l), 1.

125. Telephone interview with Durbin, 2 August 1995, 1.

126. Lori Hefner; telephone interview by John Kruger (ACHRE), 6 July 1995
(ACHRE No. IND-070695-A), 1.

127. Note in medical record of CAL-3 dated 1 8 July 1 947 ("Elmer Allen
Chart") (ACHRE No. DOE-051094-A-615), 2.

278

128. Wilson to Warren, 30 April 1947, 2.

129. UCSF, "Report of the USCF Ad Hoc Fact Finding Committee, Appendix
20: Summaries of the medical record of CAL-3," 3-4.

130. Ibid., 4. If the diagnosis was correct, surgical amputation would have been
appropriate treatment at the time to completely excise the tumor.

131. B. V. Low Beer et al., Radiation Laboratory, University of California,
Berkeley, 15 March 1948 ("Comparative Deposition of Zr-95 in a Reticulo-Endothelial
Tumor to Normal Tissues in a Human Patient") (ACHRE No. DOE- 101 194-B-4), 4.

1 32. Ibid. The test dose was administered to the patient just twenty-four hours
prior to the midthigh amputation of her leg for cancer.

133. Shields Warren, Director of AEC's Division of Biology and Medicine, to
Albert H. Holland, Jr., AEC Medical Adviser, 19 August 1948 ("Review of Document")
(ACHRE No. DOE-101494-B), 1.

134. Albert H. Holland, Jr., AEC Medical Adviser, to Shields Warren, Director
of AEC's Division of Biology and Medicine, 9 August 1948 ("Review of Document")
(ACHRE No. DOE-051094-A), I.

135. Langham to Howland, 2 October 1950, 1.

136. Wright Langham, Los Alamos Laboratory Health Division, to Albert H.
Holland, AEC Director of Research and Medicine, 20 March 1950 ("It seems that I
really fouled up regarding my promise to you at the Washington meeting . . .") (ACHRE
No. NARA-082294-A-155), 1.

137. L. H. Hempelmann. University of Rochester, to Charles Dunham, AEC
Division of Biology and Medicine, 23 May 1953 ("There are several things on my mind
that I would like to bring to your attention . . .") (ACHRE No. DOE-041495-A-1), 1.

138. Walter D. Claus, Acting Chief of the Biophysics Branch, AEC Division of
Biology and Medicine, to Charles L. Dunham, Chief, Medical Branch, 31 August 1950
("Physical Examinations at Rochester") (ACHRE No. DOE-051094-A-471), 1.

139. Interview with Warren, 9 April 1974, 8.

140. Patricia W. Durbin, University of California, to William E. Lotz, AEC
Division of Biology and Medicine, 13 September 1968 ("You will never guess what I
found today . . .") (ACHRE No. DOE-051094-A-606), 1.

141. Ibid.

142. Ibid.

143. Patricia Durbin, 1 972 ("Plutonium in Man: A New Look at the Old Data")
(ACHRE No. DOE-051094-A-160), 469.

144. R. E. Rowland, Argonne National Laboratory's Center for Human
Radiobiology, 8 November 1973 ("Plutonium Studies at the Center for Human
Radiobiology [CHR]") (ACHRE No. DOE-051094-A-608), 4.

145. I. E. Kirch, Radiological and Environmental Research Division, Argonne
National Laboratory, 13 June 1973 ("Center for Human Radiobiology: Radiologist's
Report") (ACHRE No. DOE-051094-A-616), 1. The report records: "In the proximal
portions of both humeri as well as in the adjacent acromions, there are some changes in
the trabeculae which are consistent with findings in early radium deposition, but not yet
completely specific. The mandible shows abnormal trabeculae, suggestive of damage
due to radiation."

Subclinical bone changes were also observed in a deceased subject who was
exhumed for the Argonne study. The same radiologist summarized that an "abnormality

279

is present, namely, that there are very many very small very dense deposits on the
surfaces of a number of the bones, and other such deposits in the soft tissues very close
to the bone surfaces. This abnormality is attributed to the plutonium which has been
administered during the subject's life. The radiographic pattern is unique." I. E. Kirch,
Radiological and Environmental Research Division, Argonne National Laboratory, 15
November 1974 ("Center for Human Radiobiology: Radiologist's Report") (ACHRE No.
DOE-051094-A-618), 1.

146. AEC Division of Biomedical and Environmental Research and Division of
Inspection, 13 August 1974 ("Disclosure to Patients Injected With Plutonium") (ACHRE
No. DOE-051094-A-586), 10.

147. Ibid.

148. Ibid.

149. Ibid.

150. Ibid.

151. Robert E. Rowland, Argonne National Laboratory, to H. A. Schultz, 21.
December 1972 ("Plutonium Cases") (ACHRE No. DOE-080795-A), 1.

152. Robert E. Rowland to Miriam Bowling (ACHRE Staff), 7 August 1995
("Attached is the memo of December 2 1 , 1972 . . .") (ACHRE No. DOE-080795-A), 1.

153. Ibid.

154. James L. Liverman to Miriam Bowling (ACHRE Staff), 20 August 1995
("With your fax of August 9 was included . . .") (ACHRE No. IND-082095-A), 1.

155. James L. Liverman, 29 April 1974 ("Briefing on Plutonium Project by Dr.
James L. Liverman on April 29, 1974") (ACHRE No. DOE-051094-A-I96), 8. The 1971
protocol referred to in this briefing had covered a follow-up project involving the radium
dial painters. Although the procedures for the two follow-up studies were similar, the
original conditions of exposure were quite different. The radium dial painters, unlike the
plutonium-injection subjects, had not been chosen as subjects in a carefully planned
medical experiment organized by the government. They had been exposed either
occupationally as dial painters or therapeutically as patients receiving one of a variety of
prewar radium treatments.

156. Signed form dated 28 August 1974 ("Acknowledgement of Disclosure")
(ACHRE No. DOE-051094-A-619), 1.

157. Document dated 24 May 1974 ("Patients Injected with Plutonium [Draft
Report of 5-24-74]") (ACHRE No. DOE-051094-A-607), 1.

158. There is some evidence suggesting that at least one subject had a serious
emotional reaction to the news, many years after the fact, that she had been injected with
plutonium. This suggests that physicians involved in the follow-up had cause to be
concerned about how at least some patients might respond to knowledge of the injections.

159. K. F. Eckerman to Barry A. Berven, 7 January 1994 ("The Boston-Oak
Ridge Uranium Study") (ACHRE No. DOE-051094-A-425), 1.

160. John C. Gallimore, Associate Health Physicist, to Dr. W. H. Sweet,
Massachusetts General Hospital, 22 March 1954 ("First Results of Uranium Distribution
and Excretion Study") (ACHRE No. NARA-082294-A-35), 1.

161. S. R. Bernard, "Maximum Permissible Amounts of Natural Uranium in the
Body, Air and Drinking Water Based on Human Experimental Data," Health Physics 1
(1958): 288-305.

280

162. According to the 1957 interim report on the study, it was Harold Hodge of
the University of Rochester's Atomic Energy Project, who had been involved with the
MED metabolism work at Rochester, who ultimately coordinated the beginning of the
joint research. S. R. Bernard and E. G. Struxness, 4 June 1957 ("A Study of the
Distribution and Excretion of Uranium in Man: An Interim Report") (ACHRE No. DOE-
051094-A-369), 3.

163. Bernard, "Maximum Permissible Amounts of Natural Uranium in the
Body, Air and Drinking Water Based on Human Experimental Data," 296-298; Standards
for Protection Against Radiation, 9 C.F.R. 20 (1958-1994).

1 64. Robert Bernard, interviewed by J. Newell Stannard, transcript of audio
recording, 17 April 1979 (ACHRE No. DOE-061794-A), 8.

1 65. A continuation of the study at lower doses was proposed by the ORNL in
1958; it is unclear whether this project went forward. Karl Morgan, Director of ORNL's
Health Physics Division, to William Sweet, Massachusetts General Hospital, 16 July
1958 ("Your help in our cooperative study on the distribution and excretion of uranium
in man has been of great value to us . . .") (ACHRE No. DOE-021695-A-1 ), 1. A study
similar to the one proposed by the ORNL in 1958 may have taken place during the mid-
1960s at Argonne Cancer Research Hospital. K. Z. Morgan to W. H. Jordan, 3
September 1963 ("Proposed Study of Distribution and Excretion of Enriched Uranium
Administered to Man") (ACHRE No. DOE-051094-A-620), 1.

166. Interview with Morgan, 6 January 1995, 118-119.

1 67. Form dated 3 November 1 953 ("Application for Approval of Radioactive
Isotopes: Massachusetts General Hospital") (ACHRE No. MGH-030395-A-1), 4.

1 68. Leonard Atkins, M.D., 26 June 1 954 ("Necropsy No. : June 26, 1 954 at

12:30 p.m.") (ACHRE No. DOE-050895-D-1), 6.

169. Ibid., 1.

170. Ibid. The "Anatomic Diagnoses" include "Uranium nephrosis, acute."

171. Ibid., 5.

172. Bernard and Struxness, "A Study of the Distribution and Excretion of
Uranium in Man: An Interim Report," 6.

173. Undated document ("#l Cloudy swelling of the epithelium of proximal
and distal convoluted tubules . . .") (ACHRE No. DOE-050895-D-2), 1. The document
records a diagnosis for the two additional patients as "acute nephrosis," and for subject
VI, as "severe subacute nephrosis."

174. Bernard and Struxness, "A Study of the Distribution and Excretion of
Uranium in Man: An Interim Report," 4.

175. William Sweet, interviewed by Gil Whittemore (ACHRE), transcript of
audio recording, 8 April 1995 (ACHRE Research Project Series, Interview Program File,
Targeted Interview Project), 46.

176. By the end of the Committee's deliberations, MGH had not yet completed
its search for the patient records of the Boston Project subjects.

177. Chapman to Area Engineer, Berkeley Area, 30 December 1946, 1 .

178. Weyzen, "Visit with Edwin R. Russell, Savannah River Plant, April 23,
1974," 1.

179. Interview with Warren, 9 April 1974, 1 1 .

180. The relatively small population that has been exposed to substantial levels
of plutonium precludes definitive conclusions about risks to humans, but the available

281

evidence clearly suggests that an epidemic of cancer of the magnitude that afflicted the
radium dial painters from an earlier era has not occurred in plutonium workers. In the
case of the radium dial painters, the unprotected handling of only a few pounds of
radium led to hundreds of deaths; in contrast, studies of plutonium workers suggest that
to date there is no definite excess mortality in this population. A forty-two-year follow-
up of twenty-six Manhattan Project workers who worked with plutonium found a total of
seven deaths, including three cancers (two lung and one osteogenic sarcoma), a
substantially lower mortality rate than expected based on the U.S. population. The
authors concluded that "the diseases and physical changes noted in these persons are
characteristic of a male population in their 60s." G. L. Voelz and J. N. Lawrence, "A 42-
year Medical Follow-up of Manhattan Project Plutonium Workers," Health Physics 61
(1991): 181-190. A larger study of 15,727 LANL workers followed through 1990, some
of whom had plutonium exposures, found no cause of death significantly elevated among
the plutonium-exposed workers compared with unexposed workers, although there was a
nonsignificant 78 percent elevation in lung cancer (a site that is directly exposed) and a
single osteogenic sarcoma, a rare cancer that has been associated with plutonium
exposure in animal studies. L. D. Wiggs, E. R. Johnson, C. A. Cox-DeVore and G. L.
Voelz, "Mortality Through 1990 Among White Male Workers at the Los Alamos
National Laboratory: Considering Exposures to Plutonium and Ionizing Radiation,"
Health Physics 67 (1994): 577-588. Another study of 5,413 workers at the Rocky Flats
Nuclear Weapons Plant found elevated risks for various cancers comparing workers with
body burdens of 2 nanocuries (nCi) or greater, but with wide uncertainties; no excesses
were seen for bone or liver cancers. . The authors concluded that "these findings suggest
that increased risks for several types of cancers cannot be ruled out at this time for
individuals with plutonium body burdens of > 2 nCi. Plutonium-burdened individuals
should continue to be studied in future years." G. S. Wilkinson et al., "Mortality Among
Plutonium and Other Radiation Workers at a Plutonium Weapons Facility," American
Journal of Epidemiology 125 (1987): 231-250.

282

6

The AEC Program of
Radioisotope Distribution

At the dawn of the atomic age, many people hoped for dramatic
advances in medicine, akin to the new miracle drug penicillin. Many of these
hopes have been fulfilled. Radioisotopes have become remarkable tools in three
areas. First, as their travels within the body are "traced," radioisotopes provide a
map of the body's normal metabolic functions. Second, building on tracer
research, diagnostic techniques distinguish between normal and abnormal
functioning. Finally, radioisotopes, carried by the body's own processes to
abnormal or cancerous cells, can deliver a lethal dose of radiation to those
undesirable cells. By supplying radioisotopes and supporting their use, the
Atomic Energy Commission (AEC) actively promoted the research needed to
achieve this progress.

The growth in the applications of radioisotopes involved thousands of
experiments using radioisotopes. No feasible method was found to review in
detail the vast number of individual radioisotope experiments in the Advisory
Committee's database. This was due not only to the large number of experiments,
but also to the scarcity of information about many of the individual experiments.
Both consent and exact dose levels were often not discussed in published work;
no federal repository was found that had collected records documenting these
aspects of experiments. Given the decentralized structure of American medicine,
it is not surprising that the Committee found that records on consent and exact
dose, if they exist, would still be held at the local institutions conducting research
or perhaps even in the private papers of physicians and scientists. Even when

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records were found at the local level, there was little documentation about
consent.

Thus, for the largest group of human radiation experiments, little
documentation remains, and a meaningful examination of all such experiments
was not possible. The Committee instead chose to focus its energies in two
directions: examining the overall system of oversight created by the federal
government and examining small subsets of radioisotope experiments that posed
significant ethical issues. The first effort led to this chapter, an overview of the
system created by the federal government to monitor radioisotope experiments.
The second effort led to the case study on experiments involving children (chapter
7) since those raised questions of both additional biological risk and justification
for doing nontherapeutic research on minors.

The AEC's isotope distribution program was faced with three essential
ethical questions. The most immediate question concerned the allocation of a
scarce resource. Given the likelihood that demand for radioisotopes would exceed
supply, how should priorities be set? The question involved not simply the choice
among competing proposals for "human uses" (including experimentation,
treatment of disease, and diagnosis), but between human uses and other kinds of
uses (for example, basic scientific research or industrial uses).

Another immediate question was the safety with which this new material
would be used. Since the government was actively promoting the use of
radioactive isotopes, it had an obligation to ensure their safe use. Harm to
patients, physicians, and others involved could arise from inexperienced and
untrained users of radioisotopes. When properly used in trace amounts,
radioisotopes posed risks well below those deemed acceptable in occupational
settings. Balancing risks versus benefits—and seeking means to decrease risks and
increase benefits as the field developed— was a major ethical obligation.

Finally, there was the question of the relationship between researcher and
subject— more precisely, the question of the authorization for use in humans and
the process of disclosure and consent, if any, to be followed. These uses can be
divided into (1) therapeutic/diagnostic uses, (2) therapeutic/diagnostic research,
and (3) nontherapeutic research.

As we shall see, great attention was paid initially to the question of
resource allocation; but supply soon proved far greater than expected, and the
need for this attention evaporated. The control of the risk posed by the use of
AEC-provided radioisotopes was also a source of intense focus from the outset
and remained so as the program grew. By contrast, notwithstanding the 1947
declarations by AEC General Manager Carroll Wilson on the importance of
consent, the matter of consent received only limited attention in the early years of
the program.

284

Chapter 6

ORIGINS OF THE AEC RADIOISOTOPE DISTRIBUTION
PROGRAM IN THE MANHATTAN PROJECT

The medical importance of radioisotopes was recognized before World
War II but distribution was unregulated by government. The postwar program
for distributing radioisotopes grew out of the part of the Manhattan Project that
had developed the greatest technical expertise during the war: the Isotopes
Division of the Research Division at Oak Ridge.1 Production of useful
radioisotopes required extensive planning for both their physical creation and
their chemical separation from other materials. Plans to distribute radioisotopes
to medical researchers outside the Manhattan Project were developed in the final

year of the Project.

In June 1946, the Manhattan Project publicly announced its program tor
distributing radioactive isotopes. The new world of radioisotope research was to
be shared with all. Most research would be unclassified.2 An enthusiastic Science
magazine reported: "Production of tracer and therapeutic radioisotopes has been
heralded as one of the great peacetime contributions of the uranium
chain-reacting pile. This use of the pile will unquestionably be rich in scientific,
medical, and technological applications."3 An article in the New York Times
Magazine told readers that "properly chosen atoms can become a powerful and
highly selective weapon for the destruction of certain types of cancer." Until
now "the doctors and biologists have had to plea for samples of isotope material
from their brothers in the cyclotron laboratories. ... Now the picture has changed
in a revolutionary way. The Government has adapted one of the Oak Ridge
uranium piles to the mass production of radioactive 'by-product material."'

Extensive planning led up to this public announcement. Although the
initial expectations were that basic research would precede extensive medical
applications, from the very beginning officials planned for "clinical investigation
with humans. In doing so, they recognized that the "administration to humans
places extreme demands, both moral and legal, upon the specifications and timing
of the radioisotope material supplied."6 The recognition of special moral and
legal aspects of human experimentation and reliance on the professional
competency of those administering radioisotopes formed the cornerstones of the
radioisotope distribution system's oversight of experiments. Significantly,
however, the system was not designed to oversee consent from subjects prior to
the administration of radioisotopes.

Radioisotopes could not simply be ordered from the Manhattan Engineer
District; each purchase had to be reviewed and approved. For human applications,
each application was reviewed by a special group of experts: the Advisory
Subcommittee on Human Applications of the Interim Advisory Committee on
Isotope Distribution Policy of the Manhattan Project. According to one of the
initial planners, "The chief reason for setting this group up as a separate entity
from the Research group [another subcommittee] is that of medico-legal

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responsibility involved in the use or treatment of humans, experimentally or
otherwise."7 (When the AEC began its work, this subcommittee continued but
was renamed the "Subcommittee on Human Applications of the Committee on
Isotope Distribution of the AEC." In 1959 it was absorbed into the "Advisory
Committee on Medical Uses of Isotopes."8 In 1974, the AEC's responsibilities
were transferred to the Nuclear Regulatory Commission.) Coupled with this
review was a requirement that those wishing to purchase radioisotopes
demonstrate the special competence required for working with radioactive
materials. This mechanism for centralized, nationwide review was unusual at the
time it was begun.

The breadth of the subcommittee's purview can be seen in the range of
proposals examined. Although the Advisory Committee is concerned primarily
with medical research, the AEC subcommittee review extended well beyond this
realm. Apparently, the subcommittee reviewed all proposed uses for
radioisotopes that might result in the exposure of humans to radiation. These
included, for example, using cobalt 60 in nails in wooden survey stakes (probably
to assist in later locating them), sulfur 35 in firing underground coal mines, and
yttrium 90 as a tracer in gasoline in simulated airplane crashes.9 (Its jurisdiction
was limited to by-product material, however, and did not extend to fissionable
materials such as plutonium and uranium.)

Soon after the Manhattan Project's public announcement, both the
radioisotope distribution system and its oversight structure began operation. On
June 28, 1946, the Subcommittee on Human Applications held its first meeting.
Attending as members were Dr. Andrew Dowdy, chairman, and biophysicist
Gioacchino Failla. Dowdy was director of the University of Rochester's
Manhattan Project division, while Failla was a professor at Columbia University
and consultant to the Metallurgical Laboratory in Chicago. Not attending was the
third member of the subcommittee, Dr. Hymer Friedell, executive officer of the
Manhattan Project's Medical Section. Attending as nonvoting secretary was Paul
Aebersold, in charge of the production of radioisotopes at Oak Ridge (later to
head the AEC's Isotopes Division). His efforts to promote the use of
radioisotopes later earned him the nickname "Mr. Isotope." Also attending as
advisers from Oak Ridge were W. E. Cohn, the author of the original
memorandum proposing a system for distributing radioisotopes, and Karl
Morgan, director of Health Physics at Oak Ridge, who would, over the years,
become a leading figure in the establishment of occupational exposure limits for
radioisotopes.10

Although the primary task of the subcommittee was to oversee safety, at
the time, many expected a shortage of radioisotopes. Thus, much of this first
meeting was taken up with a discussion of priorities for allocation." (As it
happened, supply exceeded demand within one year.) It was in the context of this
discussion of allocation, not a discussion of safety or ethics, that a system of
local committees was suggested. Each local committee (also called "local isotope

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Chapter 6

committee" at this meeting) would include "(a) a physician well versed in the
physiology and pathology of the blood forming organs; (b) a physician well
versed in metabolism and metabolic disorders; (c) a competent biophysicist,
radiologist, or radiation physiologist qualified in the techniques of
radioisotopes."'2 The main advantages of a system of local committees were ^
administrative efficiency and delegation of prioritization for scarce isotopes.
The primary functions of each local isotope committee were coordination,
allocation, and safety. Evidently no mention was made of overseeing subject

consent. .

At this first meeting, the subcommittee had before it no actual requests to
evaluate. Even so, members did agree on the general principles on which they
would deny a request:

a. The requestors are not sufficiently qualified to
guarantee a safe and trustworthy investigation.

b. Insufficient knowledge exists to permit a safe
application of the material in the proposed human

14

cases.

There was no elaboration of crucial terms such as qualified, safe and trustworthy,
insufficient knowledge, and safe application. Although no standards of adequate
consent were mentioned, this degree of oversight was unusual in medical research
during this time and even later.

Although it had no specific requests before it, the subcommittee did
consider the anticipated uses of some isotopes. The uses of some isotopes were
apparently rejected, not only because of the hazards of radiation, but also because
of chemical toxicity and the availability of less-hazardous alternatives. For
others, specific limits were set. For example, the subcommittee was especially
cautious concerning isotopes of strontium because it concentrated in bone, as did
radium, which was known to be hazardous from the prewar experience of the dial
painters. The subcommittee set a specific exposure limit: "the Sr 90 (and Y 90
daughter) should not contribute in excess of 1% to the total rate of beta

disintegration."16 . •

Such general guidelines have little effect unless a procedure is established
for their implementation. At its first meeting, the subcommittee set out in detail
the mechanism for its own future operation. What the subcommittee would be
reviewing were requests to purchase isotopes for any use in human beings. Only
after the subcommittee approved a request would the isotope be sold and shipped
to the researcher. The need for speed in responding to requests for human uses

was recognized.17

Details of the procedure for purchasing isotopes were disseminated to
potential users through a brochure issued in October 1946 by the Isotopes Branch
at Oak Ridge.18 Most of the brochure concerned the paperwork, which, among

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other things, ensured that the Subcommittee on Human Applications would
actually be notified of all applications for human use.

The last stage of the purchase procedure indicates the underlying concern
with legal liability. Although Manhattan Project approval was required, the
actual purchase was from the private contractor-operator of the Clinton
Laboratories (later designated the Oak Ridge National Laboratory) in Oak Ridge,
at that time Monsanto Chemical Company. The final purchase agreement
contained a clause relieving both the government and the private contractor from
any responsibility for "injury to persons or other living material or for any
damage to property in the handling or application of this material. . . ."'9 The
Manhattan Project also required the purchaser to file with the Isotopes Office a
statement required by section 505(i) of the Federal Food, Drug, and Cosmetic
Act. However, the Advisory Committee found no evidence of direct involvement
by the FDA at that time in the planning or operation of the radioisotope
distribution program.20

By October 1 946, the distribution program was well under way: 2 1 7
requests had been received. Of these, 21 1 had been approved. Human use requests
totaled 94, of which 90 had been approved.21

THE AEC ASSUMES RESPONSIBILITY FOR
RADIOISOTOPE DISTRIBUTION

When the AEC took over responsibility for the program on January 1,
1947, the structure of the radioisotopes distribution system remained intact. The
Subcommittee on Allocation and the Subcommittee on Human Applications
remained as standing subcommittees of the Interim Committee on Isotopes
Distribution Policy, which became known as the Advisory Committee on Isotope
Distribution Policy. The forms developed by the Manhattan Project were reissued
as AEC forms without substantial revision. The system of application from
private users, review, purchase, and distribution continued to operate.

At first, there appears to have been some confusion over the responsibility
of the AEC for its own research program and for its program to distribute
radioisotopes to private researchers. As discussed in chapter 1, two 1947 letters
from AEC General Manager Carroll Wilson describe strong consent
requirements. The April letter to Stafford Warren was expressly directed to the
terms on which research conducted by AEC contractors (including universities)
would be approved. The November letter was sent to Robert Stone. As we have
discussed, those clear statements to contract researchers do not seem to have been
made to those applying for radioisotopes. This confusion about the relationship
between contract research and isotope distribution is discussed in a September 26,
1947, memorandum from J. C. Franklin, manager of Oak Ridge Operations, to
Carroll Wilson.22 Other correspondence also indicates confusion over whether the
AEC's own labs (which were themselves often operated by contractors) were to

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Chapter 6

follow the procedures for the radioisotope distribution program, which would
have placed their human use requests before the Subcommittee on Human

Applications.

Initially, requests for by-product materials from within the AEC used a
form that did not specify whether the radioisotope was to be used on humans.23
By August 1949, Shields Warren, director of the AEC's Division of Biology and
Medicine, had directed that human use by AEC laboratories be subject to review
by the Subcommittee on Human Applications.24 However, when regulations
governing radioisotope distribution were first promulgated, AEC-owned facilities
were specifically exempted from all such regulations.25 Warren's goal was
achieved instead by a memorandum from Carroll Wilson in July 1950. This
memorandum discontinued use of the earlier form and directed that all requests
use the same form used by outside purchasers, which directed human use requests
to the Subcommittee on Human Applications.26

The AEC Subcommittee on Human Applications

At the heart of overseeing the expansion of the use of radioisotopes was
the Subcommittee on Human Applications of the AEC's Advisory Committee on
Isotope Distribution. Applications had to have been approved by a local isotope
committee before even being considered by the subcommittee.27 The
subcommittee itself conducted most of its reviews by mail. Unfortunately, only
fragmentary records of this correspondence have been found.

The subcommittee formally met only once a year to discuss general issues.
By its second meeting, in March 1948, membership had grown to four. Dowdy
was no longer on the subcommittee; Joseph Hamilton and A. H. Holland had been
added. Hamilton was, as described in chapter 5, a physician-investigator with the
University of California's Radiation Laboratory in Berkeley. Holland was a
physician-investigator who became medical director at the AEC's Oak Ridge
Operations in late 1947. (As we shall see in chapter 13, he played a central role
in the question of the declassification of secret experiments.) As the
subcommittee continued to "examine each case on its own merits" it began to
generate principles for "general guidance." In doing so, it began to categorize
experiments, apparently according to the degree of hazard posed.

One category was tracer studies in "normal adult humans" using beta and
gamma emitters with half-lives of twenty days or fewer. Applications needed to
include information on biodistribution and biological half-life of the radioisotope,
based on either animal studies or references to the literature.28

A second category was studies in "normal children." In 1948 the
subcommittee did not issue detailed guidelines, but instead simply stated that such
applications "would be given special scrutiny by the Subcommittee on Human
Applications."29 In 1949 it issued more detailed guidelines, which indicate that
the concern was with minimizing risk, not requiring or overseeing consent:

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Part II

In general the use of radioisotopes in normal
children should be discouraged. However, the
Subcommittee will consider proposals for use in
important researches, provided the problem cannot
be studied properly by other methods and provided
the radiation dosage level in any tissue is low
enough to be considered harmless. It should be
noted that in general the amount of radioactive
material per kilogram of body weight must be
smaller in children than that required for similar
studies in adults.30

Coupled with the children's category in 1 949 were studies on pregnant women:
"The use of radioactive materials in all normal pregnancies should be directly
discouraged where no therapeutic benefit is to be derived."31 Although not
specifically mentioned in the minutes, such a policy may, like research in "normal
children," have been waived for "important researches" that could not otherwise
be undertaken.

One recurring difficulty was the problem of deciding when an application
could be considered "safe." There was no simple, mechanical process for making
such a judgment. This can be seen in the subcommittee's detailed consideration of
an application for phosphorus 32 to be used in a blood volume study of children.
The amount of radioactivity proposed ranged from 1/4 to 1 microcurie per
kilogram of body weight. Initially, three of the four members approved the
application and the allocation was made. However, the fourth member, replying
late, reopened the question. Following reconsideration by the entire
subcommittee, three of the four members concluded the original application for
use on children should be turned down and the investigator asked to revise the
application to "state the importance of making the study in children" and to keep
the amount of activity less than 1/2 microcurie per kilogram.32 The reduction in
allowable amount of activity illustrates both the diligence with which the
subcommittee pursued its task and the inherent difficulties in making judgments
about what constituted "safe" practices in a rapidly developing field of research.

The subcommittee's task was made a bit easier when considering
applications with adults, where it could draw upon occupational guidelines.
Requests for "long-lived radioisotopes" were placed in a third category, defined
as those with a biological half-life greater than twenty days. In contrast with
experiments on children, here the subcommittee was willing to set a general dose
limit: "The dosage in the critical tissue should be such as to conform to the
limitations stated by the National Committee on Radiation Protection."33 (The
NCRP, now the National Council on Radiation Protection and Measurements, is
an independent organization that publishes occupational radiation protection
guidelines based on expert reviews of contemporary scientific knowledge.) As

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with children, such applications "must be reviewed separately." The
subcommittee did not wish this limit to be ironclad: "In special cases, however,
the Subcommittee on Human Applications may permit the use of radioisotopes in
higher dosages."34 At this point the subcommittee appears to have been
establishing general principles; no specific radioisotopes or particular research
proposals are mentioned.

A final category was applications using radioisotopes with long half-lives
in patients with short life expectancies. The term moribund was used in
correspondence by Paul Aebersold prior to the second meeting of the
subcommittee in March 1948. He wrote to the subcommittee members explaining
that the item was on the agenda because requests for such work had been
received. He referred to a written request from a physician at Massachusetts
General Hospital to use calcium 45 and an oral request from a staff member at
Presbyterian Hospital in Chicago to use testosterone labeled with carbon 14.
Aebersold did not provide any details as to the purposes of the proposed research.
The issue was what policy to adopt when the patients were predicted not to live
long enough for long-term hazards to develop. Aebersold told the subcommittee
that "this office feels that such requests should be allowed if a satisfactory
mechanism for determining the 'moribundness' of the patients in question is
established. We believe that this question should be decided by a group of doctors
and written evidence signed by the group filed with the Isotopes Division prior to
use of the material."35

The subcommittee had no objection to the basic principle of applying
larger doses to patients with short life expectancies, but its language was more
oblique than Aebersold's letter: "It is recognized that there may be instances in
which the disease from which the patient is suffering permits the administration
of larger doses for investigative purposes."36 Safeguards were to be provided by
reliance on the judgment of local physicians, not a precise definition of moribund.
Indeed, the subcommittee did not even use the term. Applications would be
approved providing:

1. Full responsibility for conduct of the work is
assumed by a special committee of at least three
competent physicians in the institutions in which
the work is to be done. This will not necessarily be
the local Radioisotope Committee.

2. The subject has given his consent to the
procedure.

3. There is no reasonable likelihood of producing
manifest injury by the radioisotope to be
employed.37

No further explanation was given of how the second requirement, giving consent,

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would be fulfilled by a "moribund" patient, nor was additional guidance provided
to clarify the third criterion.

One instance in which this policy was applied took place at the Walter E.
Fernald State School in Massachusetts (see chapter 7). Correspondence between
the researchers and the AEC indicates that the AEC allowed the administration of
50 microcuries of calcium 45 (fifty times the amount the AEC allowed the
researchers to administer to other subjects in the study) to a ten-year-old patient
with a life expectancy of a few months, suffering from Hurler-Hunter syndrome
(a degenerative disease of the nervous system). In applying for the radioisotope,
Dr. Clemens Benda, the researcher, noted that "permission for the use of higher
doses administered to moribund patients has been granted by you to other
investigators . . . ."38 This subject was part of a study of calcium metabolism
approved by the superintendent of the school. Students had been described as
"voluntarily participating" in a letter sent earlier to the parents asking if they
objected, but that did not mention the use of radioactive tracers. Lack of response
from a parent was presumed to be approval.39 The subject with Hurler-Hunter
syndrome was found to have abnormal calcium metabolism, but died before the
study could be completed.40

Even as it developed procedures for unusual cases, the subcommittee
recognized that some existing uses were becoming routine and did not need to be
continuously reviewed by the subcommittee itself. The subcommittee delegated
the review of such requests to the Isotopes Division, setting out the criteria to be
applied:

Such applications should be justified by:

a) A commensurate increase in patient load.

b) An expanded research program.

c) Provision of adequate storage and handling facilities.

d) Assurance that personnel protection and supervision are
adequate for the larger amounts requested.41

An additional simplification occurred with the introduction in 1951 of "general
authorizations," which delegated more authority to the local radioisotope
committees of approved institutions.42 These authorizations enabled research
institutions to obtain some radioisotopes for approved purposes after filing a
single application each year, therefore eliminating the need to file a separate
application for each radioisotope order. As such, they also reduced the oversight
of the AEC's Subcommittee on Human Applications, as each order was no longer
reviewed individually. However, at first the general authorizations did not apply
to human use, and when they were expanded to human use in 1952, they were
limited to certain radioisotopes for clinical use and excluded radioisotopes in
cancer research, therapy, and diagnosis.43

Both the AEC and the subcommittee reacted strongly when proper

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bureaucratic procedures were not followed. One example was a private industrial
lab that used iodine 131 for a human study that had not been properly reviewed.
Even though no one was harmed, the AEC threatened to suspend shipments of all
radioisotopes, not just iodine 131; such action would have put the company out of
business.44 Aebersold, at the direction of the subcommittee, notified the company
president that while the incident "did not lead to any unfortunate results from the
standpoint of radiation hazard ... a recurrence of this type of violation should
result in cessation of all shipment of radioactive materials to Tracerlab, Inc."45
For his part, the company president reacted by notifying employees that such
action would be grounds for automatic dismissal.46

Thus, as it proceeded in its work of evaluating individual applications, the
subcommittee developed more general principles such as categories of human
uses based upon risk and updating of criteria based upon developing knowledge.
The goal, as the AEC's director of research, K. S. Pitzer, stated in 1950, was "to
make radioisotopes as nearly as possible ordinary items of commerce in the
technical world."47 For example, cancer researchers initially received
radioisotopes at no charge.48 This free program was changed to an 80 percent
discount program in 195249 and ended in July 1961.50

AEC Regulations and Published Guidelines

An important step toward making the use of radioisotopes a component of
medical practice routine was formally enacting regulations governing the use of
isotopes. The first regulations were enacted in 1951.5' These early regulations
essentially promulgated facility and personnel requirements without establishing
dose limits or mentioning the consent requirement established in 1949 for
administering larger doses to very sick patients. Throughout the 1950s, changes in
the regulations dealt with administrative procedures. Other concerns about
radioisotope use, such as consent requirements, were disseminated through
circulars, brochures, and guides of the Isotopes Division. In 1948 the circular
describing medical applications was only three pages long; by 1956 it had been
replaced by a twenty-four-page guide that provided detailed requirements for
many different applications of isotopes.52

This greater precision can be seen, for example, in the guidelines for
terminal patients. By the time of the 1956 guide, the use of radioisotopes with
half-lives greater than thirty days ordinarily would not be permitted without prior
animal studies establishing metabolic properties, unless patients had a short life
expectancy. The judgment of local physicians was now to be guided by a more
exact definition: exceptions would be "limited to patients suffering from diseased
conditions of such a nature (life expectancy of one year or less) that there is no
reasonable probability of the radioactivity employed producing manifest injury."53
However, while a more precise definition of terminal was now provided, there
was no longer explicit mention of a specific requirement for consent from these

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patient subjects, as had been made earlier.

Consent was required, though, in the section of the 1956 guide on the "use
of radioisotopes in normal subjects for experimental purposes." (Presumably,
"normal" here means "healthy.") This section included the earlier provisions that
the tracer dose not exceed the permissible body burden and that such experiments
not normally be conducted on infants or pregnant women. It also, however,
included a new provision that such experiments were to be limited to "volunteers
to whom the intent of the study and the effects of radiation have been outlined."54
The term volunteer would seem to imply a requirement that consent be obtained
following a disclosure of information to potential subjects. The disclosure
requirement dops not include, however, all of the elements of information that
today are included in duties to obtain informed consent.

This 1956 consent requirement now governed all radioisotope
experiments in normal subjects, a substantial expansion of the earlier requirement
of consent only from terminal patients receiving larger-than-usual doses. It also
explicitly required that both the purpose and effects of radiation be explained. It
is unclear whether the failure to mention consent in the section on terminal
patients was an oversight in drafting or a deliberate distinction between patients
and "normal" subjects. The Advisory Committee has not found documents
revealing the history of this provision, nor any explanation of the choice to limit
the broad consent requirement to "normal" subjects.55

This broad requirement continued over the next decade as part of AEC
policy. In 1965, the AEC published the "Guide for the Preparation of Applications
for the Medical Use of Radioisotopes." The guide described the application
process and specific policies for the "Non-Routine Medical Uses of Byproduct
Material." This policy statement reiterated the exclusion of pregnant women and
required that subject characteristics and selection criteria be clearly delineated in
the application. Another requirement stated that applications should include
"confirmation that consent of human subjects, or their representatives, will be
obtained to participate in the investigation except where this is not feasible or in
the investigator's professional judgment, is contrary to the best interests of the
subjects."56

During the 1960s, the entire system of oversight of radioisotope research
began to change as the Food and Drug Administration began developing a more
active role in supervising the development of radiopharmaceuticals.57 The
regulatory history of this shift in authority is complex and beyond the scope of
this report. Suffice it to say that by the mid-1960s the regulation of radioisotope
research was beginning to merge with the regulation of pharmaceutical research
in general.

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LOCAL OVERSIGHT: RADIOISOTOPE COMMITTEES

From its inception, the AEC distribution system required each local
institution to establish a "local radioisotope committee," later termed a "medical
isotopes committee." Initially, the primary purpose was to simplify the allocation
process by having local institutions establish their own priorities before applying
to the AEC.5X Soon after the program began, supply increased and no dramatic
new uses developed, so allocation was no longer a major issue. These local
committees also took on responsibilities for physical safety, usually working
closely with radiation safety offices. By October 1949 this requirement also
applied to the AEC's national labs.59 When "general authorizations" were issued
in 1951, granting broader discretion to qualifying local institutions, local isotope
committees assumed greater responsibility.60

By 1956, the functions of the local radioisotope committees included
reviewing applications, prescribing any special precautions, reviewing reports
from their radiological safety officers, recommending remedial action when
safety rules were not observed, and keeping records of their own activities. The
basic focus on radiological safety remained, although in reviewing applications a
local medical isotopes committee could also consider "other factors which the
[local medical isotopes] Committee may wish to establish for medical use of these
materials."61 Exactly what these "other factors" might be was not specified.

These local committees together reviewed thousands of applications over
the next decades. Although not federal agencies, they were required by the AEC,
and their proper functioning was an important part of the oversight system
envisioned by the AEC. To fully assess whether this system fulfilled its goals
would be an enormous task, requiring the retrieval and examination of thousands
of local records. However, to make a preliminary assessment of whether the
system as a whole generally appeared to function as planned, the Advisory
Committee did examine the records of several public and private institutions: the
Veterans Administration (VA), the University of Chicago, the University of
Michigan, and Massachusetts General Hospital (MGH).62 Doing so provided us
with an understanding of the techniques of risk management used at the local
level on a day-to-day basis. We specifically examined whether local radioisotope
committees in fact were established as directed and what techniques they
developed to monitor consent and ensure safety.

Establishment of Local Isotope Committees

Overall, the federal requirement seems to have been an effective means of
instituting a reasonably uniform structure across the nation for local radioisotope
committees. The AEC's requirements for local committees were followed in all
the institutions studied, and there is no reason for believing they were exceptional.
One local radioisotope committee, that of Massachusetts General Hospital, was

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established in May 1946, prior to the AEC requirement.63 The other institutions
established a local radioisotope committee when required to do so by the AEC.

Local committees also could have broader tasks than those required by the
AEC. For example, the Radiation Policy Committee at the University of Michigan
regulated all radioactive substances used on campus, not just those purchased
from the AEC. These included reactor products, transuranic elements, and
external sources of radiation.64

The Veterans Administration added another level of oversight in the form
of a systemwide Central Advisory Committee.65 In 1947 the VA embarked on a
radioisotope research program that would take place within newly established
radiation units in the hospitals that would be the recipients of AEC-supplied
isotopes.66 Among early research projects were the treatment of toxic goiter and
hyperthyroidism with iodine 131 and treatment of polycythemia rubra vera
(overproduction of red blood cells) with phosphorus 32 at Los Angeles,
radioactive iron tracers of erythrocytes at Framingham, and sodium 24 circulatory
tracers in Minneapolis.67 By the end of 1948, radioisotope units had been
established in eight VA hospitals.68 Each of the eight was asked to establish a
radioisotope committee (as required by the AEC) to be appointed by the Dean's
Committee of each hospital, while representatives from affiliated universities
agreed to serve as consultants in the various units.

Local Monitoring of Consent

Generally, although local institutions created clear procedures to monitor
safety, these local radioisotope committees did not establish procedures to
monitor or require consent.69 (See part I for discussion of the broader historical
context of consent in medical research.) The standard application form to the
Massachusetts General Hospital committee, as of 1953, had no place to describe
an informed consent procedure. This does not, of course, resolve the question of
whether consent was given. According to one prominent neurosurgeon
interviewed by the Advisory Committee staff, William Sweet, at that time, in the
case of brain tumor patients, oral consent was obtained from both the patient and,
since mental competency could later be an issue, the next of kin.70

Similarly, no mention of the 1947 AEC requirements stated in General
Manager Wilson's letters is contained in the advice Shields Warren gave in 1948
to the VA, even though Warren, as director of the AEC's Division of Biology and
Medicine, must have known of discussions about consent requirements. An issue
that arose before the VA Central Advisory Committee was whether patient-
subjects should sign release slips. This issue posed the question of whether the
radioisotope units in the VA hospitals were treatment wards or clinical research
laboratories. If wards, patients need not sign consent forms, for they were simply
being treated in the normal course of an illness. Shields Warren agreed with this
presumption and felt that there was no need for the patients to sign release slips:

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"The proper use of radioisotopes in medical practice is encompassed in the
normal responsibilities of the individual and of the institution or hospital."71 In
addition, he felt that the practice would draw "undue and unwholesome attention
to the use of radioisotopes."72

Movement toward more formal consent requirements gradually arose at
the local level. In 1956 the University of Michigan's own Human Use
Subcommittee directed that in an experiment using sodium 22 and potassium 42,
each "volunteer would be required to sign a release indicating that he has full
knowledge of his being subjected to a radiation exposure." Since the local
committee was concerned about what it termed "unnecessary" radiation, the
volunteers presumably were healthy subjects not otherwise receiving radiation for
treatment or diagnosis. The committee appended a recommended "release" form
to its minutes:

I, the undersigned, hereby assert that I am

voluntarily taking an injection of at a dose

level which I understand to be considered within
accepted permissible dose limits by the University
of Michigan Radio-isotope Human Use Sub-
Committee.73

By 1967, the Michigan subcommittee also required that the subject
explain the experiment to the researcher to clarify any doubts or
misunderstandings. The following statement was incorporated into all
applications to the university's Human Use Subcommittee:

The opinion of the Committee is that INFORMED
CONSENT is the legal way of describing a
"meeting of the minds" in a contract. In this
situation it means that the subject clearly
understands what the experiment is, what the
potential risks are, and has agreed, and without
pressure of any kind, elected to participate. The best
way to ascertain that the consent is informed, is to
have the subject explain back fully to the
interviewer, exactly what he thinks he is submitting
to and what he believes the risks might be. This
facilitates clarification of any doubts, spoken or
unspoken. The content of this discussion will be
recorded in detail below.74

During the 1960s, as explained in chapter 3, concern was growing over the
adequacy of consent from subjects. Although not intended by the AEC to

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monitor the obtaining of consent from subjects, over the years the local
radioisotope committees may have come to take on this task. By requiring such
local committees, the AEC had, probably unwittingly, provided an institutional
structure that allowed later concern for informed consent to be implemented at the
local level.

Local Monitoring of Risk

This local and informal approach to consent is in sharp contrast to the
detail and documentation with which risk was assessed. As discussed earlier,
monitoring risk was the major task of the AEC's Subcommittee on Human
Applications. The local committees mirrored this task, examining in detail the
various experiments presented to them. As with the AEC subcommittee, local
committees developed a variety of methods, none especially surprising, to ensure
what they believed was adequate safety.75

The basic dilemma facing local committees was to allow exploration of
new territory while attempting to guard against hazards that, precisely because
new territory was being explored, were not totally predictable. This dilemma was
apparent at the local level, as well as at the level of the AEC's Subcommittee on
Human Applications. For example, in the minutes of the Massachusetts General
Hospital local radioisotope committee in 1955, during a discussion of new and
experimental radiotherapies for patients, one member of the committee declared
that the safety of the patient was of "paramount importance."76 Yet, other
members suggested that a risk-benefit analysis needed to be an integral
component of such a policy decision. The committee as a whole concluded
merely that it was a complicated issue and that "it is not wise in any way to inhibit
investigators with ideas, and yet the safety of the patient must come first."77

Requiring prior animal studies was a basic method of assessing risk. For
example, the twenty-two studies reviewed by the University of Chicago's local
committee in 1953 included multiple therapeutic and tracer studies involving
brain tumors, the thyroid gland, metastatic masses, and tissue differentiation.
Those the Chicago committee viewed as involving any risk to the patient were
preceded by extensive animal studies.78

Animal studies were usually tailored to each project and also raised the
question of the differences between how humans and animals might respond to a
particular radioisotope. A more uniform standard directly applicable to humans
was the system of dose limits established by the National Committee on Radiation
Protection for occupational purposes: the maximum permissible dose for each
isotope. In addition, although no national system existed for reporting their
decisions, local committees drew upon their knowledge of what had been
approved at other institutions.79 At least one local committee issued its own dose
limits. The Massachusetts General Hospital local committee in 1949 issued a
seven-point policy on human use of beta- and gamma-emitting radioisotopes.80

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By 1956, the Michigan committee provided explicit limits for exposure of
volunteers/1

At other times, the condition of subjects who were patients was accepted
as justification for higher doses. For example, in 1953 the Chicago committee
approved a tracer study using mercury 203 "to study uptake by malignant renal
tissue." Although admitted to be unusual, it was approved as potentially
efficacious in patients suffering hypernephroma (a kidney cancer). Total dose
would not exceed 10 milligrams of ionic mercury, a high dose for most tracer
studies, which was approved as reasonable given the illness of the patients.82
Similarly, the Harvard Medical School committee in 1956 stipulated that "the risk
of incurring any type of deleterious effect due to the radiation received should be
comparable to the normal everyday risks of accidental injury." For seriously ill
patients receiving experimental treatment, however, the committee stated, "the
estimated deleterious effect from radiation should be offset by the expected
beneficial effects of the procedure."83

In addition to setting limits, local committees encouraged the use of
technical methods to reduce risk. Use of different detection techniques could
reduce the dose required. In 1955, for example, the Michigan committee
considered an application to administer to normal volunteers up to 30 microcuries
of sodium 22 and up to 350 microcuries of potassium 42, resulting in internal
radiation doses of up to 300 millirem per week. (The purpose was to study
sodium-potassium exchanges.) The committee asked itself: "Is it justifiable to
subject the volunteers to an exposure in excess of the maximum permissible?
This Committee did not resolve this question but came forward with the
suggestion that more-sensitive counting techniques might permit this
investigation at lower dose levels."84

Another method of reducing risk was to restrict the type of subjects to
those whose life expectancy was too short for long-term effects to appear. This
has already been seen regarding terminal patients. Another variation of the same
technique was to restrict the use of volunteers to those over a certain age. At
Michigan, age restrictions on who would be acceptable as a volunteer began
appearing in the 1960s.85

When a worthwhile experiment also involved novel risks, another method
to control risk was to require additional monitoring by the local committee as the
experiment proceeded. At times, the Michigan committee required preliminary
reports before allowing experiments to proceed further.86 In another instance, the
Michigan committee required the researcher to obtain long-term excretion data
because of concern that "the usual biologic half-life data might not be
sufficient."87 Similar additional oversight was required at the University of
Chicago in 1953. A proposal was made to use tritium-labeled cholesterol to study
steroid-estrogen metabolism in women. The question of the distribution of
estrogenic hormones in humans was unexplored at the time and deemed worthy of
research. While the risk appeared low, the committee ultimately approved the

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study for the first round of the experiment only for nonpregnant women who were
sterile or pregnant women who planned to be sterilized postabortion. If data from
the first round suggested minimal risk to the women and the fetuses, the program
could be expanded.88

Thus, in establishing a system of local radioisotope committees, the AEC
effectively increased the detail with which each proposed experiment was
reviewed. Often, it appears, experimental protocols were revised at the local level
before being approved and sent on to the AEC. Thus, the system created by the
AEC did some of its most effective risk management out of sight of direct federal
oversight.

GENERAL BENEFITS OF RADIOISOTOPE RESEARCH

The system for distribution of radioisotopes worked well and encouraged
researchers to explore new applications. There are two striking aspects of the
application of radioisotopes to medicine since World War II: rapid expansion and
complexity. Practices that at the end of the war were limited to fewer than four
dozen practitioners have now become mainstays of modern medicine.89 The
second major aspect of the field is its complexity. Just as nature at times is best
regarded as a seamless web, not unconnected scientific fields, knowledge
nurtured in one field often provides unexpected benefits in another. A few
examples can illustrate how some of the hopes at the dawn of the atomic age have
actually been realized.90

Improved Instrumentation to Detect Radiation

Improved instruments, the basic tools for all biological research using
radioisotopes, were developed through the interaction of biology and medicine
with physics and engineering. Improvements not only provide greater precision,
they also allow the same amount of information to be gathered with lower doses
of radiation, thereby reducing the risk.

Perhaps the best-known example is the application of the "whole-body
counter" to biological problems. The device was originally developed as a tool
for physics, enabling measurements of minute amounts of radiation by combining
sensitive detectors with extensive shielding to eliminate extraneous radiation.
The result was similar to placing a sensitive microphone in a sound-proofed room,
allowing lower levels of radioactivity to be detected than was previously possible.
For some research, no radioisotope at all was administered; the counters could
measure naturally occurring radioisotopes. Whole-body counters also greatly
simplified metabolic studies. In some studies, subjects who previously would
have had to reside continuously in a metabolic ward could now schedule visits to
the whole-body counter for their natural radioactivity to be measured on an
outpatient basis.91 This device was later adapted for whole-body counting after

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administration of tracer amounts of radioisotopes and is the basis for a number of
fundamental nuclear medicine tests.

In the early 1 970s, computerized tomographic scanning (CT) was
introduced. This technique was first applied to x-ray imaging by taking multiple
x-ray "slices" through a region of the body, then programming a computer to
construct a three-dimensional image from the information. Thus, internal
structures of the body may be imaged noninvasively. Newer types of
tomographic scanning include positron emission tomography (PET), in which
various metabolites or drugs are labeled with a very short half-life positron-
emitting radioisotope, such as fluorine 18, and the passage of the labeled material
is tracked throughout the body by taking multiple images over several minutes or
hours.

Diagnostic Procedures

The first medical application of any radiation was the use of x rays for
diagnostic purposes, such as locating broken bones inside the patient.
Radioisotopes later opened another window into the body. The natural tendency
of certain organs to preferentially absorb specific radioisotopes, coupled with
ever-improving detection techniques, allowed radioisotopes to be used to increase
the contrast between different parts of the body. X rays could distinguish
between hard and soft tissues because of their different densities. Radioisotopes
could go one step further and distinguish different kinds of tissues from one
another based upon their metabolic function, not merely their physical density.

Radioisotopes also could go beyond detecting different types of tissues.
Since they were distributed throughout the body by the body's own metabolism,
their location provided a picture not only of structure, but also of processes.
Tracing radioisotopes was a means of observing the body in action. The earliest
success was using radioiodine to measure the activity of the thyroid. The gland
cannot distinguish between radioactive and nonradioactive forms of iodine and
therefore preferentially absorbs all isotopes of iodine. Thus, the activity of the
gland can be assessed by observing its absorption of radioiodine. Largely as a
result of these advances, the thyroid gland is arguably the best understood of all
human endocrine organs, and its hormones the best understood of all endocrine
secretions. Since the incidence of thyroid disease is second only to diabetes
mellitus among human endocrine diseases, this understanding is basic to therapy
in large numbers of patients.92

Because the brain is a crucial and delicate organ, techniques for
diagnosing brain tumors without surgery were vital. In 1948 radioactive isotopes
were applied to this task. Using radiotagged substances that were preferentially
absorbed by brain tumors, physicians could more accurately detect and locate
brain tumors, allowing better diagnosis and more precise surgery. Similar
"scanning" techniques were later developed for the liver, spleen, gastrointestinal

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system, gall bladder, lymphomas, and bone.

As mentioned, a recently developed technique is PET scanning, which is
especially helpful in studying the human brain in action. Glucose is the primary
food for the brain; by tagging a glucose analog with fluorine 18, investigators can
identify the actively metabolizing portions of the brain and relate that to function.
This technique, has opened a new era of studies of the brain. Outwardly
observable functions, such as language, object recognition, and fine motor
coordination can now be linked with increased activities in specific areas of the
brain.

Radioisotopes allow investigators to increase the sensitivity for analyzing
biological samples, such as tissue and blood components, especially when
separating out the material of interest using chemical processes would be difficult.
Because instruments to measure radioactivity are so sensitive, radioisotopes are
frequently used in tests to detect particular hormones, drugs, vitamins, enzymes,
proteins, or viruses.

Therapeutic Techniques

Radioisotopes are energy sources that emit one or more types of radiation
as they decay. If radioisotopes are deposited in body tissues, the radiation they
emit can kill cells within their range. This may be harmful to the individual if the
exposed cells are healthy. However, this same process may be beneficial if the
exposed cells are abnormal (cancer cells, for example).

The potential for radiation to treat cancer had been recognized in the early
days of work with radiation, but after World War II the effort to develop radiation
therapy for cancer increased. Iodine 1 3 1 treatment for thyroid cancer was
recognized as an effective alternative to surgery, both at the primary and
metastatic sites. Cancer is not the only malady susceptible to therapy using
radioisotopes. The use of radioiodine to treat hyperthyroidism is perhaps the
most widespread example. It illustrates the progression from using a radioisotope
to measure a process (thyroid activity) to actually correcting an abnormal process
(hyperthyroidism).93

Not all experimental applications of radioisotopes are successful. Some
experiments end in blind alleys, an important result because this prevents
widespread application of useless or even harmful treatments. Negative results
also help researchers to redirect their efforts to more promising areas. The
importance of negative results is sometimes not appreciated because they do not
lead to effective treatments. Negative results may range from simply not
obtaining an anticipated beneficial effect to the development of severe side
effects. Such side effects may or may not have been anticipated; they may occur
simultaneously with beneficial effects, such as the killing of cancer cells.
Occasionally negative results include earlier-than-anticipated deaths of severely
ill subjects. An example is the experimental use of gallium 72 in the early 1950s

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on patients diagnosed with malignant bone tumors.94

Another radioisotope, cobalt 60, has been used successfully to irradiate
malignant tumors, but in this case the radioisotope is not administered internally
to the patient; rather, the cobalt 60 forms the core of an external irradiator, and the
gamma radiation emanating from the radioisotope source is focused on the
patient's tumor. Although cobalt 60 irradiators have been largely replaced by
linear accelerators, they were developed under AEC sponsorship and were
responsible for many advances in radiation therapy.

Recent efforts to utilize radioisotopes in cancer diagnosis and treatment
are based on the ability of antibodies to recognize and bind to specific molecules
on the surface of cancer cells and the ability of biomedical scientists to custom-
design and manufacture antibodies, thus improving their specificity. These fields
are now contributing to a hybrid technique: cloning antibodies and tagging them
with radioactive isotopes. As the antibody selectively binds to its target on the
surface of the cancer cell, the radioactive isotopes attached to the antibody can
either tag the cell for detection and diagnosis or deliver a fatal dose of radiation to
the cancer cell. The Food and Drug Administration recently approved the first
radiolabeled antibody, to be used to diagnose colorectal and ovarian cancers.95

Even in the case of widespread metastases where cure is no longer
possible, radiation treatments will often produce tumor regression and ease the
pain caused by cancer. Phosphorus 32 has been used to ease (palliate) the bone
pain caused by metastatic prostate and breast cancers. Recently, the FDA
approved the use of strontium 89 for similar uses.9''

Metabolic Studies

Studies of the basic processes within the body may not have any
immediate application in diagnosis or therapy, but they can indirectly lead to
practical applications. One example is in the study of the metabolism of iron in
the body. Iron is an important part of hemoglobin, which carries oxygen from the
lungs to all cells in the body. Studies using radioactive iron established the
pathway iron takes, from its ingestion in food to its use in the blood's hemoglobin
and its eventual elimination from the body; these studies had practical
applications in blood disease, nutrition, and the importance of iron metabolism
during pregnancy.

Radioisotopes have also been used to study how the weightlessness of
space travel affects the human body. Radioisotopes have allowed more precise
observation of effects of space travel on blood plasma volume, total body water,
extracellular fluid, red cell mass, red cell half-life, and bone and muscle tissue
turnover rates.

Other uses of radioisotopes are in studies of the transport and metabolism
of drugs through the body. New drugs for any clinical application, whether
diagnostic or therapeutic, must be understood in detail before the FDA will

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approve them for general use. One method for readily determining how a drug
moves through the blood to various tissues, and is metabolically changed in
structure, is to incorporate a radioactive isotope into the structure of the drug.

Unexpected results from an experiment can at times have widespread
consequences. An example is how the work of Rosalyn Yalow and Solomon
Berson of the Bronx VA Medical Center opened up the field of
radioimmunoassay. In the early 1950s, it was discovered that adult diabetics had
both pancreatic and circulating insulin. This appeared odd; previously, it had
been believed that all diabetics lacked insulin. To explain the presence of
diabetes in people with pancreatic insulin, Yalow and Berson decided to study
how rapidly insulin disappeared from the blood of diabetics. To do this, they
synthesized radioiodine-labeled insulin. This would act as a radioactive tag,
making it much easier to measure the presence of insulin in blood. To their
surprise, they found that insulin disappeared more slowly from diabetic patients
than from nondiabetic people.97

Their work had an impact beyond the study of diabetes, however. In the
process of studying the plasma of patients who had been injected with insulin,
they discovered that the radioactively tagged insulin was bound to an antibody, a
defensive molecule that had been produced by the patient's body and custom-
designed to attach itself to the foreign insulin molecule. This was a surprise, since
prevalent doctrine held that the body did not produce antibodies to attack small
molecules such as insulin. To study the maximum binding capacity of the
antibodies, they did saturation tests, using fixed amounts of radiolabeled insulin
and of antibody to measure graded concentrations of insulin. With this technique
Yalow and Berson realized they could measure with great precision the quantities
of insulin in unknown samples. They thus developed the first
radioimmunoassay. This technique, for which Rosalyn Yalow was awarded the
Nobel Prize in Medicine in 1977, has become a basic tool in many areas of
research. Radioimmunoassay revolutionized the ability of scientists to detect and
quantify minute levels of tissue components, such as hormones, enzymes, or
serum proteins, by measuring the component's ability to bind to an antibody or
other protein in competition with a standard amount of the same component that
had been radioactively tagged in the laboratory. This technique has permitted the
diagnosis of many human conditions without directly exposing patients to
radioactivity.

No discussion of the impact of radioisotopes on biomedical science would
be complete without a recognition of their fundamental importance in basic
biological investigations. The ability of radioisotopically labeled metabolites to
act like, and therefore trace, their nonradioactive counterparts has allowed
scientists to follow virtually every aspect of metabolism in cells of bacteria,
yeasts, insects, plants, and animals, including human cells. Among the benefits of
such studies are (a) an understanding of the similarities in metabolism of
organisms throughout the evolutionary scale, (b) identification of sometimes

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subtle differences in cell structure and function between organisms and thus the
ability of drugs to kill bacteria, fungi, or insects without harming humans, and (c)
elucidation of the fundamental properties of genetic material (DNA), The last of
these examples has important implications today, as the human genes controlling
many important bodily functions are being identified and cloned and gene therapy
is just beginning to find its way into clinical application. Many benefits of
understanding the human genetic code have already been realized, and others will
likely accrue in the next few years. These benefits are the result of fundamental
advances in genetics and molecular biology of the past half century, which in turn
depended heavily on studies with lower organisms and with radioisotopically
labeled materials. Thus, human health is benefiting from both human and
nonhuman research with radioisotopes.

The grandest dream of the early pioneers—a simple and complete cure for
cancer-remains unfulfilled. Promising paths at times proved to be dead ends.
However, the AEC's widespread provision of radioisotopes, coupled with support
for new techniques to apply them, laid the foundation stones for much of modern
medicine and biology. This section has only skimmed the field of nuclear
medicine, with its vast array of diagnostic and therapeutic techniques, and the use
of radioisotopes in many areas of basic research.

An Example of Hopes Unfulfilled: The Gallium 72 Experiments

Human experiments with gallium 72, as discussed in the section titled "General Benefits
of Radioisotope Research," were conducted at the Oak Ridge Institute of Nuclear Studies in the
early 1950s. The experiments used gallium 72 because of its short half-life (14.3 hours) and
because an earlier animal study indicated it concentrated in new bone, making it useful as a tumor
marker and possibly for therapy." The 1953 published report stated that the purpose of the study
was "to investigate the therapeutic possibilities in human tumors involving the skeletal system. "b
In 1995 one of the original researchers stated to Advisory Committee staff a somewhat broader
purpose: "to exploit to the fullest possible extent any possible use of this isotope as a bone seeking
element rather than to seek a cure for a specific malignant bone tumor, such as osteogenic
sarcoma. . . . While the GalIium-72 studies did include osteogenic sarcomas, they only represented

a. Herbert D. Herman. M.D., FACR, to Dan Guttman, Executive Director, Advisory Committee
on Human Radiation Experiments, 19 May 1995 ("It has come to my attention . . ."), 2. Dr. Kerman cites as
the preceding study: H. C. Dudley and G. E. Maddox, "Deposition of radiogallium (Ga-72) in skeletal
tissues," Journal of Pharmacology,' and Experimental Therapeutics 96 (July 1949): 224-227.

b. Gould A. Andrews, M.D., Samuel W. Root, M.D.. and Herbert D. Kerman, M.D.. "Clinical
Studies with Gallium-72," 570, in Marshall Brucer, M.D. (ed.), Gould Andrews, M.D., and H. D. Bruner,
M.D., "Clinical Studies with Gallium-72," Radiology 66 (1953): 534-613.

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less than half (9/21 ), 43%, of all the other primary and metastatic skeletal malignancies studied.'"

Patients were chosen who had been diagnosed with "ultimately fatal neoplasms not
amenable to curative surgery or radiotherapy.'"1 The diagnosis later proved to be accurate in all but
one of the fifty-five subjects.0 In one part of the study, thirty-four patients were given trace
amounts of gallium. Both external radiation measurements and a variety of excreta, blood, and
tissue samples were analyzed to determine the localization of gallium. In another part of the study,
twenty-one other patients were given doses that the researchers hoped would be in the therapeutic
range. Total doses ranged from 50 to 777 microcuries.1 The gallium was administered in
fractionated doses biweekly. According to the medical investigators, these patients "were, in
general, in a more advanced stage of disease and were completely beyond even palliation from
conventional forms of therapy."6 For these patients, "doses which were believed to be moderate
were given and gradually increased to toxic level. "h The conclusion of the report notes that "most
of the patients in whom gallium therapy was attempted were given maximum amounts of the
isotope. Only the hopelessness of their prognoses justified a trial of doses so damaging to the
hematopoietic tissues.'"

A major difficulty was lack of knowledge about both the chemical toxicity of stable (that
is, nonradioactive) gallium and the radiation toxicity of gallium 72. Calculations and small animal
studies indicated that dosimetry techniques used for other radioisotopes would "be of little value."1
During the study, close monitoring was done of many bodily functions to observe toxic effects as
soon as they began to appear. Blood tests revealed changes that "were prominent and were usually
of primary importance in determining when the treatments should be discontinued. "k Other effects
included drowsiness, then anorexia, nausea, vomiting, and skin rash.

One problem was determining whether these effects were due to chemical toxicity,
radiation toxicity, or a combination. Due to technical difficulties in separating out pure gallium

c. Kerman to Guttman, 19 May 1995, 2. Dr. Kennan presumably was referring to the twenty-one
subjects who received doses in the therapeutic range, not the thirty-four who received trace doses.

d. Andrews, Root, and Kerman, "Clinical Studies with Gallium-72," 570.

e. A patient was diagnosed with osteogenic sarcoma in his leg, which was amputated. X rays also
revealed dense nodules in his lung, which were diagnosed as inoperable but typical pulmonary metastases.
He was discharged after the gallium study. When he later returned to the hospital, an operation revealed that
the nodules were not typical metastases, but unidentifiable lesions "not characteristic of any specific lesion."
This could not have been known prior to the study, when only x rays were available for diagnosis. Ibid., 585.

f. The researchers reported that these doses were equivalent to 8.5-89.2 mg/kg of body weight.
Ibid., 574-577.

g. Ibid., 570.
h. Ibid., 571.
i. Ibid., 587.

j. The investigators wrote that "[njormal tissue and whole-body tolerances for amounts of
radiogallium necessary to produce a significant effect upon malignant tissues were unknown. Preliminary
calculations and small animal experiments had indicated that accepted radiation dosimetry as applied to other
isotopes would be of little value in calculating radiation dosage to tissues. It was therefore necessary to
utilize the hematologic picture to assess the damaging effects of whole-body irradiation, and clinical and
roentgenographic experience in evaluating a therapeutic response." Ibid., 571.

k. Ibid., 573.

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72. the radioactive gallium was injected with larger amounts of stable gallium, so both chemical
and radiation effects could be present. To distinguish them, one patient was administered an
amount of stable gallium equal to a therapeutic dose, but with only an insignificant amount of
radioactive tracer (to determine localization). Observed toxic effects in this patient did not include
bone marrow depression. The researchers concluded, therefore, that the "profound bone marrow
depression is characteristic of radiation damage and is probably chiefly caused by radiation,
though an element of stable metal toxicity may also be contributory."1

Bone marrow depression gradually ended after gallium injections were stopped. While it
lasted, bone marrow depression led to greater susceptibility to infection and bleeding. Two
subjects died sooner than anticipated, one from infection and bleeding and the other from
infection, while their bone marrow was still depressed. "These two patients died in spite of
antibiotics, blood transfusions, and toluidine-blue therapy.'"" The researchers reported that "in two
patients our estimates of safe dosage limits were in error and radiogallium is believed to have
hastened death."" One researcher, writing in 1995, stated that "since 'safe dosage' levels were only
estimates and seven other patients had survived with even higher dosages, our choice of language
[citing the preceding quotation] was unfortunate. It must be emphasized that this portion of the
study must be likened to a current clinical Phase I trial where in a limited fashion [a] broad range
of toxicity levels may at best be only estimated."0

The major conclusion of the experiment was that hopes for gallium therapy were
unfulfilled. Even though the maximum tolerated doses had been administered, the researchers
reported that "we were impressed with the almost complete lack of any clinical improvement
following gallium treatment, even in patients who showed evidence of striking differential
localization of gallium in tumor tissue."0

Concerning patient consent, the published study says nothing, which was normal for
scientific articles at that time. Near the end of the Advisory Committee's deliberations, ORINS
reportedly found consent forms signed by subjects in the gallium study.4 One of the researchers in
1995 did offer his recollections regarding consent to the Committee:

Forty-five years ago all of our patients and their families were
given a booklet of information explaining how radioisotopes
were used in medicine and more specific information about

I. Ibid., 575.

m. Ibid., 573. Neither had suffered from osteogenic sarcoma; one had suffered from
adenocarcinoma of the kidney with lytic bone metastases and another from cancer of the prostate with
metastatic skeletal involvement, Kerman to Guttman, 19 May 1995, 3.

n. Andrews, Root, and Kerman, "Clinical Studies with Gallium-72," 571.

o. Ibid.

p. Ibid., 587. Researchers reported evidence of concentration in tumors as being one of the
following: "no data," "none." "little," "moderate," or "pronounced." Ibid., 574.

q. Dr. Shirley Fry, telephone interview with Dan Guttman (ACHRE), 30 August 1995, I. The
Advisory Committee did not have enough time to review the forms and related file materials once they were
identified, which, because ORINS deemed them privacy-protected material, would have required review at
Oak Ridge.

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their own involvement including the possible known risks.
Signed applications for admission and waiver and release
forms were demanded for all patients. When, as in the ongoing
gallium studies, toxicity or enhanced risks were encountered,
these were immediately made clear to the patients and their
families if they were known in that time frame. Very often
toxicity is only apparent after review of the clinical data. In the
gallium studies, when on review of the data it was determined
that no therapeutic benefit had occurred, the study was
immediately terminated/

CONCLUSION

At the end of World War II, radioisotopes were regarded as the most
promising peacetime application of our new knowledge of the atom. Venturing
into new fields carried with it substantial risks: risks due to our ignorance of what
lay ahead, and risks due to the lack of training of many would-be explorers. The
AEC consistently accepted and acted upon its responsibility to manage this risk.
An extensive administrative system was created to oversee the safety of human
radiation experiments that used radioisotopes supplied by the AEC. At the heart
of the system was the AEC's Subcommittee on Human Applications of the
Advisory Committee on Isotopes Distribution Policy. This system regulated the
types of uses allowed according to their hazard and the extent of our knowledge
of the risks. It required and provided training of those who would use
radioisotopes. It required the establishment of local radioisotope committees,
which not only reviewed proposals but suggested changes at the local level in
experimental design to reduce risk.

While extensive measures were taken to minimize risk, few measures
were taken to ensure that all the explorers, subjects as well as researchers, were
fully informed and willing members of the expedition. No evidence has yet been
found that the standards for documented consent, articulated by AEC General
Manager Carroll Wilson in 1947, were applied by the AEC Isotopes Distribution
Division. A limited consent requirement was instituted only for the administration
of larger-than-usual doses to very sick patients. Only in the late 1950s did a
consent requirement for normal volunteers appear in the AEC guidelines.

Based on the records examined by the Advisory Committee, the adjunct

r. Kerman to Guttman, 19 May 1995, 3. The booklet, "ORINS Patient Information Booklet"
(circa May 1950). is discussed in chapter 1 . ORINS hospital was known to be dedicated to experimental
work with radiation and radioisotopes. Patients were admitted to the hospital only if they were willing to be
experimental subjects. It is not as clear, however, whether the details of any particular experiment were
always explained adequately to patients.

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system of local radioisotope committees appears to have functioned as planned.
The records of local institutions indicate that they established their own local
radioisotope committees, as required by the AEC, and that these local committees
closely assessed the risks of experiments. At times, this system went beyond
what the AEC had planned. Some local committees had jurisdictions that
extended to all radiation-related work, not merely to radioisotopes supplied by the
AEC. The local committees also provided, probably unintentionally, a ready-
made vehicle for administering greater oversight of consent practices, as concern
developed in the 1960s. Requirements for consent on a federal level changed only
in the late 1960s, as part of a governmentwide concern.

309

ENDNOTES

1. The first complete proposal for radioisotope distribution is contained in a
memo dated 3 January 1946. Radioisotope Committee of Clinton Laboratories (Oak
Ridge, Tennessee) to Colonel S. L. Warren, Medical Director of the Manhattan Project,
3 January 1946 ("Specific Proposals for the National Distribution of Radioisotopes
Produced by the Manhattan Engineer District") (ACHRE No. NARA-082294-A-31).
This memo, in turn, was derived from a more extensive document prepared by Waldo
Cohn, a member of the lab staff. W. E. Cohn, 3 January 1946 ("The National
Distribution of Radioisotopes from the Manhattan Engineer District") (ACHRE No.
DOE-051094-A-317).

2. The press release announcing the program noted that, in addition to technical
qualifications of researchers, "An additional qualification will require all groups using
the isotopes for fundamental research or applied science to publish or otherwise make
available their findings, thereby promoting further applications and scientific advances."
Headquarters, Manhattan District (Oak Ridge, Tennessee), 14 June 1946 ("For Release
in Newspapers Dated June 14, 1946") (ACHRE No. NARA-082294-A-31), 1.

3. "Availability of Radioactive Isotopes: Announcement from Headquarters,
Manhattan Project, Washington, D.C.," Science 103 (14 June 1946): 697-705.

4. Harry H. Davis, New York Times Magazine (typescript), 22 September 1946
("The Atom Goes to Work for Medicine") (ACHRE No. DOE-051094-A-408), 2.

5. Ibid., 6.

6. Cohn, 3 January 1946, 10.

7. Ibid., 14.

8. R. E. Cunningham, 20 February 1971 ("Historical Summary of the
Subcommittee on Human Applications") (ACHRE No. NRC-012695-A), 6.

9. AEC Subcommittee on Human Applications of the Committee on Isotope
Distribution, 13 March 1949 ("Revised Tentative Minutes of March 13, 1949, Meeting
of Subcommittee on Human Application of the Committee on Isotope Distribution of
U.S. Atomic Energy Commission: AEC Building, Washington, D.C.") (ACHRE No.
NARA-082294-A-62), 7.

10. Advisory Subcommittee on Human Applications of the Interim Advisory
Committee on Isotope Distribution Policy, 1 1 July 1946 ("Minutes of Initial Meeting-
Held June 28, 1946; Oak Ridge, Tennessee") (ACHRE No. NARA-082294-A-84), 1.

11. Ibid., 2-8.

12. Ibid., 5.

13. Ibid., 6.

14. Ibid., 10.

15. For example, proposals to study possible therapeutic uses of UX1/ UX2, a
"naturally radioactive pair [that] behaves chemically as UX1, a thorium isotope

(Th 234). . . . Aside from the danger of bone damage, the material would have to be used
with much caution because of likely kidney damage. No advantage could be seen in the
use of radiothorium over the use of certain other beta ray emitting radioisotopes which
deposit in bone." Ibid., 9.

16. Ibid.

17. "In general, there is more of a need for speed in handling requests for human
applications than for others because: (1) therapeutic action may be needed urgently, (2)

310

the case may be an exceptionally good one for some purpose and may only be available
for study immediately (for example, the chance to obtain tracer samples resulting from a
special operation)." Ibid., 10.

18. Isotopes Branch, Research Division, Manhattan District, Oak Ridge,
Tennessee, 3 October 1946 ("Details of Isotope Procurement") (ACHRE No.
NARA-082294-A-31).

19. Isotopes Branch, Research Division, Manhattan District, Oak Ridge,
Tennessee, 3 October 1946 ("Agreement and Conditions for Order and Receipt of
Radioactive Materials") (ACHRE No. NARA-082294-A-31), 2.

20. The statement read:

This is to certify that the undersigned has adequate facilities for the
investigation to be conducted by him as proposed in the 'Interim

Period Request for Radioelement, Form 313,' Serial Number ,

and that such drug will be used solely by him or under his direction
for the investigation, unless and until an application becomes
effective with respect to such drug under section 505 of the Federal
Food, Drug and Cosmetic Act, Isotopes Branch, Research Division,
Manhattan District, Oak Ridge, Tenn.
Isotopes Branch, Research Division, Manhattan District, Oak Ridge, Tennessee, 3
October 1946 ("Certificate . . . EIDM Form 465") (ACHRE No. NARA-082294-A-31),
1.

21. Isotopes Branch, Research Division, Manhattan District ("Report of
Requests Received to July 31,1 946," "2nd Report of Request Received August 1 to 3 1 ,
1946," "3rd Report of Request Received September 1 to 30, 1946," "4th Report of
Requests Received October 1 to 31, 1946") (ACHRE No. NARA-082294-A-31).

22. Franklin asked:

What is the relationship of the Atomic Energy Commission Medical
Division to the Isotopes Branch and the medical and biological aspects
of the isotope distribution program?

(1) Will allocations for human administration be subject to medical
review and what control will be exercised?

(2) What responsibilities does the Atomic Energy Commission bear
for the human administration of isotopes (a) by private physicians and
medical institutions outside of the Project, and (b) by physicians within
the Project? This latter category includes contractor personnel
employing Atomic Energy Commission funds (indirectly) to perform
tracer research, some of which is of no immediate therapeutic value to
the patient. What are the criteria for future human tracer research?

(3) What responsibilities does the Atomic Energy Commission bear
for the safe handling by the recipient of the more hazardous
radioisotopes?

(4) What responsibilities does the Atomic Energy Commission bear
for radioactive waste disposal outside the Project?

J. C. Franklin, Manager, Oak Ridge Operations, to Carroll Wilson, AEC General
Manager, 26 September 1947 ("Medical Policy") (ACHRE No. DOE-1 13094-B-3), 2.

311

23. Research Division, Manhattan District, 3 October 1946 ("Isotope Request,
For Manhattan Project Use Only . . . EIDM Form 558") (ACHRE No. NARA-082294-A-
31), 1.

24. In a 5 October 1949 memorandum to Carroll Tyler, Manager of Los Alamos,
Paul Aebersold, Chief of the Isotopes Division, noted that "Dr. [Shields] Warren
instructed that such allocations would be made by the Isotopes Division only after
review and approval by the Subcommittee on Human Applications of the Commission's
Committee on Isotope Distribution. It should be emphasized that the instruction applies
even though the radiomaterial is produced in the laboratory where it is to be used.

"Since this procedure has not been uniformly followed in the past, we are
writing to acquaint you with the appropriate details." Paul Aebersold, Chief, Isotopes
Division, to Carroll Tyler, Manager, Los Alamos, 5 October 1949 ("Use of Radioisotopes
in Human Subjects") (ACHRE No. DOE-021095-B-4), 1 . An identical memo was also
sent to the manager of the AEC's New York office regarding requirements for
Brookhaven National Laboratory. Paul Aebersold, Chief, Isotopes Division, to W. E.
Kelley, Manager, New York, 5 October 1949 ("Use of Radioisotopes in Human
Subjects") (ACHRE No. DOE-012795B).

25. Presumably codifying existing practice, 10 C.F.R. 30.10 (1951 supplement
to 1949 edition) states:

The regulations in this part do not apply to persons to
the extent that such persons operate Commission-owned
facilities in carrying out programs on behalf of the
Commission. In such cases, the acquisition, transfer,
use, and disposal of radioisotopes are governed by the
contracts between such persons and the Commission,
and internal bulletins, instructions and directives issued
by the Commission.

26. Carroll L. Wilson, AEC General Manager, to Principal Staff, Washington,
and Managers of Operations, 7 June 1950 ("Bulletin GM-161, Procedure for Securing
Isotopic Materials and Irradiation Services") (ACHRE No. NARA-122994-B), 1.

27. Subcommittee on Human Applications, 13 March 1949, 1.

28. Ibid., 3.

29. Ibid. These minutes include a review of the minutes of the 22-23 March
1948, meeting.

30. Ibid., 10-11.

31. Ibid., 10.

32. Ibid., 12-13.

33. Ibid., 4.

34. Ibid.

35. Paul Aebersold, Chief, Isotopes Division, Oak Ridge Operations, to Hymer
Friedell, G. Failla, Joseph G. Hamilton, and A. H. Holland, Jr., 9 March 1948 ("Meeting
of Subcommittee on Human Applications in Washington, March 22 and 23") (ACHRE
No. NARA-082294-A-17), 2.

36. Subcommittee on Human Applications, 13 March 1949, 5-6.

37. Ibid.

38. Clemens Benda, Director of Research and Clinical Psychiatry, to AEC
Subcommittee on Human Applications, 29 September 1953 ("This letter is written in

312

order to elicit your permission to administer a dose of 50 uc Ca45 to a moribund gargoyle
patient now hospitalized in our institution . . ."), 1 . Reproduced at appendix B-27, Task
Force on Human Subject Research, to Philip Campbell, Commissioner, Commonwealth
of Massachusetts Executive Office of Health and Human Services, Department of Mental
Retardation, April 1994 ("A Report on the Use of Radioactive Materials in Human
Subject Research that Involved Residents of State-Operated Facilities within the
Commonwealth of Massachusetts from 1943 to 1973") (ACHRE No. MASS-072194-A).

39. Clemens Benda, Clinical Director, to "Parent," 28 May 1953 ("In previous
years we have done some examinations in connection with the nutritional department of
the Massachusetts Institute of Technology . . ."), 1. Reproduced at appendix B-23, Task
Force on Human Subject Research, to Philip Campbell, April 1994.

40. Task Force on Human Subject Research, to Philip Campbell, April 1994, 16.

41. Subcommittee on Human Applications, 13 March 1949, 8.

42. AEC Isotopes Division, "General Authorizations for Procurement of
Radioisotopes," Isotopics: Announcements of the Isotopes Division 1 (April 1951): 1-3.

43. AEC Isotopes Division. "General Authorizations for Clinical Use of
Radioisotopes," Isotopics: Announcements of the Isotopes Division 2 (April 1952): 1-2.

44. Subcommittee on Human Applications, 13 March 1949, 1 1.

45. Paul C. Aebersold, Chief, AEC Isotopes Division, to William E. Barbour,
Jr., President, Tracerlab, Inc., 1 1 April 1949 ("Violation of 'Acceptance of Terms and
Conditions for Order and Receipt of Byproduct Materials [Radioisotopes]'") (ACHRE
No. NARA-082294-A-4), 1.

46. William Barbour, President, Tracerlab, Inc., to Employees, April 1949
("Violation of AEC Regulations") (ACHRE No. NARA-082294-A-4), 1 . Barbour stated
that a recurrence would

mean cessation of all radiochemical operations of the
Company. In turn this would jeopardize the investments
of several thousand new stockholders who have placed
great faith in the integrity and ability of the management.
A violation of a specific agreement with the AEC would
be a breach of that faith and could only result in the
automatic dismissal of anyone contributing to such a
violation.

47. AEC Isotopes Division, 23 March 1950 ("Meeting of the Advisory
Committee on Isotope Distribution, March 23 and 24, 1950, Washington, D.C.,
Minutes") (ACHRE No. NARA- 1 22994-B- 1 ), 4.

48. AEC Isotopes Division, September 1949 ("Supplement No. 1 to Catalogue
and Price List No. 3") (ACHRE No. DOD-122794-A-1), 1.

49. Paul C. Aebersold, Director, Isotopes Division, to T. H. Johnson, Director,
Division of Research, 2 November 1954 ("Providing Radioisotopes at Reduced Prices
for Medical, Biological, or Other Research Uses") (ACHRE No. TEX-101294-A-4), 1 .

50. 10 C.F.R. 37(1961).

51. A conscious decision was made not to include detailed standards in the
regulations. The discussion is summarized in Advisory Committee on Isotope
Distribution, 23 March 1950, 7-8. The regulations were first promulgated in 10 C.F.R.
30.50(1951 supplement to 1949 edition).

313

52. AEC Isotopes Division, 6 December 1948 ("Isotopes Division Circular D-4:
Radioisotopes for Use in Medicine") (ACHRE No. DOE-101 194-A-5); Isotopes
Division, "Supplement No. 1," September 1949; Isotopes Extension, Division of Civilian
Application, U.S. Atomic Energy Commission, "The Medical Use of Radioisotopes:
Recommendations and Requirements by the Atomic Energy Commission," RC- 1 2
(February 1956).

53. Isotopes Extension, February 1956, 14.

54. Ibid., 15.

55. R. E. Cunningham, "Historical Summary," 5.

56. AEC Division of Materials Licensing, "Non-Routine Medical Uses of
Byproduct Material," A Guide for the Preparation of Applications for the Medical Use of
Radioisotopes (November 1965), 47-48.

57. See, for example, Bryant L. Jones, Division of Oncology and
Radiopharmaceuticals, Bureau of Medicine, Food and Drug Administration, 1 8 May
1967 ("FDA Responsibility in Radiopharmaceutical Research") (ACHRE No. DOE-
051094-A-236).

58. Advisory Subcommittee on Human Applications, 1 1 July 1946, 6.

59. This requirement is stated in Aebersold's memo of 5 October 1949, quoted
earlier in endnote 24, which notified AEC labs that their applications for human use
would now be reviewed by the Subcommittee on Human Applications of the AEC's
Committee on Isotope Distribution. Concerning local isotope committees, the memo
states: "It should be emphasized that each application should be accompanied by a
formal, written endorsement, signed by the Chairman of the local "Isotopes Committee,"
the recommended membership of which is outlined on pages 30 and 31 of the catalog."
Paul Aebersold, Chief, Isotopes Division, to Carroll Tyler, Manager, Los Alamos, 5
October 1949 ("Use of Radioisotopes in Human Subjects") (ACHRE No. DOE-021095-
B-4); Paul Aebersold, Chief, Isotopes Division, to W. E. Kelley, Manager, New York, 5
October 1949 ("Use of Radioisotopes in Human Subjects") (ACHRE No. DOE-0 12795-

B).

60. AEC Isotopes Division, Isotopics 1,1.

61. Isotopes Extension, February 1956, 7. The full description of the functions
of the Medical Isotope Committee is:

1. Formation of a Medical Isotopes Committee. The
Medical Isotope Committee shall include at least three
members. Membership should include physicians expert
in internal medicine (or hematology), pathology, or
therapeutic radiology and a person experienced in assay
of radioisotopes and protection against ionizing
radiations. It is often appropriate that a qualified
physicist be available to the Committee, at least in
consulting capacity. It is recognized that the
composition of local isotope committees may vary from
institution to institution depending upon the individual
interests of a particular medical facility.

2. Duties of the Medical Isotopes Committee

314

Generally, the Committee should have the following
responsibilities:

a. Review and grant permission for, or disapprove, the
use of radioisotopes within the institution from the
standpoint of radiological health safety and other factors
which the Committee may wish to establish for medical
use of these materials.

b. Prescribe special conditions which may be necessary,
such as physical examinations, additional training,
designation of limited area or location of use, disposal
methods, etc.

c. Review records and receive reports from its
radiological safety officer or other individual responsible
for health-safety practices.

d. Recommend remedial action when a person fails to
observe safety recommendations and rules.

e. Keep a record of actions taken by the Committee.

62. The Advisory Committee also reviewed materials from the AEC's Oak
Ridge, Los Alamos, Argonne, and Brookhaven laboratories, the Air Force School of
Aviation Medicine, and the University of California. The development of research at the
University of California at Berkeley and San Francisco is the subject of a case study
appearing in a companion volume to this report.

63. N. W. Faxon, Director, Massachusetts General Hospital, to Drs. Aub,
Moore, Shulz, and Rawson, 3 May 1946 ("At the meeting of the General Executive
Committee held on May 1, 1946, consideration of the use of radioactive isotopes was
discussed . . .") (ACHRE No. H AR- 100394- A- 1), 1.

64. "It should be emphasized that the University Radiation Policy Committee
was established to deal with all types of radiation problems at the University and was not
limited to the scope of 'radioisotope committees' suggested by the AEC for radioisotope
procurement. In fact this Committee predated the earliest suggestions of the AEC by
almost a year." W. W. Meinke, Chairman, University of Michigan Radiation Policy
Committee, to I. Lampe, 27 February 1956 ("On October 13, 1950, the President of the
University of Michigan established the Radiation Policy Committee . . .") (ACHRE No.
MIC-010495-A-2), 1.

65. Consisting of Hugh Morgan (Vanderbilt University), Stafford Warren
(University of California at Los Angeles), Hymer Friedell (Case Western Reserve
University ), Shields Warren (AEC Division of Biology and Medicine), and Perrin Long
(Johns Hopkins University).

66. There was some debate at the beginning as to the name of the units. With
"radioactive" still a charged word for much of the population, an early memo suggested
that "it could to advantage be called a Metabolism Ward." Veterans Administration, 15
September 1948 ("Minutes of the Meeting, Central Advisory Committee on
Radioisotopes, U.S. Veterans Administration") (ACHRE No. UCLA- 100794- A), 23.

67. The chairman listed the already-achieved benefits to thyroid gland research
and blood volume diagnosis, and claimed, "It is not an overstatement to say that progress
can be expected to be rapid and on a wide front as greater use is made in medical and
biological research when this new tool is applied in attempts to solve such problems."

315

Ibid., 3.

68. Framingham, Massachusetts; Bronx, New York; Cleveland, Ohio; Hines,
Illinois; Minneapolis, Minnesota; Van Nuys, California; Los Angeles, California; and
Dallas, Texas.

69. Joseph C. Aub et. a!., to the Executive Committee, Massachusetts General
Hospital, 17 June 1946 ("The Radioactive Isotope Committee had its first meeting on
June 15th . . .") (ACHRE No. HAR-100394-A-2), 1-2.

70. William Sweet, interviewed by Gilbert Whittemore (ACHRE), transcript of
audio recording, 8 April 1995 (ACHRE Research Project Series, Interview Program File,
Targeted Interview Project), 20.

7 1 . VA Central Advisory Committee on Radioisotopes, 1 5 September 1 948, 26.

72. Ibid.

73. University of Michigan Subcommittee on Human Use of Isotopes, 10
December 1956 ("Minutes, Meeting of the Subcommittee on Human Use of Isotopes")
(ACHRE No. MIC-010495-A-3), 1.

74. William H. Beierwaltes to Edward A. Carr, Chairman, University of
Michigan Subcommittee on Human Use of Radioisotopes, 20 May 1968 ("Enclosed are
our calculations to date on our first two patients studied in the Clinical Research Unit . .
.") (ACHRE No. MIC-010495-A-6), 3. The form includes space for a signature by a
witness as well as the patient.

75. In an effort to develop an overall assessment of the possible harm from
radioisotope experiments conducted in the past, the Advisory Committee extracted dose
data from our Experiment Database, whenever available, in order to perform risk
analyses using contemporary standards. Unfortunately, most of the data recovered by the
Committee was fragmentary and did not provide a sufficient basis for an analysis of
possible harm in most cases.

76. Massachusetts General Hospital Radioactive Isotope Committee, 15 March
1955 ("Meeting of the Massachusetts General Hospital Radioactive Isotope Committee")
(ACHRE No. HAR-100394-A-4), 1.

77. Ibid.

78. One proposal, for example, involved saturating gelfoam with silver 1 1 1 or
yttrium 90, and then implanting the gelfoam into the tumor. Preliminary work had been
done on animals in the previous year on normal brain tissue. After extensive animal
testing, the procedure was to be attempted on those humans who already suffered brain
cancer and had undergone surgery. Theodore Rasmussen, 29 May 1952 ("Local
Application of Beta Ray Isotopes to Brain Tumors") (ACHRE No. DOE-122194-A).

79. For example, in 1 953 the Chicago committee approved a proposal to use
tritium and C-14-labeled acetate to trace the development of adrenal cholesterol in
advanced cancer patients as well as a control group. The committee noted that the doses
"are smaller than have been used in human studies at other institutions and in no case
involve amounts which will produce internal radiation in excess of maximum permissible
dose." George V. LeRoy, Chairman, Radioisotope Committee, 24 February 1953
("Minutes of the Radioisotope Committee Meeting") (ACHRE No. DOE- 122 1 94- A), 1.

80. This included recommendations for using the minimum amounts of isotopes
possible, a limitation of 1 rep [roentgen equivalent physical] for tracers, mandatory blood
tests before administration and forty-eight hours after, and a listing of dose
recommendations. The policy on patients and children was specific: "Adult humans who
are ill and who are expected to receive benefit from the procedure, shall not receive tracer

316

doses of radioactive material giving off radiation in excess of a total of 4 rep. Children
(all patients below 15 years of age) shall not receive more than a total of 0.8 rep." J. C.
Aub, A. K. Solomon, and Shields Warren, Harvard Medical School, 7 May 1949 ("Tracer
Doses of Radioactive Isotopes in Man") (ACHRE No. HAR-100394-A-3), 1.

81 . The committee stated that all volunteers receiving Na-22 and K-42 should
be subjected to doses no more than 100 millirads for the whole body, nor more than one-
third the maximum permissible values to a specific organ. University of Michigan
Subcommittee on Human Use of Isotopes, 10 December 1956, 1.

82. W. F. to University of Chicago Radioisotope Committee, 28 September
1953 ("Permission is requested to administer intravenously 500 microcuries, or less, of
radio-mercury to a patient . . .") (ACHRE No. DOE-122194-A-2), 1 .

83. Harvard Medical School Committee on Medical Research in Biophysics,
August 1957 ("Tracer Doses of Radioactive Isotopes in Man") (ACHRE No. HAR-
100394-A-5), 2.

84. University of Michigan Subcommittee on Human Use of Isotopes, 27
September 1955 ("Minutes of Human Use Committee Meeting") (ACHRE No. MIC-
010495-A), 2.

85. A 1963 memorandum indicates the committee's unwillingness to allow a
procedure involving selenium 75-labeled methionine for parathyroid scanning limited to
use in patients over forty years old, while in a 1 966 letter Carr stated that he was
"strongly inclined to refuse to permit the use of radioisotopes in all volunteers below the
age of 21, unless there are special mitigating circumstances approved by the whole
subcommittee." Ronald C. Bishop, Acting Chairman, Subcommittee on Human Use, 13
August 1963 ("Dr. E. A. Carr has asked me to act as chairman of the Subcommittee on
Human Use in his absence . . .") (ACHRE No. MIC-010495-A-4), 1; Edward A. Carr to
Dr. Bishop, 3 September 1966 ("To Members of the Subcommittee on Human Use of
Radioisotopes") (ACHRE No. MIC-010495-A-5), 1.

86. In 1 968 the committee approved a proposal for an experiment that involved
doses of NM-125 labeled with 1-131 or 1-125 for patients with melanomas or a reasonable
clinical suspicion of melanoma for thirty patients, and then wished to see results before
approving of further administration. Likewise, the committee gave approval to a closely
related experiment involving use of the same substances in patients with lung cancer. For
that regime, the committee demanded feedback after fifteen patients. For a further
related matter involving the same substances in patients with pulmonary carcinoma, the
committee limited the work to five patients. In each case the dose was to exceed 2
millicuries per patient. Edward A. Carr, Chairman, Subcommittee on Human Use, to
William H. Beierwaltes, Director, Nuclear Medicine, 27 September 1968 ("This is to
inform you that the Sub-committee on Human Use of Radioisotopes, at its meeting of
September 26, 1968, approved the use of a single dose of NM-1 13 . . .") (ACHRE No.
M1C-010495-A-6), 1.

87. A researcher had applied to use sodium 22 in a tracer procedure with several
patients. The committee was concerned that "a small but significant fraction of one of
the radioisotopes might remain localized in the body for a long period of time . . ."
Edward A. Carr, 3 June 1968 ("Sub-committee on Human Use of Radioisotopes, Minutes
of the Meeting of June 3, 1968") (ACHRE No. MIC-010495-A-7), 1 .

88. George V. LeRoy, 3 November 1953 ("Minutes of the Radioisotope
Committee Meeting") (ACHRE No. DOE-122194-A-3), 1.

317

89. Paul C. Aebersold, Chief, Isotopes Division, to John Z. Bowers, Assistant to
Director, Division of Biology and Medicine, 18 March 1948 ("Investigation of Patients
Who Have Received Radioactive Isotopes") (ACHRE No. DOE-061395-E-1), 1.

90. A comprehensive history of the application of radioisotopes is well beyond
the scope of this chapter and would needlessly duplicate substantial histories already
written. See, for example, J. Newell Stannard, Radioactivity and Health: A History
(Springfield, Va.: Office of Scientific and Technical Information, 1988).

91. An example is Konstantin N. Pavlou, William P. Steffee, Robert H. Lerman,
and Belton A. Burrows, "Effects of Dieting and Exercise on Lean Body Mass, Oxygen
Uptake, and Strength," Medicine and Science in Sports and Exercise 17(1 985): 466-47 1 .
The study was conducted at the Boston University Medical School and the Boston VA
Medical Center.

92. There is a vast literature on radioiodine and the thyroid. Government studies
specifically noted by the Veterans Administration as significant are the following: H. C.
Allen, R. A. Libby, and B. Cassen, "The Scintillation Counter in Clinical Studies of
Human Thyroid Physiology Using 1-131," Journal of Clinical Endocrinology and
Metabolism 1 1 (1951): 492-51 1; B. A. Burrows and J. A. Ross, "The Thyroid Uptake of
Stable Iodine Compared with the Serum Concentration of Protein-Bound Iodine in
Normal Patients and in Patients with Thyroid Disease," Journal of Clinical
Endocrinology and Metabolism 13 (1953): 1358-1368; S. A. Berson and R. S. Yalow,
"Quantitative Aspects of Iodine Metabolism: The Exchangeable Organic Iodine Pool,
and the Rates of Thyroidal Secretion, Peripheral Degradation and Fecal Excretion of
Endogenously Synthesized Organically Bound Iodine," Journal of Clinical Investigation
33 (1954): 1533-1552; M. A. Greer and L. J. DeGroot, "The Effect of Stable Iodide on
Thyroidal Secretion in Man," Metabolism 5 (1956): 682-696; K. Sterling, J. C. Lashof,
and E. B. Man, "Disappearance from Serum of 1-131 Labeled I-Thyroxine and 1-
Triiodothyronine in Euthyroid Subjects," Journal of Clinical Investigation 33 (1954):
1031; K. Sterling and R. B. Chodos, "Radiothyroxine Turnover Studies in Myxosema,
Thyrotoxicosis, and Hypermetabolism Without Endocrine Disease," Journal of Clinical
Investigation 35 (1956): 806-813.

93. See, for example, J. F. Ross, "Cooperative Study of Radioiodine Therapy for
Hyperthyroidism," Bulletin of the Committee on Veterans Medical Problems (National
Academy of Sciences) (1952): 576-578.

94. Gould A. Andrews, M.D., Samuel W. Root, M.D., and Herbert D. Kerman,
M.D., "Clinical Studies with Gallium-72," 570-588 in Marshall Brucer, M.D. (ed.),
Gould Andrews, M.D., and H.D. Bruner, M.D., "Clinical Studies with Gallium-72,"
Radiology 66 (1953): 534-613.

95. OncoScint, developed by Cytogen, was approved by the FDA for diagnosis
of colorectal and ovarian cancers on 29 December 1992, Product License Application no.
89-0601, with Amendment no. 90-0278. The use of monoclonal antibodies to treat cancer
is discussed in Oliver W. Press, M.D., Ph.D., et al., "Radiolabeled-Antibody Therapy of
B-Cell Lymphoma with Autologous Bone Marrow Support," New England Journal of
Medicine 329 (21 October 1993): 1219-1224. Progress in the field is reviewed in an
accompanying editorial, Robert C. Bast, Jr., M.D., "Progress in Radioimmunotherapy,"
New England Journal of Medicine 329(21 October 1993): 1266-1268.

96. Strontium 89, commercially available as Metastron from Amersham-
Mediphysics, was approved on 18 June 1993, New Drug Application no. 20134. One of
its therapeutic uses is described in an article by Arthur T. Porter. M.D., and Lawrence P.

318

Davis, M.D., "Systemic Radionuclide Therapy of Bone Metastases with Strontium-89,"
Oncology 8 (February 1994): 93-96.

97. R. S. Yalow and S. A. Berson, "Assay of Plasma Insulin in Human Subjects
by Immunological Methods," Nature 184 (1959): 1648.

319

nontherapeutic research on

Children

In the late 1940s and again in the early 1950s, Massachusetts Institute of
Technology scientists conducting research fed breakfast food containing minute
amounts of radioactive iron and calcium to a number of students at the Walter E.
Fernald School, a Massachusetts institution for "mentally retarded" children.1
The National Institutes of Health, the Atomic Energy Commission, and the
Quaker Oats Company funded the research, which was designed to determine
how the body absorbed iron, calcium, and other minerals from dietary sources and
to explore the effect of various compounds in cereal on mineral absorption.

In 1961, researchers from Harvard Medical School, Massachusetts
General Hospital, and Boston University School of Medicine administered small
amounts of radioactive iodine to seventy children at the Wrentham State School,
another Massachusetts facility for mentally retarded children. With funding from
the Division of Radiologic Health of the U.S. Public Health Service, the scientists
conducting this experiment used Wrentham students to test a proposed
countermeasure to nuclear fallout. Specifically, the study was meant to determine
the amount of nonradioactive iodine that would effectively block the uptake of
radioactive iodine that would be released in a nuclear explosion.

Recently, these two studies have received considerable media attention,
and an official Massachusetts state task force has reported on both episodes in
some detail.2 Although they represent special cases because they involve
institutionalized children, the Fernald and Wrentham experiments nonetheless are
the most widely known examples of a category of research that raises particular
concerns for the Committee: nontherapeutic experimentation on children.

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Experiments involving children are important to the Committee for two
reasons. First, children are more susceptible than adults to harm from low levels
of radiation, and thus as a group they are more likely than adults to have been
harmed as a consequence of their having been subjects of human radiation
experiments. Second, an evaluation of research with children is critical to
determining whether any former subjects of radiation experiments should be
notified in order to protect their health, one of our specific charges.3 Subjects
who were children at the time of their exposure are more likely than adults to be
candidates for such notification, both because of their increased biological
sensitivity and because they are more likely to still be alive. (See chapter 18 for
the Committee's recommendations with respect to notification and follow-up.)

We elected to focus on pediatric research that offered subjects no prospect
of medical benefit, so-called nontherapeutic research, because it is this kind of
research that has generated the most public concern and is the most ethically
problematic. This is not to say, however, that experiments on children in which
the children stand to benefit medically never raise ethical issues; such research
certainly can and does. But in deciding how to allocate our limited resources, we
chose to concentrate where the issues are mostly sharply drawn. Also, because
most nontherapeutic research with children involved tracer doses of radioisotopes,
focusing on this work allowed us a window into radioisotope research generally.

We begin the chapter by setting the context for nontherapeutic radiation
experiments on children. We review those factors that make nontherapeutic
research on children ethically problematic and how such research has been
viewed historically. We next consider what the practices and standards were for
research on children in the 1940s, 1950s, and 1960s. This is a continuation of the
discussion in chapter 2, which focused on professional standards and practices for
human research.

The next three sections address human radiation experiments in terms of
the central ethical issues raised by nontherapeutic research involving children-
level of risk, authorization for the involvement of children, and selection of
subjects. To address the question of risk, we analyzed twenty-one nontherapeutic
radiation experiments with children conducted during the 1944-1974 period. The
focus of this analysis is whether it is likely that any of the subjects of these
experiments was harmed or remains at risk of harm attributable to research
exposures. A table summarizing these experiments and our risk estimates can be
found at the end of this chapter. The twenty-one experiments were selected from
eighty-one pediatric radiation research projects identified by the Committee from
government documents and the medical literature. Although these eighty-one by
no means constitute all the pediatric radiation research conducted during this
time, they include what are likely fairly typical examples of such research. Of the
eighty-one, thirty-seven studies were judged to be nontherapeutic, and twenty-one
of these were conducted or funded by the federal government and thus fell under
the charge of the Committee. Included within these twenty-one studies were the

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two nutrition experiments conducted at the Fernald School and one fallout-related
study conducted at the Wrentham School discussed in the introduction to this
chapter. All twenty-one studies employed radioisotopes to explore human
physiology and pathology.

We turn next to a consideration of how authorization for the inclusion of
the children in these experiments was obtained and who these children were.
Unfortunately, for most of these experiments, little is known about either of these
issues. The last section of the chapter focuses specifically on the experiments at
the Fernald School where, thanks to the work of the Massachusetts Task Force on
Human Subject Research, relevant information is available. Throughout the
chapter, we focus only on research in which children could not have benefited
medically. The Committee did not have the resources to pursue two related areas
of research—nontherapeutic research on pregnant women and therapeutic research
on children. We include two capsule descriptions of examples of these types of
research at the end of this chapter.

THE CONTEXT FOR NONTHERAPEUTIC RESEARCH WITH
CHILDREN

Children as Mere Means

In both law and medical ethics, it has long been recognized that children
may not authorize medical treatment for themselves, except in special
circumstances.4 Instead, authorization must be sought from the parent.
Historically, the source of this respect for parental authority rested upon the view
that children were the property of their parents, and thus parents had the right to
determine how their "property" Was to be treated. Today, we still speak of
parental rights, although the justification for these rights no longer rests on an
analysis of children as property. Instead, respect for the rights of parents is
viewed as a mechanism for valuing and fostering the institution of the family and
the freedom of adults to perpetuate family traditions and commitments. Another
important line of justification for respecting the authority of parents relies not on
a recognition of parental rights but on the view that the interests of the child are
generally best served by ceding decisional authority to the parent. The parent is
thought not only to be in the best position to determine what is in the interests of
the child but is also thought to be generally motivated to act in the child's best
interests.5

When research involving children offers a prospect of medical benefit to
the child-subject, the application of the above analysis is straightforward. Parents
are generally thought to have the authority to determine whether their children
should be made subjects of such research. Certainly today, any use of a child in
research would not be ethically acceptable or legally permissible without the
parent's permission/' Where the research does not offer any prospect of benefit to

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the child, however, the legitimacy of the parent as authorizer is less clear.

Respect for the authority of parents to make decisions for their children
and otherwise control their children's lives is not without bounds. The law
recognizes several exceptions, designed primarily to protect the child from what
society at large considers to be unacceptable or unjustifiable harm or risk of
harm.7 Laws against the physical abuse of children are perhaps the most obvious
example of such limitations on parental authority. In the context of research, the
question arises of whether a parent has the authority to permit a child to be put at
risk of harm in an experiment from which the child could not possibly benefit
medically. In this case, the child is to be used as a means to the ends of others.
Children are not in a position to determine for themselves whether they wish to
agree to such a use and thus cannot themselves render the use morally acceptable.
Should parents have such authority? Should anyone?

This question was resolved as a matter of public policy in the 1970s
through the work of the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research and the subsequent adoption, in
1983, of federal regulations governing research involving children that were
guided by the recommendations of the National Commission.8 These regulations
state that children can participate in federally funded research that poses greater
than minimal risks to the subject if a local review committee (an institutional
review board, or IRB) finds that the potential risk is "justified by the anticipated
benefit to the subjects"; "the relation of the anticipated benefit to the risk is at
least as favorable to the subjects as that presented by available alternative
approaches"; and "adequate provisions are made for soliciting the assent of the
children and permission of their parents or guardians."9 The word consent is
purposely avoided in these regulations to distinguish parental permission and
minor assent from the autonomous, legally valid consent of a competent adult.

Federal regulations do allow nontherapeutic research on children if an IRB
determines that the research presents "no greater than minimal risk" to the
children who would serve as subjects, although no clear definition of what
constitutes minimal risk is provided.10 As with therapeutic pediatric research,
parents or guardians must grant "permission" and children who are deemed
capable must offer "assent."

The regulations also allow for nontherapeutic research with children that
does present more than minimal risk, again with parental permission and assent of
the child (as appropriate), but only if 'the risk represents a minor increase over
minimal risk, the procedures involved are commensurate with the general life
experiences of subjects, and the research is likely to yield knowledge of "vital
importance" about the subjects' disorder or condition." Research with children
that is not otherwise approvable may be permitted, but only under special, and
presumably rare, circumstances. In addition to local IRB review, such research
must withstand the special scrutiny of the secretary of the agency sponsoring the
research, who is to be advised by a special IRB.12 The secretary must also allow

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the opportunity for "public review and comment" on a proposed nontherapeutic
research project that is not otherwise approvable.

The regulations thus draw a sharp distinction between therapeutic and
nontherapeutic research. Nontherapeutic research, while severely restricted, is
not banned. The decision to permit parents to authorize the use of their children in
nontherapeutic research reflects both the recognition that some important
advances in pediatrics could come only from research with children that was of no
benefit to them and the recognition that we all—as parents, as potential future
parents, and as members of society— share in the interest of advancing the health
of the young. At the same time, however, parental authority to permit such use of
a child is generally restricted to research judged to pose little risk; as important as
it is to promote the welfare of children (as a class), this interest justifies only
minor infringements of the principle not to use people as mere means to the ends
of others.

These 1983 regulations, and the reasoning behind them, were the
culmination of considerable public debate and scholarly analysis, much of which
occurred in the 1970s. To situate properly the experiments of interest to the
Committee, it is necessary to examine the social and professional roots of the
issues and arguments that ultimately led to the federal regulations.

Public Attitudes, Professional Practices

Attitudes and Practices Prior to 1944

There was significant research interest in infants and children as early as
the eighteenth century, as scientists began to experiment with vaccines and
immunization. Children were particularly valuable subjects for this type of
research because in general, they were less likely than adults to have been
exposed to the disease being studied.13 A child's response to immunizations was
also of great interest because most immunizations are performed during
childhood.

During the nineteenth century, the Industrial Revolution greatly increased
the number of child laborers, and the public began to acknowledge the need for
laws to protect children from abuse.14 Physicians started to specialize in
pediatrics, studying specifically the health problems and diseases that afflicted
children. Simultaneously, as social reformers were creating a wide range of
institutions for children, such as orphanages, schools, foundling homes, and
hospitals, scientists recognized the value of research conducted in these types of
institutions. In the late nineteenth and early twentieth centuries, Alfred F. Hess,
the medical director of the Hebrew Infant Asylum in New York City, conducted
pertussis vaccine trials and undertook extensive studies of the anatomy and
physiology of digestion in infants at the asylum. According to Advisory
Committee member and historian Susan Lederer, Hess sought to take advantage

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of the conditions in the asylum as they approximated those "conditions which are
insisted on in considering the course of experimental infection among laboratory
animals, but which can rarely be controlled in a study of infestation in man."15

Although many shared Hess's laudable goal of improving the health of
asylum children, many people drew the line at the pediatrician's investigations of
scurvy and rickets. In order to study the disease, Hess and his colleagues
withheld orange juice from infants at the asylum until they developed lesions
characteristic of scurvy. Responding to the public discussion of the ethics of
using children in such nontherapeutic experiments, the editors of one American
medical journal insisted that such investigations gave the children an opportunity
to repay their debt to society, even as they conceded that experimentation on
human beings should be limited to "children as may be utilized with parental
consent."16

Hess's work was not the only case in which experiments involving
children attracted negative public opinion. In 1896, for example, American
antivivisectionists attacked a Boston pediatrician, Arthur Wentworth, who
performed lumbar punctures on infants and children in order to establish the
safety and utility of the procedure. The antivivisectionists were particularly
alarmed because this procedure, which caused pain and discomfort, did not confer
any benefits to the subjects. John B. Roberts, a physician from Philadelphia,
labeled Wentworth's procedures "human vivisection," saying that "using the
children in the hospital without explaining his plan to their mothers or gaining
their permission intensified public fear of hospitals."17

The twentieth century brought new drugs and advanced technologies,
which allowed for increased research on children. The conduct of this
experimentation, however, was largely left to the individual investigator. When
his experimental gelatin injections provoked "alarming symptoms of prostration
and collapse in three normal children (including a 'feeble-minded' four-year-old
girl), the physician Isaac Abt stopped his pediatric experiments and began
experimenting on rabbits."18 Meanwhile, legislation was being proposed
throughout the country to protect children and pregnant women from
experimenting physicians. Two proposals were introduced in the U.S. Senate in
1900 and 1902; proposals '"to prohibit such terrible experiments on children,
insane persons and pregnant women . . . ,' and to ensure 'that no experiment
should be performed on any other human being without his intelligent written
consent' were introduced in the Illinois legislature" in 1905 and 1907; in 1914 and
1923, the New York legislature considered bills that prohibited exoerimentation
with children.19 Although these bills did not become law, it is clear that some
unease concerning nontherapeutic research on children existed among the public
and elected officials.

Reaction to the polio vaccine trials conducted during the 1930s further
demonstrated the growing discomfort over pediatric experimentation as thousands
of American children were involved in what some considered at the time to be

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premature human trials of the polio vaccine. Although it appears that parental
consent was obtained for a number of these studies, the controversy over these
trials stalled polio vaccine research for almost two decades and generally made
investigators ambivalent about the use of human subjects.20

Although there are no legal cases that bear directly on nontherapeutic
research with children during this period, an appellate court ruling in 1941,
Bonner v. Moran, involving the performance of a nontherapeutic medical
procedure on a child without parental consent, suggests how such a case might
have been decided.21 John Bonner, a fifteen-year-old African-American boy from
Washington, D.C., had undergone an experimental skin graft for the benefit of
Clara Howard, a cousin suffering from severe burns. When he discovered that
John Bonner had the same blood type as the burn victim, Howard's plastic
surgeon, Robert Moran, persuaded Bonner to allow him to fashion "a tube of
flesh" by cutting from the boy's "arm pit to his waist line."22 This procedure,
however, was conducted without the consent of a parent, as "his mother, with
whom he lived, was ill at the time and knew nothing about the arrangement."23
Moran then attached the free end of Bonner's flesh tube to Clara Howard, hoping
that the flesh-and-blood link would bring benefit to the burned girl. Due to poor
circulation in the tube, the procedure did not help the burn patient and put the
healthy boy, who was required to stay in the hospital for two months, at
significant risk (and left him with permanent scars). Bonner's mother brought suit
against Moran for assault and battery.

The appellate court based its ruling against Moran on what it perceived as
a disturbing combination of a lack of direct benefit for John Bonner and a lack of
permission from the boy's mother:

[H]ere we have a case of a surgical operation not
for the benefit of the person operated on but for
another. . . . We are constrained, therefore, to feel
. . . that the consent of the parent was necessary.24

The court did not refer to the episode as an instance of experimentation, but the
parallels between this novel procedure performed for the benefit of another and a
nontherapeutic medical experiment are quite powerful.25

Attitudes and Practices 1944-1974

As best the Committee can establish, there were no written rules of
professional ethics for the conduct of research on children prior to 1964. Taken
literally, the Nuremberg Code, which requires that all subjects of research "have
legal capacity to give consent," precludes all research with children.26 There is no
reason to believe, however, that the judges at Nuremberg meant to impose such a
prohibition, and the Nuremberg Code did not result in a ban on research with

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children.

Pediatric research flourished after World War II, as did biomedical
research in general. What is less clear is how this research was conducted, and on
whom. One source of evidence about legal thinking on pediatric research, if not
actual practice, is the writings of Irving Ladimer, a lawyer who, in 1958, was
completing a doctoral degree in juridical science at the same time he was
employed as an administrator at the National Institutes of Health. Ladimer
concluded his doctoral dissertation, "Legal and Ethical Implications of Medical
Research on Human Beings," with an appendix devoted to the issues surrounding
"Experimentation on Persons Not Competent to Provide Personal Consent,"
whom he defined broadly as minors and mental incompetents.27 Ladimer argued
that it was "permissible to employ minors and incompetents as subjects of
medical investigations . . . where there is informed consent by a parent or
guardian (including the state) for procedures which also significantly benefit or
may be expected to benefit the individual. "2X Ladimer was less sanguine,
however, about nontherapeutic research with these populations. He expressed
particular concern about the use of institutionalized children— even with proxy
permission—in research that did not hold the possibility of personal benefit:
"Permission given by parents or the state to utilize institutionalized children,
without any suggestion of benefit to the children, may well be beyond the ambit
of parental or guardianship rights."29

Ladimer did, however, leave open a window for the use of legally
incompetent subjects in nontherapeutic research, but he clearly harbored great
discomfort with his own suggestion:

[T]he availability of certain persons, not able to
consent personally, may constitute a strategic
resource in terms of time or location not otherwise
obtainable. It must be remembered, however, that
the Nazis hid behind this rationalization in
explaining certain highly questionable or
clandestine medical experiments. Such justification
should not even be considered except in dire
circumstances. If ever employed, it should not be
assimilated into the concept of personal benefit, else
there may be no legal or ethical control for the
protection of both prospective subject and
investigator and their individual integrity.30

As part of the Committee's Ethics Oral History Project, we interviewed
two pediatricians who were beginning their careers in academic medicine in the
late 1940s. One of these respondents, Dr. Henry Seidel, had some research
experience with institutionalized children. He noted that "we got access [to the

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children] very easily," and although his research was merely observational, it was
"not hard to imagine" that experimental research with these children could have
been conducted.31 When asked about the studies conducted by Dr. Saul Krugman
on institutionalized children at the Willowbrook State School (discussed later in
this chapter), Seidel observed, "I didn't have any problem imagining that
possibility. In retrospect, I'm sure it could happen, you know. There was
something about those reports that rang true. . . ."32 William Silverman, the other
pediatrician interviewed, had clear recollections of how research was conducted
in pediatrics at that time. He recalled that, in the 1950s, many pediatricians,
including himself, believed that it was not necessary to obtain the permission of
parents before using a pediatric patient as a subject in research-even if the
research was nontherapeutic (he has since become a strong proponent of the
parental permission requirement in pediatric research).33 He also asserted that
performing nontherapeutic experiments on children without authorization from
parents was part of a broader "ethos of the time" in which "everyone was a
draftee" in a national war on disease.34 Dr. Silverman's account squares with the
picture that emerged in chapter 2 of practices in research with adults, in which it
was not uncommon to use adult patients as subjects of research without their
knowledge or consent.

Silverman was among the researchers invited by Boston University's Law-
Medicine Research Institute (LMRI) to participate in a conference on "Social
Responsibility in Pediatric Research" held in May 1961.35 This meeting was one
in a series of closed-door conferences organized by LMRI to investigate actual
practices among clinical researchers. The transcripts of the conference provide an
important window onto practices and attitudes of the time; in large measure, they
confirm Silverman's recollection of his own position some thirty-five years ago.
Early in the meeting, Silverman asserted that "there is an unwritten consent by
being a living person at this time to participate in this kind of advancement of
knowledge [that is, nontherapeutic pediatric research]."3'1 Some of the other
participants employed the same analogy to the military draft that Silverman
recently used to relate his recollections.

However, there was by no means unanimity about the appropriateness of
this view:

Dr. A: [Dr. B] says that this [research without

consent] is like military conscription.

Dr. C: Not comparable. We voted to do military

conscription.37

The proceedings of the conference suggest that while it may not have been
uncommon for pediatric patients to be used as subjects of nontherapeutic research
without the permission of their parents, at least some physician-investigators,
including investigators who followed this practice, thought it was morally wrong

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to do so. Consider, for example, a story relayed by one pediatrician-investigator
at the conference who seemed to embrace with particular earnestness the desire of
the conference organizers to learn the unvarnished reality of clinical research. In
the opening minutes of the meeting, this researcher reminded his colleagues that
"the question for us to discuss here today is how we operate on a daily basis."38
He offered for discussion a provocative case from his personal experience in
which he and his associates "wanted [to do] lumbar punctures on newborns. "39
He explicitly noted that "this study [was] not of benefit to the individual; it was an
attempt to learn about normal physiology."40 One of the other conferees asked,
"Did you ask [parental] permission?" The researcher responded, "No. We were
afraid we would not get volunteers."41 The case prompted a great deal of
discussion at the conference, but perhaps most tellingly this researcher frankly
acknowledged toward the end of the discussion— in a meeting that had begun with
an assurance of confidentiality from the organizers—that he had "sinned" in
carrying out these lumbar punctures in "normal infants" without parental
permission.42

The proceedings of the conference also suggest that at least some
pediatrician investigators routinely obtained the permission of parents before
embarking on research with their children. It is perhaps significant that the
pediatric researcher who articulated this position at the conference was from
Canada— and the conference transcript seems to suggest that he was providing a
general characterization of practices in his country:

Dr. A: Let's ask [Dr. B] from Canada.
Dr. B: We have been quite sticky on consent. If we
want a biopsy or a radioactive exposure and the
parent says "no" then we don't do it. . . . The
question of morals is too valuable.43

If this statement represents the sensitivity of Canadian pediatrician-investigators
to issues of parental permission (which this single quotation does not prove),
there is no obvious explanation as to why many of their colleagues in the United
States behaved differently.

The LMRI conference is noteworthy not only for what it reveals about the
range of views and practices concerning parental permission for nontherapeutic
research, but also for the unanimity expressed about the importance of obligations
to prevent or minimize harm to pediatric subjects of research. Minimizing risk
was recognized by those at the conference as the most important (and, for some
participants, the only) moral duty of pediatric investigators.44

Three years after the LMRI conference, in the summer of 1964, the World
Medical Association ratified a code of ethics for human experimentation at a
meeting in Helsinki. Unlike the Nuremberg Code, this statement, known as the
Declaration of Helsinki, recognizes that research may be conducted on people

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with "legal incapacity to consent."45 The Declaration distinguishes between two
kinds of research: "Clinical Research Combined with Professional Care" and
"Non-therapeutic Clinical Research."46 It permits the use of people with legal
incapacity to consent as subjects in both kinds of research, provided that the
consent of the subject's legal guardian is procured.

Subjects of the first kind of research are referred to as patients; disclosure
to and consent from patient-subjects are required by the Declaration, "consistent
with patient psychology."47 The Declaration does not specify whether
considerations of "patient psychology" also could justify not obtaining the
consent of the guardian where the subject does not have the legal capacity to
consent.

The subjects of "non-therapeutic clinical research" are not referred to as
patients but as human beings who must be "fully informed" and whose "free
consent" must be obtained.48 The Declaration also requires that nontherapeutic
research be discontinued if in the judgment of the investigators to proceed would
"be harmful to the individual."49 Thus, although the Declaration permits parents
to authorize the use of their children as subjects in nontherapeutic research, such
research is not intended to be "harmful" to the subjects.

The language and reasoning of the Declaration was unclear and confusing
with regard to clinical research, both therapeutic and nontherapeutic, on legally
incapacitated individuals. It was revised in 1 975, at a time when the ethics of
research with human subjects was receiving considerable public attention in the
United States (see chapter 3).

Both in the 1960s and early 1970s, public controversies erupted about
several cases of research involving human subjects, controversies that led to the
establishment of the National Commission and publication of the federal
regulations (see chapter 3). One of the most well known of these cases involved
research on institutionalized children. During the 1950s and 1960s, Dr. Saul
Krugman of New York University conducted studies of hepatitis at the
Willowbrook State School, an institution for the severely mentally retarded.50 To
study the natural history, effects, and progression of the disease, Krugman and his
staff systematically infected newly arrived children with strains of the virus.
Although the investigators did obtain the permission of the parents to involve
their children in the research, critics of the Willowbrook experiments maintained
that the parents were manipulated into consenting because, at least in the later
years of the research, the institution was overcrowded and the long waits for
admittance were allegedly shorter for children who were entering the research
unit. Henry Beecher, a Harvard anesthesiologist whose impact on the history of
research ethics is detailed in chapter 3, condemned Krugman and his staff for not
properly informing the parents about the risks involved in the experiment.51
Beecher also challenged the legal status of parental consent when no therapeutic
benefit for the child was anticipated. A New York state senator, Seymour R.
Thaler, criticized the Willowbrook research on the pages of the New York Times

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in 1967, only to come to its defense later in 1971. Also in the early 1970s
Willowbrook became the subject of a heated debate in the medical literature.52

Interestingly, Dr. Krugman was one of the participants at the LMRI
"Social Responsibility in Pediatric Research" conference where he expressed
pride that he routinely obtained permission from the parents of the children in his
studies. In that group in 1961, Krugman was thus among those pediatric
investigators most sympathetic to the position that children could not be used as
mere means to the ends of the researcher without the authorization of the parent.

AEC Requirements for Radiation Research With Children

Although in the 1940s and 1950s there were apparently no written rules of
professional ethics for pediatric research in general, there were guidelines for the
investigational use of radioisotopes in children. In 1949, the Subcommittee on
Human Applications of the Atomic Energy Commission's Isotope Division
established a set of rules to judge proposals submitted by researchers for the use
of radioisotopes in medical experiments with human subjects, including "normal
children."" These standards appeared in the fall 1949 supplement to the AEC's
isotope catalogue and price list. Under the heading "Normal Children" the
isotope catalogue offered the following statement:

In general the use of radioisotopes in normal
children is discouraged. However, the
Subcommittee on Human Applications will
consider proposals for such use in important
researches, provided the problem cannot be studied
properly by other methods and provided the
radiation dosage level in any tissue is low enough to
be considered harmless. It should be noted that in
general the amount of radioactive material per
kilogram of body weight must be smaller in
children than that required for similar studies in the
adult.54

These guidelines did not mention consent--of parents, guardians, or
children.55 Instead, this statement simply discouraged nontherapeutic experiments
with children. The guidelines did not, however, suggest that the practice was
completely inappropriate; the subcommittee asserted that "important" research
using "harmless" levels of radiation dosage with children was acceptable. The
crucial terms important and harmless were left undefined.

It seems reasonable to expect that "important" pediatric research would
address a significant medical problem affecting children or would explore key
aspects of normal human physiology-relevant to health promotion or disease

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prevention— for which research on children is indispensable. By these standards,
the twenty-one nontherapeutic radiation experiments with children whose risks
we review in the next section of this chapter could all be said to address important
questions relevant to pediatric health care. This judgment is not based on a
determination of whether a given study proved important in the subsequent
development of a particular field. Such retrospective analysis would place an
unreasonable burden on investigators of the past, as research is an inherently
speculative enterprise. Many experiments that prove to be of little value in the
advance of medical knowledge are, at the time they are implemented, well
designed and appropriate attempts to address important research questions.

It is easier to infer what the members of the AEC Subcommittee on
Human Applications would have considered "important" research than what the
subcommittee would have considered "harmless" radioisotope research. Acute
toxicity is not seen following administration of nontherapeutic (tracer) doses of
radioisotopes. Thus, the principal potential harm from radiation exposure at
lower doses is the subsequent development of cancer. In the 1940s and 1950s,
some in the field apparently discounted the risk, while others were wary of a
prevailing uncertainty. Dr. John Lawrence, an early radioisotope researcher at the
University of California, described how some researchers conducted public
demonstrations of tracers, using an "unsuspecting physician out of the audience to
act as the guinea pig," presumably to reassure the audience that tracers were
innocuous.56 By contrast, other investigators focused on the tragedy of the radium
dial painters, concerned that this might be repeated with man-made radionuclides.

Evidence of how well the AEC enforced its 1949 guidelines with respect
to research on children is elusive (see chapter 6). AEC correspondence with
researchers at the Fernald School suggests that in at least one case there was
oversight of research in which children were administered radioisotopes.57

RISK OF HARM AND NONTHERAPEUTIC RESEARCH
WITH CHILDREN

The Twenty-One Case Examples

During the 1944-1974 period, there was an explosion of interest in the use
of radioisotopes in clinical medicine and medical research, including pediatrics.
The twenty-one research projects we review here include only a small number of
all those that were likely conducted. These twenty-one do include, however,
every nontherapeutic study that was funded by the federal government and fell
into our original group of eighty-one pediatric radiation experiments. The table
that appears at the end of the chapter provides information about the number of
children involved in each of the experiments, the radioisotopes used, and risk
estimates for cancer incidence. These twenty-one represent a subset of eighty-one
studies identified in documents of the Atomic Energy Commission and a review

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Chapter 7

of the medical literature that met the criteria described above."

All twenty-one projects analyzed in detail involve the administration of
radioisotopes to children in order to better understand child physiology or to
develop better diagnostic tools for pediatric disease. In this respect, the studies
supported by the federal government do not differ from those reviewed that had
other funding sources. With the exception of the study at the Wrentham school to
evaluate protective measures for fallout, none of the twenty-one experiments
reviewed was related to national defense concerns. Seventeen of the twenty-one
experiments involved the use of iodine 131 for the evaluation of thyroid function.
Three examples of research reviewed by the Committee will help illustrate
the nature of the experiments and the risks posed to children. In the first example
investigators at Johns Hopkins in 1953 injected iodine 131 into thirty-four
children from ages two months to fifteen years with hypothyroidism and an
unknown number of healthy "control" children in order to better understand the
cause of this disease.59 Iodine is normally taken up and used by the thyroid gland
for hormone production. In this experiment, a radiation detector was placed over
the thyroid to detect the amount of iodine 1 3 1 taken up. Most children with
hypothyroidism have an underdeveloped thyroid gland, in which case only very
low levels of iodine 131 uptake will occur. Indeed, this is what the investigators
found in this experiment, which was one of the first projects to use iodine 131
uptake as a measure of thyroid function in children. Hypothyroidism is a
relatively common condition (1 per 4,000 births) that can cause profound mental
retardation if untreated. Today, better diagnostic tests for thyroid function
including radioimmunoassay and effective thyroid hormone replacement have
virtually eliminated hypothyroidism as a cause of mental retardation in the
developed world.

A second example of research reviewed by the Committee is an
experiment by investigators at the University of Minnesota in 1951 in which four
children with nephrotic syndrome were injected with an amino acid labeled with
sulfur 35, along with two "control" children hospitalized for other conditions.60
Nephrotic syndrome is a serious pediatric condition in which protein is excreted
by the kidneys in large quantities. There was controversy at the time over
whether children with nephrotic syndrome have low blood protein levels solely
because of renal losses or whether they also have impaired protein production
This experiment looked at the incorporation of the radioisotope-labeled amino
acid into protein, and the results suggested that the protein production in children
with nephrotic syndrome is normal.

A third example of research reviewed by the Committee is a study of
iodine 125 and iodine 131 uptake by eight healthy children performed at the Los
Alamos Laboratory in 1963.61 The purpose of the study was to evaluate the use of
radioisotopes in very small doses (nanocurie levels) as a measure of thyroid
function. The study demonstrated that the technique was scientifically valid and
exposed the children to smaller radiation doses than earlier methods

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Estimating Risk

How can the risks posed to children in these types of experiments be
estimated? The primary risk posed by the administration of radioisotopes is the
potential development of cancer years, even decades, after the exposure. As will
be discussed further, the risk of cancer following external radiation exposure was
not well documented until the late 1950s and the early 1960s. Thus, the published
reports of research projects prior to that time rarely discuss the issue of long-term
risks.

The principles of risk assessment for radioisotopes are laid out in "The
Basics of Radiation Science" at the end of "Introduction: The Atomic Century."62
To review: the increased risk of cancer is generally assumed to be proportional to
the dose of radiation delivered to the various organs of the body. This dose
depends upon a number of factors, including the amount of radioactivity
administered, its chemical form (which determines which organs will be
exposed), and how long it stays in the body, which in turn depends upon the
radioactive decay rate and the body's normal excretion rate for that substance.
For many radioisotopes, the overall personal dose can be derived by the
"effective-dose method," in which the doses to the ten most sensitive organs are
computed and added together, weighting the various organs in proportion to their
radiosensitivity. Thus, this effective dose can be thought of as producing the
same excess risk of cancer (all sites combined) as if the whole body had received
that amount as a uniform dose. This risk is then computed by multiplying the
effective dose by established risk estimates per unit dose for various ages. For
this chapter, the Advisory Committee has adopted the effective doses and risk
estimates tabulated by the International Commission on Radiation Protection and
the National Council on Radiation Protection.63 The lifetime-risk estimate used in
this chapter is 1/1,000 excess cancers per rem of effective dose for children and
fetuses exposed to slowly delivered radiation doses, like those from radioactive
tracers.

The risks of thyroid cancer following exposure to radioactive iodine
(generally 1-131) represent a special case for three reasons. First, use of the
effective-dose method is inappropriate because the dose is much greater to the
thyroid than for other organs, and the lifetime risk is therefore dominated by the
thyroid cancer risk. Therefore, risk is best calculated using only the thyroid dose
and its associated risk. Second, the thyroid cancer risk varies even more by age
than for other cancers. Third, the risk for iodine 1 3 1 has not been measured
directly, but several lines of evidence suggest that it may be substantially lower
than for external radiation. For this chapter, the Advisory Committee has adopted
estimates provided by three follow-up studies of external irradiation of the thyroid
by x rays or gamma rays in childhood: 2,600 children who received x-ray
treatment for enlarged thymus glands in the first year of life;64 1 1,000 children
who were treated by x rays in Israel for ringworm under age ten;65 and Japanese

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atomic bomb survivors under age twenty.66 The risk estimates from these studies
were divided by three to convert them to internal iodine 131 exposures.67 The
estimates from these studies are for cancer incidence; for mortality we have
divided them by 10, since 90 percent of thyroid cancers are curable. The resulting
estimates are summarized in table 1 . These are the same estimates used by the
Massachusetts Task Force, which investigated the Fernald and Wrentham
experiments.68

We can use data from the previously described Johns Hopkins iodine 1 3 1
study as an example. In this study, the amount of radioactivity administered was
1.75 microcuries per kilogram body weight; equivalent to 44 microcuries in a
seven-year-old child weighing 25 kilograms. Based on interpolation of the tables
in ICRP 53, and assuming a 13 percent thyroid uptake, this would produce a
thyroid dose of 1 15 rem to a child aged seven. In this age range (5-9), the lifetime
risk of developing thyroid cancer would be calculated by multiplying this dose by
20 per million person rems to produce an estimate of 2.3 cases per 1,000 exposed
individuals, or 0.23 percent for a particular child. The risk of dying of thyroid
cancer would be one-tenth of this, or 0.023 percent.

The twenty-one experiments subjected to the Committee's detailed risk
analysis included approximately 800 children. Eleven of the studies produced
estimates of average risk of cancer incidence within the range of 1 and 0.1
percent; eight studies ranged within 0.09 and 0.01 percent, and the remaining two
studies produced average risk estimates of 0.001 percent. The maximum potential
risk estimate was 2.3 percent in a few children aged one to two years at the time
of exposure. The average risk of cancer incidence for the Fernald radioiron and
radiocalcium studies were 0.03 percent and 0.001 percent respectively, and for the
Wrentham fallout (iodine 131) study, 0. 10 percent. All of the highest-risk
experiments involved iodine 131, and hence the risks of dying of cancer would be
about ten times smaller. (See table 2 at the end of this chapter for further details.)

Based on the average risk estimate for each of the twenty-one
experiments, we would estimate an excess cancer incidence of 1 .4 cases for the
entire group of 792 subjects. However, given the uncertainties built into the risk
analysis, it is also possible that no excess cases resulted. Furthermore, since most
of that excess would have been thyroid cancer, it is particularly unlikely that any
cancer deaths would have been caused. Finally, as thyroid cancer does occur in
the general population, it would be difficult to attribute these cases to an
individual's involvement in research. In addition, any cases of thyroid cancer
among former subjects attributable to their participation in research conducted in
the 1940s and 1950s are likely to have occurred already, although there is little
long-term follow-up data to know for certain what the ultimate lifetime risk might
be.

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Table 1. Summary of Risk Estimates for Thyroid Cancer

from Iodine 131

EXPOSURE AT VARIOUS AGES

Age

0-4*

5-9+

10-14*

15-19§

Lifetime risk" of cancer incidence per million exposed per rem

Males

27

13

6.7

1.9

Females

53

27

13

3.7

Both

40

20

10

2.8

Lifetime risk of cancer mortality per million exposed per rem

Males

2.7

1.3

0.7

0.2

Females

5.3

2.7

1.3

0.4

Both

4.0

2.0

1.0

0.3

* From R. E. Shore et al., "Thyroid Tumors Following Thymus Irradiation,"
Journal of the National Cancer Institute 74 ( 1 985): 1 1 77- 1 1 84, based on 2.9 cases per
million person-year-rem.

t From E. Ron and B. Modon, "Thyroid and Other Neoplasms Following
Childhood Scalp Irradiation," in J. D. Boice, Jr., and J. F. Fraumeni, Jr., eds., Radiation
Carcinogenesis: Epidemiology and Biological Significance (New York: Raven, 1984),
139-151, based on the risk in this age group being half that in the 0-4 age group.

\ From R. L. Prentice et al., "Radiation Exposure and Thyroid Cancer Incidence
Among Hiroshima and Nagasaki Residents," National Cancer Institute Monographs 62
(1982): 207-212, based on the risk in this age group being one-third of that in the 0-9 age
group.

§ Ibid., based on 0.21 per million person-year-rem.

I Based on an assumed forty-year period at risk from five to forty-five years
after exposure and assuming females have twice the excess risk of males.

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How do these risk figures compare with what is acceptable in
nontherapeutic research today? As noted earlier in this chapter, the contemporary
regulatory standard permits children to be involved in nontherapeutic research if
the research poses no more than "minimal risk" to the subjects. "Minimal risk" is
defined by analogy only: "A risk is minimal where the probability and magnitude
of harm or discomfort anticipated in the proposed research are not greater, in and
of themselves, than those ordinarily encountered in daily life or during the
performance of routine physical or psychological tests. "^ The regulations also
allow for nontherapeutic research with children that does present more than
minimal risk, but only //"the risk represents a minor increase over minimal risk,
the procedures involved are commensurate with the general life experiences of
subjects, and the research is likely to yield knowledge of "vital importance" about
the subjects' disorder or condition.70 The regulations do not specify what would
count as a minor increase over minimal risk. With this general guidance, it is the
obligation of individual institutional review boards (IRBs) to determine whether a
nontherapeutic study involving children is acceptable.71 It is likely that a cancer
risk of greater than 1 per 1 ,000 subjects would be considered by most, if not all
IRBs to be unacceptable by a minimal-risk standard, even for nonfatal cancers. It
is less clear whether this risk would be considered unacceptable by the "minor
increase over minimal risk" standard (assuming the research satisfied the "vital
importance" condition). The difficulty of establishing an acceptable level of risk
in nontherapeutic radiation research with children is currently being debated in
the medical literature,72 a debate that will likely continue at least until federal
guidelines become more specific.

What Was Known at the Time About Risk in Children

Assuming that any study that posed risks of greater than 1 excess case of
cancer per 1,000 subjects would be judged to be more than minimal risk, eleven
of the twenty-one research projects reviewed by the Committee exposed children
to higher risk than is acceptable today for nontherapeutic experiments. From a
moral perspective, a crucial question is whether investigators at the time could or
should have known that they were putting their pediatric subjects at greater than
minimal risk. If they could have known, then, arguably, these investigators were
not conforming to the AEC's requirement permitting nontherapeutic research in
children provided that "the radiation dosage level in any tissue is low enough to
be considered harmless."

It is clear that the medical community's understanding of the nature and
magnitude of risks posed to children by radiation exposure is not what it is today.
Researchers did not positively associate prior exposure to external radiation with
an increased risk of cancer until the mid to late 1950s. In 1950, Duffy and
Fitzgerald raised the question as to whether there might be cause to investigate a
possible association between therapeutic thymic irradiation during childhood and

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subsequent development of thyroid or thymic cancers:

To pose a cause and effect relationship between
thymic irradiation and the development of cancer
would be quite unjustified on the basis of data at
hand when one considers the large number of
children who have had irradiation of an "enlarged
thymus." However, the potential carcinogenic
effects of irradiation are becoming increasingly
apparent, and such relationships as those of thymic
irradiation in early life and the subsequent
development of thyroid or thymic tumors might be
profitably explored.73

By 1959, several studies had reported an association between radiation
exposure and the subsequent development of leukemia.74 Saenger et al.
performed an epidemiologic study of several thousand children in 1960 to
evaluate the association between radiation exposure and cancer.75 They stated:

The question of whether or not radiation can be
indicted as the principal causative factor in the
induction of neoplasia following radiation exposure
for either diagnostic or therapeutic purposes has
been of increased interest over the past several
years.76

In completing their analysis, they concluded: "It remains a fact, indisputable in
all respects, that the rate of thyroid cancers in the irradiated group is
disproportionately high."77

In 196U Beach and Dolphin prepared a detailed analysis of the literature
on the relationship between radiation and thyroid cancer in children.78 They
reported:

The thyroid has always been considered to be an
organ comparatively radio-resistant to alteration
and subsequent tumor development. Although no
definite development of radiogenic tumor has been
reported in adults after therapeutic administration of
iodine-131, Jelliffe and Jones (1960) discuss a total
of 10 cases of thyroid cancer reported in the
literature in persons treated early in life by x-ray
irradiation in the neck region. [T]he total of
malignant thyroid tumors which develop in children

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given a dose of x-radiation to the thyroid that is of
the same order of magnitude as the incidence
estimated for other tumors if a linear dose-response
relationship is assumed. No biologic significance is
attached to this point, apart from noting the fact that
the child's thyroid appears to be more radio-
sensitive than an adult's but not more sensitive than
some adult tissues.79

This lack of appreciation for the potential long-term effects of radiation in
children is further reflected in institutional policy development for use of
radioisotopes at the time. The Massachusetts General Hospital developed
standards for tracer doses of radioisotopes in May 1949. Dr. Shields Warren
director of the AEC Division of Biology and Medicine, assisted in the
development of the MGH standard:

Tracer doses in humans will always be kept to the
absolute minimum required to make the
observation.

Adult humans who are ill and who are expected to
benefit from the procedure, shall not receive tracer
doses of radioactive material giving off radiation in
excess of a total of 4 rep. Children (all patients
below 15 years of age) shall not receive more than a
total of 0.8 rep.sn

In any other cases, tracer doses will be limited to
radioactive material giving off radiation in an
amount less than a total of 1 rep.

In the case of iodine, the thyroid, which retains
most of the radioactivity, is radioresistant. In this
case, the permitted dosage may be increased by a
factor of 100.81

Despite the cautious tone of this document, the policy illustrates the
complete lack of understanding of the true radiosensitivity of the thyroid gland
especially in the pediatric population. Further allowances must be made with '
regard to what was known about the distribution of radioisotopes in children at
the time. It is evident that investigators using radioisotopes in children were not
employing available information on organ weights in children to calculate tissue
exposures at least until the mid-1960s. When "standard man" assumptions were

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used to calculate pediatric exposures before pediatric standards were developed,
investigators may have significantly and systematically underestimated effective
tissue dosages in children. It is notable that the highest levels of risk posed in the
experiments reviewed were to infants administered iodine 131.

Iodine 131 was routinely used for diagnostic procedures in the pediatric
population until the 1980s, when it was replaced by 1-123, a newly available
radioisotope with a significantly shorter half-life, which reduced the thyroid dose
markedly. The Wrentham fallout study, performed in 1 96 1 , employed doses of
iodine 131 that resulted in an average dose of 44 rad to the gland, slightly less
than the dose that would have been received for a diagnostic thyroid scan during
this time. ,

Although the doses of radioisotopes subsequently declined during these
years for both therapeutic medicine and nontherapeutic research, these guidelines
were not based on long-term outcome studies of exposed individuals but rather
on conservative extrapolations from high-dose studies and on the dosages
necessary to enable detection with the available equipment.

The debate over the potential risks of low-dose exposure continues today,
as epidemiological studies of thyroid cancer incidence subsequent to iodine 131
administration in both the diagnostic as well as therapeutic dose range have been
largely negative. Risks as a result of iodine 131 exposure are still unclear, and
risk analyses for exposure to radioisotopes are thus based on extrapolations from
studies involving external irradiation.

In summary, during the period in which children were exposed to the
highest levels of risk from nontherapeutic research involving radioisotopes,
investigators had a limited understanding of the potential long-term risks of low-
dose radiation and of methods to accurately calculate the tissue doses in children.
Today, we cautiously assume that any exposure to radiation likely produces some
small increase in cancer risk, so that no exposure is absolutely harmless. Instead,
the concept of minimal or acceptable risk is commonly used, as discussed earlier.
Some of the studies during this period involved risks that would be judged as
minimal even today, whereas others would be clearly viewed as unacceptable
today. Should the investigators then have viewed any of these studies as
harmless? Though an understanding of the association between exposure to
external radiation and subsequent development of cancer was emerging during
this time, a similar association had not been made for exposure to low dose levels
of radioisotopes. In addition, the relative radiosensitivity of many pediatric
tissues, including thyroid, had not been established, and most researchers during
this period subscribed to the "threshold" theory of risk, which assumed that
sufficiently low doses were probably harmless. In the face of such widespread
factual ignorance, it is difficult to hold these investigators culpable for imposing
risks on their subjects that were not appreciated at the time.

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BEYOND RISK: OTHER DIMENSIONS OF THE ETHICS OF
NONTHERAPEUTIC RESEARCH ON CHILDREN

The level of risk to which children are exposed is critical in evaluating the
ethics of nontherapeutic research on children. Also important, however, is
whether and how the authorization of parents was solicited, and also which
children were selected to be so used. For nineteen of the twenty-one studies
reviewed by the Committee, we know almost nothing about whether the
permission of parents was sought or what the parents were told about their
children's involvement. Two of the studies conducted at the Fernald School were
the exceptions, as a result of extensive historical and archival research by the
Massachusetts Task Force on Human Subjects Research.

There is a reference to parents in the published literature on only one of
the remaining nineteen studies, a 1954 iodine uptake experiment at the University
of Tennessee. This paper included the following line: "The procedure was
described to the mothers of the infants studied, and the mothers gave consent for
the study before the tests were made."*2 (The inclusion of this line is noteworthy
for it suggests that at least some investigators thought parental permission was
worth mentioning in published reports of their research.)

If the Committee had devoted extensive investigatory resources to these
nineteen studies, it is likely we would have learned more about whether or how
parental authorization was obtained in at least some cases. It is also almost
certain that even the deepest archival digging would have produced no useful
information about parental authorization for some of these experiments. The
recent experience of the Massachusetts Task Force demonstrates the possibility of
both outcomes: for some of the experiments conducted at the Fernald School, the
task force's diligent historical research uncovered a variety of documents that
shed important light on what both parents and children were told; for the
experiments at Wrentham, similar efforts did not produce any significant
information on questions of parental authorization.

Again with the exception of the experiments conducted at Fernald and
Wrentham, we know almost nothing about who the children were who served as
subjects in these experiments. The journal articles on these remaining studies do
not describe the sociodemographic characteristics of the subjects. They do
sometimes mention whether the subjects had relevant medical conditions and
usually that the children, including the "control" subjects, were hospitalized
patients. In some of the experiments reviewed by the Committee, the scientific
research questions of interest could have been pursued only in children who were
ill and hospitalized. In other instances, however, the hospitalized children were
likely samples of convenience. This is particularly plausible in the case of control
subjects, when a sample of healthy, nonhospitalized children might have made a
better control group from a scientific perspective. As we saw in chapter 2,
hospitalized patients were often viewed by physician-investigators as a

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convenient source of research subjects.

Because so little is known, the Committee cannot draw conclusions about
the ethics of most of the nontherapeutic studies involving children we reviewed,
apart from the important issue of risk of harm to the children involved. We turn
now to an analysis of the studies where relevant information about parental
authorization, disclosure, and subject selection is available: the studies conducted
at the Fernald School.

THE STUDIES AT THE FERNALD SCHOOL

Researchers from the Massachusetts Institute of Technology, working in
cooperation with senior members of the Fernald staff, carried out nontherapeutic
nutritional studies with radioisotopes at the state school in the late 1940s and
early 1950s. The subjects of these nutritional research studies were young male
residents of Fernald, who were members of the school's "science club." In 1946,
one study exposed seventeen subjects to radioactive iron. The second study,
which involved a series of seventeen related subexperiments, exposed fifty-seven
subjects to radioactive calcium between 1950 and 1953. It is clear that the doses
involved were low and that it is extremely unlikely that any of the children who
were used as subjects were harmed as a consequence. These studies remain
morally troubling, however, for several reasons. First, although parents or
guardians were asked for their permission to have their children involved in the
research, the available evidence suggests that the information provided was, at
best, incomplete. Second, there is the question of the fairness of selecting
institutionalized children at all, children whose life circumstances were by any
standard already heavily burdened.

Parental Authorization

The Massachusetts Task Force found two letters sent to parents describing
the nutrition studies and seeking their permission. The first letter, a form letter
signed by the superintendent of the school, is dated November 1949." The letter
refers to a project in which children at the school will receive a special diet "rich"
in various cereals, iron, and vitamins and for which "it will be necessary to make
some blood tests at stated intervals, similar to those to which our patients are
already accustomed, and which will cause no discomfort or change in their
physical condition other than possibly improvement." The letter makes no
mention of any risks or the use of a radioisotope. Parents or guardians are asked
to indicate that they have no objection to their son's participation in the project by
signing an enclosed form.84

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The second letter, dated May 1953, we quote in its entirety:
Dear Parent:

In previous years we have done some
examinations in connection with the nutritional
department of the Massachusetts Institute of
Technology, with the purposes of helping to
improve the nutrition of our children and to help
them in general more efficiently than before.

For the checking up of the children, we
occasionally need to take some blood samples,
which are then analyzed. The blood samples are
taken after one test meal which consists of a special
breakfast meal containing a certain amount of
calcium. We have asked for volunteers to give a
sample of blood once a month for three months, and
your son has agreed to volunteer because the boys
who belong to the Science Club have many
additional privileges. They get a quart of milk daily
during that time, and are taken to a baseball game,
to the beach and to some outside dinners and they
enjoy it greatly.

I hope that you have no objection that your
son is voluntarily participating in this study. The
first study will start on Monday, June 8th, and if
you have not expressed any objections we will
assume that your son may participate.

Sincerely yours,

Clemens E. Benda, M.D.
[Fernald] Clinical Director

Approved:.

Malcom J. Farrell, M.D.
[Fernald] Superintendent85

Again, there is no mention of any risks or the use of a radioisotope. It was
believed then that the risks were minimal, as indeed they appear to have been, and
as a consequence, school administrators and the investigators may have thought it
unnecessary to raise the issue of risks with the parents. There was no basis,
however, for the implication in both letters that the project was intended for the

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children's benefit or improvement. This was simply not true.*6

The conclusion of the Massachusetts Task Force was that these
experiments were conducted in violation of the fundamental human rights of the
subjects. This conclusion is based in part on the task force's assessment of these
letters. Specifically, the task force found that

1 [t]he researchers failed to satisfactorily inform the
subjects and their families that the nutritional
research studies were non-therapeutic; that is, that
the research studies were never intended to benefit
the human subjects as individuals but were intended
to enhance the body of scientific knowledge
concerning nutrition.

The letter in which consent from family members
was requested, which was drafted by the former
Fernald superintendent, failed to provide
information that was reasonably necessary for an
informed decision to be made.87

Fairness and the Use of Institutionalized Children

The Fernald experiments also raise quite starkly the particular ethical
difficulties associated with conducting research on members of institutionalized
populations-especially where some of the residents have mental impairments.
Living conditions in most of these institutions (including Fernald and Wrentham)
have improved considerably in recent years, and sensitivity toward people with
cognitive impairments has likewise increased. As Fred Boyce, a subject in one of
these experiments has put it, "Fernald is a much better place today, and in no way
does it operate like it did then. That's very important to know that."ss

The Massachusetts Task Force describes conditions in state-operated
facilities like Fernald, particularly as they bear on human experimentation, as
follows:

Until the 1970s, the buildings were dirty and in
disrepair, staff shortages were constant, brutality
was often accepted, and programs were inadequate
or nonexistent. There were no human rights
committees or institutional review boards. If the
Superintendent (in those days required to be a
medical doctor) "cooperated" in an experiment and
allowed residents to be subjects, few knew and no
one protested. If nothing concerning the

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experiments appeared in the residents' medical
records, if "request for consent" letters were less
than forthright, or if no consent was obtained there
was no one in a position of authority to halt or
challenge such procedures.89

Although public attitudes toward people who are institutionalized are
admittedly different today than they were fifty years ago, it is likely that this state
of affairs would have been troubling to most Americans even then. Historian
Susan Lederer has revealed several episodes of experimentation with
institutionalized children in America that caused considerable public outcry even
before 1940, presaging the concern generated by Willowbrook when this research
became a public issue in the 1960s.90

The LMRI staff reported in the early 1960s that the pediatric researchers
whom they had gathered agreed in principle that the convenience of conducting
research on institutionalized children did not outweigh the moral problems
associated with this practice:

Several investigators spoke about the practical
advantages of using institutionalized children who
are already assembled in one location and living
within a standard, controlled environment. But the
conferees agreed that there should be no differential
recruitment of ward patients rather than private
patients, of institutionalized children rather than
children living in private homes, or of handicapped
rather than healthy children.91

A particularly poignant dimension of the unfairness of using
institutionalized children as subjects of research is that it permits investigators to
secure cooperation by offering as special treats what other, noninstitutionalized
children would find far less exceptional. The extra attention of a "science club," a
quart of milk, and an occasional outing were for the boys at Fernald extraordinary
opportunities. As Mr. Boyce put it:

I won't tell you now about the severe physical and
mental abuse, but I can assure you, it was no Boys'
Town. The idea of getting consent for experiments
under these conditions was not only cruel but
hypocritical. They bribed us by offering us special
privileges, knowing that we had so little that we
would do practically anything for attention; and to
say, I quote, "This is their debt to society," end

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quote, as if we were worth no more than laboratory
mice, is unforgivable.92

Even when a child was able to resist the offers of special attention and
refused to participate in the experiment, the investigators seem to have been
unwilling to respect the child's decision. One MIT researcher, Robert S. Harris,
explicitly noted that "it seemed to [him] that the three subjects who objected to
being included in the study [could] be induced to change their minds."93 Harris
believed that the recalcitrant children could be "induced" to join in the study by
emphasizing "the Fernald Science Club angle of our work."94

From the perspective of the science, it was considered important to
conduct the research in an environment in which the diet of the children-subjects
could be easily controlled. From this standpoint, the institutional setting of
Fernald was ideal. The institutional settings of the boarding schools in the
Boston area, however, would have offered much the same opportunity. Although
the risks were small, the "children of the elite" were rarely if ever selected for
such research. It is not likely that these children would have been willing to
submit to blood tests for extra milk or the chance to go to the beach.

The question of what is ethical in the context of unfair background
conditions is always difficult. Perhaps the investigators, who were not
responsible for the poor conditions at Fernald, believed that the opportunities
provided to the members of the Science Club brightened the lives of these
children, if only briefly. Reasoning of this sort, however, can all too easily lead to
unjustifiable disregard of the equal worth of all people and to unfair treatment.

Today, fifty years after the Fernald experiments, there are still no federal
regulations protecting institutionalized children from unfair treatment in research
involving human subjects.95 The Committee strongly urges the federal
government to fill this policy void by providing additional protections for
institutionalized children.96

CONCLUSION

If an ethical evaluation of human experiments depended solely upon an
assessment of the risks to subjects as they could reasonably be anticipated at the
time, the radiation experiments conducted on children reviewed in this chapter
would be relatively unproblematic.97 During this time, the association between
radiation exposure and the subsequent development of cancer was not well
understood, and in particular, little was known about iodine 131 and the risk of
thyroid cancer. Both researchers and policymakers appear to have been alert to
considerations of harm and concerned about exposing children to an unacceptable
level of risk.

At the same time, however, the scientific community's experience with
radionuclides in humans was limited, and this approach to medical investigation

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was new. Although the available data about human risk were encouraging and
the biological susceptibility of children to the effects of radiation was not
appreciated, we are left with the lingering question of whether investigators and
agency officials were sufficiently cautious as they began their work with children.
This is a difficult judgment to make at any point in the development of a field of
human research; it is particularly difficult to make at forty or fifty years' remove.
Investigators and officials had to make decisions under conditions of considerable
uncertainty; this is commonplace in science and in medicine. Although the
biological susceptibility of children was not then known, investigators and
officials held the view that children should be accorded extra protection in the
conduct of human research, and they made what they thought were appropriate
adjustments when using children as subjects. If human research never proceeded
in the face of uncertainty, there would be no such experiments. How little
uncertainty is acceptable in research involving children is a question that remains
unresolved. Today, we continue to debate what constitutes minimal risk to
children, in radiation and in other areas of research. The regulations governing
research on children offer little in the way of guidance, either with respect to
conditions of uncertainty about risk or when risks are known.

As best as we can determine, in eleven of the twenty-one experiments we
reviewed, the risks were in a range that would today likely be considered as more
than minimal, and thus as unacceptable in nontherapeutic research with children
according to current federal regulations. It is possible, however, that four of the
eleven might be considered acceptable by the "minor increase over minimal risk"
standard.98 In these four experiments, the average risk estimates were between
one and two per thousand, the studies were directed at the subjects' medical
conditions, and they may well have had the potential to obtain information of
"vital importance."

Physical risk to subjects is not the only ethically relevant consideration in
evaluating human experiments. With the exception of the studies at Fernald, we
know almost nothing about whether or how parental authorization for the
remaining nineteen experiments we reviewed was obtained. And with the
exception of the Fernald studies and the experiment at Wrentham, we know very
little about the children who were selected to be the subjects of this research.
Therefore, we cannot comment on the general ethics of these other experiments.

The experiments at Fernald and at the Wrentham School unfairly burdened
children who were already disadvantaged, children whose interests were less well
protected than those children living with their parents or children who were
socially privileged. At the Fernald School, where more is known, there was some
attempt to solicit the permission of parents, but the information provided was
incomplete and misleading. The investigators successfully secured the
cooperation of the children with offers of extra milk and an occasional outing-
incentives that would not likely have induced children who were less starved for
attention to willingly submit to repeated blood tests.

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One researcher speaking almost thirty-five years ago set out the
fundamental moral issue with particular frankness and clarity:

... we are talking here about first and second class
citizens. This is a concept none of our consciences
will allow us to live with. . . . The thing we must all
avoid is two types of citizenry."

It might have been common for researchers to take advantage of the convenience
of experimenting on institutionalized children, but the Committee does not
believe that convenience offsets the moral problems associated with employing
these vulnerable children as research subjects~now or decades ago.

The Vanderbilt Study

In an exceptionally large study" at Vanderbilt University in the 1940s, approximately 820
poor, pregnant Caucasian women were administered tracer doses of radioactive iron. Vanderbilt
worked with the Tennessee State Department of Health, and the research was partly funded by the
Public Health Service.11 Today, most women take iron supplements during pregnancy. This
experiment provided the scientific data needed to determine the nutritional requirements for iron
during pregnancy.

The radioiron portion of the nutrition study, directed by Dr. Paul Hahn, was designed to
study iron absorption during pregnancy.' The women, who were anywhere from less than ten
weeks to more than thirty-five weeks pregnant, were administered a single oral dose of radioactive

a. Most of the other tracer studies involving pregnant women and offering no prospect of benefit
that were reviewed by the Committee involved fewer than twenty women as subjects.

b. William J. Darby, Director of the Tennessee-Vanderbilt Project et al., Summary Report. Section
B. Tennessee-Vanderbilt Nutrition Project. July 1. 1946 to December 31. 1946 (ACHRE No. CORP-020395-
A), 97-1 10. This nutrition study summary report notes, "Considerable expansion of the program of study of
maternal and infant nutrition has been made possible by a grant of $9,000 per year which was made by the
U.S. Public Health Service. These funds were available beginning November 1, 1946." Ibid., 99. The
summary observes that the grant was to be used for additional personnel, including the appointment of Dr.
Richard Cannon, an obstetrics resident, to the staff of the Division of Nutrition beginning 1 January 1947.
Dr. Cannon's name subsequently appears as an investigator in the medical report discussing the radioiron
portion of the study, along with Dr. Paul Hahn's and others.

c. P. Hahn et al., "Iron Metabolism in Human Pregnancy as Studied with the Radioactive Isotope,
Fe-59," American Journal of Obstetrics and Gynecology 61 (March 1951): 477-486. The exact years of the
radioiron portion of the nutrition study are uncertain. Minutes from a meeting of the nutrition study
investigators indicate the study was to begin in September 1945. Tennessee-Vanderbilt Nutrition Project,
Nutrition in Pregnancy Study, "Minutes of Meeting for Discussion of Nutrition in Pregnancy Study, August
17, 1945" (ACHRE No. CORP-020395-A). 17A-C. The radioiron study probably began at approximately
that time and appears to have continued until sometime in 1947, based on a review of periodic study
summaries.

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iron, Fe-59, during their second prenatal visit, before receiving their routine dose of therapeutic
iron.'1 On their third prenatal visit, blood was drawn and tests performed to determine the
percentage of iron absorbed by the mother. The infants' blood was then examined at birth to
determine the percentage of radioiron absorbed by the fetus. The doses to the women were
estimated in the study article, using crude dose-estimation methods available at the time, to be
from 200,000 to 1,000,000 countable counts per minute." Although the investigators did not
estimate doses to the fetuses in the original study. Dr. Hahn later estimated fetal doses to be
between 5 and 15 rad. This estimate, however, has been questioned.1

There is at least some indication that the women neither gave their consent nor were
aware they were participating in an experiment. Vanderbilt study subjects, expressing bitterness at
the way they believed they had been treated, testified at an Advisory Committee meeting that the
proffered drink, called a "cocktail" by the investigators, was offered with no mention of its
contents. "1 remember taking a cocktail," one woman said simply. "I don't remember what it was,
and I was not told what it was."B Although it is not clear what, if anything, the subjects were told,
information about the Vanderbilt experiment was available to the general public. In late 1946
news reports appeared in the Nashville press.1'

The actual risk to the fetuses in the Vanderbilt experiment has long been a matter of
study. In 1963-1964, a group of researchers at Vanderbilt found no significant differences in
malignancy rates between the exposed and nonexposed mothers.1 However, they did identify a
higher number of malignancies among the exposed offspring (four cases in the exposed group:
acute lymphatic leukemia, synovial sarcoma, lymphosarcoma, and primary liver carcinoma, which
was discounted as a rare, familial form of cancer). No cases were found in a control group of
similar size, and approximately 0.65 cases would have been expected on Tennessee state rates,
compared to which the three observed cases is a marginally significant excess. This led the
researchers to conclude that the data suggested a causal relationship between the prenatal exposure
to Fe-59 and the cancer. The investigators also concluded that Dr. Hahn's estimate of fetal

d. The Advisory Committee has not been able to determine whether Dr. Hahn got the radioactive
iron used in the study from a private or government source, or both.

e. Counts per minute is a measure of the radioactivity detected by a specific counting instrument.
The sensitivities of counting instruments vary; a specific instrument may not "see" and count all the radiation
coming from a particular substance. Thus, the total amount of radiation emitted by a substance may be
calculated by considering the sensitivity of the counter.

f. Contemporary estimates of the fetal doses by the Committee and others suggest that the fetal
effective dose was a few hundred millirems.

g. Wilton McClure, transcript of audio testimony before the Advisory Committee on Human
Radiation Experiments, Small Panel Meeting, Knoxville, Tennessee, 2 March 1995, 182.

h. "Iron Doses with Radioactive Isotopes Aid to Pregnancy, Experiment Shows," Nashville
Banner, 13 December 1946; "VU to Report on Isotopes," The Nashville Tennessean, 14 December 1946
(ACHRE No. CORP-020395-A).

i. The investigators identified the hospital records of 751 exposed mothers and 771 unexposed
controls, as well as 719 exposed offspring and 734 unexposed offspring, and mailed them questionnaires. Of
the exposed mothers, 90.4 percent responded, as did 91.45 percent of the unexposed mothers, 88.2 percent
of the exposed offspring, and 89.2 percent of the unexposed. Ruth M. Hagstrom et al.,"Long Term Effects
of Radioactive Iron Administered During Human Pregnancy," American Journal of Epidemiology 90 ( 1 969):
1-8.

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exposure was an underestimation of the fetal-absorbed dose.

A 1969 study, funded by the AEC and conducted by one of the investigators from the
1963-1964 study, attempted to reconstruct the doses of Fe-59 to the fetuses in the original
Vanderbilt study .J The investigators observed that the one case of leukemia might have been due
to radiation damage, but that the doses in the other two cases were low; therefore, the relationship
between the radiation exposure and the cancer in those cases might not have been causal.
However, the researchers also noted that due to incomplete data, they could not estimate the dose
absorbed by the fetus with confidence and that no definitive conclusions could be drawn from this
study as to whether these exposures resulted in damage to the fetus. k

The Vanderbilt study raises many of the same ethical issues as the experiments reviewed
in this chapter. Like these experiments, the Vanderbilt study offered no prospect of medical
benefit to the pregnant women or their offspring, raising the question of the conditions under
which it is acceptable to put children at risk for the benefit of others, whether before or after birth.
What could the investigators reasonably have been expected to know about the risks to which they
put their subjects? Did they exercise appropriate caution in exposing fetuses to radiation? What
were the pregnant women told, if anything, and was their permission sought? Who were these
women, and how were they positioned relative to pregnant women, generally?

The Committee did not have the resources to pursue these questions in both research in
which children were the subjects and research in which children were exposed as fetuses. We did
establish that the Vanderbilt study was not the only experiment during this period to expose
fetuses in research that offered no prospect of medical benefit to them or their mothers. While the
Committee did not conduct an exhaustive review of the scientific literature, we did find twenty-
seven human radiation studies that included pregnant or nursing women as subjects between 1944
and 1974.' Of these studies, eight were considered therapeutic, and nineteen offered no prospect of
benefit to the subject. Most of the nineteen were tracer experiments.

These studies were performed in order to examine human physiology during pregnancy
or to study the uptake of radioactive substances by fetuses or nursing infants."1 They generally

j. Norman C. Dyer and A. Bertrand Brill, "Fetal Radiation Dose from Maternally Administered
Fe-59 and 1-131," in Radiation Biology of the Fetal and Juvenile Mammal: Proceedings of the Ninth Annual
Hanford Biology Symposium at Richland. Washington. May 5-8. 1969, eds. Melvin R. Sikov and D. Dennis
Mahlum (Washington, D.C.: GPO, December 1969), 78-88. This study was reviewed in detail by the
Committee. The study also investigated fetal absorption of radioiodine because that isotope was and is
commonly used in diagnosis and therapy, including in pregnant women.

k. Ibid., 85.

1. All of the nineteen studies reviewed in detail by the Committee were conducted or at least
partially funded by the federal government or were supplied with radioisotopes by the AEC. For the earlier
years, the Committee relied on the ACHRE experiments database, AEC isotope distribution lists provided by
DOE, and relevant biographies. The Committee also consulted relevant medical indexes and computer
databases; the isotope distribution lists provided by DOE did not cover these years. While the computer
search would have located nontherapeutic tracer experiments for this period as well, very few were
identified.

m. Of the nineteen tracer experiments (funded by the government) involving pregnant or nursing
women identified by the Committee, only three administered tracer doses to nursing women that offered no
prospect of benefit; in at least one of the studies the infants were exposed. In one case, six nursing women
were given radioiodine to determine excretion in breast milk, the infants were not given the exposed milk. In

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addressed valid scientific questions that could not be investigated in other populations.
Knowledge of fetal exposure to radioiodine. for example, was relevant to issues such as potential
harm to the fetus from maternal uptake of radioiodine in diagnostic tests or to estimate the
potential effects of environmental exposure to radioiodine on the human fetus. In other studies,
radioactive iron was administered to better understand the physiology of maternal and fetal intake
of iron during pregnancy.

another case, two infants were intentionally exposed to the breast milk of their mothers, who were given I-
131. An I- 1 3 1 tracer study on the general population, incidentally included two nursing women. The report
indicates that both had been nursing their children, and since there is no indication that the mothers were
warned to avoid breastfeeding after the exposure, it is quite probable that the infants were exposed.

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Nasopharyngeal Irradiation

Nasopharyngeal irradiation," introduced by S. J. Crowe and J. W. Baylor of the
Otological Research Laboratory at the Johns Hopkins University, was employed from 1924 on as
a means of shrinking lymphoid tissue at the entrance to the eustachian tubes to treat middle ear
obstructions, infections, and deafness. For this treatment, intranasal radium applicators (sealed
ampules containing radium salt) were inserted (at least three insertions per treatment cycle) into
the nasopharyngeal area for twelve-minute periods.11 The therapeutic effect of the treatments
resulted from the penetrating radiation emitted from the radium source (gamma and beta rays), not

a. Nasopharyngeal irradiation was studied in adults as well as children. In the early 1940s, 732
submariners were subjects of a controlled experiment designed to test whether nasopharyngeal radium
treatments could be used to shrink lymphoid tissue surrounding the eustachian tubes, thereby preventing and
treating aerotitis media in submariners by equalizing external and middle ear pressure. This treatment was
successful in 90 percent of the cases. H. L. Haines and J. D. Harris, "Aerotitis Media in Submariners,"
Annals of Otology. Rlrinology. and Laryngology 55 ( 1 946): 347-37 1 . In a 1 945 journal article, it was noted
that a controlled study was considered by the Army Air Forces, but rejected because of the urgent need to
treat fliers immediately and keep them flying. However, the published report describes differences between
various dose groups, implying an uncontrolled experimental comparison was made. Captain John E.
Hendricks et al., "The Use of Radium in the Aerotitis Control Program of the Army Air Forces: A Combined
Report by the Officers Participating," Annals of Otology, Rlrinology. and Laryngology' 54 ( 1 945 ): 650-724.
Tens of thousands of servicemen were subsequently given this nasopharyngeal radium treatment.

Relying on the risk estimate developed in the Sandler study, Stewart Farber, a radiation-monitoring
specialist with a background in public health, has projected 5 1 .4 excess brain cancers over a fifty-year
period in the 7,613 servicemen irradiated in the Navy and Army Air Forces studies noted above. Stewart
Farber, Consulting Scientist of the Public Health Sciences, to Stephen Klaidman, ACHRE Staff. 8 March
1995 ("Nasopharyngeal Radium Irradiation-Initial Radiation Experiments Performed by DODon 7,613
Navy and Army Air Force Military Personnel during 1944-45"). Alan Ducatman, M.D.. of the University of
West Virginia School of Medicine, who coauthored a letter with Farber to the New England Journal of
Medicine regarding the radium exposure of military personnel, wrote that he found "no convincing evidence
of excess cancer in the exposed population." He added, however, "there is also no good evidence for the null
hypothesis." Alan Ducatman, West Virginia University School of Medicine, to Duncan Thomas, Member of
the Advisory Committee on Human Radiation Experiments, 22 February 1995 ("I'm sorry I could not
respond . . .") (ACHRE No. WVU-02 1 795-A).

Han K. Rang, with the Environmental Epidemiology Service of the Veterans Health
Administration, is currently conducting a study to assess the feasibility of an epidemiologic study of Navy
veterans who received radium treatments. Han K. Rang. Environmental Epidemiology Service, Veterans
Health Administration, "Feasibility of an Epidemiologic Study of a Cohort of Submariners Who Received
Radium Irradiation Treatment," 23 August 1994. It is not clear, however, that sufficient numbers of
treatment-documented personnel can be identified, as a group representing submariners has apparently been
able to identify only six former Navy personnel from of a pool of twenty-seven whose records indicate they
received radium treatment. (It is not clear whether the data being collected by the VFW with the support of
Senator Joesph Lieberman of Connecticut will be from a representative sample of respondents. If, in fact,
these data are from a highly nonrepresentative sample, the study may not be considered scientifically valid.)
However, the Veterans of Foreign Wars organization apparently is now processing hundreds of surveys filled
out by veterans who say they underwent nasopharyngeal radium treatment. Once this task is completed.
Senator Lieberman plans to present the data to the Department of Veterans Affairs with a recommendation
that an epidemiologic study be conducted.

b. Samuel J. Crowe, "Irradiation of the Nasopharynx," Annals of Otology, Rhinology and
Laryngology 55 (\9Ad): 31.

352

Chapter 7

from the internal deposition of radium itself. Crowe and his colleagues reported that "under this
treatment, the lymphoid tissue around the tubal orifices gradually disappeared, marked
improvement or complete return of the hearing followed, and in many the bluish discoloration of
the tympanic membrane also disappeared."" This method was used for more than a quarter century
as a prophylaxis against deafness, for relieving children with recurrent adenoid tissue following
tonsillectomy and adenoidectomy, and for children with chronic ear infections. Asthmatic
children with frequent upper respiratory infections were also often considered for this type of
irradiation.

An average of 1 50 patients a month, mostly children, were given the treatment at the
Johns Hopkins clinic over a period of several years.'1 Many children received the treatment more
than once as recurrent lymphoid tissue Was considered an indication for treatment.

Crowe and his colleagues reported that the results following irradiation of the
nasopharynx alone were not only as good as, but often better than, those following removal of
tonsils and adenoids." In review articles, they noted that approximately 85 percent of treated
patients responded with decreased numbers of infections and/or improved hearing when treated at
young ages. They also concluded that "it is effective, safe, painless, inexpensive and has proved
particularly valuable for prevention of certain ear, sinus and bronchial condition in children."1
Although early articles by Crowe and colleagues indicate that nasopharyngeal radium treatments
were accepted as standard procedure for the prevention of childhood deafness, these treatments,
like most standard interventions in medicine, had not been subjected to formal scientific
evaluation. A controlled study was conducted from 1948 to 1953 by Crowe and his colleagues to
determine "the feasibility of irradiation of the nasopharynx as a method for controlling hearing
impairment in large groups of children associated with lymphoid hyperplasia in the nasopharynx;
to draw conclusions concerning the per capita cost of such an undertaking as a public health
measure."6 Crowe et al. wrote in an NIH "Notice of Research" that "the procedure of treatment is
not new, as an individual measure; this is the first adequately controlled experiment of sufficient
size for accurate statistical analysis."'1

This work was funded by NIH for the entire period of study. As recorded in an NIH grant
application, the study involved approximately 7,000 children screened for hearing impairment.' Of
those screened, approximately 50 percent were selected for further study based on the chosen
criteria for hearing loss. Half of this study group was irradiated with radium, while the other half
served as a control group. Crowe and colleagues reportedly concluded from this study (published
in 1955) that the radium treatments did shrink swelling of lymphoid tissue and improve hearing.1
This type of therapy was ultimately discontinued because of newly available antibiotics and the

c. Ibid.. 30.

d. Ibid., 33.; Dale P. Sandler et al., "Neoplasms Following Childhood Radium Irradiation of the
Nasopharynx," Journal of the National Cancer Institute 68 ( 1982): 3-8.

e. Ibid., 33.

f. Ibid.

g. S. J. Crowe et al.. The Johns Hopkins University School of Medicine and School of Hygiene
and Public Health, to Federal Security Agency, Public Health Service, National Institutes of Health, July
1948 ("The Efficiency of Nasopharyngeal Irradiation In the Prevention Of Deafness in Children, Notice of
Research Project, Grant No. B-19") (ACHRE No. HHS No. 092694-A).

h. Ibid,
i. Ibid.
j. Ibid.

353

Part II

use of transtympanic drainage tubes, as well as awareness of the potential risks of radiation
treatment.

In addition to the targeted lymphoid tissue, the brain and other tissues in the head and
neck region, including the paranasal sinuses, salivary glands, thyroid, and parathyroid glands are
also exposed to significant doses of radiation during the radium treatments, prompting concern that
these treated individuals might have been placed at increased risk for radiation-induced cancers at
these sites. Dale P. Sandler et al., in their 1982 study of the effects of nasopharyngeal irradiation
on excess cancer risk for children treated at the Johns Hopkins clinic, found "a statistically
significant overall excess of malignant neoplasms of the head and neck among exposed subjects,"
based however on only four cases in comparison with 0.57 expected.1 This excess was accounted
for mainly by three brain tumors that occurred in the irradiation subjects. One other malignant
tumor, a cancer of the soft palate, was also reported. The Department of Epidemiology at the
Johns Hopkins University has undertaken a further follow-up study of the Crowe et al. cohort of
children irradiated there, previously studied by Sandler et al.1 Verduijn et al., in their 1989 study
of cancer mortality risk for those individuals (mostly children) treated by nasopharyngeal
irradiation with radium 226 in the Netherlands, reported that "the present study has found no
excess of cancer mortality at any site associated with radium exposure by the Crowe and Baylor
therapy. Specifically,

the finding of Sandler et al. of an excess of head and neck cancer was not found in this study
group.""'

Among the Japanese atomic bomb survivors, no excess of brain tumors was found.
However, several studies have noted an increased risk of both benign and malignant brain tumors
following therapeutic doses of radiation to the head and neck region during childhood." From the
Committee's own limited risk analysis of these experiments, we concluded that the brain and
surrounding head and neck tissues would be put at highest risk and estimated the lifetime risk at
approximately 4.35 per 1,000 and an increased relative risk of 62 percent."

k. For the combination of benign and malignant neoplasms, there were 23 cases, for a relative risk
of 2.08 with a 95 percent confidence interval of 1.12 to 3.91. Sandler, "Neoplasms Following Childhood
Radium Irradiation," 5.

I. Jessica Yeh and Genevieve Matanowski, fax to Anna Mastroianni (ACHRE), 7 July 1995
("Nasopharyngeal Power Analysis"), 1-3.

in. Verduijn et al., "Mortality after Nasopharyngeal Irradiation," Annals of Otology. Rhinology,
and Laiyngolog}- 98 ( 1 989): 843.

n. S. Jablon and H. Kato, "Childhood Cancer in Relation to Prenatal Exposure to Atomic-Bomb
Radiation," The Lancet, ii (1970): 1000-1003.; M. Colman, M. Kirsch, and M. Creditor, "Radiation Induced
Tumors," in Late Biological Effects of Ionizing Radiation. Vol. I (Vienna: International Atomic Energy
Agency, 1978), 167-180; R. E. Shore, R. E. Albert, and B. S. Pasternak, "Follow-up Study of Patients
Treated by X ray Epilation for Tinea Capitis: Resurvey of Post-Treatment Illness and Mortality Experience,"
Archives of Environmental Health 31(1 976): 1 7-24; and C. E. Land.Xarcinogenic Effects of Radiation on
the Human Digestive Tract and Other Organs." in Radiation Carcinogenesis, eds. A. C. Upton et al. (New
York: Elsevier, 1986), 347-378.

o. The radiation dose estimate to the head and neck region was calculated according to the
following assumptions: ( I ) Source description: 50 ing of radium, active length 1 .5 cm, filtered by 0.3 mm of
Monel metal. (2) Average treatment: 60 mg/hrs; based on three 12-minute treatments (radium applicators
inserted through both nostrils)= ( 12x3x50x2 )/60 mins per hour= 60 mg-hrs. (3) Dose rate at points in a
central orthogonal plane surrounding the source: for distances up to 5 centimeters dose estimated using
published data (Quimby Tables, Otto Glasser et al.. Physical Foundations of Radiology, 3d ed. [New York:
Paul Hoeber, Inc., 1961]) for linear radium sources with dose increased by 50% to allow for the reduced

354

Chapter 7

The Hopkins nasopharyngeal study raises different ethical issues than those posed by the
other experiments reviewed in this chapter, all of which offered no prospect of medical benefit to
the children who served as subjects. By contrast, the nasopharyngeal irradiation experiment was
designed to determine whether children at risk for hearing loss would be better off receiving
radiation treatments or not receiving such treatments. A central issue here was whether it was
permissible to withhold this intervention from "at risk" children. The application of radium was at
this point a common, but scientifically unproven, treatment for children at risk of hearing loss; the
risks of the treatment were not well characterized. If it was really unknown which was better for
children-receiving radium or no intervention-then the medical interests of the children were best
served by being subjects in the research because, as a consequence, they would have a 50 percent
chance of receiving the better approach. The nasopharyngeal experiment thus belongs to a class of
research the Committee did not investigate-therapeutic research with children.

filtration provided by the applicator wall and converting roentgen to rad by a multiplication factor of 0.93.
For distances greater than 5 centimeters, the dose rate is reduced in accordance with the inverse square law,
with a proportionality constant of 690 rad-cnr. There was no dose correction for attenuation of the gamma
rays by tissue absorbtion, which has been calculated to be about 2%/cm (yielding a dose reduction of about
20% at 10 cm).

The local gamma dose to the head and neck region was assumed to be distributed according to an
inverse square law d(r) = 690/r rad. The Committee approximated the exposed region of the body by a
sphere with radius 10 centimeters. This was felt to be a conservative assumption, because although the dose
does not go to zero at the base of the neck, a 10-centimeter sphere would also extend outside the skull.
Averaging this dose distribution over the exposed sphere, the average dose to the head was found to be 20.7
rad. The exposed volume is about 4189 cm', or 29 percent of the total body, so the average whole body dose
is about 6.0 rad. Multiplying this by the BEIR V risk coefficient for children exposed at age five. 1.4/1,000
person-rad, produces a lifetime risk of about 8.4/1,000. This calculation assumes that the brain and other
head tissues have average radiosensitivity. BEIR V also gives absolute-risk coefficients for brain cancer
ranging from 1 to 9 per million person-year-rad, with 3 being a reasonable average. Applying this figure to
an average head dose of 20.7 rad, the Committee estimates a lifetime risk of about 4.35/1,000. The
corresponding relative risk coefficients average about 3 percent per rad, so this dose would correspond to an
excess relative risk of 62 percent.

355

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ENDNOTES

1 . As noted in the report of the Massachusetts Task Force, "many of the people
who became residents of the Walter E. Fernald School . . . were not admitted with a
diagnosis of mental retardation. Societal and cultural norms of the day permitted persons
to be admitted to state-operated institutions for a number of reasons. All were labeled
mentally retarded just by virtue of having lived within the facility." Task Force on
Human Subject Research, to Philip Campbell, Commissioner, Commonwealth of
Massachusetts Executive Office of Health and Human Services, Department of Mental
Retardation, April 1994, "A Report on the Use of Radioactive Materials in Human
Subject Research that Involved Residents of State-Operated Facilities within the
Commonwealth of Massachusetts from 1943 to 1973" (ACHRE No. MASS-072194-A),
1.

2. Task Force on Human Subject Research, April 1994 ("A Report on the Use
of Radioactive Materials in Human Subject Research that Involved Residents of State-
Operated Facilities within the Commonwealth of Massachusetts from 1943 to 1973");
and the Working Group on Human Subject Research to Philip Campbell, June 1994
("The Thyroid Studies: A Follow-up Report on the Use of Radioactive Materials in
Human Subject Research that Involved Residents of State-Operated Facilities within the
Commonwealth of Massachusetts from 1943 through 1973") (ACHRE No. MASS-
072194-B).

3. Unfortunately, the published reports of the twenty-one research projects we
review in this chapter often provide little or no information that could be used to identify
the individual children. Many published reports provide information only about the
child's age, weight, and diagnosis. Other reports provide only the child's initials and
diagnosis. In either case, it would be difficult or impossible to identify specific
individuals from this limited information. An existing chart may or may not confirm a
child's involvement in a research project. If the investigators maintained records, those
could serve as a key to identify the individuals. Even if the hospital records do exist,
however, records for a period of several years prior to publication of the research would
have to be reviewed in order to match a set of initials with a diagnosis. However, it is
unlikely that research records have been maintained for many of these projects for the
past three to five decades. Finally, the identification of an individual would be only the
first step in tracking him to his current location.

Many of the children at the Wrentham and Fernald Schools have been located
through extensive local efforts. The existence of the research records, as well as the
records of these long-term residential institutions, have made these identifications
possible.

4. There are a few exceptions to the usual involvement of parents in decisions
concerning their minor children. Children who are considered either "emancipated
minors" or "mature minors" are generally able to receive routine medical care without
any need for parental involvement. Emancipated minors are minor children who have
taken on adult responsibilities, such as maintaining financial independence and/or living
away from the parents' home. A mature minor, on the other hand, is considered to be
decisionally capable under special circumstances because he or she has demonstrated the
maturity and ability to decide treatment decisions for himself or herself. Adolescents can
be considered emancipated or mature minors and are thereby exempted from parental
consent. In addition, if a minor is close to the age of majority (at least fifteen), the
treatment clearly benefits the minor and is medically necessary, there is good justification
for not obtaining parental consent, and if the procedure is not extraordinary or one

358

involving substantial risk to the child, then practitioners are usually able to deliver
medical care without parental permission. A number of states permit minors to give
consent to the diagnosis or treatment of venereal disease, drug addiction, alcoholism,
pregnancy, or for purposes of giving blood. For more information on this subject, please
see: A. R. Holder, Legal Issues in Pediatrics and Adolescent Medicine (New Haven, Yale
University Press, 1985), 123; and Robert H. Mnookin and D. Kelly Weisberg, Child,
Family, and State: Problems and Materials on Children and the Law (Little Brown and
Company, New York, 1995).

5. Mnookin and Weisburg, Child, Family, and State, 536. In addition, parents
are considered to be "legally responsible for the care and support of their children," and
"the parental consent requirement protects parents from having to pay for unwanted or
unnecessary medical care and from the possible financial consequences of supporting the
child if unwanted treatment is unsuccessful."

6. In addition to the exceptions given in endnote 4, there are other standard
common law and statutory limitations and exceptions to the general parental consent
requirement. "These relate to mandatory immunizations and screening procedures
(applicable to all children), the neglect limitation (where a court may override a parental
decision for an individual child), the emergency treatment of children (where no parental
consent is required if the parent is unavailable)." Ibid.

7. "Some medical procedures are required of all children and in this sense
represent generally applicable limitations on parental prerogatives. The Supreme Court
has held, for example, that a state could impose a compulsory smallpox vaccination law
as a 'reasonable and proper exercise of police power.' Jacobsen v. Massachusetts, 197
U.S. 1 1, 35 (1905) quoting Viemeister v. White, 72 N.E. 97 (1904). A vaccination
requirement may act to protect society from various public health hazards created by
communicable diseases where a parental decision may endanger not only a particular
child but society at large." Mnookin and Weisburg, Child, Family, and State, 55 1 .

8. The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, Research Involving Children: Report and
Recommendations (Washington, D.C.: GPO, 1977), and Protection of Human Subjects,
45 C.F.R. § 46, subpart D.

9. Protection of Human Subjects, 45 C.F.R. § 46.408.

10. Ibid., § 46.404.

11. Ibid., § 46.406.

12. Ibid., § 46.407.

13. Susan E. Lederer and Michael A. Grodin. "Historical Overview: Pediatric
Experimentation," in Children as Research Subjects: Science, Ethics, and Law, eds.
Michael A. Grodin and Leonard H. Glantz (New York: Oxford University Press, 1994),
4.

14. Ibid., 5.

15. Ibid., 6.

16. "Orphans and Dietetics," American Medicine 27 (1921): 394-396.

1 7. Lederer and Grodin, Children as Research Subjects, 11-12.

18. Ibid., 14.

19. Ibid., 12.

20. Ibid., 15.

2 1 . This ruling is summarized in Jay Katz, Experimentation with Human
Beings, the Authority of the Investigator, Subject, Professions, and State in the Human
Experimentation Process (New York: Russell Sage Foundation, 1972), 972-974.

22. Ibid.

23. Ibid.

359

24. Ibid.

25. This case is also discussed in "Use of Fifteen Year Old Boy as Skin Donor
Without Consent of Parents as Constituting Assault and Battery: Bureau of Legal
Medicine and Legislation Society Proceedings," Journal of the American Medical
Association 1 20 ( 1 7 October 1942): 562-563.

26. For more information on the Nuremberg Code, please see United States v.
Karl Brandt, et ai, "The Medical Case," Trials of War Criminals before the Nuremberg
Military Tribunals under Control Council Law No. 10 (Washington, D.C.: GPO, 1949),
2; Jay Katz, "Human Experimentation and Human Rights," St. Louis University Law-
Journal 38 (1993); and George J. Annas and Michael A. Grodin, eds., The Nazi Doctors
and the Nuremberg Code: Human Rights in Human Experimentation (New York:
Oxford University Press, 1992).

27. Irving Ladimer, "Legal and Ethical Implications of Medical Research on
Human Beings," (S.J.D. diss., George Washington University, 1958), appendix II, 202-
208.

28. Ibid., 207.

29. Ibid., 206.

30. Ibid., 208.

3 1 . Henry Seidel, interview by Gail Javitt ( ACHRE), transcript of audio
recording, 20 March 1995 (Research Project Series, Oral History Project), 67-68.

32. Ibid.

33. William Silverman, interview by Gail Javitt (ACHRE), transcript of audio
recording, 14 February 1995 (Research Project Series, Oral History Project), 26.

34. Ibid.

35. Boston University, Law-Medicine Research Institute, 1 May 1961
("Conference on Social Responsibility in Pediatric Research")(ACHRE No. BU-062394-
A). This was part of a larger LMRI project (which was funded by NIH) to investigate
actual practices in clinical research. The project began in early 1960 and continued until
1963, resulting in a lengthy final report, which was never published.

36. Ibid., 5. In this document, speakers are identified by initials. A list of
participants found in these same records generally makes identifying particular speakers
in the transcripts quite straightforward. In this case, however, a complexity arises
because the speaker is identified as "WF." The list of participants reveals no one with
these initials, and "WF" appears only once in the transcripts. It is almost certain that
"WF" is a typographical error, and given the flow of the transcripts, it is also almost
certain that "WF" should have been "WS"--William Silverman.

37. Ibid., 7.

38. Ibid,, 3.

39. Ibid.

40. Ibid., 2.

41. Ibid., 6.

42. Ibid., 17.

43. Ibid., 15.

44. Ibid.

45. The Declaration of Helsinki can be found in many sources, but its earliest
published appearance was perhaps "Human Experimentation: Code of Ethics of the
World Medical Association," British Medical Journal 2 (1964): 177.

46. Ibid.

47. Ibid.

48. Ibid.

49. Ibid.

360

50. Much has been written on the Willowbrook studies; for a short summary of
this episode see Ruth R. Faden and Tom L. Beauchamp, A Histoiy and Theoiy of
Informed Consent (New York: Oxford University Press, 1986), 5, 163-164.

5 1 . Henry Beecher, Research and the Individual: Human Studies (Boston:
Little, Brown, and Company, 1970), 122-127.

52. There were many exchanges in the medical literature over the hepatitis
studies conducted by Saul Krugman at the Willowbrook State School. Stephen Goldby
wrote an editorial to The Lancet, expressing his outrage over The Lancet's position on
Krugman's research, saying that the research was "quite unjustifiable, whatever the aims,
and however academically or therapeutically important are the results. ... Is it right to
perform an experiment on a normal or mentally retarded child when no benefit can result
to that individual?" The editors of The Lancet responded to Goldby's letter, expressing
agreement with his position, stating, "The Willowbrook experiments have always carried
a hope that hepatitis might one day be prevented there and in other situations where
infection seems almost inevitable; but that could not justify the giving of infected
material to children who would not directly benefit." Krugman responded to these
editorials by arguing,

Our proposal to expose a small number of newly
admitted children to the Willowbrook strains of hepatitis
virus was justified in our opinion for the following
reasons: 1 ) they were bound to be exposed to the same
strains under the natural conditions existing in the
institution, 2) they would be admitted to a special, well-
staffed unit where they would be isolated from exposure
to other infectious diseases which were prevalent in the
institution. . . . Thus, their exposure in the hepatitis unit
would be associated with less risk than the type of
institutional exposure where multiple infections could
occur; 3) they were likely to have a subclinical infection
followed by immunity to the particular hepatitis virus;
and 4) only children with parents who gave informed
consent would be included.

The debate over these experiments continued, as evidenced by editorials by Geoffrey
Edsall, Edward Willey, and Benjamin Pasamanick in The Lancet and through an editorial
in JAMA as well. Jay Katz, Experimentation with Human Beings, 1007-1010; Geoffrey
Edsall, "Experiments at Willowbrook," The Lancet ( 1 0 July 1971): 95; Edward N. Willey
and Benjamin Pasamanick, "Experiments at Willowbrook," The Lancet (22 May 1971):
1 078- 1 079; and "A Shedding of Light," Journal of the American Medical Association
212(11 May 1970): 1057-1058.

53. S. Allan Lough, Chief of the Radioisotopes Branch, AEC Isotopes Division,
to Drs. Hymer L. Friedell, G. Failla, Joesph G. Hamilton, A. H. Holland, Members of
AEC Subcommittee on Human Applications, 19 July 1949 ("Revised Tentative Minutes
of March 13, 1949 Meeting of Subcommittee on Human Applications of Committee on
Isotope Distribution of U.S. Atomic Energy Commission, AEC Building, Washington,
D.C.") (ACHRE No. NARA-082294-A-24). For price list and isotope catalogue, see
AEC Isotopes Division, Supplement No. 1 to Catalogue and Price List No. 3, September
1949 (ACHRE No. DOD-122794-A), 3-4.

54. S. Allan Lough, 19 July 1949 ("Revised Tentative Minutes of March 13,
1949 Meeting..."), 10.

361

55. AEC General Manager Carroll Wilson's two 1947 letters that address the
consent issue (see chapter 1) did not specifically mention children. The second letter,
dated November 1947, required that "the patient give his complete and informed consent
in writing, and (c) that the responsible nearest of kin give in writing a similarly complete
and informed consent. . . ." It is not clear, however, that Wilson's phrase, "responsible
nearest of kin," was written out of concern for children and other patients not capable of
giving "complete and informed consent," as opposed, for example, to adult patients who
were too sick to give such consent. Moreover, it is not even clear whether the letter was
intended to apply to experiments with healthy subjects, as opposed to sick patients, or to
experiments using tracer amounts of radioactive substances. The second letter is
specifically focused on "substances known to be, or suspected of being, poisonous or
harmful." It is plausible, for example, that tracer amounts of radionuclides were
considered "harmless," especially since the Wilson letter expressly prohibited the
administration of "harmful" substances unless there was a reasonable hope that "such a
substance will improve the condition of the patient." Carroll L. Wilson, General Manager
of the AEC, to Stafford Warren, the University of California, Los Angeles, 30 April 1947
("This is to inform you that the Commission is going ahead with its plans . . .") (ACHRE
No. DOE-051094-A-439), 1. Also C. Wilson, General Manager, AEC, to Robert Stone,
University of California, 5 November 1947 ("Your letter of September 1 8 regarding the
declassification of biological and medical papers was read at the October 1 1 meeting of
the Advisory Committee on Biology and Medicine.") (ACHRE No. DOE-052295-A).

56. J. H. Lawrence, "Early Experiences in Nuclear Medicine," The Journal of
Nuclear Medicine 20 (1979): 561 . (Publication of speech given in 1955). Dr. Lawrence
concludes, however, that "as a matter of fact, in the 20 years since we first used
artificially produced radioisotopes in humans, we have not run into delayed effects or
complications as some of the skeptics predicted we would." Ibid., 562.

57. This correspondence can be found in Task Force on Human Subject
Research, A Report on the Use of Radioactive Materials, appendix B, documents 16-18.

58. Citations for the studies for which the Committee performed detailed risk
analysis can be found in the supplemental volumes.

59. S. H. Silverman and L. Wilkins, "Radioiodine Uptake in the Study of
Different Types of Hypothyroidism in Childhood," Pediatrics 12 (1953): 288-299.

60. V. C. Kelley et al., "Labeled Methionine as an Indicator of Protein
Formation in Children with Lipoid Nephrosis," Proceedings of the Society for
Experimental Biology and Medicine 76 ( 1 950): 1 53- 1 55.

61 . M. A. Van Dilla and M. J. Fulwyler, "Thyroid Metabolism in Children and
Adults Using Very Small (Nanocurie) Doses of Iodine- 125 and Iodine- 131," Health
Physics 9 (\963): 1325-1331.

62. For more information, please see the "Introduction: The Atomic Century,"
sections entitled "How Do We Measure the Biological Effects of Internal Emitters?" and
"How Do Scientists Determine the Long-Term Risks From Radiation?"

63. International Commission on Radiological Protection, Publication 53: Data
for Protection Against Ionizing Radiation from External Sources (New York: Pergamon
Press, 1973); see also National Council on Radiation Protection and Measurements,
Report 80: Induction of Thyroid Cancer by Ionizing Radiation— Recommendations of the
National Council on Radiation Protection and Measurements (New York: The Council,
1985).

64. R. E. Shore et al., "Thyroid Tumors Following Thymus Irradiation," Journal
of the National Cancer Institute 74 ( 1 985): 1 1 77- 1 1 84.

65. E. Ron and B. Modan, "Thyroid and Other Neoplasms Following Childhood
Scalp Irradiation," in J. D. Boice, Jr., and J. F. Fraumeni, Jr., eds., Radiation

362

Carcinogenesis: Epidemiology and Biological Significance (New York: Raven, 1 984),
139-151.

66. R. L. Prentice et al., "Radiation Exposure and Thyroid Cancer Incidence
among Hiroshima and Nagasaki Residents," National Cancer Institute Monographs 62
(1982): 207-212.

67. National Council on Radiation Protection and Measurements, Report 80:
Induction of Thyroid Cancer by Ionizing Radiation. The BIER V report recommends a
figure of 0.66 but with a broad confidence interval of (0.14-3.15). National Research
Council, Board on Radiation Effects Research, Committee on the Biological Effects of
Ionizing Radiation, Health Effects of Exposure to Low Levels of Ionizing Radiation:
BIER V{ Washington, D.C.: National Academy Press, 1990), 5, 298.

68. Task Force on Human Subject Research, "A Report on the Use of
Radioactive Materials in Human Subject Research that Involved Residents of State-
Operated Facilities within the Commonwealth of Massachusetts from 1943 to 1973."

69. Protection of Human Subjects, 45 C.F.R. § 46. 1 02.

70. Ibid., § 46.406.

71 . F. P. Castronovo, "An Attempt to Standardize the Radiodiagnostic Risk
Statement in an Institutional Review Board Consent Form," Investigative Radiology 28
(1993): 533-538.

72. W. L. Freeman, "Research with Radiation and Healthy Children: Greater
than Minimal Risk," IRB: A Review of Human Subjects Research 5, no. 16 (1994): 1-5.

73. B. J. Duffy and P. J. Fitzgerald, "Thyroid Cancer in Childhood and
Adolescence: A Report of Twenty-eight Cases," Cancer 3 (November 1950): 1018-1032.

74. R. Murray, P. Heckel, and L. H. Hempelmann, "Leukemia in Children
Exposed to Ionizing Radiation," New England Journal of Medicine 261(1 959): 585-597.

75. Eugene L. Saenger et al., " Neoplasia Following Therapeutic Irradiation for
Benign Conditions in Childhood," Radiology 74 (1960): 889-904. For more information
on the work of Eugene Saenger, please see chapter 8, "Total-Body Irradiation: Problems
When Research and Treatment Are Intertwined."

76. Ibid., 889.

77. Ibid., 901.

78. S. A. Beach and G. W. Dolphin, "A Study of the Relationship Between X-
Ray Dose Delivered to the Thyroids of Children and the Subsequent Development of
Malignant Tumors," Physics in Medicine and Biology 6 ( 1 962): 583-598.

79. Ibid., 583.'

80. One rep (roentgen equivalent physical), a unit that is no longer used, is
approximately equivalent to one rem (roentgen equivalent man).

81. J. C. Aub, A. K. Solomon, and Shields Warren, Harvard Medical School, 7
May 1949 ("Tracer Doses of Radioactive Isotopes in Man") (ACHRE No. HAR- 100395-
A). It appears that at least one physician-researcher of the time determined to avoid an
unknown risk by not administering radioisotopes in studies with pregnant women and
children. In his recent autobiography, Dr. Francis Moore, an eminent Boston-based
surgeon, recalled that "in pregnancy, even very small doses of radiation are dangerous to
the unborn child, so we did not use radioactive isotopes in studying the body composition
in pregnant women or in young children." Presumably Dr. Moore is referring to the
1940s when he began his pioneering research employing radioisotopes to determine the
composition of the body, although this is not clear. Whether Dr. Moore's view was
informed by dialogue with the relevant pediatric perspectives reviewed here also is
unclear. Francis D. Moore, M.D., A Miracle and a Privilege: Recounting a Half Century
of Surgical Advance (Washington, D.C.: Joseph Henry Press, 1995), 109, 111.

363

82. L. Van Middlesworth, "Radioactive Iodide Uptake of Normal Newborn
Infants," American Journal of Diseases of Children 88(1 954): 44 1 .

83. Malcom J. Farrell, Superintendent, Walter E. Fernald State School, to
Parent, 2 November 1949 ("The Massachusetts Institute of Technology and this
institution are very much interested . . ."), as cited in the Task Force for Human Subject
Research, "A Report on the Use of Radioactive Materials," appendix B, document 19.

84. This form states,

To the Superintendent of the Walter E. Fernald State
School:

This is to state that I give my permission for the

participation of in the project mentioned in your

letter of

Witnessed by:

Signature
Date:

Relationship

Permission form from Parent to the Superintendent of the Walter E. Fernald State School,
2 November 1949 ("This is to state that I give my permission . . ."), as cited by the Task
Force on Human Subject Research, in "A Report on the Use of Radioactive Materials,"
appendix B, document 19.

85. Clemens E. Benda, Director of Research, the Walter E. Fernald State
School, to Parent, 28 May 1953, as cited by the Task Force on Human Subject Research,
in "A Report on the Use of Radioactive Materials," appendix B, document 23.

86. As stated in the Massachusetts Task Force report, the purpose of the
nutritional research studies was to "understand how the body obtained the minerals iron
and calcium from dietary sources and to find out whether compounds in cereals affected
their absorption ... the immediate goal of the research was to understand if either of
these cereals was preferable from a nutritional point of view." Ibid., 16.

87. Ibid., 43.

88. Fred Boyce, transcript of audio testimony before the Advisory Committee
on Human Radiation Experiments, 16 December 1994, 38.

89. Task Force on Human Subject Research, in "A Report on the Use of
Radioactive Materials," 33.

90. Susan E. Lederer and Michael A. Grodin, "Historical Overview: Pediatric
Experimentation," 12-13.

91. Boston University, Law-Medicine Research Institute, 1 January 1960 to 31
March, 1963, /J Study of the Legal, Ethical, and Administrative Aspects of Clinical
Research Involving Human Subjects: Final Report of Administrative Practices in Clinical
Research, Research Grant No. 7039 (ACHRE No. BU-053194-A), 34.

92. Fred Boyce, 16 December 1994, 38.

93. Robert S. Harris, Professor of Biochemistry and Nutrition, Massachusetts
Institute of Technology, to Clemens E. Benda, 1 May 1953, as cited by the Task Force
on Human Subject Research, in "A Report on the Use of Radioactive Materials,"
appendix B, document 21,1.

364

94. Ibid.

95. Children who are considered "wards of the State or any other agency,
institution, or entity" can become subjects of research if the research is related to their
status as wards and conducted in a setting in which the majority of children involved in
the research are not wards. If the research meets these conditions, the IRB must then
appoint a special advocate not associated in any way with the research, who will act in
the best interests of the child. Protection of Human Subjects, 45 C.F.R. § 46.409.

96. There are also no special regulations protecting institutionalized adults. The
Committee believes that the federal government should inplement public policies to fill
this regulatory gap.

97. This conclusion does not hold for people who believe that it is never
acceptable to use children as subjects in nontherapeutic research, even if the research is
risk-free.

98. G. S. Kurland et al., "Radioisotope Study of Thyroid Function in 21
Mongoloid Subjects, including Observations in 7 Parents," Journal of Clinical
Endocrinology and Metabolism 17 (1957): 552-60; A. Friedman, "Radioactive Uptake in
Children with Mongolism," Pediatrics 16 (1955): 55; S. H. Silverman and L. Wilkins,
"Radioiodine Uptake in the Study of Different Types of Hypothyroidism in Childhood,"
288-299; and E. H. Quimby and D. J. McCune, "Uptake of Radioactive Iodine by the
Normal and Disordered Thyroid Gland in Children," Radiology 49 (1947): 201-205.

99. Boston University Law-Medicine Research Institute, Final Report of
Administrative Practices in Clinical Research, 34.

365

8

Total-Body Irradiation:

Problems when Treatment and

Research Are Intertwined

In the fall of 1971, a public controversy erupted about the ethics of a
research project at the University of Cincinnati College of Medicine funded for
more than a decade by the Department of Defense (DOD). In this research, the
subjects were cancer patients who underwent external total-body irradiation (TBI);
the DOD was funding postirradiation research on the biological effects of this type
of exposure to radiation. Critics of the research charged that the physician-
investigators were exposing unknowing patients to potentially lethal doses of TBI-
-not to treat their cancer, but to collect data on the effects of nuclear war for the
military—and that numerous patients had died or seriously suffered from the
radiation. Defenders asserted that the TBI was reasonable medical treatment for
people with incurable cancer and that this treatment was performed in accordance
with contemporary professional ethics. Over the next four months, the research
was reviewed favorably by ad hoc committees of physicians appointed by the
American College of Radiology (ACR), the preeminent professional organization
of radiologists, and by University of Cincinnati officials, but critically by an ad
hoc committee of junior nonmedical faculty members at the university. Following
these reports, the university president rejected further Defense Department funding
for the posttreatment data-collection program, and the use of TBI was suspended.

When news reports about human radiation experiments appeared in late
1993, journalists and investigators again focused on this Cincinnati project.
Critics charged that the reviews commissioned by the university and the ACR

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Chapter 8

were biased and had been "whitewashes"; supporters countered that the
Cincinnati research had been conducted in the open, had been thoroughly and
favorably reviewed by the medical community, and was old news. In addition,
patients were identified publicly for the first time, leading a number of their
family members to file a lawsuit against the university, the physicians, and other
parties in federal court.' The family members also formed an advocacy group
called the Cincinnati Families of Radiation Victims Organization.

The University of Cincinnati was only the last in a line of institutions that
received funds to provide data to the government on the effects of total-body
irradiation on humans. In this chapter we review thirty years of research
supported by the Manhattan Project, the Department of Defense, and the AEC
aimed at gathering data on the effects of radiation on hospitalized patients who
were medically exposed to total-body irradiation. Much of the record is
incomplete, and some of it is contradictory. We cannot and do not resolve all the
inconsistencies and uncertainties in the record. We do, however, focus on the
ethical issues that emerged in this research, some of which are still with us today.

The history of TBI research is important to the Committee for several
reasons. First, in the other case studies conducted by the Committee, there was
never any expectation or any claim that subjects, even if they were patients,
would benefit medically from their being involved in experiments. By contrast,
in the TBI research, the TBI itself was recommended as treatment for incurable
cancer, for which the expectation of benefit was low, although possible;
chemotherapy, which would be considered "standard" today, was not well
established until the mid- to late 1960s. (The postradiation effects studies
sponsored by the DOD, however, were not intended to benefit the patients.) As
we noted in chapter 4, the presence of an intent to benefit, if that intent is both
genuine and reasonable, alters the ethics of the situation. An intent to benefit the
patient-subject does not, however, ensure that an experiment is ethically
acceptable. Many perplexing questions about the ethics of research involving
human subjects that we face today occur at the bedside with patient-subjects who
may or may not benefit medically by their participation. The TBI story thus
foreshadows important issues we discuss in part III of this report when we focus
on contemporary research involving human subjects, much of which involves
patient-subjects and the prospect of medical benefit. The core of the ethical
problem is straightforward. Whenever the treatment of a patient is intertwined
with the conduct of research, the potential emerges for conflict between the
interests of science and the interests of the patient. The patient may, for example,
be exposed to additional risk or discomfort as a consequence. At the same time,
for some patients, participation in research may offer the only chance, or the best
chance, of improving their medical condition.

The second reason the history of TBI research is important to the
Committee is that although the research was conducted on cancer patients, the
government's interest in the research was not to advance the treatment of cancer

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Part II

but to find answers to problems facing the military in the development and use of
atomic weapons and nuclear-powered aircraft. It is this disparity that raised
questions, both in 1971 and today, about the motivations behind treatment of
these patient-subjects with TBI. Whether it matters morally that the government
pursued its interests in the effects of TBI on patient-subjects depends in large
measure on whether the government's objectives in supporting this research
inappropriately compromised the medical care the patient-subjects received. We
have just noted that the conjoining of research with medical care necessarily
creates a potential for conflict between the interests of the research and the
interests of the patient. This is true even where the objective of the research is to
find a treatment for the condition from which the patient suffers. A central issue
in the case of the TBI research is whether this conflict was exacerbated by the
nature of the gap between the interests of the patient and the objectives of the
research. A complicating feature of the TBI story is that the DOD did not pay
directly for the patients to be administered TBI; the funding by these agencies
was restricted to the costs associated with the physiological and psychological
measurements taken in conjunction with the TBI, rather than the costs of the TBI
itself.

The Committee was also struck with how well the history of TBI research
illustrates two very contemporary problems—how to draw boundaries between
medical care and medical research, and how to draw boundaries between research
with patient-subjects that is "therapeutic" and research that is "nontherapeutic."
Was the administration of TBI always an instance of medical research, was it ever
standard care, or was it sometimes administered as a departure from standard care
outside of research? When TBI was administered in the context of research, was
there a basis for believing that there was a reasonable prospect that patients could
benefit, or was it the kind of research from which patients could not benefit
medically? Because of conflicting and incomplete evidence, these were questions
that we could not always answer but that guided our inquiry.

The Committee began our review by seeking to track down TBI research
identified in a "Retrospective Study" of TBI exposures conducted in the mid-
1960s by the Oak Ridge Associated Universities on behalf of the National
Aeronautics and Space Administration (NASA), which collected records on more
than 2,000 TBI exposures on both radiosensitive and radioresistant cancers from
forty-five U.S. and Canadian institutions.2 The Committee then focused on
approximately twenty research studies that were published between 1940 and
1974 on the use of TBI in the United States. Nine of these twenty studies
involved at least some patients with "radioresistant" cancers. Eight of the nine
institutions that conducted the studies received funding from either the Manhattan
Project or the DOD;3 the Atomic Energy Commission sponsored one of the
studies involving "radiosensitive" cancers at the Oak Ridge Institute of Nuclear
Studies (ORINS).4 In addition, the Committee found only one instance in which

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Chapter 8

nongovernment-funded TBI research involved patients with radioresistant

cancers.5

In this chapter, we begin with a definition of TBI, including a discussion
of the then-contemporary distinction between the use of TBI to treat
radiosensitive and radioresistant tumors. The distinction is important to what
follows, because patients with radiosensitive cancers (for which TBI was
considered most promising medically) were less useful subjects for obtaining the
type of information that the military sought— information on the acute effects of
radiation on healthy soldiers or citizens during the course of atomic warfare-
related activities. In these patients, it would be less clear whether signs such as
nausea, vomiting, or other acute effects were due to rapid destruction of cancer
cells by the radiation or due to the radiation acting on normal tissue, such as
normal blood cells. Similarly, patients with radiosensitive cancers were less
useful for research intended to find biological measures of radiation doses
("biological dosimeters"), because this research depended on measuring various
cell products in the blood or urine that could also be released by tumor cells that
were destroyed. Patients with radioresistant tumors were more desirable because
it was more likely that the effects seen were related to radiation effects on normal
tissue rather than rapid destruction of their tumor cells.

Following a discussion of TBI itself, we turn to a chronological history of
government sponsorship of research related to the effects of TBI with
radioresistant tumors. This research began during the Manhattan Project. In 1949
and 1950, as we next discuss, DOD and AEC experts and officials met to consider
the need for further TBI human experiments in order to gain information needed
in the development of the nuclear-powered airplane. When the decision was made
not to proceed with human experiments involving healthy subjects, the military
began to fund research on the effects of TBI on patients undergoing treatment for
cancer. As we discuss, this program began in 1950 at the M. D. Anderson
Hospital for Cancer Research in Houston and continued through the end of the
Cincinnati research, in the early 1970s. We conclude our review with a discussion
of the AEC-funded TBI research conducted at Oak Ridge between 1957 and
1974, which focused on patients with radiosensitive cancers.

WHAT IS TBI?

Medically administered total-body irradiation, also known as whole-body
radiation, involves the use of external radiation sources that produce penetrating
rays of energy to deliver a relatively uniform amount of radiation to the entire
body. Total-body irradiation was used as a medical treatment long before the
1944-1974 experiments, and it continues to be used today. Soon after doctors
began to experiment with radiation, they recognized that radiation had different
effects on different types of cancers. They thus began to distinguish between
radiosensitive cancers, which generally responded to the radiation treatment, and

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Part II

radioresistant cancers, which most often did not respond. By the 1940s, TBI was
recognized as an acceptable treatment for certain radiosensitive cancers that are
widely disseminated throughout the body, such as leukemia and lymphoma (a
cancer whose origin is in the lymphoid tissue). By the late 1950s, TBI was also
being used to assist in conjunction with research on bone marrow transplantations
for radiosensitive cancers. During this period, TBI was also explored as a
possible palliative treatment (providing relief, but not cure) for disseminated
radioresistant cancers, such as carcinomas of the breast, lung, colon, and other
organs (carcinoma is a cancer that originates from the cells lining these organs).6
However, TBI alone did not prove to be of value in treating these cancers
because, without support measures to maintain bone marrow function, the doses
needed to significantly shrink the tumors were potentially lethal to the patient.

In the 1950s, there were few effective methods for treating radioresistant
cancers. Chemotherapy was just being developed; it was risky to use and only
marginally effective. With no better alternatives, interest in TBI continued. In
addition, the development in the 1950s of high-energy sources of radiation-
cobalt 60, cesium 137, and megavolt x-ray sources— represented a significant
advance in technology. These new teletherapy units allowed high-energy
radiation to penetrate deeper into the body without damaging the overlying skin
and soft tissues; thus higher absorbed marrow doses (in rad) could be delivered
than with previous equipment. The advent of this new teletherapy encouraged
researchers to retest TBI on patients with radioresistant cancers even though prior
TBI techniques with older x-ray therapy machines had failed. By the late 1960s,
however, chemotherapy began to be recognized as more effective, and interest in
TBI waned. During the 1 970s, researchers explored the effectiveness of
administering TBI without bone marrow transplant through multiple exposures at
lower doses (e.g., 10 to 30 rad), known as "fractionated radiation," to achieve
cumulative total body doses of 150 to 300 rad, rather than single exposures of an
equivalent total body dose.7 They also focused much more extensively on partial-
body irradiation, because the risk of patient bone marrow failure was lower.
Since the 1980s, TBI has again been used to treat certain widely disseminated,
radioresistant carcinomas at doses as high as 1,575 rad in conjunction with
effective bone marrow transplantation, which became routinely available in the
late 1970s.8

TBI can cause acute health effects during the first six weeks following an
acute (single) exposure. The type and severity of the effects depend, among other
things, on the dose, the dose rate, and the individual's sensitivity to radiation.9
The most serious side effects seen during this period are related to radiation-
induced depression of the bone marrow, which can cause a decrease in the
number of circulating platelets and white blood cells, which in turn can result in
small hemorrhages and infections, possibly leading to death. Moderate bone
marrow depression results with doses of about 125 rad. The following table
describes the general acute effects that are likely to occur to healthy persons from

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a single exposure;10 these effects can be exaggerated and prolonged for people
who are ill or have had prior radiation treatments. As with an ordinary diagnostic
x ray, the patient feels nothing during the radiation exposure itself. In addition,
TBI, like most other forms of radiation exposure, can potentially have long-term
effects such as cancer induction; however, most patients who receive TBI do not
live long enough to experience most long-term effects.

Midline Tissue
Dose

Symptoms

Percentage

Time
Postexposure

50-100 rad

nausea

5-30

3-20 hours

1 00-200 rad

nausea

vomiting

death"

30-70
20-50
<5

4-30 hours
6-24 hours
5-6 weeks

200-350 rad

nausea

vomiting

death

70-90
50-80
5-50

1-48 hours
3-24 hours
4-6 weeks

350-500 rad

nausea

vomiting

death

90-100
80-100
50-99

1-72 hours
3-24 hours
4-6 weeks

550-750 rad

death

100

2-3 weeks

EARLY USE OF TBI FOR RADIORESISTANT TUMORS:
THE MANHATTAN PROJECT EXPERIMENTS ON
PATIENTS AND THE SUBSEQUENT AEC REVIEW

In the early 1930s, researchers at Memorial Hospital in New York, a
major cancer research center (now known as the Memorial Sloan-Kettering
Cancer Research Institute) engaged in an extensive study on the medical effects
of total-body irradiation. As part of this study, the researchers attempted to treat a
few radioresistant carcinomas. When they published their results in 1942, they
noted that "[e]xcept for transient relief of pain in a few cases, the results in
generalized carcinoma cases were discouraging. The reason for this is quickly
apparent. Carcinomas are much more radioresistant than the lymphomatoid
tumors, and by total body irradiation the dose cannot be nearly large enough to
alter these tumors appreciably." They cautioned that a cancer-killing dose "will
produce deleterious reactions in the bone marrow and general metabolism which
may prove lethal to the patient."12 The equipment used to deliver the TBI during
this time was suboptimal because most of the radiation was deposited in

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superficial structures such as the skin and other soft tissues.

During World War II, Memorial Hospital was one of three medical
institutions chosen by the Health Division of the Manhattan Project's
"Metallurgical Project" to conduct TBI experiments in order to help understand
the effects of radiation; the other two were the Chicago Tumor Institute13 and the
University of California Hospital.14 All three studies focused on individuals with
radioresistant diseases. From the limited records that are currently available, it
appears that these three studies achieved little, if any, medical benefit to subjects.
In addition, the interest of the military in these studies was classified and kept
secret from the patients in order not to reveal the ongoing atomic bomb project.

The first experiment was carried out from 1942 to 1946 at the University
of California Hospital in San Francisco to "study the effects of total-body
irradiation with x-rays of varying energy on hematologically normal
individuals."15 Twenty-nine patients were treated with total dosages ranging from
100 to 300 R (using a 250-KV machine). The investigators noted that the
"treatments were administered as part of the normal therapy of these patients" and
reported that "advantage was taken of the fact that patients were receiving such
treatment by making numerous blood studies for the Manhattan Project.""' Little
is known, for this and the other two studies, about the treatment of the patients or
the issue of patient consent. A number of the patients in the University of
California study had rheumatoid arthritis, and the use of TBI for that disease was
severely criticized after the war by the Advisory Committee for Biology and
Medicine of the newly formed Atomic Energy Commission (see below).17 In
1948 Dr. Robert Stone, chief of the Manhattan Project's Metallurgical Laboratory
Health Division, noted that although "no signed consent was received from the
patient ... the treatment was explained to them by the physicians and they, in full
knowledge of the facts, accepted the treatments." At the same time, however, it
was admitted that "the fact that Manhattan District was interested in the effects of
total body irradiation was kept a secret."18

A second Manhattan Project experiment was performed from December
1942 to August 1944 at Memorial Hospital in New York by one of the researchers
who had previously written that they were "discouraged" by the use of TBI for
radioresistant cancers~Dr. L. F. Craver.19 Despite his earlier negative results,
eight patients were given a total of 300 R (using a 250-KV machine), at various
dose rates, in order "to yield some detectable effects on the blood count and to
serve as a guide to the clinical tolerance for whole-body irradiation."20 The
patients had to have

metastatic cancer of such an extent and distribution
as to render their cases totally unsuitable for any
accepted method of surgical or radiological
treatment, yet . . . be in good enough general
condition so that they might be expected not only to

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tolerate the exposure to 300 R of total-body
irradiation in a period often to thirty days, but also
to survive the combined effects of their disease and
the irradiation for at least six months in order that
some conclusions might be drawn as to the later
effects of the irradiation.21

The report on this experiment makes clear that the primary purpose of this TBI
was to obtain data for the military. Dr. Craver essentially acknowledged that
there was little prospect of actual medical benefit to the patients in light of the
previous failure using the same procedure.22

A third TBI study involving fourteen people was performed at the Chicago
Tumor Clinic from March 1943 to November 1944; doses up to 120 R were given
with a 250-KV machine.23 None of these individuals had radiosensitive cancers.
The use of TBI was justified by the investigators because there were no known
treatments for their illnesses, and therefore, "x-ray exposures that were given were
as likely to benefit the patient as any other known type of treatment, or perhaps
even more likely than any other."24 This study appears to be the only TBI study
that included healthy subjects: three "normals" were each given three doses of 7 R.

After the war, Dr. Stone took on the task of editing an official history of
the experiments done for the plutonium project. At one point, he complained to
Dr. Shields Warren, chief of the AEC's Division of Biology and Medicine
(DBM), that declassifies were withholding the report of the Chicago TBI
experiment on grounds that its release would cause "adverse publicity and even
encourage litigation."25 Stone proposed to solve the problems by carefully
rewording the report. The report would make clear that the patients were
suffering from incurable illnesses for which radiation was as good, if not better
than, any other known treatment. Stone then proposed to deflect the likelihood of
adverse publicity or litigation by deleting identifying information so that the
patients could never "connect themselves up with the report."26 The study was
declassified and published in the form that Stone proposed.27

At about the same time in the fall of 1948, Dr. Alan Gregg, chairman of
the AEC's Advisory Committee for Biology and Medicine (ACBM), engaged
Stone in an exchange regarding the Manhattan Project TBI experiment on the
arthritic patients at the University of California Hospital. Stone, who by this time
had returned to the staff of the UC Hospital, had requested funding to monitor
these arthritic patients. Gregg told Stone that "I think that I do not misrepresent
the opinion of the Advisory Committee [for Biology and Medicine] in saying that
we agree with those who believe the x-ray treatment of arthritic patients you have
been giving patients is not justified."28 (Despite Dr. Gregg's concerns, the role of
TBI in the treatment of benign autoimmune diseases such as rheumatoid arthritis
continues to be explored today.29) Gregg stated that the AEC had an obligation to
provide a check on overly enthusiastic researchers. While admitting that a

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conservative consensus against certain treatments is not always correct, Gregg
cautioned that "there is plenty of experience that shows that some forms of
therapy attract enthusiastic supporters only to be discarded later as unsafe or
unjustified."30

In response, Stone acknowledged that the military's need for worker safety
information during the war was a primary motivation for choosing patients with
nonradiosensitive carcinomas and some benign disorders such as arthritis. "At
that time I was confronted with the problem of building up the morale of the
workers on the new atomic bomb project, many of whom were seriously worried
about the effects of prolonged whole body irradiation." But he countered that he
and the other researchers did believe that the total-body irradiation would be
therapeutic. Moreover, Stone retorted, Gregg's statements threatened researcher
and doctor freedom: "Wittingly or otherwise you have dictated how I should treat
patients even outside of the Atomic Energy Commission's supported activities."31
Stone's declaration marked a boundary that government officials (including
Stone's fellow medical researchers) would not be eager to cross.

RENEWED INTEREST IN TOTAL-BODY IRRADIATION

In 1949 AEC and Defense Department planners were seeking information
on the human effects of a nuclear reactor-powered airplane. The proponents of
the so-called NEPA project,32 which at the time was managed out of Oak Ridge
by the Fairchild Engine and Airplane Corporation on behalf of the Air Force and
the AEC, needed to know how much external radiation air crews could tolerate.
This question was critical because, depending upon the answer, the shielding
needed to separate the crew from the aircraft's nuclear reactor might render the
project impractical.

Those involved with the NEPA project were primarily interested in the
acute effects of total-body exposure over a relatively short time (although they
were also concerned about long-term effects of radiation on longevity and
reproduction). It was anticipated that NEPA pilots would be exposed to as much
as 25 roentgens in the course of a twenty-four-hour flight. How would this
amount of radiation affect the crew's abilities to fly the plane and perform their
tactical military function? How many such missions could a crew endure before
being incapacitated for flight duty, as well as facing a significant risk of
developing a life-shortening disease?

In early 1949, the NEPA Medical Advisory Committee was created to
research the questions noted above and to advise on the project. Dr. Andrew
Dowdy of UCLA was the chairman.33 Dr. Robert Stone was chosen to head a
human experiment subcommittee. At an April 3, 1949, meeting, Stone proposed
to the full committee a program of experimentation using total-body irradiation on
healthy subjects. In defense of this proposal. Stone noted that experimentation
with normal human subjects had been done in the past when there was no other

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way to obtain necessary data. At the same time, however, Stone discounted the
value of the TBI research that had been performed on sick patients.34 As
Brigadier General James P. Cooney, representing the AEC's Division of Military
Applications, put it, "We have lots of cases of whole body radiation treatments,
but all of them in patients and we have no controls and we don't have anything we
can put our finger on. . . . Most of this work was unsatisfactory because the data
was poor."35 However, Shields Warren was not persuaded that experiments on
healthy men would provide any more useful information and was concerned about
the long-term health consequences. Warren noted that "[i]t was not very long
since we got through trying Germans for doing exactly the same thing."36
Nonetheless, General Cooney argued that even if the data would not be
statistically valid, "psychologically it would make a lot of difference to the soldier
if we were able to tell him that various doses of total-body irradiation were given
to a group of people and here are the effects that were discerned."37

As we have seen in earlier chapters, the question of medical ethics was
considered by the NEPA discussants. Stone urged that the committee approve
TBI human experimentation in accordance with three basic principles of the 1946
American Medical Association Judicial Council: (1) "the voluntary consent of
the person on whom the experiment is to be performed must be obtained"; (2) "the
danger of each experiment must have been previously investigated by animal
experimentation"; and (3) "the experiment must be performed under proper
medical protection and management."38 Shields Warren added that the
experiments should be unclassified, so that there would be "no suspicion that
anything is being hidden or covered up, that it is all being done openly and
straightforwardly."39 MIT's Robley Evans responded that "we don't have to
advertise it, but at the same time it doesn't have to be concealed, as Dr. Shields
Warren has said."40 Dr. Hymer Friedell raised the question of whether decisions
on these issues could be made by doctors alone: "I am just wondering whether
someone else ought not to hold the bag along with us with regard to making such
a recommendation. Previously in medical experiments the physicians and doctors
have made such recommendations because the problem was primarily a medical
one. I think this is something larger than that. It is really not a medical problem
alone. It has to do with how critical this is with regard to the safety of the
nation."41

In January 1 950, the NEPA Medical Advisory Board recommended, with
the exception of one member (not named), that human experimentation be
conducted.42 Dr. Stone then prepared a January 1950 paper on "Irradiation of
Human Subjects as a Medical Experiment" to be presented to the DOD's
Research and Development Board (RDB). The paper explained that as long as
they kept doses below 1 50 R, the chances of long-term effects such as "leukemia
could be entirely ruled out."43 (This assertion would prove to be inaccurate;
subsequent epidemiological research has shown that radiation doses at such levels
will produce approximately a sevenfold increase in leukemia risk and a doubling

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in the risk of many other cancers.)44 Accordingly, the experiments were designed
only to analyze the acute effects of radiation. Stone extolled the "inestimable
value" that would come from being able to tell pilots that "normal human beings
had been voluntarily exposed without untoward effects to larger doses than they
would receive while carrying out a particular mission." Stone then described a
"plan of attack," in which he would start with 25 R total-body irradiation and then
gradually increase the dose to 50 R, 100 R, and 150 R if no immediate effects
were seen.45

The RDB's Joint Panel on the Medical Aspects of Atomic Warfare met in
March 1950 and endorsed the NEPA recommendations in Stone's paper.46 From
there, the issue was debated by the RDB's Committee on Medical Sciences (CMS)
in May 1950. When one committee member asked whether "you can get answers
from people subjected to radiation therapy usually by reason of neoplastic
disorders" as an alternative to experiments on healthy persons, Dr. Stone
responded that it might be possible, but only if the patients had radioresistant
cancers: "you can't pick lymphomas, but [rather] carcinomas [sic] types of
metastases"47~the death of lymphoma cells would release quantities of unknown
biologic chemicals and complicate the data collection.

The Defense Department shied away from making a final decision and
instead deferred the matter to the AEC on the grounds that NEPA involved
"civilian" as well as military problems. Accordingly, the AEC appointed another
panel of experts, who met in Washington, D.C., on December 8, 1950.4S This ad
hoc "biological and medical committee," which included a number of participants
in the DOD's NEPA advisory committee, addressed four questions:

• Assume that troops are acutely exposed to penetrating ionizing
radiation (gamma rays). At what dosage level will they become
ineffective as troops?

• What dosage will render an air crew . . . unable to complete a
mission during a flight of one to three, four to twelve, and twelve
to forty-eight hours?

• How often may an aircraft crew accept an exposure of 25 R per
mission and still be a reasonable risk for subsequent missions?

• A submarine crew are receiving 25 R per mission. How many
missions should they be allowed to make?49

This group of experts concluded, somewhat in contrast to Stone, that the
acute effects of doses of 150 R or more would pose "grave risks" of rapidly
making troops "ineffective as fighting units," but that doses held below 75
roentgens should be "unimportant in determining the success of a mission

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provided the crew members had not previously received an appreciable amount of
radiation." (Current reports suggest that tolerance levels for acute effects may be
a little higher, and that a dose of 125 rad (approximately 200 roentgens) would
cause vomiting in approximately 30 percent of those exposed within twenty-four
hours, and 200 rad would cause vomiting in 50 percent.)50 They also said that air
and submarine crews could withstand eight missions of 25 roentgens, but that
cumulative doses of more than 200 roentgens could "substantially reduce the life
expectancy of the irradiated individual." The ad hoc committee based these
conclusions on "the results of extensive animal experiments, the response of
patients treated for disease by X-ray and radium, observations on the effect of
radiations from the atomic bombs detonated over the Japanese cities of Hiroshima
and Nagasaki, and accidental exposures within the Manhattan Project and the
Atomic Energy Commission."51 Accordingly, this committee found that
additional human experimentation was not needed to come up with reasonable
answers.

Dr. Joseph Hamilton, a Manhattan Project physician involved with the
plutonium injections, was unable to attend the December 8 meeting and sent a
note to Shields Warren explaining his views:

For both politic and scientific reasons, I think it
would be advantageous to secure what data can be
obtained by using large monkeys such as
chimpanzees which are somewhat more responsive
than the lower animals. Scientifically, the use of
such animals bears the disadvantage of the fact that
they are considerably smaller than most adult
humans and a critical evaluation of their subjective
symptoms is infinitely more difficult. If this is to be
done in humans, I feel that those concerned in the
Atomic Energy Commission would be subject to
considerable criticism, as admittedly this would
have a little of the Buchenwald touch. The
volunteers should be on a freer basis than inmates
of a prison. At this point, I haven't any very
constructive ideas as to where one would turn for
such volunteers should this plan be put into
execution.52

Following the ad hoc committee's conclusion, the AEC's Division of
Biology and Medicine, headed by Shields Warren, declared "that human
experimentation at the present time is not indicated." Moreover, the AEC also
stated that such experiments "would have serious repercussions from a public
relations standpoint, particularly if undertaken by an agency that has to do a

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portion of its work in secret." If data were needed, the DBM concluded, they
could be obtained from the sources cited by the ad hoc committee.53 The AEC
position spelled the end of the DOD's request to do radiation exposure
experiments on healthy people, and roughly coincident with the rejection of this
proposal, the DOD contracted to gather data from cancer patients receiving TBI
treatments.

POSTWAR TBI-EFFECTS EXPERIMENTATION:
CONTINUED RELIANCE ON SICK PATIENTS IN PLACE OF
HEALTHY "NORMALS"

In October 1950, the Air Force entered into a contract with the M. D.
Anderson Hospital for Cancer Research in Houston, Texas, to provide the DOD
with data obtained from TBI studies on cancer patients. Dr. Shields Warren, who
seemed to oppose human experimentation on healthy persons during the NEPA
debates, did not appear to have any misgivings about this project.54 By the end of
that decade, the DOD would have several contracts with TBI researchers. When,
in 1959, a DOD newsletter announced the renewal of a TBI contract between the
Army and the Sloan-Kettering Institute in New York, readers were told: "It is
hoped to make this work [by Sloan-Kettering] as well as the work of Baylor
University College of Medicine and University of Cincinnati a complete program
to provide us with answers on the human whole body radiation effects."55 The
Navy also conducted TBI-related research in conjunction with patient treatments
at the Naval Hospital in Bethesda, Maryland. All five of these studies used TBI
on many patients with radioresistant cancers. 5(' In contrast, physicians at the
AEC's hospital in Oak Ridge operated by the Oak Ridge Institute of Nuclear
Studies (ORINS), a university-based consortium, chose to perform TBI only on
patients with radiosensitive diseases. In each project, the research institutions
accepted the dual purposes of treating the patients' illnesses and collecting and
analyzing postexposure information for the military.

The DOD-funded experiments would seek to address the three main
questions the military wanted answered: How do different doses of radiation
correlate with the acute effects? How do different doses of radiation influence
psychological effects? And most important, is there a way to find a biological
dosimeter to measure how much radiation someone has received? The military
was also interested in the diagnosis and treatment of radiation injuries. One
reviewer of the initial Cincinnati proposal described the interest in finding a
biological dosimeter: if "accurate knowledge of the total dose of radiation
received could be determined it would be of inestimable value in case of atomic
disaster or nuclear warfare."57

When the DOD contracted with medical professionals to perform
additional research on their patients receiving TBI, it is not clear whether
department officials believed that the TBI itself should be covered by the ethical

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standards being established for "human experimentation" following the
Nuremberg trials. For example, in the NEPA debates, Dr. Robert Stone
distinguished experiments, which involved healthy persons such as the prisoners,
from studies, which involved sick patients. 5* Did Stone mean by this that patients
receiving treatment did not need to give informed consent, while healthy subjects
should? The AEC, for example, took the view that the consent standards should
apply to patients. Indeed, as we saw in chapter 1, AEC General Manager Carroll
Wilson wrote in a 1 947 letter to Robert Stone that "the patient [must] give his
complete and informed consent in writing."59

In 1953, Secretary of Defense Charles Wilson issued a memo establishing
the Nuremberg Code as DOD policy. The Wilson memo required that all
experimental subjects sign a statement that explained "the nature, duration, and
purpose of the experiment; the method and means by which it is to be conducted;
all inconveniences and hazards reasonably to be expected; and effects upon his
health or person which may possibly come from his participation in the
experiment." Unlike the AEC's 1947 pronouncements, the 1953 Wilson memo
did not explicitly refer to patients. In addition, if DOD officials believed that the
experiments they were sponsoring did not include the administration of the
radiation, but only the collection of postradiation biochemical and psychological
data, then they might have interpreted the Wilson memo as applying only to the
postexposure testing, not to the radiation treatments.

Although the Wilson memo was classified, its requirements were
reiterated by the surgeon general of the Army in a 1 954 document that was
transmitted to at least some university contract researchers. The Committee found
no evidence that this memo was transmitted to the TBI contractors in particular.
As discussed in chapter 1, in 1952 Congress had passed legislation that provided
for Defense Department indemnification of private contract researchers in cases
where human experiments resulted in injury to subjects.60 As we have seen, the
DOD appears to have linked the requirements of this statute to contractor
adherence to the principles stated by the 1 954 Army surgeon general memo,
including written consent of the subject. For example, in a March 1957 letter to
the University of Pittsburgh, which was proposing to use medical student-
volunteers in a (nonradiation) experiment, the Army stated that the
indemnification provision in the contract was "contingent upon your adhering to
the following [March 1954 Office of the Surgeon General] principles, policies,
and rules for the use of human volunteers in performing subject medical research
contracts."61 Although this indemnification provision was in the contract of at
least one of the five institutions that conducted DOD-sponsored TBI-effects
research,62 no available information indicates that its inclusion demanded
adherence to the principles set forth by the surgeon general. Nonetheless, at least
three of the institutions had written forms authorizing the radiation treatment
procedure, although the forms did not explicitly spell out all of the risks and

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benefits of the additional experiments. This chapter will now review what is
known about the five DOD-sponsored experiments.

M. D. Anderson Hospital (Houston, Texas)

The Air Force's School of Aviation Medicine (SAM) contract with M. D.
Anderson Hospital for Cancer Research, in association with the University of
Texas Medical School, declared that the Air Force was willing to use sick patients
for the needed data because "human experimentation" had been prohibited by the
military:

The most direct approach to this information would
be by human experiment in specifically designed
radiation studies; however, for several important
reasons, this has been forbidden by top military
authority. Since the need is pressing, it would
appear mandatory to take advantage of investigation
opportunities that exist in certain radiology centers
by conducting special examinations and measures
of patients who are undergoing radiation treatment
for disease. While the flexibility of experimental
design in a radiological clinic will necessarily be
limited, the information that may be gained from
the studies of patients is considered potentially
invaluable; furthermore, this is currently the sole
source of human data.63

The M. D. Anderson TBI-effects study extended from 1951 to 1956 and
involved 263 cancer patients.64 M. D. Anderson had a well-established and
ongoing radiation treatment program. The project began at the same time that M.
D. Anderson received the first cobalt 60 teletherapy unit developed by the AEC's
Oak Ridge Institute of Nuclear Studies (ORINS). The M. D. Anderson study
involved three phases beginning with low doses— 15 to 75 R— and gradually
increasing to a maximum of 200 R. The patients in the first group were "in such a
state that cure or at least definite palliation could still be expected from established
methods of treatment [in addition to the TBI]."65 Based on these results, the
researchers then moved to the second phase, which involved doses ranging from
1 00 to 200 R. The researchers noted that this greater possible risk necessitated
"the selection of patients whose disease had advanced to such a state that, in
general, significant benefit could not be expected from conventional procedures
other than systemic ones."66

The final phase involved thirty patients, all of whom had radioresistant
carcinomas for which "cure by conventional means was regarded as completely

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hopeless."67 These thirty received the highest doses, 200 R, and reportedly "knew
about the advanced state of their disease and the experimental nature and possible
risks of the proposed radiotherapy."68 The Advisory Committee has found no
written documentation on what types of risks were described to and understood
by these patients. Beginning in 1953, patients signed a release form authorizing
the physicians to administer "x-ray therapy, radium and radioactive isotopes, . . .
which in their judgment they deem necessary or advisable, in the diagnosis and
treatment of this patient."69 This form was designed apparently to waive legal
liability, but did not inform the patient of the risks and benefits of treatment and
thus did not meet the other requirements established by the 1953 Wilson memo.

With respect to the biomedical findings, a 1954 Air Force review noted
that M. D. Anderson had obtained positive preliminary results by finding a
biological dosimeter in the blood. However, one of the reviewers commented that
because "the patients were not normal people the changes could very well be the
effect of the radiation on the abnormal tissue."70 The review noted that an effort
earlier in the study to find a marker in patients who received repetitive small
doses of radiation, similar to what might occur on repeated NEPA flights, was not
successful; accordingly, the researchers looked for it in patients who received
larger doses in single exposures.7'

An additional aspect of the M. D. Anderson study was the mental and
psychomotor tests that most of the patients were subjected to before and after
receiving TBI. (The patients reportedly participated "by their own consent and
judgment of the hospital staff."72) They performed three tests related to the skills
required for piloting aircraft. But the value of testing the abilities of extremely ill
patients as a measure for the performance of highly fit pilots was doubtful to the
Air Force.73 In an attempt to lessen this problem, the investigators sought
outpatients who were in reasonably good physical and mental condition.74
Nonetheless, because patients received TBI radiation doses according to the
severity of their disease rather than from an arbitrary experimental protocol, there
was difficulty in determining whether the performance changes noted resulted
from the underlying disease or the radiation.75

The M. D. Anderson researchers found medical benefit in three of thirty
patients who received 200 R:76 "200 [roentgens] whole-body x-irradiation
produced a definite transitory amelioration of the disease in 3 cases, and a
questionable improvement in several additional patients."77 The study concluded
that "the threshold dose, beyond which in a small percentage of patients severe
complications begin to appear, lies somewhere between 150 and 200 r."7S This
conclusion seems to have moved the threshold tolerance level for acute effects
slightly higher than the 1950 level; at that time the AEC's ad hoc NEPA
committee had decided that doses above 150 R would pose "grave risks" to
troops.

There is very little information concerning subject selection. It appears
that many of the patients were indigent members of minorities, although no

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information is available to determine whether the ratio of minorities differed in
relation to the general hospital population. In the context of an Air Force
discussion about the costs of the study, one report noted that "there is some racial
problems [sic] involved with colored patients and the colored out-patient
maintenance facilities were located in another part of the city and, therefore, it
would be difficult to have them transported back and forth to the hospital for
testing. . . . Colonel McGraw stated that if we are paying for the maintenance of
indigents of the State of Texas with research funds, and the State is also paying
for the maintenance of those patients, there could be some difficulty. . . ,"79
Another report stated that "language barriers, both of degree and kind," caused
problems in the testing of cognitive functions as part of the psychomotor study.80

Several years later, researchers at the School of Aviation Medicine and the
University of Texas issued a report comparing the effects of radiation based on
TBI treatment of eleven patients (most of whom had radiosensitive diseases) with
the M. D. Anderson group. The researchers used the data to report on the civil
defense implications that would result from mass exposures to doses between 150
and 200 R. They concluded that 60 percent of the people would experience
varying degrees of disability from acute radiation sickness that would cause
fatigue, nausea, and vomiting for the first twenty-four hours.8 '

TBI-Effects Studies at Baylor University College of Medicine, Memorial
Sloan-Kettering Institute for Cancer Research, and the U.S. Naval Hospital
in Bethesda

Within a few years after the Air Force's M. D. Anderson program began,
the Army funded two TBI-effects programs with leading cancer centers, both of
which appear to have been using TBI to treat radioresistant cancers even before
receiving the Army contract. The studies began before M. D. Anderson had
published any of its findings.

From 1954 to 1963, Baylor University College of Medicine in Houston,
Texas, performed TBI on 1 12 patients (54 of whom had radioresistant cancers)
during the military study; doses ranged from 25 to 250 R, and a 2-megavolt (MV)
machine was used in place of a 250-KV machine after the first two years.82 The
principal researchers, Drs. Vincent Collins and Kenneth Loeffler, again sought a
biological dosimeter and data on the acute effects of radiation.83 The researchers
noted that even though a significant amount of data had been amassed on
radiation effects, no one had been able "to establish clear and dependable
relationships with precise physical data."84 There is no discussion of consent or
peer review in any of the twelve available reports or published papers currently
available.

The Baylor researchers recognized the same problem that confronted M. D.
Anderson: that seeking data from sick patients who require therapeutic TBI
treatments may be in conflict with an optimal experimental design.85 They also

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noted the problems with giving "last-resort" treatment of this kind:

When patients are referred as a "last resort," the
radiotherapist does not wish to withhold treatment
that may offer possible benefit but he cannot be
certain that the benefit will outweigh the risk. The
risk is not that the patient will die but that the
undesirable effects of radiation [i.e., bone marrow
suppression] will appear more severe in the terminal
cancer patient and that the time of death may be
destined to coincide with the undesirable effects of
radiation.86

They concluded that for patients, radiation sickness may be avoided for doses up
to 200 R by administering proper care (the researchers suggested that nausea and
vomiting for some patients may have been caused by the power of suggestion).87
They then hypothesized that "with correct information and proper preparation,
normal healthy individuals could tolerate even higher exposures without undue
incapacitation."88 Efforts to find a biological dosimeter were said to be
unsuccessful because the pool of patients was too small and many either died or
were unable to tolerate the necessary tests.89

From 1954 to 1961, Dr. James J. Nickson of the Memorial Sloan-
Kettering Institute for Cancer Research in New York City performed TBI on
more than twenty patients with doses ranging from 20 to 150 R and participated
in a DOD study on the acute effects of radiation on humans.c)0 Again, the military
aims were to find a biological dosimeter and better understand the effects of
radiation.91 Sloan-Kettering was a leading U.S. cancer research center and had a
long history of using and experimenting with TBI. The patients selected at Sloan-
Kettering had a variety of radioresistant and radiosensitive cancers and were in
"relatively good condition."92 However, patients with kidney, liver, or bone
marrow impairment were deliberately excluded from the study because their
conditions would "contaminate" biological dosimeter data (the record does not
indicate whether these patients who were excluded still received TBI). There is
no mention in the currently available records regarding consent of the patients or
any form of peer review of the protocol or the experiments.

Between 1959 and 1960, the Navy treated seventeen patients using TBI
for a variety of radioresistant and radiosensitive disorders at the Naval Hospital in
Bethesda, Maryland, with a cobalt 60 teletherapy unit.93 The report on these
treatments concluded that "total-body radiation therapy in a dose range of 100-
400 [roentgens] [air dose] appears to offer relatively safe and reasonably effective
palliative therapy for advanced radiosensitive disease."94 There was no equivalent
success on the radioresistant tumors. Urine from some of the patients was
collected and retained for analysis to see if there was any amino acid change that

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corresponded to the radiation exposure received by patients, as part of another
attempt to identify a biological dosimeter in the urine. The investigators of the
urine study could not find any direct correlation between the dose of radiation and
biochemicals in the urine, and they acknowledged that the poor state of health of
the patients, as well as age, nutritional state, and renal function changes, may
have contributed to this problem.95

Surviving patient records indicate that the Naval Hospital used an
authorization form, which states that the patient "hereby consents] to the
performance . . . of total body radiation therapy. This procedure has been fully
explained to me by a staff physician of the Department of Radiology."96 There is
no information available to determine if patient permission was or was not given
for the collection of urine for evaluation as a biological dosimeter or if the
biological dosimeter project had any effect on the patients' treatment. Neither is
any information currently available on whether the patients were informed about
the additional military research interest in the project, or whether there was any
form of review of the project as required by Navy procedures.

The early postwar TBI researchers, such as those at M. D. Anderson, may
have been enthusiastic to test the new cobalt 60 teletherapy TBI technology on
cancers that resisted older TBI techniques, but by the end of the 1950s the new
technology did not appear to be producing any more favorable results on
radioresistant cancers. Dr. Shields Warren seemed to confirm this view in a 1959
article in Scientific American; he noted that "radioresistant tumors are generally
not treated with radiation because the damage to surrounding tissue is too great."97

However, in March 1960 the Defense Atomic Support Agency (DASA)
sponsored a conference on the effects of whole-body radiation on humans. A
DASA summary of the meeting reported: "First, experience at the dosage levels
up to 200 r indicates that man is able to tolerate far greater radiation dosages than
was predicted in the NEPA report of 1949; second, there is a need for
continuation of this work and, more important, investigation and analysis of the
radiation syndrome in man up to the 300 r level, is the next logical area of
study."98 Indeed, DASA had just signed a contract with the University of
Cincinnati to provide information on the effects from these higher doses of TBI.

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The University of Cincinnati College of Medicine--the Last DOD-Sponsored
TBI-Effects Study

The University of Cincinnati (Cincinnati) was the last institution that the
Department of Defense contracted with to collect information on radiation effects
from patients exposed to total-body irradiation. From 1960 to 1971, Dr. Eugene
L. Saenger and a team of medical researchers from the university's College of
Medicine (referred to in this chapter as the "Cincinnati doctors")99 conducted TBI
and partial-body irradiation (PBI) on approximately eighty-eight cancer patients.
Cincinnati was the only nonmilitary research institution in the DOD program that
did not have preexisting clinical experience with TBI therapy.100 It was also the
only institution using TBI to focus almost exclusively on patients with
radioresistant cancers (except for three children with Ewing's sarcoma, a
childhood bone cancer for which widespread irradiation is still considered an
accepted form of treatment.)101 The military contract was, as before, to obtain
more information on the acute effects of radiation and to find a biological
dosimeter.

The University of Cincinnati experiments came to public attention in
1971, a time in the national debate over the Vietnam War when university
associations with the military were being questioned by students, the press, and
the public. Research by Roger Rapoport, who subsequently wrote a book entitled
The Great American Bomb Machine, led to a story in the Washington Post on
October 8, 1971, that described the Department of Defense contract with the
University of Cincinnati to measure radiation effects in humans.

It appears that by 1971 the University of Cincinnati was the only
remaining institution doing post TBI-effects studies for the Department of
Defense. The publicity prompted the University of Cincinnati to hold a news
conference on October 11, 1971, to explain its TBI program. The public attention
resulted in three investigations of the Cincinnati experiments, all of which
reported their findings in January 1972: ( 1) a January 3, 1972, American College
of Radiology report in response to a request by Senator Mike Gravel (the ACR
report),102 which was generally supportive of the program; (2) a January 1972 Ad
Hoc Review Committee of the University of Cincinnati Report to the Dean of the
College of Medicine on "The Whole Body Radiation Study at the University of
Cincinnati" (the Suskind report),103 which probed the facts and supported the
overall objectives of the study; and (3) a January 25, 1972, "Report to the Campus
Community" of the Junior Faculty Association of the University of Cincinnati
(the JFA report),104 which severely criticized the TBI program. Following these
reviews, the president of the University of Cincinnati decided not to renew the
DOD contract in the spring of 1972. The use of TBI was suspended after that
time, and the effects study was ended. As recently as April 1994 in a
congressional hearing, an ACR representative reiterated its belief that the
Cincinnati project was reasonably conducted based on the standards of the time,

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even if "one might judge them harshly from a perspective 20 years later."105
Because of this public attention, a substantial number of documents
concerning the University of Cincinnati experiments were preserved, including
the original application and subsequent progress reports by the researchers for the
Department of Defense, records of the Faculty Committee on Research (the
Cincinnati IRB) review of a midcourse research protocol, relevant medical
literature, and certain patient medical records. In addition to reviewing these
documents, the Advisory Committee staff also interviewed Dr. Eugene Saenger,
the principal investigator of the study; and the Committee and staff met with and
heard from numerous patient family members and other critics of the Cincinnati
experiments. The Advisory Committee also held a public hearing in Cincinnati
on October 21, 1994, where more than thirty family members and other interested
parties related their concerns about what they believed was wrong with the
Cincinnati TBI experiments, chiefly that informed consent was inadequate. Other
family members have appeared before the Advisory Committee at another public
hearing in Knoxville, Tennessee, and at the Advisory Committee's meetings in
Washington, D.C. The Committee also heard public testimony from Dr. Bernard
Aron, a coresearcher of Dr. Saenger, and heard from counsel for Dr. Saenger and
others involved in pending litigation.

What Was the Purpose of the University of Cincinnati TBI Program?

The experimenters were supported by the military to find a biological
dosimeter and provide additional human performance data of military interest.
There is no question that the patients were seriously ill with terminal cancers;
indeed, many received other forms of treatment in addition to TBI, including
surgery, chemotherapy, and localized radiation. Although there is no indication
that the Defense Department had any direct role in patient selection or treatment,
there have been questions raised publicly as to whether the military interest
influenced or at all compromised the physicians' willingness to objectively
present reasonable treatment options (including no treatment at all) to these
cancer patients. Thus, the Advisory Committee has sought to determine what
effect, if any, the DOD contract requirements had on the actual treatment of
patients.

In 1958 Dr. Saenger applied to the Department of the Army for funding of
a research proposal entitled "Metabolic Changes in Humans Following Total
Body Radiation."106 (Dr. Saenger had joined the radiology department of the
University of Cincinnati College of Medicine in 1949 and became the director of
its Radioisotope Laboratory in 1950, serving until 1987. Before and after starting
the TBI program, he was a consultant in radiology to the Army, the Air Force, the
AEC, DASA, and the PHS.)107 The primary purpose of his proposal was to
determine whether amino acids or other biochemicals in the urine could "serve as
an indicator of the biological response of humans to irradiation."108

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Later, the first of approximately ten progress reports to DASA described
the purpose of the research program it was funding as "to obtain new information
about the metabolic effects of total body and partial body irradiation so as to have
a better understanding of the acute and subacute effects of irradiation in the
human."109 The second progress report added that "this information is necessary
to provide knowledge of combat effectiveness of troops and to develop additional
methods of diagnosis, prognosis, prophylaxis and treatment of these injuries.""0
The study would focus generally on post-TBI effects in patients with
radioresistant carcinomas; those with radiosensitive lymphomas and other
hematological diseases were for the most part not included, with the exception of
the children with Ewing's sarcoma.1" Dr. Saenger reported to DASA in 1962 that
the further studies would be conducted "so long as the following criteria are
fulfilled: 1. There is a reasonable chance of therapeutic benefit to the patient. 2.
The likelihood of damage to the patient is no greater than that encountered from
comparable therapy of another type. 3. The facilities for support of the patient
and complication of treatment offer all possible medical services for successful
maintenance of the patient's well being.""2

Midway into the study, the post-TBI-effects researchers added a program
of psychological and psychiatric testing, to determine "whether single doses of
whole or partial radiation produce any decrement in cognitive or other functions
mediated through the central nervous system.""3 They also recorded data on the
incidence of nausea and vomiting from radiation. Within the first three years, the
Cincinnati doctors reported to the DOD the information that the March 1960
DASA conference had sought, that "[h]uman beings can tolerate doses of 200 rad
(300 r) relatively well as far as combat effectiveness is concerned.""4

In 1973, two years after their work terminated, the Cincinnati doctors
published a journal article describing the purpose of their irradiation study as "to
improve the treatment and general clinical management and if possible the length
of survival of patients with advanced cancer.""5 Unfortunately, no written
research protocol now exists for this treatment study, nor did Dr. Saenger state
that they had a written protocol while carrying out the TBI palliation treatment
study. This lack of a written protocol is consistent with the confusion doctors had
at this time (and to a lesser extent today) distinguishing what constituted research
from what constituted innovative treatments (see chapter 2).

The clinical objective of the Cincinnati TBI treatments remains difficult to
categorize precisely even now. Dr. Saenger stated in a 1994 interview with
Advisory Committee staff that there was no need for an experimental treatment
protocol because the TBI treatments were given as a palliative cancer therapy for
people for whom there was no better alternative."6 In contrast, the Suskind and
ACR reports seem to have assumed that the TBI treatments were experimental;
they both describe them as being in "Phase II" of a standard three-phase
experimental process."7

Because the Cincinnati doctors recognized that higher doses of TBI (150

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rad and above) were causing severe bone marrow suppression in some of the
patients, beginning in 1963 they sought to develop countermeasures through the
use of bone marrow transplants. Over a six-year period, they instituted a program
to remove bone marrow from the patient prior to the radiation and to reinfuse it
afterward so as to counter any deleterious effect. In 1 966, they submitted a
protocol on bone marrow transplantation to the College of Medicine's
institutional review board, which provisionally approved it in 1967. However, the
use of high-dose TBI continued during this time, with the first successful
transplant being administered in 1 969.

Critics have suggested that the irradiation of the patients who were
subjects of the Cincinnati experiments may not have taken place at all in the
absence of DOD funding. The TBI regimen did not begin until after the DOD
funds were secured in 1960. The DOD provided a total of $651,482 for the TBI-
effects study. In addition to the DOD funds, Dr. Saenger has estimated that the
hospital spent $483,222 on patient care."8 Dr. Saenger has stated that he was
very careful to separate the DOD work from the patient care and to make sure that
the DOD funding was in no way used for the patient therapy."9 For this reason,
he states that he was never personally involved in patient selection or treatment,
in order not to influence the judgment of the attending physicians.'20

When asked if TBI treatment could have begun before the DOD money
arrived, Dr. Saenger said: "No, we had to, we hired some people. We had
laboratory equipment to set up It proceeded as one, as really a sort of a two-
pronged investigation."121 Dr. Saenger stated that the work for the DOD "started
when we started [administering TBI]~this [DOD] protocol permitted us to get a
technique going in trying to look at whole body radiation in comparison with
other forms of palliation."122 Dr. Saenger also said that "if we had found in the
first ten or twelve patients a clear biochemical indicator, we possibly would have
done something else. We kept being on the edge of finding what we were looking
for so we kept on treating the patients."123

In the 1 969 proposal to renew the DOD contract, Dr. Saenger wrote that,
in light of "world tensions from the possibility of nuclear warfare on any scale . . .
it is necessary to pursue with increased diligence the scientific investigations of
acute radiation effects and the attendant treatment possibilities in the human
being." In outlining a plan to compare total-body, partial-body, and trunk and
thorax irradiation, the proposal noted that in most cases bidirectional radiation
would be used for each of these treatments, but that "whenever possible
unidirectional radiation will be attempted since this type of exposure is of military
interest."124 There is no available evidence to show that the Cincinnati doctors
ever actually used unidirectional' radiation.

The military's interest in the onset level for the acute effects of radiation,
such as nausea and vomiting, led the Cincinnati doctors to intentionally withhold
from the patients, as discussed later in the chapter, any premedication or
information about these effects for the first three days after irradiation in order not

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to induce them via psychological suggestions. No mention was made of nausea
or vomiting in any of the consent forms.

To the extent that palliation of cancer symptoms was the goal of the
Cincinnati doctors, TBI presumably would have been given either as part of a
planned experimental protocol or as conventional clinical therapy. If the former,
then the currently available evidence indicates rather poor scientific design, even
by contemporary standards; if the latter, then the TBI treatment administered for
the vast majority of patients was nonstandard therapeutic practice for patients
with radioresistant carcinomas at that time.

Institutional Review

Department of Defense

The Army Research and Development Command review of Dr. Saenger's
proposal in 1958 was limited to an evaluation of the usefulness of the proposed
work to the military. One Army medical officer wrote that there are "so few
radiobiologists in the country willing to do total body radiation that those that are
should be encouraged." The proposal should be approved even though there was
"very little hope that [this study] will result in practical data. As is pointed out in
the proposal, a number of people have looked at the problem and the levels vary
widely and there appears to be no consistency. A great deal of work has been
done in animals, again without consistent findings." The reviewer hoped that the
researchers "will soon decide that some other phase of the radiation program
should be investigated and switch to this."125

Another reviewer noted that Saenger's study would "augment work being
done by Dr. Collins at Baylor and the Sloan-Kettering Institute who are working
with humans."126 This point was reiterated when the contract was approved, at
which point the approving officer declared that "diversification is required to
achieve adequate results in a field of whole body radiations [sic] in humans."127 A
third reviewer noted that correlating tumor response to total dose of irradiation
"would be of great value in the field of cancer . . . [and] in case of atomic disaster
or nuclear accident."128

There is no indication that the Army reviewers considered whether any
therapeutic benefits to the patients outweighed the risks that the TBI treatments
might pose. These reviewers seemed to have based their support for funding this
proposal on the military's need for collaborative researchers and the reputation of
the applicant, rather than on the substance of the science within the application or
their knowledge of radiation therapy practice at that time.

There is no evidence that the DOD reviewed the treatment of the patients
as the study progressed, even though the University of Cincinnati appears to have
been the only federally funded institution in the country that was treating
radioresistant carcinomas with total-body irradiation at that time. The Cincinnati

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doctors administered doses up to 250 rad, and had indicated in their first DASA
progress report that they planned to go up to 600 rad,129 without seeming to raise
any concerns within the DOD contract office.

University of Cincinnati

As was customary at the time, there was no formal review of the TBI
proposal within the University of Cincinnati when it was initially submitted to the
DOD in 1958. The University of Cincinnati established an institutional review
board, known as the University of Cincinnati Faculty Committee on Research
(FCR), in 1964. (IRBs were just beginning to be formed at this time and did not
become formalized in most institutions until several years later, nor were they
required as a condition of government funding until 1974.)

Subsequent internal reviews by Cincinnati committees raised several
concerns. In March 1966, Dr. Saenger and a colleague submitted a protocol
entitled "Protection of Humans with Stored Autologous Marrow" to the
University of Cincinnati FCR. This proposal was considered an adjunct to the
TBI treatments, which Saenger said he did not consider an experiment, and was
therefore not subject to review.130 Some members of the FCR, however, raised
concerns that attended to the underlying TBI treatments. These questions
included whether each patient was advised that "no specific benefit will derive to
him," the need for a more detailed description of the potential hazards, and
whether the irradiation would "influence the morbidity or the mortality in these
patients."131

The proposal was revised and resubmitted on March 1 967 under the title
"The Therapeutic Effect of Total Body Irradiation Followed by Infusion of Stored
Autologous Marrow in Humans." A five-person FCR subcommittee reviewed
the proposal. One member, Dr. George Shields, recommended that the study be
disapproved because "the radiation proposed has been documented in the author's

own series to cause a 25% mortality I believe a 25% mortality is too high,

(25% of 36 patients is 9 deaths) but this is of course merely an opinion." Shields
added that if the study were to be approved, then his concern could be addressed
by improving the consent process-that is, by ensuring that "all patients are
informed that a 1 in 4 chance of death within a few weeks due to treatment exists,
etc."'32 Another member, Dr. Thomas E. Gaffney, initially recommended
disapproval for several reasons, including the "considerable morbidity associated
with this high dose radiation,"133 but he subsequently recommended approval
along with Dr. Harvey Knowles, Dr. Edward Radford, and R. L. Witt. The
proposal was then given "provisional approval" on May 23, 1967. The
requirements did not include Shields's recommendation on mortality, but did
stipulate that "the protocol should be modified to indicate that the exclusive
purpose of the study is to determine the therapeutic efficacy of whole body
irradiation."134 There is no written evidence as to whether the FCR ever re-

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reviewed and approved the revised protocol or the new consent forms that the
investigators produced in response to this review.

In 1 970, the FCR reexamined the bone marrow protocol because it had not
been reviewed since it received provisional approval in 1967. Following two
protocol revisions intended to meet the committee's concerns, the FCR noted that
it still could "not find adequate methods of evaluation in this study protocol. . . .
The real problem seems to be how are we going to evaluate the effectiveness of
marrow transplants in protecting against the side effects of total body irradiation.
Secondly, how are we going to evaluate the effectiveness of total body
irradiation."135 Nonetheless, after yet another revision, the protocol was approved
on August 9, 1971.

In April 1972, Dr. Edward Silberstein, a colleague of Dr. Saenger,
submitted a protocol to the FCR entitled "Evaluation of the therapeutic
effectiveness of total and partial body irradiation as compared to chemotherapy in
humans with carcinoma of the lung and colon."136 This presumably was to be the
next experimental phase of the ongoing TBI work, for which an NIH grant was
also contemplated. But that same month, the president of the University of
Cincinnati refused to allow continued DOD funding for the post-TBI treatment
data collection and analysis following the negative public attention brought to the
study. TBI was suspended pending FCR review. Dr. Silberstein's protocol was
approved by the university's FCR in August 1972 as a grant application to the
NIH's National Cancer Institute.137 However, in February 1973 the NIH elected
not to fund the proposal.

National Institutes of Health

The TBI research was incorporated into a general research grant that the
NIH funded beginning in 1966. According to Dr. Evelyn Hess, chair of the FCR,
writing in 1971:

Background to Grant Approvals: This research had,
of course, been submitted to the DOD initially with
yearly reports since the initiation of the project.
The entire total body irradiation protocol, including
all the therapeutic, metabolic, chemical,
hematologic, immunologic, and psychologic studies
was incorporated as one of the components for the
General Clinical Research Center (GCRC) grant
submitted to the NIH in 1966. There was a site visit
and counsel visit on this grant application and many
aspects of the radiation project were presented to
the scientific review committees. This NIH grant
was given full approval and was funded. It came up

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for renewal in 1970, and again all aspects of the
radiation study were incorporated. This grant also
had full approval by the NIH.I3X

However, a 1 969 internal FCR memorandum from the then-chairman of
the Cincinnati FCR, Dr. Thomas Gaffney, noted that the NIH had rejected a
University of Cincinnati grant application for TBI research "on ethical grounds,"
even though it had been approved by the FCR: "We learned that two applications
received by NIH from this institution have been rejected on ethical grounds. Both
had been through this committee. As far as I know, neither of the principal
investigators involved were notified of the reason of the rejection by the NIH.
One of these grants was the total body radiation study in patients with
malignancy. . . ."139

In 1974, D. T. Chalkley, then chief of the NIH's Office for Protection of
Research Risks, vigorously responded to a magazine article criticizing the
Cincinnati experiments. Chalkley stated that "none of the patients involved died
from radiation sickness. ... In all instances, death was clearly attributable to the
advance of cancer, or to intercurrent disease associated with advanced cancer."'40

Risk of TBI on Mortality and Morbidity

The risks associated with total-body irradiation were reported by all of the
previous DOD-sponsored TBI research institutions and were known to the
Cincinnati doctors. Midway into the program, the Cincinnati doctors
acknowledged that the TBI treatments posed a risk of death: "bone marrow
suppression was the most life threatening radiation effect at the doses used."141 In
their 1966 report to the DOD, they noted that the general response of the first fifty
patients was that their "total white count falls to a low point 25 to 40 days after
irradiation. There was lymphopenia [low white blood cell count] which persisted
for 40 to 60 days."142 The same report stated that "severe hematologic depression
was found in most patients who expired."143 Although the efforts by the
Cincinnati doctors to employ bone marrow transplantation in response to this
problem did not succeed until 1969, they continued to administer TBI without
bone marrow transplantation throughout the six-year interim period: thirteen
patients received doses of 150 or 200 rad TBI (including five on whom
autologous marrow infusion was attempted but did not succeed); nine of these
patients died between twenty-five and seventy-four days after being irradiated,
and the other four survived longer.144

Some relatives of deceased TBI patients contend that their relatives may
not have been as seriously ill as the reports claim. While all patients had
advanced cancer (indicated either by the presence of metastatic or locally
advanced tumors) and thus could be considered "end stage" in terms of unlikely
curability, they were clearly not all "near death," in that family members reported

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some of the patients feeling well enough to carry on normal activities of daily life
(e.g., holding down jobs, caring for children) until the day they received the TBI.
Patient status reports written by the Cincinnati doctors seem to bear out this view.
For example, the first seventeen patients were described as all having "incurable
and/or metastatic cancer . . . although in reasonably good clinical condition
[emphasis added]."145 Similarly, the 1969 DASA report states that the patients
"have inoperable, metastatic carcinoma but are in relatively good health
[emphasis added]."146 The 1970 DASA report states that the studies conducted
during the prior year "were all performed on ambulatory human subjects . . .
[who] were all clinically stable, many of them working daily [emphasis
added]."'47 This report also noted the "comparatively better physical condition of
these new subjects" and went on to state that "only three of our 1 1 new patients
died in less than 100 days following irradiation. This was in sharp contrast to the
almost 50 percent low survival rate for earlier years in this study,"148 when lower
radiation doses had been administered.

Although the Advisory Committee has received some partial patient
hospital records, it has not analyzed the records of every patient, which would be
required to determine if any deaths could be attributed to the TBI alone, or if such
conclusions could be reached at all from the data currently available. (The
Committee did not have the time or resources to review the individual files of
every patient from this and the numerous other experiments that it has
investigated.) Contemporaneous reports, however, state that TBI treatments may
have contributed to the deaths of at least eight and as many as twenty patients.
The Suskind report, for example, said that "19 died within 20-60 days and
possibly could have died from radiation alone," but noted that bone marrow
failure was found in only eight at the time of death.149 (An additional death
occurred six days after irradiation to a patient under anesthesia in the course of a
bone marrow transfusion to support the TBI, bringing the number to twenty.) The
Suskind report also stated that "there is absolutely no evidence that whole body
radiation shortened the period of survival of the treated patients," referring,
apparently, to the statistical "survival rate" of the entire group of patients.150
Similarly, the 1972 ACR report associated the death of eight patients to the fact
that "the bone marrow function was subnormal and thus relatable to radiation
syndrome." The ACR report also noted that "it is not possible to determine
positively that those patients who died within 60 days of the treatment would not
have succumbed to their disease within that period, even though the clinical
assessment had been that their disease was stable enough to justify their inclusion
in the study. "'51

Similarly, following the completion of their study, the Cincinnati doctors
wrote that "if one assumes that all severe drops in blood cell count and all
instances of hypocellular or acellular marrow at death were due only to radiation
and not influenced by the type or extent of cancer and effects of previous therapy,
then one can identify 8 cases in which there is a possibility of the therapy

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contributing to mortality."152 In 1994 Dr. Saenger wrote:

It is important to realize that in any given patient it
is not possible to determine objectively whether
death occurred too soon or was prolonged as a
consequence of treatment. The only way that an
estimate can be made is to compare the length of
survival of a group of patients with the same tumor
and extent of tumor treated by radiation to a group
of patients with the same tumor and extent of tumor
treated by different methods.153

The attempt by the Cincinnati doctors in their 1 973 article to compare
survival rates for their TBI patients with the statistics from other published
reports'54 is problematic for a number of reasons: first, the comparisons were not
controlled for known prognostic factors, such as age, tumor subtype, and stage;
second, comparisons with external and historical comparison groups are easily
confounded by unmeasured characteristics, such as differences in patient
populations and trends in prognosis over time; and third, survival from time of
irradiation (some considerable time after diagnosis) in the TBI series is compared
to survival from diagnosis in the published series, without using appropriate
survival analysis methods. A more meaningful comparison would have been
between subgroups of the patients receiving different doses of radiation,
preferably including a concurrent unexposed chemotherapy group, adjusting for
the interval from diagnosis to the time of death and other relevant prognostic
factors. Although limited statistical data were made available to the Advisory
Committee, they were not adequate to allow meaningful statistical analysis, and it
was not feasible for us to abstract the necessary data from the charts. The
Suskind report stated that "before 1966 the design of the study to measure
palliation was unstructured and not uniformly applied, particularly as regards
uniform definitions and methods of reporting."155 The report also noted that "it is
uncertain whether this study and similar studies reported in the medical literature
are truly comparable in all major factors that influence survival, such as selection
of patients and ancillary medical management. Therefore, the significance of
comparisons of survival rates is doubtful, unless marked differences are found."156

The nature of the DOD-sponsored research raises additional concerns as to
whether patients were subjected to unnecessary discomfort without full disclosure
of experimental purpose or prior consent. In order to collect data on certain side
effects of radiation for the military, the patients were not premedicated or
informed of potential acute side effects of TBI such as nausea and vomiting so as
not to induce these effects psychologically.157 Patients were to be treated to
relieve their symptoms if they affirmatively requested medication. In contrast,
researchers at the City of Hope Medical Center conducting a purely clinical TBI

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study (from 1 960 to 1 964) gave antinauseant medication to all patients who
received 40 or more rad within one hour prior to being irradiated to alleviate
possible side effects. I5S

Informed Consent

There is no indication that the DOD ever informed the Cincinnati doctors
about the secretary of defense's 1953 Nuremberg Code directive or any
subsequent Army implementation of the directive. It is not clear what patients (or
family members) were told about the TBI program in the early years of the
experiments, because written consent forms were not standard practice at that
time. During the later years of the program, written consent forms were
employed, but they have been criticized for not clearly stating all of the risks
involved.159

Written consent forms were first produced and used in the experiments in
1965, two years before they were required by the University of Cincinnati review
committee and NIH;160 the form was revised twice thereafter. According to the
Cincinnati doctors' 1973 article summarizing the study, all patients gave
informed consent in accordance with the requirements of the Cincinnati Faculty
Committee on Research and the National Institutes of Health. Although by the
end of the study the consent forms did describe the TBI procedure and its effects,
information about risks associated with TBI--nausea and possible death from
bone marrow suppression-was not included in these forms.

The first Cincinnati form, dated May 1, 1965, is entitled "Consent for
Special Study and Treatment." It states that the "nature and purpose of this
therapy, possible alternative methods of treatment, the risks involved, the
possibility of complications, and prognosis have been fully explained to me. The
special study and research nature of this treatment has been discussed with me
and understood by me."161 There was no mention in the form about the possible
risk of death from bone marrow suppression or of the possible side effects of
nausea and vomiting, which the doctors were studying and did not want to induce
by suggestion. There is no available documentation on what the patients were
told orally about the "risks involved." Because Dr. Saenger was not responsible
for recruiting or treating patients, he could not speak to what was actually said to
the patients.

In 1981, Dr. Robert Heyssel, director of Johns Hopkins Hospital,
discussed the ethical climate before the mid-1960s:

I should say that in the climate of those times . . .
that many things were done with human subjects,
including the investigator himself, which would no
longer be condoned. . . . None of these activities
had to be reviewed by anyone else in any formal

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sense within the institutions. I think this was the
situation probably up to and around 1966 in most
institutions. I am not suggesting that that was the
proper thing; I am simply saying that was the case.
In terms of experimental therapeutics, I think an
honest effort was made by most investigators to
explain to families, to patients, that what was being
done was in the range of the untried or
experimental, but there were certainly no informed-
consent rules that anyone was operating under
during that period of time up to the midsixties.162

A second consent form went into effect in 1967, following the 1967 FCR
review of the bone marrow protocol discussed above. This form listed the risks as
these: "The chance of infection or mild bleeding to be treated with marrow
transplant, drugs, or transfusion as needed." It also said that consent was for "a
scientific investigation which is not directed specifically to my own benefit, but in
consideration for the expected advancement of medical knowledge, which may
result for the benefit of mankind."163 One member of the University of Cincinnati
FCR had suggested in 1967 that the consent form should inform the patient of a
one-in-four risk of death. The 1967 FCR review of the protocol required only that
the form make clear "the danger inherent in the method and the steps intended to
protect the patient."

In 1971, a third form came into use, following the second Faculty
Committee review of the bone marrow protocol. This form expanded on the
previous form by explaining that "the bone marrow's ability to make [white] cells
will be decreased for four or five weeks after you receive your radiation. If you
receive a dose of radiation of 200 rads or more, which your doctor will tell you,
your blood counts will fall to levels where infection or bleeding could be a
problem." It also refined the previous form by describing the research as "a
scientific investigation which is not only directed specifically to my own benefit,
but also in consideration for the expected advancement of medical knowledge,
which may result for the benefit of mankind."'64 There was no mention of any
risk of death.

Beginning in 1968, patient consent was solicited over a two-day period.
Dr. Saenger described this process: "Dr. Silberstein was the person who did all
this, in that phase. He would explain to somebody the first day what the problems
were, what was going to happen, what the risks were, etc. or what the benefits
were. Then he had the patient and a representative come back the next day, the
representative could have been the patient's mother or cousin, or some family
person, or it could have been the patient's minister. And you go through the
whole thing with the minister, and the patient and family were all happy with this
desperate situation, and the signature was affixed."165 To the extent it was

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employed, this procedure appears to have been innovative and above the standard
practice of the time.

Family members of some patients testified to the Advisory Committee that
neither the patients nor their families were adequately informed about the nature
and risks of the radiation treatments. They claim that this occurred despite
multiple and persistent requests by family members to meet and discuss their
concerns with the doctors involved in administering these treatments. Family
members also told the Advisory Committee that patients were not informed about
the source of the program funding (although it should be noted that such
disclosures are still not mandatory in most institutions). 16ft The Suskind report
noted that "this information was not withheld if the patient asked about this
matter. The procedure follows the custom of every other research project in this
University."'67 The ACR report stated that "in the last few years they were told
that the information might have military as well as clinical significance."168

Subject Selection

All but five of the patients were referred into the study from either the
wards of the Cincinnati General Hospital or its Out-Patient Tumor Clinic. The
remaining five were private patients, three of whom were children treated for
Ewing's sarcoma. The Suskind report noted that fifty-one of eighty-two patients
were black (62 percent) and most were indigent; the report commented that "this
distribution reflects the patient population of the Cincinnati General Hospital."169
Psychological data from the TBI study suggest that some of the subjects may have
been of questionable competence or may have been temporarily incapacitated.
However, the meaning and importance of these data have been criticized and are
in dispute.'70

AEC-SPONSORED TBI AT OAK RIDGE

At the same time that the University of Cincinnati was conducting TBI
experiments for the DOD, the Medical Division of the AEC's Oak Ridge Institute
of Nuclear Studies (ORINS)'7' was also treating patients with selected rumors
with TBI; retrospective and prospective analyses of these data were supported by
the National Aeronautics and Space Administration.172 ORINS was established in
the late 1940s as a research institution to help advance the field of nuclear
medicine through research, training, and technology development.'73 From 1957
to 1974, the ORINS/ORAU hospital treated 194 patients with TBI. In contrast
with the DOD-sponsored experiments at Cincinnati and the other institutions,
ORINS/ORAU used TBI only to treat patients with radiosensitive cancers.

Indeed, in 1 972, the ORAU Medical Program Review Committee issued a
report on the ORAU TBI activities in light of the recent revelations about the
University of Cincinnati TBI program, noting that the studies were ethically

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conducted and that survival rates were as good as with other methods of
treatment.174

Nonetheless, similar questions have been raised about the dual-purpose
nature of the Oak Ridge program. As happened at Cincinnati, the Oak Ridge TBI
experiments, although known in the national and international medical and
scientific communities through presentations and publications, first came to the
attention of the general public through the news media. In September 1981,
Mother Jones magazine published an article charging that ORINS/ORAU treated
its patients with total-body irradiation in order to collect data for NASA.'75 The
article focused on one patient in particular—Dwayne Sexton, who suffered from
acute lymphocytic leukemia and was treated with TBI and chemotherapy over the
course of three years until he died in 1968. That article prompted an investigation
and public hearing by the Investigations and Oversight Subcommittee of the
House Science and Technology Committee, which was chaired by Representative
Albert Gore.176 Testifying before the subcommittee were patients and patient
relatives; administrative officials from Oak Ridge, the AEC, and NASA; the
medical staff of ORAU; and two cancer experts: Dr. Peter Wiernik, director of
the Baltimore Cancer Research Center, and Dr. Eli Glatstein, who was then chief
of radiation oncology at the National Cancer Institute and is now a member of the
Advisory Committee on Human Radiation Experiments.

ORINS began treating patients with TBI in 1957. Following a 1958
accident at the Oak Ridge Y-12 production plant, in which eight workers were
irradiated and treated by the ORINS hospital, ORINS took a heightened interest
in the use and effects of TBI. As William R. Bibb, then director of the
Department of Energy's Research Division at Oak Ridge, testified at the Gore
Hearing: "In order to provide the best possible care in case of an accident the
AEC expected that hematologic data from patients being treated with total body
irradiation in addition to being used to benefit other patients would also be used to
benefit any radiation accident victim."177 In 1960, the ORINS hospital completed
a newly designed irradiation facility that could deliver a uniform dose to all
portions of the body without having to move the patient, known as the Medium
Exposure Total Body Irradiator (METBI). The METBI facility delivered
approximately 1.5 rad per minute. Several years later, ORINS sought to test the
hypothesis that exposure to low doses of radiation over an extended period of
time would be more effective than a single administration of a similar total
radiation dose to the whole body in treating certain types of diffuse tumors known
to be responsive to radiation. Accordingly, it developed the Low Exposure Total
Body Irradiator (LETBI) as a "one of a kind" system to test this hypothesis.
LETBI, which could deliver a whole-body radiation dose of 1 .5 rad per hour,
went into operation in 1967 and patients could spend several days or weeks in this
facility. AEC sponsored all activities concerned with the construction and
operation of the LETBI and its use in patient treatment. The results of this
treatment approach, however, were found to be no better than others then

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available, and the use of the LETBI was discontinued in the early 1970s.

The LETBI project was conceived at approximately the same time that
NASA had commissioned ORINS to study the effects of total-body irradiation.
NASA was particularly interested in the effects of low dose-rate radiation that the
LETBI would produce because astronauts would most likely be exposed to low-
dose cosmic radiation. Accordingly, NASA provided approximately $65,000 to
the AEC for monitoring equipment and the radiation sources used for the
LETBI.178 At the Gore Hearing, officials from the AEC and NASA testified that
the LETBI program was conceived purely for therapeutic purposes and that
NASA's interest in the data from LETBI exposures in no way influenced the
decision to construct the facility or its use for patients. Dr. Clarence Lushbaugh,
who ran the LETBI facility under Dr. Gould Andrews, and succeeded Andrews as
director of the ORAU medical division, testified: "First, neither NASA nor AEC
program monitors, to my knowledge, ever attempted to become involved directly
or indirectly with the treatment of patients at the ORINS/ORAU Medical
Division. Second, the ORINS/ORAU NASA study group never influenced the
clinicians in their selection of patients or the prescription of the exposure dose
and dose rates."179

There was little dispute with the view of the 1972 Medical Program
Review Committee, expressed above, that, at least in the early years, TBI was a
legitimate form of treatment worth exploring for the radiosensitive cancers that
ORINS/ORAU was treating. The Review Committee's concern was whether the
Oak Ridge medical staff conducted their investigations in an effective manner and
whether the AEC's or NASA's interest in the data compelled the continuation of
this modality at a time when other forms of treatment were considered more
effective. Dr. Peter H. Wiernik, one of the two expert witnesses, acknowledged,
for example, that in the early years it was legitimate to experiment with TBI at the
high doses being used to try to improve treatment, because "clearly treatment
needed to be advanced in those days."IS0

The record of the 1972 review suggests that the ORINS/ORAU staff did
not engage in the type of rigorous, systematic research that would be necessary to
evaluate the usefulness of that type of therapy. The Oak Ridge doctors
acknowledged that they were not evaluating the long-term effectiveness of single-
exposure, high-dose TBI and that fractionated exposures (in which numerous
smaller doses are given over a period of several weeks or months) "probably
offers a preferable approach for total-body irradiation therapy."181 Dr. Lushbaugh
explained that, because the doctors would administer whatever treatment they
thought was "best for each patient," they did not adhere to an established research
protocol based exclusively on TBI.182

In commenting on the 1972 report before the Gore Committee, Dr.
Glatstein questioned the "manner of administration and the uncontrolled nature of
the studies." Oncology research, he said, requires "an obsession with time"~the
effect that a given treatment has over months or years. Glatstein noted that the

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reports he reviewed "are interesting in terms of acute radiation effects but really
don't have any substance in terms of oncologic practice."183 Glatstein summarized
his view of the ORINS/ORAU TBI research program: "If you are talking about
the early 60's I think this is probably fairly representative of protocols that were
going on at that time. . . . [B]y the end of that decade I believe this was probably
not acceptable."184

Both Wiernik and Glatstein criticized Dwayne Sexton's medical
(nonradiation) treatment, in particular the decision to withhold maintenance
chemotherapy, which was recognized as an effective treatment at that time, in
order to attempt a never-before-used experimental procedure.185 Even if the new
treatment was worth pursuing, they argued, it should have been done only as part
of a larger protocol and only when the patient was in secondary remission
following the failure of more-effective treatments.

All patients accepted into the ORINS/ORAU hospital program signed a
"Patient Admittance Agreement" that explained that the hospital operated for the
purpose of conducting radiation-related research. The form stated that the patient
is being admitted because his physical condition "makes me a suitable patient for
a currently active clinical research project," that experimental examinations,
treatments, and tests may be prescribed for which the patient hereby gives his or
her consent, and that the patient "can remain in the research hospital only so long
as I am needed for research purposes." Additional forms were used to establish
"Consent for Experimental Treatment," which stated that "the nature and purpose
of the treatment, possible alternative methods of treatment, the risks involved, and
the possibilities of complications have been explained to me. I understand that
this treatment is not the usual treatment for my disorder and is therefore
experimental and remains unproven by medical experience so that the
consequences may be unpredictable."186 The form made no mention of the
possible risk of death from bone marrow suppression or specific side effects such
as nausea or vomiting.

In 1974, the AEC conducted a program review of the Medical Division of
ORAU. It recommended that the clinical TBI programs be closed, having found
that the METBI and LETBI programs had "evolved without adequate planning,
criticism or objectives, and have achieved less in substantial productivity than
merits continued support."187

At the end of his hearing, Gore noted that the subcommittee would issue a
report with conclusions and recommendations. Although no formal report was
ever completed, the full committee issued the following statement in January
1983: "The Subcommittee testimony revealed that while many of the conditions
at [ORAU] were not satisfactory, particularly when judged by the routine
institutional safeguards and medical knowledge of today, the more scandalous
allegations could not be substantiated. Given the standards of informed consent
at the time, and the state of nuclear medicine, the experiments were satisfactory,
but not perfect."188

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Perhaps the most striking contrast between philosophies of the Oak Ridge
and the University of Cincinnati TBI programs can be gleaned from an exchange
that occurred in 1966. That year, the AEC's Medical Program Review
Committee suggested that ORAU consider using TBI for treatment of
radioresistant cancers (similar to what was being done at Cincinnati).189 The
ORAU physicians responded that they had carefully considered treating such
diseases, but had declined to do so:

[W]e are very hesitant to treat them because we
believe there is so little chance of benefit to make it
questionable ethically to treat them. Lesions that
require moderate or high doses of local therapy for
benefit, or that are actually resistant (gastroenteric
tract) are not helped enough by total body radiation
to justify the bone marrow depression that is
induced. Of course, in one way these patients
would make good subjects for research because
their hematologic responses are more nearly like
those of normals than are the responses of patients
with hematologic disorders.190

CONCLUSION

When we began our work, the controversy surrounding the Cincinnati TBI
research had been rekindled. There was, however, little public awareness that
Cincinnati was the last in the line of many years of sponsorship of similar TBI-
related research by the Defense Department and other federal agencies. The
ethical issues raised by the Cincinnati case are made more acute by the fact that
both the government and the medical community already had had decades of
experience with TBI, although comparatively less experience with cobalt 60 as a
means to deliver higher doses than had been delivered in the earlier era.

This history provides compelling evidence of the importance of the rules
that regulate human subject research today—prior review of risks and potential
benefits, requirements of disclosure and consent, and procedures for ensuring
equity in the selection of subjects. The history also highlights four issues in the
ethics of research with human subjects that are as important today as they were
then, issues that are not easily resolved or even addressed by present-day rules.
As discussed below, these issues are (1) how to protect the interests of patients
when physicians use medical interventions that are not standard care; (2) the
effects and attendant obligations of the government when it funds research
involving patient-subjects; (3) the impact on patients when research is combined

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with medical care; and (4) what constitutes fairness in the selection of subjects for
research.

The first issue is how best to protect the interests of patients when
physicians propose to use medical interventions that are not standard care.
Today, when nonstandard interventions are part of a formal research project, the
interests of the patient are protected in theory by the institutional review board,
which is charged with determining that the risks of the nonstandard intervention
are acceptable in light of the available alternatives and the prospect for benefit.
Patients are also protected by the requirement of informed consent, which is
intended to allow the potential patient-subject to assess whether the balance of
risks to potential benefits is acceptable. There is no federally mandated parallel
IRB mechanism of review, however, when a medical intervention that is
experimental or innovative or even controversial is to be used outside the confines
of a research project, although some institutions voluntarily have adopted
mechanisms of peer review. The requirement of informed consent remains; the
physician is obligated to inform the patient that the proposed intervention is not
standard practice, whether it is controversial within the field, and how it compares
with alternative approaches, but this requirement provides the patient less
protection than would a professional peer review.

At the time of the TBI studies, none of these mechanisms were well
developed. During the Cincinnati project, IRBs were in their infancy and the
convention of obtaining informed consent from patient-subjects was just
emerging. The record is confused and confusing as to whether or when TBI at
Cincinnati was viewed as part of a cancer research project and thus properly the
subject of IRB review. It is not clear whether the treatment of the Cincinnati
patients with TBI was initially intended to be research. In the practice of
medicine there has always been a fine boundary between practices or treatments
that are accepted as standard, those that are "innovative," and those that are
experimental or the subject of research. The use of TBI at Cincinnati is
emblematic of the difficulties inherent in sorting through these categories.

By the mid- 1 960s, TBI without bone marrow protection was a treatment
that had been tried and had not been proven effective for patients with
radioresistant cancers. By this time, total-body irradiation was not standard
treatment for such cases, nor could it be called innovative treatment; some at the
time considered its continued use in patients with radioresistant cancers to be
controversial. The history of medicine, however, is replete with instances in
which failure is followed by success. The continued use of TBI in patients with
radioresistant cancers would not have been unethical if the physicians had
established clear benchmarks for determining how much additional use was
warranted, and if patients had been informed of the speculative nature of the
treatment and the gravity of the risks involved. It is not clear that either of these
things occurred.

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What is clear is that neither the university's IRB nor the funding agency
reviewed the appropriateness of continuing to treat patients with radioresistant
cancers using TBI without bone marrow protection, despite mounting evidence
casting doubt on the utility of TBI treatment for radioresistant tumors in the
absence of bone marrow protection. It is also clear that the consent forms did not
disclose that it was by this time at best unconventional to treat patients with
radioresistant cancers with TBI and that no other medical centers were engaged in
this practice at the time; whether physicians told this to their patients is not
known. The system of checks and balances that is usually in place today to
protect patients' interests was in its early phase at the University of Cincinnati
and the system did not work well at the time. The responsibility for failure rests
at all levels, but it is reasonably clear that patient protection was compromised.

Today, as in the past, there are occasions when nonstandard medical
interventions are not subject to human research regulations. In such situations
neither IRB review nor the rigors of scientific design are in place to help
determine whether an experimental intervention should continue to be used
Today, for example, many innovations in reproductive technologies and surgery
proceed with little oversight and few constraints on the practices of physicians A
physician wishing to use an intervention that other colleagues in the field believe
to be ineffective or inferior-as was arguably the case with TBI and radioresistant
tumors after several years in the Cincinnati program-will find little standing in
his or her way to do so save the fear of malpractice claims and, increasingly the
likelihood that such interventions will not be reimbursed, particularly in
managed-care settings. The Cincinnati experience underscores the importance of
( 1 ) establishing benchmarks forjudging the propriety of continued use and (2)
providing for special disclosures to patients in all cases where interventions are
not standard-without regard for whether the intervention is deemed "human
subject research" or is governed by the Common Rule (see chapter 3).

The question of what role the Department of Defense should have played
in reviewing the appropriateness of TBI as medical care for the patient-subjects in
its bio ogical dosimetry and radiation-effects research points to the second major
issue illustrated by our review of the TBI history. Arguably, the ultimate
responsibility for determining that TBI was acceptable medical practice rested
with the physicians at Cincinnati and with the university and associated hospitals
At the same time, however, thirty years of government interest in the effects of
I HI also arguably had a significant influence on medical practice

From one vantage, the DOD had little or no obligation to consider the
value of TBI to the patients who provided the data it was seeking. The DOD was
not paying for the irradiation of the patients. It had reason to assume that the
decision about the propriety of the treatment would be made by doctors whose
judgment in the matter could be trusted. Yet the TBI experience illustrates that
when the government funds research, particularly over a long period, its funding
may well have effects beyond the simple conduct of the science and well beyond

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the confines of the strict terms stated in the contracts or grants authorizing the
research.

Over the course of three decades, there was a substantial coincidence
between the use of TBI on patients with radioresistant cancers and funding from
the Department of Defense and its predecessor. With the exception of work
conducted at the City of Hope Hospital, every journal article in the professional
literature on the use of TBI with radioresistant tumors during this period was
reporting on work supported by the government for military purposes.

In the case of Cincinnati, Dr. Saenger told the Advisory Committee in
1994 that the irradiation of patients might not have been initiated were it not for
funding by the DOD and, once initiated, might not have been continued if the
objective sought by the DOD (a biological dosimeter) had been realized early on.
As Dr. Saenger explained, while the DOD did not directly pay for irradiation, its
funding provided for other items — including laboratory equipment and
specialists— that facilitated the initiation and maintenance of the TBI program.

Even where the medical care of patients is peripheral to the interests of a
funding agency, so long as the research supported by the agency is to be
conducted on patient-subjects, it is likely that the research will affect the care
patients receive. This is particularly true when agencies support research
programs extending over many years, as was the case with the Department of
Defense and TBI. Such programs can motivate physician-investigators to alter
their practice and can stimulate the adoption of different approaches to the care
of patients. Although there is today a greater appreciation of the impact on
medical practice of funding patterns in research, it is not clear even now that
funding agencies regularly think through the implications for medical care of the
research programs they support or that they monitor the impact on patients of
their programs over time.

That the joining of research with medical care can alter what happens to a
patient is the third issue in research ethics illustrated by the TBI experience. Each
purpose introduced into the clinical setting in addition to the treatment of the
patient increases the likelihood that the patient will receive more, fewer, or
different medical interventions than he or she would otherwise receive. It is naive
to think that, either today or thirty years ago, research can be grafted on to the
clinical setting without changing the experience for the patient, now turned
subject. When the demands of science alter the standard medical practice by
increasing the monitoring of physiological indicators, the additional blood tests or
bone scans or biopsies are frequently presented as in the interest of patient-
subjects. Sometimes this claim is defensible, and the patient-subjects are indeed
advantaged by more careful monitoring of their medical condition; at other times,
however, this claim is an insupportable rationalization, and there are no offsetting
benefits to patients for the risks and discomforts associated with additional
monitoring.

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In the case of the Cincinnati experiments, the impact of the research
protocol on the care of the patient-subjects cannot be construed as beneficial to
the patients; in addition, there is evidence of the subordination of the ends of
medicine to the ends of research. The decisions to withhold information about
possible acute side effects of TBI as well as to forgo pretreatment with
antiemetics were irrefutably linked to advancing the research interests of the
DOD. To the extent that this deviated from standard care, and caused
unnecessary suffering and discomfort, it was morally unconscionable; to the
extent that the standard of care in this area is uncertain, it is morally questionable.
As troubling as this is, far more troubling is the evidence, including the testimony
of the principal investigator, that TBI might not have been employed as treatment
for the patients, or once employed continued, in the absence of the government's
funding and research requirements.

Whether the ends of research (understood as discovering new knowledge)
and the ends of medicine (understood as serving the interests of the patient)
necessarily conflict and how the conflict should be resolved when it occurs are
still today open and vexing issues. Increasingly, advocates for patients with
serious, chronic diseases such as AIDS and breast cancer maintain that it is often
in the interests of patients to participate as subjects in clinical research. These
advocates are particularly concerned to ensure fair access to participation in
research for people who are politically less powerful, such as the poor, minorities,
and women. This contemporary perspective upends the traditional way of viewing
the fourth issue in research ethics raised by the TBI experiments— fairness in the
selection of subjects.

At both M. D. Anderson Hospital and the University of Cincinnati, almost
all the patients were drawn from public hospitals, and many were African-
Americans. It was common during this period for medical research to be
conducted on the poor and the powerless. In part, this practice reflected a general
societal insensitivity to questions of justice and equal treatment. In this case,
people who were poor disproportionately bore the burdens of questionable
research to which their interests as ill people were subordinated. The practice
also reflected the view, however, that poor people were better off being patients
at hospitals affiliated with research-oriented medical schools where they were
likely to become subjects of research (as well as subject matter for clinical
teaching). Such institutions, it was thought, offered poor people their best, and
perhaps their only, chance to secure quality medical care. Recently, this kind of
reasoning has emerged again, as constraints on access to medical care—from the
narrowing of entitlement programs to the narrowing of coverage in managed-care
medical plans— have made participation in research, as a route to medical care,
more attractive. The question of whether the "side benefits" of being a subject
should be weighted in the review of the risks and potential benefits of research
remains unresolved today.

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These findings highlight the contemporary resonance of the TBI story.
The issues discussed above are either not now addressed or not addressed
adequately by regulation; neither are they covered by clear conventions or rules of
professional ethics. Thus, the history of TBI research sponsored by the
government is important not only for what it tells us about our past but also for
how it illuminates the present.

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ENDNOTES

1 . As of September 1995, the lawsuit was still ongoing. In January 1995, the
court issued an opinion rejecting the defendants' request to dismiss the case, thus
allowing the plaintiffs to proceed with discovery and a possible trial. In re Cincinnati
Litigation, 874 F. Supp. 796 (S.D. Ohio, 1995). That decision is now on appeal in the
U.S. Court of Appeals.

2. A list was published in the 1967 National Academy of Sciences report on
"Radiobiological Effects of Manned Space Flight" and is reprinted in Hearing on the
Human Total Body Irradiation (TBI) Program at Oak Ridge before the Subcommittee on
Investigations and Oversight of the House Science and Technology Committee [Gore
Hearing], 97th Cong., 1st Sess. (23 September 1981), 355. The Advisory Committee
requested information from most of these institutions (except for those performing five or
fewer procedures) on their use of TBI. Virtually all of them informed the Advisory
Committee that they no longer have any records describing these activities, besides what
has been published in the literature; some of the institutions have informed the staff
orally that they did "nonexperimental" TBI treatments on patients with leukemia during
the 1950s and therefore would have no protocols or review documents of that work.

3. Three were conducted during the Manhattan Project years, and five between
1951 and 1971. ;

4. Renamed the Oak Ridge Associated Universities (ORAU) in 1966.

5. City of Hope Hospital in Duarte, California. Melville L. Jacobs and Fred J.
Marasso, "A Four-Year Experience with Total-Body Irradiation," Radiology 84 (1965):
452-456 (using a cobalt 60 teletherapy unit).

6. The terms radiosensitive and radioresistant are relative terms that appear to
have little meaning in current medical parlance, but were widely used at least into the
1970s.

7. J. T. Chaffey et al., "Total Body Irradiation in the Treatment of Lymphocytic
Lymphoma," Cancer Treatment Report 61 (1977): 1 149-1 152; M. H. Lynch et al., "Phase
II Study of Busulfan, Cyclophosphamide, and Fractionated Total Body Irradiation as a
Preparatory Regimen for Allogeneic Bone Marrow Transplantation in Patients with
Advanced Myeloid Malignancies," Bone Marrow Transplant 15, no. 1 (January 1995):
59-64 (This study combines chemotherapy with doses of 1,200 rad of TBI).

8. R. A. Clift, C. D. Buckner, and F. R. Appelbaum, "Allogeneic Marrow
Transplantation in Patients with Chronic Myeloid Leukemia in the Chronic Phase: A
Randomized Trial of Two Irradiation Regimes," Blood 77 (1991): 1660.

9. The methods of reporting radiation doses have changed over the years.
Throughout the 1950s, researchers tended to report the dose in roentgens ("R" or "r"),
which represented the amount of radiation emanating from the source; from the 1960s
through the present, researchers reported the dose in rad (also known as centigrays),
which represent the amount of radiation absorbed by the body. For x rays, the rem-- for
roentgen equivalent man— is equivalent to a rad. A given air dose (roentgen) of radiation
is generally equivalent to a lesser body dose (rad). For example, 325 R (air dose) was
reported in one experiment as approximately equivalent to 200 rad (body dose).

10. Fred A. Mettler, Jr., and Arthur C. Upton, Medical Effects of Ionizing
Radiation, 2d ed. (Philadelphia: W. B. Saunders Co., 1995), 41, 278 (table adapted from

407

J. T. Conklin).

1 1 . One of the difficulties in reporting the chance of death at a given dose is a
confusion between the use of air (or skin) dose as opposed to body (or midline tissue)
dose (the former is generally significantly higher than the latter), and whether or not
medical care is provided. Many investigators fail to indicate clearly what type of dose
they are using. Mettler and Upton report that "[i]t is probable that with appropriate
medical treatment, the LD50 [lethal dose for 50 percent of recipients] skin dose may be in
the range of 6 Gy (600 rad) or an MTD [midline tissue dose] of 3.96 Gy (396 rad)."
Mettler and Upton, Medical Effects of Ionizing Radiation, 278.

12. Fred G. Medinger and Lloyd F. Craver, "Total Body Irradiation, with review
of cases, "American Journal of Roentgenology 48 (1942): 651, 668. The investigators
used a 250-kilovolt (K.V) machine and doses up to 450 R. The dose that would cause
severe bone marrow damage and be potentially lethal was considered to be between 200
and 400 roentgens. This figure can vary depending on the length, frequency, and
intensity of the dose; for example, a single dose of 200 R will generally cause more
severe reactions than five doses of 40 R spaced over one or two weeks.

13. J. J. Nickson, "Blood Changes in Human Beings Following Total-Body
Irradiation," in Industrial Medicine on the Plutonium Project: Survey and Collected
Papers, ed. Robert S. Stone (New York: McGraw-Hill Book Co., 1951), 337.

14. B. V. A. Low-Beer and Robert S. Stone, "Hematological Studies on Patients
Treated by Total-Body Exposure to X-ray," in Stone, Industrial Medicine, 338.

15. Ibid.

16. Ibid., 338-39.

17. Alan Gregg, M.D., Chairman of the AEC Advisory Committee on Biology
and Medicine, to Dr. Stone, 20 October 1948 ("The secrecy with which some of the
work . . .") (ACHRE No. UCLA-1 1 1094-A-24), 1.

18. Robert Stone, M.D., to Allen Gregg, M.D., Chairman of the AEC Advisory
Committee on Biology and Medicine, 4 November 1948 ("The candor of your letter of
October 20th . . .") (ACHRE No. UCLA-1 1 1094-A-25), 3.

19. Medinger and Craver, "Total Body Irradiation," 668.

20. L. F. Craver, "Tolerance to Whole-Body Irradiation of Patients with
Advanced Cancer," in Stone, Industrial Medicine, 485.

21. Ibid., 486.

22. Ibid.

23. See Nickson, "Blood Changes in Human Beings Following Total-Body
Irradiation," in Stone, Industrial Medicine. After World War II, Dr. Nickson continued
to engage in TBI research at Sloan-Kettering.

24. Ibid., 309. "The persons who were subjected to radiation during this study
were divided into three general groups. The first group consisted of eight persons who
had neoplasms that could not be cured but still were not extensive enough to influence
general health. . . . The second group consisted of three persons who had illnesses that
were generalized and chronic in nature [two had arthritis]. . . . The third group consisted
of three normal volunteers from among the personnel of the Metallurgical Laboratory."
Ibid.

25. Robert Stone, M.D., to Shields Warren, M.D., 6 October 1948 ("I have
recently been shown a letter from Mr. Keller . . .") (ACHRE No. DOE-120994-A-27), 1.

408

26. Ibid.

27. The chief of the AEC's Insurance Branch supported declassification: "It is
conceivable that if it became a matter of common knowledge that experiments on human
beings such as those described in this document were being carried on by the
Commission it might result in some adverse publicity and perhaps encourage litigation.
However, we feel that this objection is outweighed by the advantages to be gained by
making this information available to technically trained personnel." Clyde E. Wilson,
Chief of the AEC Insurance Branch, to Anthony Vallado, Deputy Declassification
Officer, AEC Declassification Branch, 10 September 1948 ("Review of Document")
(ACHRE No. DOE-120894-E-42).

28. Gregg to Stone, 20 October 1948, 1 .

29. For example, M. Soden et al., "Lymphoid Irradiation in Intractable
Rheumatoid Arthritis: Long-term Follow-up of Patients Treated with 750 rad or 2,000
rad, . . ." Arthritis and Rheumatism 15, no. 3 (May 1989): 577-582.

30. Ibid.

3 1 . Stone to Gregg, 4 November 1 948, 2.

32. NEPA stood for Nuclear Energy for the Propulsion of Aircraft.

33. Other participants included Robley Evans, Hymer Friedell, Robert Stone,
Shields Warren, and Stafford Warren, all of whom were often called on for other
radiation research advice in the late 1 940s and 1 950s by the AEC, the DOD, and other
agencies. NEPA Advisory Committee on Radiation Tolerance of Military Personnel,
proceedings of 3 April 1949 (ACHRE No. DOE-120994-B-1).

34. In a subsequent paper, Stone cited Jenner's experiments with smallpox,
Walter Reed's experiments with yellow fever, and World War II experiments with
malaria on prisoners as examples. Robert S. Stone, paper of 3 1 January 1 950 for the
NEPA project ("Irradiation of Human Subjects as a Medical Experiment") (ACHRE No.
NARA-070794-A-9). Stone also sought to justify the use of normal humans on national
security grounds: "The information desired is sufficiently important to the safety of the
U.S.," and the doses would be "relatively low in relation to the lethal doses." The "safety
of the U.S." language was later dropped by the full committee. NEPA Advisory
Committee, 3 April 1949, 43-48.

35. Advisory Committee for Biology and Medicine, transcript (partial) of
proceedings of 10 November 1950 (ACHRE No. DOE-012795-C-1), 6.

36. Ibid., 29.

37. ACBM, transcript of proceedings of 3 April 1949.

38. Ibid., 39-40. Stone noted that "volunteering exists when a person is able to
say Yes or No without fear of being punished or of being deprived of privileges due him
in the ordinary course of events." Ibid., 39.

39. Ibid., 40.

40. Ibid., 42.

41. Ibid., 41.

42. NEPA Medical Advisory Committee, 5 January 1950 ("Radiation Biology
Relative to Nuclear Energy Powered Aircraft") (ACHRE No. DOE-060295-C-1), 4.

43. Robert S. Stone, 3 1 January 1950, 3. "The extremely small hazard of
undetectable genetic effect, undetectable effect on the life span and possibly slight effect
on the blood picture are the extremely small hazards that must be weighed against the
value of having actual experience with exposure of humans." Ibid., 4.

409

44. See Committee on the Biological Effects of Ionizing Radiation, National
Research Council, Health Effects of Exposure to Low Levels of Ionizing Radiation: BEIR
V (Washington, D.C.: National Academy Press, 1990), 168-169, 171-175,242-253. See
also Donald A. Pierce and Michael Vaeth, "Cancer Risk Estimation from the A-Bomb
Survivors: Extrapolation to Low Doses, Use of Relative Risk Models and Other
Uncertainties," in Low Dose Radiation: Biological Bases of Risk Assessment, eds. K. F.
Baverstock and J. W. Stather (London: Taylor & Francis, 1989), 54, 58-59. The BEIR V
leukemia model includes both a linear and quadratic term in dose, the latter dominating
the risk above 90 rad. For a single exposure to 10 rad, the BEIR report gives an
estimated excess relative risk of 15 percent (lifetime, averaging over ages at exposure).
Extrapolating this figure linearly to 1 50 rad would produce an excess relative risk of
2.25, but when the quadratic term is included, the total relative risk becomes 7. This
estimate is in perfect agreement with the observed and fitted risks among the atomic
bomb survivors at 150 rad, as plotted by Pierce and Vaeth. For exposures at particular
ages and expressed at particular follow-up times, the relative increase can be either larger
or smaller than this figure.

45. Ibid., 3-4.

46. W. A. Selle, Secretary, NEPA Medical Advisory Committee, to Dr. Richard
Meiling, Director, Medical Services Division, 22 March 1950 ("As indicated to you in
person on March 8 . . .") (ACHRE No. NARA-070794-A-9).

47. DOD Research and Development Board, Committee on Medical Sciences,
proceedings of 23 May 1950 (ACHRE No. DOD-042994-A-15), 10.

48. Marion W. Boyer, AEC General Manager, to Robert LeBaron, Chairman,
Military Liaison Committee, 10 January 1951 ("As you know, one of the important
problems that would confront us . . .") (ACHRE No. DOE-040395-B-1), 3-4.

49. Participants were Alan Gregg (ACBM chairman). Dr. Austin Brues of the
Argonne National Laboratory (operated by the University of Chicago), Dr. Simon
Cantril of Swedish Hospital in Seattle, Dr. Andrew Dowdy (who had chaired the NEPA
Medical Advisory Committee), Dr. Louis Hempelmann of Rochester, Dr. Robert Loeb of
Columbia, Dr. Curt Stern of the ACBM, and Dr. Shields Warren of the DBM. Ibid.

50. Mettler and Upton, Medical Effects of Ionizing Radiation, 278.

5 1 . Marion W. Boyer, AEC General Manager, to Robert LeBaron, Chairman,
Military Liaison Committee, 10 January 1951 ("As you know, one of the important
problems that would confront us . . .") (ACHRE No. DOE-040395-B-1), 3-4.

52. Joseph Hamilton to Shields Warren, 28 November 1950 ("Unfortunately, it
will not be possible . . .") (ACHRE No. IND-071395-A-9).

53. Armed Forces Medical Policy Council to the Secretary of Defense, 30 June
1951 ("Annual Report") (ACHRE No. DOD-091694-A-1), 158.

54. Interview of Colonel John Pickering by Dr. John Harbert and Gilbert
Whittemore (ACHRE staff), transcription of audio recording, 2 November 1994
(ACHRE Research Project Series, Interview Program File, Targeted Interview Project),
14ff.

55. Wilson F. Humphreys, Colonel, USMC, Assistant Chief of Staff, to
Commanding Officers, 16 November 1959 ("DAS A Base Commanders' Weekly
Bulletin") (ACHRE No. DOD-082694-A-1), 2.

56. At least four of the five DOD institutions used the new, high-energy
radiation sources-cobalt 60 or megavoltage x rays. (The available data did not make

410

clear what type of unit Sloan-Kettering used.)

57. John A. Isherwood, Chief, Army Radiological Service, to Assistant Chief,
U.S. Army Medical Research and Development Command, 22 October 1958 ("1.
Recommend approval . . .") (ACHRE No. DOD-042994-A-16).

58. Executive Panel of the NEPA Medical Advisory Committee, proceedings of
8 July 1949 (ACHRE No. DOD-042994-A- 17), 77 (emphasis added).

59. Carroll Wilson, AEC General Manager, to Robert Stone, 5 November 1947
("Your Letter of September 18 . . . ") (ACHRE No. DOE-052295-A-1).

60. P.L. 82-557, sec. 5, 66 Stat. 725 (16 July 1952).

61. Max Brown to Vice Chancellor, University of Pittsburgh, 12 March 1957
("This in reply . . .") (ACHRE No. NARA-012395-A-6).

62. Department of Defense, Defense Atomic Support Agency, Contract DA-49-
146-XZ-029 (contract with the University of Cincinnati), Modification no. 1, ASPR. no.
7-203.22, 28 February 1961 (ACHRE No. DOD-042994-A-23).

63. Lieutenant Lando Haddock, USAF, 19 October 1950 ("Negotiation of Cost-
Reimbursement") (ACHRE No. DOD-062 1 94-B-3 ).

64. The results were published in Lowell S. Miller, Gilbert H. Fletcher, and
Herbert B. Gerstner, to the School of Aviation Medicine, report of May 1957 ("Systemic
and Clinical Effects Induced in 263 Cancer Patients by Whole Body X-Irradiation with
Nominal Air Doses of 15 to 200 R") (ACHRE No. DOD-102594-A-1); and Lowell S.
Miller, Gilbert H. Fletcher, and Herbert Gerstner, "Radiobiologic Observations on Cancer
Patients Treated with Whole-Body X-Irradiation," Radiation Research 4 ( 1 958): 1 50-
165.

65. Miller, Fletcher, and Gerstner, "Systemic and Clinical Effects," 1. "Colonel
McGraw stated that he thought that the cases studied were terminal cases. He was
answered in the negative." Air Force Research Council, proceedings of 14 January 1954
(ACHRE No. DOD-092894-A-1), 7.

66. Miller, Fletcher, and Gerstner, "Systemic and Clinical Effects," 2.

67. Ibid. The report also states that "[a]t the time of irradiation, these patients
were still able to walk and perform light physical tasks."

68. Ibid.

69. Attachment, Lester J. Peters, Division of Radiotherapy, M. D. Anderson
Cancer Center, to Steve Klaidman (ACHRE), 22 December 1994 (ACHRE No. CORP-
010995-A-l).

70. School of Aviation Medicine (SAM) Research Council, proceedings of 14
January 1954 (ACHRE No. DOD-092894-A-1), 6-7.

71. Ibid.

72. Robert B. Payne to the School of Aviation Medicine, report of February
1963 ("Effects of Acute Radiation Exposure on Human Performance") (ACHRE No.
DOD-121994-C-1), 10.

73. One Air Force reviewer stressed that "the patients cannot be considered as
normal people." SAM Research Council, proceedings of 14 January 1954, 6. Even the
study investigator warned that "the application of these results to operational problems
should be made with cautious regard for the medical status of the subjects and the
limited relevance of experimental criteria." Payne, "Effects of Acute Radiation," 12.

74. SAM Research Council, proceedings of 14 January 1954, 7.

411

75. SAM Research Council, proceedings of 29 August 1955 (ACHRE No.
DOD-092894-A-2), 6.

76. Miller, Fletcher, and Gerstner, "Systemic and Clinical Effects," 20. The
researchers noted that their paper deals only with "those aspects of the problem which are
of general radiobiological interest; a strictly clinicotherapeutic evaluation will be given
elsewhere." Ibid., 1 . It is not known if such a therapeutic evaluation was ever completed,
and none has been located to date.

77. Ibid., 7. The report states that 30 percent claimed subjective improvement,
but that this was possibly due to psychological rather than clinical factors. Ibid.

78. Ibid., 20. They cautioned, however, that the condition of terminally ill
patients may increase their sensitivity to both acute and longer-term radiation symptoms.
Ibid.

79. SAM Research Council, proceedings of 14 January 1954, 7.

80. Colonel Robert B. Payne, "Effects of Acute Radiation Exposure on Human
Performance," Review 3-63, USAF School of Aerospace Medicine, Aerospace Medical
Division, February 1963, 3.

81. William C. Levin, Martin Schneider, and Herbert B. Gerstner, paper of
1960 for Air University, School of Aviation Medicine ("Initial Clinical Reaction to
Therapeutic Whole-Body X-Irradiation") (ACHRE No. DOD-072794-B-18).

82. The original contract was for a "Study of the Effects of Total and Partial
Body Radiation on Iron Metabolism and Hematopoiesis"; it was later known as "The
Effect of Total Body Irradiation on Immunologic Tolerance of Bone Marrow and
Homografts of Other Living Tissue." (The Advisory Committee has eight progress
reports.) At least three of the patients had arthritis. Baylor University College of
Medicine to the Armed Forces Special Weapons Project (AFSWP), report of 1 January
1954 (ACHRE No. BAY-101794-A-1). This condition was not among the diseases listed
as having been treated in the Baylor University College of Medicine to Defense Atomic
Support Agency (DASA), report of 1 February 1963-31 January 1964 (ACHRE No.
BAY-101794-A-2), 6.

83. The "fundamental problem has been to define effect of irradiation and
quantitate effect with amount of radiation exposure." Baylor University College of
Medicine to DASA, report of 1 February 1963-31 January 1964, I. Collins and Loeffler
published preliminary findings in 1956. Vincent P. Collins and R. Kenneth Loeffler,
"The Therapeutic Use of Single Doses of Total Body Radiation," American Journal of
Roentgenology 75 (1956): 546. Collins appears to have first conducted DOD-sponsored
TBI research in 1953 while at Columbia University. See Joint Panel on the Medical
Aspects of Atomic Warfare, proceedings of 7 January 1953 (ACHRE No. DOD-072294-
B-l), item 10.

84. Baylor University College of Medicine to AFSWP, report of 1 September
1955-31 January 1956 ("A Study of the Effects of Total and Partial Radiation on Iron
Metabolism and Hematopoiesis") (ACHRE No. DOD-090994-D-2), 6.

85. Baylor University College of Medicine to DASA, report of 1 February
1963-31 January 1964, 1; Baylor University College of Medicine to Defense Atomic
Support Agency, report of 1 February 1961-31 January 1962 (ACHRE No. BAY-
101794-A-3),2.

86. Baylor University College of Medicine to DASA, report of 1 February
1963-31 January 1964,7-8.

412

87. Ibid., 5-6.

88. Ibid., 6.

89. Ibid., 12.

90. Because the Advisory Committee did not receive all of the progress reports
on this study, the total number of patients cannot be determined. Nor could the Advisory
Committee determine what type of teletherapy unit the investigators used. Memorial
Hospital was the site of the second Manhattan Project experiment under Dr. Craver. Dr.
Nickson was the author of the report on the third Manhattan Project experiment at
Chicago; he came to Sloan-Kettering after World War II.

91. Sloan-Kettering Institute for Cancer Research to AFSWP, report of 1 March
1958 ("Quarterly Report-Study of the Post- Irradiation Syndrome in Humans") (ACHRE
No. DOD-062194-A-9).

92. Sloan-Kettering Institute for Cancer Research to AFSWP, report of 1 May
1956 ("Annual Report") (ACHRE No. DOD-060794-A-1 ), abstract page.

93. Captain E. Richard King, "Use of Total-Body Radiation in the Treatment of
Far Advanced Malignancies," Journal of the American Medical Association 1 77 (2
September, 1961): 86-89.

94. Ibid., 613.

95. Ralph R. Cavalieri, Milton Van Metre, F. W. Chambers, and R. Richard
King, "Taurine Excretion in Humans Treated by Total-Body Radiation," Journal of
Nuclear Medicine 1 (1960): 186, 187, 190. Taurine is an amino acid that is excreted in
the urine. A 1962 request for funding document from the Navy Bureau of Medicine and
Surgery proposed to continue the biological dosimeter project through 1 967 by collecting
"daily urine specimens from patients exposed to total body irradiation for therapeutic
purposes." U.S. Navy, Bureau of Medicine and Surgery, 1 June 1962 ("Biological
Dosimeter of Radiation Injury") (ACHRE No. DOD-090994-C-3), 1-4. The Navy
informed the Advisory Committee that there is no evidence that this project was ever
funded.

96. Standard Form 522, revised August 1954 ("Authorization for Administration
of Anesthesia and for Performance of Operations and other Procedures") (ACHRE No.
DOD-020695-B- 1 ). Standard Form 522 was modified for TBI procedures. A second
form was sometimes used for "consent to drastic radiation/chemical therapy," which
states that "[t]he possibility that drastic radiation therapy may be useful . . . , the results
expected, and the consequences likely to ensue, have been explained to me and I hereby

give my consent " NHBETH Form 27B, August 1959 ("Consent to Drastic

[Radiation] Therapy") (ACHRE No. DOD-020695-B-2).

97. Shields Warren, "Ionizing Radiation and Medicine," Scientific American,
September 1959, 165.

98. AG Central Files, January-May 1962 ("Conference, Meetings, Military,
Naval and All Divisions") (ACHRE No. DOD-081994-A-1), 2.

99. Over the course of the eleven-year DOD study, ten researchers participated
in the project and contributed to the DASA reports: Eugene L. Saenger, M.D.; Edward
B. Silberstein, M.D.; Ben L. Friedman, M.D.; James G. Kereiakes, Ph.D.; Harold Perry,
M.D.; Harry Horwitz, M.D.; Bernard S. Aron, M.D.; I-Wen Chen, Ph.D.; Carolyn
Winget, M.A.; and Goldine C. Gleser, Ph.D. Dr. Saenger was the principal investigator of
the study, but not the attending physician or the administering radiologist for any of the
patients.

413

100. Dr. Saenger had developed an interest in studying the "effect of whole
body radiation on the patient suffering from cancer" while serving in the military as chief
of the radioisotope laboratory at Brooke General Hospital, Fort Sam Houston, Texas.
Raymond Suskind et al. to Dean of the College of Medicine, University of Cincinnati,
January 1972 ("The Whole Body Radiation Study at the University of Cincinnati")
(ACHRE No. DOD-042994-A-2) (hereafter "Suskind Report"), 40. He also "had treated
occasional private patients with leukemia and lymphoma in my office using whole body
radiation and had been impressed with its potentiality." Saenger's response to "Questions
from the [Suskind] Committee" (undated) (ACHRE No. DOD-042994-A-24), 2.

101. Philip A. Pizzo et al., "Solid Tumors of Childhood," in Cancer: Principles
and Practice of Oncology, 4th ed., eds. Vincent T. Devita, Samuel Hellman, and Steven
A. Rosenberg (Philadelphia: J. B. Lippincott, Co., 1993), 1782-1783.

102. Robert W. McConnell, President of the American College of Radiology, to
U.S. Senator Mike Gravel, 3 January 1972 ("This letter represents our response . . .")
(ACHRE No. DOD-042994-A-7). The ACR is the principal organization serving
radiologists, with programs that focus on the practice of radiology and the delivery of
comprehensive radiological health services. The stated purposes of the ACR are to
advance the science of radiology, improve radiologic service to the patient, study the
economic aspects of the practice of radiology, and encourage improved and continuing
education for radiologists and allied professional fields. The ACR committee consisted
of Drs. Henry Kaplan (Stanford), Frank Hendrickson (Chicago Presbyterian-St. Lukes),
and Samuel Taylor (also Presbyterian-St. Lukes).

103. Suskind report (released in February 1972). The Suskind Committee was
appointed by the dean of the medical school at the University of Cincinnati. It was
constituted of eleven physicians from the University of Cincinnati; one of the members,
Dr. Bernard S. Aron, had worked on the TBI program.

104. Junior Faculty Association, 25 January 1972 ("A Report to the Campus
Community") (ACHRE No. DOD-042994-A-8). The JFA was a group of untenured arts
and sciences faculty who organized at the University of Cincinnati in the late 1960s to
protect each other's rights to speak out on social issues and to work for fair tenure
procedures. In the fall of 1971, a committee of this association, chaired by Martha
Stephens, currently professor of English at the university, obtained the reports submitted
to the DOD by the Cincinnati doctors and studied the TBI project's history of consent, as
well as the blood counts and survival times of the subjects. The JFA then held a press
conference on 25 January 1972, charging that "many patients in the project paid severely
for their participation and often without even knowing they were part of an experiment"
and asking that the study be terminated by the president of the university (which did in
fact take place the following March). The JFA report was covered widely in the press
and in a number of subsequent studies.

105. James M. Cox, past Chairman of the ACR Commission on Radiation
Oncology, statement at Hearing on Radiation Experiments Conducted by the University
of Cincinnati Medical School with Department of Defense Funds before the
Subcommittee on Administrative Law and Governmental Relations of the House
Judiciary Committee, 103d Cong., 2d Sess., 1 1 April 1994 (ACHRE No. IND-091594-A-

1).

106. Dr. Eugene Saenger, University of Cincinnati, to Department of the Army,
Office of Surgeon General, 25 September 1958 ("Application for Research Project:
Metabolic Changes in Humans Following Total Body Irradiation") (ACHRE No. UCIN-

414

103194-A-l).

107. Dr. Saenger is also a long-standing member of the American College of
Radiology and has served on the National Council on Radiation Protection and
Measurements (NCRP) and the BEIR (Biological Effects of Ionizing Radiation)
Committee in 1972. In 1963, he wrote the AEC's handbook on Medical Aspects of
Radiation Accidents and regularly consulted for the AEC on radiation accidents and
workers' claims of radiation exposure. Saenger has written almost 200 articles in the
medical literature on radiology and other topics. Eugene L. Saenger, statement at
Hearing on Radiation Experiments Conducted by the University of Cincinnati Medical
School with Department of Defense Funds before the Subcommittee on Administrative
Law and Governmental Relations of the House Judiciary Committee, 103d Cong., 2d
Sess., 1 1 April 1994 (ACHRE No. IND-091594-A-1).

108. Saenger to the Department of the Army, 25 September 1958, 3. Dr.
Saenger's proposal to the DOD was restricted to a description of the post-TBI metabolic
studies for which he was requesting funding, and it made no mention of a primary
clinical purpose for the TBI such as a medical therapy or therapeutic research.

109. University of Cincinnati College of Medicine to the Defense Atomic
Support Agency, report of February 1960-October 1961 ("Metabolic Changes in
Humans Following Total Body Irradiation") (ACHRE No. DOD-042994-A-1), 1.

1 10. University of Cincinnati College of Medicine to the Defense Atomic
Support Agency, report of 1 November 1961-30 April 1963 ("Metabolic Changes in
Humans Following Total Body Irradiation") (ACHRE No. DOD-042994-A-1), 3.

111. See, for example, ibid., 3 ("Patients with solid neoplasms which are not
radiosensitive are sought."). Three children with Ewing's sarcoma were also treated and
included in the study. In addition, the original grant proposal stated that they would
compare one group of patients "with relatively radio-resistant lesions (e.g., stomach,
bowel, brain)" with a second group "with highly radio-sensitive tumors (lymphomas)."
Saenger to the Department of the Army, 25 September 1958, 4-5. The records indicate
that the latter group was never used.

1 12. Eugene Saenger and Ben Friedman, 14 November 1962 ("An appraisal of
Human Studies in Radiobiological Aspects of Weapons Effects") (ACHRE No. DOD-
09 1 894- A- 1).

113. University of Cincinnati College of Medicine to the Defense Atomic
Support Agency, report of February 1960-30 April 1966 ("Metabolic Changes in
Humans Following Total-Body Irradiation") (ACHRE No. DOD-042994-A-1), 2.

1 14. University of Cincinnati College of Medicine to DAS A, report of 1
November 1960-30 April 1963, 19.

1 15. Eugene L. Saenger et al., "Whole Body and Partial Body Radiotherapy of
Advanced Cancer," American Journal of Roentgenology 117(1973): 670-685. The
article makes no mention of the Defense Department-related funding or studies that were
performed as part of this program.

1 16. Eugene Saenger, M.D., interview by Ron Neumann, M.D., Gary Stern, and
Gilbert Whittemore (ACHRE staff), transcript of audio recording, 15 September 1994
(ACHRE Research Project Series, Interview Program File, Targeted Interview Project),
50-51.

1 17. Suskind report, 12; ACR report, 10.

415

1 1 8. Calculated from 3,804 patient days at approximately $114 per day. Eugene
L. Saenger, statement at Hearing on Radiation Experiments Conducted by the University
of Cincinnati Medical School with Department of Defense Funds before the
Subcommittee on Administrative Law and Governmental Relations of the House
Judiciary Committee, 103d Cong., 2d Sess., 1 1 April 1994 (ACHRE No. IND-091594-A-
D.7.

1 19. Interview with Saenger, 15 September 1994, 50; Saenger testimony, 1 1
April 1994,7.

120. Interview with Saenger, 15 September 1994, 54.

121. Interview with Saenger, 20 October 1994, 22-23.

122. Interview with Saenger, 15 September 1994, 64.

123. Ibid., 94.

124. Eugene L. Saenger to Dr. Steven Kessler, DASA Project Officer, 19
February 1969 ("Enclosed are eight copies . . ."), item 9 ("Dosimetry").

125. Lieutenant Colonel James B. Hartgering, Director of the Army Division of
Nuclear Medicine and Chemistry, to Lieutenant Colonel Arthur D. Sullivan, Assistant
Chief of the Army Medical Research and Development Command, 7 November 1958
("Application for Research Contract") (ACHRE No. DOD-042994-A-18) (reviewing
application submitted by Dr. Eugene Saenger).

126. Lieutenant Colonel Arthur D. Sullivan, Assistant Chief of the Army
Biophysics and Astronautics Research Branch, to Colonel Hullinghorst, 12 November
1958 ("Application for Research Contract") (ACHRE No. DOD-042994-A-19).

127. Captain David Lambert, Deputy Chief of DASA Weapons Effects and
Tests, to DASA Director of Logistics, 29 October 1959 ("Negotiation of Contract")
(ACHRE No. DOD-042994-A-20).

128. Colonel John A. Isherwood to Assistant Chief of the Army Biophysics
and Astronautics Research Branch, 22 October 1958. Isherwood also described Dr.
Saenger as "well qualified to conduct such research."

129. University of Cincinnati College of Medicine to DASA, report of February
1960-October 1961, 1.

1 30. Dr. Saenger informed the Advisory Committee that he did not believe that
he was required to submit the marrow proposal to the FCR, but elected to do so on his
own. Interview with Saenger, 20 October 1994, 6.

131. Dr. Edward A. Gall, FCR Chairman, to Dr. Clifford G. Grulee, Dean of the
University of Cincinnati College of Medicine, 6 May 1966 ("This relates to a request . .
.") (ACHRE No. DOD-042994-A-1 1).

132. Dr. George Shields to Dr. Edward A. Gall, FCR Chairman, 13 March 1967
("Protection of Humans with Stored Autologous Marrow") (ACHRE No. DOD-042994-
A-l 1). Shields also indicated that he was withdrawing from the FCR subcommittee "for
reasons of close professional and personal contact with the investigators and with some
of the laboratory phases of this project." Ibid.

133. Thomas E. Gaffney to Dr. Edward A. Gall, FCR Chairman, 17 April 1967
("I cannot recommend approval . . .") (ACHRE No. DOD-042994-A-1 1). In a
subsequent letter, dated 18 May 1967, Gaffney indicated to Gall his approval subject to a
proviso (ACHRE No. DOD-042994-A-1 1).

134. Dr. Clifford G. Grulee, Dean of the College of Medicine, to Dr. Ben I.
Friedman, 23 May 1967 ("The Research Committee has reported . . .") (ACHRE No.

416

DOD-042994-A-11).

135. Dr. Evelyn V. Hess, FCR Chairman, to Drs. Edward B. Silberstein and
Eugene L. Saenger, 22 July 1971 ("The Therapeutic Effect of Total Body Irradiation
Followed by Infusion of Autologous Marrow in Humans") (ACHRE No. DOD-042994-
A-l 1), 2.

136. Dr. Edward B. Silberstein to Dr. Evelyn Hess, 4 April 1972 ("Enclosed
is the protocol . . .") (ACHRE No. DOD-042994-A-1 1[5]>.

137. Dr. Evelyn Hess, FCR Chairman, to Clifford G. Grulee, Jr., Dean, College
of Medicine, 28 August 1972 ("Evaluation of the Therapeutic Effectiveness of Wide-
Field Radiotherapy . . .") (ACHRE No. 042994- A- 1 1 [25]).

138. Evelyn Hess, 20 December 1971 ("Historical Review of the Total Body
Irradiation and the Faculty Research Committee Reviews") (ACHRE No. CORP-080195-
A-l).

139. FCR Chairman to the Members of the Faculty Committee on Research,
18 April 1969 ("NIH Review . . .") (ACHRE No. DOD-042994-A-2 1 ), 1 (describing
meeting with Dr. Mark Connor, NIH representative from the Institutional Relations
Division).

140. D. T. Chalkley, Ph.D., Chief of the NIH Office for Protection of Research
Risks, to U.S. Senator Sam Nunn, 9 December 1974 ("Thank you for your notes . . .")
(ACHRE No. DOD-042994-A-12[5]),l-2. In his letter to Senator Nunn, Chalkley states
that "[w]hole-body radiation at levels of a few hundred rads is lethal only when it
destroys the blood building cells of the bone marrow. In the treatment of these patients
who had widespread metastatic cancer, a large part of the marrow was first removed, the
patient was then treated and the marrow returned. None of the patients involved died
from radiation sickness." However, the marrow transplants that Chalkley refers to were
not successfully performed until 1969 and were done on only eight of the eighty-eight
patients. See Saenger et al., "Radiotherapy of Advanced Cancer," 682.

141. University of Cincinnati College of Medicine to the Defense Atomic
Support Agency, report of 1 May 1966-30 April 1967 ("Metabolic Changes in Humans
Following Total-Body Irradiation") (ACHRE No. DOD-042994-A-1).

142. University of Cincinnati College of Medicine to DASA, report of February
1960-30 April 1966,31.

143. Ibid., 17.

144. Saenger, et al., "Radiotherapy of Advanced Cancer," 682.

145. University of Cincinnati College of Medicine to DASA, report of February
1960-October 1961, 20 (emphasis added). Note that the Sloan-Kettering study sought
patients in similar condition.

146. University of Cincinnati College of Medicine to the Defense Atomic
Support Agency, report of 1 May 1968-30 April 1969 ("Radiation Effects on Man:
Manifestations and Therapeutic Effects") (ACHRE No. DOD-042994-A-1), 1 (emphasis
added).

147. University of Cincinnati College of Medicine to the Defense Atomic
Support Agency, report of 1 May 1969-30 April 1970 ("Radiation Effects on Man:
Manifestations and Therapeutic Effects") (ACHRE No. DOD-042994-A-1), 1 (emphasis
added).

148. Ibid., 34. Over the course of the study, twenty-eight patients lived more
than one year after being irradiated; seventeen survived for more than two years, at least

417

three people lived more than five years.

149. Suskind report, 65.

150. Ibid., 63.

151. McConnell to Gravel, 3 January 1 972, 8. Autopsies were performed on
only eight patients, so bone marrow biopsies were used for this evaluation.

152. Eugene L. Saenger et al., "Radiotherapy of Advanced Cancer," 677.

153. Eugene L. Saenger, 20 October 1994 ("How Can the Quality and Length of
Life of a Cancer Patient Be Determined?") (ACHRE No. IND-021095-B-2).

1 54. The article reported that the median survival time for the three cancers for
which there was a statistically large-enough group-colon, cancer, breast-was longer
than comparable groups receiving no treatment, and almost as long as for patient groups
receiving chemotherapy. Saenger et al., "Radiotherapy of Advanced Cancer," 672-676.

155. Suskind report, 59.

156. Ibid.

157. University of Cincinnati College of Medicine to the Defense Atomic
Support Agency, report of February 1 960-October 1961 ("Metabolic Changes in
Humans Following Total Body Irradiation") (ACHRE No. DOD-042994-A-1), 3-4.
When asked by ACHRE staff whether information on these side effects would have been
withheld in the absence of the DOD funding, Dr. Saenger replied in the first interview
that "we would not have [had that period of silence]." Interview with Saenger, 15
September 1994, 74. In the second interview he said that he probably would still have
withheld the information. Interview with Saenger, 20 October 1994, 12. A number of
contemporary articles discuss the use of compazine in the treatment of radiation sickness.
See, for example, Joseph H. Marks, "Use of Chlorpromazine in Radiation Sickness and
Nausea from Other Causes," New England Journal of Medicine (June 1 954): 999- 1 00 1 ;
M. J. Solan, "Prochlorperazine and Irradiation Sickness," British Medical Journal (21
November 1959): 1068-1069; G. H. Berry, W. Duncan, and Carol M. Bowman, "The
Prevention of Radiation Sickness: Report of a Double Blind Random Clinical Trial
Using Prochlorperazine and Metopimazine," Clinical Radiology 22 (1971): 534-537.

158. Melville L. Jacobs and Fred J. Marasso, "A Four-Year Experience with
Total-Body Irradiation," Radiology 84 (1965): 452-456 (twelve of fifty-two patients still
experienced some degree of nausea and vomiting). This was the only known U.S. TBI-
effects study that performed TBI on patients with radioresistant cancers that does not
appear to have been funded by the DOD. Sixteen of the fifty-two patients had
radioresistant carcinomas and were chosen because they had life expectancies of less than
one month. Ibid.

159. Three main consent forms were used: the first beginning in 1965; the
second beginning in 1967; and the third beginning in 1971 (ACHRE No. DOD-042994-
A-22).

160. Dr. Saenger stated that he was prompted to begin the use of written consent
when he received a letter in 1964 from the DASA requiring all DOD components and
contractors to obtain written consent for the use of "investigational drugs in any manner,
including research programs." Saenger said he reasoned that there was little difference
between drugs and radiation in this context and therefore applied the same standard.
Interview with Saenger, 15 September 1994, 77.

161. A second form went into effect at the same time for bone marrow
aspiration and storage and is basically the same as the above.

418

162. Gore Hearing, 35-36.

163. University of Cincinnati Medical Center, Faculty Committee on Research,
1967, "Voluntary Consent Statement."

164. University of Cincinnati, "Consent Form," 1971.

165. Interview with Saenger, 20 October 1 994, 7-8. This procedure is also
described by Dr. Silberstein in "Extension of Two-part Consent Form," New England
Journal of Medicine 29 1 ( 1 974): 155-1 56.

166. Advisory Committee on Human Radiation Experiments, transcript of
Cincinnati Small Panel Meeting, 21 October 1994, 136.

167. Suskind report, 50.

168. ACR report, 7.

169. Suskind report, 28-29. It also notes approximately 2 percent of all patients
(both in- and outpatient) at the hospital were private patients. Ibid., 29.

170. In 1969, several of the University of Cincinnati researchers reported on the
effects of TBI and PBI on cognitive and emotional processes based on a study involving
sixteen of the patients. The published article notes that the "relevant intellectual
characteristics of the patient sample were as follows: a low-educational level (ranging
from 0 to eight years of education with a mean of 4.2 years), a low-functioning
intelligence quotient (ranging from 63 to 1 12 on the full-scale Wechsler-Bellevue with a
mean of 84.5), and a strong evidence of cerebral organic deficit in the baseline
(preradiation) measure of most of the patients." Louis A. Gottschalk, Eugene L. Saenger
et al., "Total and Half Body Irradiation: Effect on Cognitive and Emotional Processes,"
Archives of General Psychiatry 21 (November 1969): 574,575. Although these
findings suggest that there may have been serious issues about competence among the
Cincinnati subjects, questions have been raised about this interpretation. For example,
Martha Stephens, former chair of the JFA, has argued as follows: "These citizens were
not necessarily dumb or defective, and nothing whatever, in my view, can be judged from
the batteries of tests of the psychologists; in the very face of them, they are unconvincing
and contradictory. . . . These individuals were in a bad place in life— cancer was more
frightening then than it is now, and so were public hospitals. To find people coming to
tumor wards (or in the hospital for evaluation of their cancers) to be depressed and upset
and somewhat disoriented, and not particularly interested in answering irrelevant
questions . . . would be quite normal, I would guess. ... It seems to be best not to lead
the public to believe that what happened in Cincinnati could only have happened to
people who weren't smart enough to protect themselves, were virtually retarded." Martha
Stephens to Gary Stern, Advisory Committee staff, 3 June 1995 ("I want to thank you for
the documents . . .") (ACHRE No. IND-060595-A), 10-11.

171. ORINS was renamed the Oak Ridge Associated Universities (ORAU) in
1966. In 1991, ORAU became the contractor of the Oak Ridge Institute for Science and
Education (ORISE).

172. Following standard retention schedules, NASA destroyed funding and
procurement records on the Oak Ridge project in 1980. Additional administrative,
technical monitoring, and contractor reports still exist. Medical records associated with
this project were never in the possession of NASA and always resided with
ORINS/ORAU.

173. ORINS had training courses in the handling and use of radioisotopes; it
also helped develop the supervoltage cobalt 60 teletherapy machine.

419

174. Gore Hearing, 110.

175. Howard L. Rosenberg, "Informed Consent: How the Space Program
Experimented with Dwayne Sexton's Life," Mother Jones, September/October 1981, 31-
44. On 13 March 1994, 60 Minutes aired a story based on the Mother Jones article.

176. Gore Hearing, 1 10.

177. Gore Hearing, 144.

178. Gore Hearing, 161 (statement of Andrew J. Stofan, Acting Associate
Administrator for NASA Office of Space Sciences).

179. Ibid., 200. See also page 151 (testimony of William R. Bibb, Director of
the Research Division, Oak Ridge Operations Office) and 159-63 (testimony of Stofan).

180. Ibid., 290.

181. G. A. Andrews et al., paper of December 1 970 for Oak Ridge Associated
Universities ("Hematologic and Therapeutic Effects of Total-Body Irradiation (50 R-100
R) in Patients with Malignant Lymphoma, Chronic Lymphocytic and Granulocytic
Leukemias, and Polycythemia Vera"), 2, reprinted in Gore Hearing, 49.

182. Gore Hearing, 264.

183. Ibid., 291.

184. Ibid., 293.

185. Ibid., 294-295. Following the Gore Hearing, Dr. Helen Vodopick, one of
the ORAU physicians who testified, wrote a memo to the file stating that "the therapy
given was different from other therapy given that had been tried at that time. However,
the other therapies that were being investigated were also radically different. ... All of
these various approaches were tried since nothing had worked before and certainly
something new and innovative had to be tried to try to improve the survival rate of acute
leukemia in children." Comments to the file prepared by Helen Vodopick, M.D.,
following the Gore Hearing, 6.

186. Reprinted in Gore Hearing, 32-33.

187. U.S. Atomic Energy Commission, report of 16 April 1974 ("ORAU
Review"), reprinted in Gore Hearing, 186. William Bibb testified that this report was
written for the purpose of shutting down the hospital, which had outlived its purposes
and could no longer be justified as a necessary AEC program. Accordingly, he stated,
some of the statements in the report were "overstatements in order to accomplish what
we felt should be accomplished, knowing full well that closing down any Government
hospital is hard, closing down that hospital was extraordinarily hard." Gore Hearing,
182.

188. H. R. Resolution 1010, 97th Cong., 2d Sess. 186(1983). The Committee
noted that a later hearing was held on the state of radiation epidemiology within DOE on
19 May 1982. Ibid.

189. It had recommended that ORAU compare the effect of TBI with
chemotherapy "for a variety of other solid tumors such as carcinoma of the breast,
carcinoma of the gastroenteric tract, the urogenital tract, etc., as well as for lymphomas."
U.S. Atomic Energy Commission, report of 16 April 1974, reprinted in Gore Hearing,
247.

190. Ibid., reprinted in Gore Hearing, 252.

420

PRISONERS: A CAPTIVE RESEARCH

POPULATION

In July 1949 a medical advisory panel met in Washington, D.C., to
discuss psychological problems posed by radiation to crews of a then-planned
nuclear-powered airplane. During the meeting an Air Force colonel noted that
crewmen were concerned about anything physically harmful, but especially
anything seen as a threat to what he delicately called, using a euphemism of that
gentler era, the "family jewels."', The nuclear-powered airplane was never built,
but concern about radiation hazards to testicular function in space flight, weapons
plants, nuclear power plants, and on an atomic battlefield remained.

This concern provides some of the context for a brace of almost identical
experiments carried out between 1963 and 1973 in which 131 prisoners in Oregon
and Washington submitted to experimental testicular irradiations with national
security and other societal goals, but no potential for therapeutic benefit for the
subjects. The studies were directed by Carl G. Heller, M.D., a leading
endocrinologist of his day, and by Dr. Heller's protege, C. Alvin Paulsen, M.D.
Perhaps because they involved irradiation of the testicles, they have caused great
public concern. They were also noted briefly among the thirty-one experiments
Representative Edward J. Markey of Massachusetts publicized in his 1986 report
on radiation research on human subjects.2 Both studies were funded solely by the
Atomic Energy Commission. Drs. Heller and Paulsen were interested in the
effects of radiation on the male reproductive system, especially the production of
sperm cells. The government was interested in the effects of ionizing radiation on
workers, astronauts, and other Americans who might be exposed, in a nuclear
attack for example.

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Part II

Both doctors viewed prisoners as ideal subjects. They were healthy, adult
males who were not going anywhere soon. In 1963 few if any researchers had
moral qualms about using them as subjects, although there seems to have been a
consensus in the research community on the rules that should govern such
experimentation. By 1973, however, some ethicists, researchers, and others, such
as the investigative journalist Jessica Mitford, pointed out that incarcerated people
were not well placed to make voluntary decisions. In 1976, the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research recommended the banning of almost all research on prisoners. Prison
experimentation effectively came to an end in this country a few years after the
commission offered its recommendations.

The Heller and Paulsen experiments were groundbreaking scientifically,
and they were conceived as having an important government purpose-protecting
Americans engaged in building the nation's high-priority nuclear and space
programs. But looking back through the lens of history, there appears to be an
inconsistency between the way human subjects were treated in this research and
the standards intended to govern their treatment. Although both Dr. Heller and
Dr. Paulsen showed sensitivity to some ethical issues, in both cases the
researchers themselves and some of those charged with oversight at both the
federal and state levels did not completely live up to what appear to have been
well-understood standards applicable to their research. In this failure they were
no different from many if not most of their contemporaries. Times were
changing, however, and in the end, state officials shut down both sets of
experiments, bringing practice more into line with the standards already on the
books of some government agencies and private research organizations.

Among researchers who used prisoners as subjects, as early as 1958 the
Nuremberg Code was recognized as a model set of rules for conducting human
subject research.3 It is equally clear that the work in the Oregon and Washington
prisons did not carefully follow all these rules. Moreover, the funding agency,
the Atomic Energy Commission, had its own rules for the conduct of research
with human volunteers, which were not fully observed in these experiments. As
discussed in chapter 1, in 1956 the AEC's Isotope Division program provided that
where healthy subjects were used for research, they needed to be volunteers "to
whom the intent of the study and the effects of radiation have been outlined." A
1966 memorandum from the AEC's office of general counsel to the director of the
Division of Biology and Medicine sheds some light on the agency's standards at
that time, and why it had them. The specific experiments referred to in the
memo-plutonium and promethium injections or ingestion— appear not to have
been carried out, but the "use of human volunteers in experiments" is addressed in
general terms. The memo calls for "volunteers]" to sign a written, witnessed
agreement attesting to their sound mental state and free will, to their
understanding of the purposes and risks of the planned experimentation, and that
the experiment was not being done for their benefit. The relevant paragraph

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Chapter 9

concludes: "Assuming complete understanding and no unequal bargaining factors
(e.g. pressure on prisoners to submit), such an agreement would protect against
liability for unauthorized invasion of the person."4

Finally, those attending a 1962 conference on research using prisoners as
subjects reached a consensus on a higher standard for subject selection and
informed consent than was typically observed in Oregon and Washington. For
example, the conferees argued that potential prisoner subjects should have enough
information to avoid their being deceived and that inducements to prisoners
should not be so high as to invalidate consent.

The surviving researchers disagree somewhat about the genesis of the
testicular irradiation experiments, which the available documentary evidence does
not completely resolve. What follows is a version based on and consistent with
both the Heller and Paulsen accounts.

Early in 1963 the AEC held a conference in Fort Collins, Colorado, for
investigators who were using radiation in studies of reproduction in animals. Dr.
Heller was invited. In a bedside deposition taken after he suffered a stroke in
1976, he recounted what happened:

The whole conference finally focused on man. A
given group at Fort Collins was working on mice
and another group was working on bulls, and then
they concluded, what would happen to man[?]
They extrapolated the data from bulls or mice to
man. I commented one day to Dr. [Paul] Henshaw,
who was then . . . with the AEC, that if they were so
interested in whether it was happening to man, why
were they fussing around with mice and beagle
dogs and canaries and so on? If they wanted to
know about man, why not work on man[?]5

According to Dr. Heller, that remark stimulated the AEC to solicit a
research proposal from him to study the effects of radiation on the male
reproductive system.

Dr. Paulsen, however, recalled a different scenario in a 1994 interview by
Committee staff at his office in Seattle.6 He said he was invited to the AEC's
Hanford, Washington, facility in 1962 to act as a consultant after three workers
were accidentally exposed to radiation. Like Dr. Heller, Dr. Paulsen had no
previous experience with radiation exposure. He said he was brought in because
of a chapter he had written on the testes in an endocrinology text. As a result of
that experience, Dr. Paulsen said, he became interested in doing work on the
effects of radiation on testicular function, discussed his idea with colleagues, and
contacted the AEC to see if the agency would be interested in funding his work.

Whether or not Drs. Heller and Paulsen initiated their projects separately,

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Part II

the practical result was that both received AEC funding and carried out their
research projects during the 1960s and early 1970s in the Oregon and Washington
state prisons, respectively. Although the two studies were very much alike in
their methods and objectives, there were small differences. They used different
consent forms, different levels and means of irradiation, and different subject-
selection procedures.

This chapter provides accounts of the Washington and Oregon
experiments that focus on the failure of these two research projects to live up fully
to ethical standards of their time; the Committee's analysis of the risk to subjects
in the two experiments; capsule descriptions of a number of other radiation
experiments using prisoners as subjects; and a general ethical analysis of radiation
experiments using prisoners as subjects.

THE OREGON AND WASHINGTON EXPERIMENTS

Oregon

In 1963 Carl Heller was an internationally renowned medical scientist, a
winner of the important Ciba Prize. In the field of endocrinology, he was a
preeminent researcher, so it is not surprising that when the AEC decided to fund
work on how radiation affects male reproductive function, they would turn to
him. He designed a study to test the effects of radiation on the somatic and
germinal cells of the testes, the doses of radiation that would produce changes or
induce damage in spermatogenic cells, the amount of time it would take for cell
production to recover, and the effects of radiation on hormone excretion.7 To
accomplish this he had a machine designed and built that would give a carefully
calibrated, uniform dose of radiation from two sides. The subject lay face down
with his scrotum in a small plastic box filled with warm water to encourage the
testes to descend. On either side of the box were a matched set of x-ray tubes.
The alignment of the x-ray beams could be checked through a system of
peepholes and mirrors. Subjects were required to agree to be vasectomized
because of a perceived small risk of chromosomal damage that could lead to their
fathering genetically damaged children. To carry out this work Dr. Heller was to
receive grants totaling $1.12 million over ten years.

Mavis Rowley, Dr. Heller's former laboratory assistant, who was
interviewed by Advisory Committee staff in 1 994, said that the AEC "was looking
for a mechanism to measure the effect of ionizing radiation on the human
body. . . ." She said testicular irradiation was promising because the testes have "a
cell cycle and physiology which allows you to make objective measurements of
dosimetry and effect without having to expose the whole body to radiation."8

Although official documentation is fragmentary, it is clear from other
evidence such as interviews and contemporary newspaper articles that the
concerns cited above—worker exposures, potential exposures of the general

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population as a result of accidents or bomb blasts, and exposures of astronauts in
space-- were of interest to the AEC.

In the case of the astronauts, the National Aeronautics and Space
Administration has been able to find no evidence of direct involvement in Dr.
Heller's project. Yet Ms. Rowley remembers with clarity that NASA
representatives, even astronauts themselves, attended meetings with their research

team. In her 1994 interview, she said, "NASA was also very interested in this

There was a section of activity which was devoted to what effect would the sun
flares and so forth, which give out significant radiation have on the astronauts.
And so there were meetings that went on which actually included some of the

astronauts attending them " Rowley explained that the astronauts were

concerned that reduced testosterone production might make them lose muscle
function, which could compromise their mission, but, belying the comment of the
colonel in the 1 949 nuclear-powered airplane meeting who said that crewmen
were concerned about anything physically harmful, she said they seemed
altogether unconcerned "about their own health."9 During his 1976 deposition.
Dr. Heller remarked: "What we would like to supply the medical community with
is what happens when you give continual very small doses such as might be given
to an astronaut."10 Moreover, in 1965, Dr. Heller served as a consultant to a
Space Radiation Panel of the National Academy of Sciences-National Research
Council. And finally, Harold Bibeau, an Oregon subject, recalls that Dr. Heller
told him when he signed up for the program that NASA was interested in the
results."

At the time the Oregon experiment got under way, using prisoners as
research subjects was an accepted practice in the United States. And in this
particular study Oregon law was interpreted by state officials as permitting an
inmate to give his consent to a vasectomy, which they appear to have seen as
analogous to consenting to becoming an experimental subject. However,
important ethical concerns of today such as balancing risks and benefits, the
quality of informed consent, and subject-selection criteria appear, on the whole,
not to have been carefully addressed or not addressed at all by the investigators
or those responsible for oversight.

With respect to the health risks associated with the testicular irradiations,
there was very little reliable "human" information at the time about the long-term
effects of organ-specific testicular exposure to radiation. Hiroshima and
Nagasaki bomb data, however, which of course were not organ specific,
suggested that the likelihood of inducing cancers with the amount of radiation Dr.
Heller planned to use was small. By way of comparison, today's standard
radiotherapy of the pelvis, for prostate cancer for example, often results in doses
to the testicles in the ranges encountered in these experiments.

So what did Dr. Heller tell subjects about the chronic risk? The answer
appears to have been nothing in the early years and, later on, perhaps a vague
reference to the possibility of "tumors" but not cancer. In a deposition taken in

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Part II

1 976 a subject named John Henry Atkinson said he was never told there was a
possibility of getting cancer or any kind of tumors as a result of the testicular
irradiation experiments. Other subjects deposed in 1 976 also said they had not
been warned of cancer risk, and when asked by one subject about the potential for
"bad effects," Dr. Heller was reported to have said, "one chance in a million."12
When asked in his own deposition what the potential risks were, Dr. Heller said,
"The possibility of tumors of the testes." In response to the question "Are you
talking about cancer?" Dr. Heller responded, "I didn't want to frighten them so I
said tumor; I may have on occasion said cancer."13

The acute risks of the exposures included skin burns, pain from the
biopsies, orchitis (testicular inflammation) induced by repeated biopsies, and
bleeding into the scrotum from the biopsies. Using consent forms and depositions
as a basis for determining what the subjects were told, it appears that they were
adequately informed about the possibility of skin burns; sometimes informed, but
perhaps inadequately, about the possibility of pain; informed about the possibility
of bleeding only from 1970 on; and never informed of the possibility of orchitis.

As far as the quality of consent is concerned, the evidence suggests that
many if not most of the subjects might not have appreciated that some small risk
of testicular cancer was involved. It is also not clear that all subjects understood
that there could be significant pain associated with the biopsies and possible long-
term effects.

In selecting subjects, Dr. Heller appears to have relied on the prison
grapevine to get out the word about a project he apparently believed the Atomic
Energy Commission did not want publicized. In a 1964 memorandum he was
paraphrased as saying "at Oregon State Penitentiary, the existence of the project is
practically unknown."14 In a 1966 letter to the National Institutes of Health
describing the review process at the Pacific Northwest Research Foundation, a
respected, free-standing research center, Dr. Heller and two colleagues wrote that
"the inmates are well informed by fellow inmates regarding the general
procedures concerned (i.e., collecting seminal samples, collecting urines for
hormone studies, submitting to testicular biopsies, receiving medication orally or
by injection, and having vasectomies . . . )."15 If the volunteers were healthy and
normal they were accepted for a trial period during which they donated semen
samples. If all went well, in a matter of weeks they were accepted into the
radiation program, as long as the prison's Roman Catholic chaplain certified that
they were not Roman Catholics—because of the church's objection to their
providing masturbated semen samples—and they could pass what appears to have
been a cursory psychological screening designed to ensure they had no underlying
objections to the required vasectomy. A copy of a form titled "Psychiatric
Examination" provided by Harold Bibeau and signed with the initials of the
examining psychiatrist, WHC for William Harold Cloyd, says in full:

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Chapter 9

1 1-4-64 Seen for Dr. Heller — - Never married,
quite vague about future. Feels he doesn't want
children — - shouldn't have any. I agree. No
contraindication to sterilization.

As far as potential health benefits to the subjects are concerned, there were
none, and the inmates who volunteered for the research were told so. The
benefits were in the form of financial incentives. A review of applications for Dr.
Heller's program, and depositions of prisoners who sued Dr. Heller, various other
individuals, and the state and federal governments for violation of their rights,
clearly indicates that money was in most cases the most important consideration
in deciding to volunteer. In prison industry inmates were typically paid 25 cents a
day. For participating in the Heller program they received $25 for each testicular
biopsy, of which most inmates had five or more, plus a bonus when they were
vasectomized at the end of the program, which appears to have been an additional
$25. Some inmates indicated that they were grateful for an opportunity to
perform a service to society. An obvious ethical question is whether the money
constituted a coercive offer to prisoners.16

During the course of his study between 1963 and 1973 Dr. Heller
irradiated sixty-seven inmates of the Oregon State Prison. Nominally, three
institutions had some oversight responsibility for Dr. Heller's work~the Oregon
Department of Corrections, the Atomic Energy Commission, and the Pacific
Northwest Research Foundation, where Dr. Heller was employed. Practically
speaking, however, it appears that Dr. Heller conducted his research
independently. As an example of his independence, as recounted by Ms. Rowley,
the AEC requested that Dr. Heller begin irradiating subjects at 600 rad and work
upward, but he refused and in the end set 600 rad as an upper limit.17 (It is not
clear whether Dr. Heller was concerned about risk to the subjects' health or other
research criteria.) Dr. Heller also was a member of the committee at Pacific
Northwest Research Foundation that had responsibility for overseeing his
research, giving him a voice in the oversight process. This committee was
authorized under a foundation regulation titled "Policy and Procedures of the
Pacific Northwest Research Foundation With Regard to Investigations Involving
Human Subjects." In a section on ethical policy, the document says: "Since 1958
the investigators of this Foundation have conducted all research under the ethical
provisions of the Nuremburg [sic] Code, modified to permit consent by parents or
legal guardians.""*

In January 1973, in a rapidly changing research ethics environment, the
Oregon irradiations were terminated when Amos Reed, administrator of the
Corrections Division, ordered all medical experimentation programs shut down
essentially because he concluded that prisoners could not consent freely to
participate as subjects. It is not known exactly what was behind the timing of
Reed's decision, but according to Oregon Times Magazine, he had recently read

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Jessica Mitford's article in the Atlantic Monthly titled "Experiments Behind Bars"
and an article in The (Portland) Oregonian headlined "Medical Research Provides
Source of Income for Prisoners."19

In 1976, a number of subjects filed lawsuits effectively alleging poorly
supervised research and lack of informed consent. In their depositions they
alleged among other things that prisoners had sometimes controlled the radiation
dose to which they were exposed, that an inmate with a grudge against a subject
filled a syringe with water instead of Novocain, resulting in a vasectomy
performed without anesthetic, and that the experimental procedures resulted in
considerable pain and discomfort for which they were not prepared.20 These suits
were settled out of court in 1979. Nine plaintiffs shared $2,215 in damages.21

For the last twenty years all efforts to put in place a medical follow-up
program for the Oregon subjects have been unsuccessful. Dr. Heller and Ms.
Rowley explicitly favored regular medical follow-up. During the period between
1976 and 1979, the pending lawsuits might have been the reason for the state's
reluctance to initiate a follow-up program, but it is less clear why during other
periods such efforts have also failed. Two possible reasons suggested by state
officials are the cost of such a program and the difficulty of finding released
convicts. Other possible reasons are that a follow-up program would not provide
a significant health benefit to former subjects and that it would not provide
significant new scientific knowledge. According to Tom Toombs, administrator
of the Corrections Division of the State of Oregon at the time of the lawsuits, the
Corrections Division wrote to the AEC's successor (the Energy Research and
Development Administration) in early 1976 recommending medical follow-up for
the subjects. Mr. Toombs said there was no record of a response to this request.22
In 1990, James Ruttenber, an epidemiologist at the Centers for Disease Control,
designed a follow-up program for Oregon, but it has not been implemented. In an
interview with Advisory Committee staff, Dr. Ruttenber said state officials told
him that Oregon does not have sufficient funds to carry out his plan.23

Washington

C. Alvin Paulsen was a student of Carl Heller at the University of Oregon
in the late 1940s, and in the early 1950s he was a fellow in Heller's lab. But by
1963 he was ready to direct a substantial research program on his own. His
chance came when he was called to Hanford to consult on an accidental radiation
exposure of three workers. The upshot of this experience was a $505,000 grant
from the Atomic Energy Commission to study the effects of ionizing radiation on
testicular function. Dr. Paulsen remarked in the 1994 interview with Advisory
Committee staff that the main research questions he was trying to answer were
what would constitute "a reasonably safe dose" of ionizing radiation to the testes
as well as what dose "would cause some change in sperm production and
secondly, to determine the scenario of recovery."24 He recalled a 1962 letter to

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the Washington State Department of Institutions in which he wrote that he would
like to find out "the maximum dose of radiation that would not alter
spermatogenesis" and "the maximum dose of radiation that affects
spermatogenesis, but only temporarily."25 Dr. Paulsen said in a 1995 telephone
interview, however, that for reasons he can no longer remember, he limited
dosage to 400 rad, not enough to test a maximum-dose thesis.26
In the 1994 interview, Dr. Paulsen said:

When I recognized a tremendous void of
information relative to human exposure, and space
travel had started and there was the question of
solar explosions and ionizing radiation exposure in
space, the nuclear power plants were going in then,
a few men throughout the world were exposed ... I
then contacted the Atomic Energy Commission to
determine . . . whether they would entertain
receiving an application.27

Obviously, Dr. Paulsen too was interested in the space applications of his
research. In 1972 he and a colleague published their work titled "Effects of X-
Ray Irradiation on Human Spermatogenesis" in the proceedings of the National
Symposium on Natural and Manmade Radiation, a NASA-sponsored symposium.
And Dr. Paulsen said that when he explained his research to potential subjects,
one of the things he referred to was concern about exposures in space.28 An
August 1, 1963, article in the Oregonian about the Washington experiments said,
"Although one of the primary benefits of the research will be in space exploration,
the findings are also expected to be of value to an atomic industry where an
occupational hazard might exist."29

One major difference between the Heller and Paulsen projects was that
from the outset Dr. Paulsen planned to eventually move from x rays to neutron
irradiation, which, among other things, is more analogous than x rays with the
radiation encountered in space.30 A neutron generator was purchased, calibrated,
and shielding was developed. However, the work took years to complete, and this
part of the research was never carried out. Dr. Paulsen has expressed the belief
on a number of occasions that one reason his project was terminated by the state
of Washington in 1970 was concern about the possibly greater risks of exposing
subjects to neutrons. Another difference was that Dr. Paulsen used a standard
General Electric x-ray machine, which he says he believed would deliver as
precise and well-targeted a dose of radiation as Dr. Heller's specially designed
machine.31

Still another difference was that at a certain stage of the Washington
study, Dr. Paulsen used the prison bulletin board to advertise for volunteers.

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Under the headline "Subject: Additional Volunteers for Radiation Research
Project," a notice said in part:

The project concerns effects of radiation on human
testicular function and the results of the project will
be utilized in the safety of personnel working
around atomic steam plants, etc. ... It is possible
that those men receiving the higher dosages may be
temporarily, or even permanently, sterilized. It
should be understood that when sterilized in this
manner, a man still has the same desires and can
still perform as he always has. . . . Submit to
surgical biopsy. (This is a simple procedure
performed under local anesthesia. It is not a very
painful procedure.)32

According to a March 9, 1976, report prepared for then-Governor Daniel
J. Evans by Harold B. Bradley, director of Washington state's Adult Corrections
Division, neither Dr. Paulsen's 1963 outline of his research project nor the
November 1 964 announcement to inmates mentioned a requirement to undergo a
vasectomy at the end of the experiment to ensure that subjects would not father
genetically damaged children.33 Dr. Paulsen said he did not recall precisely when
in the recruitment process the vasectomy requirement was conveyed to subjects,
but he pointed out that once it was they had the option of dropping out of the
project without penalty.34

Dr. Paulsen's review process and consent procedures are less well
documented than Dr. Heller's, but he says his research application, including
provisions for subject selection and consent, was approved by what he described
as a "human experimentation committee" at the University of Washington. He
said the process was "very informal," noting that it was done over the phone.
Paulsen added that "somewhat later" his work was also reviewed by a "radiation
safety committee."35 His recollection of both processes is vague. The minutes of
a December 10, 1969, meeting of a University of Washington Research and
Clinical Investigations Committee at the U.S. Public Health Service Hospital in
Seattle includes a recommendation that Dr. Paulsen's consent form be modified to
indicate that "a risk of carcinoma of the testes exists although it is extremely
small."36 According to Mr. Bradley's report, his department's records show that
Dr. Paulsen's project was reviewed and approved on two occasions—March 1963
and June 1966--by the University Hospital Clinical Investigation Committee. The
report shows no state Department of Institutions review until mid- 1 969. 37

The Bradley report and related correspondence from 1970 show that at
that time some state officials had a sharp concern for research ethics. In mid-
1969 a review of all experimentation in the prison system was undertaken by Dr.

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Audrey R. Holliday, chief of research for the Department of Institutions At this
time Dr. Holliday took steps to temporarily halt the irradiation phase of the
project. After investigating the origins of Dr. Paulsen's research, Dr Holliday
asked the University of Washington to conduct a new review of the study
emphasizing her concern about the state's responsibility to safeguard human
rights. The university stood by its initial findings allowing the research to
continue, although at about the same time it turned down Dr. Paulsen's request to
move into the neutron-irradiation phase of his project.31*

Dr. Holliday then debated the issue with Dr. William Conte, director of
the Department of Institutions, who was disposed to allow the project to continue
On March 18, 1970, she wrote a letter to Dr. Conte noting,

. . .There is no question but what the Federal
Government has made considerable investment in
this project. The Federal Government, however, as
a reading of any newspaper will show, has
supported a number of projects over which there
have been many moral-ethical questions (both large
and small) raised, e.g., nerve gasses, toxins, etc. I
remind you that the Federal Government is not
responsible for the care, safety and safeguarding of
human rights of populations under the purview of
the Department of Institutions. This is a
responsibility we must discharge, regardless of the
amount of money that the Federal Government is
willing to invest in a project. . . .

There is no doubt but what the prison setting is an
ideal setting for this type of research. ... I suppose
concentration camps provided ideal settings for the
research conducted in them If , in fact, non-
inmates were to volunteer in the substantial
numbers of persons Dr. Paulsen needs, then I would
have less qualms about offering up a captive
population for this research, i.e., I would have some
evidence, assuming the volunteers were, in fact,
normal, that non-captive populations might make
the same decision as a captive population

I am not against high risk research. I have engaged
in some myself. I am not against federally
sponsored research. I have engaged in some
myself. However, the risk should be commensurate

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with the probable benefits to be received by the
population or others like it to follow. I don't think
we can argue that in this case.

Neither am I opposed to use of a prison population
on a volunteer basis for research projects that may
not be of direct benefit to the population, but which
are of clear benefit to society or mankind. I don't
think we can argue that in this case either.39

Dr. Holliday also argued that the study should have been done on "lower
order primates" and that if the state allowed Dr. Paulsen's study to continue it
would forfeit its right to speak out on behalf of human rights relating to future
research proposals.40

While favoring continuation of Dr. Paulsen's research, Dr. Conte
authorized a review by the Department of Institutions's Human Rights Review
Committee. The committee recommended that the study be shut down, noting
that the Paulsen project "seems clearly inconsistent with the standards laid down
by the Nuremberg Code" for the protection of human subjects with respect to
freedom of choice and consent. The recommendation went on to say that "within
the context of Dr. Paulsen's project, it is largely irrelevant whether or not a
volunteer declares his 'desire to undergo vasectomy' since there is no assurance
that his real reasons would be ethically-morally acceptable or that his reasons
(whatever they may be) will stand the test of reality after release." It specified
that the money paid for participation and the expectation of privileges, "real or
imagined," could constitute undue inducements.41

This review, according to the report, "recommended that Dr. Paulsen's
request for continuation of his study be rejected as it was found to be inconsistent
with standards for the protection of the individual as a research subject. The
essential issue raised by departmental personnel was that of informed consent."
On March 23, 1970, Dr. Holliday wrote to Dr. Paulsen to inform him that his
project was over.42 The Bradley report added that "so far as is known to
departmental personnel, no ill effects have been reported by subjects of the
experiments."43 In 1994, however, a former Washington state inmate named
Martin Smith told Karen Dora Steele of the Spokane Spokesman-Review that ever
since participating in the experiment he has suffered testicular pain.44 Dr. Paulsen
notes, however, that Smith was a control and therefore not actually irradiated,
although he did have one testicular biopsy.45

There has been less debate than in Oregon on the subject of medical
follow-up. This may be in part because Dr. Paulsen has taken the position, based
on his conversations with inmates, that the subjects of the Washington
experiments want their privacy protected, and he has refused to disclose their
names. A December 1 975 AEC memorandum from Nell W. Fraser, a government

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contract administrator, to Oscar J. Bennett, director of the Contracts and
Procurement Division, paraphrases Dr. Paulsen as saying that a follow-up
program was not medically indicated and "a follow-up program would be harmful
because most of the prisoners wish to disassociate themselves with the prison
experience."46 According to the memorandum, Dr. Paulsen also noted that his
medical malpractice insurance would apply in the event that litigation resulted
from his radiation study.47 In recent years, however, a handful of former subjects
have told reporters such as Karen Dorn Steele that they would like to be followed
up.48 In late 1 994 state officials said they would seek federal funds to carry out a
follow-up program or ask the Department of Health and Human Services to
mount such a program.

The Advisory Committee conducted its own analysis of the risks incurred
by the Oregon and Washington testicular irradiation subjects based on a 600-rem
dose, which was the maximum testicular exposure of any subject in either state.
For purposes of this analysis we assumed that the testicles have average radiation
sensitivity; that there is a linear relationship between cancer incidence and dose,
and that there is a linear relationship between the risk of cancer and the amount of
tissue exposed. Using these assumptions, we calculated that it would take more
than double the dose received by any prisoner-subject to yield an effective dose of
1 rem. This means that the predicted increase over the expected cancer rate for
the individuals who received the greatest exposure would be less that four-
hundreths of 1 percent. For those who received smaller doses of radiation, the
risk would, of course, be smaller, too.49

OTHER RADIATION EXPERIMENTS

There is no comprehensive list of radiation experiments with prisoners as
subjects, but in the course of the Advisory Committee's historical research a
handful of such experiments other than those in Oregon and Washington has been
identified. In many cases there is only fragmentary information available, which
the Committee has not always been able to verify. To provide a sense of what else
might have been going on at the time (which may or may not have been
representative), consider the following:

• A former prison administrator in Utah has confirmed that experiments

were conducted on prisoner subjects in the late 1950s or early 1960s in
which blood appears to have been removed, irradiated, and returned to the
body. Prisoners at the time who were interviewed by the Deseret News, a
Salt Lake City newspaper, said they believed that about ten prisoner-
volunteers were studied ih this way. One subject said, "They told us
nothing about the tests. They just said it wouldn't bother us."50 In a 1959
confidential report to the president of the University of Utah, Lowell A.
Woodbury, the radiological safety officer said: "One group of medical

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experimenters with authorization for human experimentation was
administering isotopes to volunteers at the state prison. This was in direct
violation of the terms of their license and while not an extremely serious
violation was apt to result in a citation [from the Atomic Energy
Commission]."51

Experiments were conducted at the Medical College of Virginia in the
early 1950s under the sponsorship of the Army and possibly the Public
Health Service using radioactive tracers. The goal was to study the life
cycle of red blood cells. As discussed in more detail in chapter 13, Dr.
Everett I. Evans, in a letter to the superintendent of the state penitentiary,
quoted from a letter from Colonel John R. Wood of the Army surgeon
general's office, which provided that no information related to research
being conducted for the Army surgeon general be released without review
by the Public Information Office of the Defense Department. Dr. Evans
said the reason for this was that "the problem of the use of prisoner
volunteers is not yet clarified."52

During the 1960s "prison volunteers" in the Colorado State Penitentiary
were used as subjects in an experiment designed to determine the survival
time and characteristics of red blood cells during periods of rapid red cell
formation and during periods of severe iron deficiency. Red cells
transfused into normal recipients were tagged with either radioactive iron
or radioactive phosphorus.53 In a 1976 report on the study, which used
five subjects, the investigators wrote:

The rights of the prisoners were respected in
conformance with the Helsinki Declaration of the
World Health Organization and the Nuremberg
Code. Approval was obtained from the Governor,
Attorney General, and Director of Institutions of the
State of Colorado, the warden and psychiatrist of
the Colorado State Penitentiary, and the nearest of
kin of each volunteer.54

It is not clear from this publication or other documents available to the
Committee precisely what use was made of the principles stated in the
Nuremberg Code and the Declaration of Helsinki in obtaining the consent
of the prisoner-subjects in this experiment. However, if the investigators
did accept Nuremberg and Helsinki as standards for consent in the 1 960s
it adds weight to other evidence (for example, the citation of Nuremberg
by the Human Rights Review Committee of the Department of Institutions

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in the Washington testicular irradiation experiment) that these
standards were considered relevant to research on prisoners in the
1960s.

• Other federally sponsored experiments on prisoner volunteers appear to

have been conducted in Pennsylvania (Holmesburg State Prison, the
effects of radiation on human skin), Oklahoma (Oklahoma State
Penitentiary, routine metabolic studies of experimental drugs using tracer
amounts of radionuclides), Illinois (Stateville Prison, measurements of
radium burden received from drinking water), and California (San
Quentin, tracking movement of iron from plasma to red blood cells using a
radioactive marker).55

HISTORY OF PRISON RESEARCH REGULATION

Dr. Paulsen reported in a recent interview that he had "asked a lot of
people" in 1963 about the use of prisoners as research subjects. He went on to
say that at that time "no one said no" to the use of such subjects in his research.
However, Dr. Paulsen explained in the same interview that he had started to sense
a shift in public opinion around 1970. In particular, he pointed to comments
critical of prison experimentation that he had heard at a New York Academy of
Sciences conference, "New Dimensions in Legal and Ethical Concepts for Human
Research," which he attended in the spring of 1969.56 Of course, we cannot rely
solely on Dr. Paulsen's recollections to provide historical context for experiments
in which he was so intimately involved— and which have now become
controversial. But ample evidence suggests that Dr. Paulsen was essentially
correct in his impression that testicular irradiation experiments in Washington and
Oregon bridged a transitional period in the history of human experimentation
generally and particularly in the history of experimentation in American prisons.

Isolated incidents of prison-based research before World War II formed
the foundation for a practice that would become firmly embedded in the structure
of American clinical research during World War II. Perhaps the most significant
wartime medical research project in which American scientists employed
prisoners as research subjects was centered in Illinois's Stateville Prison.
Beginning in 1944, hundreds of Illinois prisoners submitted to experimental cases
of malaria as researchers attempted to find more effective means to prevent and
cure tropical diseases that ravaged Allied forces in the Pacific Theater.57 In 1947,
a committee was established by the governor of Illinois to examine the ethics of
using state prisoners as research subjects. The committee was chaired by Andrew
Ivy, a prominent University of Illinois physiologist and the chief expert witness
on medical ethics for the prosecutors at the Nuremberg Medical Trial, where
prison research was a salient topic (see chapter 2). The committee pronounced
the wartime experiments at Stateville Prison "ideal" in their conformity with the

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newly adopted rules of the American Medical Association concerning human
experimentation. The AMA rules, which Ivy had played a key role in developing,
included provisions stipulating voluntary consent from subjects, prior animal
experimentation, and carefully managed research under the authority of properly
qualified clinical researchers.51* Perhaps most significantly, the findings of Ivy's
committee were announced to the American medical community when the group's
final report was reproduced in the Journal of the American Medical Association.^
The appearance of this report in the nation's leading medical journal both
represented and reinforced the sentiment that prison research was ethically
acceptable.

Publicly aired assertions that experimentation on prisoners relied on
exploitation or coercion were extremely rare in the United States before the late
1960s. One criticism of medical research behind bars did, however, emerge with
some frequency: prisoners who participated in research were somehow escaping
from their just measures of punishment. Inmates were usually offered rewards in
exchange for their scientific services, ranging from more comfortable
surroundings, to cash, to early release. Perhaps the most powerful statement of
the concern that convicts should not receive special treatment because they had
participated in an experiment came from the AMA. In 1952, this organization
formally approved a resolution stating its "disapproval of the participation in
scientific experiments of persons convicted of murder, rape, arson, kidnapping,
treason, or other heinous crimes." The AMA was alarmed that some such
criminals "have not only received citations, but have in some instances been
granted parole much sooner than would otherwise have occurred."60 (In the
Oregon testicular irradiation experiments it appears that this recommendation
against using inmates accused of "heinous crimes" was not always observed.)

It should be noted that the use of prisoners as research subjects seems to
have been a uniquely American practice in the years following World War II.
The large-scale successes of prison experimentation during World War II~and the
authoritative pronouncement of the Ivy Committee that prison research could be
conducted in an ethical fashion—seem to have given the practice a kind of
momentum in this country that it did not have elsewhere. In other countries it
seems that the first clause of the Nuremberg Code was interpreted to preclude the
use of prisoners in experimentation.61 This clause begins with the assertion that
the only acceptable experimental subjects are those who are "so situated as to be
able to exercise free power of choice."

It is difficult to overemphasize just how common the practice became in
the United States during the postwar years. Researchers employed prisoners as
subjects in a multitude of experiments that ranged in purpose from a desire to
understand the cause of cancer to a need to test the effects of a new cosmetic.
After the Food and Drug Administration's restructuring of drug-testing
regulations in 1962, prisoners became almost the exclusive subjects in
nonfederally funded Phase I pharmaceutical trials designed to test the toxicity of

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new drugs. By 1972, FDA officials estimated that more than 90 percent of all
investigational drugs were first tested on prisoners.62

It appears that throughout the history of medical experimentation on
American prisoners many inmates have valued the opportunity to participate in
medical research. One must quickly add that such an observation points to the
paucity of opportunities open to most prisoners. The common perception among
inmates that participating in a medical experiment was a good opportunity has
had an important impact on the racial aspects of prison experimentation. Because
of the large numbers of African- Americans in prison (and the overt racial
exploitation of the notorious Tuskegee syphilis study, in which black men with
syphilis were observed but not treated), it might be assumed that minorities
predominated as research subjects in prisons. The opposite has generally been
true; white prisoners have usually been overrepresented in the "privileged" role of
research subject. In most prison studies before and during World War II, it seems
that all of the research subjects were white.63 In 1975, the National Commission
for the Protection of Human Subjects of Biomedical and Behavioral Research
carefully examined the racial composition of the research subjects at a prison with
a major drug-testing program. The commission found that African-Americans
made up only 31 percent of the subject population, while this racial "minority"
formed 68 percent of the general prison population.64

The shift in public opinion against the use of prisoners as research
subjects, which began in the late 1960s, was no doubt tied to many other social
and political changes sweeping the country: the civil rights movement, the
women's movement, the patients' rights movement, the prisoners' rights
movement, and the general questioning of authority associated with the anti-
Vietnam War protests. But, as has been common in the history of human
experimentation, scandal galvanized public attention, brought official inquiry, and
resulted in significant change. A major scandal in prison experimentation came
when the New York Times published a front-page article on July 29, 1969,
detailing an ethically and scientifically sloppy drug-testing program that a
physician had established in the state prisons of Alabama.65 Even more
sensational was Jessica Mitford's January 1973 Atlantic Monthly article. In this
article, Mitford portrayed experimentation on prisoners as a practice built on
exploitation and coercion of an extremely disadvantaged class.66 When the article
reappeared later in 1973 as a chapter in her widely read book critiquing American
prisons, she had come up with an especially provocative and suggestive title for
this section of the book: "Cheaper than Chimpanzees."67 Mitford, and most of the
growing number who condemned experimentation on prisoners during the 1 970s
(and after), offered two arguments against the practice. First, prisoners were
identified as incapable of offering voluntary consent because of a belief that most
(some argued, all) prisons are inherently coercive environments. Another line of
argument was based on a principle of justice that stipulated that one class-
especially a disadvantaged class such as prisoners—should not be expected to

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carry an undue burden of service in the realm of medical research.

A few months after the publication of Mitford's article, Senator Edward M.
Kennedy of Massachusetts held hearings to investigate human experimentation.
Kennedy was primarily fired into action by the revelations of the Tuskegee
syphilis study, which made headlines in 1972, but he devoted one full day of his
hearings to the issue of prison experimentation.68 The chief outcome of Kennedy's
hearings was the formation of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research, which, among other
topics, was specifically charged with investigating experimentation on prisoners
(see chapter 3).

The eleven commissioners, including Adviory Committee member
Patricia King-with the assistance of twenty staff members-gathered a wealth of
data on prison medical research, made site visits to prisons, held extensive public
hearings, and engaged in long debates among themselves.69 After their
deliberations, the commission concluded that it was "inclined toward protection
as the most appropriate expression of respect for prisoners as persons."70 But the
commission did not call for an absolute ban on the use of prisoners in medical
research. A steadfast minority on the commission held to a belief that prisoners
should not arbitrarily be denied the opportunity to participate in medical research.
An excursion to the State Prison of Southern Michigan, where Upjohn and Parke-
Davis pharmaceutical companies had cooperatively built and maintained a large
Phase I drug-testing facility, served to reinforce the opinions of this contingent.
In candid conversations with the visiting commissioners, randomly selected
inmates spoke in convincing terms about their support for the drug-testing
program in the Michigan prison.71

The commission's final report reflected this hesitancy to call for a
complete halt to the use of prisoners in nontherapeutic experimentation. The
commission recommended that prisoners could be considered ethically acceptable
experimental subjects if three requirements were satisfied: (1) "the reasons for
involving prisoners in . . . research [were] compelling," (2) "the involvement of
[the] prisoners . . . satisfie[d] conditions of equity," and (3) subjects lived in a
prison characterized by a great deal of "openness" in which a prisoner could
exercise a "high degree of voluntariness." The final requirement involved a
detailed prison accreditation scheme intended to ensure the possibility of
voluntary consent.72

The National Commission derived its primary power from the fact that the
secretary of the Department of Health, Education, and Welfare (DHEW) was
legally compelled to respond to the commission's findings and to justify the
rejection of any commission recommendations.73 Joseph Califano, DHEW
secretary in the Carter administration, spent nearly a year formulating his
response regarding the use of prisoners in medical research. Califano explored
the possibility of an accreditation scheme as suggested by the commission.
However, in a letter to the commission, Califano reported that the American

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Correctional Association, "the one currently qualified [prison] accrediting
organization," had no interest in "accrediting correctional institutions as
performance sites for medical research." "On the contrary," Califano went on to
explain, the ACA had recently decided it "would not fully accredit any institution
which permitted research on prisoners."74 After his interchange with the ACA,
Califano ultimately decided to issue regulations that, for almost all intents and
purposes, brought an end to federally funded nontherapeutic medical research in
American prisons.75

In the interest of uniform federal regulations, Secretary Califano also
"directed" the FDA to issue similar rules governing the use of prisoners in
"research that the FDA accepted] to satisfy its regulatory requirements."76 The
FDA published final rules in the spring of 1980 that were intended, on the
planned effective date of June 1, 1981, to eliminate prisons as acceptable sites for
nontherapeutic pharmaceutical testing.77 However, in July of 1980, almost a year
before the FDA's regulations were scheduled to take effect, a group of prisoners at
the State Prison of Southern Michigan filed suit against the federal government.
These inmates claimed that the impending FDA regulations threatened to violate
their "right" to choose participation in medical research. The case was settled out
of court when FDA attorneys decided to reclassify the agency's prison drug-
testing regulations as "indefinitely" stayed. The FDA's regulations still exist in
this bureaucratic limbo.78

But even before the FDA issued its proposed regulations on the use of
prisoners in drug testing, pharmaceutical companies had already largely
abandoned a practice that had been so widespread only a few years earlier. Most
significantly, pharmaceutical researchers, along with other medical scientists, had
discovered that sufficient numbers of experimental subjects could be found
beyond prison walls. Students and poor people proved to be especially viable
alternative populations from which to draw participants for nontherapeutic
experiments—if the cash rewards were sufficient. The growing controversy
surrounding the use of prisoners as research subjects, combined with the
realization that they could find enough alternate subjects for their needs, led drug
companies to make decisions that were based not so much on ethics as
expediency. The comments of an administrator associated with an Eli Lilly
testing operation at an Indiana prison are revealing and provide a fitting
conclusion to this brief historical analysis: "The reason we closed the doggone
thing down was that we were getting too much hassle and heat from the press. It
just didn't seem worth it."79

ETHICAL CONSIDERATIONS

It is quite clear that all of the radiation experiments that have come to the
Advisory Committee's attention in which prisoners were employed as research
subjects would have been in violation of federal standards as they exist today.

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Federal regulation stipulates an extremely limited range of permissible medical
research in prison populations. Only four types of investigations can currently
receive approval: (1) low-risk studies of "the possible causes, effects, and
processes of incarceration, and of criminal behavior"; (2) low-risk studies of
"prisons as institutional structures or of prisoners as incarcerated persons"; (3)
"research on conditions particularly affecting prisoners as a class (for example,
vaccine trials and other research on hepatitis which is much more prevalent in
prisons than elsewhere . . .)"; and (4) research that has "the intent and reasonable
probability of improving the health or well-being of the subject." Almost
certainly, none of the various episodes of radiation research on prisoners treated
in this chapter would have fallen into any one of these categories.

But as noted above, widespread concern about coercion and exploitation
of prisoner-subjects-which brought about these restrictive federal regulations-
arose relatively recently in this country. For the period before roughly 1970, it is
almost certainly unfair to condemn, in retrospect, a research project as unethical
solely because researchers employed prisoners as subjects; historical sensitivity
demands some appreciation for what seems to have been a genuine lack of
widespread professional or public concern for the ethical problems of prison
research that came to the fore during the 1970s. Only in the case of the
Washington and Oregon testicular irradiation experiments do we know enough to
make any legitimate claims about the extent to which researchers conformed with
reasonable contemporary standards for the ethical conduct of prison
experimentation. And, even for these relatively well-known studies, the
individual complexities of each series of experiments have grown hazier with
time.

One of the first known efforts to examine the ethics of using prisoners as
research subjects was organized by the Law-Medicine Research Institute (LMRI)
of Boston University. The conference was called "The Participation of Prisoners
in Clinical Research," and it opened on February 12, 1962. The conference was
part of a larger LMRI project to study and report on "the actual practices,
attitudes, and philosophies currently being applied in the legal and ethical aspects
of clinical investigation" (see chapter 2). LMRI's conference on prison research
was one of several "invitational work conferences" organized to gather
information on several important topics in human experimentation (other
conferences were devoted to "the concept of consent," pediatric research, and
pharmaceutical testing). The participants at each conference received an agenda
and briefing book in advance of the meetings, but discussions tended to be free-
ranging. Those who attended the conferences understood that their words were
being recorded, but they tended to speak in a frank and revealing fashion because
LMRI pledged to preserve their anonymity when reporting on the meetings.80

A copy of the list of participants at the conference on "The Participation of
Prisoners in Clinical Research," which survives at Boston University, confirms
the following characterization of those who attended:

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Chapter 9

[T]he thirty-six invited participants comprised two
main categories. The first was composed of clinical
research administrators and clinical investigators
with a variety of academic, commercial, and
governmental affiliations, who have had experience
in conducting medical studies with prisoners as
subjects. The second category consisted of prison
administrators and prison medical officers with
various federal, state, and municipal correctional
programs. Also participating in the conference
were representatives of various related fields such
as behavioral science, criminal law, organized
medicine, pharmaceutical manufacturing, and the
military services."'

Unfortunately, a copy of the actual meeting transcript has not survived. However,
the lengthy unpublished "Analytic Summary," which contains many (anonymous)
transcript excerpts, seems to be a fair representation of the daylong meeting.*2 It
is relatively easy to extract several important points of agreement about the proper
conduct of experimentation in prisons from this report. And, given the broad
cross section of those involved in prison experimentation who attended this 1962
conference, it seems reasonable to employ the standards enunciated at this
conference as evidence of prevailing interpretation of ethical standards for
prisoner experiments that began in 1963.

First, the "conferees generally agreed that experimental risks must be
balanced against benefits." In the case of research that was not intended to be of
potential direct benefit to the subject, which was generally the case in prison
experiments, most meeting participants believed that the social or scientific value
of new knowledge that might result from an experiment should be weighed as a
benefit." However, when "confronted with the direct question of whether or not
a relatively high degree of risk can ever constitute a legitimate reason for the use
of prisoner subjects, the conferees were almost unanimous in rejecting this
position."84 Interestingly, those at the conference believed that the general public
was less inclined to worry about subjecting prisoners to high levels of
experimental risk. Two brief transcript excerpts are revealing:

When the public hears that inmates are
[participating in a seemingly very hazardous study],
they rationalize, "Well, I wouldn't do it, but it's all
right with prisoners."85

[T]he public will allow the investigator to go a lot
further, with regard to risks taken with prisoners,

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Part II

than the investigator would go himself.86

The conferees spent a large portion of their day together discussing the matter of
consent. They reached agreement that meaningful consent should be both
voluntary and informed, provided the reach of these terms is carefully
circumscribed. The report stated,

[T]he legal prerequisites of consent are, first, not
absolute free will, but sufficient free choice to avoid
coercion or duress; and, second, not absolutely
perfect knowledge, but enough information to avoid
fraud or deceit."

The conference participants "unanimously agreed that rewards offered to
prisoner volunteers should not be so high as to invalidate their consent to
participate as research subjects."™ There seems to have been considerable
disagreement about exactly where to draw the line between ethically acceptable
and unacceptable rewards to prisoners for service as experimental subjects, but
there was a general desire to "minimize rewards" because it was "consistent with
the penological desirability of maximizing prisoners' 'opportunity for altruism.'"89
As for sentence reductions, some thought that small amounts of "good time"
credits were appropriate, but all agreed that "maximum rewards of this type, i.e.,
definite promises of pardon or parole, should not be given."90 There seems to
have been little discussion of the possibility that the authoritarian structure of
prison life was in itself coercive and therefore limited a prisoner's ability to make
an autonomous decision.

The disclosure component of consent received extensive attention at the
conference. The following was offered as a summation of what the conferees
perceived as the "essential content and emphasis" of the information that should
be conveyed to "prospective prisoner-subjects":

The explanation of a clinical research project . . .
should describe completely the procedures entailed
and should stress the possible consequences of these
procedures. Even though it may be necessary to
"stop somewhere short of full revelation when you
reach intricacies a layman would never
comprehend," there should be no omission of any
adverse consequences, detriments, or risks.91

To strive toward this level of communication, the conference participants cited
procedures that were "usually" followed in most prison experiments: a general
announcement of the research project to the inmates (usually by notices posted on

442

Chapter 9

bulletin boards or printed in prison newsletters); a general explanation of the
project (often in an auditorium) to groups of prisoners who expressed initial
interest in an experiment; and, finally, one-on-one meetings between prospective
participants and research personnel.92 Conferees who had administered or
conducted prison experiments also reported that prisoner-subjects "usually
sign[ed] some type of 'consent agreement.'"93 (Generally speaking the provisions
specified above were followed in the Washington and Oregon experiments, but
the information provided was often inadequate.)

Even with all of these measures, some meeting participants asserted that
the "ideals of comprehension, evaluation, and decision on the part of prisoners
were seldom attained in practice." They pointed to two general difficulties in
achieving these ideals. First, "the lack of intelligence, education, or 'medical
sophistication' among many prisoners." Second, they cited "various 'motives or
pressures which so often stand in the way of objective understanding.'"94 The
participants in the conference also recognized that the consent forms used in
prison experiments were often less than perfect. They understood that the
"waiver or release" components of many forms were probably inappropriate.
They also recognized that reasonably predictable risks of an experiment were not
always carefully listed on consent forms, but at the same time they "agreed that
'no serious' risk should ever be disguised or concealed" on these forms.95

In sum, the records from this conference suggest that even apart from
formal, federal rules for experimentation on prisoners, ethical conditions for the
conduct of prison research were articulated in the early 1960s. Now, with these
conditions in mind, let us turn to a more detailed analysis of the Washington and
Oregon testicular irradiation experiments.

As we have noted, the Committee's ability to assess the quality of consent
obtained from a research subject thirty or forty years earlier can be confounded in
a thousand ways. To begin with, the records are invariably incomplete; then, the
investigators are either no longer alive or their memories have grown hazy or
selective with time; the same is true of subjects; and, of course, there are
confidentiality considerations, which limit the availability of records, the concern
of researchers for their reputations, and so on. All of these considerations, to
greater or lesser degrees, apply to the Oregon and Washington experiments.

With respect to these experiments, however, we believe we have a clear-
enough picture of the standards and practices of the time to evaluate the conduct
of the research against them without reference to the standards and practices of
today.

In both Oregon and Washington, some subjects were not warned, warned
only after enrolling in the experimental program, or inadequately warned that
there was potential risk, albeit small, of testicular cancer. While it might not have
been uncommon at the time for physicians to avoid using the word cancer with
sick or even terminally ill patients for paternalistic reasons, such avoidance is
harder to justify, even by the standards of the time, in the case of healthy subjects

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Part II

who are participating in research that offers them no direct benefit.96

As far as acute effects are concerned, the pain of testicular biopsy may
have been understated in both programs, and the risk of orchitis from repeated
biopsies seems to have been ignored. Some former subjects have complained of
long-term pain, sexual dysfunction, and skin rashes. It is not clear whether these
conditions were caused by the experiments, nor is it certain that long-term
medical follow-up can answer this question.

Subjects in both sets of experiments were required to have a vasectomy at
the end of the program because of concerns about possible chromosomal damage.
In both cases the vasectomy consent forms signed by the subjects, and their wives
if they were married, adequately described the procedure, its consequences, and
the small possibility it could be reversed. However, appropriate questions have
been raised about the reasons inmates might agree to vasectomy in the
circumstances of prison research, and the possibility, as actually occurred in a
number of cases, that in the end the subject would refuse to undergo the
procedure.

Finally, there appears to be little doubt that the financial incentives offered
for participation were the main reason most inmates volunteered. Payments
totaling more than $100 could be seen as unduly influencing the judgment of
potential volunteers. While money also is a powerful incentive for research
participation outside prison walls, we believe that the conditions of confinement
can magnify the perceived value of the reward. Whether the payments offered to
participants in these programs constitute an unfair inducement to participate in
research may vary from inmate to inmate.

While the prison experiments were unethical with respect to current
requirements for disclosure of risk and noncoercion, the researchers functioned
during a period of rapid evolution of the interpretation of ethical principles in the
prison context. Their actions, however, were less than fully consistent with the
existing AEC requirements, especially concerning the information the prisoner-
subjects were provided.

444

ENDNOTES

1 Colonel Don Flickinger, NEPA Medical Advisory Panel, Subcommittee IX,
Washington, D.C., 22 July 1949 (ACHRE No. DOE- 12 1494- A-2), 17.

2. Subcommittee on Energy Conservation and Power, Committee on Energy and
Commerce, House of Representatives, American Nuclear Guinea Pigs: Three Decades
of Radiation Experiments on U.S. Citizens, 99th Cong., 2d Sess., 3.

3. Pacific Northwest Research Foundation, undated ("Policy and Procedures of
the Pacific Northwest Research Foundation with Regard to Investigations Involving
Human Subjects") (ACHRE No. IND-01 1 195-A-l).

4 Bertram H Schur to Dr. Charles L. Dunham, 13 May 1966 ( Use of Human
Volunteers in Biomedical Research") (ACHRE No. DOE-051094-A-138).

5. Deposition of Mavis Rowley and Carl G. Heller, 19 July 1976, Poulsbo,
Washington (ACHRE No. CORP-0 13095- A-2), 18.

6 C. Alvin Paulsen, interview by Steve Klaidman (ACHRE), 8 September
1994, Seattle, Washington, transcript of recording (ACHRE Research Project Series,
Interview Program File, Targeted Interview Project), 10-11.

7 Pacific Northwest Research Foundation, proposal for Atomic Energy
Commission, Division of Biology and Medicine, February 1963 ("Effects of Ionizing
Radiation on the Testicular Function of Man") (ACHRE No. DOE- 122994- A-2); Carl
Heller Pacific Northwest Research Foundation, 27 April 1967 ("Fifth Yearly Proposal.
June l' 1967-May 31, 1968") (ACHRE No. DOE-122994-A-2); Carl Heller, Pacific
Northwest Research Foundation, May 1 972 ("Effects of Ionizing Radiation on the
Testicular Function of Man: 9 Year Progress Report") (ACHRE No. DOE- 122994- A-2);
Mavis Rowley, Division of Nuclear Medicine, Tumor Clinic, Swedish Research Hospital,
undated ("The Effect of Graded Doses of Ionizing Radiation on the Human Testis:
Progress Report, October 1, 1975-September 30, 1976") (ACHRE No. DOE-01 1895-B-
3). The following is a staff-prepared abstract of Dr. Heller's research based on annual
reports, the final report, and his research proposal:

I. OBJECTIVES .

To determine the nature of the cytological changes, both somatic (Sertoli cell) and
germinal (spermatogonia) induced by acute irradiation.

- To determine the dosage required to produce these changes, as well as the dose
to induce permanent damage to spermatogenic cells.

- To determine recovery time.

- To determine radiation-produced alteration of testicular parameters, such as total
gonadotropin, interstitial-cell hormone excretion, estrogen excretion, and
androgen excretion.

II. METHODOLOGY

Subjects received varying doses of X-irradiation to both testes from 8- to 600-rad
single dose. Testicular effects were determined by histological (light microscopy)
examination of pre- and serial postirradiation biopsy specimens. Sperm counts, motility,
morphology, and seminal fluid volume were monitored in serial postirradiation
ejaculates. Hormonal excretion was to be monitored by serial urine and plasma analyses.

- Radiation exposure was controlled by a specially constructed device that assured

445

uniform (plus or minus 5%) irradiation at a dose rate of 100 r/min, approximately
140 kVp with 5 mA tube current, and 2 mm Al filter.

- Some subjects received 10 uCi -'H-thymidine injected intratesticularly to assess
(via autoradiography) effects of radiation on incorporation into spermatogonia!
DNA as a measure of chromosome replication.

III. RATIONALE FOR THE USE OF HUMAN SUBJECTS

- To determine radiosensitivity of germinal elements in man. According to Dr.
Heller, man is unique among commonly studied species in being able to submit
to serial testicular biopsy without damage and biopsy-induced testicular artifacts.
(Mavis Rowley has pointed out that improved techniques have made it more
practical to do biopsies on large animals.)

- To determine germinal cell recovery, thereby allowing prognosis in cases of
accidental irradiation.

IV. FINDINGS

- Sperm count reduction and recovery of sperm count are both dose related. At
400-600 rad, sperm count was zero at 1 56 weeks.

- By autoradiographic studies of 3H-thymidine uptake into spermatocytes in
nonirradiated subjects, it was shown that there are approximately four cycles of
spermatogenesis of approximately sixteen days each, so that the complete
evolution of spermatogonia to mature sperm is approximately sixty-four days.
This is approximately the same as other mammalian species.

- Urinary and plasma gonadotropins rose in proportion to testicular dose and fell
with germinal recovery. Plasma FSH and LH also rose. Urinary estrogen
remained unchanged. Urinary testosterone fell slightly after irradiation.

- Histologically, spermatogonia were the most radiosensitive. Spermatocytes
were damaged above 200-300 rads. Spermatids showed no overt damage.

- Germinal cell recovery time increased as radiation dose increased. Complete
recovery occurred within nine to eighteen months for doses of 1 00 rad and
below. Complete recovery required five or more years for doses of 400-600
rad. Germinal tissue appears to be somewhat more radiosensitive in humans
than other studied species.

V. FINANCIAL SUPPORT

Contract AST (45-1) 1780, U.S. Atomic Energy Commission.

8. Mavis Rowley, interview with ACHRE staff, 8 September 1994 (ACHRE No.
ACHRE-051795-B)6.

9. Ibid., 12-13.

10. Deposition of Mavis Rowley and Carl Heller, 19 July 1976, 32.

11. Harold Bibeau, telephone interview with ACHRE staff, 1 1 August 1994
(ACHRE No. IND-081 194-A).

12. Depositions of John Henry Atkinson, 54; Ivan Dale Herland, 22, 68; Donald
Eugene Mathena, 94; taken 14 October 1976 in Donald Mathena et al. v. Amos Reed et
al. Civil nos. 73-326, U.S. District Court, Dist. Oregon (ACHRE No. CORP-013095-A).

13. Deposition of Carl Heller, 19 July 1976.

446

14. L. C. Wertz to Warden C. T. Gladden, 10 July 1964 ("Dr. Heller stopped in
the office . . .") (ACHRE No. IND-061594-A-1).

1 5. William B. Hutchison, M.D., Joseph E. Primeau, and Carl G. Heller, M.D.,
Ph.D., to Dr. John C. McDougall, Assistant Director for Operations, National Institute of
Child Health and Human Development, National Institutes of Health, 12 May 1966
("This letter is in response . . .") (ACHRE No. DOE-082294-B-70).

16. C. T. Gladden, Warden, to Mark Hatfield, Governor, 8 May 1963 ("I am
glad to provide . . . ") (ACHRE No. IND-061594-A), 2; C.T. Gladden, Warden, to Hon.
Robert Thornton, Attorney General, 9 September 1963 ("Carl Heller, Medical Research
Programs") (ACHRE No. IND-061595-A); undated ("Consent and Release") (ACHRE
No. IND- 11 0994- A).

17. Mavis Rowley, interview with ACHRE staff, 8 September 1994, 36.

18. Pacific Northwest Research Foundation, undated ("Policy and Procedures of
the Pacific Northwest Research Foundation with Regard to Investigations Involving

Human Subjects").

19. William Boly, "The Heller Experiments," Oregon Times Magazine,

November 1977,45.

20. Robert Case v. State of Oregon et ai, Civil no. 76-500; Paul Tyrell v. State
of Oregon et ah, Civil no. 76-499.

21 . Tom Toombs, Administrator of Corrections Division, undated testimony
before Oregon legislature (ACHRE No. IND-101294-D-1), 7.

22. Ibid., 11.

23. James Ruttenber, telephone interview with Steve Klaidman (ACHRE staff),
20 July 1995 (ACHRE No. IND-072095-E).

24. C. Alvin Paulsen, proposal to Atomic Energy Commission, undated ("Study
of Irradiation Effects on the Human Testis: Including Histologic, Chromosomal and
Hormonal Aspects") (ACHRE No. IND-1 10994-A-2). The following has been abstracted
by staff from Dr. Paulsen's research proposal and annual progress reports:

I. OBJECTIVE

- To determine the dose-dependent relationship between external irradiation and
cell kiil and inhibition of mitosis in spermatogenic cells. The cells in question
are spermatagonial stem cells, and the dose response would be expected to differ
from other kinds of cells.

II. METHODOLOGY

- Subjects with normal ejaculates received 7.5-400 rad to both testes. The details
of irradiation are not specified.

- Weekly seminal fluid was examined for the end-point response of azoospermia.
Duration was not specified.

- Subjects and some controls received periodic unilateral testicular biopsies.
Number not specified.

- Irradiated subjects agreed to be vasectomized at the completion of the
experiment.

III. RATIONALE FOR THE USE OF HUMAN SUBJECTS

447

One cannot directly relate animal data to the human male with security. Among
other things, the rate of spermatogenesis in man is different from that in various animal
species.

IV. FINDINGS

- The average presterile period was 142 days.

- The maximum sterile period was 501 days.

- Spermatogenesis in man is more radiosensitive than in rodents and recovery time
is longer. Man is more radiosensitive to complete sterility than rodents.

- Testicular biopsy by itself can reduce seminal fluid sperm concentration.

V. FINANCIAL SUPPORT

AEC contracts AT (45-1) 1781 and AT (45-1) 2225.

25. C. Alvin Paulsen, telephone interview with Steve Klaidman (ACHRE), 20
July 1995 (ACHRE No. IND-072095-D).

26. C. Alvin Paulsen, telephone interview with Steve Klaidman (ACHRE), 7
March 1995 (ACHRE No. ACHRE-030995-A).

27. C. Alvin Paulsen, interview with ACHRE staff, 8 September 1994, 9.

28. T. W. Thorslund and C. Alvin Paulsen, "Effects of X-Ray Irradiation on
Human Spermatogenesis," Proceedings of the National Symposium on Natural and
Manmade Radiation in Space, ed. E. A. Warman (NASA Document TM X-2440, 1 972),
229-232.

29. "Prison Inmates Sought in Prison Experiment," The (Portland) Oregonian,
August 1963.

30. C. Alvin Paulsen, proposal to Atomic Energy Commission, undated ("Study
of Irradiation Effects on the Human Testis: Including Histologic, Chromosomal and
Hormonal Aspects").

31. C. Alvin Paulsen, interview with ACHRE staff, 8 September 1994, 56-57.

32. C. E. Heffron, M.D., Prison Physician, to All Inmates Interested, 2
November 1964 (ACHRE No. WASH-1 12294-A-l).

33. Harold Bradley, Director, Adult Corrections Division, to Hon. Daniel J.
Evans, Governor, Washington State, 9 March 1976 ("Secretary Morris has asked . . .")
(ACHRE No. WASH- 1 12294-A-2).

34. Paulsen, telephone interview with ACHRE staff, 20 July 1995.

35. Ibid.

36. University of Washington, Research and Clinical Investigations Committee,
proceedings of 10 December 1969 (ACHRE No. WASH- 1 12294-A-3), 4.

37. Bradley to Evans, 2. .

38. George Farwell, Vice President for Research, University of Washington, to
John Totter, Division of Biology and Medicine, 16 July 1969 ("Thank you very much for
your prompt response") (ACHRE No. DOE-082294-B-7I).

39. Audrey Holliday, Research Administrator, Department of Institutions, to
William Conte, Director, Department of Institutions, 18 March 1970 ("I received the
review . . .") (ACHRE No. WASH-1 12294-A-4), 2.

40. Ibid.

448

41 . Research Review Committee, Department of Institutions, to Audrey
Holliday, Research Administrator, Department of Institutions, 13 March 1970
("Disposition of Division Review Committee in Regard to Irradiation Project of Dr. C.
Alvin Paulsen at the State Penitentiary") (ACHRE No. WASH-1 12294-A-5), 2.

41 . Audrey Holliday to C. Alvin Paulsen, 23 March 1970 ("The Department of
Institutions received copies . . .") (ACHRE No. WASH-1 12294-A-6).

43. Bradley to Evans, 9 March 1976, 2.

44. Karen Dorn Steele, "Experiments A Life Sentence," Spokane Spokesman-
Review, 19 June 1994, 1.

45. C. Alvin Paulsen, telephone interview with ACHRE staff, 7 March 1995
(ACHRE No. ACHRE-030795-A).

46. Nell Fraser to Oscar Bennett, 23 December 1975 ("Contracts AT[45-1]-
1780-1781, Irradiation of Prison Volunteers") (ACHRE No. DOE-082294-B).

47. Ibid.

48. Karen Dorn Steele, "State Agrees to Find Victims of Experiments," Spokane
Spokesman-Review, 16 December 1994, 1.

49. The Advisory Committee calculated the risk from the testicular irradiation
study as follows:

The radiation dose to the testicles ranged from 7.5 to 600 rem. The Committee's
risk analysis was based on a 600-rem dose and the following three assumptions:

1 . The testicles have average radiation sensitivity.

2. The risk of cancer is linearly related to dose.

3. The risk of cancer is linearly related to the amount of tissue exposed.

Based on these assumptions, the Committee calculated the maximum risk
expected to any of the prisoner subjects using the following two steps:

1 . Calculate effective dose by multiplying a 600-rem testicular dose by the proportion of
the body exposed: (2 x 25 grams/70 kilograms), or (50/70,000) x 600 rem = 429 mrem.

2. Calculate the risk (assuming average radiosensitivity) by multiplying this effective
dose by the age-specific risk for males age 25: (0.429 x 921/1,000,000 person rem), or a
risk of about 0.4/1,000 for males age 25.

50. Lee Davidson, "Did Secret Radiation Tests on Inmates Doom Offspring?"
Deseret News, 10 November 1994, Al .

51. Lowell A. Woodbury, Radiological Safety Officer, to Dr. A. Ray Olpin,
President of the University of Utah, 9 July 1959 ("Resume of Activities While Acting as
Health Physicist and Radiological Safety Officer to the University of Utah Isotope
Committee") (ACHRE No. UTAH-1 1 1394-A-2). A 1964 article titled "The Kinetics of
Granulopoiesis in Normal Man" appears to describe the experiment. The article
compares methods of labeling white blood cells with various radioisotopes and
formulates a concept of forming white cells in normal man based on information obtained
using a DFP32(diisopropyIfluorophosphate) label. G. E. Cartwright, J. W. Athens, and
M. M. Wintrobe, "The Kinetics of Granulopoiesis in Normal Man," Blood 24, no. 6
(December 1964).

52. Everett Evans, Professor of Surgery, Medical College of Virginia, to W. F.
Smyth, State Penitentiary, 13 December 1951 ("We continue to enjoy and appreciate

449

. . .") (ACHRE No. VCU-012595-A-17).

53. Matthew Block to John Lawrence, 10 April 1969 ("I have met a very
serious . . .") (ACHRE No. DOE-121294-B-7).

54. Matthew Block, Text-Atlas of Hematology (Philadelphia: Lea & Febiger,
1966), 503.

55. Henry De Bernardo, "University of Pennsylvania and the Holmesburg
Connection," Philadelphia News Observer, 1 2 October 1 994, 1 2; Shelby Thompson,
Director (Acting), Division of Information Services, AEC, to H. C. Baldwin, Information
Officer, Chicago Operations Office, 21 August 1953 ("Information Guidance on Any
Experimentation Involving Human Beings") (ACHRE No. DOE-051094-A-473); "10
San Quentin Felons Used for Atom Tests," source unknown, 12 April 1949; Oak Ridge
National Laboratory Human Studies Review Taskforce, University of Oklahoma Human
Studies Reviews, undated ("Findings for License 35-03176-01") (ACHRE No. NRC-
012695-A).

56. C. Alvin Paulsen, M.D., interview with ACHRE staff, 8 September 1994.
The meeting Paulsen referred to took place on 19-21 May 1969. The proceedings of the
conference are reported in the Annals of the New York Academy of Sciences 169 (21
January 1970): 293-593. Paulsen is not listed among those who offered formal
presentations.

57. Published accounts of this research include Alf S. Alving et al., "Procedures
Used at Stateville Penitentiary for the Testing of Potential Antimalarial Agents," Journal
of Clinical Investigation 27, no. 3 (part 2) (1948): 2-5; Joseph E. Ragen and Charles
Finston, Inside the World's Toughest Prison (Springfield, 111.: Charles C. Thomas, 1962),
391-395; Nathan F. Leopold, Jr., Life Plus 99 Years (Garden City, N.Y.: Doubleday,
1958), 305-355. David J. Rothman, in Strangers at the Bedside: A History of How Law
and Bioethics Transformed Medical Decision Making (New York: Basic Books, 1 99 1 ),
gives some considerable attention to this tropical disease research in Illinois in a chapter
entitled "Research at War," 30-50.

58. These rules, as approved by the AMA House of Delegates on 1 1 December
1946, read as follows:

I. The voluntary consent of the individual on whom the experiment is to
be performed must be obtained; 2. The danger of each experiment must
be previously investigated by animal experimentation, and 3. The
experiment must be performed under proper medical protection and
management.
From "Minutes of the Supplemental Session of the House of Delegates of the American
Medical Association, Held in Chicago, December 9-11, 1946," Journal of the American
Medical Association 133 (4 January 1947): 35. For more background on the
development of the AMA standards for human experimentation, see chapter 2 of this
report.

59. "Ethics Governing the Service of Prisoners as Subjects in Medical
Experiments: Report of a Committee Appointed by Governor Dwight H. Green of
Illinois," Journal oj the American Medical Association 136 (14 February 1948): 457-
458.

60. "Abstract of the Proceedings of the House of Delegates Meeting, Denver,
2-5 December 1952," Journal of the American Medical Association 150 (27 December
1952): 1699. The Illinois delegation to this meeting introduced the resolution. It is

450

likely that the Illinois group was motivated by the possibility that Nathan Leopold, who
had participated in a highly publicized kidnapping and murder that had been dubbed by
the press as "the crime of the century," might be paroled as a result of his participation
as a subject in the wartime tropical disease research at Stateville Prison.

61 . Martin Jaffe and C. Stewart Snoddy, "An International Survey of Clinical
Research in Volunteers," in Appendix to Report and Recommendations: Research
Involving Prisoners, National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research (Washington, D.C.: DHEW, 1976).

62. Aileen Adams and Geoffrey Cowan, "The Human Guinea Pig: How We
Test New Drugs," World (5 December 1971): 20.

63. Jon M. Harkness, "Vivisectors and Vivishooters: Medical Experiments on
American Prisoners before 1950," paper presented at "Regulating Human
Experimentation in the United States: The Lessons of History," Columbia College of
Physicians and Surgeons, New York, 23 February 1995.

64. National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research, Report and Recommendations: Research Involving Prisoners
(Washington, D.C.: DHEW, 1976), 36.

65. Walter Rugaber, "Prison Drug and Plasma Projects Leave Fatal Trail," New
York Times, 29 July 1 969, 1 , 20-2 1 .

66. Jessica Mitford, "Experiments Behind Bars: Doctors, Drug Companies, and
Prisoners," Atlantic Monthly 23, January 1973, 64-73.

67. Jessica Mitford, Kind and Usual Punishment: The Prison Business (New
York: Alfred A. Knopf, 1973), 138-168.

68. For an analysis of the chain of events leading up to Senator Kennedy's
hearings, see Mark S. Frankel, "Public Policymaking for Biomedical Research: The Case
of Human Experimentation" (Ph.D. diss., George Washington University, 1976), 190-
192. For the transcripts of the actual hearings, see U.S. Congress, Senate, Committee on
Labor and Public Welfare, Subcommittee on Health, Hearings on Quality of Health
Care-Human Experimentation, on S. 974, S. 878, and S. J. Res. 71, 93d Cong., 1st
Sess., part 3, 7 March 1973 (Washington, D.C.: GPO, 1973).

69. A record of the National Commission's work can be found in a complete set
of the commission's papers in the archives of the National Reference Center for Bioethics
Literature, Kennedy Institute of Ethics, Georgetown University. For a useful (and
critical) overview of the commission's work with regard to prisoners see Roy Branson,
"Prison Research: National Commission Says 'No, Unless . . .,'" Hastings Center Report,
February 1977, 15-21.

70. The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, Report and Recommendations: Research Involving
Prisoners, 8.

71. Branson, "Prison Research," 17; National Commission, Staff Paper,
"Biomedical and Behavioral Research Involving Prisoners," 5 March 1976, 12-13,
Archives, National Reference Center for Bioethics Literature, Kennedy Institute of
Ethics, Georgetown University, National Commission Papers, Box 6; form letter sent to
randomly selected prisoners for permission to conduct an interview, 3 November 1975,
Archives, National Reference Center for Bioethics Literature, Kennedy Institute of
Ethics, Georgetown University, National Commission Papers, Box 22.

72. National Commission, Report and Recommendations: Research Involving
Prisoners, 16-19.

451

73. Frankel, 402; see also the enabling legislation for the commission, the
National Research Act, P.L. 93-348.

73. Joseph Califano to Kenneth J. Ryan, Chairman of the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research, 2 May 1978; see also a
memorandum from Julius P. Richmond, Assistant Secretary for Health, to Califano, 26 July
1977. Both documents can be found in the Office of the Director (OD) Files, National Institutes
of Health, Central Files, "Human Subjects" folders.

75. For the proposed DHEW regulations see the Federal Register 43 (5
January 1978), 1050-1053; the final regulations can be found in the Federal Register 43
(16 November 1978), 53652-53656. These regulations remain essentially unchanged
today and can be found at 45 C.F.R. part 46, subpart C. These regulations have also
been adopted by other federal agencies that have any concern with human
experimentation as part of the so-called Common Rule, with the exception of the FDA
(see below).

76. Federal Register 43 (5 January 1 978), 1 05 1 .

77. Federal Register 45 (30 May 1 980), 36386-36392.

78. Henry Fante et al. v. Department of Health and Human Services et al., U.S.
District Court, Eastern District of Michigan, Southern Division, Civil Action No. 80-
72778. The records from this case are now kept at the National Archives, Great Lakes
Regional Archives, Chicago, Accession No. 21-88-0016, Location No. 331792-332283,
Box No. 269. FDA officials announced the decision to stay indefinitely the regulations
in the Federal Register 46 (7 July 1981), 35085. The current "stayed" status of the FDA
prison research regulations can be found at 21 C.F.R. part 50, subpart C.

79. Charles Miller, as quoted in Stephen Gettinger and Kevin Krajick, "The
Demise of Prison Medical Research," Corrections Magazine 5 (December 1979): 12.

80. On 1 January 1960, NIH awarded $97,256.00 to the LMRI of Boston
University to carry out this study. Irving Ladimer, who had completed a doctor of law
dissertation at George Washington University in 1958 on the legal and ethical aspects of
human experimentation, served as the project's principal investigator through June 1 962,
when he left Boston University. Ladimer was replaced as principal investigator by his
chief assistant, Donald A. Kennedy, an anthropologist by training, who saw the project
through to completion. The first characterization of the purpose of the project is taken
from page 1 of Kennedy's preface to the final report: "A Study of the Legal, Ethical, and
Administrative Aspects of Clinical Research Involving Human Subjects: Final Report of
Administrative Practices in Clinical Research, Research Grant No. 7039," Law-Medicine
Research Institute, Boston University (1963) (hereafter cited as LMRI final report); both
chapter and page numbers will be provided because pages within chapters are numbered
separately. The second, and lengthier puipose statement is taken from page 1 of chapter

1 of the LMRI final report, "Focus of the Inquiry." This unpublished report is in the
collections of the Mugar Memorial Library, Boston University (ACHRE No. BU-
053194-A). This report, which is more than 360 typewritten pages, is a wealth of
information that has remained largely untapped by recent scholars interested in the
development of research ethics in this country. The few citations of the project that do
appear in the published literature almost all refer to a threummary that appears in
William J. Curran, "Governmental Regulation of the Use of Human Subjects in Medical
Research: The Approach of Two Agencies," Daedalus 98 (spring 1969): 546-548. In
this very brief reference to the project, Curran makes no mention of the "invitational
work conferences," which the project staff identified as the investigational technique that

452

"yielded the most valuable information." This characterization appears on page 8 of
chapter 2, which is devoted to research method; pages 3-5 of the same chapter provide
more details on the specific methodology employed in these conferences.

81. LMRI final report, chapter 8, Roger W. Newman, LL.B. [of the project
staff], "The Participation of Prisoners in Clinical Research: Analytic Summary of a
Conference," 1-2. A collection of documents related to the project is located in the files
of the Center for Law and Health Sciences, School of Law, Boston University. This
entity is the successor to the Law-Medicine Research Institute (ACHRE No. BU-062394-
A).

82. Newman's "Analytic Summary" is more than 100 pages of typescript and
seems to cover the conference in considerable detail. Also, comparisons between the
transcripts of other LMRI "invitational work conferences" that have survived with the
related summaries produced for the final report reveal a skillful and fair rendering of the
meetings.

83. LMRI final report, chapter 8, 27.

84. Ibid., 18.

85. Ibid., 31.

86. Ibid.

87. Ibid., 85.

88. Ibid., 71.

89. Ibid., 72.

90. Ibid., 74.

91. Ibid., 88-89.

92. Ibid., 85-86.

93. Ibid., 93.

94. Ibid., 89-90.

95. Ibid., 96.

96. Deposition of Carl Heller, 19 July 1976, 32. Heller said he avoided the
word cancer because "I didn't want to frighten them [the prisoners]." Dr. Paulsen said in
a telephone interview on 12 September 1995 that he explained to the inmates that data
from Hiroshima and Nagasaki "showed no additional incidence of testicular cancer."
Undated consent forms from the Washington experiment differ. Some specify an
"extremely small" risk of testicular cancer, and others do not specifically mention
cancer. C. A. Paulsen, interview with ACHRE staff, 12 September 1995 (ACHRE No.
ACHRE-091295-A).

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10

Atomic Veterans: Human

Experimentation in Connection

with Atomic Bomb Tests

In 1 946, the United States conducted Operation Crossroads, the first
peacetime nuclear weapons tests, before an audience of worldwide press and
visiting dignitaries at the Bikini Atoll in the Pacific Marshall Islands. In 1949 the
Soviet Union exploded its first atomic bomb, and in December 1950, shortly after
the United States entered the Korean War, President Truman chose Nevada as the
site for "continental testing" of nuclear weapons. Testing of atomic bombs in
Nevada began in January 1951 and continued throughout the decade. Further
testing of atomic, then hydrogen, bombs took place in the Pacific. By the time
atmospheric testing was halted by the 1963 test ban treaty, the United States had
conducted more than 200 atmospheric tests and dozens of underground tests.1

The rules governing nuclear weapons tests were not spelled out by law or
handed down by tradition. They had to be created in ongoing interplay between
the new Atomic Energy Commission and the new Department of Defense.

The tests were important to many governmental agencies but, of course,
critical to the AEC and the DOD. The AEC, as the source of weapons design
expertise, was interested in the performance of new bomb designs and, along with
DOD, in the effects of the weapons. The DOD, and each of the armed services,
had particular interests in the use of the tests to learn how atomic wars could be
fought and won, if, as seemed quite possible at midcentury, they had to be. Along
with "civilian agencies," such as the Public Health Service, the Veterans
Administration, and the Department of Agriculture, they shared an interest in civil

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defense against the use of the bomb in wartime and the impact of the bomb's use-
in peacetime tests as well as war--on the public health and welfare. The bomb
tests inevitably involved risk and uncertainty; safety was a basic and continued
concern, and the development of radiation safety practices and understanding was
therefore an essential part of the test program.

At its core, the test program was established to determine how well newly
designed nuclear weapons worked; but officials and researchers quickly saw the
need and opportunity to use the tests for other purposes as well. More than
200,000 people, including soldiers, sailors, air crews, and civilian test personnel,
were engaged to staff the tests, to participate as trainees or observers, and to
gather data on the effects of the weapons.

The Committee was not chartered to review the atomic bomb tests or the
experience of the troops present at the detonations. However, early in our tenure
we heard from veterans who participated in the tests, and their family members,
who urged that we include their experiences in our review. In testimony before
the Advisory Committee, "atomic vets" and their widows stated forcefully that all
those who participated in the bomb tests were in a real sense participants in an
experiment. It also was argued that biomedical experiments involving military
personnel as human subjects took place in connection with the tests. The interest
among atomic veterans and their families in the activities of the Advisory
Committee and the government's commitment to investigating human radiation
experiments was intense. When the Department of Energy established its
Helpline for citizens concerned about human radiation experiments, for example,
bomb-test participants and their family members were the single largest group of
callers among the approximately 20,000 calls received.

That the bomb tests were in some sense experiments is, of course, correct.
The tests of new and untried atomic weapons were, wrote the chief health officer
of the AEC's Los Alamos lab, "fundamentally large scale laboratory
experiments."2 At the same time, although there was a real possibility that human
subject research had been conducted in conjunction with the bomb tests, the tests
were not themselves experiments involving human subjects.

The Committee reviewed the historical record to determine if human
experiments had taken place in connection with the tests. We found that
somewhere in the range of 2,000 to 3,000 military personnel at the tests did serve
as the subjects of research in connection with the tests. In most cases, these
research subjects were engaged in activities similar to those engaged in by many
other service personnel who were not research subjects. For example, some air
crew flew through atomic clouds in experiments to measure radiation absorbed by
their bodies, but many others flew in or around atomic clouds to gather data on
radiation in the clouds. The Defense Department generally did not distinguish
such research from otherwise similar activities, treating both as part of the duties
of military personnel. The experience of the atomic veterans illustrates well the
difficulty in locating the boundary between research involving human subjects

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and other activities conducted in occupational settings that routinely involve
exposure to hazards.

The more the Committee investigated the human research projects
conducted in conjunction with the bomb tests, the more we found ourselves
discussing issues that affected all the service personnel who had been present at
the tests, and not just those who also had been involved as subjects of research.
This occurred both because of the boundary problem just described and because
critical decisions about initial exposure levels and follow-up of veterans were
generally not made separately for research subjects and other personnel present at
the tests. Legislation passed in 1984 and 1988 that provides the basis for
compensation to some atomic veterans similarly does not distinguish between
those veterans who were research subjects and the vast majority who were not.

In this chapter we present what we have learned about human
experimentation conducted in conjunction with atomic bomb testing as well as
some observations about the experience of the atomic veterans generally. In the
first section of the chapter we focus on research involving human subjects. We
begin by a review of the 1951-1952 discussions in which DOD biomedical
advisers considered the role of troops at the bomb tests and the need for
biomedical research to be conducted in conjunction with them. We then look at a
research activity that was given the highest priority by these advisers, the
psychological and physiological testing of troops involved in training maneuvers
at bomb tests and of officers who volunteered to occupy foxholes in the range of
one mile from ground zero. We next turn to the so-called flashblindness
experiments conducted to measure the effect on vision of the detonation of an
atomic bomb. Finally, we look at research in which men were used to help
measure the radiation absorbed by protective clothing, by equipment that humans
operated, and by the human body. We note at the outset that while the studies all
took place in the context of the atomic bomb, and therefore involved some
potential exposure to radiation, none of them were designed to measure the
biological effects of radiation itself (as opposed to the levels of exposure). A
basic reason this was so was the determination of the DOD and the AEC to keep
exposure levels of test participants below those at which acute radiation effects
were likely to be experienced (and therefore measurable).

In the second section of the chapter we discuss issues of concern to the
Committee that affected all the atomic veterans. We review how risk was
considered by AEC and DOD officials at the time the tests were being planned,
the creation and maintenance of records related to bomb-test exposure, and what
is now known about the longer-term risks of participation in the tests. We also
discuss the legacy of distrust among atomic veterans and their families that stems,
in part, from the failure to create and maintain adequate records. Finally, we
conclude with a discussion of what the atomic bomb-test experience tells us about
the boundary between experimental and occupational exposures to risk and some
lessons that remain to be learned from the experience of the atomic veterans.

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HUMAN RESEARCH AT THE BOMB TESTS

The Defense Department's Medical Experts: Advocates of Troop Maneuvers
and Human Experimentation

As we saw in the introduction, in 1 949, when AEC and DOD experts met
to consider the psychological problems connected to construction of the proposed
nuclear-powered airplane, the NEPA project, there was a consensus that
America's atomic war-fighting capability would be crippled unless servicemen
were cured of the "mystical" fear of radiation.3 When routine testing of nuclear
weapons began at the test site in Nevada in 1951, the opportunity to take action to
deal with this problem presented itself. DOD officials urged that troop maneuvers
and training exercises be conducted in connection with the tests. Whole military
units would be employed in these exercises, and participation, as part of the duty
of the soldier, would not be voluntary. DOD's medical experts simultaneously
urged that the tests be used for training and "indoctrination" about atomic warfare
and as an opportunity for research. The psychological and physiological testing
of troops to address the fear of radiation was the first of the research to take place;
this testing was largely conducted as an occupational rather than an experimental
activity.

In a June 27, 1951, memorandum to high DOD officials, Dr. Richard
Meiling, the chair of the secretary of defense's top medical advisory group, the
Armed Forces Medical Policy Council, addressed the question of "Military
Medical Problems" associated with bomb tests.4 The memorandum made clear
that troops should be placed at bomb tests not so much to examine risk as to
demonstrate relative safety.

"Fear of radiation," Dr. Meiling's memorandum began, "is almost
universal among the uninitiated and unless it is overcome in the military forces it
could present a most serious problem if atomic weapons are used." In fact, "[i]t
has been proven repeatedly that persistent ionizing radiation following air bursts
does not occur, hence the fear that it presents a dangerous hazard to personnel is
groundless." Dr. Meiling urged that "positive action be taken at the earliest
opportunity to demonstrate this fact in a practical manner."5

He continued, a "Regimental Combat Team should be deployed
approximately twelve miles from the designated ground zero of an air blast and
immediately following the explosion . . . they should move into the burst area in
fulfillment of a tactical problem." The exercise "would clearly demonstrate that
persistent ionizing radiation following an air burst atomic explosion presents no
hazards to personnel and would effectively dispel a fear that is dangerous and
demoralizing but entirely groundless."6

Dr. Meiling's proposal to put troops at the bomb tests in order to allay
their fears may well have been an echo of what the military already had in mind.
The Army's 1 950 "Atomic Energy Indoctrination" pamphlet, a primer for soldiers,

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showed that the military was concerned that misperception of the effect of an air
burst could be damaging in combat. "[Lingering radioactivity will be virtually
nonexistent in the case of the normal air burst,"7 it reassured the soldiers. The
greater danger, it told them, was the probability that "an unreasoning fear of
lingering radioactivity" would take "an unnecessary toll in American lives."8

While the tests provided an opportunity to allay fears, they simultaneously
provided the opportunity to gather data. In this regard, Dr. Meiling appeared to
be ahead of his military colleagues in expressing concern that the military was not
taking adequate advantage of the bomb tests as an opportunity for "biomedical
participation." In February 1951, in fact, following tests in Nevada, he had urged
the DOD to incorporate "biomedical tests" into plans for future bomb tests.9

Meiling's suggestion that planning for biomedical tests be undertaken
wound its way through the secretary of defense's research and development
bureaucracy and fell into the lap of the civilian-chaired Joint Panel on the Medical
Aspects of Atomic Warfare.10 Under the chairmanship of Harvard's Dr. Joseph
Aub, the Joint Panel was the gathering place for the small world of government
radiation researchers and their private consultants. Its periodic "Program
Guidance Reports" laid out the atomic warfare medical research agenda,
summarizing work that was ongoing and that which remained. At its meetings,
participants heard from the CIA on foreign medical intelligence, debated the need
for human experimentation, and learned of the latest developments in radiation
injury research, of the blast and heat effects of the bomb, and of instruments
needed to measure radiation effects.

In September 1951 the Joint Panel considered a draft report on
"biomedical participation" in bomb tests." "It is, of course obvious," the report
noted, "that a test of a new and untried atomic weapon is not a place to have an
unlimited number of people milling about and operating independently."
Planning was therefore in order. There were, the document explained, basic
criteria for "experimentation" at bomb tests. For example, "Does the experiment
have to be done at a bomb detonation; is it impossible or impractical in a
laboratory?"12

The document turned to "specific problems for future tests." The list of
twenty-nine problems was not intended to be all-inclusive, but was "designed to
show the types of problems which should be considered as a legitimate basis for
biomedical participation in future weapons tests." The term human
experimentation was not used, and most of the items could be performed without
humans.13 However, the list included several examples of research involving
human subjects:

1 1 . Effects of exposure of the eye to the atomic flash . . .

24. Measurements of radioactive isotopes in the
body fluids of atomic weapons test personnel . . .

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areas.15

Chapter 10

27. The efficiency and suitability of various
protective devices and equipment for atomic
weapons war . . .

28. Psychophysiological changes after exposure to
nuclear explosions.

29. Orientation flights in the vicinity of nuclear
explosions for certain combat air crews.14

By the end of the decade, human research would be conducted in all these

At the same September meeting, the Joint Panel also considered a
"Program Guidance Report" on the kinds of atomic warfare-related research that
needed to be conducted, in the laboratory as well as in the field. The areas
singled out for immediate and critical attention included the initiation of "troop
indoctrination at atomic detonations" and "psychological observations on troops
at atom bomb tests."16

A section on "Biomedical Participation in Future Atomic Weapons Tests"
concluded that the next step should be

4. 1 To complete present program and plan for
participation in future tests in light of results from
Operation GREENHOUSE [a prior atomic test
series]. These plans should include studies on the
effect of atomic weapons detonations on a troop
unit in normal tactical support [emphasis added].17

Thus, while it was well known at the time that troops participated at the
bomb tests and were subjected to psychological testing, it now is evident that the
DOD's medical advisers advocated the presence of the troops at the tests for both
training and research purposes. The doctors were not alone in attaching high
priority to such research. The Joint Panel's September guidance punctuated,
perhaps echoed, the Armed Forces Special Weapons Projects's midsummer 195 1
call for a "systematic research study . . . [to] provide a sound basis for estimating
troop reaction to the bomb experience and ... the indoctrination value of the
maneuver."18

The HumRRO Experiments

Just two months later, in November 1951, at a bomb test in the Nevada
desert, the Army conducted the first in a series of "atomic exercises."19 This
exercise was designed primarily to train and indoctrinate troops in the fighting of

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atomic wars. The exercise also provided an opportunity for psychological and
physiological testing of the effects of the experience on the troops.

Desert Rock was an Army encampment in Nevada adjacent to the nuclear
test site. At the exercise named Desert Rock I, more than 600 of the 5,000 men
present would be studied by psychologists from a newly created Army contractor,
the Human Resources Research Organization (HumRRO). HumRRO's research
was directed by Dr. Meredith Crawford, who was recruited by the Army from a
deanship at Vanderbilt University.20 The identity of all the participants involved
in the "HumRRO experiments," and the further DOD research discussed later in
this chapter, is not known. The numbers of those who participated must be
reconstructed from available reports.21

The highly publicized bomb test was well attended by military and
civilian officials. "Las Vegas, Nevada," Time magazine reported, "had not seen
so many soldiers since World War II. . . . The hotels were jammed with high
brass. . . . [o]ut on the desert, 65 miles away 5,000 hand-picked troops were
getting their final briefing before Exercise Desert Rock I~the G.I.'s introduction
to atomic warfare."22 The detonation, Representative Albert Gore (father of the
current Vice President), told the New York Times, was "the most spectacular event
I have ever witnessed. ... As I witnessed the accuracy and cataclysmic effect of
the explosion, I felt the conviction that it might be used in Korea if the cease-fire
negotiations broke down."23

To render the experience more realistic, the observers and participants
were told to imagine that aggressor armies had invaded the United States and
were now at the California-Nevada border. An atomic bomb would be dropped,
with the troops occupying a position seven miles from ground zero. After the
detonations they would "attack into the bombed area."24

At their home base, two groups of troops-a control group that would stay
at home base and an experimental group that would go to Nevada—had listened to
lectures and seen films intended to "indoctrinate" them about the effects of the
bomb and radiation safety. Both groups were administered a questionnaire to
determine how well they had understood the information provided. Dr. Crawford
explained in a 1994 interview that "indoctrination," which today has a negative
connotation, was not intended to suggest misrepresentation of fact, but "had more
to do with attitude, feeling and motivation."25 At Desert Rock, the experimental
group was given a further "non-technical briefing." They were "reminded that no
danger of immediate radiation remains 90 seconds after an air burst; that they
would be sufficiently far from ground zero to be perfectly safe without shelter;
and that with simple protection they could even be placed quite close to the center
of the detonation, with no harm to them."26

After the blast, a questionnaire was again administered to most of the
experimental subjects, and physiological measurements including blood pressure
and heart rates were taken. The questionnaire was designed to test the success of
the "indoctrination."27 For example, questions included (answers in parentheses

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were those the HumRRO report stated were correct):

1. Suppose the A-bomb were used against enemy
troops by exploding it 2000 feet from the ground
and suppose all enemy troops were killed. How
dangerous do you think it would be for our troops to
enter the area directly below the explosion within a
day? (Not dangerous at all). . . .

6. If an A-bomb were exploded at 2000 feet, under
what conditions would it be safe to move into the
spot directly below, right after the explosion? (Safe
if you wore regular field clothing.)28

These answers were not correct. Answers to questions like the above
depend on weather conditions, the yield of the weapon, and the assumptions about
the degree of risk from low levels of exposure. For example, while an airburst
(where the fireball does not touch the ground) may result in little fallout in the
immediate area of the blast, it does not result in none; if rain is present, a
substantial amount of fallout may be localized.

Similarly, whereas the 1 946 Bikini bomb tests at Operation Crossroads in
the Pacific had caused contamination so severe that many of the surviving ships
were scrapped, the question and answer provided said:

Some of the ships in the Bikini tests had to be sunk
because they were too radioactive to be used again.
(False).29

In a 1 995 review of the 1 95 1 questionnaire, the Defense Department
found that "changes/corrections/clarifications" would be in order for nine of the
thirty questions.30

In January 1952, the Army surgeon general expressed "continuing interest
in the conduct of psychiatric observations," offering funds for "Psychiatric
Research in Connection with Atomic Weapons Tests Involving Troop
Participation."31 In March 1952, however, the Army and the Armed Forces
Special Weapons Project (AFSWP), which coordinated nuclear weapons activities
for the DOD, provided critical reflections on Desert Rock I. "[0]ne is inevitably
drawn to the conclusion," the Army reported, "that the results, though measurable,
were highly indeterminate and unconvincing. The limitations of evaluation were
inherent in the problem. Handicapped by a preconceived notion that there would
be no reaction, it took on the form of a gigantic experiment whose results were
already known. No well controlled studies could be undertaken which could
presume even superficial validity "32 In a letter to the AEC, the AFSWP went

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further. Owing to the "tactically unrealistic distance of seven miles to which all
participating troops were required to withdraw for the detonation,"33 troops might
get the wrong impression about nuclear warfare.

In 1994, Dr. Crawford reflected on the logic of testing for panic in an
environment that was thought to be too safe. "No troops," Dr. Crawford recalled,
"were exposed anywhere where anybody thought there was any danger, so you
might ask the question, so what? I've asked that question myself and I've thought
about it. It was the first HumRRO project. It was really pretty well agreed upon
before I got up here from Tennessee ... so we did what we could."34

Despite the reservations about the 1951 study, on May 25, 1952, the Army
conducted its second HumRRO experiment at the exercise called Desert Rock IV.
It was similar in methodology to the first experiment and involved about 700
soldiers who witnessed the shot and 900 who served in the control group as
nonparticipants.35 This time, to add more realism, the troops witnessed the blast,
an 1 1-kiloton weapon that was set off from the top of a tower, from four miles
from ground zero. By the end of the second research effort, there was even more
reason to question the utility of the experiments. HumRRO's report on Desert
Rock IV stated that while knowledge increased as a result of the indoctrination,
the actual maneuver experience did not produce significant improvement in test
scores and decreases were actually reported on some questions.36

In both Desert Rock I and Desert Rock IV, the Army hoped that the troops
who witnessed the blasts would disseminate information to the troops who stayed
at home base. However, the troops who participated in the exercises were warned
that discussion of their experiences could bring severe punishment, and the
researchers found that communication was at a minimum.37 Moreover, those who
stayed home, HumRRO found, "showed no evidence of great interest, of
extensive discussion, or of any important benefit from dissemination as a result of
the atomic maneuver."38 Meanwhile, the experience that the participants had been
warned not to discuss and that was of little interest to their comrades was front-
page news throughout the country. "When they returned to camp," Time reported
of the first Desert Rock exercise, "the men were quickly herded into showers.
Some were given test forms to fill out. Did you sweat? Did your heart beat fast
at any time? Did you lose bladder control? Most of the answers were no."39

Without any direct comment on the results of the Desert Rock I and IV
experiments, in September 1952, the Joint Panel urged that the psychological
research continue:

It is possible that inclination to panic in the face of
AW [atomic warfare] and RW [radiological
warfare] may prove high. It seems advisable,
therefore, to increase research efforts in the
scientific study of panic and its results, and to seek
means for prophylaxis. . . . The panel supports the

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point of view that troop participation in tests of
atomic weapons is valuable. As many men as
possible ought to be exposed to this experience
under safe conditions. Psychological evaluation is
difficult and results can be expected to appear
superficially trivial, but the matter is of such
extreme importance that the research should be
persisted in, utilizing every opportunity.

. 40

Indeed, a third set of experiments was carried out in April 1953, at Desert
Rock V; this time, the number of participants is unknown.41

The final HumRRO bomb test study was conducted in 1957 at Operation
Plumbbob.42 No formal report was prepared, but the experience was recorded in a
personalized recollection by a HumRRO staffer.43 Weather-related delays, the
departure of HumRRO staff, the continued redesign of the exercises, and the
failure of a fifth of the troops to return from a weekend pass in time for the events
took their toll. The researchers were not given the script used in the
indoctrination lectures to the troops. Thus, it was impossible for the researchers
to know whether incorrect responses were due to "lack of inclusion of the topic in
the orientation or to ineffective instruction."44 The research was to include
exercises such as crawling over contaminated ground.45 But, yet again, the
researchers found that the safety rules in force precluded important study: "shock
. . . and panic . . . would not be observed."46

There is no question that HumRRO activities were research involving
human subjects; the projects involved an experimental design in which soldier-
subjects were assigned either to an experimental or a control condition. Available
evidence suggests, however, that the Army did not treat HumRRO as a
discretionary research activity but as an element of the training exercise in which
soldiers were participating in the course of normal duty. The HumRRO subjects
were apparently not volunteers. Dr. Crawford in 1994 said of the HumRRO
subjects, "Whether they were requested to formally give their consent is pretty
unknowable because in the Army or any other military service people generally
do what they're asked to do, told to do."47 Indeed, as HumRRO's initial report
stated, the primary purpose of the atomic exercise was training; "research was
necessarily of secondary importance."48 However, Dr. Crawford felt confident
that the risks were disclosed. Because of the "number and intensity of briefings
. [n]o soldier, to our knowledge, went into the test situation with no idea about
what to expect. They were adequately informed."49

We now know that in 1952 the Defense Department's medical experts
were simultaneously locked in discussion of the need for psychological studies
and other human research at bomb tests and, as we saw in chapter 1, the need for
a policy to govern human experimentation related to atomic, biological, and
chemical warfare. In October of that year, the Armed Forces Medical Policy

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Council recommended that the Nuremberg Code be adopted, as it was by
Secretary Charles Wilson in 1953. What is still missing is information that might
show how, as seems to be the case, the same experts could have been having these
discussions without communicating the essence of them to those responsible for
conducting the human research at the tests. There is no evidence that the
investigators responsible for HumRRO were informed about the Wilson memo.
Dr. Crawford, for example, when queried in 1994, reported that he did not know
of the 1953 Wilson memorandum. It is possible that HumRRO was not viewed as
being subject to the requirements stated in the Wilson memo despite the fact that
it was human research relating to atomic warfare. Although the experimental
variable was participation at a bomb test, arguably, the troops would have been
present at the test in any event, along with many thousands of other soldiers who
were not subjects in the HumRRO research.

Atomic Effects Experiments

At the same time that the third set of HumRRO experiments was being
conducted, in April 1953 at Desert Rock V, the Army called on several dozen
"volunteers for Atomic Effects Experiments."50 According to the Army, all were
officers familiar with the "experimental explosion involved" and were able to
personally judge "the probability of significant variations in [weapon] yield."
They were instructed to choose the distance from ground zero they would like to
occupy in a foxhole at the time of detonation, as long as it was no closer than
1 ,500 yards. If the surviving documentation is the measure, these officers, and
perhaps officer volunteers in the subsequent Desert Rock series, were the only
subjects of bomb-test research who signed forms saying that they were voluntarily
undertaking risk.51 The exposures were meant to set a standard for developing
"troop exposure programs and for confirming safety doctrine for tactical use of
atomic weapons."52

An Army report on the volunteers at Desert Rock V concluded that there
would be "little more to be gained by placing volunteer groups in forward
positions on future shots."53 An April 24, 1953, Army memorandum
recommended termination of the program "as little will be gained in repeatedly
placing volunteers in trenches 2000 yards from ground zero."54 However, officer
volunteers were called on again at the next Desert Rock exercises at the 1955
nuclear test series called Operation Teapot. Following Teapot, the Army
recommended that further experiments be conducted in which the volunteers
would be moved closer to ground zero, "until thresholds of intolerability are
ascertained."55 This "use of human volunteers under conditions of calculated
risk," the Army told the AFSWP, "is essential in the final phase of both the
physiological and psychological aspects of the overall program."56

In response, the AFSWP pointed out that the injury threshold could not be
determined "without eventually exceeding it."57 The Army was essentially

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proposing human beings be exposed to the detonation's blast effects to the point
of injury. The proposal, an AFSWP memo explained, would not pass muster
under the rules of the Nevada Test Site and was otherwise unacceptable:

In particular, it is significant that the long range
effect on the human system of sub-lethal doses of
nuclear radiation is an unknown field. Exposure of
volunteers to doses higher than those now thought
safe may not produce immediate deleterious effects;
but may result in numerous complaints from
relatives, claims against the Government, and
unfavorable public opinion, in the event that deaths
and incapacitation occur with the passage of time.58

If the Army wanted more data on blast effects, AFSWP declared, it should
proceed with laboratory experiments, for which money would be made available.
The AFSWP was not opposed to the kinds of activities that had previously taken
place at Desert Rock. But those activities, AFSWP's memo observed in passing,
"cannot be expected to produce data of scientific value."59

The Desert Rock experience was apparently repeated, again with officer
volunteers, in the next Nevada test series, the 1957 Operation Plumbbob.
Although the total number of officers involved in all of the "officer volunteer"
experiments is not known, it is probably fewer than one hundred.

The Flashblindness Experiments

Beginning with the 1946 Bikini tests, experiments with living things
became a staple of bomb tests. At Operation Crossroads, animals were penned on
the decks of target ships to study the effects of radiation. In the 1948 Sandstone
series at the Marshall Islands Enewetak Atoll, seeds, grains, and fungi were
added. In 1949, the AEC and the DOD began to coordinate the planning of the
biomedical experiments at tests and set up a Biomedical Test Planning and
Screening Committee to review proposals.60 Presumably, the human experiments
at bomb tests should have been filtered through this or some other review process
designated to consider experiments. Yet, in only one case-flashblindness
experiments-did this happen.

With Dr. Meiling's 1951 call for renewed DOD effort at biomedical
experimentation came a revival of the DOD-AEC joint biomedical planning.
From the start, the AEC doubted DOD's willingness to cooperate.61 In a January
1952 letter to Shields Warren, Los Alamos's Thomas Shipman complained that
the committee was limited to reviewing proposals from civilian groups, and not
the military: "[I]f," he wrote, the "AEC can not exercise a measure of control in
this matter, they might better withdraw from the picture completely and permit

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the military to continue on its own sweet way without the somewhat ludicrous
spectacle of an impotent committee's snapping its heels like a puppy dog."62 In
retrospect, Shipman wrote to Warren's successor in June 1956, the military's
refusal to participate "reduced that committee to impotence."63

Whatever its effectiveness, in 1952 the biomedical research screening
group did consider at least one of the military's flashblindness experiments.64
Flashblindness— the temporary loss of vision from exposure to the flash— was a
serious problem for all the armed services, but particularly for the Air Force.
Pilots flying hundreds of miles an hour in combat could not afford to lose
concentration and vision even temporarily.65

The flashblindness experiments began at the 1951 Operation Buster-
Jangle, the series that included Desert Rock I, with the testing of subjects who
"orbit[ed] at an altitude of 15,000 feet in an Air Force C-54 approximately 9 miles
from the atomic detonation. . . ,"66 The test subjects were exposed to three
detonations during the operation, after which changes in their visual acuity were
measured.67 Although these experiments were conducted at bomb tests that
potentially exposed the subjects to ionizing radiation, the purpose of the
experiment was to measure the thermal effects of the visible light flash, not the
effects of ionizing radiation.

When another experiment was proposed for Operation Tumbler-Snapper,
the 1952 Nevada tests, the AEC sought a "release of AEC responsibility" on
grounds that "there is a possibility that permanent eye damage may result."68 It is
not clear how the military responded, but the experiment proceeded. Twelve
subjects witnessed the detonation from a darkened trailer about sixteen kilometers
from the point of detonation.69 Each of the human "observers" placed his face in a
hood; half wore protective goggles, while the other half had both eyes exposed.70
A fraction of a second before the explosion, a shutter opened, exposing the left
eye to the flash.71 Two subjects incurred retinal burns, at which point the project
for that test series was terminated.72 The final report recorded that both subjects
had "completely recovered."73

At the 1953 tests, the Department of Defense engaged in further
flashblindness study.74 During this experiment, "twelve subjects [dark-adapted]
in a light-tight trailer were exposed to five nuclear detonation flashes at distances
offrom7to 14 miles."75

The flashblindness experiments were the only human experiments
conducted under the biomedical part of the bomb-test program and the only
human experiments where immediate injury was recorded. They were also the
only experiments where there is evidence of any connection to the 1953 Wilson
memorandum applying the Nuremberg Code to human experimentation.

Recently recovered documents show that upon a 1954 review of a report
showing the injuries at the 1952 experiment, AFSWP medical staff immediately
declared that "a definite need exists for guidance in the use of human volunteers
as experimental subjects."76 Further inquiry revealed that a Top Secret policy on

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the subject existed. That policy detailed "very definite and specific steps" that
had to be taken before volunteers could be used in human experimentation. But,
the AFSVVP wrote, "No serious attempt has been made to disseminate the
information to those experimenters who had a definite need-to-know."77

Nonetheless, some form of consent was obtained from at least some of the
flashblindness subjects. In a 1994 interview, Colonel John Pickering, who in the
1950s was an Air Force researcher with the School of Aviation Medicine, recalled
participating as a subject in one of the first tests where the bomb was observed
from a trailer, and his written consent was required. "When the time came for
ophthalmologists to describe what they thought could or could not happen, and
we were asked to sign a consent form, just as you do now in the hospital for
surgery, I signed one."78 There is no documentation showing whether subsequent
flashblindness experiments, which followed upon the issuance of the secretary of
defense's 1953 memorandum, required informed and written consent. However,
given the recollection of Colonel Pickering and the military tradition of providing
for voluntary participation in biomedical experimentation, this may well have
been the case. (A report on a flashblindness experiment at the 1957 Plumbbob
test uses the term volunteers'™ a report on 1962 "studies" at Dominic I provides
no further information.)80

In early 1954 the Air Force's School of Aviation Medicine reported that
animal studies and injuries at bomb tests (to nonexperimental participants) had
shown that potential for eye damage was substantially worse than had been
understood.81 Studies of flashblindness with humans continued in both field and
laboratory tests through the 1960s and into the 1970s. These experiments tested
prototype versions of eye protection equipment, and the results were used to
recommend requirements for eye protection for those exposed to atomic
explosions.82

Research on Protective Clothing

In late 1951, following the first Desert Rock exercise, the government
conducted Operation Jangle, a nuclear test series that detonated two nuclear
weapons, one on the surface and one buried seventeen feet underground. The two
Jangle shots were tests where the weapon's fireball touched the ground. When a
nuclear weapon's fireball touches the ground it creates much more local fallout
than an explosion that bursts in the air. Consequently, these tests posed some
potential hazard to civilians who lived near the test site and to test observers and
participants.

Two weeks before Jangle the DOD requested an additional 500 observers
at each of the Jangle shots, to acclimate the troops to nuclear weapons. The AEC
advised against the additional participants, declaring that "[t]his [the first
detonation] was an experiment which had never been performed before and the
radiological hazards were unpredictable." In the AEC's view, no one should

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approach ground zero for three or four days after the surface shot.83

The AEC seems to have been successful in persuading the Department of
Defense not to include the extra observers, but the DOD did not agree to the
AEC's suggestion on approaching ground zero. Four hours after the first shot, the
DOD conducted research involving troops who were accompanied by radiation
safety monitors.84 Eight teams of men walked over contaminated ground for one
hour to determine the effectiveness of protective clothing against nuclear
contamination.85 Similar tests were conducted after the second shot at Jangle, but
this time after a longer period. Five days after the shallow underground shot, men
crawled over contaminated ground, again to determine the effectiveness of
protective clothing.86 Other men rode armored vehicles through contaminated
areas to check the shielding effects of tanks and to check the effectiveness of air-
filtering devices.87 According to the final report, the protective clothing was
"adequate to prevent contact between radioactive dust and the skin of the
wearer."88

The information on this research is limited. The only mention of the
subjects in the report reads, "The volunteer enlisted men, too numerous to
mention by name, who participated in the evaluation of protective clothing were
of great assistance which is gratefully acknowledged."89 It is likely that at the
time these men were not viewed as subjects of scientific research but rather as
men who had volunteered for a hazardous or risky assignment. We know nothing
about what these men were told about the risks or whether they felt they could
have refused the assignment if they had an interest in doing so.

The Jangle activities are a good illustration of difficulties in drawing
boundaries in the military between activities that are research involving human
subjects and activities that are not. Although the Jangle evaluation was likely not
considered an instance of human research at the time, it has many similarities to
ground-crawling activity conducted several years later, not in conjunction with a
nuclear test, that was treated as research involving human subjects. In 1958
ninety soldiers at Camp Stoneman, in Pittsburg, California, were asked to perform
"typical army tactical maneuvers" on soil that had been contaminated with
radioactive lanthanum.90 The soldiers were then monitored for their exposure to
study beta contamination from this nonpenetrating form of radiation. In 1963
soldiers were again asked to maneuver on ground contaminated with artificial
fallout, this time at Camp McCoy in Wisconsin.91

The plans for the 1958 maneuvers, which were administered by the Navy's
Radiological Defense Laboratory, had been submitted for secretarial approval, as
was required for biomedical experiments involving Navy personnel.92 In
accordance with the Navy rules, the soldiers signed "written statements of
voluntary participation."93 During the 1963 experiments the Army processed the
activity under its 1962 regulation on human experimentation (AR 70-25 ).94 This
rule, a public codification of the secretary of defense's 1953 Nuremberg Code
rule, also required secretarial review and written consent.95

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Cloud-Penetration Experiments

What are the dangers to be encountered by the
personnel who fly through the cloud?~How much
radiation can they stand?~How much heat can the
aircraft take?~Can the ground crews immediately
service the aircraft for another flight?— If so, what
precautions are necessary to insure their safety?96

The Air Force felt that it was essential to answer these questions. To do
so, it carried out experiments, including some with animals and a few with
humans.

At the first atomic tests the military used remote-controlled aircraft, called
"drones," to enter and gather samples from atomic clouds in order to estimate the
yield and learn the characteristics of the weapon being tested. Military pilots did,
however, "track" mushroom clouds, gathering information and plotting the cloud's
path in order to warn civilian aircraft. During a 1948 test, a cloud tracker piloted
by Colonel Paul Fackler inadvertently got too close to a cloud. But after the
accident, Colonel Fackler commented, '"No one keeled over dead and no one got
sick.'"97 Colonel Fackler's experience, an Air Force history later recorded,
showed that manned flight through an atomic cloud "would not necessarily result
in a lingering and horrible death."98

Some of the trackers had "sniffers" on their aircraft to collect small
samples. The Air Force conducted experimental sampling missions at 1951 tests
and later permanently replaced the drones with manned aircraft because drones
were difficult to use, and they often did not get the quality samples of the atomic
cloud that Atomic Energy Commission scientists desired. By Operation Teapot
(1955), the AEC considered the testing of a nuclear device "largely useless"
unless sampler aircraft were used to obtain fission debris that would be used to
estimate the nuclear weapon's performance.99

As the sampling mission became routine, a new mission in the clouds
began. At Teapot the Air Force performed the first manned "early cloud
penetration." The phrase was used by the Air Force to refer to missions
conducted as soon as minutes after detonation of the test weapon. The main
purpose was to discover the radiation and turbulence levels within the cloud at
early times after detonation.

Like the first sampling missions, the first early cloud-penetration missions
were conducted by unmanned drone aircraft. In 1951 Colonel (now General) E.
A. Pinson, an Air Force scientist who had earlier conducted tracer experiments on
himself and other scientists, placed mice aboard a drone aircraft; in 1953 he flew
mice, monkeys, and instrumentation in drone aircraft through atomic clouds.
Pinson concluded that the radiation risk from flying manned aircraft through
atomic clouds could be controlled by monitoring the external gamma dose.'00 But

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the Air Force was not convinced and asked Pinson to follow up the animal
experiments with studies with humans during Operation Teapot (1955) and
Operation Redwing (1956) to confirm the results. This research appears to have
involved a small number of subjects, perhaps in the range of a dozen or so.

Pinson designed the human experiments to "learn exactly how much
radiation penetrates into the human system"10' when humans flew through a
mushroom cloud. The Air Force had pilots swallow film contained in small
watertight capsules. The film was attached to a string held in their mouths, so
that it could be retrieved at the end of the mission.102 When the film was
retrieved, the researchers compared the exposures measured inside the human
body with those measured on the outside. They found that the doses measured
outside the body were essentially identical to the doses inside the body; this was a
critical finding, because it meant that surface measurements would be
"representative of the whole-body dose."103

For the experiment, the AEC test manager for Teapot waived the AEC's
test-exposure limit of 3.9 roentgens and permitted four Air Force officers to
receive up to 15 roentgens whole-body radiation.104 The exemption was "based
on the importance of [the project] to the Military Effects Test program and the
fact that radiation up to 1 5 R may be necessary for its successful
accomplishment."105 When the air crews entered the atomic clouds, they
measured dose rates of radiation as high as 1,800 rad per hour. Since the crews
were in the cloud for such a short period of time, however, the actual doses were
much lower than 1,800 R.106 The maximum reported dose received on a single
mission was 17 R,'07 higher than the 15 R authorized for the project. Since the air
crews flew on several missions, two of the crew members received more than 17
R.108

A year later, at Operation Redwing, where the atomic and hydrogen
bombs were tested, the Air Force conducted another series of experimental cloud
penetrations. Part of the Redwing experiment was to measure the hazard from
inhaling or ingesting radioactive particles while flying through a mushroom
cloud. When mice and monkeys were flown through clouds during earlier tests
they were placed in ventilated cages to determine the hazard from inhaling
radioactive particles. The studies found that the hazard from inhalation was less
than 1 percent of the external radiation hazard. As General Pinson put it, "In
other words, if the internal hazard were to become significant, the external hazard
would be overwhelming."109 To confirm this finding, Pinson undertook a similar
experiment with humans, and again, as with the Teapot experiment, Pinson was a
subject as well as a researcher. To perform the experiment, no filters were
installed in the penetration aircraft.110 Again, it is estimated that about a dozen
subjects were involved.

The military this time set the authorized dosage (the maximum dosage to
which Pinson could plan to have people exposed) at 25 R and a limiting dosage
(in which case a report had to be filed) at 50 R."1 During the experiment

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"maximum radiation dose rates as high as 800 r/hr were encountered, and several
flights yielded total radiation doses to the crew of 15 r.""2 (To measure the
internal dose of radiation the scientists analyzed urine samples and used whole-
body counters.)

The project, as Pinson's final report noted, marked the transition from
animal experimentation to human measurement:

Although a considerable amount of experimentation
had been done with small animals which were
flown through nuclear clouds, the early cloud-
penetration project of Operation Redwing was the
first instance in which humans were studied in a
similar situation."3

The results confirmed those of the animal experiments. The internal
hazard of radiation was insignificant relative to the external hazard.
Consequently, the researchers recommended "that no action be taken to develop
filters for aircraft pressurization systems nor to develop devices to protect flight
crews from the inhalation of fission products.""4

Experimental Purpose: Military Tactics, Money, and Morale

Why was the Air Force interested in showing that atomic clouds could be
penetrated soon after a detonation?

Most important, the military wanted to assure itself that it was safe for
combat pilots to fly through atomic clouds, if need arose during atomic war. But
the research did not make much of a scientific contribution. Researchers had
already established the levels of radiation in atomic clouds by flying drone
aircraft through them, and there was nothing pathbreaking about humans being
exposed to levels of radiation under 25 R. General Pinson later noted, "there are
no research people that I know of that gave a damn [about manned early cloud-
penetration experiments], because this is ... a negligible contribution to research
and scien[ce]~scientifically, you know, this contributes less than I suspect
anything I've ever done ... its only virtue is the practical use of it.""5

From the scientific perspective the data would not likely be of great use;
from an immediate practical perspective human data were felt to be essential for
reassurance. Should the Air Force have been satisfied with the wealth of data it
had from the drone experiments? In retrospect Pinson found the question
difficult. "There's reason to say, 'Well, you should have been satisfied with the
data that had been gathered with the drones.' But, you know, these are hard-
nosed, practical people that—that put their life on the line and in military combat .
. . where the hazards are far greater than in this modest exposure to radiation.""6

The budget also played a key role in cloud-penetration research, as well as

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the related decontamination experiments, which will be discussed shortly. The
Defense Department declared that the knowledge gained through its cloud-
penetration experiments would save "the taxpayers thousands upon thousands of
dollars" because there would be no need to develop special protective clothing or
equipment, which had been thought to be necessary."7

As in the case of the HumRRO experiments and the troop maneuvers,
indoctrination and morale were important forces behind the experimentation.
"Perhaps the most important problem of all," a popular men's magazine of the day
wrote about the Teapot experience, "might be a psychological resistance of
combat pilots and crews flying into the unknown dangers of hot, radio-active
areas.""8 The press, therefore, depicted the Teapot experiment as a message to
the world— pilots can fly through atomic clouds safely.

Research, Consent, and Volunteerism

Like the HumRRO experiments, the cloud flythrough experiments were
treated as occupational, rather than experimental, activities. None of the
participants signed consent forms, and waivers to dose limits were sought, and
approved, under the process followed for the nonexperimental flythrough
activities. In 1995 General Pinson said that he had not been aware of the ethical
standards declared in the 1953 secretary of defense memorandum. If he had been,
he "would have gotten written consent from the people that were involved in
this.""9

A 1963 Air Force history of the cloud-sampling program does not describe
the process of crew and pilot selection, but does provide a perspective:

The Strategic Air Command pilots picked to fly the
F-84G sampler aircraft were pleased to learn that
they were doing something useful, . . . not serving
as guinea pigs as they seriously believed when first
called upon to do the sampling.120

Did the personnel understand the risks? Some of them surely did. The
aircraft carried airmen and scientific observers. Because the scientific observers
were the very scientists who designed the experiments, they certainly understood
the radiation risks as well as anyone could be expected to. In this way, the cloud
flythrough experiments exemplified the ethic of researcher self-experimentation.
As Pinson recalled in 1995, "If you are going to do something like this and you
think it's safe to do it, then you shouldn't ask somebody else to do it. The way
you convince other people that at least you think it's all right, is do it yourself."121

The nonscientists were briefed and informed that the risks from their
radiation exposure would be minimal.122 A pilot in the cloud-tracking activities
recalled one of the briefings: "The scientists line up at a briefing session and tell

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you there's no danger if you will follow their instructions carefully. In fact, they
almost guarantee it."123

But many of the pilots seemed to have been neither worried at the prospect
of risk nor excited at the prospect of glory. Pinson, for example, described the
attitude of the pilot who flew his aircraft as "matter of fact."124 And at Operation
Teapot, Captain Paul M. Crumley, project officer for the early cloud penetrations,
stated, "We consider these flights routine. Neither the pilots nor observers are
unduly concerned over the fact that no one else has flown into an atomic cloud so
soon after detonation."125

Decontamination Experiments

In conjunction with the Teapot cloud flythrough experiment, the military
also conducted an experiment on ground crews "to determine how soon these
same aircraft could be reserviced and made ready to fly again."126 The Air Force
used the contaminated aircraft from the early cloud-penetration experiment.127
The research sparked a debate between the Air Force and the AEC over the costs
and benefits of safety measures, a debate that was itself resolved by further
experimentation.

In one part of the "experimental procedure," personnel (the number
involved is not reported) rubbed their gloved hands over a contaminated fuselage,
and in another part "the bare, hand was also rubbed over a surface whose detailed
contamination was known and a radioautograph of the hand surfaces [was]
made."128 None of the "survey team" exceeded the AEC's gamma exposure limit
of 3.9 R.'29 Concluding that aircraft did not need to be "washed down" or
decontaminated after they flew through the atomic clouds, Colonel William
Kieffer, deputy commander of the Air Force Special Weapons Center, proposed
that decontamination procedures be eliminated except in extreme circumstances.
This change in procedures might cause overexposures, Kieffer wrote, but they
would be acceptable as long as "dangerous" dosages would be avoided.130

The proposal was not warmly received by the AEC. Los Alamos's
Thomas Shipman complained that the goal should be to reduce exposures to
zero.131 Harold Plank, a Los Alamos scientist who was in charge of the cloud-
sampling project and who rode along on many of the cloud-sampling missions,
said, "Kieffer simply could not understand the philosophy which regards every
radiation exposure as injurious but accepts minimum exposures for critical
jobs."132

Kieffer suggested a compromise; test the proposal with only one or two
sampler aircraft.133 Plank objected, but the AEC test manager promised to "do
everything possible to obtain a waiver of AEC operating radiological safety
requirements."134 The Air Force carried out the study during the 1957 Operation
Plumbbob. An additional plane was flown through the atomic clouds created by
five "events" to determine the hazard from the Air Force's proposed procedures.135

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The study showed that decontamination would be necessary to prevent
overexposures at test sites.136 In the end, the Air Force was unsuccessful in its
attempt to change the decontamination procedures for sampler aircraft.

We do not know how the Air Force viewed this activity. Given that it did
not treat the cloud flythroughs as an experiment, it is unlikely that the Air Force
considered the ground personnel activity to be an experiment. There is no record
of what the ground personnel were told or whether they were volunteers.

THE BOMB TESTS: QUESTIONS OF RISK, RECORDS, AND
TRUST

In this chapter, the Advisory Committee reviewed six different activities
that were conducted in conjunction with bomb tests that today we would consider
research involving human subjects.137 Only two of the six—the "atomic effects
experiments" conducted on officer volunteers and the flashblindness experiments-
-were clearly treated as instances of human research at the time. The six human
research projects likely included no more than 3,000 of the more than 200,000
people who were present during the bomb tests.138 Some of the research subjects,
perhaps as many as several hundred, were placed at greater risk of harm than the
other bomb-test participants who were not also research subjects. However, most
of the research subjects were not. At this point, we turn to a consideration of
several issues that affect all atomic veterans, regardless of whether they were also
research subjects. These include how at the time the DOD and the AEC
determined what exposures would be permitted, issues of record keeping, and
what is known today about long-term risks and participation in the bomb tests.

AEC and DOD Risk Analysis for Exposure at Bomb Tests

In counseling human subject research at bomb tests, the Joint Panel on the
Medical Aspects of Atomic Warfare stated that the research had to be performed
under "safe conditions." What "safe" meant for all those exposed, both
experimental subjects and other military participants at the bomb tests, was
subject to arrangements between the AEC and the DOD.139 While the military, of
course, is responsible for the safety of its troops, the AEC had responsibility for
the safe operation of the Nevada and Pacific sites at which the weapons were
tested. "Secrecy," summarized Barton Hacker, a DOE-sponsored historian of the
bomb tests, "so shrouded the test program . . . that such matters as worker safety
could not then emerge as subjects of public debate."140

As we have seen in the case of the cloud flythrough research, by the mid-
1950s the AEC and the Defense Department had arrived at a method of operation
through which waivers to the basic radiation safety standards for the tests would
be granted for particular activities. In the early 1950s, in the context of the Desert
Rock exercises, the AEC and the DOD established the precedent for departure

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from the standards that the AEC relied on for its own bomb-test work force.

At this time the AEC was the main source of expertise on radiation
effects. Its guidepost for its own workers (at the Nevada Test Site and elsewhere)
was the 3 R per thirteen-week standard established for occupational risk by a
private organization (the National Committee on Radiation Protection). This
level, it may be recalled from the debates on nuclear airplane experimentation
(discussed in chapter 8), was well below that at which the experts assumed acute
radiation effects, such as would limit combat effectiveness, could occur.141

In 1951, the Los Alamos Laboratory, the AEC's right hand in weapons test
management, called on the Division of Biology and Medicine's director, Shields
Warren, for "official but unpublicized authority to permit exposures up to 3.9r"
for AEC test personnel.142 Warren granted the request, counseling that "this
Division does not look lightly upon radiation excesses."143

As we have seen, the DOD shortly thereafter determined to use the tests
for troop maneuvers and did so at Desert Rock I, keeping the troops at seven
miles distance during the detonation. In early 1 952 the DOD asked the AEC to
endorse its request to station troops at Desert Rock IV as close as 7,000 yards
from ground zero (approximately four miles), far closer than the seven-mile limit
the AEC permitted its own test-site personnel. The AEC's Division of Military
Applications was willing to concur. Shields Warren, however, dissented on
grounds of safety.144 The dispute was settled when AEC Chairman Gordon Dean
advised DOD that "the Commission would enter no objection to stationing troops
at not less than 7000 yards from ground zero," provided that proper precautions
were taken.145

Even so, an internal review of the Desert Rock IV exercise by the Division
of Military Applications, generally supportive of DOD's request for troop
maneuvers, raised questions about the wisdom of deviation from the AEC
standard—and the potential for "delayed" casualties.'46

Determined to proceed, DOD called for "a study to be made to determine
the minimum distance from ground zero that should be permitted in a peacetime
maneuver."147 A December 1952 report recommended that dosages for Army
personnel be above the limit set by the AEC for its personnel. The soldiers, by
comparison with the AEC personnel, would be exposed "very infrequently." The
report summarized the state of knowledge:

There is no known tolerance for nuclear radiation,
that is, there is no definite proof that even small
doses of nuclear radiations [sic] may not, in some
way, be harmful to the human body. On the other
hand, there is no evidence to indicate that, within
certain limits, nuclear radiation has injured
personnel who have been exposed to it.148

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In response to the DOD's proposal to assume full responsibility for
physical and radiological safety of troops and troop observers within the Nevada
Test Site, the AEC stated that general safety practice and criteria at the Nevada
Proving Grounds was, and must continue to be, the responsibility of the AEC.
The AEC did, however, "accept the proposal that the DOD assume full
responsibility for physical and radiological safety of troops and all observers
accompanying troops within the maneuver areas assigned to Exercise Desert
Rock V, including establishment of a suitable safety criteria." The AEC further
explained that

The Atomic Energy Commission adopts this
position in recognition that doctrine on the tactical
use of atomic weapons, as well as the hazards
which military personnel are required to undergo
during their training, must be evaluated and
determined by the Department of Defense.

The Atomic Energy Commission has, however,
established safety limits. . . . We consider these
limits to be realistic, and further, are of the opinion
that when they are exceeded in any Operation, that
Operation may become a hazardous one. So that we
may know in which particulars and by how much
these safety standards are being exceeded, we desire
that the Exercise Director transmit to the Test
Manager a copy of his Safety Plan. . . ,'49

For the spring 1953 Desert Rock V exercises, the DOD deemed the
permissible limit for the troops (for a test series) to be 6 R.'50 In the case of the
officer volunteers, a 10 R test limit was agreed to, with the proviso that "it is not
intended that these exposures result in any injury to the selected individuals."151
The Army's limit at Desert Rock was well below the level understood to
potentially cause acute effects and far below the recommendation of Brigadier
General James Cooney that the military depart from the "infinitesimal" industrial
and laboratory limits and accept 100 roentgens for a single-exposure limit.152 But
the level was not only higher than the AEC level but also above the 0.9 R per
week being urged by the British and Canadians, partners in U.S. testing.153 (The
AEC itself objected that a 0.9 R-per-week limit would make testing at Nevada
impractical.)'54

Interestingly, in 1952 the Navy, also faced with the need for more-realistic
training exercises, considered spraying radioactive materials on ships during
training exercises. The Navy's Bureau of Medicine (BuMed) rejected the
proposal. BuMed told the chief of naval operations that while it "fully

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appreciates" the need for more "realistic radiological defense training," it could
not approve the use of radioisotopes in a form other than "sealed sources
commonly used in basic training . . . since such use might produce an internal
radiation hazard serious enough to outweigh the advantages of area contamination
for training purposes."155

By the mid-1950s, AEC test health and safety staff were continually
concerned about radiation safety at the tests and the failure to reduce them to a
predictable and assuredly safe routine. "There are," Los Alamos Health Division
leader Thomas Shipman wrote to the AEC Division of Biology and Medicine's
Gordon Dunning in 1956, "two basic facts . . . which must never be lost sight of.
The first of these is that the only good exposure is zero. . . . The second fact is
that once the button for a bomb detonation is pushed you have to live with the
results no matter what they are. . . ."'56 In fact, while the AEC had set a limit of
50 kilotons (more than twice the power of the Hiroshima and Nagasaki bombs)
for Nevada tests, this limit had already been exceeded by 10 kilotons in 1953.'57
"It is all very nice," Shipman wrote in another 1956 memorandum, "to have a
well-meaning Task Force commander who by a stroke of the pen can absolve our
radiologic sins, but somehow I do not believe that overexposures are washed
away by edict."158 Shipman's comments illustrate an acute awareness among
experts at the center of the testing program of the real and continuing element of
risk and uncertainty in the attempt to define and control exposures at the bomb
tests.

The Aftermath of Crossroads: Confidential Record Keeping to Evaluate
Potential Liability Claims

In the midst of the Korean and Cold Wars, researchers and generals were
focused on the short-term effects of radiation, not effects that might take place
years later. Thus, the benefits from knowledge about the bomb, or training of
troops in its use, loomed large, and the risks from long-term exposure likely
seemed distant and small. Government officials undertook to guard against acute
radiation effects; the surviving documentation indicates that they were
remarkably successful. Of the more than 200,000 service participants in the tests,
available records indicate that only about 1 ,200 received more than today's
occupational exposure limit of 5 rem, and the average exposure was below 1
rem.159 But there was no certainty that lower exposures were risk free.

During the summer of 1946, the contamination of ships at the Crossroads
tests put officials and medical experts on alert to the radiation risk posed to
participants at atomic bomb detonations. "[Difficult and expensive medico legal
problems," Crossroads medical director Stafford Warren feared, "will probably
occur if previously contaminated target ships are 'cleared' for constant occupancy
or disposal as scrap."160 A "Medico-Legal Advisory Board" sought to deal with
these questions,161 and the Navy created a research organization dedicated to the

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study of decontamination and damage to ships.162

Concern for long-term liability stimulated by Crossroads led to more steps
to guard against the legal and public relations implications if service personnel
exposed to radiation filed disability claims.

In the fall of 1946, General Paul Hawley, administrator of the Veterans
Administration, "became deeply concerned about the problems that atomic energy
might create for the Veterans Administration due to the fact that the Armed
Services were so actively engaged in matters of atomic energy."163 In August
1947 Hawley met with representatives of the surgeon general's offices of the
military services and the Public Health Service.164 The meeting was also attended
by former Manhattan Project chief General Leslie Groves,165 (Groves reportedly
was "very much afraid of claims being instituted by men who participated in the
Bikini tests.")'66 An advisory committee was created, which included Stafford
Warren and Hymer Friedell, Warren's deputy on the Manhattan Project medical
team. The committee was given the name "Central Advisory Committee," as "it
was not desired to publicize the fact that the Veterans Administration might have
any problems in connection with atomic medicine, especially the fact that there
might be problems in connection with alleged service-connected disability
claims."167

The committee recommended the creation of an "Atomic Medicine
Division" of the VA to handle "atomic medicine matters" and a radioisotope
section to "implement a Radioisotope Program."168 The committee further
recommended that "for the time being, the existence of the Atomic Medicine
Division be classified as 'confidential' and that publicity be given instead to the
existence of a Radioisotope Program."'69

This history is contained in a 1952 report presented by Dr. George Lyon to
the National Research Council.170 The 1952 report records that "General Hawley
took affirmative actions on these recommendations and it was in the manner
described that the Radioisotope Program was initiated in the Fall of 1947."'7'
Lyon, who had worked with Stafford Warren at Crossroads, was appointed
special assistant to the VA's chief medical director for atomic medicine, and
through 1959 served in a variety of roles relating to the VA's atomic medicine
activities. Dr. Lyon's 1952 report recounts that he was present at the August 1947
meeting and involved in the deliberations of the Central Advisory Committee, as
well as subsequent developments.172

Working with the VA and the Defense Department, we sought to retrieve
what information could be located regarding the Atomic Medicine Division and
any secret record keeping in anticipation of potential veterans' claims from
radiation overexposures. Among the documents found was a Confidential August
1952 letter to the attention of Dr. Lyon, in which the Defense Department called
for comment on the Army's proposal to "eliminate the requirement for
maintaining detailed statistical records of radiological exposures received by the
Army personnel."173 The requirement, the letter recorded, "was originally

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conceived as being necessary to protect the government's interest in case any
large number of veterans should attempt to bring suit against the government
based on a real or imagined exposure to nuclear radiations during an atomic

war."174

In 1959 Dr. Lyon was recommended for a VA "Exceptional Service
Award."175 In a memo from the VA chief medical director to the VA
administrator, Dr. Lyon's work on both the publicized and confidential programs
was the first of many items for which Dr. Lyon was commended. Following a
recitation of the 1947 developments similar to those stated by Dr. Lyon in his
1 952 report, the memo explained:

It was felt unwise to publicize unduly the probable
adverse effects of exposure to radioactive materials.
The use of nuclear energy at this time was so
sensitive that unfavorable reaction might have
jeopardized future developments in the field . . .
[Dr. Lyon] maintained records of classified nature
emanating from the AEC and the Armed Forces
Special Weapons Project which were essential to
proper evaluation of claims of radiation injury
brought against VA by former members of the
Armed Forces engaged in the Manhattan project.176

The Advisory Committee has been unable to recover or identify the
precise records that were referred to in the documents that have now come to
light. An investigation by the VA inspector general concluded that the feared
claims from Crossroads did not materialize and that the confidential Atomic
Medicine Division was not activated.177 However, the investigation did not shed
light on the specific identity of the records that were kept by Dr. Lyon, as cited in
the 1959 memo on behalf of his commendation.178 While mystery still remains,
the documentation that has been retrieved indicates that prior to the atomic testing
conducted in the 1950's, the government and its radiation experts had strong
concern for the possibility that radiation risk borne by servicemen might bear
longer-term consequences.

Looking Back: Accounting for the Long-Term Risks

Civilians, a UCLA psychologist observed during a 1949 NEPA meeting
convened to consider the psychology of radiation effects, question "whether the
medical group have actually discovered thus far all the effects of radiation on
human beings . . . that is going to be one of the most insidious things to
combat. . . ."'79 "[W]hen you talk about probable delayed effects possible,
unknown, and so forth," Dr. Sells, of the Air Force, asked, "what is the proper

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evaluation of the ethical question as to how to treat the possible or probable
unknown effects?"180 While not answering the question, he observed that
"certainly we can create more anxiety by being scientifically scrupulous than if
we simply treated these matters as we are inclined to treat other matters in our
every-daylife."181

This may have been the case following Crossroads. "Now we are very
much interested in long-term effects," a military participant in a 1950 meeting of
the DOD Committee on Medical Sciences stated, "but when you start thinking
militarily of this, if men are going out on these missions anyway, a high
percentage is not coming back, the fact that you may get cancer 20 years later is
just of no significance to us."182

Decades following the 1946 Crossroads tests, researchers began to study
the longer-term effects of the bomb on test participants.

In 1980 the Centers for Disease Control (CDC) reported a cluster of 9
leukemias among the 3,224 (then identified) participants of shot Smoky at the
Nevada Test Site in 1957. I83 A later report184 increased the count of leukemias to
10 compared with 4.0 expected on the basis of U.S. rates, but found no excess
cancers at other anatomical sites (the total observed was 1 12, compared with
1 17.5 expected). The Smoky test was the highest-yield tower shot ever conducted
at the Nevada Test Site; however, the measured doses for the Smoky participants
as a group were too low to explain the excess. Whether this cluster represents a
random event, an underestimation of the doses for the few participants who got
leukemia, or some other explanation remains unclear.

In light of the CDC research, the National Academy of Sciences (NAS)
thereafter undertook an enlarged study of five series of nuclear tests totaling
46,186 (then identified) participants.185 The 1985 NAS report confirmed the
excess of leukemia at the Smoky test but found no such excess at any of the test
series (as opposed to individual tests) and no consistent pattern of excesses at
other cancer sites. Later, however, the NAS study was found to be flawed by the
inclusion of 4,500 individuals who had never participated and the exclusion of
15,000 individuals who had participated in one or more of the five series, as well
as incompleteness of dosimetry. ' 86

The belated discovery that thousands of test participants had been
misidentified punctuated the deficiencies in record creation and record keeping
faced by those who seek to reconstruct, at many years' remove, the exposures of
participants at the tests.

Documents long available, and those newly retrieved by the Committee,
provide further basis for concern about the data gathering at test series in which
human subject research took place. At the 1953 Upshot Knothole series, which
included the Desert Rock V HumRRO research, 1994 DOD data show that only
2,282 of the 17,062 participants are known to have been issued film badges to
serve as personal dosimeters.187 At Desert Rock. V, the Army surgeon general's
policy that one-time exposure need not be reported led to a determination that

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maneuver troop units would be issued one film badge per platoon, and observers
would be issued one per bus.'88 An AFSWP memo recorded that the Radiological
Safety Organization did not have enough pocket dosimeters for efficient
operation.189 A recently declassified DOD memo records that "[although film
badges on the officer volunteers [at Desert Rock V] indicated an average gamma
dose of 14 roentgens, best information available suggests that the true dose was
probably 24 rem initial gamma plus neutron radiation."190

In a 1995 report, the Institute of Medicine found that the dose estimates
that were proposed for use in the NAS follow-up study were unsuitable for
epidemiologic purposes, but concluded that it would be feasible to develop a
dose-reconstruction system that could be used for this purpose. Nonetheless,
there are some further studies that are of direct relevance.191

Recently, Watanabe et al.192 studied mortality among 8,554 Navy veterans
who had participated in Operation Hardtack 1 at the Pacific Proving Grounds in
1958. This is, to date, the only study of U.S. veterans to include a control group
of unexposed military veterans. Overall, the participant group had a 10 percent
higher mortality rate, but the cancer excess was significant only for the combined
category of digestive organs (66 deaths compared with 44.9 expected, a 47
percent increase). On average, the radiation doses were low (mean 388 mrem),
but among the 1,094 men with doses greater than 1 rem, there was a 42 percent
excess of all cancers. No categories of cancer sites showed a significant excess or
clear dose-response relationship, but the number of deaths in any category was
small.

Two sets of foreign atomic veterans have been studied. In a study of 954
Canadian participants,193 no differences with matched controls were found, but
only very large effects would have been detectable in such a small study. In
contrast, a large study of British participants of test programs in Australia found
higher rates of leukemia and multiple myeloma than in a matched control group
(28 vs. 6).194 However, the cancer rates among the exposed veterans were only
slightly higher than expected based on national rates, whereas those in the control
group were much lower than expected, and there was no dose-response
relationship. No excess was found at any other cancer site. Although the
difference between the exposed and unexposed groups was quite significant, the
interpretation of this result is unclear. Does it mean that for some unknown
reason, soldiers are less likely than the general population to get cancer (the
"healthy soldier effect," which is usually not thought to be so large for cancer), or
is it an indication of some unexplained methodological bias? This point has never
been resolved.

These observed effects need to be put in the context of what might
reasonably be expected based on current understanding of low-dose radiation
risks and the doses the atomic veterans are thought to have received.
Approximately 220,000 military personnel participated in at least one nuclear test.
The film badges for those monitored (thought to be roughly representative of all

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participants) average 600 mrem.195 As summarized in "The Basics of Radiation
Science" section of the Introduction, the consensus among scientific experts is
that the lifetime risk of fatal cancer due to radiation is approximately 8 per 10,000
person-rem. On this basis, one might anticipate approximately 106 excess cancer
deaths attributable to participation in the nuclear tests. Not only is this a number
with considerable uncertainty, it is small in comparison with the total of about
48,000 cancer deaths that are eventually anticipated in this population.

Such a small overall excess would be virtually impossible to detect by
epidemiologic methods. In some subgroups, however, the relative increase above
normal cancer rates could be large enough to be detectable. Leukemia, for
example, is proportionally much more radiosensitive than other cancers and the
largest excess occurs fairly soon after exposure, when natural rates are low.
Focusing on those with highest exposure would also enhance the relative increase,
albeit with many fewer people at risk. The Defense Nuclear Agency estimates
that about 1,200 veterans received more than 5 rem (mean 8.1 rem).196 On this
basis, about eight excess cancer deaths would be anticipated. These factors may
have contributed to the observed leukemia excess among participants of shot
Smoky, for example.

Although these numbers represent the best estimate currently available of
the expected cancer excess, there are uncertainties in both the real exposures
received by the participants and the magnitude of the low-dose risk. As described
in "The Basics of Radiation Science" section, there is roughly a 1.4 uncertainty in
the low-dose radiation risk coefficient simply due to random variation in the
available epidemiologic data, with additional uncertainties of unknown magnitude
about model specification, variation among studies, extrapolation across time and
between populations, unmeasured confounders, and so on. These uncertainties
are hotly contested, although the majority of radiation scientists believe the
figures quoted above are unlikely to be seriously in error. If low-dose radiation
risks were indeed substantially higher than this, then there would be a serious
discrepancy to explain with the effects actually observed at higher doses. The
uncertainties in the doses received by participants are perhaps more substantial,
but given the limitations in the dosimetry and record keeping, it may be difficult
ever to resolve them.

As is clear from the epidemiologic data available today, there is no
consistent pattern in increased cancer risk among atomic veterans, although there
are a number of suggestive findings, most notably the excesses of leukemia
among shot Smoky and British test participants, the causes of which are still
unclear. The low recorded doses, the small size of the expected excesses, and
problems in record keeping and dosimetry make it very difficult to resolve
whether atomic veterans as a group are at substantially elevated cancer risk and
whether any such excess can be attributed to their radiation exposures. The
Advisory Committee debated at some length the merits of further epidemiologic

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studies and concluded that the decisions to conduct such studies should be made
by other appropriately constituted bodies of experts.

Looking Back: The Legacy of Distrust

The chain of events set in motion by the CDC research, and renewed
interest in the fate of the "atomic vets," led to congressional enactment of
legislation that provides veterans exposed at atmospheric tests with the
opportunity to obtain compensation for injury related to radiation exposure.

The Veterans Dioxin and Radiation Exposure Compensation Standards
Act of 1984 provides for claims for compensation for radiation-related disabilities
for veterans exposed at atmospheric tests. The Radiation Exposed Veterans
Compensation Act of 1988 provides that a veteran who was exposed to radiation
at a designated event and develops a designated disease may be entitled to
benefits without having to prove causation.197

Notwithstanding the passage of this legislation, the Committee heard from
many atomic veterans, and their widows, who complained that the records that
were created and maintained by the government-records on which veterans'
claims may stand or fall-were inadequate, missing, or wrong.198 Atomic veterans
also stated that the laws and rules do not adequately reflect the kinds of illnesses
that may be caused by radiation, that they do not provide for veterans who were
exposed to radiation in settings other than atmospheric tests, and that the practical
difficulties~in time and resources~of pursuing their rights under the laws are
often excessive. The Committee heard from many who told of the time, expense,
and difficulty of getting information on the full circumstances of bomb-test
exposures. They told of their continued efforts, over the course of the years, to
reconcile what they have learned from government sources with that which they
have been told by other test participants, that which they recovered from the
private letters of test participants to family members, and their own further
research.

For numerous atomic veterans, the testimony was not simply that the
bomb tests themselves had been large experiments, but that they had been put at
risk in the absence of planning to gather the data and perform the follow-up
studies needed to ensure that the risks of the unknown, however small, would be
measured and adequately accounted for.

CONCLUSION

The story of human research conducted in connection with nuclear
weapons tests illustrates the difficult questions that are raised when human
research is conducted in an occupational setting, especially a setting, such as the
military, where exposure to risk is often part of the job. The story illustrates that
it may often be difficult to discern whether or not an activity is a human

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experiment. By the same token, it also illustrates the importance of guarding
participants against unnecessary risks, whether or not the activity is a human
experiment.

Human experiments at atomic bomb tests were undertaken by the military,
which had a long tradition of requiring voluntary consent from participants in
biomedical experiments. The need for written consent in experiments related to
atomic, biological, and chemical warfare was clearly stated in the secretary of
defense's 1953 memorandum. That memorandum also required the approval in
writing of the appropriate service secretary and precluded experiments that did
not adhere to its further requirements. The 1953 memorandum, however, does
not appear to have been transmitted to those involved in human research at bomb
tests, although the tenet of voluntary consent was followed in some cases. In
addition to consent, the 1953 memorandum contained other significant ethical
requirements, including that research be reasonably likely to produce useful
scientific results and that proper precautions be taken to minimize risk.

The bomb-test research illustrates the significance of the position that bad
science is bad ethics. Unless a research project is scientifically defensible, there
is no justification for imposing on human subjects even minimal risk or
inconvenience. For example, the DOD's biomedical advisers advocated the
conduct of psychological and physiological research on troops participating in
bomb tests with an awareness that the likelihood of scientifically useful results
was small and that the effort would be part of a larger exercise in indoctrination
and training. Having done so, they had an obligation to at least review continued
research efforts to determine if the research design was developing useful
information. In the case of the psychological and physiological testing, the
evidence indicates that early results showed that the research design was not
likely to produce useful scientific information, if only because the military, the
researchers, and perhaps even the subjects did not view the setting as sufficiently
realistic.

At the same time, this question of ethics and science is irrelevant if the
HumRRO activities did not entail research involving human subjects. An activity
that has a poor research design would not be an ethical human experiment.
However, the same activity might be ethical if conducted as a training activity
whose essential purpose is to provide reassurance. Similarly, to the extent that
research was intended solely to provide reassurance, ethical questions arise that
might not be present if the activity were not experimental.

Just what makes something an instance of research involving human
subjects? The answer to this question is not discoverable; instead, it is fashioned
by people in particular contexts for particular purposes. Today, we would likely
consider all the activities reviewed in the first part of this chapter —the HumRRO
testing, the "atomic effects experiment," the flashblindness experiments, the cloud
flythroughs, and the protective clothing and decontamination tests— to be cases of
research involving human subjects to which the current federal regulations and

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the current rules of research ethics would apply. Some of these activities are,
nevertheless, more paradigmatically instances of human research than others.
Depending on the context, for example, the protective clothing and
decontamination tests might be considered within the normal course of duty for
military personnel.

One of the reasons it is important to be able to distinguish research
involving human subjects from other activities is that military policy clearly states
that service personnel may not be ordered to be human subjects. In contrast to
much else in military service, participation in research is a discretionary activity
that service personnel are permitted under military policy and federal regulation
to refuse. Thus, in the military as elsewhere, human subjects are supposed to be
volunteers whose valid consent has been obtained.

Human subject research is not the only activity in the military, however,
for which consent is a requirement. The military also often asks for volunteers in
settings where the risk is unusually great. For example, the testing of equipment
may often be hazardous, may involve the use of volunteers, but may not be
considered human research. Thus, in the case of test pilots, there may be
significant risk, volunteers may be called for, but the activity might not be
considered research with human subjects and thus would not be thought subject to
human use research regulations.

Conversely, a requirement of consent may not necessarily mean that
subjects have some measure of control over the risks to which they are to be
exposed. Even under today's rules, informed consent in the HumRRO tests would
be limited to the psychological and physiological testing, and not required for
participation in the bomb test itself.

Whether the activity is research involving human subjects or an unusually
risky assignment that is not considered human subject research, how free are
military personnel to accept or refuse offers (as opposed to orders) put to them?
Dr. Crawford, when asked to comment in 1994 on consent in his HumRRO
research, responded by observing that "military service people generally do what
they're asked to do, told to do." He was speaking of an army that included many
conscripts; today's all-volunteer military is doubtless different in many respects
that bear on questions of voluntariness. Nevertheless, the culture of the military,
with its emphasis not only on following orders but on the willingness to take risks
in the interests of the nation, surely influences and in some circumstances may
restrict how service personnel respond to such offers.

Because in the military volunteering is often seen as a matter of duty and
honor, and the boundaries between experimental and occupational activities may
not be clear, the importance of minimizing risk emerges as a central concern.
Above all, the activities discussed in this chapter confirm that the ethical
requirement that risks to service personnel be minimized should not depend on
whether an activity is characterized as an experiment or occupational. In the case
of the atomic veterans, the risks run were usually no different for those who were

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subjects of research and those who were not.

The military took precautions, with great success, to preclude exposure to
radiation at levels that might produce acute effects. However, bomb-test
participants were exposed to lesser, long-term risks without adequate provision
for (1) the creation and maintenance of records that might be needed, in
retrospect, to determine the precise measure of risks to which military personnel
were exposed; (2) the tracking of those exposed to risk, so that follow-up and
assurance, as needed, could be efficiently undertaken.

It might be argued that, at the time, there was no awareness of a potential
for long-term risk, or that the potential was understood to be nonexistent. But,
while the possibility of long-term risk from low exposures was seen as low, it was
not seen as nonexistent. Following the 1946 Crossroads tests, officials and
experts connected with the DOD, AEC, and VA thought action was needed to
collect data in secret to evaluate potential disability claims.

Since the bomb tests, the Defense Department has come to recognize the
importance of providing for an independent risk assessment when service
personnel may be exposed to new weapons-regardless of whether the exposure is
classed as experimental or occupational.199

However, for the numerous atomic veterans (and their family members)
who spoke to the Committee, a continuing source of distress is not simply that the
government put service personnel at risk but that, having undertaken to do so, the
government did not undertake to collect the data and perform the follow-up that
might provide them knowledge and comfort in later years. The Advisory
Committee agrees. When the nation exposes servicemen and women to
hazardous substances, there is an obligation to keep appropriate records of both
the exposures and the long-term medical outcomes.

From listening to those who appeared before us, and from reflection on the
laws that are already in effect, the Committee came to appreciate that there are
several reasons record keeping is important. First, those who served, and their
widows and surviving family members, have a great interest in knowing the facts
of service-related exposures. We repeatedly heard from veterans and family
members whose inquiries into the circumstances and details of exposures has
spanned many years. Second, information may provide basis for scientific
analysis that may shed light on the relation between exposure to risk and
subsequent disability or disease. Third, where disability or disease appears to be
a possible result of exposure, data are needed to provide the basis for a fair and
efficient system of remedies.

The experience of the bomb-test participants indicates that several
different kinds of records or data should be of use. First, of course, there are data
about the exposure of individual service personnel to particular potential hazards.
In the case of the atomic bomb tests, the potential that radiation would be a hazard
was, of course, obvidus. In addition, radiation is a phenomenon that is almost
uniquely susceptible to measurement. In other settings faced by service

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personnel, the precise nature of the hazard may not be easily anticipated or, even
if anticipated, readily measurable. Second, there are data concerning the location
of service personnel. In the case of the bomb tests, as we have seen, data on the
identity and location of all test participants (so that their position in relation to the
putative hazard can be retrospectively reconstructed, if need be) were not readily
available. Even if the hazard cannot be anticipated, such data can be useful in
later efforts to reconstruct the nature of the hazard and its effect. Third, the
maintenance of complete medical records, including linkages where multiple sets
of records exist, is essential. Records suitable for use in epidemiologic studies of
long-term medical consequences of military actions would be valuable for both
medical science and service members.

But having heard from many atomic vets and their family members, the
Advisory Committee does not believe that, but for the inadequate record keeping
and lack of follow-up, there would be no anger or disappointment among atomic
veterans and their families. The real offense to many is the belief that the risk
was unacceptable and that they or their loved ones may suffer illness
unnecessarily as a consequence. Proper attention to record keeping should
provide some basis for gaining and assuring the trust of those who are exposed to
risk in the future and, perhaps, scientific results that may be of real value to them,
but it is hardly a guarantee against perceptions of abuse or unfairness.

If nothing else, our experience makes us appreciate the difference between
technical, analytic data and the reality of the human experience. The available
data, as we have discussed, indicate that the average amount of radiation to which
bomb-test participants were exposed was low. But those who believe they have
suffered as a consequence of these exposures do not believe these risks to have
been as slight as the data indicate. When we review this decades later, we rely on
numbers; the atomic veterans and their family members who have appeared
before the Committee associate, in a "cause and effect" way, the exposure with
some kind of result that they have personally experienced or witnessed. The
emotions and concerns expressed to the Committee by these citizens (and those
downwind from atomic tests and intentional releases) were very, very real. Both
the public and the scientific community must understand that, when data indicate
that risks are low, the risks are not necessarily zero; and it is possible for a rare
event to occur. The risk analysis may only indicate that it is unlikely that such
events will occur with significant frequency or probability.

487

ENDNOTES

1 . See Department of Energy, Announced United States Nuclear Tests: July
1945 Through December 1992 (Springfield, Va.: National Technical Information
Service, May 1993); Department of Energy, Expanded Test Information for Nuclear
Tests With Unannounced Simultaneous Detonation (Springfield, Va.: National Technical
Information Service, 20 June 1994).

2. Thomas L. Shipman, Los Alamos Laboratory Health Division Leader, to Dr.
Harry G. Ehrmentraut, Committee on Medical Sciences, Research and Development
Board, Department of Defense, 25 July 1951 ("Dr. Robert Grier has passed on to

me . . .") (ACHRE No. DOE-033195-B), 2.

3. See the July 1949 transcript of a meeting convened by the NEPA [Nuclear
Energy for the Propulsion of Aircraft] Medical Advisory Panel to discuss the
"Psychological Problem of Crew Selection Relative to the Special Hazards of Irradiation
Exposure," 27. NEPA Medical Advisory Panel, Subcommittee IX, proceedings of 22
July 1949 (ACHRE No. DOD-121494-A-2).

4. Richard L. Meiling, Chairman, Armed Forces Medical Policy Council, to the
Deputy Secretary of Defense et al., 27 June 1951 ("Military Medical Problems
Associated with Military Participation in Atomic Energy Commission Tests") (ACHRE
No. DOD-122794-B), 1.

5. Ibid.

6. Ibid.

7. Department of the Army, September 1950 ("Atomic Energy Indoctrination")
(ACHRE No. DOD-020395-D), 73.

8. Ibid.

9. Richard L. Meiling, Chairman, Armed Forces Medical Policy Council, to the
Chairman, Research and Development Board, 23 February 1951 ("Department of
Defense Biomedical Participation in Atomic Weapons Tests") (ACHRE No. NARA-
071194-A), 1.

10. The Joint Panel was created in 1949 by the Committee on Medical Sciences
and the Committee on Atomic Energy, which were committees of the Research and
Development Board. (See the Introduction and chapter 1 for further discussions of the
Joint Panel.)

1 1 . The agenda noted that while civilians were polled in the preparation of the
draft, "very few" responded. The draft was therefore " offered not as a proposed
statement, to be accepted after only minor revisions, but as a general guide to the type of
paper which is expected of the Joint Panel." Joint Panel on the Medical Aspects of
Atomic Warfare, 20 September 1951 ("Agenda, 8th Meeting, Item 3 - Preparation of
Statement on Biomedical Participation in Future Weapons Tests") (ACHRE No. DOD-
072294-B), 1-2.

12. Joint Panel on the Medical Aspects of Atomic Warfare, 20 September 195 1
("Biomedical Participation in Future Atomic Weapons Tests [Attachment to Agenda, 8th
Meeting]") (ACHRE No. DOD-072294-B), 2. The quoted language appears to have
come from Dr. Thomas Shipman of Los Alamos. See Thomas Shipman, Los Alamos
Laboratory Health Division Leader, to Shields Warren, Director, AEC Division of
Biology and Medicine, 15 September 1951 ("Permissible Exposures, Test Operations")
(ACHRE No. DOE-120894-C).

488

13. The draft stated a concern that "actual animal exposures should be limited
as much as possible," but did not expressly address human experimentation. Joint Panel
on the Medical Aspects of Atomic Warfare, 20 September 1951, ("Biomedical
Participation in Future Atomic Weapons Tests"), 3.

14. Ibid., 5-7.

15. We discuss the data gathering on radioisotopes in the body fluids in chapter
13, in the context of a discussion of secret human data gathering on fallout.

16. Joint Panel on Medical Aspects of Atomic Warfare, 20 September 1951
("Program Guidance Report") (ACHRE No. DOD-072294-B), 23.

17. Ibid., 20. A further section on "Psychological Studies" recommended the
following:

4.1.3 Continue studies in psychology of panic.

4.1 .4 Seek technics [sic] for reducing apprehension and
for producing psychologic resistance to fear and panic,
especially in presence of radiation hazard (emotional
vaccination).

4.1.5 Spread knowledge of radiation tolerance, technics
[sic] of avoidance, and possibility of therapy through
military and civilian populations and measure their
acceptance.

4. 1 .6 Prepare to make psychologic observations at and
after bomb tests.

Ibid., 14.

18. Colonel Michael Buckley, Acting Deputy Assistant Chief of Staff, Research
and Development, to Chief of Army Field Forces, Fort Monroe, Virginia, 20 August
1951 ("Proposed Study of Behavior of Troops Exposed to A-Bomb") (ACHRE No.
NARA-013195-A), 1.

19. Peter A. Bordes et al., February 1953 ("DESERT ROCK I: A Psychological
Study of Troop Reactions to an Atomic Explosion [HumRRO-TR-1]") (ACHRE No.
CORP-111694-A),3.

20. Dr. Meredith Crawford, interview by Dan Guttman and Patrick Fitzgerald
(ACHRE), transcript of audio recording, 1 December 1994 (ACHRE Research Project
Series, Interview Program File, Targeted Interview Project), 6-7. Dr. Crawford was
recruited to head the new HumRRO by psychologist Harry Harlow, an Army adviser
who was famed for his work with monkeys. HumRRO was a private contractor created
at the Army's behest and initially affiliated with George Washington University. In the
1951 experiments, HumRRO worked with the Operations Research Organization (ORO),
which was affiliated with Johns Hopkins University.

21. In 1 994, Dr. Crawford prepared a retrospective memorandum titled
"HumRRO Research During Four Army Training Exercises." Based on the 1953 report,
"A Psychological Study of Troop Reactions to an Atomic Explosion," Dr. Crawford
estimated that 633 service personnel were involved in the maneuvers at Desert Rock I.
Meredith P. Crawford to William C. Osbom, 27 January 1994 ("HumRRO Research
During Four Army Training Exercises Involving Atomic Weapons— 1951-1957")
(ACHRE No. CORP-1 12294-B), 8. In addition, hundreds of additional troops were
involved as the "nonparticipant" group (which did not attend the test maneuvers, but was
given psychological tests). The "experimental paradigm" for the HumRRO tests is

489

described in this 1994 memorandum. Ibid., 4.

22. "Armed Forces: Exercise Desert Rock," Time, 12 November 1951, 21-22.

23. New York Times, 1 November 1951, 4.

24. Bordes et al., "DESERT ROCK I: A Psychological Study of Troop
Reactions to an Atomic Explosion," 6.

25. Interview with Crawford, 1 December 1994, 57.

26. Bordes et al., "DESERT ROCK I: A Psychological Study of Troop
Reactions to an Atomic Explosion," 5.

27. Ibid., 103.

28. Ibid., 107-108.

29. Interestingly, the troops evidently did not buy the "correct" answer; only
about 40 percent of the troops at the maneuver were reported to have been correctly
indoctrinated. Bordes et al., "DESERT ROCK I: A Psychological Study of Troop
Reactions to an Atomic Explosion," 130.

30. The Committee asked the DOD to review the 1951 questionnaire and
comment on whether the information presented regarding the effect of an airburst is,
based on DOD's current expert understanding, still correct. DOD provided
"changes/corrections/clarifications" on nine items. In the case of items 1 and 6, quoted
in the text, DOD commented:

1) As stated, the answer is wrong. The ground zero
hazard 1 day after an atomic explosion depends on the
yield. At 20 kt, there would be no fallout for a burst at
2000 feet, but there would be induced activity. . . .

6) There is thp same problem with this answer as with 1 , above.

In one case the DOD reported that the 1951 questionnaire erred on what might
be called the side of caution; where a 1951 answer stated that a posited detonation would
not kill anybody beyond the range of three miles, the answer today would be one mile.
Department of Defense, Radiation Experiments Command Center, 26 April 1995
("ACHRE Request 032795-A, HumRRO Questionnaire and Air Burst Material")
(ACHRE No. DOD-042695-A), 1.

3 1 . Colonel R. G. Prentiss, Executive Officer, Office of the Army Surgeon
General, to Chief, Army Field Forces, Fort Monroe, Virginia, 9 January 1952
("Psychiatric Research in Connection with Atomic Weapon Tests Involving Troop
Participation") (ACHRE No. DOD-080594-A), 1. The memo recorded:

1. For your information in connection with planning for
future exercises and operations in which atomic
weapons tests will be used and troops will participate,
this office has a continuing interest in the conduct of
psychiatric observations regarding the effects of the
weapons on the participating troops.

2. Funds for the conduct of psychiatric observations
which may be approved for future atomic weapons tests
will be made available through the Surgeon General.

490

The memorandum bears concurrences from the "Medical Research and
Development Board," "Medical Plans and Operations," "Fiscal Division," and "Chief,
Psychiatry and Neurology Consultants Division." It is not clear what role Army
psychiatrists (i.e., medical doctors) played in the implementation of
the "psychological" experiments.

32. Major P. C. Casperson, for the Chief of Army Field Forces, to First Army
et. al., 7 March 1952 ("Extracts, Final Report Exercise DESERT ROCK I") (ACHRE
No. NARA-013195-A), 122. In an age of "polls and questionnaires," the report
suggested, the overpsychologized troops may have been putting the psychologists on:

The psychological evaluators, of whom there were many
and various, were perhaps too obvious and eager. This
is an era of polls and questionnaires and here was a new
and untried field with unlimited possibilities. The
ultimate response, finally, was a humorous and
deliberate program in the troops to confuse the
psychological people with fictitious reactions.
Ibid.

33. Brigadier General A. R. Luedecke, AFSWP, to Director, AEC Division of
Military Application, 7 March 1952 ("Reference is made to your letter of 28 December
1951 . . .") (ACHRE No. NARA-010495-A), 2.

34. Interview with Crawford, 1 December 1994, 12-13.

35. Dr. Crawford's 1994 reconstruction of events estimated that 672 soldiers
witnessed the shot, and 914 served in the control group as nonparticipants. Crawford to
Osborn, 27 January 1994, 10.

36. Motivation, Morale, and Leadership Division, Department of the Army,
August 1953 ("Desert Rock IV: Reactions of an Armored Infantry Battalion to an Atomic
Bomb Maneuver [HumRRO-TR-2]") (ACHRE No. CORP- 1 1 1 694- A), ix, 17.

37. Benjamin W. White, 1 August 1953 ("Desert Rock V: Reactions of Troop
Participants and Forward Volunteer Officer Groups to Atomic Exercises") (ACHRE No.
CORP-111694-A), 10.

38. Department of the Army, "Desert Rock IV: Reactions of an Armored
Infantry Battalion to an Atomic Bomb Maneuver [HumRRO-TR-2]," 72.

39. "Armed Forces: Exercise Desert Rock," Time, 12 November 1951, 22. At
Desert Rock I, physiological testing, including the use of a polygraph, sought to measure
anxiety before and after D-Day. Bordes et al., "DESERT ROCK I," chapter 6. At Desert
Rock IV, before and after "sweat tests" measured troops' hand sweating as a possible
index of fear. Department of the Army, "Desert Rock IV: Reactions of an Armored
Infantry Battalion to an Atomic Bomb Maneuver [HumRRO-TR-2]," 10.

40. Joint Panel on the Medical Aspects of Atomic Warfare, 9 September 1 952
("Minutes: 9, 10, 1 1 and 12 September 1952, Los Alamos Scientific Laboratory")
(ACHRE No. DOD-072294-B), 3-4. The panel's statement was in the form of a motion
to be transmitted to the DOD Research and Development Board's Committee on Human
Resources, to which the advisory role on the HumRRO effort was being turned over.

4 1 . The available research reports do not indicate the numbers of participants in
the research.

42. Defense Nuclear Agency, 8 August 1995 ("Atmospheric Test
Series/Activities Matrix") (ACHRE No. DOD-081 195-A).

491

43. Robert D. Baldwin, March 1958 ("Staff Memorandum: Experiences at
Desert Rock VIM") (ACHRE No. CORP-1 1 1694-A). Also at Plumbbob was an
experiment to test the efficiency of fallout shelters. Sixteen men were confined in four
shelters to collect fallout samples, so that their ability to collect samples could be studied
and so that they could be studied for the psychological effect of confinement. The study
concluded that the shelters were well suited for both manned stations at nuclear weapons
tests and for single-family fallout shelters. J. D. Sartor et al., 23 April 1963 ("The Design
and Performance of a Fallout-Tested Manned Shelter Station and Its Suitability as a
Single-Family Shelter [USNRDL-TR-647]") (ACHRE No. CORP-032395-A). See also
Nevada Test Organization, Office of Test Information, 24 July 1957 ("For Immediate
Release") (ACHRE No. DOE-033195-B); Nevada Test Organization, Office of Test
Information, 15 July 1957 ("For Immediate Release") (ACHRE No. DOD-030895-F).

44. Baldwin, "Experiences at Desert Rock VIII," 39.

45. Ibid., 12. The troops were not to be told the amount of contamination
present, which would depend upon actual fallout amounts. The course was marked by
radiation hazard markers, which might or might not reflect the actual fallout. Ibid., 23.

46. Ibid., 7.

47. Interview with Crawford, 1 December 1994, 52.

48. Bordes et al., "DESERT ROCK I: A Psychological Study of Troop
Reactions to an Atomic Explosion," 20.

49. Crawford to Osborn, 27 January 1994, 1 5.

50. CG Cp Desert Rock to CG Sixth Army, 28 March 1953 ("Reference
message G3, OCAFF No. 423") (ACHRE No. NARA-013195-A), 1. The office
volunteers participated in three detonations in the 1953 "Upshot-Knothole" series— shots
Nancy, Badger, and Simon. "DNA Fact Sheet Operation Upshot-Knothole," January
1992.

51. Captain Robert A. Hinners, USN, Headquarters, Armed Forces Special
Weapons Project, 25 April 1953 ("Report of Participation in Selected Volunteer Program
of Desert Rock V-7") (ACHRE No. DOE-033195-B), 2.

In an 1 1 February 1953 letter, the Army informed the Congressional Joint
Committee on Atomic Energy of the "steps being taken by the Army in connection with
exposure of troops at tests of atomic weapons." Lieutenant General L. L. Lemnitzer,
Deputy Chief of Staff for Plans and Research, to Honorable Carl T. Durham, House of
Representatives, 1 1 February 1953 ("The Secretary of the Army has asked that the Joint
Committee . . .") (ACHRE No. NARA-1 12594-A), 1. The Army explained that
deployment in foxholes at as close to 1 ,500 yards was needed to confirm that
commanders could risk troops at this distance. The Army assured the committee that
experts deemed it "highly improbable that troops will suffer any injury under these
conditions." Ibid., 2.

Assurance was given to Congress that no more than twelve volunteers would be
used at one shot. G3 DEPTAR, to CG Cp Desert Rock, 15 April 1953 ("Reference your
msg AMCDR-DPCO 0498") (ACHRE No. NARA-013194-A), 1.

52. Brigadier General Carl H. Jark, for the Assistant Chief of Staff,
Organization and Training Division, to Distribution, 20 February 1953 ("Instructions for
Positioning DA [Department of Army] Personnel at Continental Atomic Tests
[Attachment to 20 February 1953 memo]") (ACHRE No. NARA-1 20694-A), 2.

53. White, "Desert Rock V: Reactions of Troop Participants and Forward
Volunteer Officer Groups to Atomic Exercises," iii.

492

54. CG Sixth Army Presidio of SFran Calif, to OCAFF Ft Monroe Va, 24 April
1953 ("Reference Desert Rock msg AMCDR-CG-04237") (ACHRE No. NARA-013195-
A), 1.

55. Major R. C. Morris, for the Commanding General, to Chief of Research and
Development, 15 November 1955 ("Amendment to Proposed Project Regarding Blast
Injury Evaluation") (ACHRE No. DOD-030895-F), 1.

56. Major Benjamin I. Hill, for the Director, Terminal Ballistics Laboratory, to
Chief, Armed Forces Special Weapons Project, 13 December 1955 ("Amendment to
Proposed CONARC Project Regarding Blast Injury Evaluation") (ACHRE No. DOD-
030895-F), 1.

57. Colonel Irving L. Branch, for the Chief, AFSWP, to Chief of Research and
Development, Department of the Army, 20 January 1956 ("Annex 'A' to 2nd
Endorsement: Detailed Explanation of AFSWP Comments on Feasibility of Human
Volunteer Program") (ACHRE No. DOD-030895-F), 1.

58. Ibid.

59. Colonel Irving L. Branch, for the Chief, AFSWP, to Chief of Research and
Development, Department of the Army, 20 January 1956 ("Amendment to Proposed
Project Regarding Blast Injury Evaluation") (ACHRE No. DOD-030895-F), 1-2.

60. National Military Establishment, Military Liaison Committee, to the Atomic
Energy Commission, 24 March 1949 ("Planning for 1951 Atomic Bomb Tests")
(ACHRE No. DOE-120894-C).

61 . Howard Brown to Shields Warren, 20 August 195 1 ("Larry Tuttle advised
that he had learned from his agents in AFSWP . . .") (ACHRE No. DOE-040395-A), 1.

62. Thomas L. Shipman, Los Alamos Health Division Leader, to Shields
Warren, Director, AEC Division of Biology and Medicine, 20 January 1952 ("Since
Wright's return from the meeting in Washington . . .") (ACHRE No. DOE-120894-C), 2.

63. Thomas Shipman, Los Alamos Laboratory Health Division Leader, to
Charles Dunham, Director, AEC Division of Biology and Medicine, 9 June 1956 ("This
is a rather belated reply . . .") (ACHRE No. DOE-120894-C), 1. In response to the
suggestion that Los Alamos participate in another effort, Shipman urged that the
committee should

either be given some real responsibility or will at least be
able to speak in a loud, strong voice against any proposed
program which appears to be poorly or inadequately
planned ... or which appears to be an out and out waste of
the taxpayers' money.
Ibid.

64. T. L. Shipman to Alvin Graves, 9 August 1952 ("Meeting of Biomedical
Test Planning and Screening Committee") (ACHRE No. DOE-120894-C), 1. DOD
records show flashblindness research at Buster- Jangle (1951), Tumbler-Snapper (1952),
Upshot-Knothole (1953), Plumbbob (1953), Hardtrack II (1958), and Dominic I (1962),
in Defense Nuclear Agency, 8 August 1995, "Atmospheric Test Series/Activities Matrix."

65. The topic of the bomb's effect on vision merited instruction. The 1951
HumRRO questionnaire included: "Watching an A-bomb explode five miles away can
cause permanent blindness. (False)." Bordes et al., "DESERT ROCK I: A Psychological
Study of Troop Reactions to an Atomic Explosion"), 109. In a 1995 comment on this
question, DOD noted that "[i]n the strictest sense the correct answer is 'true'. Some

493

permanent retinal damage will occur, but complete vision loss will not." Department of
Defense, Radiation Experiments Command Center ("ACHRE Request 032795-A,
HumRRO Questionnaire and Air Burst Material"), 1.

66. Colonel Victor A. Byrnes, USAF (MC), 15 March 1952 ("Operation
BUSTER: Project 4.3, Flash Blindness") (ACHRE No. DOD-121594-C-4), 2.

67. The objectives were

(a) To evaluate the visual handicap which might be
expected in military personnel exposed, during
daylight operations, to the flash of an atomic
detonation.

(b) To evaluate devices developed for the purpose of
protecting the eye against visual impairment resulting
from excessive exposure to light.

Ibid., 1.

68. J. C. Clark, Deputy Test Director, to Colonel Kenner Hertford, Director,
Office of Test Operations, 5 March 1952 ("Attached is an outline of approved Project 4.5
. . .") (ACHRE No. DOE-020795-C), 1. The letter noted that at Buster- Jangle the AEC
had sought and received "release of AEC responsibility" in the event of such damage and
requested the same release for Tumbler-Snapper.

69. Defense Nuclear Agency, 1952 ("Operation Tumbler-Snapper") (ACHRE
No. DOD- 102 194-C),92.

70. Ibid.

71. Colonel Victor A. Byrnes, March 1953 ("Operation Snapper, Project 4.5:
Flash Blindness, Report to the Test Director") (ACHRE No. DOD-121994-C), 12.

72. Ibid., 15.

73. Ibid. The DOD reported that it does not have the ability to retrieve the
names of experimental subjects. Thus, the long-term outcome of those involved in
flashblindness tests (estimated by DOD to approximate 100) is not known to the
Committee.

74. Colonel Victor A. Byrnes, USAF (MC), et al., 30 November 1955
("Operation Upshot-Knothole, Project 4.5: Ocular Effects of Thermal Radiation from
Atomic Detonation-Flashblindness and Chorioretinal Burns") (ACHRE No. DOD-
121994-C),3.

75. Ibid.

76. Colonel Irving L. Branch, USAF, Acting Chief of Staff, to Assistant
Secretary of Defense (Health and Medicine), 5 March 1954 ("Status of Human
Volunteers in Bio-medical Experimentation") (ACHRE No. DOD-042595-A), 2.

77. Ibid, 3.

78. Colonel John Pickering; interview by John Harbert and Gil Whittemore
(ACHRE), transcript of audio recording, 2 November 1994 (ACHRE Research Project
Series, Interview Program File, Targeted Interview Project), 55. DOD did not locate any
documents showing written consent.

79. Defense Atomic Support Agency, 15 August 1962 ("Operation Plumbbob:
Technical Summary of Military Effects, Programs 1-9") (ACHRE No. DOD-100794-A),
137.

80. Defense Nuclear Agency, 1962 ("Operation Dominic I: Report of DOD
Participation") (ACHRE No. DOE-082294-A).

494

81 . John R. McGraw, Deputy Commandant, USAF, to Director. AEC, 20 March
1954 ("Examination of the Retina of Individuals Exposed to Recent Atomic Detonation")
(ACHRE No. DOE-090994-C). The memorandum stated that it "can be assumed that all
persons who viewed the actual fireball" of a recent hydrogen bomb test "without eye
protection have received permanent chorio-retinal damage." The memorandum went on
to recommend that "[papulations and observers within an approximate radius of 100
miles from ground zero should be surveyed."

82. See, for example, Byrnes, "Operation Snapper, Project 4.5," 16-17.

83. Roy B. Snapp, Secretary, AEC, minutes of meeting no. 623, 6 November
1951 (ACHRE No. DOE-033195-B), 526.

84. Defense Nuclear Agency, 23 June 1982 ("Shots Sugar and Jangle: The
Final Tests of the Buster-Jangle Series") (ACHRE No. DOE-082294-C), 46.

85. John R. Hendrickson, July 1952 ("Operation Jangle, Project 6.3-1 :
Evaluation of Military Individual and Collective Protection Devices and Clothing")
(ACHRE No. DOE-121594-C-14), 5.

86. Ibid.

87. Ibid., 5, 20.

88. Ibid., 19.

89. Ibid.,v.

90. U.S. Naval Radiological Defense Laboratory, 26 May 1958 ("Supplement
[l]toAEC-313 [2-57] USNRDL") (ACHRE No. DOD-091494-A), 1.

91. Lieutenant Colonel Gordon L. Jacks, CmlC Commanding, to TSG, DA, 12
April 1963 ("Beta Hazard Experiment Using Volunteer Military Personnel") (ACHRE
No. DOD-122294-B), 1.

92. Commanding Officer and Director, U.S. Naval Radiological Defense
Laboratory, to Secretary of the Navy, 26 May 1958 ("Authorization for use of
radioisotopes on human volunteers, request for") (ACHRE No DOD-091494-A) 1

93. Ibid.

94. Jacks to TSG, 12 April 1963, I.

95. "Research and Development: Use of Volunteers as Subjects of Research "
AR 70-25 (1962).

96. Office of Information Services, Air Force Special Weapons Center, to
Headquarters, Air Research Development Command, 27 January 1956 ("Early Cloud
Penetration") (ACHRE No. DOE-122894-B), 1.

97. Air Force Systems Command, January 1 963 ("History of Air Force Atomic
Cloud Sampling [AFSC Historical Publication Series 61-142-11") (ACHRE No DOD-
082294-A), 23.

98. Ibid., 229.

99. Air Force Systems Command, "History of Air Force Atomic Cloud
Sampling," 121.

100. E. A. Pinson [attr.], 1956 [attr.] ("Gentlemen: this morning I will discuss
the following topics . . .") (ACHRE No. DOE-033195-B), 3.

101 . Harold Clark, "I Flew Through an Atomic Hell," Argosy, December 1955
63.

102. J. E. Banks et al., 30 April 1958 ("Operation Teapot: Manned Penetrations
of Atomic Clouds, Project 2.8b") (ACHRE No. DOE-1 1 1694-A), 18.

103. The researchers found: "There appears to be no significant difference
between the dose received inside and outside of the body. This indicates that the

495

radiation which reaches the body surface is of sufficiently high energy that it is not
greatly attenuated by the body. If this is the case, then measurements made on the
surface of the body are representative of the whole-body dose." Ibid.

104. James Reeves, Test Manager, to Colonel H. E. Parsons, Deputy for
Military Operations, 1 1 April 1955 ("Radiation Dosage-Project 2.8, Operation Teapot")
(ACHRENo. DOE- 122894- A), 1.

105. Ibid.

106. Banks et al., "Operation Teapot, Manned Penetrations of Atomic Clouds
Project 2.8b," 5.

107. Ibid.

108. One received 21.8 R and another received 21.7 R. Undated document
("On-Site Personnel Overexposure") (ACHRE No. CORP-091394-A), 6.

109. Pinson [attr.], 1956 [attr.], "Gentlemen: this morning I will discuss the
following topics . . . ," 3.

1 10. "The aircraft were B-57Bs. No special filters were installed in the cockpit
pressurization system. The pilots and technical observers were given free choice of the
setting of their oxygen controls." Colonel E. A. Pinson et al., 24 February 1960
("Operation Redwing-Project 2.66a: Early Cloud Penetrations") (ACHRE DOE- 122894-
B),41.

111. William Ogle, Headquarters, Task Group 7. 1 , to Commander Joint Task
Force Seven, 8 November 1955 ("Maximum Permissible Radiation Exposure for
Personnel Participating in Projects 2.66 and 1 1.2, Operation Redwing") (ACHRE No.
DOE-013195-A),2.

1 12. Pinson et al., "Operation Redwing— Project 2.66a: Early Cloud
Penetrations," 5.

113. Ibid., 41.

114. Ibid., 51.

115. E. A. Pinson, interviewed by Patrick Fitzgerald (ACHRE), transcript of
audio recording, 21 March 1995 (ACHRE Research Project Series, Interview Program
File, Targeted Interview Project), 106.

116. Ibid., 121.

1 17. Office of Information Services to Headquarters, Air Research
Development Command, 27 January 1956, 3.

1 18. Clarke, "I Flew Through an Atomic Hell," 62.

1 19. Interview with Pinson, 21 March 1995, 94.

120. Air Force Systems Command, "History of Air Force Atomic Cloud
Sampling," 66.

121. Interview with Pinson, 21 March 1995, 15.

122. Pinson [attr.], 1956 [attr.], "Gentlemen: this morning I will discuss the
following topics . . . ," 8.

123. Raymond Thompson, "A Select Group of ARDC Men Collects Samples
from the Mushrooms," Baltimore Sun—Magazine Section, 1 May 1955, 17.

124. Interview with Pinson, 21 March 1995, 38.

125. "Center Scientists Fly Through Atom Clouds," Atomic Flyer, 29 April
1955 (ACHRE No. DOE-122894-B), 1.

1 26. Office of Information Services to Headquarters, Air Research
Development Command, 27 January 1956, 2.

496

127. Captain Paul M. Crumley et al., 1 1 October 1957 ("Operation Teapot-
Project 2.8a: Contact Radiation Hazard Associated with Contaminated Aircraft [WT-
1 122]") (ACHRE No. DOE-1 1 1694-A), 9.

128. Ibid., 20.

129. Ibid., 21.

130. Colonel W. B. Kieffer, Deputy Commander, Air Force Special Weapons
Center, to K. F. Hertford, Manager, AEC Albuquerque Operations Office, 2 1 March
1957 ("Recent discussion within the Air Force Special Weapons Center . . .") (ACHRE
No. DOE-033195-B),2.

131. Thomas Shipman, Los Alamos Laboratory Health Division Leader, to Al
Graves, J-Division Leader, 29 March 1957 ("Decontamination of Aircraft at Tests")
(ACHRE No. DOE-040595-A), 1. Thomas Shipman also argued that the new procedures
could compromise the scientific projects.

Without decontamination there will be inevitable migration
of contamination carrying activity to other areas where it
may be very undesirable. This letter has completely
overlooked the fact that people working at tests invariably
have neighbors with special requirements.
Ibid., 2.

132. Harold F. Plank, to Alvin C. Graves, Los Alamos Laboratory J-Division
Leader, 24 April 1957 ("Col. Kieffer's Proposal for the Decontamination of Sampling
Aircraft") (ACHRE No. DOE-040595-A), 2.

133. Colonel W. B. Kieffer, Deputy Commander, Air Force Special Weapons
Center, to Colonel Wignall, 22 April 1957 ("Decontamination of Sampler Aircraft at
Plumbbob") (ACHRE No. DOE-040595-A), 1.

1 34. James Reeves, Test Manager, Nevada Test Organization, to Commander,
Air Force Special Weapons Center, Attention: Colonel W. B. Kieffer, Deputy
Commander, 14 May 1957 ("Reference is made to your letter of March 21, 1957 . . . ")
(ACHRE No. DOE-032895-A), 2.

135. First Lieutenant William J. Jameson, 7 October 1957 ("Aircraft
Decontamination Study") (ACHRE No. DOE-022395-B), 1.

136. The decontamination experiment had several further components. Lead
vests were tested and found to provide a 6.0 percent reduction in exposure levels for air
crews. In addition, the experiment tested the consequences of using a fork lift to remove
air crews from contaminated planes versus the consequences of letting them climb out
with a standard ladder. It concluded that the fork lift was unnecessary. Ibid., 5-6.

Also at Plumbbob a project was undertaken "to measure the radiation dose, both
from neutrons and gamma rays, received by an air crew delivering an MB-1 rocket."
The report on the research states: "The Joint Chiefs of Staff approved the conduct of a
test as a part of Operation Plumbbob in order to obtain the necessary experimental
measurements." The report indicates that six studies were involved. Captain Kermit C.
Kaericher and First Lieutenant James E. Banks, 1 1 October 1957 ("Operation
PLUMBBOB-Project 2.9: Nuclear Radiation Received by Aircrews Firing the MB-1
Rocket") (ACHRE No. DOD-082294-A), 9.

137. The Advisory Committee is also aware of three more research activities
involving atomic veterans. As noted, the body fluid sampling research is discussed in
chapter 13. In addition, as mentioned in endnotes in this chapter, the Advisory

497

Committee notes experiments involving fallout shelters and the measurement of radiation
exposure to air crews delivering the MB-1 rocket. The inclusion of the subjects of these
three types of experiments, however, does not change our estimate that human research in
connection with bomb tests involved no more than 3,000 subjects.

138. DOD records did not permit the identification of individuals who
participated in particular research projects, and remaining reports do not always indicate
the number of subjects. The basis for the very rough estimate of 2,000 to 3,000 research
subjects in the activities reviewed by the Committee including those noted in endnote 137
is (1) 1,500 to 2,200 test-site subjects in the psychological and physiological testing,
based on reports, as cited in this chapter, for three experiments and an estimated
maximum of 800 for the fourth; (2) a dozen test-site subjects in the 1955 body-fluid-
sampling research, as cited in the report on this research referenced in chapter 13, and an
assumed comparable number for the 1956 research, for which no similar figures appear
available; (3) about 100 participants in the flashblindness research, an estimate DOD
provided to the Committee; (4) in the range of perhaps one dozen or two dozen
participants in aircrew experiments, and perhaps a dozen to several dozen participants in
decontamination experiments; (5) perhaps several dozen participants in the protective
equipment research; (6) sixteen participants in shelter research; and (7) several dozen
participants in the officer volunteer program. See further endnotes for citations related to
particular research.

139. The permissible level of risk to which humans could be exposed in
connection with bomb tests lay at the balance point of several factors. Radiation was not
the only risk at issue; harm from blast and thermal burn were also possible.

140. Barton C. Hacker, Elements of Controversy (Berkeley: University of
California Press, 1994), 118.

141. Marion W. Boyer, AEC General Manager, to Honorable Robert LeBaron,
Chairman, Military Liaison Committee, 10 January 1951 ("As you know, one of the
important problems . . .") (ACHRE No. DOE-040395-B-1).

142. Shipman to Warren, 15 September 1951, 1.

143. Shields Warren, Director, AEC Division of Biology and Medicine, to
Carroll Tyler, Manager, Sante Fe Operations Office, 1 1 October 1951 ("Permissible
Levels of Radiation Exposure for Test Personnel") (ACHRE No. DOE-013195-A), 1.

144. Warren's concern was not radiation risk, but injury from the blast. Shields
Warren, Director, AEC Division of Biology and Medicine, to Brigadier General K. E.
Fields, Director, Division of Military Application, 25 March 1952 ("Draft Staff Paper on
Troop Participation in Operation Tumbler-Snapper") (ACHRE No. DOE-040395-A), 1.

145. Gordon Dean, Chairman, Atomic Energy Commission, to Brigadier
General H. B. Loper, Chief, Armed Forces Special Weapons Project, 2 April 1952
("Reference is made to letter of March 7, 1952 . . . ") (ACHRE No. DOD- 100694- A), 2.

146. Captain Harry H. Haight to General Fields, 21 August 1952 ("Exercise-
Desert Rock IV") (ACHRE No. DOE-013195-A), 1. According to this review of Desert
Rock activities, "The military importance of permitting major personnel exposures or
decreases in drifting distances is not evident from the report. For the Commission to
prescribe one limitation for the test personnel and allow greater latitude for the DOD
would seem to be unwise and unnecessary. The Commission should strongly object to
any special dispensation to the DOD which could possibly result in personnel casualties
whether immediate or delayed.", Ibid.

498

147. Colonel John C. Oakes, by direction of the Chief of Staff, to Assistant
Chief of Staff, G-3, 5 June 1952 ("Indoctrination of Personnel in Atomic Warfare
Operations") (ACHRE No. NARA-1 12594-A), 1.

148. C. D. Eddleman, Assistant Chief of Staff, G-3, 15 December 1952
("Complete Discussion" [attachment to "Positioning of Troops at Atomic Weapons
Tests"]), 1 . In a 1953 memorandum to an AEC committee created to study the Nevada
Test Site, Division of Biology and Medicine Director John Bugher similarly wrote:

While it may be stated with considerable certainty that no
significant injury is going to result to any individual
participating in test operations at the levels mentioned [3.9 R],
and while it is true that the same thing would probably have to
be said were the limits to be set two or three times as high, it
nevertheless is true that there is no threshold to significant
injury in this field, and the legal position of the Commission at
once deteriorates if there is deliberate departure from ... the
accepted permissible limit.
John C. Bugher, Director, AEC Division of Biology and Medicine, to Members of the
Committee to Study NPG, 8 September 1953 ("Interpretation of the Standards of
Radiological Exposure") (ACHRE No. DOE-040395-A), 3-4.

149. M. W. Boyer, AEC General Manager, to Major General H. B. Loper,
Chief, AFSWP, 8 January 1953 ("Reference is made to letter from Chief. . .") (ACHRE
No. DOE-121594-C-8),2.

150. Jark to Distribution, 20 February 1953, "Instructions for Positioning DA
[Department of Army] Personnel at Continental Atomic Tests," 1.

151. Ibid., 2-3.

152. General Cooney presented this view at a July 1951 conference on Past and
Future Atomic Tests. Major Sven A. Bach, Development Branch, Research and
Development Division, 12 July 1951 ("Conference at OCAFF, Fort Monroe, Virginia, re
Past and Future Atomic Weapons Tests") (ACHRE No. NARA-042295-C), 1.

153. Atomic Energy Commission, minutes of meeting no. 862, 13 May 1953
(ACHRE DOE-013195-A), 2.

154. Ibid.

155. Chief, Bureau of Medicine and Surgery, to Chief of Naval Operations, 14
February 1952 ("Radiological Defense Training, comments and recommendations on")
(ACHRE No. DOD-080295-B), 1. The proposal would have limited "the dosage of all
personnel to 0.3 roentgens per week." Chief of Naval Operations to Chief, Bureau of
Medicine, 23 January 1952 ("Atomic Defense Training") (ACHRE No. DOD-080295-B),
1. The proposal originated with the Pacific Fleet. See Commander, Mine Force, U.S.
Pacific Fleet, to Commander in Chief, U.S. Pacific Fleet, 17 December 1951
("Radiological Defense Training") (ACHRE No. DOD-080295-B), 1. In counseling
against the use of "area contamination," BuMed solicited advice from the AEC on an
isotope that "would have such characteristics that the internal hazard involved would be
minimized even though amounts to be used would produce as much as 10 mr/hr, gamma
radiation, three feet from the surface of the contaminated area." Chief, Bureau of
Medicine and Surgery, to Director, AEC Division of Biology and Medicine, February
1952 ("Radiological Defense Training, use of radioisotopes in") (ACHRE No. DOD-
080295-B), 1.

499

1 56. Shipman's comments were specifically directed at the establishment of
standards for exposure to the general public. Thomas L. Shipman, Los Alamos
Laboratory Health Division Leader, to Gordon Dunning, AEC Division of Biology and
Medicine, 14 August 1956 ("Thanks for sending the draft concerning exposure . . .")
(ACHRENo. DOE-022195-C), 1.

1 57. Department of Energy, Announced United States Nuclear Tests: July 1945
Through December 1992 (Springfield, Va.: National Technical Information Service, May
1993), 65 (shot Climax in 1953). In the early days, when entirely new types of
experimental weapons were being rapidly developed and tested, it was not uncommon for
a particular yield to exceed estimates by 50 percent or more. In an October 1957
memorandum to AEC Division of Biology and Medicine director Charles Dunham,
Shipman explained that the unpredictability of weapons effects was making biomedical
experimentation increasingly difficult. "All too often preshot estimates of yields etc. are
just enough in error to make the results of effects tests useless." Thomas L. Shipman, Los
Alamos Laboratory Health Division Leader, to Charles Dunham, AEC Division of
Biology and Medicine, 7 October 1957 ("Payne Harris is planning to attend the
meeting . . .") (ACHRE No. DOE-120894-C), 2.

158. T. L. Shipman, Los Alamos Laboratory Health Division Leader, to Alvin
C. Graves, J-Division Leader, 6 August 1956 ("Permissible Exposures") (ACHRE No.
DOE-021095-B), 1.

1 59. Summary information provided by DOD in August 1 995 provides a total of
216,507 participants in atmospheric tests, beginning with Trinity in 1945 and concluding
with Dominic II in 1962. This tabulation shows about 1,200 instances of exposure in
excess of 5 rem. The "total dose may have been measured by one or more film badges,
may have been reconstructed, or may be the sum of both film badge data and
reconstruction." Some individuals participated in more than one test. Defense Nuclear
Agency, 8 August 1995 ("Summary of External Doses for DOD Atmospheric Nuclear
Test Participants as of 24 February 1994") (ACHRE No. DOD-081 195-A). See also
testimony of Major General Ken Hagemann: Senate Committee on Governmental
Affairs, Human Radiation and Other Scientific Experiments: The Federal Government's
Role, 103d Cong., 2d Sess., 25 January 1994, 49-50.

Coincident with the beginning of epidemiological studies discussed in the text
above, and growing congressional and public interest in the atomic vets, the Defense
Department undertook an information-gathering effort called the "NTPR" (Nuclear Test
Personnel Review). The NTPR includes a database, which seeks to include those who
participated at tests in an effort to reconstruct the doses they received at tests, and a
multivolume history of the bomb tests, which is available in many libraries.

160. Stafford L. Warren, Radiological Safety Consultant, Joint Task Force One,
to Admiral Parsons, 6 January 1 947 ("Hazards from Residual Radioactivity on the
Crossroads Target Vessels") (ACHRE No. DOE-033195-B), 2.

161 . Jonathan M. Weisgall, Operation Crossroads: The Atomic Tests at Bikini
Atoll (Annapolis, Md.: Naval Institute Press, 1994), 210-214, 270-271. Only
fragmentary records of the Medico-Legal Board remain.

162. The Naval Radiological Defense Laboratory, the new research laboratory,
was established at the Hunter's Point Naval Shipyard in San Francisco, the port to which
some ships contaminated in the 1946 Crossroads tests were sent.

1 63. George M. Lyon, Assistant Chief Medical Director for Research and
Education, to Committee on Veterans Medical Problems, National Research Council, 8

500

December 1952 ("Medical Research Programs of the Veterans Administration") (ACHRE
No. VA-052594-A), 553.

164. Ibid.

165. Ibid.

166. J. J. Fee, Commander, USN, as quoted in Weisgall, Operation Crossroads,
273-274.

167. Lyon to Committee on Veterans Medical Problems, 8 December 1952,
554.

168. Ibid.

169. Ibid.

1 70. Ibid. The report was retrieved by the VA at the time of the Advisory
Committee's formation in 1994. In an April 1994 statement to the Committee, VA
Secretary Jesse Brown stated his determination to find the facts related to the
Confidential Division. To this end the VA reviewed significant amounts of documentary
information and called on its inspector general to conduct a further review.

171. Ibid., 554.

172. Ibid., 553-554.

1 73. Major General Herbert B. Loper, Chief, AFSWP, to the Administrator,
Veterans Administration, Attention: George M. Lyon, 8 August 1952 ("This activity has
received information . . .") (ACHRE No. DOD- 100694- A), 1.

1 74. Ibid. The specific rule or policy that provided for the record keeping
referred to in this letter was not located. Thus, it is not clear whether the record keeping
referred only to nuclear war-related exposures or more generally to exposures at bomb
tests or other nuclear weapons-related activities as well.

1 75. William Middleton, VA Chief Medical Director, to the VA Administrator,
13 May 1959 ("Recommendation for Administrator's Exceptional Service Award")
(ACHRE No. VA-102594-A), 1.

176. Ibid.

177. "12 January 1995 Review of Effort to Identify Involvement with Radiation
Exposure of Human Subjects," Inspector General, Department of Veterans Affairs. The
inspector general (IG) found that "an 'Atomic Medicine Division' was discussed as a
means to deal with potential claims from veterans as a result of exposure to radiation
from atomic bomb testing and to be the focal point for VA civil defense planning and
support in case of nuclear war. However, claims did not materialize at that time and
evidence indicates that the Division was not activated." Stephen A. Trodden, VA
Inspector General, to VA Chief of Staff, 12 January 1995 ("Review of Effort to Identify
Involvement with Radiation Exposure of Human Subjects") (ACHRE No. VA-01 1795-

A), 1.

With regard to the 1952 history prepared by Dr. Lyon for the National Research
Council, which has been previously quoted in the text, the IG stated that "the reference
to the Atomic Medicine Division should not be taken literally as documentation that a
Division was ever established." Ibid., 4.

178. In communications with Defense Department officials two alternatives
were offered: (1) that the records may have been confidential medical examination data
taken from participants in Crossroads, pursuant to a regulation providing for such exams;
(2) that the records may have related to exposures of military scientists or technicians
who worked at the Manhattan Project and were confidential because they contained
weapons design or production-related data.

501

Navy regulations in 1 947 provided that

All personnel, both military and civilian, who may be
exposed to radiation or radioactive hazard, will be
required to have a complete physical examination prior
to commencing such duty. Special medical records
separate from the normal individuals' health records will
be set up and they will be classified as confidential, until
declassification is permitted.
Bureau of Medicine and Surgery, 3 1 January 1 947 ("Appendix B--Current Directives;
Subject: Safety Regulations for Work in Target Vessels formerly JTF-1") (ACHRE No.
DOD-020795-A), B-22. The Navy was not able to locate the records referred to.

The VA told the Committee that "the volume of classified records that are
unaccounted for by the VA is too small to have constituted a defense against liability
claims." Susan H. Mather, M.D., M.P.H., letter to Dan Guttman (ACHRE), 17 July
1995. Based on discussions with the VA, the basis for this statement appears to be the
fact that there were more than 200,000 test participants, and the safe maintained by Dr.
Lyon (in which secret documents would presumably have been kept) was relatively
small. In the absence of the documents themselves, the VA's statement appears to be
only one of several possible speculative alternatives. For example, the VA also explained
that few claims eventuated in the period of Dr. Lyon's service; thus, the magnitude of
necessary filekeeping may not have been great. Alternatively, documents kept by Dr.
Lyon could have been summary documents, which referred to materials in other files.
Finally, the VA's statement is also consistent with the possibility that files were kept but
that their contents were deemed inadequate to constitute a defense against potential
claims.

179. NEPA Medical Advisory Panel, Subcommittee IX, proceedings of 22 July
1949 (ACHRE No. DOD-121494-A-2), 17-18. The meeting is further discussed in the
Introduction.

180. Ibid., 18.

181. Ibid.

182. Department of Defense, Research and Development Board, Committee on
Medical Sciences, proceedings of 23 May 1950 (ACHRE No. DOD-080694-A), 10.

183. Caldwell et al., "Leukemia Among Participants in Military Maneuvers at
Nuclear Bomb Tests," Journal of the American Medical Association 244, no. 14 (1980).

1 84. Caldwell et al., "Mortality and Cancer Frequency Among Military Nuclear
Test Participants, 1957 through 1959," Journal of the American Medical Association
250, no. 5(1983).

185. CD. Robinette et al., Studies of Participants in Nuclear Weapons Test:
Final Report (Washington, D.C.: National Research Council, May 1985).

1 86. See U.S. General Accounting Office, Nuclear Health and Safety: Mortality
Study of Atmospheric Nuclear Test Participants Is Flawed (Gaithersburg, Md.: GAO,
1992), 4. Helen Gelband, Health Program, Office of Technology Assessment, Mortality
of Nuclear Weapons Tests Participants (Washington, D.C.: Office of Technology
Assessment, August 1992), 4.

1 87. The data appear in table 1 of Clark W. Heath, Chairman, Institute of
Medicine (IOM) Committee on the Mortality of Military Personnel Present at
Atmospheric Tests of Nuclear Weapons, and John E, Till, Chairman, IOM Dosimetry

502

Working Group, to D. Michael Schaeffer, Program Manager, DNA Nuclear Test
Personnel Review, 15 May 1995 ("A Review of the Dosimetry Data Available in the
Nuclear Test Personnel Review [NTPR] Program: An Interim Letter Report of the
Committee to Study the Mortality of Military Personnel Present at Atmospheric Tests of
Nuclear Weapons") (ACHRE No. NAS-051595-A), 9.

188. Hacker, Elements of Controversy, 96.

1 89. The memo explained that the need had been foreseen, but the request for
dosimeters had only been partially filled. The memo recorded that 175 "0-5 R
dosimeters" were on hand at the Nevada Test Site, but a minimum of 325 were needed
for an operation the size of Upshot- Knothole. Colonel Leonard F. Dow, Acting Director,
Weapons Effects Tests, to Manager, AEC Santa Fe Operations, 19 February 1954 ("Rad-
Safe Equipment for Nevada Proving Grounds") (ACHRE No. DOE-020795-D), 1.

1 90. Irving L. Branch, Chief of Staff, AFSWP, to Chief of Research and
Development, OCS, Department of the Army, 20 January 1956 ("Annex 'A' to 2nd
Indorsement: Detailed Explanation of AFSWP Comments on Feasibility of Human
Volunteer Program") (ACHRE No. DOD-030895-F), 2.

191 . Clark W. Heath and John E. Till, IOM, to D. Michael Schaeffer, DNA, "An
Interim Letter Report of the Committee to Study the Mortality of Military Personnel
Present at Atmospheric Tests of Nuclear Weapons," 15 May 1995.

1 92. K. K. Watanabe, H. K. Kang, and N. A. Dalager, "Cancer Mortality Risk
Among Military Participants of a 1955 Atmospheric Nuclear Weapons Test," American
Journal of Public Health 85 (April 1995).

193. S. Raman, G. S. Dulberg, R. A. Spasoff, and T. Scott, "Mortality Among
Canadian Military Personnel Exposed to Low Dose Radiation," Canadian Medical
Association Journal 136(1 987): 1 05 1 - 1 056.

194. S. C. Darby, G. M. Kendall, T. P. Fell et al., "A Summary of Mortality
and Incidence of Cancer in Men from the United Kingdom Who Participated in the
United Kingdom's Atmospheric Nuclear Weapon Tests and Experimental Programs,"
British Medical Journal 296 (1988): 332-338.

195. Human Radiation Experiments: The Federal Government's Role,
Hearings before the Committee on Governmental Affairs, United States Senate, 103d
Cong., 2d Sess., 25 January 1994, 160.

196. DNA, "Summary of External Doses for DOD Atmospheric Nuclear Test
Participants as of 24 February 1994."

197. These laws are further discussed in the Committee's recommendations. In
enacting the 1984 Veterans' Dioxin and Radiation Exposure Compensation Standards
Act, Congress, among other items, found

(8) The 'film badges' which were originally issued to members of the
Armed Forces in connection with the atmospheric nuclear test program
have previously constituted a primary source of dose information for . . .
veterans filing claims ....

(9) These film badges often provide an incomplete measure of radiation
exposure, since they were not capable of recording inhaled, ingested, or
neutron doses (although the DNA currently has the capability to
reconstruct individual estimates of such doses), were not issued to most
of the participants in nuclear tests, often provided questionable readings

503

because they were shielded during the detonation, and were worn for
only limited periods during and after each nuclear detonation.

(10) Standards governing the reporting of dose estimates in connection

with radiation-related disability claims . . . vary among the several

branches of the Armed Services, and no uniform minimum standards

exist.

1 98. For example, Frances Brown, of Southwick, Massachusetts, told the
Committee of her late husband's experience as a navigator who flew through clouds at
weapons tests. Colonel Brown was assigned the duty and was given no protective
clothing; he died of cancer in 1983. Ms. Brown shared with the Committee the story of
years of inquiry, and her continuing inability to obtain all documents that might shed
light on the duty he undertook in the service of his country.

Nancy Lynch, of Santa Barbara, California, told the Committee of her late
husband's involvement in the Desert Rock exercises at Operation Teapot in 1955 and
her questions regarding the dose reconstruction that was ultimately provided by the
government.

Vernon Sousa, a San Francisco veteran, told of years of government
"stonewalling" of his information requests. He explained that the oath of secrecy he had
taken limited his own ability to discuss the tests for decades after his time in the service
ended.

Charles McKay of Severna Park, Maryland, a Navy diver at Operation
Crossroads, recalled that he received no briefing on radiation risks before his
participation. Mr. McKay said that he received a very low dose reconstruction report
from the government, which he believed to be highly inaccurate because it did not take
into account diving experiences on Crossroads wrecks.

Rebecca Harrod Stringer of St. Augustine, Florida, wrote to the Committee
about the Navy service of her late father in Operation Dominic I, a nuclear weapons test
in the Pacific, and the fifteen years it took to obtain copies of his military and medical
records.

Linda Terry of California talked of obtaining information about her late father's
experiences at the Buster-Jangle tests in 1951-52. She called for full disclosure of
information about the weapons tests "so that families do not have to live in the darkness"
of not knowing.

Harry Lester of Albuquerque, New Mexico, testified that he was responsible for
cleanup at Operation Castle and that he experienced radiation sickness as a result of his
exposure. After his involvement in Castle, he was shipped to an Albuquerque hospital
every six months for examinations. He told the Committee that his full records remain to
be found.

Langdon Harrison of Albuquerque told the Committee about his experiences in
cloud flying activities at Operations Redwing and Plumbbob. He recalled routine
carelessness in the handling of the film badges of the pilots of cloud flythroughs and
occasions when significantly different dose readings were recorded on film badges and
personal dosimeters.

Representatives of "atomic veterans" organizations also shared with the
Committee information collected in years of research on behalf of themselves and others.
These included Pat Broudy of California, whose late husband died of lymphoma and had
served at the occupation of Nagasaki, Bikini, and in three Nevada tests; Dr. Oscar Rosen

504

of Massachusetts, who participated in Crossroads; and Fred Allingham of California,
whose father served in the occupation of Nagasaki and died several years later of
leukemia.

199. The new rules stemmed from the development of a new howitzer. Late in
the development cycle a medical hazards review found that alteration to the firing routine
was needed if the weapon was to be employed without injuring U.S. soldiers. The
discovery caused a long and expensive delay while biomedical studies of blast
overpressure effects were done in animals and man and engineering solutions were
sought to reduce the hazard. After this experience, the Army determined to conduct
health hazard assessments (HHAs) early in the development of weapons and equipment,
so that new material is not brought on line with unnecessarily great health and safety risk
to the troops using it.

Relevant DOD directives (DODD) and Army regulations are the following:
DODD 5000.1, "Defense Acquisition"; DODD 5000.2," "Defense Acquisition
Management Policies and Procedures"; AR 70-1; "Army Acquisition Policy"; AR 602-1,
"Human Factors Engineering Program"; AR 602-2, "Manpower and Personnel
Integration (MANPRINT) in the System Acquisition Process"; AR 385-16, "System
Safety Engineering and Management"; AR 40-10, "Health Hazard Assessment Program
in Support of the Army Material Acquisition Decision Process"; and AR 70-75,
"Survivability of Army Personnel and Material."

505

11

Intentional Releases: Lifting
the Veil of Secrecy

in February 1986, officials at the Department of Energy responded to
requests from activists by releasing 19,000 pages of documents on the early
operations of the world's first plutonium factory, at Hanford, Washington.
Combing through these documents, reporters and citizens found references to an
event cryptically named the "Green Run," in which radioactive material was
deliberately released into the air at Hanford in December 1949.'

In the aftermath of the public discovery of the Green Run, Senator John
Glenn asked the General Accounting Office, the investigative arm of Congress, to
find out if there were other instances in which radioactivity had been intentionally
released into the environment without informing the surrounding community. In
1993, the GAO reported twelve more instances of such secret intentional
releases.2

Following additonal research by the DOD and DOE, the number of secret
intentional releases has expanded to several hundred, conducted between 1944
and the 1960s. At the Army's Dugway Proving Ground in Utah, dozens of
intentional releases were conducted in an effort to develop radiological weapons,
some in tests of prototype cluster bombs, others using different means of
dispersal; at Bayo Canyon in New Mexico, on the AEC's Los Alamos site,
researchers detonated nearly 250 devices, which contained radiolanthanum
(RaLa) as a source of radiation to measure the degree of compression and
symmetry of the implosion used to trigger the atomic bomb. Other intentional
releases were not classified, although not all were made known to the public in
advance. At AEC sites in Nevada and Idaho, radioactive materials were released

506

Chapter 1 1

in tests of the safety of bombs, nuclear reactors, and proposed nuclear rockets and
airplanes; in still other cases, small quantities of radioactive material were
released in and around AEC facilities and in the Alaskan wilderness to determine
the pathways such material follows in the environment.3 Public witnesses from
several of these communities told the Committee that they remain deeply
disturbed by these releases, wondering whether there is still more information
about the secret releases in their communities that they do not know and how
much will, at this late date, be impossible to reconstruct.

Intentional Releases and the Charter Thirteen

The Advisory Committee is authorized by its charter to examine "experiments involving
intentional environmental releases of radiation that (A) were designed to test human health effects
of ionizing radiation; or (B) were designed to test the extent of human exposure to ionizing
radiation." The charter also called for the Committee to "provide advice, information, and
recommendations" on the following thirteen experiments and similar experiments identified by the
Interagency Working Group:

(1) the experiment into the atmospheric diffusion of radioactive gases and test
of detectability, commonly referred to as "the Green Run test," by the former
Atomic Energy Commission (AEC) and the Air Force at the Hanford
Reservation in Richland, Washington;

(2) two radiation warfare field experiments conducted at the AEC's Oak Ridge
office in 1 948 involving gamma radiation released from non-bomb point sources
or at near ground level;

(3) six tests conducted during 1949-1952 of radiation warfare ballistic dispersal
devices containing radioactive agents at the U.S. Army's Dugway, Utah, site;
[and]

(4) four atmospheric radiation-tracking tests in 1950 at Los Alamos, New
Mexico. . . .

Tests of nuclear weapons, intentional environmental releases of radiation in amounts
greatly in excess of any of the releases identified above, were not included in the charter. As
discussed in chapter 10, the Committee did seek to investigate human subject research conducted
in connection with these tests.

This chapter reports on what we found as we sought to retrieve what we
could about the releases identified in our charter, determine the nature and
number of further intentional releases, identify the ethical standards by which
these activities can be evaluated, and determine what lessons can be learned from
the past.

507

Part II

Because of the secrecy surrounding these releases— as opposed to
atmospheric nuclear weapons tests, which were impossible to hide-many of them
took place with no public awareness or understanding. The intentional releases
were conducted primarily at sites such as Hanford, Los Alamos, and Oak Ridge,
in which defense and atomic energy facilities were located, but they were largely
unknown to those who lived in surrounding areas.

There is no evidence in any of these cases that radioactive material was
released for the purpose of studying its effects on human communities. As we
discuss later in the chapter, the public often was exposed to far greater risk from
the routine course of operations of the facilities than from the intentional releases
themselves.

That the possible health effects from the Green Run and other intentional
releases are so slight that they cannot be distinguished from other sources of
disease is small comfort to "downwinders" who were put at risk without their
knowledge. The Committee heard from many of them and learned that the longer-
term costs of secrecy extend well beyond any physical injury that may have been
incurred. These costs include, first, the anxiety and sense of personal violation
experienced by those who have discovered that they have intentionally and
secretly been put at risk, however small, by a government they trusted. But they
also include the consequences for that government, and its people, of the
attendant distrust of government that has been created. And finally, they also now
include the citizen and taxpayer resources that must be expended in efforts to
reconstruct long-buried experiences, and determine, as best as can currently be
done, the precise measures of the risks involved.

The chapter is divided into two parts. The first and lengthier section
reconstructs the history of the three kinds of releases that were in our charter— the
Green Run, radiological warfare tests, and the RaLa tests— and includes a
discussion of some types of intentional releases that were not expressly identified
in the charter. This section concludes with a review of what is known today about
the likely risks of all the releases we consider, as well as a review of the science
of dose reconstruction by which this knowledge is obtained. In the second part of
the chapter, we focus on the ethical and policy issues raised by intentional
releases. We examine the rules that currently govern intentional releases in an
effort to learn whether secret environmental releases like the Green Run could
take place today and, if so, whether, in light of lessons learned from the past,
current procedures and protections are adequate.

WHAT WE NOW KNOW

The Green Run

While the other intentional releases addressed in the Committee's charter
were part of the effort to develop the U.S. nuclear arsenal, the Green Run was

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Chapter 1 1

conducted to develop intelligence techniques to understand the threat posed by
the Soviet Union. In 1947 General Dwight D. Eisenhower assigned the Air Force
the mission of long-range detection of Soviet nuclear tests.4 Based on
observations from Operation Fitzwilliam, the intelligence component of the 1948
Sandstone nuclear test series, the Air Force determined aerial sampling of
radioactive debris to be the best method of detecting atomic releases.5 An interim
aerial sampling network was in place in early September 1949 that detected
radioactive debris from the first Soviet nuclear test.6

Around the same time, Jack Healy of Hanford's Health Instrument (HI)
Divisions noticed anomalous radioactivity readings from an air filter on nearby
Rattlesnake Mountain. The HI Divisions were responsible for radiological safety,
and Healy had set up this filter to test how radioactive contamination varied with
altitude. The rapid decay of his radioactive samples led Healy to conclude that
they had come from a recent nuclear test.7 Soon after news of Healy's observation
reached Washington, D.C., Air Force specialists arrived and took Healy's samples
and data for analysis. It is not clear whether Healy's observation came in time to
support President Harry Truman's announcement on September 23 that the Soviet
Union had exploded its first atomic bomb,8 but it did confirm that radioactivity
from a nuclear test could be detected on the other side of the globe.

Now that the Soviet Union knew how to make atomic weapons, the United
States needed to know how many weapons and how much of the critical raw
material plutonium the Soviets possessed. Like nuclear testing, plutonium
production released radioactive gases that sensitive instruments could detect,
though not at such great distances.9 To identify Soviet production facilities and
estimate their rate of plutonium production, the Air Force now needed to test
ways to monitor these gases.10

Hanford: The World's First Plutonium Factory

In 1942 General Leslie Groves selected the Hanford site overlooking the Columbia River
in southeast Washington state for the Manhattan Project's plutonium factory. The river would
provide a large, reliable supply of fresh water for cooling the plutonium-production reactors, and
Hanford's relative isolation from major population centers would make it easier to construct and
operate the facility without attracting unwanted attention. The nearby towns of Richland,
Kennewick, and Pasco soon became boom towns whose economies depended on Hanford.

At Hanford, neutrons converted uranium 238 in the production reactor's nuclear fuel into
plutonium 239. Chemical separation plants then separated this plutonium from the fission
products and residual uranium in the irradiated fuel elements. The first separation plants, the T
and P plants, used acid to dissolve these fuel elements, but this was superseded by the more
efficient Redox and Purex processes in the 1 950s.

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In late 1948 and early 1949, Air Force and Oak Ridge personnel
conducted a series of twenty air-sampling flights at Oak Ridge and three at
Hanford." The results were disappointing: instruments detected airborne releases
of radioactive material at ranges of up to fifteen miles in the hills and valleys near
Oak Ridge, but no farther than two miles from Hanford, because of measures
taken to reduce radioactive emissions there. At an October 25, 1949, meeting at
Hanford, representatives of the Air Force, the Atomic Energy Commission, and
General Electric (the postwar contractor for the Hanford site) agreed to a plan to
release enough radioactive material from Hanford12 to provide a larger radioactive
source for intelligence-related experiments.13

This intentional release took place in the early morning of December 3,
1 949, but information about it remained classified until 1 986. Two periodic
reports of the HI Divisions described a plutonium production run using "green"
fuel elements.14 The story of this "Green Run" has emerged piecemeal since then.
The most complete account comes in a 1950 report co-authored by Jack Healy
(referred to as the Green Run report), which was declassified in stages in response
to requests from the public under the Freedom of Information Act and inquiries
by the Advisory Committee.15

Although cooling times of 90 to 100 days were common by 1949, the fuel
elements used in the Green Run were dissolved after being cooled for only 16
days. This short cooling time meant that much more radioactive iodine 1 3 1 and
xenon 133 were released directly into the atmosphere, rather than decaying while
the fuel elements cooled. Furthermore, pollution control devices called scrubbers
normally used to remove an estimated 90 percent of the radioiodine16 from the
effluent gas were not operated.17

When these "green" fuel elements were processed, roughly 8,000 curies of
iodine 1 3 1 l8 flowed from the tall smokestack at Hanford's T plant. This stack was
built in the early years of Hanford's operation when large quantities of radioactive
gases were routinely released in the rush to produce plutonium. Although the
Green Run represents roughly 1 percent of the total radioiodine release from
Hanford during the peak release years 1945-1947, it was almost certainly larger
than any other one-day release, even during World War II.19

One clear purpose of the Green Run was to test a variety of techniques for
monitoring environmental contamination caused by an operating plutonium-
production plant. A small army of workers, including many from Hanford's HI
Divisions, took readings of radioactivity on vegetation, in animals, and in water
and tested techniques for sampling radioactive iodine and xenon in the air.20 The
Air Force operated an airplane carrying a variety of monitoring devices— the same
aircraft used in earlier aerial surveys at Oak Ridge and Hanford-and set up a
special air sampling station in Spokane, Washington.21

Those operating the equipment encountered numerous technical problems,
including a lost weather balloon and failed air pumps. The greatest problem,
however, was the general contamination of monitoring and laboratory equipment.

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The contamination created a high background signal that made it difficult to
distinguish radioactivity on the equipment from radioactivity in the environment.
The main cause of this contamination was the weather at the time, which led to
much higher ground contamination near the stack than expected.22

The plans for the Green Run included very specific meteorological
requirements. These requirements were designed to facilitate monitoring of the
radioactive plume by aircraft, but they were similar to the normal operational
requirements, which were designed to limit local contamination:

A temperature inversion,23 to keep the effluents aloft, but at a low
altitude;

No rain, fog, or low clouds to impede aircraft operations;
Light to moderate wind speeds (less than fifteen miles an hour);

Wind from the west or southwest, so the plane would not have to
fly over rough terrain;24 and

Strong dilution of the plume before any possible contact with the
ground.25

Jack Healy reports that he made the decision to go ahead with the Green
Run on the evening of December 2, 1949, even though the weather did not turn
out as expected. Some have suggested that the Air Force pressed to go ahead
with the release in spite of marginal weather conditions, but Healy recalls no such
pressure.26 The plume from the release stagnated in the local area for several days
before a storm front dispersed it toward the north-northeast. As a consequence,
local deposition of radioactive contaminants was much higher than anticipated.27
The Green Run report concludes:

Under the worst possible meteorological conditions
for such a test, the airborne instruments detected the
radioactive gases at a distance better than 100 miles
from the stack. Under favorable conditions, it was
estimated that with the same concentrations this
distance could have been increased by up to a factor
often.28

Despite the contamination of equipment, the monitoring provided a record
of the extensive short-term environmental contamination that resulted from the
Green Run. Measurements of radioactivity on vegetation produced readings that,
while temporary, were as much as 400 times the then-"permissible permanent
concentration" on vegetation thought to cause injury to livestock.29 The current

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level at which Washington state officials intervene to prevent possible injury to
people through the food supply is not much higher than the then-permissible
permanent concentration.30 Animal thyroid specimens showed contamination
levels up to "about 80 times the maximum permissible limit of permanently
maintained radioiodine concentration."31

In spite of this contamination, the public health effects of the Green Run,
discussed later in this chapter, were quite limited. However, in 1949, at the time
the Green Run was conducted, the most important environmental pathways for
human exposure to radioiodine were unknown. (Understanding developed shortly
thereafter that environmental radioiodine enters the human body from eating meat
and drinking milk from animals that grazed on contaminated pastures.)32 Thus,
the effects of exposure through these pathways could not have been planned for,
and it is fortunate that the risks were not higher.

The Control of Risks to the Public from Plutonium Production at
Hanford

From the first years of Hanford's operation, its health physicists were
aware of the problems of contamination of the site by radioactive wastes, and it
quickly became clear that radioiodine posed the greatest immediate hazard.33
Most fission products would remain in the dissolved fuel, but iodine gas would
bubble out of the solution, up through Hanford's tall stacks into the atmosphere
and down onto the surrounding countryside. Other radioactive wastes could be
stored and dealt with later, and other radioactive gases were chemically inert and
would quickly dissipate.

Over the years, Hanford health physicists adopted three main approaches
to the iodine problem:

• Choosing meteorological conditions for releases that would
prevent air with high iodine concentrations from contaminating the
ground near Hanford;

• Letting the irradiated fuel elements cool for extended periods
before separating the plutonium, so that most of the iodine 131,
which has an eight-day half-life, could decay; and

• Beginning in 1948, using scrubbers or filters to remove iodine
from the exhaust emissions.

During World War II, producing plutonium for bombs was an urgent
priority and knowledge of both the environmental hazards from iodine and the
ways to prevent it were limited. Over the period 1944-1947, Hanford released
nearly 685,000 curies of radioiodine into the atmosphere, about eighty times what

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was released in the Green Run.34 After the war, an improving understanding of
how iodine could contaminate the food supply,35 evolving techniques to remove
iodine from the plants' emissions, and policy decisions to limit the risks to the
nearby population led to a marked reduction in iodine emissions.

When the AEC began operation in 1947, it promptly moved to review
safety practices at Hanford and other operating facilities, which had operated
largely autonomously until then. The advisory panel established for this purpose
concluded that "the degree of risk justified in wartime is no longer appropriate."36
To address the radioiodine problem at Hanford and related problems, the AEC
established a Stack Gas Working Group, which met for the first time in mid- 1948
to study air pollution from AEC production facilities. The chair of this group
noted that the AEC "desires the removal from gaseous effluents of all
[radioactive] material insofar as is humanly and economically feasible" and that
because of uncertainties in risk estimates "no limit short of zero should be
considered satisfactory for the present."37 By 1949, daily emissions of
radioiodine had fallen by a factor of 1,000 from their wartime highs.

The Green Run clearly did not conform to the practices designed to ensure
public safety at Hanford in 1949 or even during the rush to produce plutonium for
the first atomic bombs. In his monthly report for December 1949, Herbert
Parker, Hanford's manager, concluded that the Green Run had posed a
"negligible" risk to personnel, but "[t]he resultant activity came close enough to
significant levels, and its distribution differed enough from simple meteorological
predictions that the H.I. Divisions would resist a proposed repetition of the
tests."38 This suggests that Parker, at least, considered the risks of such releases
potentially excessive even for a one-time event, particularly given the degree of
uncertainty.

Parker's recognition of the uncertainties surrounding environmental risks
from Hanford's radioiodine emissions was appropriate. At the time, it was not
known that drinking milk from cows that graze on contaminated pastures is the
main source of exposure, especially for children. Jack Healy recently suggested
that if Parker had known of the milk pathway, he would have objected strongly to
the Green Run.39 The question remains as to the consideration that was given by
the Green Run's planners to the possibility that they might not fully understand
the risks that might be imposed on nearby communities.

Benefits of the Green Run

The Advisory Committee attempted to assess of the national security
benefits that were expected and actually resulted from the Green Run. A planning
memorandum before the Green Run notes, "the possibility of the detection of
stack effluents is of great importance to the intelligence requirements of the
country."40 How important the detection of stack effluents was to the security of
the nation in 1949 is not something the Advisory Committee was in a position to

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judge. We did attempt to ascertain, however, the purpose of the Green Run and
the extent to which this purpose was served.

The Green Run report focuses primarily on ground-based monitoring of
radioactive contamination in the environment, which provided a test for
techniques that could be used on the ground in the Soviet Union. The report also
describes efforts to track the radioactive plume by aircraft, but their significance
is unclear. Aerial monitoring turned out to be the most effective method for
detecting atmospheric nuclear tests, and perhaps it was expected to be equally
effective for monitoring Soviet plutonium production. Plutonium production
releases relatively little radioactivity into the atmosphere, however— too little to
detect outside Soviet air space, and flying inside Soviet air space would have been
risky. Alternatively, aerial radiation tracking may have been designed to test
techniques for use in monitoring nuclear weapons tests. Finally, the Green Run
report compares the pattern of the plume's dispersion with theoretical models, but
this appears to be an attempt to estimate the pattern of contamination rather than
to test the already well-established theory regarding atmospheric diffusion of
gases developed in the 1930s.

It is difficult to ascertain how useful the Green Run actually was. The
classified histories of the Air Force's atomic intelligence activities contain no
references to the Green Run. These histories jump from events that directly
preceded the Green Run—the Oak Ridge and Hanford aerial monitoring tests— to
later ones, without any mention of the Green Run.41 Perhaps most telling, a 1952
AEC report entitled "Technical Methods in Atomic Energy Intelligence" does
mention the Green Run in the text, but only in a list of occasions on which a
particular type of instrument was used. In describing ways of detecting
plutonium-production facilities, the report relies on routine reports of
environmental surveys from Hanford's routine operations.42

Secrecy and Public Risk

The Advisory Committee accepts that there may be conditions under
which national security can justify secrecy in intentional releases like the Green
Run, even as we recognize that secrecy can increase the risk to the exposed
population.

In discussing this question it is important to explain that when we use the
term secret we can be referring to secrecy regarding the very fact that a risk has
been posed, secrecy regarding the purpose behind the risk, or secrecy regarding
the means (for example, the science of technology) by which the risk was
imposed. These distinctions are important because even if we agree that the
undertaking of an activity is required for national security reasons, it does not
follow that secrecy should govern all aspects of the activity. Thus, as an obvious
example, atomic bomb tests were quintessential national security activities;
information on the design of the bomb was secret, as was information on many of

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the specific purposes of the tests; however, in many (but not all) cases the public
was given notice that a hazardous activity was being undertaken. Similarly, in the
cases of other environmental releases, it may be that national security requires
secrecy for some aspects of the release but does not necessarily preclude public
disclosure sufficient to give basic notification of the existence of potential risk.
The Committee is not equipped to say whether this was so in the case of the
Green Run. However, in the case of radiological warfare, as we will discuss later,
there was contemporary argument that some public disclosure was not
inconsistent with national security.

If a release is conducted publicly, affected communities have an
opportunity to comment and perhaps influence the conduct of the release in ways
that serve their interests. Downwinders can be warned, giving them the options
of staying indoors with their windows closed, wearing protective clothing,
altering their eating habits, or evacuating the area. If the release is conducted in
secret, foreign adversaries are less likely to be alerted, but downwinders will be
deprived of their options. Of course, evacuation may not be warranted, and other
precautions may not be needed, or they may be of limited value. But, as we have
learned during the course of our work, secrecy, even where initially merited, has

its long-term price.

At Hanford, as we have noted, the Green Run represented only a fraction
of the risks (including nonradiation as well as radiation hazard) to which local
communities may have been exposed in secret. The delayed legacy of these risks,
in uncertainty and distrust, as witnesses from the Hanford community told the
Committee, is only becoming apparent as the secret history of early Hanford
operations has been made public.

During World War II, officials at Du Pont, the contractor for Hanford at
that time, proposed a practice evacuation to prepare for a possible emergency.
General Groves turned them down, saying that "any practice evacuation of the
Hanford Camp would cause a complete breakdown in the security of the
project."43 As noted in the Introduction, at the onset of the Manhattan Project
concern for the effects of Hanford operations on the surrounding environment,
including the salmon in the Columbia River, led to a secret program of research
on the environmental effects of Hanford's operations.44

Secrecy remained the rule at Hanford after the war. In 1946, as recalled
years later by an early biologist at Hanford who wrote to radiation researcher and
historian Newell Stannard, Hanford researchers resorted to deception simply to
collect information about possible iodine contamination in livestock, by having
employees pretend to be agricultural inspectors while surreptitiously monitoring
iodine levels in animal thyroids. The biologist wrote: "Though the
Environmental Study Group at Hanford had been sampling air, soil, water, and
vegetation in a wide area surrounding the Hanford site for several years previous
to 1946, it was agreed that sampling from farm animals for uptake of fission
product plant wastes would be a much more sensitive problem. At the time, the

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revelation of a regional 1-131 problem would have had a tremendous public
relations impact and furthermore the presence of other radionuclides . . . was of
possible National Defense significance."

He explained that he was called at home and told to report to work at the
director's office in downtown Richland. There:

I was introduced to two security agents of the
Manhattan Engineer District . . . who were to be my
escorts and contact men during the day. They
proved to be the best straight faced "liars" I had
ever known. I was no longer "Karl Herde of
DuPont" but through the day would be known and
introduced as Dr. George Herd of the Department of
Agriculture. I was to simulate an animal husbandry
specialist who had the responsibility of testing a
new portable instrument based on an unproven
theory that by external readings on the surface of
the farm, the "health and vigor" of animals could be
evaluated. I was advised not to be alarmed if at
times during the conversations with farmers that
they appeared critical or skeptical. I was to be very
reserved and answer questions as briefly and
vaguely as seemed acceptable. They agreed to carry
a clipboard ... I was to concentrate on the high
readings (thyroids, of course) and furnish those for
recording when not being observed.

That day we visited several diversified farms under
irrigation from the Yakima River between
Toppenish and Benton City. . .Smooth talk and
flattery enabled us to gain one hundred percent
cooperation. . . .

I was successful in placing the probe of the
instrument over the thyroid at times when the
owner's attention was focused on the next animal or
some concocted distraction.45

In 1948, the AEC prepared a public relations pamphlet entitled Handling
Radioactive Wastes in the Atomic Energy Program. The Department of Defense
objected to the description of Hanford's operations, arguing that any description
of the methods used to reduce contamination might be used by the Soviet Union
to avoid detection of its plants.46 The AEC decided at its October 7, 1949,

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meeting to release the pamphlet, which contained no specific numbers, in order to
"dispel and allay possible latent hysteria."47

With a major expansion of Hanford's operations under way in 1954,
questions arose over whether to publish information about contamination of the
Columbia River. Parker warned that it might be necessary to close portions of the
river to public fishing, but he and others noted that this could have a substantial
public relations impact.48 At the same time, there was concern that information
on river contamination could make it possible to ascertain Hanford's plutonium
output.49 For this combination of public relations and security reasons, Hanford
did not release any quantitative information or public warning on contamination
of fish in the Columbia River until many years later.

It is difficult to argue with the need for secrecy about the purposes of the
Green Run. Making information on U.S. atomic intelligence methods openly
available could have led the Soviet Union to develop countermeasures to these
methods. The issue remains important today in responding to the potential
proliferation of nuclear weapons capabilities around the world.

But the results of the long delay in informing the public about the
activities of which the Green Run was only a part are now evident in public anger
and distrust toward the government. At the Advisory Committee's public meeting
in Spokane on November 21, 1994, Lynne Stembridge, executive director of the
Hanford Education Action League, argued that

Information regarding that radiation release was
kept secret for almost 40 years. There was no
warning. There was no informed consent. Citizens
down wind were never advised of measures that
could have been taken to safeguard the health of
themselves or their children.

Although the Green Run was not as direct as
handing a patient orange juice laced with
radioactivity, or giving someone an injection, the
Green Run was every bit as intentional, every bit as
experimental, every bit as unethical and immoral as
the medical experiments which have made
headlines over the last year.50

Among the most damaging dimensions of the legacy of distrust created
by the secrecy that surrounded the routine and intentional releases at Hanford is
the government's loss of crediblity as a source of information about risk. Now,
when the government is attempting to find out what damage these releases
actually did and share that information with the people affected, these people
question why they should believe what the government says.51 Federally funded

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scientists at the Fred Hutchinson Cancer Research Center in Seattle, Washington,
are now studying those exposed as children to all of Hanford's iodine emissions-
the many routine emissions as well as the Green Run-to see whether any health
effects are detectable.52 Whatever this study concludes, many residents are
convinced that they have already seen the effects. Tom Bailie, who grew up and
still lives on a farm near Hanford, spoke to the Advisory Committee's meeting in
Spokane in November 1994. He pointed on a large map to what he called a
"death mile," where "100 percent of those families that drank the water, drank the
milk, ate the food, have one common denominator that binds us together, and that
is thyroid problems, handicapped children or cancer."53 It is doubtful that the
results of any study supported with federal funds, no matter how impeccably
conducted, would be believable to people like Mr. Bailie. Assuming that the
Hutchinson Cancer Research Center study is so conducted, and assuming the
study finds that at least some outcomes of concern to the community are not
attributable to the Hanford emissions, government secrecy will have deprived Mr.
Bailie and people like him of an important source of reassurance and peace of
mind.

The Green Run, and the far greater number of environmental releases
resulting from Hanford's routine operations, raises challenging questions about
the balance between openness and secrecy in settings where citizens may be
exposed to environmental hazards. Citizens may reasonably ask whether releases
have been determined to be necessary in light of alternatives, whether actions
have been taken to minimize risk and provide for any harm that might occur,
whether disclosure will be made at the earliest possible date, and whether records
will be created and preserved so that citizens can account for any health and
safety consequences at the time of disclosure. As we will see, these questions
were posed with regard to other environmental releases, and they remain with us
today.

Radiological Warfare

The first proposed military application of atomic energy was not nuclear
weaponry but radiological warfare (RW)--the use of radioactive materials to
cause radiological injury. A May 1941 report by the National Academy of
Sciences listed the first option as the "production of violently radioactive
materials . . . carried by airplanes to be scattered as bombs over enemy
territory."54 It was not until later that year that a calculation by British physicists
demonstrated the feasibility of nuclear weapons, and attention quickly turned to
their development.

Military interest in both offensive and defensive aspects of radiological
warfare continued throughout World War II. In the spring of 1943, when it was
still unclear whether the atomic bomb could be built in time, radiological
weapons became a possible fallback. Manhattan Project scientific director

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J. Robert Oppenheimer discussed with physicist Enrico Fermi the possibility of
using fission products, particularly strontium, to poison the German food supply.
Oppenheimer later wrote to Fermi that he thought it impractical unless "we can
poison food sufficient to kill a half a million men." This proposal for offensive
use of radiological weapons appears to have been dropped because of its
impracticality.55 At the same time, military officials developed contingency plans
for responding to the possible use of radiological weapons by Germany against
invading Allied troops.

The peacetime experience of Operation Crossroads in 1946, particularly
the contamination of the Navy flotilla from the underwater nuclear test shot
labeled Baker, revived interest in radiological warfare. Some, including
Berkeley's Dr. Joseph Hamilton, concluded that radiological poisons could be
used as strategic weapons against cities and their food supplies.56 Once absorbed
into the body, radioactive materials would cause slow, progressive injuries.
Others proposed that RW could be a more humane form of warfare. Using
radioactive material to contaminate the ground would render it temporarily
unhabitable, but it would not be necessary to kill or injure people.57

Although many discussions of radiological warfare took place in classified
military circles,58 the basic notion of radiological warfare was not secret and was
a subject of public speculation. But the government's program in radiological
warfare remained largely secret, except in its broadest outlines. The postwar
interest in radiological warfare spawned competing programs on radiological
warfare both in the AEC and in various parts of the Department of Defense.59 To
meld these into a coherent program, the AEC and DOD established a joint study
panel in May 1948, chaired by the chemist W. A. Noyes from the University of
Rochester and including civilian experts and DOD and AEC officials.

At its first meeting that month, the Noyes panel recommended work in
three areas: (1) biological research on the effects of radiation and radioactive
materials, to be carried out mainly at the Army Chemical Corps's Toxicity
Laboratory, located at the University of Chicago;60 (2) studies on the production
of radioactive materials for use in radiological warfare, carried out mainly by the
AEC; and (3) military studies of possible RW munitions, also carried out mainly
by the Chemical Corps.

The latter program was the focus of the Advisory Committee's attention
because it involved the intentional release of radioactive materials during several
dozen tests of prototype radiological weapons at the Chemical Corps's Dugway
Proving Ground in the Utah desert. The offensive radiological warfare program
field- testing program coincided with the Korean War years. The Noyes panel
issued its final report after its sixth meeting, in November 1950,61 and was revived
briefly in 1952 to assess the status of the RW research program.62

The first two field tests were conducted at Oak Ridge. These involved
sealed sources of radioactive material that were placed in a field in order to
measure the resulting radiation levels. These measurements may have helped

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predict the effectiveness of radiological weapons. The sources were then returned
to the laboratory and left no residual contamination in the environment.63

Most of the radiological warfare field tests were carried out by the
Chemical Corps at the Dugway Proving Ground, using radioactive tantalum
produced at Oak Ridge.64 From 1949 to 1952, the Chemical Corps conducted
sixty-five field tests at Dugway, intentionally releasing onto the ground roughly
13,000 curies of tantalum in the form of dust, small particles, and pellets. These
were prototype tests, releasing much smaller quantities of radioactive material
than the millions of curies per square mile that an operational radiological weapon
would need to render territory temporarily uninhabitable.65 Furthermore, the
field-test programs used tantalum primarily because it could be produced at
existing facilities. An operational radiological warfare program required
materials that could be produced in greater quantities than tantalum, but this
would have meant constructing special production facilities.66

In May 1949, the Chemical Corps established a panel of outside experts to
provide advice on the safety of its field-testing program. Chaired by Dr. Joseph
Hamilton, a strong advocate of the RW research program,67 the panel was
chartered to consider radiological hazards to the civilian population, including
hazards to "the water supply, food, crops, animal population, etc." Occupational
safety was left to the Chemical Corps.68

Under Hamilton's leadership, this panel raised a number of safety concerns
but in the end appears to have been satisfied with the safety of the test program.
Several months before the first panel meeting, Hamilton himself had objected to
the use of the relatively long-lived isotope tantalum 182 (half-life, 1 17 days) as
the radiological warfare agent in these field tests. He proposed using gold 198
instead (half-life, 2.7 days) to eliminate any lingering radiation hazard to the
general population.69

At its first meeting, on August 2, 1949, the RW test safety panel
provisionally accepted the proposed testing program of the Chemical Corps,
subject to a radiological safety review of the results of the first two tests.
Hamilton's potential opposition clearly was of consequence, and his agreement to
proceed was cause for relief.70

Other members of the test safety panel, including Karl Morgan, head of
health physics at Oak Ridge, raised concerns about the possible hazard posed by
radioactive dust at an arid site like Dugway,71 both on- and off-site. Morgan
proposed the use of airborne monitoring equipment developed at Oak Ridge in
tests that preceded the Green Run.72 The use of such aircraft and other monitoring
equipment evolved and expanded as the Dugway field tests continued over the
next few years. Panel members approved the continuation of the program based
in part on the results of these radiological surveys, which showed that
contamination of the area was limited in size.73

In 1952 the Chemical Corps proposed a significant expansion of the
radiological warfare program, with a large test of 100,000 curies planned for 1953

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and still larger tests proposed for later. The test safety panel once again raised
concerns over the radioactive dust hazard. Hamilton noted that there were several
"hot spots'—areas of unusually high radiation-at Dugway and that trucks at one
of the target areas were kicking up significant quantities of radioactive dust.74 A
Chemical Corps study in early 1953 concluded that the hazard was relatively
slight.75

Hamilton favored going ahead with the 1953 tests and was greatly
disappointed when they were canceled, and with them the entire radiological
warfare test program.76 The reasons for this cancellation are not entirely clear,
but two factors are evident. The next phase of the program would have required
the construction of expensive new production facilities, which collided with
military budget cuts at the end of the Korean War. Furthermore, by 1953, only
the Chemical Corps maintained a strong interest in the radiological warfare
program, making it vulnerable to questions about whether it satisfied any unique
military need.77 The radiological warfare program did not end completely, but its
focus narrowed to defensive measures, including shielding and decontamination,78
with atmospheric nuclear tests providing the main opportunity for study.79

The radiological warfare test safety panel was an early example of the use
of an expert panel to evaluate possible risks of planned government activities.
Ideally, such a panel should not be chaired by a proponent of the program in
question, although those with such knowledge of, and interest in, the program are
of obvious value to a safety effort. Hamilton's evident enthusiasm for radiological
warfare research raises questions about his impartiality as head of the panel,80 but
the panel as a whole appears to have dealt with serious public health issues in a
responsible manner.

Secrecy in the Radiological Warfare Program

The U.S. radiological weapons-testing program appears to have remained
formally secret until 1974 and remained largely unknown to the public until the
GAO's report in 1993.81 There was a recurring tension at the time between those
who wanted to release information to allay unwarranted public fears about
radiation hazards and those who thought that publicity would create unwarranted
attention and public apprehension that could interfere with the successful
prosecution of the program. If there was a concern that public knowledge of the
general outlines of the program would undermine national security, none of the
available documents state this argument explicitly, except through their
classification markings.

In May 1948, at its first meeting, the Noyes panel recommended that the
entire program be classified Secret, Restricted Data;82 the Chemical Corps's RW
program was classified at this level.83 At its second meeting, in August, the
Noyes panel revised this recommendation to conclude that "[t]he existence of an
RW Program should be considered as unclassified information."84 The Noyes

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panel was responding to the recommendation by the AEC's ACBM "that the
Advisory Committee on Biology and Medicine urge that the broad subject of
Radiological Warfare be declassified" on the grounds that "the subject appears in
nearly every Sunday supplement in a distorted manner" and that "better work
could be done from the scientific and medical standpoint" if the program were
declassified.85

In February 1949, Defense Secretary James Forrestal, responding to
requests for greater public disclosure of U.S. nuclear activities, appointed Harvard
University President James Conant to chair a confidential ad hoc committee to
make recommendations on "the information which should be released to the
public concerning the capabilities of, and defense against, the atomic bomb and
weapons of biological, chemical, and radiological warfare."86 This high-level
committee's work ended in October 1949 in deadlock, without making any strong
recommendations. Its report to President Truman was quickly forgotten and, if
anything, provided the basis for continuing the existing pattern of secrecy.87

Among the listed rationales provided by the majority of committee
members who opposed the release of further information on the capabilities of
atomic weapons was the absence of "public demand" for the information. (The
positions taken "by certain well-known and probably well meaning pressure
groups," they suggested, "do not spring from any general public sentiment in this
regard and should, therefore be ignored.") James Hershberg, in his biography of
Harvard University President James Conant, who chaired "The Fishing Party" (as
the committee was code-named), has observed:

Notably missing from this list is any indication that
they were worried that the Soviet Union might
derive military benefit from the release of data
under consideration. . . . The observation [of the
majority] that the "public would seem to be more
concerned lest their officials release too much
classified information, rather than too little" may
have been accurate, but would the attitude have
been the same if it were known the government was
hiding the information not from Moscow but from
its own people because it did not trust them? How
else to explain the fear that "even a carefully
reasoned statement . . . might have a very disturbing
effect on the general public and could be
misinterpreted by pressure groups in support of any
extreme position they were currently advocating"?88

In May 1949, while Conant's panel deliberated and the Chemical Corps
was preparing for the initial Dugway field tests, the Defense Department's

522

Chapter 1 1

Research and Development Board (RDB) addressed the question of releasing
information on radiological warfare. The RDB's Committee on Atomic Energy
recommended against a public release of information. Soon after, a joint meeting
of the Military Liaison Committee and the General Advisory Council considered,
but rejected a drafted letter to the President, also recommending a press release on
the RW program. Later that year, on advice from Joseph Hamilton, the Chemical
Corps prepared a release regarding munitions tests at Dugway. The Chemical
Corps's proposal for a release was discussed with AEC and DOD officials, who
rejected it, saying such a release was "not desirable."89

At roughly the same time, Defense Secretary Louis Johnson briefed
President Truman on the radiological warfare program. The briefing
memorandum prepared for Truman said that the planned tests posed a "negligible
risk," but argued that "should the general public learn prematurely of the tests, it
is conceivable that an adverse public reaction might result because of the lack of a
true understanding of radiological hazards." It also noted that "a group of highly
competent and nationally recognized authorities is being assembled to review all
radiological aspects of the tests before operations are initiated at the test site."90

The reference in the briefing memorandum was to the radiological warfare
test safety panel, which was being selected at that time. In August, at the first
meeting of this panel, Albert R. Olpin, president of the University of Utah, noted
the risk that uranium prospectors might stumble onto the site.91 Citing Olpin's
concern, Joseph Hamilton noted,

While the hazards to health for both man and
animals can be considered relatively slight, the
adverse effects of having public attention drawn to
such a situation would be most deleterious to the
program. In particular, Dr. Olpin brought up the
interesting point that most of Utah is being very
carefully combed by a large number of prospectors
armed with geiger counters. Needless to say, it is
imperative that such individuals be denied the
opportunity to survey any region containing a
perceptible amount of radioactivity arising from the
various radioactive munitions that are to be
employed.92

Soon after this meeting, Hamilton also proposed a public release of
information, perhaps reasoning that a program that was announced, but played
down,93 would attract less attention than one that was discovered accidentally.
Hamilton's proposal was refused.94 Echoing Hamilton's concerns, the Chemical
Corps proposed once more that the tests be made public, again citing the risk of
discovery by uranium prospectors.95 Robert LeBaron, chairman of the DOD's

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Part II

Military Liaison Committee to the AEC, turned down this request, claiming the
need for review by the Armed Forces Policy Council.96

The official silence about the prospects for radiological warfare prompted
some public speculation about the government's activities, including a report
appearing in the Bulletin of the Atomic Scientists, a journal created following the
war to give a policy voice in print to many of the physicists who had worked on
the bomb. The journal had some following in the general public as well as the
scientific community. The report mirrored much of the analysis of the Noyes
panel and concluded that RW had significant military potential.97

In September 1949, the AEC's Declassification Branch recommended that
certain general information, civil defense problems, and medical aspects of RW
be declassified. Details regarding specific agents and methods of delivery,
however, should remain secret.98 These suggestions appear to have been adopted
shortly thereafter, as AEC and DOD reports at the end of 1949 and into the early
1950s discuss some aspects of the RW program in very broad terms.99 The
closest thing to an official announcement of the field-test program appears to have
come in a report for the first half of 1 95 1 . ' 00 This report briefly noted that
"research and development activities in chemical, biological, and radiological
warfare were accelerated," and that "Dugway Proving Ground . . . was
reactivated, and major field-test programs in offensive and defensive
toxicological warfare were started," but provided no details. The 1994 summary
of declassification policy by the Department of Energy notes that offensive
radiological warfare was declassified in 1951 by the AEC, although the Defense
Department appears to have kept this aspect of the program classified until much
later.101

The secrecy that surrounded the radiological warfare field-test program
raises two related questions. The first question is whether concerns over public
reaction are a legitimate basis for security classification. Officials at various
levels cited fears of "public anxiety," "undue public apprehension," and even
"public hysteria" to justify keeping even the most general information secret.

The documents reviewed by the Advisory Committee do not record the
actual decisions at various stages to keep the field-testing program secret; they
refer only to such decisions being made by others. It may be that those decisions
reflected other reasons for secrecy. Or it may be that public reaction was
considered a national security issue. This can be a legitimate argument, when the
program in question is considered vital to the nation's security. However, the
nation has a vital interest in open public participation in representative
government, and making exceptions to the rule of openness requires a high
standard of national need.

The second question is the same as the one raised for the Green Run: Can
potentially important public health information about secret activities be made
available to the public without compromising secrecy about the details and

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Chapter 1 1

purposes of the activity? As described later in this chapter, this remains a live
issue today.

The RaLa Tests: Two Decades of Experimentation

From 1944 to 1961, the Los Alamos Scientific Laboratory used lanthanum
140 (also known as radiolanthanum or RaLa) in 244 identified tests of atomic
bomb components.102 These tests were critical to the development of the
plutonium bomb, which required a highly symmetrical inward detonation of high
explosive—known as implosion—to compress the plutonium fuel and allow a
critical chain reaction. The RaLa method (see "What Were the RaLa Tests?") was
the only technique available for measuring whether the implosion was
symmetrical enough and continued to be used for testing bomb designs until the
early 1960s, when technical advances allowed the use of alternative techniques

103

What Were the RaLa Tests?

Implosion devices use carefully timed detonations of carefully shaped high-explosive
charges to generate a spherically symmetrical inward-directed shock wave. This shock wave in
turn compresses the nuclear fuel of an atomic bomb— usually plutonium— causing it to "go critical"
and undergo a nuclear chain reaction."

In the RaLa tests, the plutonium core was replaced by a surrogate heavy metal with an
inner core of lanthanum. Lanthanum 140 has a half-life of forty hours, emitting a high-energy
gamma ray in its decay. Some of these gamma rays were absorbed as they passed through the
outer components of the implosion device, the degree of absorption depending on how compressed
those components were. Radiation measurement devices placed in various directions outside the
device would indicate the overall compression and whether that compression was symmetrical or
instead varied with direction. The lanthanum sources typically ranged from a few hundred to a
few thousand curies, the average being slightly more than 1,000 curies, and were dispersed in the
cloud resulting from the detonation.

In 1950 the Air Force flew a B-17 aircraft carrying an atmospheric
conductivity apparatus in four radiation-tracking experiments at Los Alamos.
These four experiments were identified subsequently by the General Accounting
Office104 and appear in the Advisory Committee's charter.105 A historical analysis
undertaken by the Los Alamos Human Studies Project Team in 1994 identified

a. Lillian Hoddenson et al., Critical Assembly: A Techincal History of Los
Alamos during the Oppenheimer Years, 1943-1945 (New York: Cambridge University
Press, 1993), 268-271.

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Part II

three of these experiments, in which the environmental release of radiation was
incidental to the experiment, as part of the series of 244 intentional releases
mentioned above; the presence of the tracking aircraft is all that distinguishes the
three in the Advisory Committee's charter from the other 24 1.106

The Los Alamos Scientific Laboratory was established in 1 943 as the
atomic bomb design center for the Manhattan Project on a mesa overlooking the
Rio Grande valley, about forty miles northwest of Santa Fe, New Mexico. The
RaLa tests were conducted in Bayo Canyon, roughly three miles east of the town
of Los Alamos, which grew up next to the lab. Although radioactive clouds from
the RaLa tests occasionally blew back toward the town, the prevailing winds
usually blew those clouds over sparsely populated regions to the north and east.
Aside from a small construction trailer park and a pumice quarry within three
miles, the next nearest population center was the San Ildefonso pueblo, roughly
eight miles downwind of the test site in the Rio Grande valley. Several Pueblo
Indian and Spanish-speaking communities lie within twelve miles of Los Alamos.

Risks to the Public

Concerns over risks to the public arose at the beginning of the RaLa
program. In the early years, Los Alamos planners and health physicists worried
that the detonations could cause some contamination in areas outside the test site,
such as the construction trailer park and nearby hiking trails.107

As the RaLa program continued, several patterns of public safety practices
developed. Initially, the principal way to protect people was to keep them out of
the immediate test areas, but in later years it became the practice to test only when
the weather was favorable, and later still to survey surrounding roads to detect
whether contamination had reached hazardous levels.

Perhaps because early atmospheric monitoring had produced only
negative results and because surveys in Los Alamos had indicated only minimal
levels of contamination,108 ground contamination was not believed to be a
significant problem at first. Environmental surveys after RaLa tests indicated
significant contamination at some locations within three miles of the release, but
not at greater distances.

This observation, and the opening of a pumice quarry within three miles of
Bayo Canyon, led to intensive studies of fallout from the RaLa tests in 1949 and
1950. These studies led Los Alamos to conclude that "any area which is two
miles or more from the firing point may be regarded as a non-hazardous area."109
As a result of these studies, Los Alamos restricted RaLa testing to take place only
when the winds were blowing away from the town and laboratory of Los
Alamos."0 Systematic weather forecasting, therefore, began only in 1949, after
more than 120 tests had been carried out, and maintaining the capability to
forecast wind conditions for these tests remained an important requirement over
the years. ' ' '

526

Chapter 1 1

The meteorological constraints presumably reduced the radiation
exposures in Los Alamos itself; exposures in more distant communities, while
probably more frequent, remained lower than Los Alamos. At the Advisory
Committee's public meeting in Santa Fe on January 20, 1995, however, Los
Alamos activist Tyler Mercier commented that most of the "shots were fired when
the wind was blowing to the northeast. At this point in time, that's where most of
the population of this region lived. I mean, half of it is Spanish and half of it
Native American." Mercier concluded that there "appears to be a callous
disregard for the well-being and lives of the Spanish and Native Americans in our
community.""2

The RaLa tests were suspended from July 1950 to March 1952. Routine
radiological survey procedures were put into place when testing resumed.
Surveyors would drive along roads in three sectors monitoring radiation hazards.
Readings were typically below 1 mrad per hour (1 mR/hr), but reached levels of
up to 15 mR/hr at nearby locations and up to 3 mR/hr at distances of several
miles. Readings in excess of 6 mR/hr required further action, including possible
road closure. If the surveyors detected significant levels, they would continue
monitoring in the next canyon downwind. On at least one occasion, ground
contamination at relatively large distances from Los Alamos led monitors to
extend their survey to a nearby town (Espanola), where they detected no
radioactivity."3

The RaLa tests were understood from the beginning to be hazardous, but
they were also critical to the design of nuclear weapons. Los Alamos officials
took significant steps to understand and limit those risks. On at least two
occasions-in late 1946 and from 1950 to 1952-they suspended testing amid
questions about the continuing need and decided to continue testing."4 When the
RaLa tests finally ended in 1961, an alternative means of obtaining needed
information had become available.

Risks to Workers

From the beginning, the RaLa tests also raised concerns over hazards to
workers, particularly the chemists, in spite of elaborate measures adopted to limit
these chemists' radiation exposures."5 Lanthanum 140, with a half-life of forty
hours, is itself the decay product of barium 140, which was separated from spent
reactor fuel at Oak Ridge or Idaho National Engineering Laboratory in later
years' '"and transported in heavily shielded containers to Los Alamos. There,
chemists would periodically separate out the highly radiaoactive lanthanum for
use in the implosion tests.

Soon after testing began on September 21, 1944, the RaLa program posed
a puzzle for radiation safety. On October 16, Louis Hempelmann, director of the
Health Division at Los Alamos, wrote to Manhattan Project medical director

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Part II

Stafford Warren about blood changes observed in the chemists working on the
most recent RaLa test:"7

[I]t looks now as though I was too excited about the
blood changes, but at that time it seemed to me to
be such a clear cut case of cause and effect that I
thought the measurements of dosage must have
been incorrect. Now I feel reasonably certain of the
dosage. ... It was a case where risk was taken
knowingly and willingly because it seemed
necessary for the project. ... It is my feeling that it
should be the decision of the Director whether or
not risks of this type should be taken. . . ."8

In August 1946 Hempelmann termed the exposures of personnel in the
Chemical Group "excessive" and recommended that no more "RaLa shots" be
attempted until "replacements are obtained for each member in this team.""9 The
tests were suspended temporarily "because of over-exposure of personnel to
radiation."120 Los Alamos was faced with the alternative of increasing its staff (so
that individual exposures could be reduced) or shutting work down until safety
measures were installed.

RaLa testing resumed in December 1 946, after a review to determine
whether it was still necessary,121 but no documents are available to determine
whether safety procedures or staffing were changed. What did change was that
researchers began a formal study of the relationship between the radiation
exposures and blood counts of the Bayo Canyon chemists. The chemists'
depressed white blood counts (lymphopenia), presumably the same changes noted
two years earlier, posed a puzzle that continued for at least a decade, resulting in
three scientific reports.122 In 1954, Thomas Shipman, who had replaced
Hempelmann as Health Division director, wrote to the AEC that

The blood counts were done with extreme care . . .
and we are satisfied that the changes in counts are
actual and not imaginary. It is our belief, however,
that they don't mean anything; if they do mean
anything, we don't know what it is.123

The cause of these blood effects remains uncertain. The reported doses of
roughly 10 rad per year are well below levels expected to produce any detectable
blood changes, a fact that was known by 1950.124 While it is possible the effect
could have been due to undetected internal contamination,125 a more likely
explanation may be that the chemists were exposed to chemical compounds that
produced the observed blood changes.126

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Chapter 1 1

It appears that in the latter part of the 1940s some Los Alamos officials
worried about the possible consequences of publicly releasing data on health
effects, including those related to the chemists. A 1946 internal Los Alamos
memo records that Dr. Oppenheimer asked that "all reports on health problems be
separately classified and issued at his request." The author of the memo indicated
his belief that the purpose was to "safeguard the project against being sued by
people claiming to have been damaged."127 Two years later, Norman Knowlton, a
Los Alamos hematologist, reported on the blood changes in ten workers at the lab.
A 1948 memo from the AEC's insurance branch argued that releasing this report
on blood counts could have "a shattering effect on the morale of the employees if
they became aware that there was substantial reason to question the standards of
safety under which they are working" and concluded that "the question of making
this document public should be given very careful study."128 The report was not
classified, however, although later reports were stamped "Official Use Only."

While the remaining information on the Los Alamos chemists is
fragmentary, the experience raises an enduring question: What are the obligations
of the government and its contractors to notify and protect employees whose work
may expose them to continuing hazards, even when the risk is known to be small
or is uncertain? As is discussed in chapter 12, during the same period, issues of
worker protection and notification were raised much more starkly in the case of
the uranium miners, who were placed at significant risk, a risk they had not
"knowingly and willingly" taken.

Informing the Public

Although many in Los Alamos-those who worked on bomb design-knew
of the RaLa program and its potential hazards, there is no indication of any
discussion with other workers or local communities. For example, from the mid-
1940s to the mid-1950s many Pueblo people who may not have been informed
worked at the lab as day laborers, domestics, and manufacturers of detonators.129
The first public mention appears to have come in 1963, when the Los Alamos
laboratory newsletter printed an article describing the cleanup of Bayo Canyon.130
Los Alamos reports that its first concerted efforts to tell the Pueblo people about
the RaLa program did not occur until 1994, when Los Alamos began its review of
the RaLa program.131

Representatives of the pueblos near Los Alamos most likely to be affected
by the RaLa tests have complained about past and continuing failures of
laboratory officials to communicate with Pueblo workers or communities. Recent
efforts at Los Alamos to undo this legacy of secrecy have created a continuing
sense of frustration; Pueblo representatives state that information and other
relations with the lab are still too tightly controlled to be trusted completely.132

It is difficult for any outsider to appreciate fully the unique cultural and
religious viewpoint from which the Pueblo Indians perceive the effects of

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Part II

environmental releases. In addition to having several holy sites located near Los
Alamos, the Pueblo have a deep respect for the land, which appears to have been
violated by many of the activities at Los Alamos.133 The Pueblo continue to rely
to some degree for the basic necessities of food, heat, and shelter on plants,
animals, and the earth, and they suspect that they may be at added risk of
exposure to radioactivity in the environment.'34

George Voelz, a Los Alamos physician who was at the lab during some of
the RaLa tests, told the Advisory Committee, "As far as I know there was not
much communication going on with the people in the area. And that, in
retrospect was a mistake."135 As a result of these failures of communication, Los
Alamos now faces a difficult challenge, five decades later, of attempting to
establish trust with neighboring communities that have become more suspicious
because of what they have learned. Here, as in Hanford, credibility is the casualty
of silence and secrecy.

Studies of Environmental Risks and Safety

The Green Run and the radiological warfare and RaLa programs were by
no means the only government-sponsored experiments in which radioactive
materials were intentionally released into the environment. Scientists undertook a
wide variety of studies designed to understand the risks of environmental
exposure to radioactive materials. For example, tests of experimental nuclear
reactors at the National Reactor Testing Station in Idaho and the National Reactor
Development Station in Nevada were designed to simulate possible accident
scenarios under carefully controlled and isolated conditions. Similarly, tests at
the Nevada Test Site were designed to understand the possible effects of an
accidental (nonnuclear) explosion of a nuclear weapon.136

In addition to intentional releases designed to test the safety of nuclear
machinery, safety was also a concern in studies designed to understand the fate of
radioactive materials in the environment. Many of these studies simply took
advantage of releases that occurred accidentally or were incidental to other
projects. In 1943, studies of the exposure of salmon in the Columbia River to the
radioactive effluent from Hanford's reactors set in motion the growing and largely
public science of radioecology. The environmental analogue of radioisotope
tracer studies designed to better understand the workings of the human body,
these studies were intended both to follow the course of radionuclides released
into the environment during nuclear weapons production and testing, and use
radionuclides to trace the basic workings of the environment. The deliberate
release of very small quantities of radioactive material provided the opportunity
for more-controlled environmental study than those studies that simply observed
radionuclides already released into the environment.137 The Advisory Committee
did not attempt to survey the entire field of radioecology, but we have reviewed
the following examples in some detail.

530

Chapter 11
Project Chariot

Project Chariot was a component of Project Plowshare, the brainchild of
physicist Edward Teller, who helped develop the first hydrogen bomb. Plowshare
arose in the late 1950s in response to public protests against atmospheric nuclear
testing and was intended to demonstrate that "clean" nuclear explosives would
provide safe, peaceful uses of atomic energy.138

In 1958, Teller selected a site in northern Alaska for Project Chariot, the
proposed excavation of an Arctic seaport using a series of nuclear explosions.
The site chosen was near Cape Thompson, roughly thirty miles from the Inupiat
Eskimo village of Point Hope. This proposal, which was the subject of public
debate, died in 1962 in the face of popular opposition.139 However, extensive
observations of the Alaskan ecosystem were undertaken between 1958 and 1962
to provide a baseline for comparison with results of the planned nuclear
explosions. These observations led to the first awareness of the environmental
hazards of cesium 137 from distant (primarily Soviet)140 atmospheric nuclear tests
and led to a series of studies on cesium in the food chain and in humans.141

Most of the environmental studies in Project Chariot were purely
observational, but one series of studies involved the intentional release of small
quantities of radioactive materials--a total of 26 millicuries of iodine 131,
strontium 85, cesium 137, and mixed fission products.142 In several studies,
researchers from the U.S. Geological Survey spread radioactive materials on the
surface of small plots of land and observed their spread across the surface when
sprayed with water to simulate rainfall. In another, researchers placed mixed
fission products in a small pit and measured their transport through the subsurface
clay, and in yet another, researchers studied the spread of radioactivity in a creek
contaminated with radioactive soil from Nevada. After these studies, the
contaminated soil was removed and buried in above-ground mounds. Although
this was a technical violation of regulatory requirements, an AEC memo
expressed general satisfaction with the cleanup, noting that burial in the
permafrost would have been too difficult.143

After the initial cleanup, the site remained dormant for thirty years until
1992, when a researcher discovered correspondence between the AEC and USGS
about the tracer studies. In response to public concerns, the Department of
Energy undertook to clean up the mounds' potentially contaminated soil. A
survey indicated no externally observable radioactivity, and very little, if any
measurable, radioactive material was believed to remain. In 1993, the mounds of
soil were removed for disposal at the Nevada Test Site.144 Caroline Cannon, an
Inupiat Indian resident of Point Hope, told the Advisory Committee at its public
meeting in Santa Fe,

I have lived in Point Hope all my life and eaten the
food from the sea and the land and drank the water

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Part II

of Cape Thompson, along with the others. I have to
wonder about my health, what impact the poison on
the earth will have all through my lifetime,
emotionally, physically, and most of all for my
children and my grandchildren.145

Although the risk to the population was minimal, residents still wonder
whether other experiments might have occurred and remain secret.146 Here again,
government secrecy in the past is undermining government credibility in the
present. How much comfort are Ms. Cannon and others like her able to take in
reassurances from the government about risks to future generations, a government
that they perceive unjustifiably kept them in the dark?

Controlled Radioiodine Releases

A small number of intentional releases involved the deliberate exposure of
human subjects to trace quantities of radioisotopes in the environment. The most
systematic of these were five of the roughly thirty Controlled Environmental
Radioiodine Tests (CERT), carried out at Idaho National Engineering Laboratory
(INEL) between 1963 and 1968. Small quantities of 1-131 were released into the
atmosphere under carefully monitored meteorological conditions.147

In one study, seven volunteers drank milk from cows that grazed on the
contaminated pasture. The quantity of iodine was measured carefully in the air,
on the grass, in the milk, and later in the volunteers' thyroids, allowing a
quantitative reconstruction of the full environmental pathway.148 The maximum
exposure among these volunteers was reported as 0.63 rad to the thyroid, nearly a
factor of 50 below the contemporary annual occupational exposure limits.149 In
four other studies, a total of about twenty volunteers stood downwind at the time
of the release; their exposures, from inhaling 1-131 in the air, were much lower.'50
Apparently, all these volunteers were members of the INEL staff.151
Measurements of the radioactivity in their thyroids provided a quantitative
reconstruction of the inhalation pathway.

Studies similar to the CERT took place at Hanford in 1962, 1963, and
possibly in 1965. The 1963 Hanford test involved human volunteers from
Hanford's health physics staff, as did studies of iodine uptake from milk.152

The subjects in all these studies are referred to as volunteers in the
relevant documents. No evidence is available bearing on what these subjects
knew or were told about the experiments or the conditions under which they
agreed to participate. The subjects were all staff members of the agency (or its
contractors) conducting the research. The documents suggest that these staff
members included knowledgeable individuals who participated in these
experiments in the spirit of self-experimentation.

532

Chapter 11
Reconstructing, Comparing, and Understanding Risks

Thus far, we have only briefly characterized the risks associated with the
intentional releases reviewed in this chapter. Just how risky were those
intentional releases and how much of this risk materialized? Although these
questions cannot be answered with certainty, the answers can be approximated.
Actual and suspected failures to respect public health in the environmental
practices of the past have often led to efforts to reconstruct the basic facts and
estimate the likely harm from environmental releases of radioactive materials.
This process of environmental dose reconstruction has become an essential part of
informing the public.

The task of estimating past environmental exposures to radioactive
materials is a complex, multistep process. The first step is to collect data from
historical records on the amount of material released. The second is to use
records on weather, actual measurements of radioactivity in the environment, and
computer models to reconstruct where this material went. The third step is to
estimate how this distribution of material might result in radiation exposures to
humans. Finally, these exposure estimates can be combined with mathematical
models of radiation risks to estimate the resulting harm to people who were
exposed.

Radioactive materials released into the environment can affect humans in
two ways. First, they can be a source of radiation external to the body: beta
radiation, which affects the skin, or more penetrating gamma radiation. Second,
they can enter the body from contaminated air, food, or water and provide an
internal source of radiation. Of these environmental pathways to radiation
exposure, the food pathway is by far the most complicated. Radionuclides can
enter the food chain at many points, through contaminated air, water, and soil,
resulting in contaminated fruits, vegetables, meat, and dairy products.

The hazards from environmental exposures to radionuclides differ in
important quantitative ways from those due to medical procedures or participation
in biomedical research. The natural dilution of materials in the environment
means that individual exposures even from massive releases are often quite small,
although the chemical and biological processes involved in exposures through the
food chain can lead to effects that counteract this dilution. Finally, many more
people may be exposed, with exposures that vary widely from person to person.

Because individual exposures are generally too low to produce any acute
effects, the main form of injury possible from environmental radiation exposure is
cancer, which may occur many years after the exposure, and the number of cases
attributable to such exposures can be expected to be relatively small. Evidence of
cancer from exposure to radiation is difficult to separate out from other possible
causes of those injuries; for the intentional releases discussed in this chapter, it is
essentially impossible. Instead, we must rely on models of risk based on studies
of other human radiation exposures.

533

Table 1.

Magnitude of Radioactive Releases

Event

Location

Year(s)

Curies Released

Isotopes

Risk (fatal cancers)'

(number)

(Total)

Chernobyl

Ukraine,

1986

950,000

Cs-134;

17,400 expected/2.9

Soviet Union

1,900,000
17,000,000

Cs-137;
1-131";

billion exposed'

Household

United States

Lifetime

N/A

Ra-222

14,000 per year

radon

expected/ 240 milliond

Atomic

Worldwide

1945-

-26 million (Cs-

Cs-137;

12,000 expected/ 5

weapons testing

1980

137); -18 million

Sr-90;

billion '

(atmospheric)

(Sr-90);

-19 billion (1-131);
-6.5 billion (H-3);
-6 million (C- 14)

1-131;

H-3;

C-14

First A-bombs

Hiroshima &

1945

-250,000,000

Short-

300 estimated\76,000

Nagasaki,

lived

tracked8

Japan

fission
products'

Early Hanford

Hanford,

1945-

700,000

1-131 "

-1.6 cases of thyroid

operations

Washington

1947

cancer expected/
3,200 '

Three Mile

Harrisburg,

1979

15

1-131;

0.7/ 2 million exposed

Island

Penn-
sylvania

10,000,000

noble
gasesJ

k

RaLa tests

Los Alamos,

1944-

250,000

La- 140

0.4 cases/ 10,000

(254)

New Mexico

1962

exposed1

Green Run

Hanford,

1949

8,000

1-131;

0.04 expected/30,000

Washington

20,000

Xe-133

exposed"1

R W field tests

Dugway,

1949-

13,000

Ta-182n

Unknown"

(65)

Utah

1952

a. For every event but one, this column displays the risk of excess cancer fatalities. For I -131
released during "Hanford early operations," it displays the risk of excess cases of thyroid cancer.

b. United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), Sources
and Effects of Ionizing Radiations (New York: United Nations, 1993), 1 14, basing findings on L. A. Ilyin et
al., "Recontamination Patterns and Possible Health Consequences of the Accident at the Chernobyl Nuclear
Power Station," Journal of Radiological Protection 10 (1990): 3-29. The radioactivity released in the
Chernobyl accident would include other fission products, particularly long-lived ones, but isotopes of cesium

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and iodine posed the greatest health hazard.

c. Lynn R. Anspaugh, Robert J. Catlin, and Marvin Goldman, "The Global Impact of the
Chernobyl Reactor Accident," Science 242 (1988): 1516.

d. Environmental Protection Agency, Public Health Service, A Citizen's Guide to Radon,
(Washington, D.C.: GPO, May 1992), 2.

e. United Nations Scientific Committee on the Effects of Atomic Radiation, Ionizing Radiation:
Sources and Biological Effects (New York: United Nations, 1 982), 2 1 2-226. While the list of fission
products released is incomplete, other products do not contribute much in the way of effective doses.

f. This is the rough level of radioactivity remaining one day after each of the explosions, including
biologically active and relatively active isotopes. Samuel Glasstone, ed.. The Effects of Atomic Weapons
(Washington, D.C.: GPO, 1950), 220. The level of radioactivity diminished rapidly thereafter. Prompt
neutron and gamma radiation from the nuclear explosion, rather than fallout, was responsible for most of the
radiation exposures.

g. "Life Span Study," in Hiroshima Radiation Effects Research Foundation [electronic bulletin
board] (cited 31 May 1995); available from www.rerf.or.jp; World Wide Web. This is the number of excess
cancer fatalities between 1950 and 1985 among the 76,000 for whom doses have been calculated.

h. Sara Cate, A. James Ruttenber, and Allen W. Conklin, "Feasibility of an Epidemiologic Study
of Thyroid Neoplasia in Persons Exposed to Radionuclides from the Hanford Nuclear Facility between 1944
and 1956." Health Physics 59 (1990): 169.

i. Kenneth Kopecky et al., "Clarification of Hanford Thyroid Disease Study," HPS Newsletter,
July 1995,24-25.

j. UNSCEAR, Sources and Effects of Ionizing Radiation, 1 1 4.

k. Report of the President's Commission on the Accident at Three Mile Island: The Need for
Change: The Legacy of ' TMl (New York: Pergamon Press. 1979), 12.

1. This is an upper estimate based upon a preliminary dose reconstruction by staff of the Los
Alamos National Laboratory of 1 . 1 mSV (1.1 rem). "Assuming an individual had been at the Los Alamos
site continuously throughout the experiments, the total dose from the 1 8 year RaLa series was estimated to
have been approximately 1.1 mSv." Using the average dose of 0.6 mSv (0.6 rem), the excess cancer risk falls
to 0.24. Los Alamos notes, "A somewhat abbreviated approach could be used wherein a static population of
10,000 is assumed to be uniformly distributed across the Los Alamos of the 1950s. The dose as a function of
distance could be used to estimate approximate population doses." D. H. Kraig, Human Studies Project
Team, Los Alamos National Laboratory, fax to Gilbert Whittemore (ACHRE staff), 14 September 1995
("Dose Reconstruction for Experiments Involving Lal40 at Los Alamos National Laboratory, 1944-1962")
(ACHRE No. DOE-091495-A).

m. Maurice Robkin, "Experimental Release of 1-131: The Green Run," Health Physics 62, no. 6
(July 1992): 487-495.

n. See, for example Chemical Corps, 1952 ("Explosive Munitions for RW Agents") (ACHRE No.
NARA-1 12294-A-10); Chemical Corps, 1952 ("Testing of RW Agents") (ACHRE No. NARA-1 12294-A-7);
George Milly, Chemical Corps, 27 June 1952 ("Report of Field Tests 623 and 624 Airburst Test of Two
1,000 Lb. Radiological Bombs") (ACHRE No. DOD-062494-A-16); E. Campagna, Chemical Corps, 18
September 1953 ("Static Test of Full Diameter Sectional Munitions, E83") (ACHRE No. DOD-062494-A-
15).

o. The Advisory Committee knows of no dose reconstructions for these releases.

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Increased cancer rates among Japanese survivors of the atomic bombings
provide the basis for most current radiation exposure risk estimates.153 Health
effects from the massive accident at Chernobyl and from other sites in the former
Soviet Union should also be detectable and eventually may improve our
understanding of the risks of chronic, low-level radiation exposure. The
uncertainties in these scientific analyses are a major component of the uncertainty
in risk estimation from environmental exposures.

In addition to individual exposures, it is important to know how many
people were exposed. The population dose-obtained by adding up the individual
exposures-provides a measure of the overall risk to the exposed population.
According to models used by the Environmental Protection Agency (EPA), we
can expect about one induced fatal cancer for every 1 ,940 person-rem of radiation
exposure.154 While the risk to any one person may be small, the exposure of a
large population can lead to a statistically significant increase in the number of
fatal cancers, but it will be impossible to attribute any particular cancer to
radiation exposure.

The Committee was not equipped to reconstruct historical doses from
intentional releases, but can make some rough judgments based on more formal
analyses performed by others.

The Green Run

The Green Run took place after years of routine emissions of radioiodine
from the wartime and early postwar operations of the Hanford plant, and it added
a relatively small amount to the overall risk (see the accompanying table 1,
"Magnitude of Radioactive Releases"). In 1987 the Department of Energy
established the Hanford Environmental Dose Reconstruction (HEDR) project to
provide an estimate of all the exposures that might have resulted and continues to
refine its estimates of the resulting radiation doses to people.155 These exposures,
primarily through the food chain, may have produced a measurable excess in
thyroid disease. A follow-up study of the exposed population is attempting to
ascertain whether excess thyroid disease can indeed be seen.

The Green Run represents only about 1 percent of all the radioiodine
releases from Hanford. Fortunately for most nearby residents, it occurred at a time
of year when people were not eating fresh garden vegetables or drinking milk
from cattle grazing in open pastures. The estimated radiation dose to members of
the public from Hanford's operations for all of 1949 probably did not exceed 600
mrad to the thyroid, and doses ten times lower were more typical of the most
highly exposed population. The Committee estimates that the Green Run may
have increased the expected number of fatal thyroid cancers in the exposed
population by 0.04, within broad error margins.156 This means it is highly
unlikely that even one person died as a result of the Green Run. A larger
incidence of benign thyroid conditions is likely, but there is no evidence to

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support a connection between the intentional releases and any other possible
medical conditions.

Radiological Warfare

No formal dose reconstruction has been done for the radiological warfare
field tests at Dugway. Although the radioactive tantalum used in these tests does
not concentrate in the food chain, because of its long half-life there may have
been many opportunities for people to be exposed. Weather and vehicle traffic
could have spread some of the contamination outside the Proving Ground, and
even repeated low-level exposures to uranium prospectors or hikers who regularly
wandered onto the site may have been possible.

Whatever public health hazard the RW tests at Dugway may have posed at
the time, the radioactive decay of the tantalum caused the risks to dissipate over
time. By 1960, no more than a few millicuries of tantalum remained, dispersed so
widely that by this time it posed no conceivable human or environmental hazard.

RaLa Tests

Los Alamos's 1995 report on the history of the RaLa test program contains
basic information necessary for an environmental dose reconstruction, including
the amount of radioactivity released, a rough indication of the amount of high
explosive used in each test, and meteorological and fallout data where
available.157 Advisory Committee staff reviewed the process by which this
information was assembled and reported that the historical reconstruction appears
to be a reasonably accurate representation of what actually occurred.

Los Alamos is using this historical information to produce an
environmental dose assessment, which it is providing to the state of New Mexico
and plans to submit for publication in a peer-reviewed journal. The Committee
was not in a position to judge the adequacy of the dose reconstruction, but the
sources, methodology, and results will be available for review by outside experts.

Individual exposures from the full series of RaLa tests were somewhat
higher than for the single release of the Green Run, and the exposed population
was somewhat smaller. According to a preliminary dose reconstruction by the
Human Studies Project Team at Los Alamos, the total dose for someone living
continuously in Los Alamos for all eighteen years of the program was roughly
1 10 mrem. With a population of approximately 10,000 in Los Alamos County, 0.4
excess cancer deaths might be expected. The average dose would have been 60
mrem for someone living in Los Alamos.158

The General Accounting Office noted an Air Force report that a B- 1 7
airplane detected radioactive debris from one of the tests as far as seventy miles
away, over the town of Watrous, New Mexico, but it is unlikely that any
significant risks extended to this distance. The Human Studies Project Team

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concluded, however, that the cloud could not have gone as far as claimed at the
time of the observation and suggests that the atmospheric conductivity apparatus
used by the Air Force was sensitive to effects other than radioactivity.159

Los Alamos has not attempted to reconstruct the doses to the Bayo
Canyon chemists. Using data from one of the reports, however, it would appear
that the total exposure for these chemists was high enough to place these
individuals at some increased risk for developing a radiation-induced cancer.160

Other Intentional Releases

No risk estimates are available for the other releases the Committee has
studied, and aside from DOE's Idaho National Engineering Laboratory, no dose
reconstructions have been undertaken. It does appear, however, that the human
health risks were small even compared with the minimal risks of the intentional
releases discussed above and with other, more familiar exposures to radioactivity
in the environment (see the accompanying table, "Magnitude of Radioactive
Releases").

POLICIES AND PRINCIPLES GOVERNING SECRET
INTENTIONAL RELEASES: THE EFFECTIVENESS OF
CURRENT REGULATIONS

Policies and Practices in the Early Years

When the federal government set out to apply atomic energy to national
needs, there were no specific rules or policies to govern the deliberate release of
radionuclides into the environment. Nonetheless, the declassified record of the
releases just reviewed shows that those responsible considered the basic issues
that concern us today and that are today the subject of federal regulation. These
include the need to limit risks, the question of who should bear those risks, and
the extent of the obligation to inform affected citizens.

This record indicates that, for intentional releases as for biomedical
experimentation, the government was most concerned with, and placed the
highest priority on, limiting human health risks. At Hanford, for example, this
was done by establishing limits for the permitted level of radioactive
contamination. Some of these guidelines were exceeded, if only temporarily, by
the Green Run. For the radiological warfare program, the Department of Defense
established a panel of outside experts to safeguard against excessive risks to the
general public.

The federal government struggled throughout these early years to clarify
its obligations to protect the general public from the risks of radioactive
contamination in the environment, particularly from atmospheric nuclear weapons
testing (see chapter 10). The 1953 Nevada test series raised serious concerns

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Chapter 1 1

about whether and how radioactive fallout from the expanding testing program
was exposing nearby people and livestock to risk.161 In an analysis that seems
equally apt for intentional releases, Richard Elliott, information director of the
AEC's Santa Fe Operations Office, argued at the time that the AEC had the
obligation to show that the testing program was "vital to the nation and that it was
conducted as safely as possible." He also asserted, however, that the agency had
duties in addition to limiting risk, including

(1) To inform concerned publics of the hazards
created and of preventive action which may be
undertaken; (2) To warn people in advance of
potentially hazardous situations, or of situations
which may alarm them; (3) To report after the fact
not only with reassurances but also with details and
interpretations; (4) And, to the extent of the
agency's responsibility, to reimburse the public for
its losses.162

For most of the intentional releases described in this chapter, information
was withheld entirely, even when that information might have enabled the public
to reduce its risk, however small, of exposure to ionizing radiation.163 This
secrecy appears to have been motivated by legitimate national security needs in
the cases of the Green Run and the RaLa program. The radiological warfare
field-testing program was kept secret primarily to avoid public awareness and
controversy that might jeopardize the program. The extent of secrecy abated in
later years, and many of the intentional releases that occurred from about 1960
onward involved relatively low risks and were made known to the public.

Obligations to limit risk, to consider who should bear the risk, and to
inform the public, while recognized, were often subordinated to concerns for
national security, which were sometimes joined or melded with concerns for
public relations. The information that is available indicates that the physical harm
from the radiation is probably less than the damage— to individuals, communities,
and the government— caused by the initial secrecy, however well motivated, and
by subsequent failures to deal honestly with the public thereafter. The legacy of
distrust, as described in the histories presented above, is probably more
significant than the legacy of physical harm.

Regulating the Levels of Risk the Government May Impose

The past fifty years has seen the development of a body of laws and
regulations governing releases into the environment, including releases of
radioactive materials. These laws and regulations give legal standing to moral
considerations about limiting risk, fairness in the imposition of risk, and

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Part II

disclosure to and involvement of the public. When environmental releases take
place today-for example, in the cleanup of the nuclear weapons complex-they
are subject to rules that provide procedures for public review and comment on
proposed federal actions and to rules that limit the amounts of radiation that can
be released into the environment.

Environmental law contains a variety of quantitative standards designed to
limit the risk to human health from exposure to environmental hazards. These
limits apply both to private companies and to the federal government.

The Atomic Energy Act of 1954 and the Clean Air Act of 1970 impose the
most important constraints on intentional releases of radioactivity into the
environment.164 Regulations under both of these laws limit the maximum
exposure to any one person. These limits are often supplemented by secondary
standards (for example, on concentrations in air and water) designed to prevent
exposures from exceeding this limit. This basic form of regulation remains
largely unchanged from the early days of radiation protection, although the
quantitative limits have been greatly reduced over the years.165

The actual limits on radiation exposures to members of the public have
dropped dramatically over time. The initial postwar standard was for
occupational exposures: 0.1 R per day.166 If a person were exposed at such levels
for his or her entire working lifetime, about fifty years, a rough extrapolation of
current risk models would predict that he or she would be more likely than not to
die of radiation-induced cancer. In practice, however, it is extremely unlikely that
any worker came close to that level of lifetime exposure. Once it was recognized
that standards for the general public should be stricter than those for a potentially
hazardous workplace, the exposure standard for members of the public was set a
factor often below the occupational standard. In 1960, when the occupational
standard was reduced to 5 rem per year, the standard for exposures to members of
the general public was reduced to 500 mrem per year from all artificial
environmental sources.167

Since that time, the Environmental Protection Agency and the Nuclear
Regulatory Commission (NRC) were established as separate regulatory
agencies,168 and radiation protection standards have been tightened further. The
DOE and NRC have adopted the stricter limit of 100 mrem per year for general
population exposure, and the EPA has proposed adopting a similar standard. The
EPA's standard for atmospheric emissions under the Clean Air Act is a factor of
ten lower: 10 mrem per year. A lifetime of exposure at this level would produce
an expected excess in cancer deaths of a few in 1 0,000. 169

By way of comparison, the average human exposure to background
radiation from naturally occurring cosmic rays and radioactive materials is
roughly 300 mrem per year. Exposure limits that were initially much higher than
natural backgrounds have since fallen substantially below those levels. Actual
public exposures are much lower still, with average medical exposures of roughly
50 mrem per year and exposures from nuclear power at roughly 1 mrem per year

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Chapter 1 1

for people living closest to nuclear power plants.170 Although the risk associated
with the maximum-allowed exposure from human-controlled sources has fallen
over the years, so that it is now below that from natural background levels, it
remains higher than that for exposure to chemical carcinogens, which range from
linl0,000tolinl,000,000.171

However, standards based solely on limiting individual exposures would
not address the possibility that-as in the case of intentional releases-large
numbers of people might be exposed to risk, though likely at low levels. As
described above, the population dose, obtained by adding up all the individual
doses provides a measure of the overall risk to a large exposed population. A
more universal application of the population dose in the regulatory process would
give greater weight to this overall risk.17"

Under some circumstances, however, the federal government may invoke
exceptions to these baseline standards-imposing greater risks on its citizens
where national need dictates. Under the Clean Air Act, only the President may
invoke such exceptions, and only on the basis of "national security interest." The
President must report to Congress on any such exceptions at the end of the
calendar year.173 Under the Atomic Energy Act, however, the Department of
Energy is largely exempt from external regulation. When its predecessor, the
Atomic Energy Commission, developed regulations for the civilian nuclear power
industry, it also committed to operate its own nuclear facilities according to
certain safety provisions, but allowed itself an exemption "when over-riding
national security considerations dictate."174 Such an exception under the Atomic
Energy Act could still be invoked today. These exemptions clearly allow national
security interests to take precedence over public health concerns. The Advisory
Committee is concerned that this could occur without adequate consideration or
oversight, and without adequate protection of the public's interest in a safe
environment and public notice. Once the exemption is invoked, there is no formal
limit on the risks to which members of the public may be exposed, although the
requirement to report to Congress could deter some actions.

Public Disclosure and Formal Review

Today's environmental laws require public disclosures of the likely
environmental impacts of federal government actions, subject to public and EPA
review, and EPA oversight of federal compliance with environmental regulations.
As we will discuss below, the classification of information for national security
purposes requires certain exceptions to the general rules described here.

The National Environmental Policy Act (NEPA) of 1969 requires that the
federal government take into account and publicize the environmental impact of
its actions.176 NEPA's requirements serve the dual purposes of informing the
public and forcing agencies of the federal government to inform themselves of the
environmental impact of their actions. NEPA requires an agency to prepare an

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environmental impact statement (EIS) for any proposed "major federal action"
having a significant impact on the human environment.177

As long as an agency has followed the requisite procedures (and rationally
explained its choices in the EIS) it may choose whatever course of action it likes,
even the alternative that poses greater environmental risks. Nonetheless, the
public process can have dramatic effects on the way agencies make decisions.
Assessments that are subject to public comment and decisions that are open to
public scrutiny force agencies to consider public reaction when they choose
policy alternatives. The adequacy of the process is subject to review by EPA and,
if members of the public sue, by the courts. However, environmental impact
statement may be classified in whole or in part. The EPA is obliged to review and
comment on the classified portions.178

The EPA is also charged with making sure the federal government
complies with the substantive requirements of the Clean Air Act (and other
environmental statutes), and shares oversight responsibilities under the Atomic
Energy Act with DOE and the NRC. For example, EPA must approve the
construction or expansion of a facility, certifying that such action would not
exceed the limits of the Clean Air Act. Furthermore, agencies are required to
report on their emissions to EPA and are subject to fines if they violate the
emissions limits. Under the Federal Facility Compliance Act, EPA must list and
review environmental compliance at all federal facilities.

Selection of Sites and Affected Communities

The sites selected for intentional releases, and thus the populations
affected, do not appear to have been chosen arbitrarily, but rather for reasons that
are arguably defensible, albeit open to a charge of unfairness. Most of the releases
took place in and around "atomic energy communities" and military sites, a
choice that had several obvious advantages. First, the sites offered the expertise
and facilities, both indoors and out, for the evaluation of releases involving
radioactivity. Second, the locations of most of these facilities were originally
chosen because of their relative, if not complete, isolation from major "civilian"
population centers. Residents near these sites were generally accustomed to
secret government activities in their midst. The selection of these sites for
repeated exposure to releases of radioactivity—whether experimental, accidental,
or routine-probably resulted in fewer people being exposed, but it also meant that
the same groups were repeatedly exposed to higher than normal risks.

While there is no formal analogue to the research rules regarding fairness
in the selection of subjects in the context of environmental releases, the
environmental impact process does provide for public review of, and comment
on, the rationale for the choice of taking an action in one locale, as opposed to
another. In' addition, by a 1994 executive order, President Clinton called on
decision makers to consider whether actions affecting the environment may have

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Chapter 1 1

179

disproportionate impact on the environment of poor or minority populations.
When the environmental review and decisions are made in secret, however,
opportunities for any group of citizens to make their concerns known are limited.

The Effects of Secrecy on Current Policies and Protections

As we have seen, current law permits the conduct of intentional releases
in secret. Secret intentional releases pose two kinds of problems for the interests
of the public-loss of assurance that secret releases comply with laws regulating
risk exposure and loss of the protections afforded by public disclosure and

comment.

Formally, at least, the regulations limiting radiation exposures to the
public and requiring official environmental review and oversight of government
programs apply equally to classified programs as to public ones. In practice,
however, classification creates complications that have yet to be resolved. Efforts
are now under way to put procedures into place to better address proper
environmental compliance in classified programs.

For example, security classification can interfere with official oversight of
environmental compliance. Even in recent times, environmental oversight of
classified programs has not been the rule in practice. Until 1994, the Federal
Facilities Enforcement Office at EPA, which is charged with environmental
oversight of all federal facilities, had no personnel with suitable clearances to
oversee "black" programs-programs so highly classified that their existence is
not acknowledged.180

Lack of oversight creates opportunities for violations of environmental
law to go undetected and unpunished. Some have charged that the Department of
Defense, as recently as 1993, used secrecy as a cover for violations of
environmental law. Recent lawsuits against the Department of Defense and the
Environmental Protection Agency allege that (1) illegal open-air burning of toxic
wastes took place at a secret Air Force facility near Groom Lake, Nevada, and
that (2) EPA has not exercised its required environmental oversight
responsibilities for this facility.181 Responding to the second of these lawsuits,
EPA reported that in early 1995 it had seven regulators on staff with Special
Access clearance who inspected the Groom Lake facility.'8

The Committee believes that the federal government has a particular
obligation to provide environmental oversight of classified programs and that
there is no fundamental barrier to environmental oversight in classified programs.
Regulators can be granted the appropriate clearances. For example, before its
existence was openly recognized, the F-117 Stealth fighter base in Nevada was
subject to oversight by Nevada state regulators who had received the necessary
clearances.183 Such oversight is not automatic; it requires active cooperation
between the regulatory agencies and the agencies subject to regulation. The
Department of Defense has undertaken a review of environmental compliance in

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its "black" programs and is working with EPA to establish mechanisms to provide
continuing environmental oversight of those programs.184

Even when regulators have the appropriate clearances, however, other
aspects of secrecy can create barriers to oversight. Providing clearances often
entails lengthy background investigations, which can result in delays.
Furthermore, it remains unclear what EPA can do if it detects a violation that
results in a dispute with the agency in charge of the program. This is a basis for
concern about the credibility of environmental oversight that occurs in secret.

The limits on outside oversight are ameliorated by the fact that both DOE
and DOD have established environmental and health offices that are largely
independent of their respective agencies' operational programs. Under most
circumstances these offices can probably provide adequate oversight over their
agencies' classified programs. Because of the potential institutional conflict of
interest, however, it would be preferable to have further oversight by an
independent entity.

The conduct of intentional releases in secret necessarily deprives the
public of information to which it would otherwise be entitled. Security
classification modifies or eliminates the various requirements for providing public
disclosures. The agency states that its normal practice is to send an EPA
employee with appropriate clearances to the agency in question to review the
classified information; EPA, however, does not keep copies of the reviewed
document or any other records of such reviews.185 Moreover, review by an EPA
employee is no substitute for a process open to public comment and scrutiny.

Secrecy, especially to the degree of "black" programs, severely limits or
eliminates the ability of the public to influence decisions about environmental
health, either through political action or through the courts,186 and undermines
public confidence that officials are carrying out their responsibilities to safeguard
public health. As in the secret releases of the past, there are also concerns about
whether and what kind of information can be given to the public about
environmental and public health effects when releases are classified and if
restrictions on information compromise the ability of members of the public to
take protective actions.

CONCLUSION

While the intentional releases described in this chapter put people at risk
from radiation exposures, with limited exception, they were not undertaken for
the purpose of gathering research data on humans. Thus, in contrast with the
biomedical experiments studied by the Advisory Committee, they were not
intended as human experiments.

Fifty years ago, unlike today, there was no formal and published body of
laws that defined and limited the ability of the government to release potentially
hazardous substances into the environment. Nonetheless, the duty to limit risk

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Chapter 1 1

and, by implication, the duty to balance risks against potential benefits was
understood by those who engaged in intentional releases. In the case of the Green
Run, risk from the intentional release could be gauged against preexisting
guidelines for operational releases; in the case of radiological warfare tests, a
separate safety panel was established to consider releases.

The intentional releases studied by the Committee often engaged national
security interests and were conducted in secret. However legitimate and well-
motivated the releases were, security classification prevented any public notice or
discussion of the Green Run--an experiment conducted for intelligence purposes-
the radiological weapons field tests, or the RaLa experiments testing atomic bomb
components. The essentially complete secrecy surrounding these tests prevented
any warnings that might have allowed members of the public to protect
themselves from whatever risks might have been inherent in the tests.

In retrospect, and with limited information, it is difficult to know whether
and how national security interests affected the decisions to conduct these
intentional releases. In the case of the Green Run, for example, how did decision
makers seek to balance the national security interests in learning about Soviet
bomb testing (and the risks of not performing the Green Run and thus not gaining
relevant information) against the potential risks to the local population of the

release?

The health and safety risks posed by the intentional releases appear in
retrospect to have been negligible (the Green Run, for example, in comparison
with other exposures at Hanford). But this does not mean that the intentional
releases were without negative consequences. The secrecy that surrounded the
conduct of these releases and the failure to deal forthrightly with citizens after the
fact has taken a substantial toll. People living in the affected communities have
been robbed of peace of mind, and the government has lost the trust of some of its

citizens.

Could this happen again? Could there be another Green Run? The answer

is a qualified yes.

In fact, an intentional release like the Green Run probably would not be
contemplated (because the scientific and strategic value would seem minimal),
but actions that raise similar concerns if undertaken in secrecy could still happen.
Environmental regulations apply to secret programs, but the oversight procedures
are not fully in place to ensure adherence to these regulations. The public review
process that is at the heart of current environmental protections could be limited
or rendered nonexistent if the government were to invoke exceptions for "national
security interest" to avoid these constraints.

Any government action that is conducted in secret is likely to cause
suspicion and distrust, even if the risks to members of the public are minimal or
nonexistent. Public policy should operate with a strong presumption favoring
public disclosure and openness. There doubtless are limited circumstances under
which it is justifiable to conduct an intentional release in secret. The lesson of the

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Green Run and the other intentional releases is, however, that unless great care is
taken to preserve and honor the public's trust, the cost to the body politic of such
an action is likely to be substantial. The Committee believes that the current
regulatory structure does not go far enough in this regard. Provisions must be
made for timely public disclosure, and records must be created and maintained
capable of satisfying the affected populations that their interests have been
protected. And mechanisms need to be developed to approximate the scrutiny of
the public when security interests require the classification of environmental
impact statements or otherwise limit disclosure of information to the public.
Without such protections, the greatest casualty of the Green Run— the distrust it
engendered—cannot be prevented in the future; where this happens, official
concern that the public cannot be trusted to appreciate sometimes-complex
information about health and safety will become an ever-more-corrosive self-
fulfilling prophecy.

546

ENDNOTES

1 . The story of the public discovery of the Green Run is recounted in Michael
D'Antonio's Atomic Harvest: Hanford and the Lethal Toll of America's Nuclear Arsenal
(New York: Crown, 1993), 116-145.

2. U.S. Congress, General Accounting Office, Examples of Post World War II
Radiation Releases (Washington, D.C.: GPO, 1993) (ACHRE No. DOE-042894-B-1).

3. The Committee did not undertake to review in detail the general development
of radioecology, which began during the Manhattan Project with research on the
radiosensitivity of aquatic life around the Hanford Reservation and extended to research
on flora and fauna in and around other AEC sites. For an introductory overview, see
"Survey of Radioecology: Environmental Studies Around Production Sites," in J. Newell
Stannard, Radioactivity and Health: A History (Springfield, Va.: Office of Science and
Technical Information, 1988).

4. General Dwight D. Eisenhower, to Commanding General, Army Air Forces,
16 September 1947 ("Long Range Detection of Atomic Explosions") (ACHRE No.
DOD-0U595-A).

5. Charles A. Ziegler and David Jacobson, Spying Without Spies: Origins of
America's Secret Nuclear Surveillance System (Westport, Conn.: Praeger, 1995), 133.

6. Ibid., 203-204. R. H. Hillenkoetter, Rear Admiral, USN, Central Intelligence
Agency, 9 September 1949 memorandum ("Samples of air masses recently collected over
the North Pacific . . .") (ACHRE No. CIA-01 1895-A).

7. Jack W. Healy, interview by Marisa Caputo (Department of Energy, Office
of Human Radiation Experiments), transcript of audio recording, 28 November 1994
(ACHRE No. DOE-120894-D), 7. Nuclear explosions release larger quantities of short-
lived fission products than do nuclear reactors, so the radioactive fallout from a nuclear
test decays much more rapidly than emissions from a reactor.

8. "Statement by the President on Announcing the First Atomic Explosion in
the USSR, 23 September 1949," reprinted in Robert C. Williams and Philip L. Cantelon,
eds., The American Atom: A Documentary History of Nuclear Policies from the
Discovery of Fission to the Present, 1939-1984 (Philadelphia: University of
Pennsylvania Press, 1984), 116-117.

9. For example, krypton 85 in the atmosphere comes entirely from atmospheric
testing and nuclear fuel reprocessing. Chemically unreactive, with a half-life of roughly
eleven years, it is well mixed in the atmosphere, so the concentration of Kr-85 measured
at random sites on the globe will provide a rough measure of the total production of
plutonium production over time. See Frank von Hippel, Barbara G. Levi, and David H.
Albright, "Stopping the Production of Fissile Materials for the Weapons," Scientific
American 253, no. 3 (September 1985): 43, 45.

1 0. Charles A. Ziegler and David Jacobson, Spying Without Spies, 181.

11. F. J. Davis et al., Department of Energy, 13 April 1949, ORNL-341,
declassified with deletions as ORNL-6728, 2 September 1992 ("An Aerial Survey of
Radioactivity Associated with Atomic Energy Plant?") (ACHRE No. DOE-122194-B),
7, 13, 156-157. Pages 136 and 148 refer to the possibility of tracking a "really strong
source" from the Hanford stacks.

547

12. [Deleted] to Commander, Military Air Transport Service, 10 November
1949 ("In furtherance of the research and development program . . .") (ACHRE No.
DOD-032395-A); [deleted] to Dr. S. C. Schlemmer, Manager, Hanford Operations
Officer, 10 November 1949 ("This letter will confirm the arrangements made . . .")
(ACHRE No. DOD-032395-A). The name of the author of these memorandums remains
classified.

1 3. GAO, Examples of Post World War II Radiation Releases, 9.

14. H. M. Parker, Department of Energy, 6 January 1950, HW-15550-E DEL
("Health Instruments Divisions Report for the Month of December 1949") (ACHRE No.
DOE-050394-A-4); H. J. Paas and W. Singlevich, Department of Energy, 2 March 1950,
HW- 17003 ("Radioactive Contamination in the Environs of the Hanford Works for the
Period October, November, December, 1949") (ACHRE No. DOE-050394-A-6). These
two reports were among more than 1 9,000 pages of documents on Hanford's early
operations released by the Department of Energy in 1986.

15. Lieutenant W. E. Harlan, D. E. Jenne, and Jack W. Healy, Hanford Works,
Atomic Energy Commission, 1 May 1950, HW-17381 ("Dissolving of Twenty Day Metal
at Hanford") (ACHRE No. DOD-121494-C). This document was originally classified
Secret, Restricted Data, but has been declassified in several stages; this citation is to the
version that was declassified most recently and completely, on 13 December 1994. The
GAO report Examples of Post World War II Radiation Releases also relies on interviews
with several people connected with the Green Run, including one who was involved
directly in the intelligence aspects of the Green Run, but who has since died.

16. Harlan, Jenne, and Healy, "Dissolving of Twenty Day Metal," 26.

17. Ibid., 7.

1 8. Hanford workers managing the Green Run estimated the release at 7,780
curies. Ibid., 28. Subsequent estimates have ranged from 7,000 curies to 1 1,000 curies.
Maurice Robkin, "Experimental Release of 1311: The Green Run," Health Physics 62
(June 1992): 487-495. Roughly 20,000 curies of xenon 133 were also released, but
because this gas does not concentrate in the food supply or in the thyroid, it posed
relatively little danger. The section "Reconstructing, Comparing, and Understanding
Risks" discusses the significance of these numbers.

19. M. S. Gerber, Department of Energy, May 1994, WHC-MR-0452 ("A Brief
History of the T Plant Facility at the Hanford Site") (ACHRE No. DOE-1 12294-A), 25-
32.

20. Harlan, Jenne, and Healy, ""Dissolving of Twenty Day Metal," 10-11.

21. Ibid., 12-14. See also 8, 32.

22. Healy, interview with Caputo (Office of Human Radiation Experiments),
28 November 1994, 12; Jack Healy, interview with Mark Goodman (ACHRE staff), 8
March 1995 (ACHRE Research Project Series, Interview Program File, Targeted
Interview Project), 26-27. Healy has compared the contamination with that resulting from
the 1957 Windscale nuclear reactor accident in the United Kingdom. Although
Windscale released a greater quantity of radioiodine, the Green Run contaminated an area
five to ten times as large. Healy attributed the high levels of contamination to the
weather.

23. Normally the temperature of the atmosphere falls with increasing altitude.
An inversion occurs when the temperature near the ground rises before falling at higher
altitudes. This traps contamination in the lower levels of the atmosphere.

548

24. F. J. Davis et al., "An Aerial Survey of Radioactivity Associated with
Atomic Energy Plants," 112-116. The Air Force had found it difficult to track
radioactivity from Oak Ridge's operations in the hills and valleys of Tennessee.

25. Harlan, Jenne, and Healy, "Dissolving of Twenty Day Metal, 5-6.

26. Healy, interview with Caputo (Office of Human Radiation Experiments),
28 November 1994, 13.

27. Harlan, Jenne, and Healy, "Dissolving of Twenty Day Metal," 20-25; Bruce
Napier, Battelle Pacific Northwest Laboratory, to John Kruger (ACHRE staff), 1 8 August
1995.

28. Harlan, Jenne, and Healy, "Dissolving of Twenty Day Metal," 70. Also,
W. E. Harlan, interview by Mark Goodman (ACHRE staff), transcript of audio interview,
10 April 1995 (ACHRE Research Project Series, Interview Program File, Targeted
Interview Project). Harlan recalls no plans to track the plume to greater distances.

29. The "permanent tolerance value" at the time was 0.009 microcuries per
kilogram OuCi/Kg) of vegatation. Harlan, Jenne, and Healy, "Dissolving of Twenty Day
Metal," 3. Readings from the Green Run were as high as 4.3 fid/kg. The current
intervention level is .013 //Ci/kg. Al Conklin, Washington Department of Health, 7
November 1994, personal communication with Mark Goodman (ACHRE staff).

30. In mid- 1949, the standard was lowered from 0.2 /^Ci/kg to 0.1 ^Ci/kg.
Manager, Health Instruments Division, Hanford, to AEC, Hanford Operations Office, 8
November 1950 ("Radiation Exposure Data"), which is still ten times higher than
described in Harlan, Jenne, and Healy, "Dissolving of Twenty Day Metal," 3. A footnote
in the November 1950 report suggests that the lower level (0.01/^Ci/kg) was still
controversial and considered by the author to be overly cautious.

31. H. M. Parker, "Health Instruments Divisions Report for December 1 949,"
2; Harlan, Jenne, and Healy, "Dissolving of Twenty Day Metal," 3, 65.

32. Healy, interview with Caputo, 28 November 1 994, 8-9. The largest hazard
is now known to come from drinking milk from cows that graze on pastures
contaminated with radioiodine. The earliest reference from Hanford to the milk pathway
is H. M. Parker, "Radiation Exposure from Environmental Hazards," presented at the
United Nations International Conference on the Peaceful Uses of Atomic Energy, August
1955, reprinted in Ronald L. Kathren, Raymond W. Baalman, and William J. Bair, eds.,
Herbert M. Parker: Publications and Other Contributions to Radiological and Health
Physics (Richland, Wash.: Battelle Press, 1986), 494-499. A reference to concern over
milk contamination in Utah from a 19 May 1953 atmospheric test appears in "Transcript
of Meeting on Statistical Considerations on Field Studies on Thyroid Diseases in School
Children in Utah-Arizona, December 3, 1965, Rockville, MD" (ACHRE No. HHS-
022395-A), 4.

33. Herbert Parker, Chief Supervisor, to S. T. Cantril, Assistant Supervisor, 1 1
December 1945 ("Xenon And Iodine Concentration in the Environs of the T and P
Plant") (ACHRE No. IND- 120294- A- 1); Herbert Parker to File, 17 December 1945
("Proposed Revision of Tolerances for 1131") (ACHRE No. IND- 1 20294- A-2); Herbert
M. Parker, Department of Energy, 14 January 1946 ("Tolerance Concentration of Radio-
Iodine on Edible Plants") (ACHRE No. IND-120294-A-3). This was confirmed by later
dose reconstructions. The estimated doses range up to several hundred rad (a few tens of
rem) to the thyroid. Technical Steering Panel, Department of Energy, 10 February 1990
("Hanford Environmental Dose Reconstruction Project: Finding the facts about people at

549

risk.") (ACHRE No. DOE-050694-B-3).

34. Estimates from ARH-3026, by J. D. Anderson as cited in the Technical
Steering Panel of the Hanford Environmental Dose Reconstruction Project, Department
of Energy, March 1992 ("The Green Run") (ACHRE No. ORE-1 10794- A).

35. Parker, "Tolerance Concentration of Radio-Iodine on Edible Plants,"
Kathren, Baalman, and Bair, Herbert M. Parker: Publications and Other Contributions
to Radiological and Health Physics, art. IV-7.

36. "Report of Safety and Industrial Heath Advisory Board," as cited in Daniel
Grossman, A Policy History of Hanford's Atmospheric Releases (Ph.D. diss.,
Massachusetts Institute of Technology, 1994), 169.

37. F. A. R. Stainkan to R. S. Ball, "Stack Gas Conference- Washington, D.C.,"
8 September 1948, HW- 10956. Michele S. Gerber, On the Home Front: The Cold War
Legacy of the Hanford Nuclear Site (Lincoln: University of Nebraska Press, 1 994), 89.

38. Parker, "Health Instrument Divisions Report for Month of December,
1949," 3.

39. Healy, interview with Caputo, 28 November 1994, 8.

40. [Deleted] to Dr. Schlemmer, 10 November 1949, 2.

41. "Green Run," an Air Force official noted in a 1995 comment on this
omission, "was beset by numerous technical and meteorological problems that
significantly compromised the value of the results obtained. In our view, then, this
omission implies the Green Run was not useful, rather than unnecessary." Major Meade
Pimsler, USAF, to ACHRE Staff, 19 June 1995 ("Comments on 5th Set of Review
Chapters").

42. ACHRE Research Project Series, Mark Goodman Files, 6-21 . The device in
question was the atmospheric Conductivity Apparatus; it was used in Operation
Fitzwilliam, at the radiation survey flights at Oak Ridge and Hanford, at the Green Run,
and in radiation survey flights at the Los Alamos radiolanthanum tests described in this
chapter.

43. Grossman, A Policy History of Hanford's Atmospheric Releases, 230-232
(references 24 and 35).

44. Neal D. Hines, Proving Ground: An Account of the Radiobiological Studies
in the Pacific 1946-61 (Seattle: University of Washington Press, 1962).

45. Stannard, Radiactivity and Health: A History, 76 1 -762.

46. Decision on AEC 1 80/1 and 1 80/2, as cited in Grossman, A Policy History
of Hanford's Atmospheric Releases, 244-245.

47. AEC 180/1; Ibid., 245.

48. Herbert Parker, 19 August 1954 ("Columbia River Situation--A Semi-
Technical Review") (ACHRE No. DOE-053095-A), 5.

49. William Bale, Advisory Committee for Biology and Medicine, transcript of
proceedings of 13-14 January 1950 (ACHRE No. DOE-072694-A). The ACBM decided
at this meeting that it might be possible to publish a sanitized version of the report to aid
scientists studying the contamination problem. It is unclear whether the report was
published.

50. Lynne Stembridge, Advisory Committee on Human Radiation Experiments,
transcript of proceedings of 21 November 1994 (Spokane, Wash.).

5 1 . For the perspective of a government-sponsored expert involved in the
reconstruction of the risk at Hanford and other nuclear weapons sites on the necessity of

550

public participation in dose reconstruction activities, see John Till, "Building Credibility
in Public Studies," American Scientist 83, no. 5 (September-October 1995).

52. Scott Davis, Ph.D., et al., Fred Hutchinson Research Center, 24 January
1995 ("Hanford Thyroid Disease Study: Final Report") (ACHRE No. DOE-061295-A).

53. Tom Bailie, Advisory Committee on Human Radiation Experiments,
transcript of proceedings, 21 November 1994 (Spokane, Wash.), 121-122.

54. Quoted in Richard Rhodes, The Making of the Atomic Bomb (New York:
Simon and Schuster, 1986), 365. See also Henry De Wolf Smyth, Atomic Energy for
Military Purposes (Stanford, Calif.: Stanford University Press, September 1, 1945), 71.
Princeton physicists Henry De Wolf Smyth and Eugene Wigner reported later that year
that the fission products produced in one day's operation of a 1 00-megawatt reactor could
render a large area uninhabitable. Eugene Wigner and Henry D. Smyth, National
Academy Project, 10 December 1941 ("Radioactive Poisons") (ACHRE No. NARA-
033195-A).

55. J. Robert Oppenheimer to Enrico Fermi, 25 May 1943, reproduced in
Barton Bernstein, "Oppenheimer and the Radioactive Poison Plan," Technology Review
88, no. 14 (May 1985).

56. These included Dr. Joseph Hamilton of Berkeley, who had performed
pioneering studies of the fate of radioactive materials in the bodies of animals and
humans (see chapter 5). Joseph Hamilton, M.D., to K. D. Nichols, 31 December 1946
("Radioactive Warfare") (ACHRE No. DOD-010395-C-1); Lee Bowen, U.S. Air Force
("A History of the Air Force Atomic Energy Program, 1943-1953, volume IV: The
Development of Weapons") (ACHRE No. SMITH- 120994- A- 1), 323.

57. Joseph Hamilton to D. T. Griggs, Project Rand, Douglas Aircraft Co., 7
April 1948 ("1 wish to thank you . . .") (ACHRE No. DOE-072694-B-34).

58. For example, General Douglas MacArthur proposed in 1950 to lay down a
line of highly radioactive cobalt 60 to block a Chinese return to the Korean Peninsula.
Bruce Cummings, The Origins of the Korean War, volume IT. The Roaring of the
Cataract, 1947-1950 (Princeton, N.J.: Princeton University Press, 1981), 750.

59. The Armed Forces Special Weapons Project, the Air Force, and the Army's
Chemical Corps were interested in both offensive and defensive radiological warfare,
while the Naval Radiological Defense Laboratory focused on defense.

60. This research program, led by Dr. Franklin McLean, used animals to test
the toxicity of various candidate radiological warfare agents. The Advisory Committee's
research has uncovered no evidence that human subjects were used in any of these
studies. The Toxicity Laboratory also performed studies using human subjects on the
inhalation of aerosols, but available documents do not indicate any use of radioactive
material as tracers or otherwise. These studies may have been related to the Chemical
Corps's programs in chemical and biological warefare. Frank C. McLean to Shields
Warren, Director, Division of Biology and Medicine, 5 October 1948 ("Program of
Chicago Toxicity Laboratory") (ACHRE No. DOE-082294-B-18); Walter J. Williams,
Acting General Manager, to Major General A. H. Waitt, Chief, Chemical Corps, 12 April
1948 ("For some time we have been considering ways and means of enlarging programs .
. .") (ACHRE No. DOE-012595-B-2); Shields Warren to Frank C. McLean, 4 May 1950
("In light of our conversations of January 25, 1950 . . .") (ACHRE No. DOE-012595-B-
1).

551

6 1 . Joint AEC-NME Panel on Radiological Warfare, 20 November 1 950
("Radiological Warfare Program Status Report: Sixth Meeting of the Joint AEC-NME
Panel on Radiological Warfare") (ACHRE No. CORP-010395-A-2). See also, Atomic
Energy Commission, Division of Military Application, 26 December 1950 ("Conclusions
and Recommendations of the Sixth Meeting of the RW Panel") (ACHRE No. DOE-
092694-B-3).

62. Major Thomas A. Gibson, Chemical Corps, Radiological Branch, to Chief
of Staff, AFSWP, 23 April 1952 ("A Technical Study Group to Review the Technical
Aspects of Radiological Warfare") (ACHRE No. NARA-033195-A).

63. These two tests appear in the Advisory Committee's charter. One test
involved three sources of roughly 1,280, 100, and 20 curies of radioactive lanthanum;
Karl Z. Morgan and C. N. Rucker, Oak Ridge National Laboratory, 23 July 1948 ("Single
Source Lanthanum Test-AHRUU Program") (ACHRE No. DOE-051094-A-122). The
other used 156 tantalum sources of roughly 100 millicuries each distributed in an uniform
grid; Karl Z. Morgan, Oak Ridge National Laboratory, 1 1 August 1948 ("Uniformly
Distributed Source, AHRUU Program") (ACHRE No. DOE-051094-A-1 18).

64. R. W. Cook to Brigadier General James McCormack, Division of Military
Applications, 4 May 1949 ("Irradiation of Tantalum for RW Tests") (ACHRE No. DOE-
120994-A-24).

65. Atomic Energy Commission, Division of Military Application, 26
December 1950 ("Conclusions and Recommendations of the Sixth Meeting of the RW
Panel"), 3.

66. AFSWP to Chief, Chemical Officer, Department of the Army, 3 1 December
1952 ("Re-evaluation of the Research and Development Program on Offensive
Radiological Warfare") (ACHRE No. CORP-010395-A-5); this memo makes reference to
the proposed production of zirconium and niobium radioisotopes.

67. Joseph Hamilton had written in 1948: "In concluding, I would like to
emphasize that all of the potentialities, including the rather repellent concepts of the use
of fission products and other radioactive materials as internal poisons, should be explored
up to and including a level of pilot experiments on a fairly large scale. I feel very strongly
on the point that unless we ourselves learn all we can about the use and possible methods
of protection against these agents and a wide variety of their potential applications as
military weapons, we shall have failed to explore the necessary measures which may be
desperately needed for the protection of our own people." Joseph Hamilton to D. T.
Griggs, Project Rand, Douglas Aircraft Co., 7 April 1948 ("I wish to thank you very
much for . . .") (ACHRE No. DOE-072694-B-34), 3.

68. C. B. Marquand, Secretary, Test Safety Panel, to Joseph Hamilton, Director,
Crocker Laboratory, 24 August 1949 ("Meeting of the Test Safety Panel at Dugway
Proving Ground on August 2, 1949") (ACHRE No. DOE-072694-B-29), 3.

69. Joseph Hamilton to C. B. Marquand, Office of the Chief, Chemical Corps
Advisory Board, 6 July 1949 ("I am sorry not to have had some more definitive
information . . .") (ACHRE No. DOE-072694-B-3).

70. C. B. Marquand, Secretary, Test Safety Panel, and S. C. Hardwick,
Assistant Secretary, Test Safety Panel, Atomic Energy Commission, 5 August 1949
("Preliminary Report of the Test Safety Panel Meeting at Dugway Probing Ground-
August 2, 1949") (ACHRE No. CORP-010395-A-1).

552

71. G. Failla, Columbia University, to Joseph Hamilton, 13 May 1950 ("In
answer to your letter of May 10th, I . . .") (ACHRE No. DOE-072694-B-4).

72. Karl Z. Morgan to Joseph Hamilton, 9 September 1949 (ACHRE No.
DOE-072694-B-5).

73. Joseph Hamilton to Albert Olpin, President, University of Utah, 10 May
1950 ("Please find enclosed my report and recommendations for . . .") (ACHRE No.
DOE-072694-B-7); Failla to Hamilton, 13 May 1950; Albert Olpin to Joseph Hamilton,
17 May 1950 ("It was good to hear from you again . . .") (ACHRE No. DOE-072694-B-
55); Joseph Hamilton to C. B. Marquand, 1 June 1950 ("At long last I have received
agreement from . . .") (ACHRE No. DOE-072694-B-21); Joseph Hamilton to C. B.
Marquand, 4 August 1949 ("This letter is to confirm") (ACHRE No.CORP-010395-A-l).

74. Joseph Hamilton to C. B. Marquand, 18 November 1952 ("Last week, I
spent a profitable two days . . .") (ACHRE No. DOE-072694-B-23). See also, Joseph
Hamilton to John Bugher, Director, Division of Biology and Medicine, 25 February 1953
("In my opinion . . .") (ACHRE No. DOE-072694-B-49).

75. Department of Defense, 1 1 May 1953 ("An Evaluation of the Airborne
Hazard Associated with Radiological Warfare Tests") (ACHRE No. DOE-072694-B-50),
iii.

76. Brigadier General William M. Creasy to Chief Chemical Officer,
Department of the Army, 24 June 1953 ("Minimum Fund Requirement") (ACHRE No.
DOD-030895-F-3); U.S. Army Chemical Corps, 31 December 31 1953 ("RDB Project
Card: Progress Report, Project No. 4-12-30-002") (ACHRE No. NARA-1 12294-A-l);
Joseph Hamilton to C. B. Marquand, 23 July 1953 ("I regret to hear that the RW
Program has been so drastically reduced . . .") (ACHRE No. DOE-072694-B-51).

77. Lee Bowen, United States Air Force Historical Division, "A History of the
Air Force Atomic Energy Program, 1943-1953, vol. 4: The Development of Weapons"
(ACHRE No. SMITH- 120994-A-l), 331-332.

78. Merril Evans, 3 June 1953 ("RW Decontamination and Land Reclamation
Studies") (ACHRE No. DOD-062494-A-1 1); also Chemical Corps, 1952 ("Testing of
RW Material for Detection, Protection and Decontamination") (ACHRE No. NARA-
112294-A-5).

79. Lee Bowen, "The Development of Weapons," 333-337.

80. The Chemical Corps recognized Hamilton's support for the radiological
warfare program. A 1952 Chemical Corps memorandum, Lieutenant Colonel Truman
Cook to Secretariat, Chemical Corps Advisory Council, 7 April 1952 ("Radiological
Warfare Test Saftey Panel") (ACHRE No. DOE-072694-B-46), noting the greater risk
associated with planned large-scale tests, including possible plutonium contamination
from the use of fission products, recommended that the test safety panel should be
dissolved and Hamilton and someone chosen by him be retained as a consultant.

8 1 . Joseph Hamilton's papers, including those dealing with the radiological
warfare test safety panel, were declassified in 1974, but the GAO report provided the
first opportunity for most people to learn about it.

82. Atomic Energy Commission, Ad Hoc Panel on Radiological Warfare,
proceedings of 23 May 1948 (ACHRE No. CORP-051894-A-1). Restricted Data are
atomic energy secrets as classified by statute under the Atomic Energy Act. Information
may also be classified Confidential, Secret, or Top Secret, depending on its importance
to national security, under the authority of an executive order by the President. See

553

chapter 1 3 on secrecy for details.

83. Chemical Corps, 1 January 1948 ("Quarterly Technical Progress Reports")
(ACHRE No. NARA- 1 2 1 594-B).

84. Joint NME-AEC Panel on Radiological Warfare, 29 August 1948
("Radiological Warfare Report-Second Meeting") (ACHRE No. DOD-041295-A), 72.

85. Atomic Energy Commission, Advisory Committee for Biology and
Medicine, proceedings of 1 1-12 June 1948 (ACHRE No. DOE-072694-A). The ACBM
reiterated this recommendation at its next meeting on 1 1 September 1948. Atomic Energy
Commission, Advisory Committee for Biology and Medicine, proceedings of 1 1
September 1948 (ACHRE No. DOE-082294-B-15), 15.

86. The eight members included future President Dwight D. Eisenhower, who
was president of Columbia University at the time, and New York lawyer John Foster
Dulles, who would serve as secretary of state in the Eisenhower administration. See
James Hershberg, James B. Conant: Harvard to Hiroshima and the Making of the
Nuclear Age (New York: Alfred A. Knopf, 1993), 378-383. The story of the Conant
Committee is told in chapter 20 of Hershberg's book.

87. Ibid., 390.

88. Ibid., 383. The members of the majority opposed to further release included
Eisenhower and Dulles.

89. Marshall Stubbs to Joseph Hamilton, 30 August 1949 ("Following your
suggestion that we prepare . . .") (ACHRE No. DOE-072694-B-1). Stubbs concluded by
reporting, "Both Colonel Cooney and Captain Winant reiterated that regardless of the
actions noted above, such a release is not desirable."

90. William Webster to Secretary Johnson, Department of Defense, 1 1 May
1949 ("Memorandum for the President: This memorandum is to inform you of planned
activities . . .") (ACHRE No. DOD-071 194-A-4).

91. Joseph Hamilton to C. B. Marquand, Secretary, Test Safety Panel, 4 August
1949 ("This letter is to confirm the decisions . . .") (ACHRE No. CORP-010395-A-3).

92. Ibid., 3.

93. The proposed press release falsely described the program as intended only
"to determine a proper defense," involving "the distribution of small amounts of
radioactive materials on various types of simulated targets in the field." Marshall Stubbs
to Joseph Hamilton, 30 August 1949 ("Following your suggestion . . .") (ACHRE No.
DOE-072694-B-1),2.

94. Ibid.

95. Colonel William M. Creasy, Chief, Research and Engineering Division,
U.S. Army Chemical Corps, to Director of Logistics, U.S. Army General Staff, 3 October
1949 ("Public Release On Rfadiological] W[arfare] Tests at Dugway Proving Ground")
(ACHRE No. DOD-071 194-A-l). The letter notes the draft press release contains "no
reference to the general RW program or to the use of radioactive materials as agents of
warfare. It does indicate the use of radioactive materials in the Dugway area for the
purpose of formulating defensive doctrine."

96. C. G. Helmick, Deputy Director for Research and Development, to Robert
LeBaron, Chairman, Military Liaison Committee, 3 January 1950 ("Public Release on
RW Tests at Dugway Proving Ground") (ACHRE No. DOD-071 194-A-l); Robert
LeBaron to C. G. Helmick, 19 January 1950 ("Public Release on RW Tests at Dugway
Proving Ground") (ACHRE No. DOD-071 194-A-l).

554

97. Louis N. Ridenour, "How Effective Are Radioactive Poisons in Warfare?"
Bulletin of the Atomic Scientists 6 (1950): 199-202. On the birth of Bulletin of the Atomic
Scientists and, more generally, the history of the physics community that worked on the
bomb, see Daniel J. Kevles, The Physicists: The History of the Scientific Community in
Modern America (New York: Vintage, 1979), 351.

98. Atomic Energy Commission, Declassification Branch, 30 September 1949
("Classification Guide for Radiological Warfare") (ACHRE No. DOE-070695-C).

99. U.S. Department of Defense, Semiannual Report of the Secretary of Defense
and the Semiannual Reports of the Secretary of the Army, Secretary of the Navy,
Secretary of the Air Force, July 1 to December 31, 1949 (Washington, D.C.: GPO, 1950),
65-69; Samuel Glasstone, executive editor, The Effects of Atomic Weapons (Washington,
D.C.: GPO, 1950), 287-290.

100. U.S. Department of Defense, Semiannual Report of the Secretary of
Defense and the Semiannual Reports of the Secretary of the Army, Secretary of the Navy,
Secretary of the Air Force, January 1 to June 30, 1951 (Washington, D.C.: GPO, 1951)
(ACHRE No. DOD-052695-A), 36. In an August 1951 letter to AEC Chairman Dean,
Acting Secretary of Defense Rovert Lovett noted: "The Director of Public Information,
Department of Defense, has been directed to undertake a program of public information
in this field as recommended by the [Noyes] Panel."

A further memo to the Director, Office of Public Information, the author of
which is unclear, cited the Noyes panel's recommendation that civil defense agencies and
the public be apprised "concerning the nature and possibilities of radiological warfare as
well as possible countermeasures so as to avoid the possibility of panic should an enemy
carry out an attack . . . and that studies be made of the psychological effects to be
expected." Robert Lovett to Gordon Dean, 6 August 1951 ("The Final Report of the Joint
AEC-NME Panel . . .") (ACHRE No. DOD-081695-A); memorandum to Director,
Office of Public Information, undated ("Public Information Program on Radiological
Warfare") (ACHRE No. DOD-021095-A).

101. U.S. Department of Energy, Office of Declassification, Drawing Back the
Curtain of Secrecy: Restricted Data Declassification Policy, 1946 to the Present (RDD-
1)(1 June 1994), 82.

1 02. Human Studies Project Team, Los Alamos National Laboratory, March
1995 ("The Bayo Canyon Radioactive Lanthanum [RaLa] Program [draft]") (ACHRE
No. DOE-031095-B-1). This report lists 254 RaLa tests, but 1 planned test was never
fired, and the last 9, conducted for different purposes, did not release radiolanthanum
into the environment.

103. D. P. MacDougall to N. E. Bradbury, 22 June 1961 ("RaLa Shots in
Bayo") (ACHRE No. DOE-040695-A-13), concludes that the RaLa program should not
be dismantled until the replacement procedure, Phermex, was operating. Jane H. Hall to
Distribution, 8 February 1963 ("Subject: Rala") (ACHRE No. DOE-040695-A-8),
reports that "RaLa may no longer be released into the Bayo Canyon atmosphere."

1 04. GAO, Examples of Post World War 11 Radiation Releases, 1 6.

105. The fourth experiment was not an intentional release; like the Oak Ridge
radiological warfare experiments, it involved a sealed source of radiation that was later
returned to the laboratory. Samuel Coroniti, Los Alamos Scientific Laboratory, 1 9 July
1950 ("Radiation Test Conducted at Los Alamos, New Mexico on 19 July 1950")
(ACHRE No. DOE-051095-B).

555

106. Human Studies Project Team, Los Alamos National Laboratory, March
1995 ("The Bayo Canyon/Radioactive Lanthanum RaLa Program [draft]"), 6. The GAO
report states that the Air Force Cambridge Research Laboratories and Los Alamos jointly
performed the explosions; Samuel C. Coroniti, Air Force Cambridge Research
Laboratories, 26 May 1950 ("Report on the Atmospheric Electrical Conductivity Tests
Conducted in the Vicinity of Los Alamos, Scientific Laboratories, New Mexico")
(ACHRE No. DOD-120294-A-1). S. V. Burriss, Los Alamos Scientific Laboratory, to
Colonel Benjamin G. Holzman, Research and Development, Pentagon, 1 1 October 1949
("Cloud Studies at Los Alamos") (ACHRE No. DOE-060295-B), indicates that the Air
Force simply took advantage of releases that occurred for other purposes.

107. L. H. Hempelmann to David Dow, 29 June 1944 ("Safety of
Radiolanthanum Experiment in Bayo Canyon") (ACHRE No. DOE-051094-A-15); Los
Alamos Scientific Laboratory, Safety Committee, proceedings of 7 March 1945 (ACHRE
No. DOE-052395-B-1).

108. Ralph G. Steinhardt, Jr., to Joseph Hoffman, 19 June 1945 ("Summary
Report on Health Conditions in RaLa Program") (ACHRE No. DOE-052395-B-2).

109. T. L. Shipman to R. E. Cole, Atomic Energy Commission, Office of
Engineering and Construction, through N. E. Bradbury, 4 April 1950 ("Health Hazards-
Guaje Canyon and Vicinity") (ACHRE No. DOE-052395-B), 1.

1 1 0. If the wind was blowing toward the main access road to the Los Alamos
mesa, tests could not be conducted in the late afternoon. T. L. Shipman to Donald
Mueller through N. E. Bradbury and Duncan MacDougall, 28 April 1949 ("Precaution
for Bayo Canyon Shots") (ACHRE No. DOE-042495-C).

111. Los Alamos Scientific Laboratory, 8 March 1952 ("H-l Program for
Bayo Canyon Shots") (ACHRE No. DOE-042495-C); Los Alamos Scientific Laboratory,
23 July 1952 ("H-l Program for Bayo Canyon Shots") (ACHRE No. DOE-042495-C);
Los Alamos Scientific Laboratory, 1 April 1958 ("H-l Program for Bayo Canyon Shots")
(ACHRE No. DOE-042495-C); and C. D. Montgomery, D. W. Mueller, R. O.
Niethammer, 30 June 1954, revised 15 January 1960 ("Clearance, Firing, and Monitoring
Procedures for Bayo Canyon Site") (ACHRE No. DOE-040695-A-14), 8, all describe the
continuing requirements for weather forecasting. N. E. Bradbury to Distribution, 8
March 1956 ("Meteorological Forecasting Service") (ACHRE No. DOE-040695-A-12),
notes the continuing need for weather forecasting in the context of an Air Force threat to
withdraw two meteorologists.

1 12. Tyler Mercier, Advisory Committee on Human Radiation Experiments,
transcript of proceedings of 30 January 1995, Santa Fe, N.M., 35.

113. Glenn Vogt, General Monitoring Section, Los Alamos, to Dean Meyer,
Group Leader, 20 April 1956 ("Bayo Canyon Activities, April 12, 16, 18, 1956")
(ACHRE No. DOE-041295-C).

1 14. D. W. Mueller to RaLa Committee, 22 September 1952 ("RALA Shots")
(ACHRE No. DOE-071095-B).

115. Steinhardt to Hoffman, 19 June 1945.

1 1 6. The National Reactor Testing Station was established near Idaho Falls in
1950, and plans to process Ba-140 for Los Alamos at Idaho Chemical Processing Plant
were made on 5 November 1952. Dick Duffey, Atomic Energy Commission, to W. B.
Allred, Chief, Reactor Division, Oak Ridge Operations Office, and H. Leppich, Idaho
Operations Office, 5 November 1952 ("This will confirm our telephone

556

conversation . . .") (ACHRE No. DOE-040695-A).

1 17. The third test had taken place two days earlier, on 14 October 1944.
Human Studies Project Team ("The Bayo Canyon [RaLa] Program"), appendix A-l .

1 18. Louis Hempelmann, M.D., to Colonel Stafford Warren, 16 October 1944
("Enclosed is an excerpt of my report about the health hazards . . .") (ACHRE No. DOE-
07 1494- A- 10).

1 19. Louis Hempelmann to Norris E. Bradbury, 30 August 1946 ("Excessive
Exposures at Bayo Canyon") (ACHRE No. DOE-062295-A-1).

120. E. R. Jette, Acting Director, to Technical Board Members, 3 September
1946 ("The main topic for discussion at the Technical Board meeting . . .") (ACHRE No.
DOE-062295-A-2) .

121. Ibid.

122. Norman Knowlton, Los Alamos Scientific Laboratory, "Changes in the
Blood of Humans Chronically Exposed to Low Level Gamma Radiation," LA-587, 1948
(ACHRE No. DOE-033095-A-2); Robert Carter and Norman Knowlton, "Hematological
Changes in Humans Chronically Exposed to Low-Level Gamma Radiation," LA- 1092,
1950 (ACHRE No. DOE-030695-A); Robert E. Carter et al., Los Alamos Scientific
Laboratory, July 1952, LA- 1440 "Further Study of the Hematological Changes in
Humans Chronically Exposed to Low-Level Gamma Radiation" (ACHRE No. DOE-
033095-A).

123. Thomas Shipman, Health Division Leader, Los Alamos Scientific
Laboratory, to Gordon Dunning, Division of Biology and Medicine, 21 July 1954
("When we finally decided to issue LA- 1440 . . .") (ACHRE No. DOE-020795-D-4).

124. Samuel J. Glasstone, ed., The Effects of Atomic Weapons (Washington,
D.C.: Atomic Energy Commission, 1957), 342.

125. This dosimetry appears to have been a subject of some care. See Louis
Hempelmann to Stafford Warren, 16 October 1944 ("Enclosed is an excerpt . . .")
(ACHRE No. DOE-071494-A-10), and William C. Inkret, Human Studies Project Team,
Los Alamos National Laboratory, to Michael Yuffee, Office of Human Radiation
Experiments, Department of Energy, 16 May 1995 ("This letter is a follow-up to the
other materials we have sent . . .") (ACHRE Request No. 032995-C).

126. For example, organic solvents such as benzene and toluene can cause
depressed white blood cell counts. The first of the Los Alamos reports (Knowlton, LA-
587, 1948) notes that the control group was not exposed to organic solvents, suggesting
that the researchers were aware of this fact, but does not consider this as a factor in the
chemists' blood counts.

127. J. F. Mullaney to N. E. Bradbury, 3 January 1946 ("Biological Effects of
July 16th Explosion"), 1. See also Bradbury to Mullaney, 7 January 1946.

128. Clyde Wilson, Chief, Insurance Branch, to Anthony C. Vallado, Deputy
Declassification Officer, 20 December 1948 ("Review of Document by Knowlton")
(ACHRE No. DOE-120894-E-32).

129. Leon Tafoya, interview with Mark Goodman (ACHRE staff), 10 March
1995 (ACHRE Research Project Series, Interview Program File, Targeted Interview
Project).

130. "Bye Bye Bayo Site," LASL News, 23 May 1963 (ACHRE No. DOE-
051094-A-622), 7.

557

131. William C. Inkret, Los Alamos Human Studies Project Leader, to Mark
Goodman and Dan Guttman (ACHRE staff), 17 April 1995 ("Attached are the answers to
questions 6 and 7 of . . .") (ACHRE No. DOE-042495-C), 4-5.

132. Leon Tafoya, interview with Mark Goodman (ACHRE staff), 10 March
1995; and Gilbert Sanchez, interview with Mark Goodman (ACHRE staff), 9 March
1995 (ACHRE Research Project Series, Interview Program File, Targeted Interview
Project).

133. Leon H. Tafoya, "Biocultural Dimension of Health and Environment,"
Hazardous Waste and Public Health (1994): 245-252.

134. Sanchez, interview with ACHRE staff, 9 March 1995.

135. Dr. George Voelz, Advisory Committee on Human Radiation
Experiments, transcript of proceedings of 30 January 1995, Santa Fe, N.M., 43.

136. Department of Energy, Human Radiation Experiments: The Department
of Energy Roadmap to the Story and the Records (Springfield, Va.: National Technical
Information Service, February 1995), 214-222.

137. The story of this early Hanford research is told in Hines, Proving Ground.
See also, Stannard, Radioactivity and Health, 745-1368.

138. Daniel O'Neill, The Firecracker Boys (New York: St. Martin's Press,
1 994), 28,31 -46. Some tests were designed to see whether nuclear explosions could
stimulate the release of deep deposits of natural gas. Others were conducted in Nevada
to test the ability to conduct massive civil engineering projects using nuclear explosions.
The possibility of using nuclear explosions to excavate a second Panama Canal received
serious theoretical attention.

139. Ibid., 239-257.

140. The Soviet test site at Novaya Zemla lies north of the Arctic Circle and
was responsible for most of the fallout in Alaska and other Arctic locations.

141 . Wayne Hanson, interview by Daniel O'Neill, 4 May 1988, transcribed by
ACHRE staff, 9 March 1995 (ACHRE No. ACHRE-031395-A), 56.

142. Nevada Environment Restoration Project, Department of Energy, Project
Chariot Site Assessment and Remedial Action Final Report (Springfield, Va.: National
Technical Information Service, 1994), 1-5. See also Arthur Piper and Donald Eberlein
to John Phelps, Director, Special Projects Division, 9 October 1962 ("Your letter of
September 27, 1962, to . . . ") (ACHRE No. DOE-050295-E), 3-4.

143. Ray Emens, Director, Support Division, to John Phillip, Director, Special
Projects Division, 10 April 1963 ("Radioactive Waste Mound At Project Chariot Site")
(ACHRE No. CORP-013095-A-1), 1.

144. Nevada Environmental Restoration Project, Project Chariot Site
Assessment and Remedial Action Final Report, 1 -2.

145. Caroline Cannon, Advisory Committee on Human Radiation Experiments,
transcript of proceedings of 30 January 1995, Santa Fe, N.M., 136.

146. North Slope Borough Science Advisory Committee, April 1994, "A
Preliminary Review of the Project Chariot Site Assessment and Remedial Action Final
Report" (ACHRE No. DOE-121494-E-2).

147. C. A. Hawley et al., Health and Safety Division, AEC, Idaho Operations
Office, "Controlled Environmental Radioiodine Tests at the National Reactor Testing
Station," IDO- 12035, June 1964 (ACHRE No. DOE-060794-B-37), 6. After 1968, a
variety of radioisotopes were used, and the name of the series was changed to the

558

Controlled Environmental Release Tests.

148. Ibid., iii.

149. Ibid., 3 1 . The exposure limits at the time were 30 rem to the thyroid per
year. Richard Dickson, Idaho National Engineering Laboratory, to Bill LeFurgy, Office
of Human Radiation Experiments, 16 May 1995 ("Comments on Draft Advisory
Committee Report").

150. Data on tests 2, 7, 10, and 1 1 are contained in C. A. Hawley, Jr., ed., Idaho
Operations Office, AEC, "Controlled Environmental Radioiodine Test at the Nuclear
Rector Testing Station: 1965 Progress Report," IDO-129457, February 1966, (ACHRE
No. DOE-060794-B-37); D. F. Bunch, ed., Idaho Operations Office, AEC, "Controlled
Environmental Radioiodine Tests: Progress Report Number Two," IDO- 12053, August
1966, (ACHRE No. DOE-060794-B-39), 26-30; D. F. Bunch, ed., Idaho Operations
Office, AEC, "Controlled Environmental Radioiodine Tests: Progress Report Number
Three," IDO- 12063, January 1968 (ACHRE No. DOE-101 194-B-3), 14.

151. Dr. George Voelz, interview with Marisa Caputo (DOE Office of Human
Radiation Experiments), transcript of audio recording, 29 November 1994 (ACHRE No.
DOE-061495-A), 16-18. Members of the INEL's Human Radiation Experiments Team
state that the identities of these subjects could be determined from records.

152. [Deleted] Senior Engineer to R. F. Foster (PNL-9370), 1 August 1963
("Monthly Report: July 1963 [handwritten draft]") and PNL-9369-DEL, 23 August 1963
("Monthly Report: August 1963"). A proposal for a second Hanford iodine 131 field
release test was never implemented. E. C. Watson, BWWL-CC-167, 22 July 1965
("Proposal for a Second Iodine-131 Field Release Test") (ACHRE No. DOE-033095-A-
1 ). A handwritten notation on the cover sheet reads: "This test was not run. D Gydesen.
3/24/86." The DOE interview with Jack Healy includes descriptions of his role in a study
involving iodine uptake through milk. Jack Healy, interview with Mark Goodman
(ACHRE staff), 8 March 1995, transcript of audio recording (ACHRE No. DOE-050295-
A), 32.

153. The exposures at Hiroshima and Nagasaki came primarily from acute
exposure to gamma and neutron radiation, rather than from radioactive fallout.

1 54. U.S. Environmental Protection Agency, Estimating Radiogenic Cancer
Risks, EPA, 402-R-93-076, June 1994 (DOE-061 195-A). One person-rem corresponds
to an aggregate dose of 1 rem spread over any number of people. The result from BEIR
V is roughly one cancer fatality for every 1,120 person-rem (see chapter 4, "BEIR V"),
but this is from a single exposure to gamma radiation.

1 55. This project has since been transferred to the Centers for Disease Control
and Prevention.

1 56. The Committee has not attempted to estimate the range of uncertainty in
this estimate. Some of the relevant figures are the estimated maximum 600-mrad thyroid
dose from Hanford emissions in 1949, the more typical 1 80-mrad dose for residents of
Richland and the roughly 30,000 population of the Richland area at the time, suggesting a
total population exposure of roughly 5,400 person-rad to the thyroid. See W. T. Farris et
al., Hanford Environmental Dose Reconstruction Project, PWWD-2228 HEDR, April
1994, ("Atmospheric Pathway Dosimetry Report, 1944-1992 [draft]"), C. 6. Using
NCRP risk estimates of 7.5 excess cancer deaths per million person-rad to the thyroid,
this leads to an estimate of 0.04 excess thyroid cancer deaths. The corresponding
estimate for nonfatal thyroid cancer is a factor of 10 higher. There are many uncertainties
in this estimate, but they do not consistently overstate or understate the risk. For

559

example, we have ignored the smaller exposures to other population centers and the
relatively high doses and risks to children, as well as the offsetting facts that the Green
Run represented only about 80 percent of Hanford's 1-131 emissions in 1949 and
occurred in December when the food pathway was suppressed.

157. Meteorological and fallout data are more or less complete after 1950. A
total of roughly 250,000 curies of radiolanthanum were released (remarkably, less than
half a gram) from 1944 to 1960, with releases peaking in 1955 and 1956 at roughly
40,000 curies a year. Strontium 90 was a minor contaminant, with total releases of about
200 millicuries. Los Alamos Human Studies Project Team (draft, 9 March 1995) ("Bayo
Canyon/[RaLa] Program"), 1 5, appendix A.

158. D. H. Kraig, Human Studies Project Team, Los Alamos National
Laboratory, 1995 ("Dose Reconstruction for Experiments Involving La 140 at Los
Alamos National Laboratory, 1944-1962") (ACHRE No. DOE-091495-A).

1 59. General Accounting Office, Examples of Post World War II Radiation
Releases, 16. Los Alamos Human Studies Project Team, "Bayo Canyon/RaLa Program,"
9-10. In tandem with its historical reconstruction, the Human Studies Project Team at
Los Alamos is preparing a report estimating radiation exposures to the general
population.

160. According to LA- 1440, ten workers were exposed to an average exposure
of at least 34 R, and the total exposure was at least 340 person-R, corresponding to
roughly 0.2 fatal cancers. Knowlton reports that ten men received an average of 1 6.2 1 R
over a 77-week period. Knowlton, LA-587, 2.

161. Barton C. Hacker, Elements of Controversy: The Atomic Energy
Commission and Radiation Safety in Nuclear Weapons Testing, 1947-1974 (Berkeley:
University of California Press,' 1 994), chapters 4 and 5.

162. Richard Elliott, Director, Public Information Division, San Francisco
Office, AEC, to Public Information Officers, Division Offices, AEC, 2 December 1953
("The Public Relations of Atmospheric Nuclear Tests") (ACHRE No. DOE-030195-C),
2. Hacker, in Elements of Controversy, provides some of the background for the
discussion of Elliott's paper, including high levels of fallout observed in communities in
southern Utah and injuries and death to livestock that had grazed in the fallout area.

1 63. We should emphasize that public notification does not mean that members
of the public would need to or could take precautionary actions that would not otherwise
be taken. Given the relatively low risk posed by the intentional releases, evacuation
could have had costs greater than the possible benefits. In the case of the Green Run, a
warning not to eat certain foods might have been useful; however, the food pathways
were not known at the time. On the other hand, the prospectors around the Dugway site
and the Pueblo Indians around Los Alamos could have been warned not to wander into
certain areas that may have posed some hazard, however small.

1 64. Both statutes have since been amended by subsequent legislation. The
relevant provisions of the Clean Air Act are the National Emission Standards for
Hazardous Air Pollutants (42. U.S.C. 7412), and those of the Atomic Energy Act are 42
U.S.C. 21 14, 2133. Other environmental statutes either explicitly exempt most
radioactive materials (the Clean Water Act) or are less directly relevant to intentional
releases (the Safe Drinking Water Act, the Resource Conservation and Recovery Act, and
the Comprehensive Environmental Compensation, Response, and Liability Act).

165. As noted in the Introduction, radiation standards were initially established
as recommendations by two private advisory bodies: the International Commission on

560

Radiological Protection (ICRP) and the U.S. National Committee on Radiation
Protection, now the National Council on Radiation Protection and Measurements
(NCRP). Over time federal and state agencies have based regulatory standards on these
recommendations.

1 66. As noted above, this standard was a recommendation by the NCRP, later
adopted as policy by the AEC. Carroll Wilson to Lauriston Taylor, 10 October 1947, as
cited in Gilbert Whittemore, "The National Committee on Radiation Protection, 1928-
1960: From Professional Guidelines to Government Regulation" (Ph.D. diss., Harvard
University, 1986), 326-327.

167. This standard took the form of guidance issued by the Federal Radiation
Council in 1960, "Radiation Protection Guidance for Federal Agencies," in Fed. Reg. 25,
4402-4403 (1960); and Fed. Reg. 26, 9057-9058 (1961). See also, D. C. Kocher,
"Perspective on the Historical Development of Radiation Standards," Health Physics 61
no. 4 (October 1991).

168. The EPA was established by President Nixon. The NRC was formed in
1 974 under the Energy Reorganization Act to take over the regulatory functions of the
AEC. See 42 U.S.C. 5801 et seq.

1 69. U.S. General Accounting Office, Consensus on Acceptable Radiation Risk
to the Public is Lacking, GAO/RCED-94-190, summarizes the existing radiation
protection standards in the federal government (see especially table 1, p. 5).

1 70. Committee on the Biological Effects of Ionizing Radiation, BEIR V, 1 8.
Table 1-3 provides a comparison on typical exposure to natural and artificial sources of
ionizing radiation.

171. 54 Fed. Reg. 5 1 657; 54 Fed. Reg. 5 1 655; 56 Fed. Reg. 33080, as cited in
David O'Very and Allan Richardson, unpublished, "Regulation of Radiological and
Chemical Carcinogens: Current Steps Toward Risk Harmonization," 1995.

1 72. Some regulations already take the population dose into account. The
DOE and NRC use the population dose in implementing the principle that radiation
exposures be made as low as reasonably achievable (a principle that goes by the acronym
ALARA), applying cost-benefit analysis to reduce population doses from the operation of
a given facility. As another example, releases of Kr-85 from nuclear power plants are
limited on the basis of population doses. 40 C.F.R. 190.10(b).

173. The national security interest exemption to the Clean Air Act is provided
in 42 U.S.C. 7412(i)(4): "The President may exempt any stationary source from
compliance with any standard or limitation under this section for a period of not more
than two years if the President determines that the technology to implement such standard
is not available and is in the national security interest of the United States to do so."
Other environmental statutes have similar exemptions.

174. AEC 132/64, 7 January 1964, cited in J. Samuel Walker, Containing the
Atom (Berkeley: University of California Press, 1992), 11-12. Except for such
circumstances, the AEC declared its intention to ensure that "reactor facilities are
designed, constructed, operated, and maintained in a manner that protects the general
public, government and contractor personnel, and public and private property against
exposure to radiation from reactor operations and other potential health and safety
hazards."

1 75. The ability to delay any report to Congress by as much as a year greatly
limits the effectiveness of this reporting requirement. There also remains the possibility

561

that the information provided to Congress would be classified, and so the report would
not be made public.

176. See42U.S.C4321 etseq.

1 77. The basic requirements for environmental impact analyses appear at 40
C.F.R. part 1500 et seq. As a preliminary step, an environmental assessment may be
done to determine whether the "significant impact" threshold is met and a full EIS is
necessary. This EIS must include an analysis of the environmental impact alternatives to
the proposed action. Normally, a draft EIS must be made available for public
information and comment, and the agency must respond to any comments of the public.

178. The regulations implementing NEPA provide that "environmental
assessments and environmental impact statements which address classified proposals
may be safeguarded and restricted from public dissemination in accordance with
agencies' own regulations applicable to classified information." 40 C.F.R. 1507.3(c).
This provision for secret procedures does not relieve an agency of the obligation to
inform itself of the environmental impacts of its actions, nor does it relieve EPA of the
requirement to review those impacts.

179. On 1 1 February 1994, President Clinton signed Executive Order 12898,
"Federal Actions to Address Environmental Justice in Minority Populations and Low-
Income Populations," which requires each federal agency to address disproportionate
human health or environmental effects of its policies. This includes requirements to
assess those impacts and to seek greater public participation in environmental planning
and policymaking. Executive Order 12898, 59 Fed. Reg. 7629 (16 February 1994).

180. Richard Sanderson, Director, Office of Federal Activities, EPA, to Donald
Weightman (ACHRE Staff), 22 March 1995 ("NEPA Oversight of Classified
Documents"). Such programs are offically referred to as Special Access programs.

181. See Helen Frost et al. v. William Perry, Secretary of the United States
Department of Defense et al, Civil Action no. CV-S-94-795-PMP (RLH), filed August
1 5, 1 994 (ACHRE No. 5 VVU-04 1 495- A), and John Doe et al. v. Carol M. Browner,
Administrator, United States Environmental Protection Agency, Civil Action no. CV-S-
94-795-DWH (LRL), both of which were filed in the U.S. District Court for the District
of Nevada.

182. Craig Hooks, Associate Director, Federal Facilities Enforcement Office,
EPA, to Donald Weightman (ACHRE staff), 1 1 April 1995 ("Please find enclosed . . .")
(ACHRE No. EPA-041395-A).

183. Gary Vest, Deputy to the Assistant Secretary of Defense for
Environmental Security, interview with Mark Goodman (ACHRE staff), 13 December
1994, staff notes (ACHRE Contact Database).

184. Mark Hamilton, USAF, telephone interview with Mark Goodman
(ACHRE staff), 4 January 1995, staff notes (ACHRE Contact Database).

185. Richard Sanderson, Director, Office of Federal Activities, EPA, to Donald
Weightman (ACHRE Staff), 22 March 1995 ("NEPA Oversight of Classified
Documents").

186. The Supreme Court has ruled that the question of an agency's compliance
with NEPA is "beyond judicial scrutiny" when a trial of the case would "inevitably lead
to the disclosure of matters which the law itself regards as confidential, and respecting
which it will not allow the confidence to be violated." Weinberger v. Catholic Action of
Hawaii/Peace Education Project, 454 U.S. 139, 146 (1981).

562

12

Observational Data Gathering

Oupplies of uranium to build atomic bombs; a remote, sparsely inhabited
site to test the bombs; information about the health effects of both the raw
material and the bomb: these were the Cold War needs that led directly to the
events with which this chapter is concerned.

This chapter examines whether the U.S. government wronged or harmed
uranium miners in the American West and Marshall Islanders in the mid-Pacific,
in both cases by exposing them to radiation hazards: in the case of the miners by
failing to inform them about the risk and failing to mitigate it; and in both cases,
perhaps to different degrees, by studying them without having obtained adequate
consent. Although the mines of the Colorado Plateau and the seas surrounding
the atolls of the Marshall Islands were seen by U.S. policy planners as ideal sites
for the government's primary missions-mining uranium and detonating atomic
and hydrogen bombs--they became laboratories for studying radiation damage to
humans. We also touch briefly on a radiation experiment conducted with a view
to the natural laboratory in which the subjects were set: in 1956 and 1957 the Air
Force administered iodine 131 to Alaskan residents to determine the role of the
thyroid gland in adapting to extreme cold.

The uranium mines, the Marshall Islands, and Alaska were not, of course,
the first such occasions for studying the effects of radiation on people. As has
been reported in earlier chapters, radium dial painters were studied, and in the
largest epidemiological study of radiation effects ever, the survivors of the
Hiroshima and Nagasaki bombs continue to be followed. The Atomic Bomb
Casualty Commission (now the Radiation Effects Research Foundation) began its
work soon after World War II. The organization's projects include a mortality
study, a periodic health examination study, a study of people exposed in utero,

563

Part II

and a genetic effects study. Some of the most important data available on long-
term radiation risks have come from these studies. These data have also provided
the basis for most current radiation exposure standards. The Hiroshima-Nagasaki
studies are different from the cases of the uranium miners and the Marshallese,
however, because the exposure ended before the epidemiologic study got under
way.

While the miners, and the Marshallese after their high initial exposure,
were subjected to continuous exposure to radiation—relatively high for the miners,
relatively low for the Marshallese— they were not exposed for the purpose of
studying the effects of radiation on their health. But the exposures resulting from
the mining and bomb tests provided the government an opportunity, and some
would say a duty, to collect needed information on radiation effects on human
beings. In both cases researchers were interested in determining the health
consequences of exposure to specific and quantified forms and levels of ionizing
radiation over a long term. For the miners it was radon gas and its radioactive
decay products. For the Marshallese it was the fallout products of nuclear
explosions such as iodine 131, strontium 90, and cesium 137. Also, in both cases,
the United States has provided, and in the case of the miners, continues to
provide, financial compensation. In addition, a class-action lawsuit, Begay v.
United States, was brought on behalf of a group of Navajo miners.

There were, however, major differences between the situation of the
miners and that of the Marshallese. In the case of the miners, the research was
conducted even though there were data from European studies clearly indicating
that uranium miners were at high risk for lung cancer, which could have been
substantially mitigated by ventilating the mines. The study of the miners,
conducted by the Public Health Service, was epidemiological in nature and
unrelated to their clinical care. The Marshallese were the first population exposed
to amounts of fallout perceived as acutely dangerous.' The long-term effects of
exposure to fallout were unknown; therefore it was important to gather data while
treating the exposed population. It appears that the medical monitoring of the
exposed population was directly integrated with the management of their health
care.

To gather information on the health effects of radiation, federal
government agencies mounted observational studies, a term indicating that the
conditions of exposure are not under the control of the investigator who is
studying the health effects.

For a long time, while they were being studied, it seems evident that no
one explained to the miners the extent to which their exposure to radiation might
be hazardous and, in many cases, lethal. Nor, it appears, were they told that
ventilation of the mines could significantly reduce the hazard. And, evidently no
one seems to have told the miners the true purposes of the research. With respect
to the Marshallese, efforts to explain to them the purpose of the studies and the
hazards of their contaminated environment were inadequate well into the 1960s,

564

Chapter 12

and the difference between medical care and treatment-related research was not
clearly explained. The Advisory Committee reports here on both studies and
concludes with a discussion of the cold-weather experiment in Alaska in which
servicemen, Eskimos, and Indians were given tracer amounts of iodine 131. We
begin with the uranium miners.

THE URANIUM MINERS

The competition with the Soviet Union to build atomic arsenals spurred a
uranium boom. In the late 1940s, there was a perceived need for a large and
reliable domestic source of uranium to replace supplies predominantly from the
Belgian Congo and, to a lesser degree, Canada. The AEC's announcement in
1 948 that it would purchase at a guaranteed price all the ore that was mined set
off a stampede on the Colorado Plateau.2 Hundreds of mines, ranging from mines
run by the prospectors themselves to larger corporate operations, were opened in
the Four Corners area of Arizona, New Mexico, Utah, and Colorado, and several
thousand miners, many of them Navajo, went to work.3

Some of the mines were large open pits, but most were underground
networks of shafts, caverns, and tunnels, shored up by timbers. Because uranium
milling and open-pit mining is conducted above ground, radon levels tend to be
quite low, as radon is readily dispersed into the atmosphere. However, millers are
exposed to uranium dust and thorium 230, both of which may have chemical or
radiological toxicity, as well as additional chemicals used in the extraction
process. In the remainder of this chapter, we focus on the underground miners
who were exposed to much higher levels of the hazards that are the principal
cause of lung cancer in the miners.4

The American boom followed centuries of experience with uranium
mining in Europe, where a mysterious malady had been killing silver and uranium
miners at an early age in the Erzgebirge (ore mountains) on the border between
what is now the Czech Republic and Germany. In 1879, two researchers
identified the disease as intrathoracic malignancy. They reported that a miners'
life expectancy was twenty years after entering the mine, and about 75 percent of
the miners died of lung cancer.5 By 1932, both Germany and Czechoslovakia had
deemed the miners' cancers a compensable occupational disease.

In 1942, Wilhelm C. Hueper, a German emigre who was founding director
of the environmental cancer section of the National Cancer Institute (NCI), one of
the National Institutes of Health, published a review in English of the literature on
the European miners suggesting that radon gas was implicated in causing lung
cancer.6 He eliminated nonoccupational factors because excess lung cancer
showed up only among miners. He also eliminated occupational factors other
than radon .because these other factors had not caused lung cancer in other
occupational settings.7 Among Hueper's peers, dissenters, such as Egon Lorenz,
also of the NCI, focused on contaminants other than radon in the mine, the

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possible genetic susceptibility of the population, and the calculated doses to the
lung, which seemed too low to cause cancer because the role of radon daughters—
which the radioactive polonium, bismuth, and lead decay products of radon gas
are known as—was not yet understood.8

At the time its own program began, the AEC had many reasons for
concern that the experience of the Czech and German miners portended excess
lung cancer deaths for uranium miners in the United States. The factors included
the following: (1) No respected scientist challenged the finding that the Czech
and German miners had an elevated rate of lung cancer; (2) these findings were
well known to the American decision makers; (3) as Hueper points out, genetic
and nonoccupational factors could be rejected; and (4) radon standards existed for
other industries, and there was no reason to think that conditions in mines ruled
out the need for such standards. Moreover, as soon as the government began to
measure airborne radon levels in Western U.S. uranium mines, they found higher
levels than those reported in the European mines where excess cancers had been
observed.9 As Public Health Service (PHS) sanitary engineer Duncan Holaday,
who spent many years studying the miners, recalled in 1959 congressional
testimony, there was early recognition that while there were substantial
differences between European and American settings, the exposure levels in U.S.
mines were high:

In 1 946 our American mines were not as deep as those in
Europe. The men did not work long hours. Furthermore, a
great many of them were more or less transient miners, in
and out of the industry.

However, our early environmental studies in these
early American mines indicated that we had
concentrations of radioactive gases considerably in
excess of those that had been reported in the
literature.10

One important hole in Hueper's argument was that the calculated dose of
radiation from the radon in European mines did not seem high enough to cause
cancer." But when William Bale of the University of Rochester and John Harley,
a scientist at the AEC's New York Operations Office (NYOO) who was working
toward his doctorate at Renssaelear Polytechnic Institute, were able to show and
explain in 1951 the importance of radioactive particles that attached to bits of dust
and remained in the lung, the discovery had a tremendous impact.12 When doses
to the lung were recalculated using Bale and Harley's models, they increased 76
times,13 making them high enough to explain the observed cancer rates.14
Recognizing the importance of radon daughters also explained why animal
experiments using pure radon gas had not caused cancer.15

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In the absence of Atomic Energy Commission willingness to press for
relatively safe tolerance levels for radon in U.S. mines and to institute an effective
program of mine ventilation to reduce the hazard, and a mixed, but mainly
unsatisfactory response from the states, the stage was set for intergovernmental
buck passing and decades of study, a course that resulted in the premature deaths
of hundreds of miners. An analysis of eleven underground miners' studies
published in 1994 by the National Cancer Institute supports the view that radon
daughters are responsible for an even greater number of lung cancers than
previously believed.16

The Advisory Committee heard from many miners and their families
about the devastation wrought by the experience in the mines and the
government's ability to prevent it. Dorothy Ann Purley, from the pueblo of
Laguna in New Mexico, told Advisory Committee members at a public meeting
in Santa Fe, "Nowadays people come out and say, 'Did you know so and so died
of cancer?' 'I have a brother in law who has got cancer. He worked at the
mine.""7

Philip Harrison, a spokesman for Navajo miners and their families, told
the Advisory Committee that in New Mexico mines "the working conditions were
sometimes unbearable. . . . The government knew all along what the outcome
would be and . . . initiated studies on the miners . . . without their knowledge and
consent."18

A Standard for Beryllium, But Not for Uranium

In 1948, Merril Eisenbud, an industrial hygienist, was recruited by the
AEC's New York Operations Office to help set up a health and safety laboratory.
The NYOO was responsible for all raw materials procurement for the AEC.19 At
the request of the AEC's Raw Materials Division, Dr. Eisenbud and Dr. Bernard
Wolf, a radiologist, reported on potential health hazards in the mines to the
NYOO field office in Colorado and to AEC headquarters staff.20 Dr. Eisenbud
and the New York Operations Office recommended that the AEC write
requirements for health protection into its contracts with the mine operators.21

The AEC had used contract provisions in the case of beryllium, another
key (but not radioactive) element in bomb production. One month before Dr.
Eisenbud filed his report on the uranium mines, the Cleveland News reported on a
conference convened to discuss cases of beryllium poisoning at plants in
Massachusetts and Lorain, Ohio.22 Among the fatalities in Lorain were five
residents living near the Beryllium Corporation plant.23 The plant owner, Dr.
Eisenbud recalled in 1995, was eager to have conditions studied "because he
wanted to know what his liability was."24

That same month, June 1948, responding to the "considerable publicity . .
. given by the press to cases of berylliosis among plant workers and residents,"
the AEC set a tentative standard for the permissible levels of exposure to

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beryllium. The NYOO, "with the approval of the Division of Biology and
Medicine, has insisted that the AEC-recommended tolerance levels be met in all
plants processing beryllium or beryllium compounds for the Commission."25
Despite the fact that by September 1 949 there had been at least twenty-seven
deaths attributed to beryllium in plants where the AEC had contracts (no one
became sick with berylliosis after the tolerance limits had been set in place), the
DBM objected to AEC "establishment and enforcement of standards or
regulations pertaining to health and safety conditions" and wanted to turn the
matter over to the states.26 Nevertheless, the NYOO enforced standards for
beryllium.27

The uranium and beryllium situations had much in common. In both cases
the AEC was the sole or primary purchaser! In both cases the AEC's New York
Operations Office sought to control the hazard. And in both cases there were
arguments to be made for inaction: The causation mechanism for the disease was
poorly understood, and the legal authority of the AEC to regulate private
production was questionable. The essential difference between the two cases
was that the illness caused by beryllium appeared shortly after exposure and
aroused publicity and associated public concern. By contrast, it would take more
than a decade before uranium miners would begin to die of lung cancer, and
causality would be harder to infer.

The DBM and the AEC Raw Materials Division rejected Dr. Eisenbud's
recommendation for health protection, arguing that the Atomic Energy Act did
not give the AEC authority over uranium mine health and safety.28 The New
York Operations Office took the same position that it had taken on beryllium: if
it was going to procure uranium, it was going to control radon in the mines.29 The
AEC responded by transferring uranium procurement to a newly created section
of the Raw Materials Division in Washington.30 According to Dr. Eisenbud, the
director of the New York Operations Office and many of its employees quit over
this move, at least some of them because the shift was intended to keep the AEC
out of health-related matters in the uranium mining industry.31

Eisenbud's perspective was echoed in at least part of the AEC's
Washington office. In May 1949, A. E. Gorman, a sanitary engineer at the AEC,
wrote a memo for the files in which he reported on a meeting with Lewis A.
Young, director of the Colorado Department of Health's division of sanitation,
and Dr. John Z. Bowers, deputy director of the Division of Biology and Medicine.
Bowers "indicated that health conditions [on the Colorado Plateau] were not
satisfactory," and Mr. Young reported that "conditions under which uranium ore
was being mined and processed were not good."32 Bowers, the memo recorded,
said his office did not want to recommend "drastic steps" to require correction of
deficiencies, but preferred to gather facts about the hazard and cooperate with
mine operators and state agencies to correct unsatisfactory conditions. Gorman,
however, recorded:

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I expressed the opinion that if the State of Colorado
had only two inspectors to cover industrial hygienic
conditions in all mines in the state, it would not be
realistic to expect very extensive follow up of the
hazards problems [sic] involving silicosis and
radioactivity; also that since AEC was purchasing a
very large percentage of the uranium produced, we
had a moral responsibility at least to improve any
unsatisfactory condition which was known to exist
involving the health of workers. I suggested that
this might be taken care of by a clause in our
contracts even though it might result in a higher
cost of production. I questioned the point that such
action might seriously affect the production of
uranium.33

Gorman's perspective did not win out. By the 1950s occupational
standards or guidelines existed not only for radium34 (a maximum permissible
body burden) but also for radon. By 1 94 1 the data from the European mines had
been used to establish a radon standard for "air in plant, laboratory, or office [of]
10 picocuries per liter."35 But when it came to the mines the federal government
took nearly two decades to issue enforceable standards and actions to protect all
those miners known to be exposed to significant risk. Instead, it debated
responsibility for action while it pursued a long course of epidemiological study.
The episode, the judge would declare in the Begay case decision in 1984, was a
"tragedy of the nuclear age."36

The PHS Study

On August 25, 1949, the state of Colorado and U.S. Public Health Service
officials met to explore radiation safety in the uranium mines and mills.37
Colorado was home to about half of the U.S. uranium mines. Because many of
them were small mines, they employed less than 10 percent of the country's
uranium miners. (New Mexico, with much larger mines on average, had a fraction
of the mines, but nearly half of the miners.)38 The Colorado Department of Health
established an advisory panel of federal, state, and uranium industry officials to
oversee a comprehensive study. The panel advised the health department that
more information was needed on the medical hazards of the uranium mines. In
August 1949, the health department, along with the Colorado Bureau of Mines
and the U.S. Vanadium Company, formally requested a study of the mines and
mills, which the PHS agreed to do.39 The PHS initiated both environmental
studies of the mines40 and epidemiologic studies of the miners.41 The
environmental study ended in 1956, but the epidemiologic study is ongoing.

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In 1949, Henry Doyle, a sanitary engineer who was the chief PHS
representative in Colorado, began environmental sampling in the mines.42 Doyle
recruited Holaday to direct the study.43 The health departments of Utah, New
Mexico, and Arizona also participated.44 The environmental part of the study
began first, in 1950. Between 1950 and 1954 medical examinations of uranium
miners and millers were done on a "hit-or-miss basis,"45 but in 1954 a systematic
epidemiological study of the miners was begun.

Between 1949 and 1951, PHS investigators took environmental
measurements of radon levels in the mines. Like Dr. Eisenbud, they detected
high levels of radon.46 In a February 1950 memo to the PHS Salt Lake City
office, Holaday reported on a survey of four mines on the Navajo reservation. He
declared that while he "anticipated that the samples would show high radon
concentrations, the final results were beyond all expectations." The samples
disclosed a "rather serious picture," leading Holaday to conclude "that a control
program must be instituted as soon as possible in order to prevent injury to the
workers."47

On January 25, 1951, representatives from the AEC, the PHS Division of
Industrial Hygiene, and other branches of PHS convened to discuss in detail the
radon concentrations discovered by the PHS study and what could be done about
them.48 The PHS staff explained that the uranium study demonstrated "radon
concentrations ... in the mines high enough to probably cause injury to the
miners. . . ,"49 They also said the hazard could be abated by proper ventilation.
The group concluded that the radon concentrations should be reduced to the
lowest level possible consistent with good mine ventilation practices, but found it
"unrealistic" to set a definite level that mine operators should meet.50 They
recommended further research, especially on ventilation techniques.51 By this
route, "the radon concentrations in the mines would be materially reduced in all
cases, and valuable information would be yielded as to the effectiveness of
standard ventilation practice in the control of radon."52 It also was noted at this
meeting that the acceptable level of radon in manufacturing was only 10
picocuries per liter, one to three orders of magnitude lower than the observed
levels in the mines.53

The PHS Progress Report for the second half of 1951 explained that
because of the "acuteness of the radon problem it was felt that it was necessary to
temporarily put aside our full-scale environmental investigation of this industry
and concentrate on the control of this contaminant."54 The PHS met with the
mining companies to discuss the hazards and urged them to undertake ventilation
measures.55 In 1979, Duncan Holaday testified to Congress that "by 1940 I do not
believe there was any prominent scientist or industrial hygienist in the United
States, except one [presumably Lorenz], who was not thoroughly convinced of the
dangers, and it had been demonstrated that the radioactive elements could be
removed from a closed area and be completely avoided."56 However, it appears
the mining industry lacked the commitment to improve worker conditions.57

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The PHS distributed its interim report on a "restricted" basis to state and
federal government officials and mining companies in May 1952.58 A June 26,
1952, press release announcing the completion of the interim report began with
the statement that "no evidence of health damage from radioactivity had been
found."59 Mining had been going on for only a few years, and lung cancer has a
ten- to twenty-year latency period. The introduction to the report itself noted,
however, that "certain acute conditions are present in the industry which, if not
rectified, may seriously affect the health of the worker."60

Meanwhile, as evidence of hazard mounted, Dr. Hueper, now at the
National Cancer Institute, reported continued efforts to limit his speech on the
risks involved. Dr. Hueper reported that in 1952 he was invited to speak to the
Colorado Medical Society, but declined to attend when ordered by the director of
the NCI, at the request of the AEC's Shields Warren, to delete references "to the
observation of lung cancer in from 40 to 75 percent of the radioactive ore miners
in . . . [Europe] although these occupational cancers had been reported repeatedly
since 1879."6' In a 1952 memo to the head of the Cancer Control Branch of NIH,
Hueper reported that an AEC representative had objected that references to
occupational cancer hazards in the mines were "not in the public interest" and
"represented mere conjectures."62 After the Colorado episode, according to
Hueper, Warren wrote to the director of the NCI, asking for Dr. Hueper's
dismissal for "bad judgment." Dr. Hueper kept his job, but was, according to
Victor Archer, one of the physicians who ran the uranium miner study, forbidden
to travel west of the Mississippi for research purposes.63

U.S. officials, including those from the PHS, had no independent authority
to enter the privately owned mines-as opposed to those owned by the AEC and
leased to private operators-without permission of the mine owners.64 Duncan
Holaday testified in court proceedings that in order to gain access to the mines, an
oral agreement was made with mine owners not to directly inform those most
affected by their findings, the miners.65 According to Holaday, "this was routine
procedure that was followed in every industrial survey I was aware of . . . this
went back for many decades." To gain entry to the mines the researchers agreed
that the PHS would not "alarm the miners" by warning them of hazardous
conditions.66 In 1983 Holaday testified in Begay that "you had to get the survey
done and you knew perfectly well you were not doing the correct thing ... by not
informing the workers."67 A medical consent form from the PHS study dated May
1960 says nothing about the risk of lung cancer or any other health risk associated
with working in uranium mines.68 "[T]here would be no overt publicity," Holaday
recalled in a 1985 deposition, "and when we reported the information that we
found, it would be done in such a way that the facilities where a particular set of
samples were taken would not be identified and that we would not inform the
individual workers of what data we found."69

Holaday told Stewart Udall, a former secretary of the interior who
represented the miners in the Begay case, that he did not try to go public because

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he didn't think that Washington would notice a "little Utah tweet" from him.70
Eisenbud has suggested that perhaps this was because in the Cold War
environment, with nuclear weapons testing under way, no one would pay much
attention to the long-term health risks of a small group of miners.71

Although the PHS and the AEC already knew the danger of radon in the
mines in 1951, and had pressed the states to take action with mixed results, PHS
doctors nonetheless began to conduct basic health examinations to collect
baseline data against which long-term health effects of radon could be gauged.72
These medical examinations did not initially find evidence of harm caused from
working in the mines. However, one would not have expected to find such effects
because few miners had been on the job for more than five years and lung cancer
takes ten to fifteen years to appear.

By 1953, the PHS had completed a series of ventilation studies. As early
as 1951, federal and state officials meeting with mine owners in Colorado had
told them that "ventilation had been tried in other mines and found to be
satisfactory."73 But while some large mines were ventilated during the 1950s and
1960s, most of the small mines were not ventilated until the 1960s or later, and in
those mines that had ventilating systems earlier, they were not always properly
used.74

The uranium miners were discussed at a January 1956 meeting of the
AEC's Advisory Committee for Biology and Medicine. The formally secret
transcript records that in a "status report on the Colorado plateau," the Division of
Biology and Medicine's Dr. Roy Albert stated:

There are no pressing—particularly pressing—problems
associated with it now, but there has always been a
rumbling of discontent with the status of the health
conditions in the uranium mines of the Colorado Plateau
because this is a mining industry which is essentially
controlled by the Federal Government and by the AEC in
terms of how much it can produce and how much it paid for
its product.

Albert explained that the tentative decision was to "sit tight" because it
would be "an unusual step" for the federal government to enter the mining
industry and the AEC could take a "wait and see" approach as the states "took up
the cudgel."75

Merril Eisenbud responded, to no evident effect, that the federal
government should pay to ventilate the mines: "I think here is where our
responsibility lies, because I think this industry would not exist except for the fact
that we need uranium. If the cost of operating these mines as determined by us
does not permit adequate ventilation of those mines, we will have to change the
price. It is as simple as that."76

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In October 1958, LeRoy Burney, the surgeon general of the Public Health
Service, wrote to Charles Dunham, director of the AEC's Division of Biology and
Medicine, that the "numbers are too small to permit conclusions to be drawn at
this time" about whether there were excess lung cancer deaths among the uranium
miners. However, he added, "if this proportion of mortality . . . should increase or
even continue in the future, then it might be appropriate to conclude that our
American experience is not inconsistent" with that in the Czech and German
mines. Dr. Burney added:

Although we do not have complete environmental
measurements in all mines, it appears that about
1,500 men in some 300 mines are working in
uncontrolled or poorly controlled environments.
The median level of alpha emitters in the mines of
one state is five times the recommended working
level, and in some mines the level is exceeded by
more than 50 times. ... It is usually the older,
smaller mines in which the workers are still
exposed to these high levels.77

Burney concluded by suggesting that as the "sole purchaser of ores
produced in the mines," the federal government could require mine owners to
conform to federal safety standards.

Several months later, Dunham wrote a memo to AEC General Manager A.
R. Luedecke, reporting "it is doubtful if the Commission's regulatory Authority
could be extended to cover the mines."78 The same day, March 1 1, 1959, AEC
General Counsel L. K. Olson wrote to Dunham reporting that "there is nothing in
the legislative history of the 1954 [Atomic Energy] Act, or the 1946 [Atomic
Energy] Act, which indicates that Congress may have intended to permit AEC to
regulate uranium mining practices."79

Later in 1959, the AEC asked the Bureau of Mines to inspect mines it
leased and then made follow-up inspections to see that the bureau's
recommendations were followed, closing sections of mines temporarily until
corrective measures were completed. In the ten months between July 1959 when
the inspections began and May 1960, levels of radon in these mines improved
dramatically.80

As the judge in the Begay decision found, "the AEC concluded that it
could enforce health and safety measures in leased mines [as distinct from
privately owned mines] pursuant to the leasing provisions of the Atomic Energy
Act" and amended its mines' leases "to contain explicit enforcement language
and procedures."81 The states began to enact standards in 1955,82 but inspection
and enforcement came later and varied greatly. New Mexico began enforcement
in 1958.83 Colorado and Utah did not begin serious enforcement until the 1960s,84

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and Arizona, according to Duncan Holaday, did "nothing outside of take air
samples."85

In late 1959, the miners were provided with the PHS pamphlet that warned
them about the hazards of radon exposure. The pamphlet mentioned the
possibility of radon causing lung cancer, but said nothing of the experience of
U.S. or European miners or the level of risk. It said that "scientists are working
hard to get the final answer on how much radon and its breakdown products,
known as daughters, you can be exposed to safely."86 It did not tell the miner the
"suggested figures," but suggested bringing "enough clean, fresh air to the face to
sweep out the radon gas and dust," as well as several other measures to reduce

07

exposures.

All mining is dangerous, and there is no reason to think that any miners
went into the uranium mines unaware of this. Whether the uranium miners had an
appreciation of the added cancer risk from radon is another matter. The 1959
pamphlet is the first document we could find that indicated that the federal
government tried to warn the miners of the radiation hazards. While the pamphlet
mentioned the possibility of radon causing lung cancer, it gave no indication of
the level of risk.88 Duncan Holaday told a congressional hearing in 1979, "We, in
the Public Health Service, made every effort to communicate with the men the
situation that they were in. We put out pamphlets . . . conducted medical
examinations ... we told them what the story was."89 This statement is hard to
reconcile with Holaday's other statements, as quoted earlier, that the researchers
had agreed not to warn the miners as the condition for access to the mines. When
Senator Orrin Hatch of Utah suggested to Mr. Holaday that some of the miners
"just were not capable of understanding or knowing the dangers to which they
were subjected," Mr. Holaday responded, "I understand this perfectly well."90

In 1960, the PHS presented to the governors of the mining states what it
believed to be conclusive evidence from the PHS study of a correlation between
uranium mining and lung cancer. The evidence showed that at least four and a
half times more lung cancers were observed than would normally be expected
among white miners-for whom comparison data were available-and that there
was less than a 5 percent chance that such a difference had appeared by chance.
The results of a study of 371 mines (the number of miners surveyed was not
stated) in 1959 showed that the number of mines with unacceptable levels of
radon had increased from 1958.91 Yet the federal government continued to defer
to the states on rule setting and enforcement in the case of the mines that were not
AEC property, and the AEC, the PHS, and the states continued studies and
discussions.

Finally, in 1967, Secretary of Labor Willard Wirtz announced the first
federally enforceable standard for radon and its daughters in uranium mines that
supplied the federal government. "After seventeen years of debate and
discussions regarding the respective private, state, and federal responsibilities for
conditions in the uranium mines," Wirtz told Congress, "there are today (or were

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when the hearings were called) no adequate health and safety standards or
inspection procedures for uranium mining."92 The standard was set at 0.3
Working Level (WL).93 Wirtz established this criterion under the 1936
Walsh-Healy Act, which provided for the regulation of health and safety
conditions under government contracts.94 It is not clear why the authority granted
the secretary of labor under this 1936 law was not used earlier to control radon in
the mines, but it might have been because most of the mines were privately
owned and did not operate under federal contacts, which made the applicability of
the act questionable.95

The Begay Decision

Begay v. United States was filed on behalf of a group of miners in federal
district court in Arizona in 1979; the case came to trial in 1983. During the
1950s, according to the court, the PHS found radiation exposures in some mines
higher than the level it recommended, and "even higher than the doses received as
a result of the atomic bomb explosion in Japan."96 But on July 10, 1984, the court
decided that the United States was immune from suit,97 although the judge wrote
that the miners' situation "cries for redress."98

The decision in the Begay case poses basic questions regarding the
responsibility of the government and its researchers. The court found that the
government's actions were motivated by strong national security interests:

The government, in making its decision in this area,
was faced with the immediate need of a constant,
uninterrupted and reliable flow of great quantities of
uranium ... for urgent national security purposes
and as an energy source in the future for the
growing peacetime nuclear energy industry. . . .
[T]he decision makers had to be concerned that
there was adequate data available to justify the
standards to be set and that labor and management
would have the tools to know when they were in
violation. . . ."

The court is not clear, however, on why or how a standard for radon in the
mines would have interrupted the flow of uranium, damaged national security
interests, or interfered with the development of peaceful uses of nuclear energy.
Ventilating the mines would have been relatively inexpensive, and it would have
improved working conditions-this was demonstrated in PHS ventilation studies
in 1951 l00-making it more rather than less attractive to a potential work force. In
1960 the deputy commissioner of mines of Colorado is reported as having said
that 98 percent of the mines would have to suspend work if forced to abide by a

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working level standard proposed in 1955: 100 picocuries of radon in equilibrium
with 300 picocuries of radon daughters.101 In any event, the federal government
did not invoke national security as a basis for its inaction. For example, in 1986
Duncan Holaday responded in the negative when asked in a deposition, "in all
[your] years from 1949 until your retirement, did you ever receive directly or
receive indirectly, any document [from the] Public Health Service, from the
Atomic Energy Commission, or from any other source, indicating you or directing
you that you are to pull punches or nothing was to be done because of national
security considerations?"102 As for the federal government's policy of not
regulating the mines, this appears to have involved questions of the AEC's
understanding of its authority and political questions relating to the traditional
relationship between the states and the federal government.

Was the failure to apply the same approach to the uranium miners as to the
beryllium workers a matter of the absence of legal authority, as claimed by the
AEC, or of reasoned deference to state regulators, as the court suggested? The
court's decision did not address the AEC's action to require its beryllium
contractors to comply with hazard standards, nor did it address the fact that
radiation standards were enforced in industrial settings. Fragmentation of
responsibility— both at the federal level and between the states and the federal
government— appears to have provided a convenient opportunity for the federal
government to pass the buck among agencies and avoid decisive action until long
after such action should have been taken.

Under what conditions should researchers enter into a long-term study
where there is reason to suspect at the outset that the subjects are, each day, at
continuing and largely avoidable and unnecessary risk?

The Begay decision states clearly the bargain entered into by the
government and its researchers, on behalf of the epidemiological study:

... it was necessary to obtain the consent and
voluntary cooperation of all mine operators. To do
this, it was decided by PHS under the surgeon
general that the individual miners would not be told
of possible potential hazards from radiation ... for
fear that many miners would quit and others would
be difficult to secure because of fear of cancer.
This would seriously interrupt badly needed
production of uranium. . . . [N]o individual mine, or
mines, would be publicly identified in connection
with that data. Consequently, the voluntary consent
of mine operators was secured to conduct the PHS
study.103

The Begay decision does not address questions such as whether the

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researchers could have worked more effectively with state agencies that had
authority to enter the mines, or whether they could have conducted the study in
mines on federal or Navajo land, to which they had access. In any case, there is
no obvious national security or other ground on which to justify the continued
exposure of miners to the radon hazard.104

As to medical examinations of the miners, the court found that the
physicians who had conducted them "had the responsibility for dealing only with
the examination and the results of that examination."105 Thus, the court
concluded, "it was neither necessary nor proper for those physicians to advise the
miners voluntarily appearing for examinations of potential hazards in uranium
mines."'06 In the case of the epidemiological study, the court explained:

An epidemiological study deals with group statistics
and the conclusions of such a study appropriately
cannot be applied to specific participants of a
group. . . . The government did not seek volunteers
to work in the mines so that they could become part
of the study group. . . ,107

On this point, the Advisory Committee disagrees with the court. In
epidemiological studies such as the one under discussion, group conclusions are
applicable to the members of the population of which the group is intended to be a
representative sample. That is, each individual can be told the probability of
developing disease based on his level and conditions of exposure. If the study
was poorly designed, then such applicability may not hold, but to the Committee's
knowledge, no one has argued this about the PHS study. Moreover, the PHS
researchers had opportunities to warn the miners face to face because they
examined them periodically over more than twenty years. There is some
disagreement about whether any miners were warned of the risk of lung cancer,
but even Duncan Holaday, who in one instance indicated that some miners
received warnings, acknowledged that very likely these warnings were
ineffective.

Radiation Exposure Compensation Act

The Begay decision concluded that the plight of the uranium miners "cries
for redress." Because of the doctrine of sovereign immunity, however, the court
declared that it could not provide the appropriate remedy. By 1990, 410 lung
cancer deaths had occurred among the 4, 1 00 miners in the Colorado Plateau study
group; about 75 lung cancer deaths would normally have been expected in a
group of miners such as this.108 In the same year, Congress responded with
legislation, the Radiation Exposure Compensation Act (RECA), which provided
$100,000 compensation for miners with lung cancer or nonmalignant respiratory

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disease, subject to certain conditions. In the case of lung cancer, the act requires
that the claimant demonstrate an occupational exposure to radon daughters from
200 WLM (working level months) to 500 WLM, depending upon his age and
smoking history, the higher figure applying to smokers and older miners. In the
case of nonmalignant respiratory disease, the act also requires documentation of
disease by a panel of radiologists certified in assessing x-ray evidence of lung
disease. In both cases, records of occupational histories and civil records for
next-of-kin claimants (such as marriage certificates) are also required— records
that are often nonexistent or difficult to obtain, particularly for Navajo miners.
The most recent and authoritative analysis of risks of lung cancer from
radon in uranium mining comes from a 1994 NIH publication109 that reanalyzed
all eleven of the major occupational radon studies worldwide. This analysis
considerably extends that undertaken by the National Academy of Sciences BEIR
IV Committee,"0 which was available in 1986 prior to the enactment of RECA.
This report used similar methods of analysis but more recent and more detailed
data on a larger set of studies. The most important conclusions of this report are

• that the risk rises approximately linearly with level of exposure, with an
average slope that is similar to that estimated by earlier committees,
including BEIR IV;1"

• that the risk per WLM varies strongly by age, latency, mining cohort, and
especially by dose rate or duration, the latter being a relatively recent
observation, but one that is now widely accepted;"2

• that there is little evidence that the proportional increase in lung cancer
risks is substantially different for smokers and nonsmokers~as a
consequence, the probability that a particular lung cancer was caused or
contributed to by radon is not materially altered by smoking history;"3

• that on average more than half of the lung cancers among white miners in
the Colorado plateau cohort and the Navajo New Mexico cohort were
caused by radon exposures;"4 and

• that there were substantial uncertainties in the actual doses received by
miners in different mines."5

Thus, the 200 WLM figure that is used in RECA as the criterion for
awarding compensation is not unreasonable as a "balance of probabilities" for the
miners as an entire group, but (1) is a much higher risk threshold than is required
for either the downwinders of the Nevada Test Site or the atomic veterans covered
in the same act and (2) ignores substantial variation in age, latency, and other
factors and substantial uncertainties in dose estimates for individuals within the

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group of all miners, so that many miners whose cancers are likely to have been
caused by radon would not have attained this criterion. Furthermore, the
distinction between smokers and nonsmokers established in the act is not well
supported by currently available scientific evidence and tends to deny
compensation to many miners, most of whom are smokers but suffered substantial
increases in risk due to the synergistic effect of the two carcinogens.

Clearly some miners have a stronger case for compensation than others,
and RECA makes an attempt to make such distinctions. In principle, it would be
possible to construct a formula for determining the probability of causation that
would better reflect the current state of scientific knowledge and a threshold on
this scale of probabilities that would treat the miners more equitably vis-a-vis the
other groups covered by the act. However, the case of the uranium miners
presents insurmountable obstacles in this regard, including the loss of records
pertaining to occupational histories and exposures and variations in cultural
practices that have made record-keeping burdens on claimants especially onerous.
When the difficulty of meeting such bureaucratic requirements is coupled with the
strong link between lung cancer and uranium mining, the scheme unjustly places
too great a burden on the individual. The Committee is strongly persuaded to
propose an adjustment in the criteria so that the evidence of a minimum duration
of employment underground would be sufficient to qualify for compensation.
Any compensation scheme is necessarily imperfect, but given the strength of
causal connection, and the severity of the injury, the time spent in the mines is a
rational and equitable basis for determining exposure levels.

Conclusions About the Uranium Miners

The Advisory Committee concludes that an insufficient effort was made
by the federal government to mitigate the hazard to uranium miners through early
ventilation of the mines, and that as a result miners died. The Committee further
concludes that there were no credible barriers to federal action. While national
security clearly provided the context for uranium mining, our review of available
records reveals no evidence that national security or related economic
considerations were relied on by officials as a basis for not taking action to
ventilate the mines. Since most of the mines were not ventilated, the federal
government should at least have warned the miners of the risk of lung cancer they
faced by working underground. We recognize that the miners had limited
employment options and might have felt compelled to continue working in the
mines, but the information should have been available to them. Had they been
better informed, they could have sought help in publicizing the fact that working
conditions in the mines were extremely hazardous, which might have resulted in
some mines being ventilated earlier than they were.

The court in the Begay decision did not exaggerate when it called the
abuse of these miners "a tragedy of the nuclear age."

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The Committee believes that after 1951, when William Bale and John
Harley's findings on radon daughters established that miners were getting a much
larger dose to the lungs than previously suspected, the mine owners, the state
governments, and the federal government each had a responsibility to take action
leading to ventilation of all mines. There are basic ethical principles to not inflict
harm and to promote the welfare of others (as described in chapter 4) under which
all the relevant parties ought to have acted to prevent harm to the miners.

The Advisory Committee has found no plausible justification for the
failure of the federal government, which is the focus of our inquiry, to adhere to
these principles. It is clear that officials of the federal government were convinced
by the early 1950s that radon and radon-daughter concentrations in the mines
were high enough to cause lung cancer. The federal government's obligation
flows from this knowledge and its causal link to the mining activity. Without the
federal government to buy uranium, there would have been no uranium mining
industry. Since the miners were put at risk by the federal government, a minimal
moral requirement would be that the government ensure that the risk was reduced
to an acceptable level. Because the federal government did not take the necessary
action, the product it purchased was at the price of hundreds of deaths.

The historical record is tangled and incomplete, but legal responsibility for
the health and safety of the miners appears to have rested largely, but not
exclusively, with the states. At the same time, the resources to implement
remedial measures existed mainly within the federal government.

The Atomic Energy Commission, which was the contracting agency of the
federal government in its role as sole purchaser of uranium, interpreted the
Atomic Energy Act as not providing it with authority over health and safety in the
mines. It is not clear to the Committee why the AEC, as in the case of beryllium,
could not have made ventilation a requirement of any contract to mine uranium,
or, in any event, why the AEC could not have sought clarification of its authority
from Congress. The Labor Department appears to have had authority under the
1936 Walsh-Healy Act to ensure safe working conditions in the mines, but for
reasons that are again unclear to the Committee, it was not until 1967 that the
Department of Labor applied the act.

According to the Begay decision, the United States did not recruit miners
to work in the mines, nor did it cause the miners to be exposed to hazard or
withhold treatment from any individual. None of the considerations, however,
detracts from what was for the Advisory Committee an overarching determinative
consideration: without the federal government's initiative and its role as sole
purchaser, there would not have been an American uranium industry. Because
the government played a pivotal role in putting the miners in harm's way, it
follows that the government had a moral obligation to ensure that the harm be
controlled, at least to a level of risk that was not in excess of those risks normally
associated with underground mining, an argument the government used to act in
the case of beryllium.

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The uranium mines were not ventilated, however, adding particular
significance to a second moral issue raised by this case: Why were the miners not
warned about the risk to which they were being exposed, particularly as the likely
magnitude of the hazard became clear? Although this question can be properly
put to all the relevant parties, including the mine owners, the state governments,
and the various federal agencies, most attention has focused on the Public Health
Service. Investigators of the PHS were the only federal officials in direct contact
with miners as they recruited and then followed the miners in the course of their
epidemiological studies. Also, it was in the course of these studies that important
evidence about the severity of the risk was accumulated.

When the data collected by the PHS indicated the miners were working in
an environment where the threat of lung cancer was significant, which was clearly
the case after the Bale-Harley findings, and when the PHS observed in the early
1950s that the states and owners were not ventilating the mines to mitigate the
hazard, the PHS was obligated to warn the miners about the implications of its
research. This research appears to have been conducted, however, under oral
understandings with the mine owners that the PHS researchers would not directly
warn the miners of the level of hazard."6

The question arises, of course, of whether the PHS should have entered
into an agreement to study the miners conditioned on not warning them of the
hazard to which they were being exposed. The argument for accepting this
condition is that it was the only way the PHS researchers could gain entry to the
mines and that ultimately the study results would be valuable and likely save
some lives. But acceptance of the condition precluded the PHS from dealing in a
straightforward manner with the people they were proposing to study and from
providing a warning that had the potential, in this case, for saving at least some
lives. The Committee is divided on this issue. Some members concluded that the
condition was morally objectionable and should have been rejected, even if this
meant that the research could not go forward or could go forward only in a limited
way."7 Others argued that a morally acceptable course would have been to accept
the condition and, as the results emerged, warn the miners anyway, because in
this case the duty of promise keeping was justifiably overridden by the duty to
prevent harm.

The PHS's decision to abide by the agreement not to warn the miners is
particularly troubling in light of a regulation, as noted by the court in the Begay
decision, in force from 1951 to 1978, that governed the disclosure of information
obtained and conclusions reached for PHS surveys, research projects, and
investigations. The regulation said, in part, that information "obtained by the
Service under an assurance of confidentiality . . . may be disclosed . . . whenever
the Surgeon General specifically determines disclosure to be necessary (1) to
prevent an epidemic or other grave danger to the public health. . . .""8 Certainly
at some point the potential and eventually realized lung cancer epidemic qualified
under this regulation. The PHS's 1952 interim report is clear that "certain acute

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conditions are present in the industry which, if not rectified, may seriously affect
the health of the worker.""9 So, while the PHS had legal as well as moral
standing to breach its confidentiality agreement, it did not do so, although it
appears to have made efforts to communicate its findings, their implications, and
abatement recommendations to health authorities, the AEC, mine operators and
owners, and state agencies.120

The agreement between the PHS and the mine owners no doubt also
affected what PHS investigators were willing to tell the miners about the purpose
of their investigations at the time the miners were recruited to participate. The
PHS told the miners little more than that they were studying "miners' health."121
In fact they were studying (1) the relationship between exposure to radon and
other conditions in the mines and miners' health and (2) engineering methods
(specifically, ventilation techniques) for controlling radiation hazards.122 Had
miners been told the true purpose of the study then, even in advance of any
warnings connected with the progress of the research, it is possible the miners
could have used this information to advocate for their interests. Even if the
miners were not well positioned to seek employment elsewhere or to advocate for
improved working conditions, the principle of respect for the self-determination
of others would have required a more straightforward disclosure.

Current guidelines for the ethics of epidemiological research, as well as
current practices, would not counsel the original bargain with the mine owners,
the minimal disclosure made to workers about the purpose of the research, or the
failure to warn the workers as the hazard became clear. For example, the current
Council for International Organizations of Medical Sciences (CIOMS) guidelines
explain: "Part of the benefit that communities, groups and individuals may
reasonably expect from participating in studies is that they will be told of findings
that pertain to their health."123 The CIOMS guidelines also specify a duty not to
withhold, misrepresent, or manipulate data.124 Today, it is widely recognized
among epidemiologic researchers that they have an obligation to report findings
indicating potential or actual harm, along with the uncertainties of those findings,
to the people being studied and to the public at large.

Although the Committee believes that the federal government should have
acted to ensure that the mines were ventilated and that the PHS should have
informed the miners about the severity of the risk it was investigating, the
Committee did not have enough information to assess the moral responsibility of
individual AEC and PHS employees and officials for these failures. Some effort
was made by some investigators to get the states and mine owners to ventilate the
mines, and some warnings may have been given to individual miners. But the
ventilation effort was inadequate and the warnings ineffectual. We lack the
information to evaluate whether officials such as Duncan Holaday, Henry Doyle,
and Merril Eisenbud should have done more than they did to protect the miners,
granting that their superiors had ultimate responsibility for decisions not to press
for ventilation and warnings. Whistleblowing to avert serious harm is an

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important moral responsibility, but there are personal prudential considerations
unknown to us that must be weighed before judging whether these people failed
in their duty.'25

While federal and state agencies may debate internally and with one
another the limits of their authority, from the vantage of those exposed to risk by
the government, the government should be reasonably expected to do what is
needed to sort out responsibility and to ensure that action is taken to address risk.
This did not happen. Perhaps the most remarkable aspect of the uranium miners
tragedy is that, notwithstanding the national security context, so much of it took
place in the open; so many federal and state agencies were participants, often with
some formal degree of responsibility or authority in an unfolding disaster that
appears to have been preventable from the outset.

THE MARSHALLESE

Following World War II, the United States selected the Marshall Islands
as the site of the Pacific Proving Grounds for testing nuclear weapons. The
Marshall Islands are a widely scattered cluster of atolls located just above the
equator north of New Zealand. They were designated a trust territory of the
United States by the United Nations in 1947. The Marshallese were granted
independence under a Treaty of Free Association that went into effect in 1986.
The U.S. Department of the Interior oversees relations with the Marshall Islands,
with responsibility to ensure that the terms of the Trusteeship Agreement are
carried out. According to the 1947 Agreement, the United States as trustee "shall
. . . protect the health of the inhabitants."126

Testing of nuclear weapons began on July 1, 1946, with Operation
Crossroads, two tests at Bikini Atoll. In preparation for this operation, the
Bikinians were evacuated in March of that year. Crossroads did not lead to any
immediate exposure of the native population. However, the second shot in the
series, Baker, was a 21-kiloton underwater blast that contaminated the surviving
test ships, posing major decontamination problems for the military participants. It
also contaminated the atoll itself, which, along with further testing, delayed the
return of the Bikinians, who began returning to the island in 1 969. Although
some radioactive contamination was still known to linger, it was believed at the
time that restrictions on the consumption of certain native foods and provision of
imported foods would make Bikini habitable. Unfortunately, these assumptions
proved wrong. After the resettlement, the AEC and its successors monitored the
internal contamination levels of the Bikinians and observed increases in
plutonium, leading to their reevacuation in 1978.127 Today, the Bikinians remain
scattered around the Marshall Islands, while a new radiological cleanup of their
atoll is in progress.

In 1954, the Bravo shot of the Operation Castle series was detonated at
Bikini Atoll. Bravo was the second test of a thermonuclear (hydrogen) bomb,

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with a yield of 15 megatons, a thousand times the strength of the Hiroshima
bomb. A change in wind direction carried fallout from the test toward Rongelap
and other inhabited atolls downwind of it. The populations of the Rongelap and
Utirik Atolls were evacuated, but not until after they had received serious
radiation exposure (about 200 roentgens on Rongelap and about 20 on Utirik).
What followed was a program by the U.S. government— initially the Navy and
then the AEC and its successor agencies— to provide medical care for the exposed
population, while at the same time trying to learn as much as possible about the
long-term biological effects of radiation exposure. The dual purpose of what is
now a DOE medical program has led to a view by the Marshallese that they were
being used as "guinea pigs" in a "radiation experiment."

As happened at Bikini, the Rongelapese were resettled onto their atoll, but
after an interval of only three years. Again, it was recognized at the time that
some radioactivity remained, but U.S. officials concluded that appropriate dietary
restrictions would minimize the danger.128 Unlike the case of the Bikinians,
however, the medical follow-up program has continued to the present, reflecting
the seriousness of the initial exposure and the added risk of continuing exposure
at low levels. Five years after the Bravo shot, Dr. Robert A. Conard, then the
director of the AEC's Brookhaven National Laboratory (BNL) medical team,
wrote,

The people of Rongelap received a high sub-lethal
dose of gamma radiation, extensive beta burns of
the skin, and significant internal absorption of
fission products. . . . Very little is known of the late
effects of radiation in human beings. . . . The
seriousness of their exposure cannot be minimized.

Low levels of radioactive contamination persist on
Rongelap Atoll. The levels are considered safe for
habitation. However, the extent of contamination is
greater than found elsewhere in the world and, since
there has been no previous experience with
populations exposed to such levels, continued
careful checks of the body burdens of radionuclides
in these people is indicated to insure no unexpected
increase.

From these considerations it is apparent that we are
obligated to carry out future examinations on the
exposed people to the extent that they are deemed
necessary as time goes on so that any untoward
effects that may develop may be diagnosed as soon

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as possible and the best medical therapy instituted.
Any action short of this would compromise our
responsibility and lay us open to criticism.129

These and similar documents discussed below lay out clearly the purposes
of the medical program. However, at the fourth meeting of the Advisory
Committee, representatives of the Republic of the Marshall Islands presented
documents to support their contention that by ignoring forecasts about the
weather patterns at the time of the Bravo shot,130 and by resettling the
Rongelapese on their atoll despite knowledge of residual contamination, the U.S.
government was using the Marshallese as guinea pigs in a deliberate human
radiation experiment.

The Committee heard extensive testimony about the difficulties the
Marshallese have had in obtaining information relevant to their health. Their own
medical records are only now being made readily available to them. Many other
documents describing U.S. government activities conducted on their soil have for
too long been shrouded in secrecy or made inaccessible to the Marshallese by
bureaucratic obstacles. This inaccessibility of records, combined with a history of
inadequate disclosure of hazards known to U.S. researchers, has contributed to a
climate of distrust.

In our review of materials that are now becoming available, we found no
evidence to support the claim that the exposures of the Marshallese, either
initially or after resettlement, were motivated by research purposes. On the
contrary, while there is ample evidence that research was done on the
Marshallese, we find that most of it offered at least a plausible therapeutic
rationale for the potential benefit of the subjects themselves. We have found only
two examples of research in the Rongelap and Utirik populations that appear to
have been nontherapeutic: this research was intended to learn about radiation
effects in this population and offered little or no prospect of benefit to the
individual subjects.

There is, of necessity, some tension between data gathering and patient
care when the same physician is responsible for both. The Advisory Committee
has found no clear-cut instance in which this tension was likely to have caused
harm to patients, but some may have been subjected to biomedical tests for the
primary purpose of learning more about radiation effects. This inherent tension,
coupled with the additional strains of language and cultural differences between
the Marshall Islanders and the physicians, appears to have compromised the
process of informing the subjects of the purpose of the tests and of obtaining their
consent, which has doubtless contributed to their sense of being treated as guinea
pigs. Insensitivity to cultural differences, failure to involve the Marshallese in the
planning and implementation of the research and medical care program, divided
responsibilities for general medical care, and failure to be fully open about
hazardous conditions have all contributed to unfortunate and probably avoidable

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distrust of the American medical program by the Marshallese.

It is of concern to the Advisory Committee that problems arose in
explaining to the Marshallese the nature and purpose of the research activities that
accompanied their treatment and in obtaining their consent for both research-
related interventions (such as bone marrow, blood, dnd Urine tests) and treatment.
Both Brookhaven researchers and the Marshallese agree that general medical care
provided by the Trust Territory government was inadequate,131 but this question
was outside the scope of the Advisory Committee's investigation. What follows,
as best we can piece it together, is the story of how the United States handled its
responsibility to provide medical care to citizens of a U.S. trust territory exposed
to hazard by a U.S. nuclear bomb test that went awry.

The Bravo Shot

The Bravo shot was detonated on Bikini at 6:45 a.m. on March 1, 1954.
Its yield was substantially greater than expected. The radioactive cloud rose to an
altitude of about 100,000 feet before blowing east toward the inhabited atolls of
Rongelap, Ailinginae, and Rongerik, and still farther east, toward Utirik, Ailuk,
and Likiep, instead of north into the Pacific as planned. It was soon clear to the
task force command in charge of the shot that evacuations would be necessary
and by the evening of March 2 a ship was steaming toward Rongelap to remove
the population. Over the next three days, 236 Marshallese were transported by sea
and 28 U.S. servicemen were airlifted from a weather station on Rongerik to
Kwajelain Atoll, south of the fallout pattern, and then to a U.S. naval base with
medical facilities.132

Merril Eisenbud has observed:

There are many unanswered questions about the
circumstances of the 1954 fallout. It is strange that
no formal investigation was ever conducted. There
have been reports that the device was exploded
despite an adverse meteorological forecast. It has
not been explained why an evacuation capability
was not standing by, as had been recommended, or
why there was not immediate action to evaluate the
matter when the task force learned (seven hours
after the explosion) that the AEC Health & Safety
Laboratory recording instrument on Rongerik was
off scale. There was also an unexplained interval of
many days before the fallout was announced to the
public.133

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The Marshallese and Americans were not the only ones exposed to fallout
from Bravo. A 100-ton Japanese fishing vessel with a crew of twenty-three called
the Fukuryu Maru (Lucky Dragon) was sailing some eighty miles from Bikini
when the bomb exploded. Within days, crew members suffered from acute
radiation sickness. Seven months after the test, one of the crew members died.134
The others were hospitalized for more than a year, until May 1955. The event
received international attention and contributed to a worldwide protest of
atmospheric testing of nuclear weapons.

Dr. Victor Bond, a member of the medical team sent from the United
States to treat the exposed population immediately after the accident, said in an
interview with Advisory Committee staff that "initial statements by Washington
officials underplayed the severity of the effects of the exposure."135 Dr. Eugene
Cronkite, who headed the medical team, said he told Lewis Strauss, chairman of
the Atomic Energy Commission in 1954, of his concern that the New York Times
and others had reported a "downright lie" in reporting that the fallout hazard was
minimal.136 Dr. Cronkite recalled Strauss's response: "Young man, you have to
remember that nobody reads yesterday's newspapers."137

On March 6, the task force command approved a request by the Armed
Forces Special Weapons Project to establish a joint study of the "response of
human beings exposed to significant gamma and beta radiation due to high yield
weapons."138 Thus, it appears to have been almost immediately apparent to the
AEC and the Joint Task Force running the Castle series that research on radiation
effects could be done in conjunction with the medical treatment of the exposed
populations.

Medical Follow-up

On March 8, Dr. Cronkite's mission was formally established in a letter to
him that was classified Secret and Restricted Data and said, "The objective of this
project is to study the response of human beings in the Marshall Islands who have
received significant doses due to the fall-out from first detonation of Operation
Castle."139 The project was given the designation 4. 1 and titled, "Study of
Response of Human Beings Exposed to Significant Beta and Gamma Radiation
Due to Fallout from High Yield Weapons."140 The letter continued: "Due to
possible adverse public reaction, you will specifically instruct all personnel in this
project to be particularly careful not to discuss the purpose of this project and its
background or its findings with any except those who have a specific 'need to
know.""41

As Dr. Cronkite understood it, his mission was to "examine and treat the
Marshallese and the American servicemen that were exposed."142 Initial exposure
estimates ranged from 1 5 rad for people on Utirik to 1 50 rad for those on
Rongelap.143 Dr. Bond, who accompanied Dr. Cronkite on the mission, told
Advisory Committee staff that "we were given estimates of dose. But they were

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poor, and we still don't know very well the effects."144 The Marshallese were
exposed to highly penetrating gamma radiation, which resulted in whole-body
exposure, external radiation from deposition of fission products on the skin,
internal radiation from consumption of contaminated food and water and, to a
lesser extent, from inhalation of fallout particles. During the first few days after
Bravo, several of the people from Rongelap were suffering from nausea and
vomiting (the first signs of radiation sickness), depressed white blood cell counts,
and slight hair loss. Only one of the Marshallese exposed on Ailinginae Atoll had
these symptoms, and none from Utirik had them. The American servicemen on
Rongerik were asymptomatic, as well.145

Although the medical program for the exposed Marshallese was
designated a "study," both Dr. Cronkite and his successor, Dr. Robert A. Conard,
maintain the project never included nontherapeutic research.146 Both men assert
that the primary goal has always been the treatment of the exposed population and
that the data that were collected were always intended first and foremost to
benefit the Marshallese. There is no conclusive evidence available to the
Advisory Committee to contradict their statements. In examining various studies
of the Marshallese that could have been driven by pure research goals, the
Advisory Committee has found treatment-related goals that are at least plausible.
It appears that in the medical follow-up to the Bravo shot, treatment and research
objectives were essentially congruent.

Dr. Cronkite and his team arrived on Kwajalein the same day he received
the memorandum establishing their mission. They set up examination and lab
facilities in a building adjacent to the living quarters of the Marshallese and began
their work. Team members took medical histories with the help of translators,
inspected skin to monitor for radiation burns, took body temperatures, drew blood
regularly to check white cell counts, platelet levels, leukocytes, and red cells, took
urine samples, checked for eye injuries, and monitored pregnancies. I47

In the Rongelap population, platelet levels fell to about 30 percent of
normal by the fourth week, white blood cell counts fell to half of normal by the
sixth week, but at the six-week point, when the initial examinations were
completed, these blood elements began moving back up toward normal levels.148
There was substantially less depression of platelet and white cell counts in the
other groups, which received significantly lower doses of radiation. Despite the
low platelet and white cell counts, there appears to have been little unusual
bleeding or increased susceptibility to infection. Dr. Bond, said "There was
some . . . excessive menstruation and blood in the urine ... but nothing that
merited strenuous therapy."149 About ten to fourteen days after exposure, radiation
burns began appearing.150 These burns were much more pronounced among the
Rongelap people than those from Ailinginae or the U.S. servicemen on Rongerik,
and there were no burns noted in the Utirik group. Often the burns were
accompanied by itching and some of the lesions on the top of the feet were
described as painful. In two to three weeks the burns began healing.151 There was

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some weight loss in the exposed population, and about 90 percent of the children
and 30 percent of the adults lost hair.152

Dr. Bond told Advisory Committee staff that the exposed Marshallese
"seemed to be perfectly healthy people [but] we were well aware of the latent
period, and that they might well become ill later." He went on to say:

And quite frankly. I'm still a little embarrassed
about the thyroid. [T]he dogma at the time was that
the thyroid was a radio-resistant organ. . . . [I]t
turned out they had . . . very large doses of iodine . .
. to the thyroid.153

Dr. Cronkite noted that "there was nothing in the medical literature ... to
predict that one would have a relatively high incidence of thyroid disorders."134

In May 1954 the AEC told the DOD that the "Utirik people" could return
home following the completion of the current tests, "provided that specimens
reveal absence of radioactive materials in quantity injurious to health."155 On
Rongelap. however, radiation levels were considered to be too high. The
Rongelapese were moved to Eijit. a small island in Majuro Atoll.1"6 The United
States continues regularly to followup the exposed Rongelapese and Utirikese.
The U.S. servicemen were sent to Honolulu for further examination by Army
physicians.'5 But according to Dr. Cronkite, "Somebody at a higher level within
DOD decided that they did not want to study the American servicemen and cast
them to the wind. Sort of forget them. I think that's a terrible thing to do, but it
was done. Medically, it was unacceptable."1-8 Dr. Cronkite went on to explain
that if an induced cancer had been identified, early diagnosis and treatment might
have benefited the exposed serviceman.1-9 The DOD reported to the Advisory
Committee that twelve of the twenty-eight servicemen were examined in 1979 by
the Veterans Administration as part of a notification and medical examination
program for military personnel exposed to radiation. We have not been able to
determine whether any of the twenty-eight had any other medical follow-up.160

The Ailuk Exposure

According to a report by Lieutenant Colonel R. A. House, based on an
aerial survey done within forty-eight hours of the Bravo blast. "The only other
atoll which received fallout of any consequence at all was Ailuk [it is not clear to
which atolls the word "other" applies]. . . . [I]t was calculated that a [lifetime]
dose would reach approximately 20 roentgens." about the same as or slightly
higher than the exposure of the Utirik population.161 Unlike the people of Utirik
and Rongelap, however, the 401 people of Ailuk, south of Utirik in the eastern
Marshalls, were not evacuated at all. The January 18. 1955. final off-site
monitoring report of Operation Castle, however, gave the Ailuk exposure, based

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on several aerial and ground readings, as 6.14 roentgens. Readings from this
report for other exposed atolls were as follows: Rongerik, 206; Rongelap, 202;
Utirik, 24; Ailinginae, 6.7; Likiep, 2.19; and Wotje, 2.54. I62 People living on
these atolls would be exposed to additional radiation as a result of consuming
contaminated food. Based on the initial reading of 20 roentgens, the U.S. task
force should have evacuated the people of Ailuk. A 1987 epidemiological study
reported in the Journal of the American Medical Association, however, shows
higher rates of thyroid abnormalities on other atolls to the south and east of the
blast site, including Jaluit and Ebon.163

By the afternoon of March 4, two ships, both destroyer escorts, seem to
have been available to evacuate the 400 or so people on Ailuk.164 But according to
Colonel House, "the effort required to move the 400 inhabitants," when weighed
against potential health risks to the people of Ailuk, seemed too great, so "it was
decided not to evacuate the atoll."165 However, evacuation would have reduced
the lifetime exposures of the Ailuk population by a factor of three, according to an
estimate provided by Thomas Kunkle of Los Alamos National Laboratory.166 In
testimony before the Advisory Committee, Ambassador Wilfred Kendall of the
Republic of the Marshall Islands noted that "the United States Government
studied with interest the unexpected and dramatic incidence of thyroid disease on
Utirik Atoll [but] no effort was made to reassess the health of the population on
Ailuk, or Likiep, or other mid-range atolls."167

Resettlement of Rongelap

Between March 1954 and mid-1956, the Rongelap population on Eijit was
followed medically, with visits from a U.S. medical team at six months, one year,
and every year thereafter.168 According to a preliminary report on the two-year
medical resurvey, "There has been little illness among the people [and] none of
the clinical entities noted in the Rongelap people appear to be related in any way
to radiation effect."169

By late 1956, about a dozen radiological surveys of Rongelap and
neighboring atolls had been conducted to determine contamination levels.170 On
February 27, 1957, the AEC informed the commander of the Pacific Fleet that
resettlement was approved'71 despite lingering residual radiation, most
pertinently, in the food supply.172 This decision, which was consistent with
international pressure for resettlement, was made even though in 1954 U.S.
medical officers had recommended that the exposed Rongelapese "should be
exposed to no further radiation, external or internal with the exception of essential
diagnostic and therapeutic x-rays for at least 12 years. If allowance is made for
unknown effects of surface dose and internal deposition there probably should be
no exposure for rest of natural lives."173 However, the displaced Rongelapese
were eager to return to their home island. In March 1956, Dr. Conard wrote to
Dr. Charles L. Dunham, director of the AEC's Division of Biology and Medicine,

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that "we are committed to return the people to their homes and that is their
express wish."174

In June 1957, a final resettlement radiosurvey was made from the air.
Gordon Dunning, an AEC health physicist,wrote he would have preferred a full
survey, but that "it appears we will have to settle for the external readings
only."175 The exposed Rongelap people and 200 other Rongelapese, who were not
on the atoll at the time of the Bravo shot, were returned to their home islands at
the end of June. The Advisory Committee has not been able to learn why
Dunning's advice to carry out a more thorough, land-based survey was not
heeded. A 1957 project report notes that while "the radioactive contamination of
Rongelap Island is considered perfectly safe for human habitation. . . . The
habitation of these people on this island will afford most valuable ecological
radiation data on human beings."176 Nevertheless, the Advisory Committee does
not conclude that the resettlement decision was motivated by AEC research goals.
From 1954 on, the U.S. researchers recognized the importance of the opportunity
that had been presented to gather data on radiation effects. However, we have
seen no evidence, including this report, that convincingly demonstrates that
research goals took priority over treatment in a way that would expose the
populations to greater than minimal risk.

Apart from the radiation deposited by the Bravo shot, there is evidence
that later bomb tests also contributed to the overall radiation level on Rongelap.
For example, a January 1957 letter from Dr. Edward Held, the director of a
University of Washington group conducting ecological studies for the Joint Task
Force, said that "activity levels in the water at Rongelap were higher in July 1956
than the levels . . . obtained at earlier visits [and] the best evidence seems to
indicate that the increase ... is due to the recontamination of Rongelap from the
1956 series of weapons tests."177 The letter goes on to say, "The decay of the
newly added radioactivity is such that it will soon be insignificant when compared
with that from the 1954 series."178

Atmospheric testing of nuclear weapons was ended in 1963 by
international agreement.

Post-Resettlement Medical Follow-up

After the population returned to Rongelap in 1957, Dr. Conard visited
annually with a medical team from Brookhaven National Laboratory.179 The
team's primary mission, according to Dr. Conard, "was to treat the people. I don't
think at any time the motivation . . . was anything other than treatment of the
effects of radiation." He added, however, that "we [also] were trying to get as
much information as we could into the medical literature. We knew that we were
dealing with an area that was unexplored in human beings and we wanted to find
out as much as we could about" the effects of radiation exposure resulting from
fallout from a nuclear explosion.180

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After their return to their native island in 1957, the Rongelapese continued
to be monitored annually by the Brookhaven teams. On Utirik, exams were
carried out every three years, then annually with the appearance of thyroid
abnormalities."*1 The examinations included complete physicals; blood tests;
examinations of reproductive effects including fertility, miscarriages, stillbirths,
observable birth defects/2 and genetic studies; growth and development studies
of children; thyroid function tests and palpation; and studies of absorption,
metabolism, and excretion of radioisotopes.11*3 In addition to the annual exams
conducted in the Marshalls, in 1957 some Marshallese were flown from their
islands to Argonne National Laboratory in Chicago, where a whole-body counter
and other advanced equipment was available."*4 When Marshallese developed
medical problems that required treatment in the United States, such as thyroid
nodules requiring surgery, they were sent to Metropolitan General Hospital in
Cleveland or to other hospitals.185 One eighteen-year-old male was treated in
1972 at NIH and at a Western Reserve University teaching hospital for leukemia,
which proved fatal.'**6

In our search of documents related to the Brookhaven medical program,
the Advisory Committee has found only two examples of studies that were not
primarily intended to benefit the individual participants. In one, a "chelating"
agent (EDTA), normally administered shortly after internal radiation
contamination to remove radioactive material, was administered seven weeks
after exposure. The stated rationale was that the agent would "mobilize and make
detection of isotopes easier, even though it was realized that the procedure would
have limited value at this time."187 Because there was virtually no therapeutic
benefit envisioned, it appears the primary goal of the study was to measure
radiation exposures for research purposes, although the knowledge may have been
helpful in the clinical care of the patient. In the second experiment, a radioactive
tracer (chromium 5 1 ) was used to tag red blood cells in ten unexposed
Rongelapese to measure their red blood cell mass. The purpose was to determine
whether the anemia that had been observed among Marshallese was an ethnic
characteristic or due to their radiation exposures.188 The tracer dose used would
have posed a very minimal risk, but it was clearly not for the benefit of the ten
subjects themselves. The data could, however, have benefited Marshallese
exposed as a result of the Bravo explosion. No documentation addressing
whether consent was sought is available for either experiment.

The AEC was responsible only for continuing studies of the Marshallese
to detect radiation effects and for medical care required for radiation-related
effects, while the Trust Territory government under the Department of Interior
was responsible for general medical care, but this appears to have been a
meaningless distinction to the Marshallese. "All they knew," Dr. Cronkite told
Advisory Committee staff, "is that something had happened to them and they
wanted to be taken care of, very logically."189 Often, Dr. Cronkite noted, the
members of the Brookhaven team did take care of nonradiation-related health

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problems. "Physicians being what they are," he said, "you see disease and there's
something you can do about, you like to take care and help people."190 The
Brookhaven team sometimes included a dentist because severe dental problems
had been observed. The dentist mostly did extractions and "a little restoration."'91
According to Dr. Cronkite, the Marshallese appreciated getting dental care
because "they were getting something they had never had before in their lives and
they liked it."192 Although the extractions appear to have been done for
therapeutic or prophylactic purposes, the extracted teeth were analyzed for
radioactive content.

Primary care, however, remained inadequate. There were serious
epidemics of poliomyelitis, influenza, chicken pox, and pertussis, all of which,
according to Dr. Conard, were imported into the Marshalls by the U.S. medical
teams.193 The epidemics were severe, with high mortality rates, and could have
been prevented by the use of available vaccines. The AEC insisted that primary
care be left to the Trust Territory, which had neither the personnel nor the
equipment to provide adequate services. Dr. Hugh Pratt, who succeeded Dr.
Conard in 1977, wrote as late as December 1978, "The Marshall Islands medical
'system' under the Trust Territory is underfinanced. The professional staff is
undertrained and overworked. Critical supplies are usually not available."194

By 1958, Dr. Conard was aware of Marshallese dissatisfaction with the
annual exams and wrote to Dr. Dunham:

I found that there was a certain feeling among the
Rongelap people that we were doing too many
examinations, blood tests, etc. which they do not
feel necessary, particularly since we did not treat
[emphasis in the original] many of them. Dr.
Hicking and I got the people together and explained
that we had to carry out all the examinations to be
certain they were healthy and only treated those we
found something wrong with. I told them they
should be happy so little treatment was necessary
since so few needed it . . . etc., etc. Perhaps next trip
we should consider giving more treatment or even
placebos.195

Also in 1958, Edward Held, the University of Washington professor
involved in environmental surveys of the islands, wrote to Dr. Conard about a
meeting he had with Amata, son of a paramount chief of the Marshalls, in which
Amata said the Marshallese were "apprehensive about being stuck with
needles."196 Amata, who is now president of the Republic of the Marshall Islands,
asked about the need for continued medical examinations, and Dr. Held told him
that he should talk to Dr. Conard, but Held also wrote that "there have been

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medical benefits not connected with radiation which have resulted from the
medical surveys." Held added that Amata agreed this was true.197

The annual exams given to the people of Rongelap were described by
Konrad Kotrady, a Brookhaven physician resident in the islands from 1975 to
1976, from the Marshallese point of view:

[E]ach March a large white ship arrives at your
island. Doctors step ashore, lists in hand of things
to do, and people to see. Each day a jeep goes out
to collect people for examinations, totally
interrupting the normal daily activities. Each
person is given a routing slip which is checked off
when things are done. They are interviewed by a
Marshallese, then examined by a white doctor who
does not speak their language and usually without
the benefit of a Marshallese man or woman
interpreter. Their blood is taken, they are measured,
and at times, subjected to body scans.198

Eventually, Dr. Conard tentatively arranged for the AEC to pay the Utirik
participants $100 each for their inconvenience.199

A Marshallese who acted as a translator for the Brookhaven team said that
people didn't believe Dr. Conard. According to this man, they began to say, "You
people coming back every 2 years to . . . just do the experiments on us like guinea
pigs."200 According to Dr. Pratt, some of the distrust of Dr. Conard, at least
among the people of Utirik, was the fact that he predicted that there would be no
cases of thyroid carcinoma in this population and one occurred.201 Dr. Kotrady
wrote that "for 22 years, the people have heard Dr. Conard and other doctors tell
them not to worry, that the dose of radiation received at the island was too low to
cause any harmful effects. . . . However . . . [i]t has been found that there is as
much thyroid cancer at Utirik as at Rongelap— 3 cases each. . . . The official
explanation for the high incidence of thyroid cancer at Utirik is unknown at
present. Yet in the people's mind the explanation is that it is a radiation effect
despite what the doctors have said for 20 years."202

In 1961, Dr. Dunham wrote an open letter to the exposed people of
Rongelap in which he explained the need for medical follow-up.203 Dr. Dunham
specified that one reason was the health care of the exposed population, but that
the other was "of no direct value to you (the Rongelap population)." This is the
only instance we found in which a U.S. official explicitly says research is being
conducted that has no direct benefit to the Marshallese population under the care
of the Brookhaven doctors. The letter continued: "The [health studies] help us to
understand better the kinds of sickness caused by radiation. The United Nations
has a special scientific committee to study these things and the information we get

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from our work here is made available to that committee and to the whole
world."204 This letter was rescinded before it was sent, however. Although it was
read once over the radio, the "broadcast probably did not reach the Rongelap
people since there are only three radios on the island."205 Courts Oulahan, the
AEC's deputy general counsel, apparently requested the letter be rescinded,
although the reason for the request is unclear. The district administrator of the
Marshall Islands, William Finale, complied with the request, and the letter was
never published.206

Many complaints resulted from the fact that the U.S. researchers had
difficulty communicating with the Marshallese, most of whom did not speak
English. Information about risk, countermeasures, and radiation was not easily
explained to the Marshallese,207 and cultural differences made it difficult for the
researchers to appreciate relevant Marshallese practices and customs. According
to Dr. Bond, an early member of the medical team, the Brookhaven doctors did
not believe that they needed to obtain consent for treatment or to conduct studies
related to treatment.208 The Brookhaven team offered needed medical care;
therefore, despite complaints, the Marshallese requested extension of the medical
program provided to the Rongelap and Utirik people to include more general
medical care and to include other islands and atolls.209

Thyroid abnormalities, in addition to the one fatal case of leukemia, have
been the most significant late effect of radiation among the Marshallese. These
endpoints appear to have received both extensive study and appropriate treatment.
As thyroid abnormalities began to appear in the Utirik population, the
Brookhaven team felt a need to establish a baseline in an unexposed Marshallese
population.210 Over the years, members of the Ailuk "control" population-at best
an imperfect control population because of their exposure-had emigrated or died
and had been lost to follow-up. This population was too small to provide an
adequate baseline, so the Brookhaven team conducted surveys of 354 people at
Likiep and Wotje Atolls in 1973 and 1976. They also examined more than 900
Rongelap and Utirik people who were not on their home islands during Bravo.2"
It is likely that many if not most of the controls selected had some radiation
exposure resulting from the bomb tests.

During the early 1 970s there were increasing complaints about and
resistance to participation in the medical surveys coupled with the continuing
appearance of thyroid abnormalities, including their development in the less-
exposed Utirik population.2'2 There were also growing numbers of people from
Rongelap and Utirik who, as a result of thyroid surgery or reduced thyroid
function, needed thyroid medication and indications that those on medication
were not adequately complying with their therapeutic regimen.213

As a consequence of all these events, Brookhaven expanded its staff and
medical care programs in the Marshalls in the mid-1970s, including for the first
time primary care for a number of conditions not thought to be radiation related.
Full-time resident staff was increased. In 1973, Brookhaven stationed a full-time

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physician in the Marshalls. "His principal responsibilities included (a) monitoring
the thyroid treatment program, (b) visiting Rongelap, Utirik, and Bikini Atolls for
health care purposes every 3 to 4 months, and (c) assisting the TT [Trust
Territory] medical services with the care of Rongelap and Utirik patients at the
hospitals at Ebeye and Majuro."214

In 1 974, the researchers conducted extensive screening for diabetes, a
nonradiation-related condition, in order to determine the impact of diabetes on the
population and form the basis for development of a program for treatment and
management of this significant problem, which affects 17 percent of the
population.215 In 1976, a new agreement provided for Brookhaven to provide
examinations and health care for all Marshallese living on Rongelap and Utirik
when they made their visits and for the resident Brookhaven physician to assist in
the care of Rongelap and Utirik patients at the hospitals at Ebeye Island in
Kwajelein Atoll and Majuro, the capital of the Marshall Islands in the Majuro
Atoll.216 In 1977, an extensive program to diagnose and treat intestinal parasites
was carried out.217

By 1 978, administrative responsibility in the Trust Territory government
shifted to the individual island groups. The Marshallese at this point took
responsibility for general health care.218 While the 1947 Trusteeship Agreement
provided for health care for the Marshall Islanders, the Department of the Interior
carried out this responsibility mainly in an oversight capacity. The Department of
Energy carried on the programs of its predecessor agencies for treating radiation-
related illnesses in the people of Rongelap and Utirik. During this period the
Brookhaven medical team often treated nonradiogenic as well as radiogenic
medical conditions.219

In 1985, expressing concern that radioactivity in the food chain
represented a significant health hazard, the people of Rongelap rejected the
Department of Energy's advice that they stay on their island. At their own request
they were evacuated on the Greenpeace ship Rainbow Warrior to Majetto Island
in Kwajelein Atoll, where they remain today. In 1994 the National Research
Council published a report that, among other things, reviewed food-chain data
collected and analyzed by Lawrence Livermore National Laboratory. According
to this report,

On the basis of current radiation dose estimates,
there is no expectation that any medical illness due
to exposure to ionizing radiation will occur in any
members of the resettlement population of the
island of Rongelap from either intake of native
foods or environmental contact.220

However, the report recommended that no categorical assurances be given
the people of Rongelap that their annual exposure upon returning would be less

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than the 100-mrem limit agreed to in a 1992 memorandum of understanding
between the Republic of the Marshall Islands and the United States. Moreover,
the report recommended an initial diet in which half the food consumed would be
from nonnative sources and that no food be gathered from the northern islands of
Rongelap and Rongerik Atolls.22'

In 1986 a Compact of Free Association went into effect between the
United States and the Republic of the Marshall Islands.222 The compact
established a $150 million fund to compensate the Marshallese for damage done
by the U.S. nuclear testing program.223 The United States accepted "responsibility
for compensation owing to citizens of the Marshall Islands ... for loss or damage
to property and person of the citizens of the Marshall Islands "224

At present there are three separate health care programs for citizens of the
Republic of the Marshall Islands. There is a program of general health care for all
citizens for which the Marshallese government is solely responsible; there is a
Four Atoll Program, which is run by the Marshallese, but funded by the United
States at about $2 million a year225 (the atolls that benefit from this program are
Bikini, Enewetak, Rongelap, and Utirik), and there is the continuation of the
Brookhaven program, which is responsible for medical monitoring and care
related to radiation exposure. The Lawrence Livermore National Laboratory
conducts environmental surveys as part of the Brookhaven program, whose total
cost is about $6 million a year.226 The funding for this entire program is
discretionary and can be reduced or eliminated by Congress.

Conclusions About the Marshallese

The United States has a special responsibility to care for the radiation-
related illnesses of the exposed Marshallese because of its role as trustee and
because it caused the exposures. As best the Advisory Committee can determine,
it is carrying out this responsibility well. Treatment has been provided as needed
for acute effects, monitoring continues to this day, and latent radiation effects
have been identified early and treated. The research conducted between 1954 and
today consisted mainly of blood and urine tests and procedures to measure
radiation with little or no additional risk to the subjects. Overall, these tests seem
to have been related to patient care, although two instances of minimal-risk
nontherapeutic research have been identified. The Committee found no evidence
that the initial exposure of the Rongelapese or their later relocation constituted a
deliberate human experiment. On the contrary, the Committee believes that the
AEC had an ethical imperative to take advantage of the unique opportunity posed
by the fallout from Bravo to learn as much as possible about radiation effects in
humans.

Nevertheless, the inherent conflicts posed by combining research with
patient care could perhaps have been reduced by clearer separation of the two
activities and clearer disclosure to the subjects. For the most part, consent for

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tests and treatment appears to have been neither sought nor obtained. Although
lack of consent for minimal-risk procedures performed on a patient population
was not atypical for the time (see chapter 2), the Committee believes efforts
should have been made to ensure that the people being monitored and treated
understood what was being done to them and why, and their permission should
have been sought.

While cultural and linguistic differences made communication with the
Marshallese difficult at first, the Advisory Committee believes the situation
continued for much too long. As a consequence, dietary differences and other
eating habits were not recognized and may have led to higher exposures among
some members of the population. Cultural differences may also have resulted in
an inadequate accounting of adverse reproductive outcomes. Certainly,
differences in pace and lifestyle contributed to a perception by the Marshallese
that they were being told what to do rather than asked. The Advisory Committee
was unable to determine whether the early medical teams should have been more
aware of such cultural differences, but they do appear to have been slow to learn.

The BNL medical team was constrained by instructions from the U.S.
government to restrict its activities to treatment and research related to radiation-
related illnesses. General medical care was held to be the responsibility of the
Trust Territory government. However, there was no adequate medical service
available to refer other complaints to, so the BNL physicians were put in an
awkward situation where, as doctors, they felt obliged to treat conditions that
were presented to them. The lack of clear lines for general medical care in the
early years of the program seriously compromised relations with the Marshallese.
Since the Marshall Islands were a trust territory, both general medical care and
care for radiation injuries were ultimately the responsibility of the United States,
and the care of individuals should not have suffered as a result of bureaucratic
confusion. Thus the Committee commends the expansion of the BNL program in
the 1970s to include general health care, and the U.S.-supported Four Atoll
Program that went into effect after the Compact of Free Association was
approved in 1986. It may be, depending on factors such as food-chain and other
environmental exposure levels, that certain midrange atolls such as Ailuk and
Likiep also merit inclusion.

THE IODINE 131 EXPERIMENT IN ALASKA

In 1956 and 1957 the U.S. Air Force's Arctic Aeromedical Laboratory
conducted a study of the role of the thyroid gland in acclimatizating humans to
cold, using iodine 131. Like the case of the Marshallese, this study is another
instance in which research conducted on populations that were unfamiliar at the
time with modern American medicine posed special ethical problems and was
therefore of interest to the Advisory Committee. The study involved 200
administrations of 1-131 to 120 subjects: 19 Caucasians, 84 Eskimos, and 17

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Indians,227 with some subjects participating more than once. Animal studies had
suggested the thyroid gland might play a crucial role in adaptation to extreme
cold. This experiment was part of the laboratory's larger research mission to
examine ways of improving the operational capability of Air Force personnel in
arctic regions. The results of the study were published in 1957 as an Air Force
technical report by the principal investigator, Dr. Kaare Rodahl, M.D., a
Norwegian scientist hired by the U.S. Air Force for his expertise-rare at the time-
-in arctic medicine.228 Many observational studies of Alaska Natives were carried
out by a variety of researchers in the 1950s and 1960s; most of these did not
administer radiation to the natives, but only measured what had already
accumulated in their bodies from fallout.229 The thyroid study discussed here,
however, differed in that it actively administered radionuclides to natives, raising
more direct questions of consent, risk, and subject selection. The Alaskan 1-131
experiment also offered subjects no prospect of medical benefit.

This study is the subject of a review by a committee of the Institute of
Medicine and the National Research Council. The IOM/NRC committee was
mandated by legislation passed by Congress in 1993 and began operation in June
1994, including an on-site investigation of the experiments.230

To the extent possible, the IOM/NRC committee has provided the
Advisory Committee with information but, in accordance with its own
procedures, has kept its own deliberations confidential. The IOM/NRC report was
not available to the Advisory Committee, as it had not been completed by the time
the Committee had concluded its deliberations. We did not conduct our own on-
site investigation of the Alaskan experiments. Instead, we have relied on
published materials (primarily Rodahl's 1957 report on the study, "Thyroid
Activity in Man Exposed to Cold") and those observations presented to the
Committee in testimony by representatives of the IOM/NRC committee, as well
as by representatives of the Inupiat villages of the North Slope of Alaska where
the research was conducted. More detailed study may always, of course, lead to
different factual conclusions. The Advisory Committee was concerned with
understanding the experiments well enough to develop general remedial
principles to be applied to more detailed factual findings completed by others.

According to Dr. Chester Pierce of Harvard Medical School, chair of the
IOM/NRC committee, in 1994 Dr. Rodahl recalled that the base commander at
the Artie Aero-medical Laboratory approved the study, and headquarters in
Washington knew of the experiment.231 Participants in the study were asked to
swallow a capsule containing a tracer dose of radioiodine. Measurements were
then made of thyroid activity, using a scintillation counter, and samples taken of
blood, urine, and saliva.232 The study's overall conclusion was that "the thyroid
does not play any significant role in human acclimatization to the arctic
environment when the cold stress is no greater than what is normally encountered
by soldiers engaged in usual arctic service or by Alaskan Eskimos or Indians in
the course of their normal life or activities."233 One minor consequence of the

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experiment was to have the noniodized salt in the local stores replaced with
iodized salt. Follow-up, Dr. Rodahl told the IOM/NRC Committee, was left to the
Alaska Native Service, which was already aware of a goiter problem in these
communities.234 Alaska natives testifying in 1994 before the IOM/NRC
committee could not recall any follow-up visits by physicians, according to Dr.
Pierce.235

Risk

The Advisory Committee did not undertake a detailed dose reconstruction
or assessment of the scientific quality of the research, since these tasks were
already being undertaken by the IOM/NRC committee. The actual capsules of
iodine 131 were prepared in continental U.S. laboratories. As was common at the
time, the principal investigator, Dr. Rodahl, took a one-week course on the proper
handling and administration to humans of iodine 131.236 He then instructed the
other physicians who would be working in the field. Doses were officially
reported to range from 9 to 65 microcuries of iodine 131, with most being
approximately 50 microcuries. The doses below 50 microcuries were due to the
natural reduction in the radioactivity of the ready-made capsules during the long
trip to remote regions.237 (To compensate for the low doses, longer scanning
times were used in the field, but in the 1957 report these results were judged to be
unreliable.)238 According to Dr. Pierce, Dr. Rodahl stated in 1994 that the dosage
was standard at the time for tracer studies. This was the dose he had been taught
in his training course; the dosage was approved by the AEC.239

In terms of dosage and risk, the experiment was not significantly different
from tracer studies conducted in the continental United States with two
exceptions. First, some subjects were used more than once; several Alaska Native
subjects reported they received as many as three doses.240 Second, the subjects
included women who were pregnant or lactating. Dr. Pierce reported that
testimony at the IOM/NRC hearings in Alaska indicated that at least one subject
may have been pregnant at the time; technical reports, he said, state that two
female subjects may have been lactating at the time.241 Although the AEC
discouraged the nontherapeutic use of radioisotopes in pregnant women, such
research was sometimes conducted. What sets the Alaska experiment apart from
other studies conducted on pregnant and lactating women is that this experiment
was not investigating a research question about an aspect of pregnancy or
lactation.

As discussed in detail in chapter 6, from its mid- 1940s inception the
AEC's radioisotope distribution program required prior review of "human uses" of
radioisotopes to ensure that risks were minimized and safety precautions were
followed. (In 1952 the Air Force issued a rule that required prior review for
experiments, but the rule was limited to research conducted at Air Force medical
facilities.242) As discussed in chapter 6, in 1949 the AEC's Human Use

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Subcommittee expressly discouraged the use of radioisotopes for research with
children or pregnant women.

Disclosure and Consent

This experiment offered no prospect of medical benefit to subjects. If the
subjects in this experiment did not understand and agree to this instrumental use
of their bodies, then they were used as mere means to the ends of the
investigators and the Air Force. It was at this time conventional for investigators
to obtain the consent of "normal" (healthy) subjects or "volunteers" in
nontherapeutic research. This tradition was particularly strong in the military
services (see part I). It was also recognized by the AEC at least by February 1956
when the AEC's radioisotopes distribution program explicitly stated that where
normal subjects are to be used they must be "volunteers to whom the intent of the
study and the effects of radiation have been outlined."243

The Committee is not aware of any documents from the time of the
experiment that bear on what, if anything, the subjects were told and whether
consent was obtained. There are also no documents bearing on whether the Air
Force provided the researchers with guidelines on the use of human subjects or
requirements for obtaining consent. However, documents available to the
Committee indicate that the radioisotopes used by the Arctic Aeromedical
Laboratory and Dr. Rodahl were obtained by the Air Force under license from the
AEC.244 The AEC's provision for healthy volunteers, as just quoted, was included
in the AEC's publicly available materials and presumably should have been
known to-and abided by--those conducting government research programs
involving AEC provided radioisotopes.245

The only available evidence comes from personal recollections of the
principal investigator and a few of the former subjects. Dr. Rodahl recalled in
1994 that he obtained white volunteers through their military commanders and
Indian and Eskimo volunteers through the village elders.246 When a military
volunteer came before him, he explained, in the subject's native tongue (English),
the purpose of the study and what a subject would do and gave the person the
opportunity to decline to participate.247 When visiting the villages, the physicians
could not communicate directly in the native language. They would find an
English-speaking village elder and explain the purpose of the study. The elder
would then find people to serve as subjects. What communication occurred
between the village elder and the prospective subjects is not known. According to
members of the IOM/NRC committee, Dr. Rodahl recalled that, although all
potential subjects were given the opportunity not to participate, all of the Indians
and Eskimos who reported did participate in the experiment.248

Dr. Rodahl also reported that he did not use the term radiation in his
explanation to the English-speaking village elders who then communicated with
others in the villages. Interviews in 1994 by the IOM/NRC committee indicated

601

Part II

that there is no word for radiation in the native languages. One Alaska Native
subject, interviewed by the IOM/NRC committee in 1994, recalled that at the time
he worked in a hospital, spoke English, and did know about "radiation." He could
not recall any use of the term in the study.249 In at least one village— Arctic
Village— there were no English speakers. Subjects from this village testified in
1 994 to the IOM/NRC that they thought they were taking a substance that would
improve their own health and that they would not have participated in the study if
they had known it required them to take a radioactive tracer.250

These accounts raise difficult ethical questions about authorization and
consent, questions made the more difficult by an incomplete historical record. It
is, for example, unclear whether the village elders were employed solely as
translators who were asked to transmit individual requests for permission to
potential subjects, or whether Dr. Rodahl was responding to the perceived
authority of the village elder who then "volunteered" members of his community.
Thus we do not know what the individual subjects were told or whether their
individual permission was sought. Today we continue to debate whether, when
human research is conducted in cultures where tribal or family leaders have
considerable authority over members of their communities, it is ever appropriate
to substitute the permission of these leaders for first-person consent.251

Even if the procedure used for securing authorization through the tribal
leaders was appropriate, the available evidence suggests that the leaders may not
have understood, and thus were not in a position to communicate to the subjects,
that the experiment was nontherapeutic, that it had a military purpose, or that it
involved exposure to low doses of radiation. The ethical difficulties posed by the
language barrier were exacerbated by a significant cultural barrier. The Indian
and Eskimo villages had little exposure to modern medicine. One village— Point
Lay-is described in Rodahl's 1957 report as "relatively little affected" by the
modern world.252 There is a strong likelihood that there was no appreciation for
the difference between treatment of a patient and research unrelated to any illness
of the subject.

The danger of exploitation was further heightened by the trusting
relationship that developed between the native Alaskans and the field researchers.
In part, this trust was the customary welcome given to visitors; in part it was due
to the desire for medical care. In at least one village, harsh conditions may have
increased the need for outside assistance. Rodahl's report states that Point Lay
had suffered from semistarvation the previous year.253 Dr. Pierce testified to the
Advisory Committee that "in the mid-1950s, doctor visits to native villages were
quite scarce." Dr. Rodahl said when his plane landed, the villagers would come
running to meet him and the other physicians who came with him, and the
villagers would immediately want their ailments treated. He said the physicians
treated them because they were medical men. He also said "the natives trusted
them, and they trusted the natives."254 Testimony before the IOM/NRC
committee included the recollection of one participant that he had been paid $10

602

Chapter 12

for the study; in other testimony it appears some subjects may have believed there
was an implicit quid pro quo, trading medical treatment for participation/55 The
testimony suggests that at least some subjects understood that part of what was
being done to them was not medical care.

Subject Selection

The selection of Alaskan Indians and Eskimos as subjects for this research
was not arbitrary. In order to better understand acclimatization and human
performance under conditions of extreme cold, it was reasonable and potentially
important to study people who lived under such conditions. At the same time,
however, the population chosen was not one familiar with modern medicine, but
rather a population for whom the treatments of modern physicians were a strange
but valued innovation, and the research activities of modern medicine were totally
unknown. As a consequence, the potential for misunderstanding and exploitation
was significant. The Committee does not know whether there were at the time
other populations also acclimated to cold weather who were better positioned than
Alaskan Indians or Eskimos to be genuine volunteers for this nontherapeutic
experiment. There has been no evidence that any attempt was made to explain the
military purpose of the study to the Indians or Eskimos. Thus, in general, there
was no oversight-or even knowledge--of how the village elders recruited
participants and explained the nature of the experiment.

CONCLUSION

The three cases discussed in this chapter all raise troubling questions that
will stay with us into the future, but they do so in different ways, and with
different consequences.

The iodine 1 3 1 experiment conducted in Alaska was conventional
biomedical research, although, as discussed in chapter 1 1, the subject population
and its environment were also the object of observational study related to the
effects of fallout from nuclear weapons. This experiment took place at a time (the
mid-1950s) when the government's rules requiring disclosure and consent in the
use of radioisotopes with healthy subjects were established and public; the
available documented evidence suggests that these rules were not followed. The
evidence also suggests that, like the Marshallese, the Eskimos and Indians in
Alaska were, in the 1950s, unacquainted with modern medical science and
therefore unlikely to understand the nature and purpose of the research.

As a result of the 1954 Bravo shot, the Marshallese (and those exposed
American servicemen and Japanese fishermen) experienced the largest peacetime
exposures from fallout from detonation of nuclear weapons, and as a consequence
of subsequent detonations, they were subjected to further exposures. The
biomedical research that was conducted by the United States in the aftermath of

603

Bravo raises basic questions about the obligations of researchers when long-term
study is coupled with treatment, particularly in a setting where communication is
difficult and the subjects otherwise have inadequate medical care.

Of all those covered in this report, the uranium miners were the single
group that was put most seriously at risk of harm, with inadequate disclosure and
with often-fatal consequences. The failure of the government and its researchers
to adequately warn uranium miners who were continually being studied is
difficult to comprehend; but the greater question is why, with the knowledge that
they had, government agencies did not act to reduce risk in the mines in the first
place.

604

ENDNOTES

1 . Downwinders at the Nevada Test Site were exposed to lower levels of fallout
during the same period as the Marshallese. The residents of Hiroshima and Nagasaki
were exposed mainly to neutron and gamma radiation from the bomb's explosion.

2. Peter H. Eichstaedt, If You Poison Us: Uranium and Native Americans (Santa
Fe, N.M.: Red Crane Books, 1994), 35-36.

3. Undated document ("Radiation Exposure in the United States-Uranium
Mining Industry") (ACHRE No. HHS-092694-A), 1.

4. The Advisory Committee also heard extensive testimony from uranium
millers and open-pit uranium miners who expressed dissatisfaction that their health
problems were not covered by RECA, as were those of the underground miners. The
health problems of the uranium millers appear to have been overshadowed by the clearly
established problems of the underground miners and have received little attention in the
scientific literature: only three articles have been located by the Advisory Committee.
These papers show modest increases in certain cancers (notably lung and lymphatic) and
nonmalignant respiratory disease and contain recommendations that these problems merit
further study. No excess bone cancer, leukemia, or chronic renal disease has been
reported, however. The most recent publication found by the Advisory Committee is
dated 1983, and we are not aware of any further studies currently under way.
Nevertheless, the millers and open-pit miners attest to numerous health problems they
associate with their occupational exposures. See V. E. Archer, S. D. Wagoner, F. E.
Lundin, "Cancer Mortality Among Uranium Mill Workers," Journal of Occupational
Medicine 15(1973): 1 1-14; A. P. Polednak and E. L. Frome, "Mortality Among Men
Employed Between 1 943 and 1 947 at a Uranium-Processing Plant," Journal of
Occupational Medicine 23 (1981): 169-178; R. J. Waxweiler et al., "Mortality Patterns
Among a Retrospective Cohort of Uranium Mill Workers" in Epidemiology Applied to
Health Physics, Proceedings of the 16th Midyear Topical Meeting of Health Physics
Society, Albuquerque, N.M., 9-13 January 1983, 428-435.

5. Robert N. Proctor, Cancer Wars: How Politics Shapes What We Know and
What We Don 't Know About Cancer (New York: Basic Books, 1 995), 1 86.

6. William C. Hueper, Occupational Tumors and Allied Diseases (Springfield,
111.: C.C.Thomas, 1942).

7. Ibid., 438.

8. Egon Lorenz, "Radioactivity and Lung Cancer," Journal of the National
Cancer Institute 5 (August 1944): 13.

9. Duncan Holaday to Chief, Industrial Hygiene, 20 November 1950 ("Radon
and External Radiation Studies in Uranium Mines") (ACHRE No. IND-091394-B).

10. Duncan Holaday, Chief, Occupational Health Field Station, Public Health
Service, "Employee Radiation Hazards and Workmen's Compensation," Joint Committee
on Atomic Energy, 86th Cong., 1st Sess. (1959), 190.

1 1 . See Lorenz, "Radioactivity and Lung Cancer."

12. William F. Bale to Files, 14 March 1951 ("Hazards Associated with Radon
and Thoron") (ACHRE No. DOJ-05 1 795-A), 3-8.

13. Ibid., 6.

14. J. Newell Stannard, Radioactivity and Health: A History (Oak Ridge, Tenn.:
Office of Scientific and Technical Information, 1988), 138.

605

15. See Lorenz, "Radioactivity and Lung Cancer," for a review of animal
experimentation, 7-10.

1 6. National Cancer Institute, Radon and Lung Cancer Risk: A Joint Analysis of
II Underground Miners Studies, January 1994.

1 7. Dorothy Ann Purley, Advisory Committee on Human Radiation
Experiments, small panel meeting, Santa Fe, N.M., proceedings of 30 January 1995
(morning session), 82-83.

18. Philip Harrison, Advisory Committee on Human Radiation Experiments,
proceedings of 21 June 1995.

19. Merril Eisenbud, An Environmental Odyssey (Seattle: University of
Washington Press, 1990), 43.

20. B. S. Wolf, Medical Director, NYOO, to P. C. Loshy, Manager, Colorado
Area Office, 19 July 1948 ("Medical Survey of Colorado Raw Materials Area") (ACHRE
No. IND-091394-B),2.

2 1 . Health Impact of Low-Level Radiation: Joint Hearing before the
Subcommittee on Health and Scientific Research of the Senate Committee on Labor and
Human Resources and the Senate Committee on the Judiciary, 96th Cong., 1st Sess.
(1979), 40-41.

22. "A-Bomb Metal Affects Lungs, Doctor Reveals," Cleveland News, 22
September 1948.

23. Atomic Energy Commission, Manager of the New York Operations Office,
15 September 1949 ("Policy Regarding Special Beryllium Hazards") (ACHRE No. DOE-
01295-B), 11.

24. Merril Eisenbud, telephone interview by Steve Klaidman (ACHRE staff), 7
July 1995 (ACHRE No. IND-070795-B), 1.

25. George Hardie to John Bowers, 29 December 1949 ("Statement of Policy on
Be.") (ACHRE No. DOE-012595-B), 1.

26. Ibid., 2.

27. Shields Warren, Director, Division of Biology and Medicine, to W. E.
Kelley, Manager, New York Operations Office, 17 January 1950 ("Proposed AEC Staff
Paper on Beryllium Policy") (ACHRE No. DOE-012595-B), 1-2.

28. Eisenbud, Environmental Odyssey, 61. The DBM's position was apparently
based on the view that the Atomic Energy Act did not give authority to the AEC until
after the ore was mined. "The position of the New York Operations Office," Eisenbud
wrote, "was that while the act did not require that the AEC be responsible for uranium
mine safety, neither did it prevent the agency from doing so."

While the Committee did not locate the early AEC legal opinions on this
question, as discussed in the text, we did find documentation of AEC lawyer reassertion
of this position in the late 1950s.

29. Ibid., 62.

30. Ibid.

31. Interview with Eisenbud, 7 July 1995, 1.

32. A. E. Gorman, AEC Sanitary Engineer, to Files, 26 May 1949 ("Visit of
Lewis A. Young, Director, Division of Sanitation, Colorado Department of Health")
(ACHRE No. DOE-051 195-A), 1.

33. Ibid.

34. The radium standard was set in 1941 when the Navy came to Robley Evans,
a leading radiation researcher. A committee was established and came up with a standard

606

based on data on twenty-seven human beings who had been exposed to radium, twenty of
whom had been injured. Evans went around the room and asked each of the men for a
standard they would feel comfortable having their wives or daughters work with and they
agreed on 0.1 /<Ci. Robley D. Evans, "Inception of Standards for Internal Emitters,
Radon and Radium," Health Physics 14 (September 1981): 441-443.

35. Stannard, Radioactivity and Health, 1 3 1 - 1 32. Stannard adds in a footnote
on page 131:

This standard was not intended to be applied to the
mines. The Europeans were totally involved with the
war. In the Western Hemisphere, there were not yet
enough uranium mines per se to worry about exposure
standards. Uranium mining in the United States had
hardly begun. In 1967, NCRP representative Lauriston
Taylor testified at the congressional hearings on
Secretary of Labor Williard Wirtz's proposed uranium
mine standard that the 1941 standard was meant for
"indoor" environments "where it is quite feasible to
accomplish any degree of ventilation . . . that might
seem indicated."

According to Taylor, the PHS was handling the situation in the mines, so the NCRP
stayed out of it. Radiation Exposure of Uranium Miners, Part One: Hearings before the
Subcommittee on Research. Development, and Radiation of the Joint Committee on
Atomic Energy, 90th Cong., 1st Sess. (1967).

36. Begay v. United States, 591 Supp. 991 (D. AZ, 1984), 1013.

37. Duncan A. Holaday, August 1994 ("Origin, History and Development of the
Uranium Study") (ACHRE No. DOJ-051795-A), 2.

38. Begay v. United States, 994.

39. Undated document ("Progress Report [July 1950 - December 1951] on the
Health Study in the Uranium Mines and Mills") (ACHRE No. DOJ-051795-A), 3.

40. Duncan Holaday, Radiation Exposure of Uranium Miners, Part One, JCAE
(1967), 601.

41. Federal Radiation Council, Preliminary Staff Report, No. 8, Radiation
Exposure of Miners, Part One, JCAE (1967), 1038.

42. Henry N. Doyle, Senior Sanitary Engineer, USPHS, undated ("Survey of
Uranium Mines on Navajo Reservations, November 14-17, 1949 and January 11-12,
1950") (ACHRE No. DOJ-051795-A), 1.

43. Duncan A. Holaday, "Origin, History and Development of the Uranium
Study," 5.

44. Ibid., 12.

45. Deposition of Duncan A. Holaday, Bamson v. Foote Mineral Co., 9 October
1985,25.

46. "Progress Report (July 1950-December 1951) on the Health Study in the
Uranium Mines and Mills," 4-5, 8.

47. Duncan A. Holaday, Senior Sanitary Engineer, Radiation Unit, Division of
Industrial Hygiene, to Chief, Industrial Hygiene Field Station, 21 February 1950 ("Radon
Samples in Uranium Mines") (ACHRE No. DOJ-051795-A), 1.

607

48. Public Health Service, Division of Industrial Hygiene, proceedings of 25
January 1951 (ACHRE No. HHS-092794-A), 1.

49. Ibid.

50. Ibid., 2.

51. Ibid.

52. Ibid.

53. Duncan Holaday to J. W. Hill, General Superintendent, U.S. Vanadium
Company, 26 March 1951 ("I'm sorry that Dr. Cralley . . .") (ACHRE No. IND-091394-
B).

54. "Progress Report (July 1950-December 1951) on the Health Study in the
Uranium Mines and Mills," 1 1.

55. Ibid.

56. Duncan Holaday, "Radiation Exposure of Uranium Miners," Subcommittee
on Research, Development, and Radiation, 1967, 23.

57. A 1975 report written for National Institute for Occupational Safety and
Health (NIOSH) and released by the National Technical Information Service provides
the following analysis of the behavior of both the industry and the states: "The early
uranium mining industry, was unstable, extremely transient and highly speculative. It
was both ill-equipped to remedy the mine radiation hazard and resistant to encroachments
by the government. ..." The report also says that in the absence of actual cases of lung
cancer "companies, official agencies and miners alike remained unconvinced of the need
for preventative measures to control mine radiation." Jessica S. Pearson, "A Sociological
Analysis of the Reduction of Hazardous Radiation in Uranium Mines," National
Technical Information Service, PB-267 503 (April 1975), 12.

58. Henry N. Doyle, Senior Sanitary Engineer, Division of Occupational Health,
to Chief, Division of Biology and Medicine, AEC, 26 May 1952 ("I am pleased to
transmit . . .") (ACHRE No. DOE-061395-E), 1. Doyle wrote: "This is a restricted report
[An Interim Report of a Health Study of the Uranium Mines and Mills] and is only being
circulated to companies engaged in the production of uranium ores, certain federal
agencies concerned with the problem, and the Universities of Rochester, Colorado and
Utah."

59. Associated Press, "Survey Shows Miners Unhurt by Radiation," 26 June
1952. The lead paragraph reads: "Examinations of more than 1,100 workers in uranium
mines and mills have revealed no evidence of health damage from radioactivity." The
existence of the press release suggests the report was generally available; however, the
May 1 952 letter discussing it, as cited immediately above, indicated that it would be
available on a "restricted" basis.

60. Federal Security Agency and Colorado State Department of Public Health,
May 1952 ("Interim Report of a Health Study of the Uranium Mines and Mills")
(ACHRE No. DOE-061395-E), i.

61 . Wilhelm C. Hueper, undated, "Organized Labor and Occupational Cancer
Hazards" (ACHRE No. HHS-042495-A), 9-10. Wilhelm C. Hueper, "Adventures of a
Physician in Occupational Cancer: A Medical Cassandra's Tale" (1976). Unpublished
autobiography, Hueper Papers, National Library of Medicine (ACHRE No. HHS-
042495-A), 177-178.

62. W. C. Hueper, M.D., to Dr. R. F. Kaiser, Chief, Cancer Control Branch,
NIH, 3 April 1952 ("Re.: Cancer Control Grant") (ACHRE No. IND-083094-A), 4.

63. Proctor, Cancer Wars, 44.

608

64. Duncan Holaday testified in 1983 that "the Division of Industrial Hygiene
[PHS] had no right of entry to any facility. We had to have the permission of the owner
of the facility in order to get on the property." Begay v. United States, Civ. 80-982 Pet.
WPC, transcript of trial proceedings, 3 August 1983 (ACHRE No. DOJ-051795-A), 1 14.
With respect to AEC-owned mines, E. C. Van Blarcom of the AEC noted that "the
Commission ha[d] carried out independent observations in mines under its control." In
addition, the AEC requested that the Bureau of Mines conduct its own independent
investigation because of "its statutory responsibility to assist, on request, other Federal
and State agencies in matters concerning mine safety and health." Department of Health,
Education, and Welfare, PHS, 16 December 1960 ("Proceedings of the Governors'
Conference on Health Hazards in Uranium Mines") (ACHRE No. DOJ-051795-A), 29.

65. Barnson v. Foote Mineral Co., Consolidated Action Nos. C-80-01 19A, C-
81-0719W, C-81-0045W & C-81-0715J, deposition taken upon oral examination of
Duncan Holaday, 9 October 1985 (ACHRE No. DOJ-051795-A), 12. Begay v. United
States, Civ. 80-982 Pet. WPC, transcript of trial proceedings, 3 August 1983, 116-119.

66. Begay v. United States, 116-119.

67. Ibid., 119.

68. Department of Health, Education, and Welfare, Public Health Service, Rev.
5-60 ("Uranium Miner Study Record, PHS 2766, Rev. 5-60") (ACHRE No. IND-0 12395-

A), 1.

69. Deposition of Duncan Holaday, Barnson v. Foote Mineral Co., 12.

70. Stewart Udall, The Myths of August (New York: Pantheon Books, 1994),

199.

71. Merril Eisenbud, interview by Steve Klaidman (ACHRE) 7 July 1995, 1.

72. Federal Security Agency and Colorado State Department of Public Health
("An Interim Report of a Health Study of the Uranium Mines and Mills") (ACHRE No.
DOE-032195-B), 3-5, 6.

73. P. W. Jacoe to Lester Cleere, 28 March 1951 ("Regarding a Discussion with
Uranium Producers on Radon Gas Problems in Mines") (ACHRE No. IND-083094-A),

1.

74. Duncan Holaday, Joint Committee on Atomic Energy, Subcommittee on
Research, Development and Radiation, 26 July 1967, 90th Cong., 1st Sess., 1213.

75. Advisory Committee for Biology and Medicine, transcript of proceedings of
13-14 January 1956 (ACHRE No. DOE-072694-A), 22, 23-24.

76. Advisory Committee for Biology and Medicine, transcript of January 13-14.
1956 (ACHRE No. DOE 072694- A), 7. Some state regulators and mine owners took the
position that the imposition of a strict safety standard would have resulted in the closing
of large numbers of small mines. While conceivably the cost to the federal government
of ventilating hundreds of small mines could have been prohibitive, the federal
government does not appear to have invoked this claim as a basis for inaction.
According to Duncan Holaday, the cost of ventilating these mines would have translated
to an increase of 50 cents to $1 a pound in the price of uranium, and the average price of
fully processed uranium was in the range of $20 a pound. Richard Hewlett, Francis
Duncan, and Oscar Anderson, Jr., Atomic Shield (Berkeley: University of California
Press, 1990), 173. The second volume of a history of the AEC cites a 1948 estimate of
about $20 for uranium mined and processed in the United States.

77. L. E. Burney, Surgeon General, to C. L. Dunham, 27 October 1958 ("Since
1950, as you know . . .") (ACHRE No. IND-083094-A).

609

78. C. L. Dunham to A. R. Luedecke, 1 1 March 1959 ("Letter from Surgeon
General to C. L. Dunham Concerning Radiation Exposure to Miners in Certain Mines")
(ACHRE No. DOE-040395-A), 2.

79. L. K. Olson, AEC, General Counsel, to C. L. Dunham, 1 1 March 1959
("Health Hazards in Uranium Mines") (ACHRE No. DOE-040395-A).

80. Department of Health, Education, and Welfare, "Proceedings of the
Governors' Conference on Health Hazards in Uranium Mines," 29-33.

81. Begay v. United States, 591 F. Supp. 991 (D. AZ., 1984), 1002.

82. Duncan A. Holaday, "Origin, History and Development of the Uranium
Study," 12.

83. Ibid., 14.

84. Ibid., 16.

85. Begay v. United States, Civ. 80-982 Pet. WPC, transcript of trial proceedings
(3 August 1983), 152.

86. Department of Health, Education, and Welfare, Public Health Service and
U.S. Department of the Interior, Bureau of Mines ("Uranium Miners: Your Ounce of
Prevention") (ACHRE No. IND-083094-A).

87. Ibid., 8.

88. Ibid., 4.

89. Health Impact of Low-Level Radiation, 24.

90. Ibid., 25.

91 . Department of Health, Education, and Welfare, "Proceedings of the
Governors' Conference on Health Hazards in Uranium Mines," 17-23.

92. Holaday, "Radiation Exposure of Uranium Miners," 88.

93. A working level is any combination of short-lived radon daughter products
per liter of air that releases an amount of energy equal to the energy that would be
released by the short-lived daughter products in equilibrium with 100 picocuries of radon
per liter of air.

94. Holaday, "Radiation Exposure of Uranium Miners," 89. Wirtz explained:
"Since so much of the uranium ore mined in this country is used by mills which have
contracts with the Atomic Energy Commission, the Public Contracts Act [Walsh-Healey]
authority has clear applicability to the uranium miners situation. This has not been
questioned, except with respect to certain details regarding the coverage of 'independent'
mines (those not owned or operated by the milling companies). The AEC contracts with
the mills contain broadly phrased 'health and safety' stipulations in accordance with the
Public Contract Act Requirements."

95. George T. Mazuzan and J. Samuel Walker, Controlling the Atom (Berkeley:
University of California Press, 1984), 308.

96. Begay v. United States, 591 F. Supp. 991, 1007.

97. Under U.S. law, the federal government may be sued only in circumstances
in which it waives its sovereign immunity. The Federal Torts Claims Act spells out these
circumstances. Under that law, the federal government cannot be sued when the actions
complained of are "discretionary functions" of government. Ibid., 1007-1013. The
general theory behind this limitation is that the ability of officials to govern would be
seriously compromised if their basic decision making were routinely subject to court
challenge. The judge in the Begay case concluded that because "conscious policy
decisions based on political and national security feasibility factors" were involved, he
had no authority provide a remedy. Ibid., 1012.

610

98. Ibid., 1013.

99. Ibid., 1011-1012.

100. Federal Security Agency and Colorado State Department of Public Health
("An Interim Report of a Health Study of the Uranium Mines and Mills"), 9.

101. Mazuzan and Walker, Controlling the Atom, 3 1 7.

102. Duncan Holaday, deposition, 19 March 1986, Begay v. United States, Civ.
80-982, and Anderson v. United States, Civ. 81-1057 (ACHRE No. IND-091494-A),
102.

103. Begay v. United States, 591 F. Supp. 991, 995.

104. On the question of the economic impact of ventilation costs on the price of
uranium from U.S. mines (which was already significantly higher than that from the
Belgian Congo, but was, of course, a more secure source), Eisenbud noted in 1956:
"While it has a big effect on the price of ore, by the time you get it into a reactor or into a
bomb that differential is insignificant." ACBM, transcript of proceedings of 13-14
January 1956 (ACHRE No. DOE-012795-C), 35. See also, Victor Archer, interview by
Ken Verdoia (KUED-TV, Salt Lake City, Utah), transcript of audio recording, July 1993
(ACHRE No. CORP- 122794- A), 14.

105. Begay v. United States, 591 F. Supp. 991, 997.

106. Ibid.

107. Ibid.

108. Richard Lemen, Assistant Surgeon, to D. A. Henderson, Deputy Director,
National Institute of Occupational Safety and Health, 12 May 1995 ("Populations at
Risk: The Ethics of Observational Data Gathering"). This was a response to a draft
ACHRE chapter sent to the agency for review.

109. National Cancer Institute, National Institutes of Health, Radon and Lung
Cancer Risk: A Joint Analysis of 11 Undergound Miner Studies, Publication No. 94-3644
(Washington, D.C.: National Institutes of Health, January 1994).

1 10. Committee on the Biological Effects of Ionizing Radiation, Health Risks of
Radon and Other Internally Deposited Alpha- Emittters, BEIR IV (Washington, D.C.:
National Academy Press, 1986).

111. The average risk estimate for all eleven mining cohorts is 0.49 percent per
WLM, which translates to a "doubling dose"-the dose at which the probability of
causation equals 50 percent~of 204 WLM.

1 12. For example, the doubling dose for the Colorado cohort is 238 WLM,
whereas for the New Mexico cohort it is only 58 WLM. The doubling dose is as low as
84 WLM under age fifty, and exposures at different latency periods should be
accumulated with different weights. A consistent "inverse dose rate effect" was found,
such that a long low-dose-rate exposure is much more hazardous than a short, intense one
(this is the reverse of the usual pattern for x rays and gamma rays). Thus, exposures at a
dose rate of greater than 15 WL have 1/10 the effect of those at a rate of less than 0.5
WL, or equivalently a 35+ year exposure is 13.6 times more hazardous than one of less
than 5 years.

1 13. The studies differ considerably in the quality of data available on smoking
and on the pattern of interactions between smoking and radon found. Because of these
limitations, a joint analysis of smoking and the above temporal modifiers was not
attempted for all studies. One analysis gives an estimated doubling dose of 97 WLM for
nonsmokers and 294 WLM for smokers in all cohorts combined. The latter figure is
close to the 300 WLM figure specified for smokers in RECA. However, for specific

611

cohorts, the results are quite different. Neither the Colorado nor the New Mexico cohorts
show any significant differences in slope between smokers and nonsmokers, although the
estimated slopes appear to vary in opposite directions. In the Colorado cohort, the
doubling doses are higher for smokers, whereas in the Naw Mexico cohort the doubling
doses are lower for smokers.

1 14. The report estimates that 59 percent of the lung cancer deaths in the
Colorado cohort and 66 percent of the New Mexico deaths are attributable to radon
exposure (87 percent and 47 percent, respectively, among nonsmokers, 59 percent and 74
percent among smokers).

115. These uncertainties (95 percent confidence limits) are typically of the order
of sevenfold, with about 90 percent of the estimates being based on extrapolations from
other mines or other years in the absence of any actual measurements.

1 16. The court in the Begay decision concluded that the epidemiological study
and the conduct of the researchers were consistent with the "medical, ethical and legal
standards of the 1940s and 1950s." The researchers "were not experimenting on human
beings. They were gathering data to be used for the establishment of enforceable
maximum standards of radiation. ..." Begav v. United States, 591 F. Supp. 991, 997-
998.

1 1 7. The PHS could have conducted its research on only the small number of
mines that were not privately owned.

118. 42 C.F.R. § 1.103 quoted in Begay v. United States, 591 F. Supp. 991,
1011.

119. Federal Security Agency and the Colorado State Department of Public
Health ("An Interim Report of a Health Study of the Uranium Mines and Mills"), i.

120. For example, see the May 1952 "Interim Report of a Health Study of the
Uranium Mines and Mills" compiled by PHS and the Colorado State Department of
Public Health; "Proceedings of the Governors' Conference" held in 1960; and
correspondence between the Industrial Hygiene Field Station and mining concerns.
Duncan A. Holaday, Senior Sanitary Engineer, to J. W. Hill, General Superintendent,
U.S. Vanadium Company, 26 March 1951 ("I'm sorry that Dr. Cralley . . .") (ACHRE No.
IND-091394-B).

121. Department of Health, Education, and Welfare, undated ("Uranium Miner
Study Record, PHS 2766, Rev. 5-60") (ACHRE No. IND-012395-C), 1.

122. Uranium Study Advisory Committee, proceedings of 3 December 1953
(ACHRE No. DOE-012595-B), 1.

1 23. International Guidelines for Ethical Review of Epidemiological Studv
(Geneva: CIOMS, 1991), 13.

124. Ibid., 18.

125. Judith Sweazey and Stephen Scher, "The Whistleblower as a Deviant
Professional: Professional Norms and Responses to Fraud in Clinical Research,"
Whistleblowing in Biomedical Research, proceedings of a workshop, 21-22 September
1981, 180-2. President's Commission for the Study of Ethical Problems in Medicine and
Biomedical Research, 1981.

126. U.S. Department of State, "Trusteeship Agreement," reprinted in Trust
Territories of the Pacific Islands, 1993, appendix B.

127. According to a 1976 Lawrence Livermore National Laboratory Study:
"Bikini Atoll may be the only global source of data on humans where intake via ingestion
is thought to contribute the major fraction of plutonium body burden. ... It is possibly

612

the best available source of data for evaluating the transfer of plutonium across the gut
wall after being incorporated into biological systems." W. L. Robison and V. E.
Noshkin, 27 September 1976 ("Plutonium Concentration in Dietary and Inhalation
Pathways at Bikini and New York") (ACHRE No. DOE-021795-A), 15.

128. Due to cultural differences and the language barriers, however, Marshallese
dietary customs were unknown or ignored. For example, differences in the eating habits
between men and women may have led to higher exposure in women. The differences of
retention of radionuclides by coconut and land crabs also were not recognized by the
American doctors. Ambassador Wilfred Kendall, Advisory Committee on Human
Radiation Experiments, proceedings of 15 February 1995; Gordon Dunning to A. H.
Seymour, 13 February 1958 ("Operational Responsibilities").

129. Robert Conard to L. H. Farr, 2 June 1959 ("Future Marshallese Surveys").

130. See for example, Joint Task Force-7, spring 1954 ("Operation Castle-
Radiological Safety, Final Report") (ACHRE No. CORP-063095-A), K-3; and R. A.
House, 1 March 1954 ("Memo for the Record").

131. Robert Conard, Fallout: The Experiences of a Medical Team in the Care of
a Marshallese Population Accidentally Exposed to Fallout Radiation (Upton, N.Y.:
Associated Universities, Inc., September 1992) (ACHRE No. DOE-082494-A), 15.

132. Jonathan Weisgall, Operation Crossroads (Annapolis, Md.: Naval Institute
Press, 1994), 303.

133. Merril Eisenbud, interview with ACHRE staff, 12 September 1995
(ACHRE No. ACHRE-091895-A).

134. There has been a diffference of opinion regarding whether the death, caused
by liver disease, was due to radiation exposure or a blood transfusion received after the
incident. Stannard, Radioactivity and Health, 914.

135. Victor Bond, interview by Gil Whittemore and Faith Weiss (ACHRE staff),
1 December 1994, transcript of audio recording (ACHRE Research Project, Interview
Program Series, Targeted Interview Project), 57.

1 36. Eugene Cronkite, interview by Gil Whittemore and Faith Weiss (ACHRE
staff), 1 December 1994, transcript of audio recording (ACHRE Research Project,
Interview Program Series, Targeted Interview Project), 42.

137. Ibid.

138. Commander, Joint Task Force-7, to Chief, Armed Forces Special Weapons
Project, 6 March 1954 ("Project 4.1 Study. . .") (ACHRE No. DOE-033195-B).

139. E. K. Gilbert, Commander Task Unit 13, USAF, to Commander Eugene P.
Cronkite, 8 March 1954 (Letter of Instruction to Cmdr. Eugene P. Cronkite, USN")
(ACHRE No. DOE-033195-B).

140. Ibid.

141. Ibid.

142. Interview with Cronkite, 1 December 1994, 37.

143. Gordon Dunning, Biophysics, to John Bugher, Division of Biology and
Medicine, 8 June 1954 ("Basis for Estimation of Whole Body Gamma Dose to Exposed
Personnel in the Pacific") (ACHRE No. DOE-033195-B).

144. Interview with Bond, 1 December 1994,36.

145. Naval Station Kwajalein to AEC, 16 March 1954 ("Pastore, Hollifield, and
staff. . .") (ACHRE No. DOE-033195-B).

146. Robert A. Conard, telephone interview with Steve Klaidman (ACHRE
staff), 29 June 1995; Interview with Cronkite, 1 December 1994, 60.

613

147. Project Officers for Follow-up Studies on Marshallese to John Bugher,
DBM, 20 July 1954 ("Plans for the first follow-up study on the Marshallese") (ACHRE
No. DOE-051095-B), 3.

148. Cronkite et al., "Response of Human Beings Accidentally Exposed to
Significant Fallout Radiation," Journal of the American Medical Association ( 1 October
1955): 427-434.

149. Interview with Bond, 1 December 1994, 38.

150. Ibid.

151. Cronkite et al., "Response of Human Beings Accidentally Exposed," 433.

152. Ibid.

153. Interview with Bond, 1 December 1994, 42.

154. Interview with Cronkite, 1 December 1994,67.

155. Francis Midkiff, High Commissioner, Trust Territories of the Pacific
Islands, to Major General P. W. Clarkson, Joint Task Force-7, 6 May 1954 ("Dr. John
Bugher . . . conferred with my staff. . . ") (ACHRE No. DOE-033195-B).

156. Ibid.

157. Director, Project l-M-54, to Surgeon General, 5 July 1954 ("Report of 1-
M-54 on 30 Servicemen Exposed to Residual Radiation at Operation Castle") (ACHRE
No. DOD-092394-C), 2.

158. Interview with Cronkite, 1 December 1994, 46.

159. Ibid.

160. Colonel Claud Bailey, Department of Defense, Radiation Experiments
Command Center, to David Saumweber, ACHRE staff, 14 July 1995 ("DNA response to
ACHRE Request 070695-B").

161. Lieutenant Colonel R.A House, undated, "Discussion of Off-Site Fallout,"
in Operation Castle, Radiological Safety, Final Report," vol. 1, spring 1954 (ACHRE
No. CORP-063095-A), K-59.

162. Alfred J. Breslin and Melvin E. Cassidy, 18 January 1955 ("Radioactive
Debris From Operation Castle Islands of the Mid-Pacific") (ACHRE No. DOE-033195-
B).

163. Thomas Hamilton et al., "Thyroid Neoplasia in Marshall Islanders Exposed
to Nuclear Fallout," Journal of the American Medical Association (7 August 1987): 630.

164. House, "Discussion of Off-Site Fallout," K-59.

165. Ibid.

166. Thomas Kunkle, Los Alamos, to Ellyn Weiss, Office of Human Radiation
Experiments, 17 April 1995 ("More Comments on the Draft ACHRE Chapter"), 19.

1 67. Ambassador Wilfred Kendall, Advisory Committee on Human Radiation
Experiments, proceedings of 15 February 1994.

168. Conard, F allout, 15.

169. Robert A. Conard, undated, "Preliminary Report on the Two- Year Medical
Resurvey of the Rongelap People" (ACHRE No. DOE-033195-B).

170. Gordon Dunning, Division of Biology and Medicine, November 1956
("Review of Data: Radioactive Contamination of Pacific Areas from Nuclear Tests")
(ACHRE No. DOE-051095-B).

171. Holmes & Narver, Inc., November 1957, "Report of Repatriation of the
Rongelap People," prepared for the Albuquerque Operations Office of the AEC (ACHRE
No. DOE-033195-B), 1.18.

614

172. K. E. Fields to Anthony Lausi, Department of the Interior, 4 March 1957
("The Atomic Energy Commission . . .") (ACHRE No. DOE-033195-B).

173. Eugene Cronkite to Commander, Joint Task Force-7, 21 April 1954 ("Care
and Disposition of Rongelap Natives") (ACHRE No. DOE-051995-B).

174. Robert A. Conard to Charles L. Dunham, 28 March 1956 ("The medical
team . . .") (ACHRE No. CORP-062295-B).

175. Gordon M. Dunning, Health Physicist, Division of Biology and Medicine,
to C. L. Dunham, Director, Division of Biology and Medicine, 13 June 1957 ("Resurvey
of Rongelap Atoll") (ACHRE No. CORP-072195-B). In a 13 February 1958
memorandum to Dr. A. H. Seymour of the Division of Biology and Medicine, Dunning
characterized the radiological survey as "a poor second alternative" that provided "only a
small part of the data we should have obtained." Gordon M. Dunning to A. H. Seymour,
13 February 1958 ("Operational Responsibilities") (ACHRE No. CORP-072195-B).

176. Robert Conard etal., March 1957 ("Medical Survey of Rongelap and Utirik
People Three Years After Exposure to Radioactive Fallout") (ACHRE No. DOE-033195-

B), 22.

177. Lauren R. Donaldson, University of Washington, to Allyn H. Seymour,
Division of Biology and Medicine, AEC, 1 1 January 1957 ("During a conversation . . .")
(ACHRE No. CORP-072195-B).

178. Ibid.

179. Robert Conard, Review of Medical Findings in a Marshallese Population
Twenty-Six Years After Accidental Exposure to Radioactive Fallout (Upton, N.Y.:
Associated Universities, January 1980), 8.

180. Dr. Robert A. Conard, interview by Steve Klaidman, 30 June 1995.

181. Conard, Fallout, 15.

1 82. According to an interview with Marshallese senator Tony deBrum, taboos
would have kept Marshallese women from reporting births of severely deformed children
to the BNL medical team. Senator Tony deBrum, interview with Steve Klaidman
(ACHRE staff), 16 July 1994.

183. Robert Conard, Three Year Report, 22-23.

184. Ibid., 6.

1 85. Robert Conard, Fallout, 26.

186. Ibid., 24.

187. E. L. Cronkite, V. P. Bond, and C. L. Dunham, Some Effects of Ionizing
Radiation on Human Beings (Washington, D.C.: Atomic Energy Commission, July
1956) (ACHRE No. CORP-062295-A), 75 .

188. Undated, "Evaluation of Total Body Water and Blood Volume Using
Marshallese Individuals" (ACHRE No. CORP-062295-B).

189. Interview with Cronkite, 1 December 1994, 59.

190. Ibid.

191. Ibid., 60.

192. Ibid.

193. For example, Conard noted, "Polio was introduced into the Islands by an
infected sailor from a visiting ship. A widespread epidemic occurred, with nearly 200
cases of paralysis." Conard, Fallout, 14.

1 94. Hugh Pratt, "Position Paper for the Marshall Islands Study from
Brookhaven National Laboratory," 1 December 1978 (ACHRE No. DOE-051094-A).

615

195. Robert Conard to Charles Dunham, 5 June 1958 ("I sent you a letter . . .")
(ACHRE No. CORP-012395-A), 2.

196. Edward E. Held to Robert A. Conard, 16 September 1958 ("We have been
back in Seattle . . .") (ACHRE No. CORP-062295-B).

197. Ibid.

198. Konrad Kotrady, "The Brookhaven Medical Program to Detect Radiation
in the Marshallese People," 1 January 1977 (ACHRE No. CORP-062295-B), 5.

199. Robert A. Conard to John R. Totter, 4 November 1970 ("I have just
returned . . .") (ACHRE No. DOE-052695-A).

200. Ezra Riklon, interview by Holly Barker, transcript of audio recording, 18
August 1994, provided by Marshallese Embassy (ACHRE No. CORP-092694-A).

201. Dr. Hugh Pratt, telephone interview with ACHRE staff, 29 July 1995
(ACHRE No. ACHRE-091895-A).

202. Kotrady, "Brookhaven Medical Program," 8.

203. Charles L. Dunham to the People of Rongelap, 2 February 1961.

204. Ibid.

205. Robert Conard to Courts Oulahan, Deputy General Counsel, AEC, 17 April
1961 ("In regard to our telephone conversation . . .") (ACHRE No. CORP-062295-B).

206. Ibid.

207. Conard, Twenty-Six Year Report, vi.

208. Bond, interview with ACHRE staff, 1 December 1994, 80-81.

209. Kotrady, "Brookhaven Medical Program," 13.

2 1 0. Conard, Twenty-Six Year Report, vi.

211. Ibid.

212. Martin Biles, AEC, Division of Operational Safety, to Julius Rubin
Assistant General Manager for Environment and Safety, 13 March 1972 ("Summary of
Activities Related to Several Pacific Atolls") (ACHRE No. DOE-033195-B), 2.

213. Conard, Twenty-Six Year Report, v.

214. Conard, Twenty-Six Year Report, v.

215. Ibid., 44.

216. Ibid., v-vi.

217. Ibid., vi.

218. Jim Beirne, Senate Energy Committee, interview with Steve Klaidman
(ACHRE staff), 3 July 1995 (ACHRE No. ACHRE-091895-A).

219. Conard, Fallout, 14; Conard, Twenty-Six Year Report, vi.

220. National Research Council, Radiological Assessments for Resettlement of
Rongelap in the Republic of the Marshall Islands (Washington, D.C.: National Academy
Press, 1994), 86.

221. Ibid., 6-7.

222. Compact of Free Association, 48 U.S. C, sec. 177(c).

223. Ibid.

224. Ibid., sec. 177(a).

225. Interview with Beirne, 3 July 1995.

226. Ibid.

227'. Kaare Rodahl, M.D., and Gisle Bang, D.D.S., "Thyroid Activity in Men
Exposed to Cold," Technical Report 57-36 (Alaskan Air Command, Arctic Aeromedical
Laboratory, Ladd Air Force Base: October 1957) (ACHRE No. CORP-071294-A), 81.
Charts appearing in the report indicate slightly different subject numbers.

616

228. Loren Setlow, Advisory Committee on Human Radiation Experiments,
transcript of proceedings of 16 March 1995, 440.

229. For an extensive bibliography see Robert Fortuine, M.D., et al., "The
Health of the Inuit of North America," Arctic Medical Research 52, supplement 8 (1953):
86-91. All fifty-one studies listed under "Radiobiology and Radioactive Substances" are
either reports on monitoring fallout or survey articles.

230. The IOM/NRC Committee's members are Professor Chester M. Pierce,
Harvard Medical School; Dr. David Baines, native Alaskan physician; Professor Inda
Chopra, UCLA School of Medicine; Associate Professor Nancy M. P. King, University
of North Carolina School of Medicine; Professor Kenneth Mossman, Arizona State
University. Administering the committee is Loren Setlow, director of the NRC's Polar
Research Board. The committee is examining the 1-131 study to determine compliance
with contemporaneous guidelines for human subject research; compliance with
contemporaneous and modern radiation exposure standards; notification of participants
of possible risk; and whether follow-up studies should have been conducted. The
IOM/NRC committee will make recommendations to the Department of Defense, which
must then report to Congress.

23 1 . Chester Pierce, Advisory Committee on Human Radiation Experiments,
transcript of proceedings of 16 March 1995, 429.

232. Rodahl and Bang, "Thyroid Activity in Men Exposed to Cold," 75-77.

233. Ibid., 83.

234. Pierce, Advisory Committee on Human Radiation Experiments, transcript
of proceedings of 16 March 1995, 433.

235. Ibid., 433-434.

236. Ibid., 429.

237. Rodahl and Bang, "Thyroid Activity in Men Exposed to Cold," 3.

238. See Loren Setlow, Advisory Committee on Human Radiation Experiments,
transcript of proceedings of 16 March 1995, 442. Concerning longer scanning times, see
Rodahl and Bang, "Thyroid Activity in Men Exposed to Cold," 32.

239. Pierce, Advisory Committee on Human Radiation Experiments, transcript
of proceedings of 16 March 1995, 430-431.

240. Ibid., 430-431.

241. Ibid., 432.

242. Department of the Air Force, "Research and Development, Clinical
Research," AFAR 80-22 (28 July 1952).

243. Atomic Energy Commission, Division of Civilian Application, "The
Medical Use of Radioisotopes: Recommendations and Requirements by the Atomic
Energy Commission, " February 1956 (ACHRE No. NARA-082294-A-96), 15.

244. See 15 March 1957 letter from Kaare Rodahl, M.D., to Colonel D. M.
Alderson, USAF, Deputy Chief, Preventive Medicine Division, Office of the Surgeon
General ("In accordance with your letter of June 21, 1956 . . .") (ACHRE No. NAS-
072195-A), and 26 April 1957 letter from Cecil R. Buchanan, Assistant Chief, Byproduct
Licensing Branch, Isotopes Extension, Division of Civilian Application, to Colonel Jay F.
Gamel, Headquarters, Air Material Command, United States Air Force ("License no. 46-
50-1") (ACHRE No. NAS-072195-A).

245. Ibid., 1-2.

246. Pierce, Advisory Committee on Human Radiation Experiments, transcript
of proceedings of 16 March 1995, 429.

617

247. Ibid., 434.

248. Ibid., 436.

249. Ibid.

250. Ibid., 437.

25 1 . C. C. Ijsselmuiden and R. R. Faden, "Research and Informed Consent in
Africa: Another Look," New England Journal of Medicine 326, no. 12 (1992): 830-834.

252. Rodahl and Bang, "Thyroid Activity in Men Exposed to Cold," 15.

253. Ibid., 16.

254. Pierce, Advisory Committee on Human Radiation Experiments, transcript
of proceedings of 16 March 1995, 435.

255. Chester Pierce and Loren Setlow, Advisory Committee on Human
Radiation Experiments, transcript of proceedings of 16 March 1995, 454.

618

13

Secrecy, Human Radiation
Experiments, and Intentional

Releases

W hen news reports of human radiation experiments sponsored by the
government appeared in late 1993, most citizens were startled to learn about such
seemingly secret activities. However, some said that there was nothing new or
secret; not only had such experiments been the subject of government inquiry in
prior years, but they also had been openly published in the medical literature, and
even the popular press, at the time they were performed. Not unlike the atomic
bomb itself, human radiation experiments were said to be the darkest of secrets
and yet no secret at all. What was secret about human experiments and what was
not? This chapter, drawing on what we have reported and adding some new
material, summarizes what we have learned about both the rules governing
secrecy in human subject research and data gathering and the actual practices
employed.

To most citizens it is axiomatic that openness in government is a
cornerstone of our society. We believe this is so for many reasons. In a
democracy, the free flow of information is essential if we are to choose our
governmental leaders, understand their policy choices, and hold them
accountable. In our society, when the government puts citizens at risk, those
citizens reasonably expect to be informed-both in advance about the potential
risks and in retrospect about the consequences. In the tradition of science, as well

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as that of democracy, secrecy has often been said to be anathema. Good science
requires the testing of theories and findings, and the open flow of information is
essential to this end.

Yet we also know that the government must keep some secrets for reasons
of national security. But national security may not be the only reason the public
cannot obtain information about government activities. In the absence of an
affirmative requirement that the government must provide the public with access
to information-such as the Freedom of Information Act (FOIA), enacted in
1966-much information that is not classified under secrecy laws is, for practical
purposes, out of the citizen's reach. Even under FOIA, access can be denied for
reasons other than national security.1 Finally, the government can make
information public in a form--such as technical research reports-that is too
obscure or costly to be within the practical reach of many citizens. In short, our
discussion of secrecy must begin, but not end, with information intentionally
concealed through the formal system of classification.2 It must also cover
information that is intentionally concealed through other means and information
that may not have been intentionally concealed but remains inaccessible to the
public.

The government's use of secrecy is a measure of its citizens' ability to
understand, participate in, and trust government. Because the government must
keep some secrets, the measure of public trust, therefore, is not simply whether
secrets are kept but the integrity of the rules used to keep them. The question,
then, is not simply whether secrets were kept. Were the rules governing secrecy
clear and known to all? Were they reasonable? Were they honored in practice?

To answer these questions, we begin by describing the rules of secrecy
that governed the the AEC and the Defense Department at the beginning of the
Cold War. We found that in addition to national security, classification
guidelines instructed officials to keep secrets for other reasons, including the
protection of the "prestige" of the government.

We begin reviewing the practices of secrecy with the story of a debate
within the early AEC over declassification of Manhattan Project human radiation
experiments. While publicly professing the need to limit secrecy in science to
matters of national security, the AEC kept information on experiments secret for
reasons of public relations and liability. We next turn to the practice of secrecy
that began roughly in 1950. We have learned that since that time, human subject
research (including those that served military purposes) have typically not been
classified. Nonetheless, some important information on human radiation
experiments was still concealed from the public. After these two sections on the
practices of secrecy in clinical research, we turn to the issue of secrecy in
environmental releases of radiation. When radiation was released into the
environment, the government concealed information for reasons that included but
were not limited to national security. Finally, we look at the government's
practice of record keeping. The government records that the Advisory Committee

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and the Human Radiation Interagency Working Group have retrieved are
invaluable, and the history described in this report could not have been told
without them. At the same time there are important gaps in the records that limit
the public's ability to know about the rules and practices of secrecy, and most
important, the activities that were conducted-in whole or in part-in secret.

While the Cold War is over, the choices faced by biomedical officials and
researchers from the onset of the period, and the decisions they made, have
substantial relevance today. Early AEC leaders and biomedical advisers came
from traditions of science and democracy that recognized that while some secrets
must be kept, secrecy is corrosive, and over the longer term secrecy itself can
endanger national security. At the same time, these individuals were confronted
with continued temptation to keep secrets out of concern that public opinion about
sensitive matters would itself imperil programs they believed to be important.
The boundary between legitimate concern for national security requirements and
concern for the consequences of public opinion was continually tested. The
problem of defining this boundary, and ensuring its integrity, remains with us
today. So, too, does the no less important question of the means of ensuring
public trust in cases where secrecy is merited. In what follows we seek to
determine what can be learned from the experience of those for whom the
question of defining the rules of secrecy and putting them into practice was
routine and essential.

NATIONAL SECURITY AND GOVERNMENTAL PRESTIGE:
THE LEGAL TRADITION INHERITED BY COLD WAR
AGENCIES

To many citizens, the idea of secrecy in government is linked to the idea
of "national security secrets" or "classified information." As we have noted, the
government also keeps secrets that fit in neither of these categories. The system
of classification, nonetheless, occupies a special place in governmental secrecy.
Classified information is accessible only to those who have been "cleared"
following investigation and who agree to abide by the rules regarding access to
this information; the violation of these rules can result in severe criminal
penalties.3

Today, classification is limited to matters of national security. At the start
of the Cold War, however, the legitimate reasons for classification were not so
limited. The legal tradition that information can only be classified for reasons of
national security was just beginning to displace a tradition that allowed
classification for other interests of state.

The authority to classify information derives from legislation and from
presidential executive order. In 1917, Congress passed the Espionage Act to
address wartime spying,4 and further legislation providing for military secrets was
enacted in 1938.5 In 1940 President Franklin D. Roosevelt issued the first

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executive order on classification, which was based on the authorization of the
1938 law enacted to protect military installations and equipment.6

The regulations that interpreted the World War I law declared that secrets
could be kept not only for national security reasons but also for other reasons. In
1936, for example, the Army issued rules that provided for Secret, Confidential,
and Restricted information. The definition of Confidential provided that

A document will be classified and marked
"Confidential" when the information it contains is
of such nature that its disclosure, although not
endangering our national security, might be
prejudicial to the interests or prestige of the Nation,
an individual, or any governmental activity, or be of
advantage to a foreign nation [emphasis added].7

Similarly, data could be classified Secret where it might endanger national
security "or cause serious injury to the interests or prestige of the Nation, an
individual, or any government activity [emphasis added]."8

The Manhattan Project's "Security Manual" followed the Army rules,
requiring classification of information as Confidential, and even at the higher
level of Secret, in the absence of likely harm to national security.9 Before the end
of World War II, therefore, there was precedent for using the classification system
to do more than protect national security.

The era of atomic energy presented the government with unique questions
of secrecy. The government built the atomic bomb behind an extraordinary shield
of wartime secrecy. The very existence of the newly created communities
surounding AEC laboratories in Los Alamos, New Mexico; Hanford,
Washington; and Oak Ridge, Tennessee; was a secret. Children at Oak Ridge
schools did not use their full names, and houseguests were introduced as "Mr.
Smith."10 Following the Hiroshima bombing, the government faced the somewhat
paradoxical task of protecting its single most important military secret while
having to inform the public, if not the world, about both the hazards and
peacetime spinoffs that the creation of the bomb had engendered-from radiation
fallout and waste to nuclear power and radioisotopes for medical research and
treatment.

At the war's end, a committee (known after its chair as the Tolman
Committee)" convened to determine what information from the Manhattan
Project should be declassified. In its report, the Tolman Committee concluded
that "in the interest of national welfare it might seem that nearly all information
should be released at once."12 But national welfare had to be considered in light
of national security. Still, "it is not the conviction of the [Tolman] Committee
that the concealment of scientific information can in any long term contribute to
the national security of the United States."13 The progress of science, the

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committee reasoned, depends on the free flow of information, and long-term
national security depends on the progress of science. In the short term, however,
the security of the nation required some secrecy. Thus, the Tolman Committee
concluded that secrecy could be justified for reasons of national security and then
only if "there is a likelihood of war within the next five or ten years."14 Applying
this general philosophy to the question of secrecy in medical research, it
recommended that "all reports on medical research and all health studies" be
immediately declassified except for those reports that contained information
independently classified in the interest of short-term national security.15

While the Tolman Committee report generally advocated openness, it also
set the precedent for keeping declassification guides secret. The report
recommended that "the whole of the Declassification Guide should not, however,
be generally distributed since it gives an overall picture of the whole project and
makes mention in certain instances of extremely secret matters. The portions of
the Declassification Guide needed for the work of anyone concerned with
declassification should be made available."16 By following this recommendation,
the AEC, and later the Department of Energy, would keep from the public the
ever-accumulating rules governing weapons-related information. Indeed, the first
three declassification guides covering information on nuclear weapons, published
in 1946, 1948, and 1950, were declassified only in 1995. I7

In 1946 Congress enacted the Atomic Energy Act, which, in creating the
AEC, expressly addressed the protection of atomic energy information. The act
provided that all information related to atomic energy was to be considered as
Restricted Data (RD) until the AEC reviewed it and decided that it should be
unprotected (RD was, therefore, said to be "born secret").18 The act prohibited the
unauthorized disclosure of RD (making it a capital crime to do so in the course of
espionage) and prohibited anyone from receiving access to it without first
receiving a security clearance. At the same time, however, the act instructed the
AEC not to protect information if the AEC did not consider its disclosure harmful
to the national security. Thus, the statute defined RD to mean "all data
concerning the manufacture or utilization of atomic weapons, the production of
fissionable material, or the use of fissionable material in the production of power,
but shall not include any data which the Commission from time to time
determines may be published without adversely affecting the common defense and
security [emphasis added]."'9

As we look back on a Cold War that spanned four decades, the Tolman
Committee's view that secrecy could be justified for reasons of national security
only if there is a "likelihood of war within the next five or ten years" may seem
quaint. In the decades following the Tolman Committee's work, the possibility of
nuclear war would loom as a reality, and information on nuclear weapons design
and development would be, and remains today, most closely guarded. But, in the
immediate postwar period in which the Tolman Committee worked and the
Atomic Energy Act was passed, the question of whether information on atomic

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energy could, as a practical matter, long be kept secret by one nation, or whether
international control of atomic energy and atomic energy information was the best
course to national security, was itself a subject of highest-level policy discussion.
Most notably, this question was addressed in 1946 by a committee appointed by
Secretary of State James F. Byrnes, and chaired by future Secretary of State Dean
Acheson. Acheson selected David Lilienthal (soon to be the first chairman of the
new AEC) to chair a board of consultants, which included J. Robert
Oppenheimer, the Manhattan Project's senior scientist. In early 1946 the
"Acheson-Lilienthal Report" proposed international control of atomic energy
under an "Atomic Development Authority." The story of how this proposal was
overtaken by the dawning of the Cold War is beyond this report's purview.20
Nonetheless, as we turn to the new AEC's treatment of information on biomedical
research, it is important to recall that in the immediate aftermath of Hiroshima
and Nagasaki, there was a window in our history in which the most basic
questions of the role of secrecy in nuclear weapons development were an open
subject of high-level and public debate.

THE PRACTICE OF SECRECY

The AEC Addresses Secret Manhattan Project Experiments

When it began operation in 1947, the AEC was heir to two traditions: one
in which official secrets could extend beyond national security to matters of
prestige and another in which the interest in promoting openness and limiting
secrecy to matters of national security was recognized. In public, AEC
biomedical officials and advisers advocated the latter policy. In secret they
embraced the former and even expanded it to encompass "embarrassment."
Through as late as 1949, the declassification of reports on human experiments
involved their review for public relations and legal liability implications.
Documents revealing the dual tracks of public policy making and the secret
review process did not become public until 1994. Important pieces of the story
remain unclear, including the way in which AEC officials and advisers reconciled
seemingly contrary principles.

As described in chapter 5, when Manhattan Project medical official
Hymer Friedell recommended in late 1946 that one of the reports on the
plutonium injection experiments be declassified, officials inside the new AEC
reacted strongly. On March 19, 1947, AEC Medical Division chief Major B. M.
Brundage countermanded the declassification decision, on grounds of "public
relations." The plutonium report produced the strongest reaction, but it was not
the only report on human data at issue. Brundage's March 19 memo also stated
that further reports ("Studies of Human Exposure to Uranium Compounds" and
"Uranium Excretion Studies") should remain classified. On March 2 1 , an AEC
declassification officer confirmed the reclassification on the ground that "these

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documents may involve matters prejudicial to the best interests of the Atomic
Energy Commission in that experiments with humans are involved." The memo
expressed hope that "a definite policy in this matter will be announced or
explained in the near future."21

In April 1947 that hope was partly fulfilled when Colonel O. G. Haywood
of the Corps of Engineers wrote to H. A. Fidler, an AEC information officer, that
"it is desired that no document be released which refers to experiments with
humans and might have adverse effects on public opinion or result in legal suits.
Documents covering such work should be classified as secret."22

Shortly thereafter the AEC seemingly embraced both of the contradictory
traditions to which it was heir. In June 1947, the AEC approved the basic policy
of the 1945 Tolman report as an "interim policy."23 In August 1947 General
Manager Carroll Wilson publicized that approval in a letter appearing in the
Bulletin of the Atomic Scientists. The letter indicated that the AEC endorsed the
Tolman report, quoting sections that advocated declassification of nuclear
weapons information that posed no "danger to our military security."24

Also in June 1947, Chairman David Lilienthal's blue-ribbon Medical
Board of Review issued its recommendations on the biomedical program.
"Secrecy in scientific research," the board declared, "is distasteful and in the long
run is contrary to the best interests of scientific progress." The board
recommended that "in so far as it is compatible with national security, secrecy in
the field of biological and medical research be avoided."25 The endorsement of
the Tolman report and the broad statement of the Medical Board would seem to
indicate that high-level AEC officials and biomedical advisers were opposed to
secrecy not required by national security.

But these broad statements left unaddressed the specific response to
continued requests to declassify Manhattan Project human experiments. In a June
5 response to researcher Robert Stone, General Manager Wilson suggested that
any experiments involving "unwitting subjects" should remain classified as they
"might have an adverse effect on the position of the Commission" in "the eyes of
the American people and the medical profession in general."26 In an August 12
letter to Stone, Wilson indicated that the Medical Board of Review had
considered the question of secrecy and human experiments in mid- June, but the
matter had been deferred.27

On August 9, John Deny, serving as acting general manager, evidently in
Wilson's absence, proposed a set of guidelines that restated the proposition that
secrecy could be based on reasons other than national security. The definition of
Confidential that he proposed went beyond the Army and Manhattan Project
rules:

CONFIDENTIAL: Documents, information or
material, the unauthorized disclosure of which,
while not endangering the National security, would

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Part II

be prejudicial to the interests or prestige of the
Nation or any Governmental activity, or individual,
or would cause administrative embarrassment, or be
of advantage to a foreign nation shall be classified
CONFIDENTIAL [emphasis added].28

The Deny memo called for review by a classification board assembled
from the AEC's regional sites. In September, this board assembled in Oak Ridge.
The available documentation does not show that Derry's proposed rules went into
effect, but does show that the Classification Board blessed the illustrations of
matter that "should be graded" Secret or Confidential. The former category
included "certain selected human administration experiments performed under
MED [Manhattan Engineer District]."29 The latter category contained a broad
catch-all:

All documents and correspondence relating to
matters of policy planning and procedures, the
given knowledge of which might compromise or
cause embarrassment to the Atomic Energy
Commission and/or its contractors [emphasis
added].30

Following the Classification Board's meeting, Oak Ridge officials wrote to
Washington headquarters in search of policy guidance on human subject research.
Oak Ridge explained that researchers were eager to have their work declassified.
"However, there are a large number of papers which do not violate security, but
do cause considerable concern to the Atomic Energy Commission Insurance
Branch and may well compromise the public prestige and best interests of the
Commission." A problem arose, for example, "in the declassification of medical
papers on human administration experiments done to date. Again many of these
radioactive agents have been of no immediate value to the patient but rather a
much needed opportunity for tracer research."31

The problem, Oak Ridge pointed out, was not limited to data from human
experiments, but also included health risks that radiation posed for workers and
for the public:

Papers referring to levels of soil and water
contamination surrounding Atomic Energy
Commission installations, idle speculation on future
genetic effects of radiation and papers dealing with
potential process hazards to employees are
definitely prejudicial to the best interests of the
government. Every such release is reflected in an

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Chapter 13

increase in insurance claims, increased difficulty in
labor relations and adverse public sentiment.32

Indeed, the Insurance Branch had already reviewed some papers that were
slated for declassification. It had advised against publishing papers that suggested
health hazards to the public. In the case of one paper, for example, the Insurance
Branch wrote in June 1947:

We question the advisability of publishing this
document unless the contractor involved is able to
establish that the amounts of fissionable material
leaving the area is in no way a health hazard to the
people living down stream.33

In an October memo to Washington, Oak Ridge suggested that the Insurance
Branch should routinely review declassification decisions for liability concerns:

Following consultation with the Atomic Energy
Commission Insurance Branch, the following
declassification criteria appears desirable. If
specific locations or activities of the Atomic Energy
Commission and/or its contractors are closely
associated with statements and information which
would invite or tend to encourage claims against the
Atomic Energy Commission or its contractors such
portions of articles to be published should be
reworded or deleted. The effective establishment of
this policy necessitates review by the Insurance
Branch, as well as the Medical Division, prior to
declassification.34

Oak Ridge explained that its acting medical adviser, Dr. Albert Holland,
Jr. (whose contribution had been praised in the June 1947 report of the Medical
Board of Review), would be in Washington on October 1 1 to discuss the matter
further.35 On that date the Advisory Committee for Biology and Medicine met
and concluded that the "important" policy questions raised by Oak Ridge would
require "more study."36

While the discussion of Oak Ridge's inquiry did not resolve the question
of classification, the matter was otherwise addressed at the October 1 1 meeting.
The draft of the secret minutes of the meeting record the discussion of yet another
letter from Dr. Robert Stone, regarding the release of "classified papers
containing information on human experiments with radioisotopes conducted
within the AEC program."37 The ACBM concluded that the "problem" was

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addressed by "the recommendations of the Medical Board of Review and that
papers on this subject should remain classified unless the stipulated conditions
laid down by the Board of Review are complied with.""

What were the recommendations of the Medical Board of Review that the
ACBM referred to? Recall that its public report did not address human
experiments but briefly declared the importance of limiting secrecy. The matter is
cleared up by two letters written by General Manager Wilson on November 5~the
first to Stone (this is the "second Wilson letter" discussed in chapter 1 ) and the
second to ACBM Chair Alan Gregg.39 Consistent with the October 1 1 ACBM
minutes, the letter to Stone explained that all classified research not in compliance
with certain conditions laid down by the Medical Board would remain classified.
These conditions, as we discussed in chapter 1 included written "informed
consent" from the patient and the next of kin. This requirement, Wilson further
explained, was contained in an "unpublished and restricted" draft report of the
Medical Board of Review, which had been read to the Commission in June. The
letter to Gregg, who had served on the Medical Board of Review, indicated that
the ACBM need not consider the matter further because the Medical Board of
Review's statement was sufficient.

Thereafter, documents show that the AEC continued to review reports for
possible public relations and liability consequences and, as Oak Ridge had
recommended, called on the AEC Insurance Branch to vet reports for public
relations and liability implications.

In 1948 former Manhattan Project researchers pressed the AEC to
declassify data from human experiments for inclusion in a history of Manhattan
Project medical research as part of a group of publications called the National
Nuclear Energy Series, or "NNES." In February 1948, the University of
Rochester's Harold Hodge complained about classification officers gutting his
chapter on uranium toxicology. "I would like," Hodge wrote, "to advance the
argument that Chapter XVI does not report experiments with humans, and should
never have been classified on this basis in the first place."40

The researchers sought a "final policy" decision on reports regarding
plutonium and uranium from the Division of Biology and Medicine and its
advisory committee. In a March 15 letter to a participant in the NNES project,
Oak Ridge's Holland reported that it was "the feeling" of these groups that the
reports should not be declassified. "While I am sure we both fully appreciate the
desirability of declassification, I feel certain that the various individuals
concerned will also understand and appreciate the reasons for this decision."41
(The minutes of the March 10, 1948, ACBM meeting, themselves declassified in
1994, do not refer to the policy decision.)

The policy of classifying reports for reasons of public relations and
liability was not limited to human experiments conducted under the Manhattan
Project; it extended to at least one human experiment conducted under the AEC.
In late 1948, Division of Biology and Medicine chief Shields Warren stated his

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Chapter 13

"complete agreement" with Oak Ridge's Holland that a report on a 1948
University of California experiment with zirconium (the research has since
become known as the "CAL-Z" experiment; see chapter 5) had to be kept under
wraps.42 The report had to remain secret because "it specifically involves
experimental human therapeutics" and could not be rewritten in a way that
"would not jeopardize our public relations."43

In addition, data on workers, as well as sick patients, was vetted for labor
relations and legal concerns. In chapter 1 1 we discussed the exposure of Los
Alamos workers involved in the "RaLa" intentional releases. In late 1948 the
AEC Declassification Branch reviewed a study entitled "The Changes in Blood of
Humans Chronically Exposed to Low Level Gamma Radiation." The document,
a memo from the Declassification Branch recorded, "has been issued as an
unclassified report by Los Alamos, since it clearly falls within the open fields of
research." While agreeing with Los Alamos, the Declassification Branch sent the
document to the Insurance Branch, at the suggestion of the medical adviser.44

In a December 20, 1 948, memo to the Declassification Branch, the
Insurance Branch recorded its alarm over the study's finding that accepted gamma
radiation safety levels "may be too high." In calling for "very careful study"
before making the report public the Insurance Branch declared:

We can see the possibility of a shattering effect on
the morale of the employees if they become aware
that there was substantial reason to question the
standards of safety under which they are working.
In the hands of labor unions the results of this study
would add substance to demands for extra-
hazardous pay . . . knowledge of the results of this
study might increase the number of claims of
occupational injury due to radiation and place a
powerful weapon in the hands of a plaintiffs
attorney.45

While the Insurance Branch reviewed declassification decisions it did not
automatically veto the release of all human experimental data. In an October
1947 memo, Holland approved a report ("The Effect of Folic Acid on Radiation
Induced Anemia and Leucopenia") for publication "since purportedly the human
work was done in the Department of Medicine of the University of Chicago," and
not, presumably, an AEC or Manhattan Project facility.46 Even when publication
might result in bad public relations or might encourage litigation, information was
sometimes released.47

Thus, while the evidence of formal policy-making that can be recovered is
fragmentary, it appears that even though the AEC biomedical officials and
advisers publicly advocated limiting secrecy to matters of national security, they

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Part II

secretly endorsed a different policy and followed the secret one. The AEC
employed the concepts of "prejudicial to the best interests of the government" and
"administrative embarrassment" in determining what information to withhold on
human experiments. This course was crafted and administered in secret and
remained a secret for decades. Its full reach remains unknown.

While our discussion thus far has focused on the AEC, it was not alone in
its concerns that data on human radiation exposure could cause public relations or
legal liability problems. As we saw in chapter 10, in 1947, former Manhattan
Project head General Groves, and the chair of the new AEC's Interim Medical
Advisory Committee, Stafford Warren, were evidently among those who
counseled the Veterans Administration to keep secret records in anticipation of
potential claims from servicemen. In both cases, the impulse to keep such
information secret was accompanied by the decision to create a highly publicized
program of radioisotope research, which resulted in numerous human radiation
experiments that were not secret.

The practice (and any policy) of keeping information secret on grounds of
embarrassment or potential legal liability should have ended no later than 1951,
and perhaps as early as 1949.4S In its 1949 "Policy on the Control of
Information," the AEC recognized that secrecy must be balanced against not only
the value of the progress of science but also the value of a well-run democracy.
Limiting secrecy, the AEC said, ensures "that people may be able to judge the
action of their representatives and officials and to participate in public policy
decisions. Information about a public enterprise of such consequence as the
atomic energy program should be concealed only for reasons soundly based upon
the common defense and security."49 In 1951 President Harry Truman issued a
new executive order on classification.50 While the order expanded government
secrecy by giving every department and agency the authority to classify
information, it limited the reasons for classification to national security. Today,
the governing executive order expressly prohibits classification of information "in
order to: (1) conceal violations of the law, inefficiency, or administrative error;
(2) prevent embarrassment to a person, organization, or agency; (3) restrain
competition; or (4) prevent or delay the release of information that does not
require protection in the interest of national security." The order also prohibits
classification of "basic scientific research information not clearly related to
national security."51 As we shall see later in this chapter, while the law has long
since begun to draw a line against the keeping of classified secrets for reasons
other than national security, the boundary between national security and public
relations rationales remains murky.

Human Radiation Experiments In the 1950s: Experiments Are Not
Classified, but Some Secrets Remain

The 1947-1948 AEC declassification controversy may have taught Shields

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Warren and other AEC biomedical officials that secrecy and human radiation
experimentation were a troubling mix, to be avoided if possible. The search
efforts of the Human Radiation Interagency Working Group and the Committee
located very few human radiation experiments in the post-Manhattan Project
period that were classified secrets. Nonetheless, important information relating to
many experiments was still intentionally concealed from the public.

When the AEC and DOD debated the need for human experiments for the
proposed nuclear-powered airplane (NEPA) in 1950, Warren and the Advisory
Committee for Biology and Medicine counseled the Defense Department that
there would be "serious repercussions from a public relations standpoint" if
human experiments were conducted by an agency that did some of its work in
secret.52 As we saw in chapter 1, in March 1951, Los Alamos asked Warren to
state the policy on human experimentation. In transmitting to Los Alamos
excerpts from General Manager Wilson's November 1947 letter to Stone, which
cited the requirement for "informed consent," Warren added further counsel
against secrecy. Warren cited the Medical Board of Review's public declaration
that secrecy should only be countenanced when required by national security. He
then quoted ACBM chairman Alan Gregg: "The secrecy with which some of the
work of the Atomic Energy Commission has to be conducted creates special
conditions for the clinical aspects of its work in that the public is aware of this
necessity for secrecy and of the subsequent difficulty of probing into it."53 When
in 1952 the DOD's Joint Panel on the Medical Aspects of Atomic Warfare called
for renewed discussion of human experiments, Warren reportedly advised "that
studies of this type under the Joint Panel's purview should be conducted by the
Public Health Service or some agency where security restrictions would not lead
to misunderstanding."54

Thus, Warren and Gregg's statements convey a profound concern for the
public's perception of human experiments, particularly where human experiments
are conducted by agencies that also conduct activities in secret.

Under Paul Aebersold, the AEC isotope distribution program~the
provider of the source material for many hundreds of human experiments-
became a showcase for public research (see chapter 6). At the Defense
Department as well, biomedical human radiation experiments—even when there
was clear military purpose—were typically not classified. For example, post-
Manhattan Project total-body irradiation research sponsored in part by the
military, in the wake of the controversy that raged when similar human
experiments were proposed for the NEPA project, was not conducted in secret
(see chapter 8).

But if the experiments themselves were not secret, important decision-
making context for them was sometimes secret, and hidden rules or practices may
have also limited what the public was told about particular experiments. The
ability of the public and the press to probe experiments connected to secret
programs was limited, making it difficult for the public to critically assess the

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practices of its government.

For example, the 1950-1952 meetings in which DOD biomedical officials
discussed the need for an ethical code to govern human experiments were
classified.55 So were the meetings of the Joint Panel on the Medical Aspects of
Atomic Warfare. Similarly, meetings of the ACBM were often conducted in part
or whole in secret. These meetings, as we have seen from the review of the 1947-
1948 secret keeping, included seminal discussions of the ethics of human
experimentation and the rules governing declassification of experimental data.56

To some degree experiments sponsored by civilian agencies such as the
National Institutes of Health were also rooted in this secret context. The 1952
letter that reported Warren's belief that human experiments should be separated
from secret programs communicated the willingness of NIH and PHS to
cooperate in conducting research needed for military purposes. These civilian
agencies were themselves participants in DOD biomedical planning for atomic
warfare, and their research was also listed in the secret digests (which included
classified and nonclassified research) of atomic warfare-related research that the
DOD's Committee on Medical Sciences provided to the Joint Panel on the
Medical Aspects of Atomic Warfare.57 Also in 1952, an internal report on
"Defense Activity of the National Institutes of Health (1950-52)" noted that "a
second major activity of the NIH relating to radiation research has been
participation in the medical and biological aspects of atomic bomb tests. A large
share of this activity has been borne by the Armed Forces Special Weapons
Project. The substance of this work is classified."58

The country's research resources should have been available to serve
national security needs. But, as Warren and Gregg suggested, when human
research and national security are intertwined, care must be taken to ensure that
the public has means to separate out secret and nonsecret purposes with
confidence. At this time it is not clear what, if any, classified human radiation
experiments were conducted by DHHS's predecessors and what was said in
secret about otherwise public human radiation experiments.59

Similarly, while most AEC biomedical radiation research was not
classified, some was. From available records, it appears unlikely that much of the
secret research involved humans. But, given the secrecy and the absence of clear
records, certainty is impossible.60

Moreover, even if little human subject radiation research itself was
classified, information about the research could be concealed by less formal
means. As we discussed in the Introduction and chapter 10, in July 1949, the
NEPA advisory group met with a group of psychologists and psychiatrists to
discuss the psychology of radiation risk. The participants were told:

This is not a closed meeting. Some of our ,
advisers . . . have not been cleared. Ordinarily,
medical and biological discussions are not, of

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course classified. We shall ask you, however, to
refrain from discussing these matters on the outside,
since of course we do not want newspapers to know
of these discussions at this time.61

Moreover, the determination to render information formally secret could
be applied in a manner that was invisible and arbitrary, as illustrated by the
following case. At midcentury, the Medical College of Virginia (MCV)
performed research on the effect of thermal burns for the Defense Department.
MCV's research, conducted with animals, prisoners, and medical students,
initially appears to have been a matter of public record. In January 195 1,
following inquiry by a reporter from the Richmond Times-Dispatch, MCV
investigator Dr. Everett I. Evans grew alarmed that press reports decrying the use
of dogs would "greatly harm the work we are doing on the experimental burn in
relation to atomic bomb injuries."62 Evans called on the chairman of the Army's
Medical Research and Development Board to classify the work so that "I would
have legal means of preventing a public newspaper discussion of these
experiments. . . .""

The Army immediately provided a declaration that all work under the
MCV contract "will be classified RESTRICTED."64 The Army decreed that a
bureaucratic obstacle course would have to be overcome before information was
released, including "coordination" with the experimenters, and evaluation by "the
other branches of the Armed Forces, the Federal Civil Defense Administration,
the National Security Resources Board, the Atomic Energy Commission, and the
National Research Council."65 This rigor was essential because "individual
releases may be mistaken for official advice to civil defense groups and result in
confusion of training and procedure, the stockpiling of unnecessary or
inappropriate materials, etc."66 Finally, perhaps on the possibility that the local
reporter might be uniquely dogged, the Army added that it "is also the policy of
the Department of Defense that public releases to the press are made
simultaneously to all national news services, and that the releases are not made to
individual reporters or newspapers."67 While the secrecy was prompted by
revelations on animal experiments, in late 1 95 1 Dr. Evans invoked it to close the
curtain on the use of prisoner volunteers at the state penitentiary.68 The prison
assured Evans that inmates and staff were informed that "no publicity should be
given to the experiment being carried on at the Medical College."69

In the case of research related to chemical and biological warfare, the
military issued a secret edict that published articles be cleansed of any reference
to military purpose.™ In many cases the opportunity to obscure the full purpose
of research by careful wording was obvious. As a DOD document put it, "the
term 'radiobiology' is so flexible semantically that, depending upon the
investigator's point of view, any project could be classified as 'clinical' or 'basic'
or 'nuclear weapons effects.'"71 In 1961, the U.S. Department of Agriculture

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issued an extensive bibliography of research on strontium and calcium. The
preface made clear the publication was relevant to those researching fallout
(radioactive strontium being a major fallout concern).72 However, Advisory
Committee staff review of many of the articles on human experiments included in
the bibliography revealed few indications of fallout as a purpose for the
research.73

The difficulty of determining what was secret is compounded because the
government sometimes actively deceived or lied. Most remarkably, the AEC
continually told inquiring members of the public that it did not perform human
experiments— even when its isotope division very publicly supported them. In
1948, for example, the AEC wrote to a member of the public that "there is no
possibility, at present or projected, of human experimentation with atomic
energy."74 In 1951, when the press pursued a rumor that the AEC was sponsoring
an experiment with prisoners, the AEC's chief public information official assured
the Associated Press that the AEC "has never sponsored a medical research
project where human beings were being used for experimental purposes."75 In
1953 the AEC wrote to members of the public that it "does not deliberately
expose any human being to nuclear radiation for research purposes unless there is
a reasonable chance that the person will be benefited by such exposure."76 At the
same time an internal AEC memo from the public information office noted that
"any experimentation on humans has obvious and delicate public relations
aspects. Any project involving such experimentation must have careful prior
consideration by both the field and Washington, particularly as to content of any
public statements."77

As we saw in chapter 1 2, uranium miners were not adequately informed
about the purpose of research regarding their exposure to radon in the mines.
Above and beyond lack of disclosure, there is evidence that deception was not
unusual in data gathering on AEC workers, as illustrated by a 1955 exchange
between the University of Rochester's Dr. Louis Hempelmann and the AEC
Division of Biology and Medicine regarding a proposed study evidently designed
to measure the occurrence of lung cancer among a group of former workers.
"You will have to find a good excuse so as not to worry the person you are
contacting," Hempelmann wrote to DBM chief Charles Dunham. "This isn't very
clever but, perhaps, you could say in some convincing way that you, or rather the
person conducting the study, represents a life insurance company studying the
health of people employed by the Harshaw Company during a certain period."78
Dr. Hempelmann apologized for his lack of imagination:

I don't know whether these ideas are helpful at all.
It is more difficult to find an excuse for these
individual workers than it is in the case of patients
who were treated for something or other at a
hospital. I think that someone with imagination

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might come up with a better idea than I have had to
date.79

This last comment implies that it was not only workers, but also patients,
who were deceived about their participation in research, and more easily at that.
The statement is particulary striking when it is recalled that Dr. Hempelmann
was, as an adviser to Robert Oppenheimer, a proponent of the plutonium injection
experiments, and, following the war, became professor of experimental radiology
at the University of Rochester, a major AEC biomedical contractor. Thus, if the
statement is a reflection of the readiness to deceive patients, it is one mady by a
doctor at the center of the AEC biomedical community and, indeed, was made
directly to the head of the AEC's Division of Biology and Medicine.

Dunham's assistant evidently agreed that workers should be deceived, but
"we have racked our brains for any useful subterfuge in carrying out the study but
none came to mind which could possibly hold water for any length of time."80
The AEC opted for subtle deception:

The attack with which we are going to start the
study will be to inform the old Harshaw employees
that our interest in them is only part of an over-all
program to make sure that the safety controls in the
atomic energy business are absolutely perfect. To
be sure, such an approach might cause some alarm
but this should not be too great, I hope, because it is
essentially a negative one; namely, the Commission
is sure that there will be no injury to its workers but
it needs to document this fact for the record.81

The AEC official agreed that "routine physical examination would be
relatively fruitless since the ultimate objective is to determine the incidence of
lung cancer, which can be obtained best with a post-mortem examination. On the
other hand," the official noted, "the attitude of the Western Reserve group [with
whom the AEC was proposing to contract for the study] is that physicial
examinations are a useful means for maintaining close contact with people and
will improve the chances of getting post-mortem information."82

In sum, after the Manhattan Project the governing presumption, to which
the Advisory Committee found little exception, has been that biomedical human
radiation experiments should not be classified. But the presumption included
important qualifications, some of which were hidden at the time, and others of
which may be beyond our ability to retrieve and reconstruct. These qualifications
are shortcomings and legitimate cause for public concern, especially when held
up to the ideals publically espoused by the AEC's initial leaders.

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Human Data Gathering Connected with Bomb Tests and Intentional
Releases: National Security, Secrecy, and Public Opinion

The view that a line needed to be drawn to ensure that human radiation
experiments were not too closely associated with secret keeping was not easily
translated to settings where entire groups of people were placed at risk by
environmental releases of radiation. In March 1951, as we have just noted,
Shields Warren advised Los Alamos to avoid secrecy in human experimentation.
Warren and other AEC officials also told the military of their concern for public
repercussions if human experiments were conducted in close proximity to
government secret keeping. At the same time, however, Warren and other AEC
biomedical experts were called on to advise on nuclear weapons activities that
might place entire populations at risk. Here, the question of public disclosure was
more difficult to resolve. In May 1951 for example, as discussed in the
Introduction, Warren chaired a secret meeting in Los Alamos to consider the
safety concerns of the first underground test of a nuclear weapon. The record of
the meeting shows that Warren and other experts worried that fallout from the
tests could endanger citizens around the Nevada Test Site. The public was not
given access to the discussion of testing that the participants were concerned
might endanger surrounding communities.83 Press information stressed the
absence of public danger.84

As we saw in the discussion of intentional releases (chapter 11), little or
no information was contemporaneously made public about the radiological
warfare tests at Dugway, the RaLa tests at Los Alamos, or the Green Run at
Hanford. National security required some degree of secrecy; but whether more
could or should have been disclosed is unclear in retrospect. In the case of at
least the Dugway tests, secrecy was fueled by concern that the public might not
understand the tests and might question the program.

Atmospheric nuclear weapons tests were, in contrast to the intentional
releases and underground nuclear weapons tests, much more difficult to keep
secret. In chapter 10 we saw that activities could simultaneously have elements
of deep secrecy and appear as front-page news. A then-secret report on the
Desert Rock exercises observed, "It was a constant source of amusement at the
camp that the newspapers carried accounts of the atomic tests which included
information, usually accurate, which the men had been expressly forbidden to
reveal."85 At the same time that the bomb tests were highly publicized, basic
information on the risks to participants was not public. "Secrecy," summarized
Barton Hacker, author of a DOE-sponsored history of the bomb test program, "so
shrouded the test program . . . that such matters as worker safety could not then
emerge as subjects of public debate."86

Once bomb tests became routine, fallout presented a further opportunity
and obligation for the government to sponsor data gathering, including human
subject data gathering. It did so on a global scale. As discussed in chapter 12, the

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research on the Marshall Islanders to measure fallout effects began in secret.
"Due to possible adverse public reaction, "the director of the research project was
counseled, those involved should limit discussions of the research to those with a
"need to know."87 The Marshall Islands research was only one component of a
worldwide data-gathering program that was constructed and operated in
substantial secrecy until the latter part of the 1950s. The Advisory Committee
was not created to study atomic bomb testing or the related debate about the
effects of fallout. However, the human subject research related to bomb-test
fallout also presents questions about openness and secrecy in human research and
the ethics of human data gathering.

The Fallout Data Network: Projects Gabriel and Sunshine

The study of fallout began with the effects of the first atomic bomb test in
New Mexico in 1945.88 In 1949 the AEC commissioned Project Gabriel, a study
to determine how many atomic weapons could be detonated before radioactive
contamination of air, water, and soil would have a long-range effect upon crops,
animals, and humans.89 The AEC soon created a worldwide network for the
collection and measurement of fallout (typically by permitting it to fall on a
horizontal gummed paper or plastic sheet).90 By 1954 Gabriel included about
seventy investigations supported by the Division of Biology and Medicine,
involving 325 person years of labor per year and costing $3,325 million

annually.91

In the early 1950s the Defense Department created its own fallout research
program, under the auspices of the Armed Forces Special Weapons Project. The
Public Health Service joined with the AEC and the DOD in monitoring fallout
around the Nevada Test Site.92

In 1953, under contract to the AEC and the Air Force, the Rand
Corporation convened a review of Gabriel.93 The study was directed by Dr.
Willard Libby, a University of Chicago radiochemist who would receive the
Nobel Prize in 1960 for the development of the radioactive carbon dating method.
The resulting report concluded that strontium 90 (Sr-90) was the most dangerous
long-term, global radioactive product of bomb testing and that a global study of
strontium 90 fallout was needed.94

The report noted how atmospheric testing had, as an unintended side
effect, introduced tracers into the world's ecosystem: "Until comparatively
recently it would have been extremely difficult, if not impossible, to obtain a
measure of a number of the parameters. Today we are afforded the opportunity of
doing a radioactive-tracer chemistry experiment on a world-wide scale." The
group recommended that "studies then current be supplemented by a world-wide
assay of the distribution of strontium 90 from the nuclear detonations which have
occurred. This assay has been designated Project Sunshine." The name for the
project would be variously attributed to the project's gestation in Santa Monica,

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California, (where Rand was headquartered) and to the determination to measure
the presence of strontium in "sunshine units." Three laboratories were engaged to
analyze samples of strontium 90: one at Libby's research center at the University
of Chicago, another at the Lamont Geological Observatory of Columbia
University, and a third at the New York office of the AEC.

The long-term goals of the full-scale study would be to (1) determine if a
hazard had already been created by fallout; (2) determine the number of bombs
that could be exploded without creating a hazard, and (3) determine the
mechanisms by which radioactive materials might become concentrated.96

Secrecy and Deception in Fallout Studies: Project Sunshine's Collection of
Human Bones

Project Sunshine was born in secrecy.97 The decision to keep the
existence of the worldwide assay Secret "limited the freedom with which suitable
combinations of samples might be obtained from foreign countries."98 For the
pilot program, the report suggested that twelve human samples (bone and teeth)
be drawn from each of six regions around the world. In addition, samples would
be drawn from livestock, foodstuffs, water, and soil.99 The discussion of
collecting individual samples was limited to means of ensuring uniformity in
practice, without mention of the ethical relationship between investigators and
human subjects. An early effort concerned the collection of baby bones.

In an October 1953 letter to Dr. Libby, Robert A. Dudley of the DBM
explained that the collection process would proceed "through personal contacts
with foreign doctors" and groups like the Rockefeller Foundation, which had
many overseas contacts. Because the chief of the DBM, Dr. John Bugher,
advised that "security specifications" needed to be maintained, a cover story
would be employed.100

The stated purpose of the collection is to be for a
survey of the natural Ra [Radium] burden of human
bones . . . there are still enough uncertainties
regarding threshold dose for injury ... to provide a
plausible explanation for further surveys. ... As for
the emphasis on infants, we can say that such
samples are easy to obtain here, and that we would
like to keep our foreign collections comparable.101

Dudley explained that the AEC wanted to be kept "out of the picture
where possible," but to be helpful "I would still be prepared to do all the work
except for providing the signature."102

One week later Dudley wrote to Shields Warren in Boston. Dudley,
noting that the effort was proceeding "pretty much on the lines you suggested,"

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sought Warren's assistance in contacting another Boston doctor who might not be
in on the full story. Dudley offered that "while the real purpose will of course
remain secret ... we do expect to make radium analyses on at least some of the
samples, so our story is merely incomplete, not false."10

On the same day, Dudley wrote to his father, the director of a missionary
organization, also in Boston. The letter explained the public purpose of the data
gathering and solicited assistance.104 On November 10, evidently from a referral
from his father, the AEC official wrote to the Christian Medical Association in
Nadya Pradesh, India, also soliciting assistance. Finally, the DBM sought
assistance from civilian organizations that already had well-developed contacts at
the local level in foreign countries.105

What was the "real purpose" that had to be kept so carefully concealed,
even from those who were actually assisting the project? On December 9, Dudley
sent a letter to a doctor at the AEC's project at the University of Rochester that
explained "for you alone" the AEC's real interest:

This letter will explain in a little more detail than I
was able to do over the phone our interest in
obtaining infant skeletons from Japan.

The Division of Biology and Medicine is engaged
in a project to evaluate the long range radiological
hazard which might result from the large scale use

of atomic weapons In order to help in the

evaluation of the hazard, we are providing for the
direct measurement of the world-wide Sr-90
distribution which has resulted from the 40 or 50
nuclear detonations in the last few years. One type
of sample on which we are concentrating is the
bones of infants, either stillborn or up to a year or
two of age. We have found that stillborn bones are
easy to obtain in the United States, and are trying to
extend our collection to foreign countries. It
appears that the ABCC [Atomic Bomb Casualty
Commission] would be a logical contact in Japan.
We could use perhaps 6 or 8 skeletons from that
area.

It has been decided, for various reasons including
public and international relations, to classify this
project SECRET for the present. Hence, the
unclassified description of our purpose in obtaining
these bones is for Ra analyses.

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The July 1954 Gabriel report summarized the "human, animal and animal
product samples" that had been analyzed.107 The list included stillborns from
Chicago (fifty-five), Utah (one), Vellore, southern India (three), and human legs
from Massachusetts (three).108

Soon, the DOD was also engaged in fallout data gathering. In the fall of
1954, the Armed Forces Special Weapons Project established a "Fall-out Study
Group" following a request for information from the Joint Chiefs of Staff.'09 In
1 954 DOD planned a secret project to collect human urine and animal milk and
tissue samples following the 1955 Operation Teapot tests in Nevada. The work
was coordinated by the Walter Reed Army Institute for Research, with review
from researchers at the Harvard Medical School and the National Institutes of
Health. The purpose of the effort was to establish a baseline for forthcoming
Pacific tests."0 The military data gathering also involved a cover story. A
December 16, 1954, memorandum from the chief of the Armed Forces Special
Weapons Project stated, at least in regard to the animal sampling:

The actual data obtained are SECRET and the
sample collection should be discreetly handled. It
is suggested that a statement be included in the
instructions to the effect that these samples are
being collected for nutritional studies.'"

In January 1955 the Gabriel-Sunshine program was the subject of a
classified "Biophysics Conference" convened by the Division of Biology and
Medicine. The spring 1954 Marshall Islands disaster had, the attendees were told,
added new urgency to their task. "I keep reading," noted one participant, "the
articles by the Alsops and others [journalists] of the high level groups which are
frantically trying to find the answer to how many bombs we can detonate without
producing a race of monsters.""2

The Secret transcript of the conference, declassified from Restricted Data
status only in 1995, shows that the AEC and its researchers assigned a high
priority to what was referred to as "body snatching." No AEC program, explained
Dr. Libby, who had become an AEC commissioner, was more important than
Sunshine. There were great gaps in knowledge and human samples were essential
to fill them. "[HJuman samples are of prime importance and if anybody knows
how to do a good job of body snatching, they will really be serving their
country.""3 In the 1953 Rand Sunshine study, Libby recalled, an "expensive law
firm" was hired to study the "law of body snatching." The lawyers' analysis
showed "how very difficult it is going to be to do it legally.""4

Nonetheless, "excellent sources" were available from several places,
including New York, Vancouver, and Houston. In Houston, said Columbia
University's Laurence Kulp, "they intend to get virtually every death in the age
range we are interested in that occurs in the City of Houston. They have a lot of

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poverty cases and so on.""5

Where good personal relationships with medical sources existed, Dr. Kulp
offered, "the men did not require you to tell them anything except that they
realized it was something confidential. They could guess, and they probably
didn't guess very wrong, but they were willing to cooperate just on the basis that
this was an important thing.""6 With a connection "through one of the top
medical people who is internationally known, it will not be hard at all to be able
to establish the sites that we should establish." The DBM's Dr. Bugher explained
that the AEC was exploring the possibility of a special clearance ("L") so that
medical professionals who did not want to "fill out any forms" could be briefed on
a limited basis. "You are," he stated, "dealing with directors of hospitals and
pathologists and persons in general who have an understanding of the seriousness
of the project in which we are engaged.""7

Libby hoped to declassify at least the existence of the Sunshine program.
"Whether this is going to help in the body snatching problem, I don't know, I
think it will. It is," he said, "a delicate problem of public relations, obviously."1"*

The efforts bore fruit. A report on Sunshine's 1955-1956 operations
recorded that during that period hundreds of human bone samples were collected
by dozens of stations abroad and by researchers in Boston, Denver, Houston, and
New York."9

In addition to the Sunshine-related research, the AEC sponsored further
efforts to gather human tissue in order to study the effects of radiation on
weapons complex workers, as well as fallout on citizens. In a June 1995 report,
the General Accounting Office summarized fifty-nine studies, most of which were
conducted and terminated in the 1950s and 1960s. While many, probably the
great majority, were not secret programs, the GAO found that typically no
information can now be located about the consent practices that were followed.
Today, the Department of Energy sponsors a program under which those with
documented exposures to certain radioactive elements may donate their tissues for
research. The operations of the transuranium and uranium registries are subject to
review by an institutional review board, and donors must sign a consent form.120

In sum, during the 1950s the AEC promoted human tissue sampling for
studies on fallout and other research, and its efforts involved secrecy and
deception. The AEC evidently considered the legal aspects of "body snatching,"
but there is no evidence that it sought to consider any independent ethical
requirements for disclosure to the families of the subjects (or the subjects
themselves, where alive) whose tissue was sampled. While further rationale for
keeping the data gathering secret may have existed, in surviving documents
concern for public relations emerges as the dominant motivation. At the same
time, the AEC recognized that secrecy hampered the conduct of research that it
believed central to the public interest.

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Secrecy, Public Opinion, and Credibility

On reviewing the transcript of the 1955 Biophysics Conference in 1995,
Dr. Merril Eisenbud, a former AEC official who participated in the session,
expressed surprise that the document had been classified in the first place.121
There was, he observed, nothing that merited national security classification; if
anything, perhaps it merited the category of Official Use Only, which instructs
officials not to publicize the document but is not a category in the formal
classification system.122 As in the case of the AEC's 1947-1948 decision to keep
experimental data secret, however, information on fallout data gathering appears
to have been classified out of concern that public opinion (in the United States,
but also elsewhere) might imperil U.S. weapons development programs.

In November 1954 AEC officials met for lunch with Secretary of Defense
Charles Wilson, the signator of the 1953 memorandum discussed in chapter 1, to
discuss civilian evacuation in case of atomic warfare and the related question of
what the public should be told about fallout. "Secretary Wilson," an AEC record
of the meeting summarizes,

stressed the importance of not arousing public
anxiety in this country or abroad by public official
discussions of the dangers of atomic warfare,
particularly with reference to fall-out. He expressed
the view that much too much had already been said
publicly about fallout, and he urged that before the
Government reveals the full extent of the dangers to
be expected the Government work out the answers
to a lot of questions as to what our citizens could do
in the event of an atomic blitz.123

"Obviously," records a history of the AEC by AEC and DOE historians,
"estimates of the biological effects of fallout on large human populations were
more likely to arouse fear and controversy than were small-scale experiments on
laboratory animals. Thus, it was not surprising that initial studies of large-scale
effects were highly classified and unknown to the public."124

Within a very short period, however, much of the secret research was
disclosed, but under circumstances where, as the AEC itself came to recognize, its
credibility as an information source was seriously impaired.

The Marshall Islands disaster, and the attendant controversy related to the
irradiation of the crew of a Japanese fishing boat in the area, marked the
beginning of a worldwide debate on fallout that would end with a ban on
atmospheric testing.125 Following this event, ban-the-bomb protests began in
Britain.126 Two years later, in 1956, presidential candidate Adlai Stevenson called
for an end to nuclear testing. Soon thereafter, the closely held fallout research

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began to become public. In October, Libby, addressing the American Association
for the Advancement of Science at the dedication of its new headquarters in
Washington, reported that the amounts of strontium 90 entering the bodies of
children were well below the maximum permissible concentration.127 In February
1957 Dr. Kulp and his associates presented the results of their study of 1,500
human bones from around the world. The report made the front page of the New
York Times.m In June, the National Academy of Sciences issued a report noting
that strontium 90 and genetic effects were two potentially long-term hazards from
nuclear testing.

The public fallout debate was on, pitting scientists against one another.
"Test ban advocates," a historian of the fallout controversy recounted, "always
stressed the great potential hazard from fallout over a long period of time; their
opponents minimized the danger by pointing to similar or greater risks that people
routinely accepted, such as luminous wristwatches and medical X-rays."129

In May and June 1957, Congress's Joint Committee on Atomic Energy
held its first public hearings on the dangers of fallout. The initial 1953 Sunshine
report, "Worldwide Effects of Atomic Weapons-Project Sunshine," was
apparently declassifed on May 25, two days before the hearings began.130 Most of
the debate focused on the dangers of strontium 90. In June, Commissioner Libby
responded to a proposal from an NIH official for the use of children's milk teeth
to measure strontium 90. The idea was good, but he advised (in the immediate
aftermath of the first highly publicized hearings on fallout), "I would not
encourage publicity in connection with the program. We have found that in
collecting human samples publicity is not particularly helpful."131

In October 1958, a moratorium on nuclear testing began, and in May 1959
the Joint Committee on Atomic Energy held a second series of hearings on
fallout. The hearings concluded that the risk was worth the returns to national
security; but the public debate continued.132

As AEC documents on the fallout debate have become available in the
intervening years, it has become clear that the government's effort to manage
public opinion was rooted in a sensitivity to its importance. For example, in
1953, following the spring Nevada test series, ranchers in Utah began to report
the deaths of their sheep from what, it appeared, might be radiation burns from
the tests.133 The AEC convened a panel to consider the continuation of testing at
the Nevada Test Site. The panel concluded that continued testing was justified by
the national interest, although risks were inevitable.134 The tests to date were
relatively safe, but there were serious problems with "public reaction."135 The
panel found that "a sufficient degree of . . . public acceptance has not been
achieved."136 Radiation remained a "mysterious threat."137 But the government
had surrounded the program with an aura of secrecy, its own statements were not
clear, and statements by former AEC experts or officials had caused "near-panic
concern."138 The public, "which is expected to accept a certain degree of hazard,
has not been adequately informed of the extent and nature of the hazard."139 An

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extensive program of public education was called for.140

The AEC study found the problem was not only with the public; there was
a "lack of agreement and acceptance, first, within AEC and test management, and
second, among health, medical, and other scientific individuals and groups." The
problem was exacerbated by "lack of knowledge of this new subject, by lack of
definition, by the extreme sensitivity of the subject, and by the resulting
nervousness of the various levels of management."14' As shown by the secrecy
surrounding the ongoing Project Sunshine, however, the public was not let in on
the uncertainty of knowledge or on the steps being taken to answer questions of
admitted import to all citizens.

AEC insiders recognized that credibility was a problem. In a December
1954 letter to DBM's director, Charles Dunham, Los Alamos Health Division
Leader Thomas Shipman touted the importance of Sunshine and suggested a
possible role for Los Alamos. At the same time he lamented the lack of
credibility possessed by those too closely associated with the AEC:

There is also the fact that Los Alamos may be
regarded as a rather biased institution. Some people
may feel that we are interested parties. I certainly
am only too well aware of a resistance, particularly
in the Press, to accept pronouncements and
conclusions coming out of the AEC itself.
Strangely enough, they were quite willing to accept
the conclusions of the National Academy of
Sciences, completely forgetting that the
subcommittees were in very large measure
composed of AEC or AEC contractor
representatives. They were the same guys wearing
different hats.142

In the late 1950s the AEC itself came to question whether its data-
gathering efforts were serving the purposes of scientific knowledge and public
understanding, as had been hoped. Sunshine, internal memos recorded, lacked
coordination and clear goals, and the confusion of roles cost credibility. "[T]he
primary reason," wrote Hal Hollister, an AEC fallout expert, "the AEC is now in
the soup with respect to Congress, the public, and the fallout problem is that all
three of these relationships with the public (reporting data scientifically, getting it
across to the public, and telling official interpretations of it) have been
inextricably mixed up. This has continued to be true after the hearings, and the
future promises more of the same."143

In 1959 President Dwight Eisenhower acted to take responsibility for
radiation safety away from the AEC, placing it in the hands of a new Federal
Radiation Council, chaired by the secretary of the Department of Health,

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Education, and Welfare.

By the mid-1960s the possibility that data gathering could only get the
AEC into more trouble became an incentive to "not study at all." In 1965 Dwight
Ink, general manager of the AEC, advised against conducting proposed studies on
the detrimental effects of nuclear testing partly because of liability concerns:
"[Performance of the above U.S. Public Health Service studies will pose
potential problems to the Commission. The problems are: (a) adverse public
reaction; (b) law suits; and (c) jeopardizing the programs at the Nevada Test
Site."144

In his DOE-sponsored history of the AEC and nuclear testing safety,
Barton Hacker, laboratory historian at DOE's Lawrence Livermore Laboratory,
concludes that while AEC officials did not doubt that testing could be done safely
if precautions were taken, there was divergence about what to tell the public, and
reassurance won out over information:

[T]he people in the field, those involved in the test
program directly, tended to favor telling the public
just what the risk was and stressing that whatever
risk testing might impose was far outweighed by the
national importance of the test program. Openness,
they argued, would retain public trust and ensure
continued testing.145

However:

AEC officials in general, headquarters staff
members in particular, mostly preferred to reassure
rather than inform. Convinced that trying to explain
risks so small would simply confuse people and
might cause panic, they feared jeapordizing the
testing vital to American security. Their policy
prevailed. A formal public relations plan became as
much a part of every test as the technical operations
plan. Carefully crafted press releases never to my
knowledge lied, though they sometimes erred. Yet,
by the same token, they rarely if ever revealed all.
Choices about which truths to tell, which to omit,
could routinely veil the larger implications of a
situation 146

"Reluctance to acknowledge any risk, the policy that mainly prevailed in
the 1950s," Hacker concluded, "undercut the AEC's credibility when the public
learned from other sources that fallout might be hazardous."147

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THE RECORDS OF OUR PAST

The story that we have told in this report could not have been told if the
government did not keep records that could be retrieved. By the same token, the
story is often disturbingly fragmentary; seemingly contradictory statements of
principle or policy abound, and the trail from policy to practice is often hard to
discern. The story is complex, but it is also hard to reconstruct because,
notwithstanding considerable search efforts of the Human Radiation Interagency
Working Group, many documents appear to have been long since lost or
destroyed. In each case, we emphasize, any loss or destruction took place
prior-most often many years prior-to the Advisory Committee's creation.
Federal records management law provides for the routine destruction of older
records, and in the great majority of cases it should be assumed that loss or
destruction was a function of normal record-keeping practices. At the same time,
however, the records that recorded the destruction of documents, including secret
documents, have themselves often been lost or destroyed. Thus, the
circumstances of destruction (and indeed, whether documents were destroyed or
simply lost) is often hard to ascertain.

As Shields Warren and Alan Gregg suggested, where human research is
connected to secret programs, the public has a special interest in the adequacy of
record keeping needed to ensure the integrity of experimental activity.
Regardless of whether documents that cannot now be retrieved contained further
secrets, they would have provided more confidence in our understanding of the
rules and practices that governed the boundary between openness and secrecy. In
too many cases, however, documents are no longer available.148 A number of
such examples follow.149

The CIA, virtually all of whose records are classified, reported that it was
unable to retrieve any records of its participation in the midcentury DOD panels
that met in secret to discuss, among other things, human experiments. In addition,
the CIA's classified records of its secret MKULTRA human experimentation
program were, as reported when the program became a public scandal in the
1970s, substantially destroyed at the direction of then-Director of Central
Intelligence Richard Helms in 1973. In 1995 the CIA concluded, following a
search for remaining records and interviews of those involved, that it did not
likely conduct or sponsor human radiation experiments as part of MKULTRA.
The Advisory Committee, which was necessarily limited in its abilities to directly
review CIA files, did not find evidence to the contrary. As a CIA report on its
own inquiry (which was declassified at the Advisory Committee's request)
concluded, the circumstances of the CIA's MKULTRA record keeping will likely
leave questions in the public's mind.150

The DOD provided many documents that shed light on the rules of
secrecy. However, some important collections are incomplete, and other
important collections (such as the records of the Naval Radiological Defense

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Laboratory, the Medical Division of the Defense Nuclear Agency, classified
records of the Navy Bureau of Medicine relating to Operations Crossroads
physical exams, and entire sections of records of the Army surgeon general)
appear to have been substantially lost or destroyed.

The DOE could locate only fragments of the records of the Insurance and
Declassification Branches, which reviewed human subject research for
declassification. The entirety of the files of the AEC Intelligence Division, which
likely contained information on intentional releases, research performed by the
AEC for other agencies, and secrecy policy and practices, was subject to "purge"
in the 1970s, and as late as 1989.15' Many other significant collections were
retrieved. However, there were often gaps, including, for example, multiyear
gaps in the Division of Biology and Medicine fallout collection, gaps in the
transcripts from the meetings of the Advisory Committee on Biology and
Medicine, and limited collections related to the work of the Isotope Distribution
Division's Human Use Subcommittee.

The DHHS was able to locate sufficient information to confirm that it
conducted classified research on behalf of the military mission, but could not
locate information needed to determine the nature and extent of this research.15'
The classified information it once maintained has been substantially destroyed (or

lost).

The VA, similarly, was able to provide fragments of information that
show that "confidential" files were kept in anticipation of potential radiation
liability claims. However, neither the VA, nor the DOE and DOD (who evidently
were parties to this secret record keeping), have been able to determine exactly
what secret records were kept and what rules governed their collection and
availability.153 VA publications did contain lists of several thousand
(nonclassified) human experiments conducted at VA facilities; however, the
information was quite fragmentary, and further information could not be readily
retrieved (if it still exists) on the vast majority of these experiments.

Thus, in looking for answers to questions about the secrecy of data on
human experiments and intentional releases, we find record-keeping practices that
leave questions about both what secrets were kept and what rules governed the
keeping of secrets.

CONCLUSION

Openness-the public sharing of all information necessary to govern-has
long been an ideal in American democracy and politics. Scientists, also, have
traditionally embraced openness as the surest guarantee of continued progress.
However, the ideal of openness has often competed of necessity with some
measure of government-imposed secrecy. This has been particularly the case in a
time of national emergency, such as war. But secrecy existed even at the roots of
our democracy: the Constitutional Convention itself was conducted out of the

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public eye.

In the early part of this century, President Woodrow Wilson called for
"open covenants openly arrived at,"seeking to shed light upon an area-
international diplomacy-traditionally shrouded in secrecy. In the half century
since the end of World War II, with the growing importance of science and
technology in our lives, the proper place of secrecy at the intersection of
government, private enterprise, and research has emerged as a question of central
and continuing importance to society.

We have focused upon only one of many Cold War settings where
secrecy was often a routine consideration. But human radiation experiments and
intentional releases of radiation were often closely related to, if not directly a part
of, some of the most closely held of secrets; including, most notably, nuclear
weapons design and testing. The episodes we reviewed reveal the tensions
underlying the necessarily delicate balance between openness and secrecy.

We found that from the onset, leading government biomedical officials
and advisers were aware of the costs of secrecy and proclaimed the need to limit
its reach. In one important respect, these officials and researchers lived up to
their publicly stated ideals. Since about midcentury, there have been very few
instances in which the very existence of human subject radiation research has
been officially classified. Nonetheless, we also found that practices often fell
short of the ideals that were publicly expressed.

We found that decision making related to the secrecy of human subject
research considered not only national security, but also other criteria. At its birth
in 1947, the AEC determined to keep Manhattan Project experiments secret on the
basis of concern for "adverse effects on public opinion" and possible "legal suits,"
even where national security itself was not expressly invoked. More generally,
we also found that decisions to keep information secret were often accompanied
by a concern that the public might not understand the information and thus
overreact or that the public would understand the information but that its
immediate reaction could undermine support for programs deemed essential by
policymakers.

Significantly, we found that AEC and DOD discussions of Cold War
human research policy were themselves conducted outside the realm of public
debate. For example, the 1947 AEC declarations of requirements for human
research involving patients were evidently given minimal distribution within the
AEC research community itself. Recently retrieved documents now show that in
1947 the requirement of "informed consent" was itself invoked in secret by the
AEC's Medical Board of Review, in response to the request for criteria that had to
be met when secret experiments could be declassified, and evidently thereafter
relied on to keep some experiments secret. Similarly, the discussions underlying
the 1953 memorandum by Secretary of Defense Charles Wilson, concerning
human experiments done under DOD auspices, were themselves secret, as, of
course, was the Wilson memorandum itself.

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Even if there is clear and public consensus on what constitutes "national
security," its application to the classification of particular information may be a
matter of disagreement. In addition, in some cases the boundary between
protecting the nation's security and simply avoiding the potential of adverse
public reaction may not be so clear. For example, in an intense national crisis, the
release of information that might jeopardize successful resolution of the crisis
should properly be proscribed. But it is also clear that the assertion that programs
will be jeopardized because of embarrassment or potential legal liability (or,
worse, because of a lack of confidence in the American public's ability to
understand) can be used to limit disclosure of precisely those matters that most
affect us all and that would most benefit from informed public discussion.

If the boundary between openness and secrecy is inherently ambiguous,
the public trust in those who define it on a daily basis requires a clear explanation
of the principles that they will follow. However, we found that some of the basic
principles and rules by which this boundary was defined were themselves kept
secret from the public. AEC officials, in consultation with biomedical advisers
internally invoked public relations and legal liability as bases for keeping secrets,
while publicly declaring that secrecy should be limited to national security
requirements. As a corollary, we found that where formal criteria for
classification were not established, secrecy was nonetheless achieved by other,
informal means. Thus, at midcentury, participants in discussions of defense-
related biomedical research were told that while the information in question was
not itself classified, it should nonetheless be kept from the press and public.

Since 1951, presidential executive orders have limited the use of
classification stamps to matters of national security. Nonetheless, the keeping of
secrets with reference to ill-defined reasons such as public relations, continued.
Indeed, as recently as the early 1 970s, adverse public relations was reportedly
invoked as a reason for keeping secret details of the plutonium injections of the
1940s. In some cases, as we look back, the public relations rationale for secrecy
appears to be more clearly documented than any national security rationale. For
example, we found that in the early 1950s public relations was an express
consideration in keeping secrets related to fallout-related human tissue sampling;
but we found it more difficult to locate contemporaneous documentation of
national security rationales, and in 1995, surviving participants found it hard to
reconstruct one as well.

We also found instances where the keeping of secrets was accompanied by
deception. The shades of deception ranged from outright denials by the AEC that
it engaged in human experimentation, to the use of cover stories in the collection
of human tissue, to incomplete information deliberately given participants in
government-sponsored biomedical research. In some such cases, such as the use
of a cover story in collecting the bones of stillborn infants, those involved
rationalized that since partial truths were being told, active deceit was not
involved. In others, a rationalization for deception was a desire not to alarm

649

Part II

exposed workers or the public. In yet others, such as the AEC's denial that it
sponsored human experiments (when its Isotopes Division publicly advertised the
success of human subject research) the rationale is hard to discern in retrospect.

In many cases, of course, some degree of secrecy was merited.154 We
found that where secrecy was initially justified by reasons relating to national
security, the classifying authority often gave too little attention to the likelihood
that there would come a time when such information was no longer sensitive.
Immediately prior to the AEC's creation, the Tolman Committee pointed out that
in the long run (which that Committee identified in terms of years, not decades)
the nation's interest lies in the disclosure of information that needs to be kept
secret over the shorter term. Yet, the practical reality was that once information
was "born secret" it often simply remained that way.

Similarly, we found that where a national security rationale for secrecy did
exist, adequate attention was often not paid to ensuring that sufficient records
would be created and maintained so that all affected individuals (and the public at
large) could later know the possible health and safety consequences. As a result,
"downwinders," as well as knowing participants in nuclear tests, today wonder
whether the information given them represents the full story of these events.
(Indeed, as we reported in chapter 1 1 , the number of once-secret intentional
releases that are publicly known burgeoned from the thirteen reported by the
General Accounting Office in late 1 993 to the far greater number reported by the
DOD and DOE following their more recent search.) When, as we reported in
chapter 10, there is evidence that government officials contemplated, and may
have kept, secret records to evaluate potential claims from service personnel
exposed to government-sponsored radiation risk, the public has a right to expect
that the government can readily and unambiguously account for any record
keeping that may have taken place. Its inability to do so is very troubling.

Finally, we found that confusion, misunderstanding, and controversy still
characterize public understanding of issues at the core of the Committee's work;
for example, what is the nature of the risk from radiation? And to what extent can
government statements about human radiation experiments and intentional
releases be trusted? It is important to reflect on the ways in which this state of
affairs may, in part, be a consequence of past secret keeping.

In testimony before the Advisory Committee, numerous witnesses
expressed a common feeling—that the government did not give adequate weight to
the interests of an informed public. Secrets, some said, were kept from the
American public, not the enemy. Even where information may have been rightly
classified in the first instance, many pointed out that there is no longer any reason
for the absence of documents that provide a clear and full accounting to all those
who were put at risk. There are too many cases where we can give no comforting
answer to these angry voices.

However, by paying heed to these voices and by trying to understand the
past they point to, we may more readily find our path into the future. Perhaps the

650

Chapter 13

first step in this direction is a simple recognition that the proper boundary
between openness and secrecy will not be immediately obvious in all cases; many
cases will not only require judgment, but also the will to avoid the temptation to
keep secrets because the benefits of secrecy may be immediate, while the costs
are longer term.

A second step is to understand that where secrecy is truly merited, and
citizens are put at risk, there must also be precautions to ensure that a timely
public accounting will be possible when the information need no longer be kept
secret.

As the Cold War recedes further into history, the issues of secrecy and
openness it posed will undoubtedly continue to present themselves, although
often in new settings. Our review of the past provides the basis for some specific
recommendations about the future, but it also points to a more fundamental
understanding of the wisdom of those leaders of the day who identified the long-
term costs of secrecy and called for policies to minimize them. The shortcomings
of past policies and actions confirm that even when principles are articulated by
well-intentioned officials, the translation of principles into practice is not
automatic and warrants careful attention by the public. At the same time, the
present-day legacy of distrust confirms that too much secrecy in the short term
will, in the long run, erode the public's trust in government and the government's
ability to keep the secrets that must be kept.

651

ENDNOTES

1 . For example, FOIA exempts from disclosure draft documents and other
records reflecting deliberations made before a decision.

2. For a discussion of the definition of secrecy see Sissela Bok, Secrets: On the
Ethics of Concealment and Revelation (New York: Vintage Books, 1989), 5-9.

3. As discussed in the text that follows, the executive orders on national security
information are perhaps the most basic source on the definition of national security
requirements in the context of security classification. The currently effective order,
Executive Order 12958, provides that '"national security' means the national defense or
foreign relations of the United States." The precise contours of this definition are, as
discussed in what follows, a perennial subject of attention. Executive Order 12958 further
provides that "a person may have access to classified information provided that: (1) a
favorable determination of eligibility for access has been made by an agency head or the
agency head's designee [i.e., a security clearance]; (2) the person has signed an approved
nondisclosure agreement; and (3) the person has a need-to-know the information."
Executive Order 12958, sec. 4.2(a), 60 Fed. Reg. 19836 (April 20 1995). The
nondisclosure agreement referred to will typically refer, in turn, to various statutes that
make it a crime to disclose classified information without authorization-for example, the
Espionage Act and the Atomic Energy Act, as also discussed in the text.

4. Espionage Act, 18 U.S.C. 793-794.

5. Military Installation and Equipment Protection Act, 1 8 U.S.C. 795-797.

6. President, executive order, "Defining Certain Vital Military and Naval
Installations and Equipment, Executive Order 8381," Federal Register 5, no. 59 (26
March 1940).

7. Army Classification Guide, AR 320-5 ( 1 936).

8. Ibid.

9. Manhattan Engineer District, 26 November 1945 ("Security Manual")
(ACHRE No. DOE-050595-B), 21.

1 0. Noted by Stafford Warren, who came from the University of Rochester to
be the medical director of the Manhattan Project. Stafford L. Warren, interviewed by
Adelaide Tusler (UCLA Oral History Program), transcript of audio recording, 21 July
1966 (ACHRE No. UCLA-101794-A), 574-575.

1 1 . Committee on Declassification to Major General L. R. Groves, 1 7
November 1945 ("Report of Committee on Declassification [Tolman Committee report]")
(ACHRE No. DOE-120594-D). The committee was chaired by Dr. H. C. Tolman, a
professor of physical chemistry and mathematical physics at the California Institute of
Technology. Tolman had advised the government on the creation of the wartime Office
of Scientific Research and Development, advised Manhattan Project director General
Groves, and served on the Target Committee that made decisions on the dropping of the
atomic bombs on Japan. Ronald L. Kathren et al., eds., The Plutonium Story: The
Journals of Professor Glenn T. Seaborg: 1939-1946 (Columbus: Battelle Press, 1994),
818-819.

12. Committee on Declassification to Groves, 1 7 November 1945, 2.

13. Ibid., 3.

14. Ibid.

15. Ibid., 4-5.

652

16. Ibid., 13-14.

17. Manhattan Engineer District, 30 March 1946 ("Declassification Guide for
Responsible Reviewers") (ACHRE No. DOE-050495-B); Atomic Energy Commission, 1
January 1948 ("Declassification Guide") (ACHRE No. DOE-050495-B); Atomic Energy
Commission, 15 November 1950 ("Declassification Guide For Responsible Reviewers")
(ACHRE No. DOE-052595-B).

18. Defense Department entities can also create and use RD. However,
presidential order has been the primary source of DOD classification authority.

1 9. Atomic Energy Act § 1 0(b)( 1 ) ( 1 946) (emphasis added). In 1 954 the Atomic
Energy Act was amended, and the requirement to declassify RD was strengthened: "The
Commission shall from time to time determine the data . . . which can be published
without undue risk of the common defense and security . . . "42 U.S.C. § 2162. In
addition, a new category of classified information, later termed Formerly Restricted
Data, was created to apply to information concerning the military use of atomic weapons
that was no longer RD. 42 U.S.C. § 2164.

20. For treatments of this complex story, see Gregg Herken, The Winning
Weapon: The Atomic Bomb in the Cold War 1945-1950 (New York: Knopf, 1980); James
Hershberg, James B. Conant: Harvard to Hiroshima and the Making of the Nuclear Age
(New York: Knopf, 1993); Richard G. Hewlett and Oscar E. Anderson, Jr., The New
World: A History of the United States Atomic Energy Commission, Volume 1 1939-1946
(Berkeley: University of California Press, 1990); George T. Mazuzan and J. Samuel
Walker, Controlling the Atom: The Beginnings of Nuclear Regulation, 1946-1962
(Berkeley: University of California Press, 1984); and Richard Rhodes, Dark Sun: The
Making of the Hydrogen Bomb (New York: Simon and Schuster, 1995).

21 . Major Richard T. Batson, Declassification Officer, Research Division, to
Dr. A. H. Dowdy, 21 March 1947 ("Reclassification of Documents") (ACHRE No. DOE-
101394-A), 1. The two reports were chapters in the volume Pharmacology and
Toxicology of Uranium Compounds, which was to be part of the public history of
Manhattan Project research.

22. Colonel O. G. Haywood to H. A. Fidler, 17 April 1947 ("Medical
Experiments on Humans") (ACHRE No. DOE-051094-A-62), 1. In May, Fidler noted
that for purposes of classification, "the Declassification Section was giving a very strict
interpretation to the above term [human experiment] and included routine checks
performed on plants' personnel who may or may not have been exposed to excess
radiation as well as known accidental exposures where plutonium, for instance, was
introduced into the body." Fidler noted, however, that "Colonel Cooney stated that only
those experiments where actual materials were intentionally introduced into the human
system need to be regarded as secret." H. A. Fidler, 14 May 1947 ("Memo to the Files on
Policy on Medical Reports") (ACHRE No. IND-071395-A), 1.

23. H. A. Fidler to Carroll L. Wilson, AEC General Manager, 26 May 1 947
("Declassification Policy") (ACHRE No. DOE-121294-C), 7; Carroll L. Wilson to H. A.
Fidler, 23 June 1947 ("Declassification Policy") (ACHRE No. DOE-121294-C), 1.

24. Carroll Wilson, "Security Regulations in the Field of Nuclear Research,"
Bulletin of the Atomic Scientists 3 (1947): 322. Wilson's 27 August 1947 letter also,
however, stated that information policies were under review and that "since the
Commission took over the facilities and operations of the Manhattan District on January
1, 1947, the information program has followed the policies inaugurated by the War
Department."

653

25. Atomic Energy Commission, 20 June 1947 ("Report of the Board of
Review") (ACHRE No. DOE-051094-A-191), 11.

26. Carroll Wilson, AEC General Manager, to Dr. Robert Stone, 5 June 1947
("Your letter of May 7, 1947 ... ) (ACHRE No. DOE-061395-A), 1.

27. Carroll Wilson, AEC General Manager, to Dr. Robert Stone, 12 August
1947 ("Declassification of Biological and Medical Papers") (ACHRE No. DOE-061395-
A), 1.

28. John A. Derry, AEC Acting General Manager, to Walter J. Williams,
Manager, Field Operations at Oak Ridge, 9 August 1947 ("Establishing Criteria for
Proper Classification of Information") (ACHRE No. DOE-020795-B).

29. Further items included the following:

(1) All medical records, reports and correspondence
which embodies or refers to other technical information
classified secret or higher. . . .

(3) All medico-legal and insurance statistics which refer
directly to process hazards.

(4) Claims, allegations or reports of injury on
'investigation prohibited' cases where the material or
process involved is considered to be classified secret.

(5) All medical reports, references and correspondence
dealing with certain special hazard problems, as for
example, the medical aspects of criticality accidents.

Albert H. Holland, AEC Acting Medical Adviser, to the Chairman, Classification Board,
12 September 1947 ("Proposed Classification for Unique Operational and Production
Hazards, Including Medical Classification") (ACHRE No. DOE-101394-A), 1.

30. Ibid., 2. Other examples of "information or matter which should be graded
confidential" included these:

(1) All documents, claims, allegations and medical
reports on injury on 'investigation prohibited' cases,
including reports of the Advisory Board on Occupational
Disease Claims.

(2) All 'programmatic' medical research.

(3) All records of exposure to classified substances.

(4) All documents and correspondence which state, refer
to or give information of known medical or public health
hazards.

Ibid., 1.

31. J. C. Franklin, Manager, Oak Ridge Operations, to Carroll L. Wilson, AEC
General Manager, 26 September 1947 ("Medical Policy") (ACHRE No. DOE-1 13094-B-
3), 2-3. We note that the documentation available does not permit a definitive
understanding of the relationship between the rationale employed for keeping data on
human radiation experimentation (and other human radiation data gathering) secret and
the particular level of security classification to which the data were assigned. As quoted
in the text, documents talk in terms of the need to keep secret information that, while not
endangering national security, could nonetheless be damaging to the government. As
also quoted in the text, the category of Confidential provided for classification on this

654

basis. However, as indicated in the text, documents invoking the "adverse effect on
public opinion" language also call for the classification of human radiation
experimentation data as Secret, a higher level of classification. Thus, while it is clear that
the rules provided for classification on bases other than national security, and it also
seems clear that those calling for continued keeping of radiation experiments secret saw a
need for secret keeping independent of national security impact, there also may have
coexisted the view that an "adverse effect on public opinion" could equate to
endangering national security.

32. Ibid., 3.

33. L. F. Spalding, Chief, Insurance Claims Section, to C. L. Marshall, Deputy
Declassification Officer, Technical Information Branch, 1 1 June 1947 ("Document by
Cheka and Morgan") (ACHRE No. DOE-070795-C), 1. See also L. F. Spalding, Chief,
Insurance Claims Section, to C. L. Marshall, Deputy Declassification Officer, Technical
Information Branch, 1 1 June 1947 ("Document by Cheka") (ACHRE No. DOE-070795-
C), 1.

34. Memorandum to Advisory Board on Medicine and Biology, 8 October 1947
("Medical Policy") (ACHRE No. DOE-051094-A-419), 8.

35. Holland had proposed that the definition of Unclassified include

All medical and biological documents, reports and
research not directly relating to experimental human
administration, process hazards, contamination hazards
or public health hazards, and which will not result in
mass hysteria on the part of employees or the public, or
in idle speculation or [illegible] adverse claims against
the Atomic Energy Commission or its contractors.
Holland to the Chairman, Classification Board, 12 September 1947, 2.

36. Advisory Committee for Biology and Medicine, 1 1 October 1947 ("Draft
Minutes, Advisory Committee for Biology and Medicine: Second Meeting") (ACHRE
No. DOE-072694-A), 10. The agenda for the 1 1 October 1947, meeting of the Advisory
Committee on Biology and Medicine also contained "publication of scientific papers"
and "secrecy of work in the field of biological and medical research." Carroll L. Wilson,
AEC General Manager, to Commissioners and Division Heads, 9 October 1947
("Meeting of the Advisory Committee for Biology and Medicine") (ACHRE No. DOE-
072694-A), 2. The minutes show the topics were discussed; however, there is no specific
reference to human experiments data in these discussions.

Regarding restrictions on the publication of scientific
papers [General Manager Wilson] expressed the hope
that these restrictions [which were not identified] would
diminish in time. He pointed out that information on the
physical science mentioned in medical and biological
papers frequently delays classification.

"Draft Minutes," 1 1 October 1947, 5-6. In addition. Chairman Gregg

read a memorandum on the publication of scientific
papers prepared jointly by Dr. A. F. Thompson, Chief

655

Technical Information Branch, and H. A. Fidler, Chief,
Declassification Branch. The memorandum explained
the present status of declassification . . . and stated that
papers are not declassified when they include
information on nuclear constraints for the heavy
elements or reference to classified technological papers.
Ibid., 6-7.

37. "Draft Minutes," 1 1 October 1947, 1 1 .

38. Ibid., 11.

39. Carroll L. Wilson, AEC General Manager, to Robert S. Stone, University of
California Medical School, 5 November 1947 ("Your letter of September 18 regarding
the declassification of biological and medical papers was read at the October 1 1 meeting
of the Advisory Committee on Biology and Medicine . . .") (ACHRE No. DOE-061395-
A), 1 . Carroll L. Wilson, AEC General Manager, to Alan Gregg, Director for Medical
Sciences, Rockefeller Foundation, 5 November 1947 ("I want to thank you for your letter
of October 14 concerning the questions raised by Dr. Stone in his letter to me of October
18 . . .") (ACHRE No. DOE-061395-A), 1.

40. Dr. Harold Hodge, Chief Pharmacologist, University of Rochester, to
Brewer F. Boardman, Chief, Technical Information Division, AEC Field Operations, 12
February 1948 ("Thank you for your letter of February 4th . . .") (ACHRE No. DOE-

1 13094-B-4), 1. Following a section-by-section review of the chapter Hodge declared, "I
wish to submit the argument that none of this material is human experimentation unless
you would class measuring a man's height or recording his weight as human
experimentation."

41. Albert H. Holland, Medical Adviser, to Dr. Hoylande D. Young, Director,
Information Division, Argonne National Laboratory, 15 March 1948 ("In accordance
with your recent request, the following documents were reviewed for reconsideration of
their classification . . .") (ACHRE No. DOE-120894-E-4), 1.

42. Shields Warren, Director, AEC Division of Biology and Medicine, to Albert
H. Holland, AEC Medical Adviser, 19 August 1948 ("Review of Document") (ACHRE
No. DOE-101494-B), 1.

43. Albert H. Holland, AEC Medical Adviser, to Shields Warren, Director,
AEC Division of Biology and Medicine, 9 August 1948 ("Review of Document")
(ACHRE No. DOE-051094-A), 1.

44. Anthony C. Vallado, Deputy Declassification Officer, Declassification
Branch, to Clyde Wilson, Insurance Branch, 8 December 1948 ("Review of Document
by Knowlton") (ACHRE No. DOE-120894-E-32), 1.

45. Clyde E. Wilson, Chief, Insurance Branch, to Anthony C. Vallado, Deputy
Declassification Officer, Declassification Branch, 20 December 1948 ("Review of
Document by Knowlton") (ACHRE No. DOE-120894-E-32), 1.

46. Albert H. Holland, AEC Acting Medical Adviser, to C. L. Marshall, Deputy
Declassification Officer, Technical Information Branch, 23 October 1947
("Declassification of Document") (ACHRE No. DOE-1 13094-B-4), 1.

47. In February 1948 the Insurance Branch opined that although a report
("Biochemical Studies Relating to the Effects of Radiation and Metals") "might arouse
some claim consciousness on the part of former employees we are unable to predict that
the Commission's interests would be unjustifiably prejudiced by its publication."
Nonetheless, if latent disabilities resulted from the exposures reported, the public

656

relations section would be involved. The Insurance Department, noting that it was
conferring with Dr. Holland on "claims similar in nature to some of the exposures"
discussed in the report, urged that he be called in. L. F. Spalding, Insurance Branch, to
Charles A. Keller, Declassification Officer, Declassification Branch, 5 February 1948
("Review of Document") (ACHRE No. DOE-1 13094-B), 1.

48. Documents available to the Committee show that medical research reports
were reviewed by Public Relations and Insurance Branch officials prior to
declassification at least as late as April 1949. See 27 April 1949 letter from Anthony C.
Vallado, Deputy Declassification Officer, Declassification Branch, to Warren C. Johnson,
University of Chicago ("Transmittal of Fink Survey Volume ['Biological Studies with
Polonium, Plutonium, and Radium'] for Final Declassification Review") (ACHRE No.
DOE-032995-A).

49. Atomic Energy Commission, 2 May 1949 ("Policy on Control of
Information") (ACHRE No. IND-071395-B), 3.

50. President, executive order, "Prescribing Regulations Establishing Minimum
Standards for the Classification, Transmission, and Handling, by Departments and
Agencies of the Executive Branch, of Official Information Which Requires Safeguarding
in the Interest of the Security of the United States, Executive Order 10290," 3 C.F.R.

( 1 949- 1 953 Compilation). The executive order provided that:

[information . . . shall not be classified under these
regulations unless it requires protective safeguarding in the
interest of the security of the United States. The use of any
of the four security classification prescribed herein . . . shall
be strictly limited to classified security info.

"Classified security information" was defined as "official information the
safeguarding of which is necessary in the interest of national security." The order did,
however, provide that it should not be construed "to replace, change, or otherwise be
applicable with respect to any material or info protected against disclosure by statute." It
would not have required the alteration of embarrassment- or public relations-based
criteria if they were supported by an independent statutory basis. Thus, if statutes like the
Espionage Act previously provided adequate basis for classification in the absence of
national security endangerment, they would continue to do so.

5 1 . President, executive order, "Classified National Security Information,
Executive Order 1 2958, sec. 1 .8 (a)-(b)," Federal Register 60, no. 76 (20 April 1 995).

52. AEC Advisory Committee for Biology and Medicine, minutes of the
twenty-third meeting, 8-9 September 1950 (ACHRE No. DOE-072694-A), 28.

53. Shields Warren, Director, AEC Division of Biology and Medicine, to Leslie
M. Redman, "D" Division, Los Alamos Scientific Laboratory, 5 March 1951 ("Dr.
Alberto F. Thompson, Chief, Technical Information Service, has asked me to reply to
your letter . . . ") (ACHRE No. DOE-051094-A-603), 2. Warren's letter attributes Gregg's
statement to a September 1948 meeting of the ACBM. While the statement is not
reflected in the minutes, a statement by Gregg in a similar vein was contained in an
October letter, as discussed in chapter 8. Alan Gregg, Chairman, AEC Advisory
Committee for Biology and Medicine, to Robert Stone, University of California Medical
School, 20 October 1948 ("The secrecy with which some of the work of the Atomic
Energy Commission has to be conducted creates special conditions for the clinical

657

aspects of its work . . .") (ACHRE No. UCLA-1 1 1094-A-24), 1.

54. Warren's view is reported in a 1952 letter from a PHS official. James G.
Terrill, Acting Chief, Radiological Health Branch, Division of Engineering Resources, to
Charles V. Kidd, Chief, Research Planning Branch, National Institutes of Health, 25
September 1952 ("At the September 8-12 meeting of the Panel at Los Alamos, several
subjects were discussed that are of general interest to the Public Health Service . . .")
(ACHRE No. HHS-092794-A), 1.

55. See Department of Defense, Research and Development Board, Committee
on Medical Sciences, 23 May 1950 ("Transcript of Meeting Held on 23 May 1950 . . .
The Pentagon, Washington, D.C.") (ACHRE No. DOD-080694-A). (The Advisory
Committee's copy of this transcript was classified Confidential and bears a 1994
declassification stamp.) See also Department of Defense, Research and Development
Board, Committee on Chemical Warfare, 10 November 1952 ("Transcript of the
Fourteenth Meeting Held 10 November 1952 .. . The Pentagon") (ACHRE No. DOD-
080694-A). (The Advisory Committee's copy of this transcript was classified Secret and
bears a 1994 declassification stamp.)

56. The Committee's copies of the minutes of the first year of meetings of the
ACBM bear a 1994 declassification stamp.

57. Committee on Medical Sciences to Chairman and Members, Joint Panel on
the Medical Aspects of Atomic Warfare, 15 December 1952 ("Department of Defense
Research Program Under the Technical Objective of AW-6") (ACHRE No. NARA-
062094-A). The NIH and PHS had representatives who were associate members on the
Joint Panel on the Medical Aspects of Atomic Warfare. See Joint Panel on the Medical
Aspects of Atomic Warfare, Minutes of the Sixth Meeting held on 31 October--l
November 1950 (ACHRE No. DOD-072294-B), and Joint Panel on the Medical Aspects
of Atomic Warfare, Minutes of the Seventh Meeting held on 25-26 January 1951
(ACHRE No. DOD-072294-B).

58. National Institutes of Health, 13 May 1952 ("Defense Activities of the
National Institutes of Health [1950-1952]") (ACHRE No. HHS-071394-A), 30.

59. Since DOD and AEC biomedical human subject radiation research was
rarely classified, it would seem most likely that the classified HHS research (except in
cases, such as the Marshallese, where there was a direct connection to weapons tests) did
not involve humans.

60. In a 7 May 1955 letter to AEC chairman Lewis Strauss, Gioacchino Failla,
chairman of the Advisory Committee for Biology and Medicine, wrote that the AEC had
reviewed the Division of Biology and Medicine's research program "and is pleased to
find that less than 5% of the medical program has security classification." Failla to
Strauss, 7 May 1955 ("The Advisory Committee for Biology and Medicine has reviewed
again the program of research in the Division . . .") (ACHRE No. DOE-082294-B), 1. In
a May 1955 letter to AEC Chairman Strauss, the ACBM recommended that the AEC
"continue to sponsor all research relative to the diagnosis and treatment of radiation
injury in a wholly unclassified way except those experiments directly related to weapons
testing or development." Ibid. However, in Senate testimony two months earlier, the
University of Chicago's George Leroy (who played a key role as an AEC adviser on
bomb test research and who, as medical school dean, oversaw AEC-funded research) told
Senator Hubert Humphrey that "there is a considerable amount of information which for
one reason or another has not been disseminated to the medical profession and scientific
profession." Subcommittee on Reorganization of the Committee on Government

658

Operations, Hearing Held Before Subcommittee on Reorganization of the Committee on
Government Operations, S. J. Res. 21, Joint Resolution to Establish a Commission on
Government Security, Statement of Dr. George V. LeRoy, M.D., 84th Cong., 1st Sess., 14
March 1955,851.

61. NEPA Medical Advisory Panel, 22 July 1949 ("NEPA Medical Advisory
Panel Subcommittee No. IX, Report No. NEPA 1 1 10-IER-20") (ACHRE No. DOD-
121494-A-2), 5. A subgroup was convened to assess what was known about the effects
of whole-body exposure to radiation. In a 1951 letter to the Air Force's School of
Aviation Medicine transmitting the conclusions, the Air Force's surgeon general
explained that "[w]hile this information is not classified, it should not be given general
publicity." Major General Harry G. Armstrong, Air Force Surgeon General, to
Commandant, USAF School of Aviation Medicine, 24 January 1951 ("Data Relative to
External Radiation from Radioactive Material") (ACHRE No. DOD-062194-B-14), 3.

62. Everett Evans, Director of the Laboratory for Surgical Research at Medical
College of Virginia, to Doctors W. T. Sanger et al., 23 January 1951 ("I think each of
you should be informed of a problem . . .") (ACHRE No. DOD-020995-A), 1. Evans
added:

There is much about this experiment I do not like but we
are doing it in a manner as humane as possible ... we
have simply had to make the choice between this type of
study which I hope will bring relief to atomic bombing
victims or simply wait for an atomic bomb attack. . . .
This issue here is one of national security.
Ibid., 2. It should be noted that the focus of the MCV atomic bomb-related research
appears to have been thermal burns, and not the effects of ionizing radiation.

63. Everett Idris Evans, Director, Laboratory for Surgical Research, Medical
College of Virginia, to Colonel John R. Wood, Chairman, Army Medical Research and
Development Board, 23 January 1951 ("You will find from the attached letter I am
having my problems with the local press . . .") (ACHRE No. DOD-020995-A), 1.

64. John Wood, Chairman, Medical Research and Development Board, to
Everett I. Evans, Director, Laboratory for Surgical Research, Medical College of
Virginia, 25 January 1951 ("Reference your letter of 23 January 1951 . . .") (ACHRE No.
DOD-020995-A), 1.

65. Ibid.

66. Ibid.

67. Ibid.

68. Everett Evans, Director, Laboratory for Surgical Research, Medical College
of Virginia, to Major W. F. Smyth, Superintendent, Virginia State Penitentiary, 13
December 1951 ("We continue to enjoy all the help you and your staff are giving us . . .")
(ACHRENO.VCU-012595-A-17), 1.

69. Major W. F. Smyth, Superintendent, Virginia State Penitentiary, to Everett
Evans, Director, Laboratory for Surgical Research, Medical College of Virginia, 19
December 1951 ("I wish to thank you for your letter of December 13 . . .") (ACHRE No.
VCU-012595-A-17), 1.

70. W. G. Lalor, Rear Admiral, U.S. Navy (Ret.), Secretary, Joint Chiefs of
Staff, to Chief of Staff, U.S. Army et al., 3 September 1952 ("Security Measures on
Chemical Warfare and Biological Warfare") (ACHRE No. NARA-012495-A), 2. In the

659

memo to the service chiefs of staff, the Joint Chiefs decreed that "responsible agencies"
should "[e]nsure, insofar as practicable, that all published articles stemming from the
B W [biological warfare] or CW [chemical warfare] research and development programs
are disassociated from anything which might connect them with U.S. military endeavor."

71 . Office of the Director of Defense Research and Engineering, Thirtieth Joint
Medical Research Conference, minutes of 8 January 1964 (ACHRE No. DOD-062994-
A),3.

72. R. Wasserman and C. Comar, Annotated Bibliography of Strontium and
Calcium Metabolism in Man and Animals (Washington, D.C.: Agricultural Research
Service, 1961), Publication no. 821, 1. The preface states:

Within recent years it has become necessary to understand
the metabolism and movement of radioactive strontium in
the biosphere. The behavior of strontium in man and
animals is closely linked with that of calcium, and it is
therefore necessary to consider the factors that govern the
behavior of both elements. This annotated bibliography . .
. should be useful to national defense workers who are
doing research on the strontium-calcium relationship.

73. In some cases, however, the fallout-related purpose of research was publicly
stated. See, for example, Robert P. Chandler and Samuel Wider, "Radionuclides in the
Northwestern Alaska Food Chain, 1959-1961— A Review," Radiological Health Data
(June 1963): 317-324.

74. John Bowers, Assistant to Director, Division of Biology and Medicine, to
A. H. Gill, 18 February 1948 ("Your letter to David E. Lilienthal . . .") (ACHRE No.
DOE-040395), 1.

75. Shelby Thompson, Chief, AEC Public Information Service, to Frank
Starzel, Associated Press General Manager, 7 December 1950 ("We have noted in the
November 29 Baltimore Sun... ") (ACHRE No. DOE-051094-A), 1.

76. John C. Bugher, Director, Division of Biology and Medicine, to Jesse Paul
Malone, 2 April 1953 ("This is in reply to your letter of March 23rd . . . ") (ACHRE No.
DOE-040395-A), 1. See also another April 1953 letter in which the AEC's Argonne
Laboratory told a citizen, "We do not conduct experiments on human beings." Harvey
M. Patt, Division of Biological and Medical Research, to Mr. Joseph Vodraska, New
York City, 14 April 1953 ("Thank you kindly . . .") (ACHRE No. DOE-050195-B).

77. Shelby Thompson, Acting Director, Division of Information Services, to H.
C. Baldwin, Information Officer, Chicago Operations Office, 21 August 1953
("Information Guidance on Any Experimentation Involving Human Beings") (ACHRE
No. DOE-040395-A), 1.

78. Louis Hempelmann, University of Rochester School of Medicine and
Dentistry, to Charles Dunham, Director, AEC Division of Biology and Medicine, 2 June
1955 ("I did not have an opportunity to speak to Roy Albert in New York . . ." ) (ACHRE
No. DOE-092694-A), 1.

79. Ibid.

80. Roy Albert, Assistant Chief of the Medical Branch of the Division of
Biology and Medicine, to Louis Hempelmann, University of Rochester School of
Medicine and Dentistry, 23 June 1955 ("Chuck Dunham passed along to me your letter
containing suggestion for the Harshaw study . . ." ) (ACHRE No. DOE-092694-A), 1.

660

81. Ibid.

82. Ibid.

83. Committee to Consider the Feasibility and Conditions for a Preliminary
Radiological Safety Shot for Operation "Windsquall" [later named Jangle], 2 1 May 1 95 1
("Notes on the Meeting ... 21 and 22 May 1951") (ACHRE No. DOE-030195-A).

84. Barton C. Hacker, Elements of Controversy; The Atomic Energy
Commission and Radiation Safety in Nuclear Weapons Tests 1947-74 (Berkeley:
University of California Press, 1994), 69.

85. Benjamin W. White, 1 August 1953 ("Desert Rock V: Reactions of Troop
Participants and Forward Volunteer Officer Groups to Atomic Exercises") (ACHRE No.
CORP-111694-A), 10.

86. Hacker, Elements of Controversy, 1 1 8. The pattern applied to animal
experiments, as well as human data gathering. A recently declassified 1952 DOD history
records that "because of anti-vivisection sentiment, release of such information would be
detrimental to the testing program. Decision was made that such information fell into a
sensitive, though non-classified, category and should not, therefore, be released to the
public." Armed Forces Special Weapons Project, undated document ("First History of
AFSWP 1947-1954, Volume 5-1952, Chapter 3-Headquarters") (ACHRE No. DOD-
120794-A), 3.12.9. Other evidence indicates, however, that animal experiments were
publicized.

87. H. K. Gilbert, Commander, USAF, to Commander Eugene Cronkite, USN,
8 March 1954 ("Letter of Instruction to CMR Eugene P. Cronkite, USN") (ACHRE No.
DOE-013195-A), 1.

88. In Rochester, New York, an Eastman Kodak researcher, observing the
fogging of a batch of Kodak film, traced the film materials to Iowa and deduced that
radiation had been transported by air following an explosion. J. Newell Stannard,
Radioactivity and Health: A History (Springfield, Va.: Office of Scientific and Technical
Information, 1988), 884-886.

89. Roy B. Snapp, 14 February 1952 ("Project Gabriel: Note By the Secretary")
(ACHRE No. DOE-033195-A), 1; Shields Warren, Director, AEC Division of Biology
and Medicine, to General Advisory Committee, 13 February 1952 ("Project Gabriel")
(ACHRE No. DOE-033195-A), 1.

90. AEC Division of Biology and Medicine, July 1954 ("Report on Project
Gabriel") (ACHRE No. DOE-040395-A), 8.

91 . AEC, 19 January 1954 ("Supplementary Information on Gabriel: Report by
the Director of Biology and Medicine") (ACHRE No. DOE-013195-A), 1.

92. Stannard, Radioactivity and Health, 934-936, 1 064- 1 080.

93. Rand, the quintessential "think tank," was created to advise the Air Force
on emerging issues of policy and strategy.

94. Rand Corporation, Worldwide Effects of Atomic Weapons: Project
Sunshine: AECU-3488 (Oak Ridge, Tenn.: U.S. Atomic Energy Commission, Technical
Information Service Extension, 1953), v-vii.

95. The report continues to explain in more detail: "The release in the world of
several kilograms (kg) of strontium 90 within less than a decade has probably
disseminated enough of the contaminant to provide amounts that are probably now
detectable in samples of inert and biological materials throughout the world." Ibid., 7.

96. Ibid., 47.

661

97. Even the initial conference was kept secret. The attendees had been told:
"The letter of invitation [to the conference] . . . should be classified ... or returned to this
office by registered mail." Ernest H. Plesset, Nuclear Energy Division, Rand Corporation,
to Forrest Western, Biophysics Branch, Division of Biology and Medicine, 31 July 1953
("We wish to thank you very much for your participation in the conference . . .")
(ACHRE No. DOE-013195-A), 1.

98. AEC Division of Biology and Medicine, "Report on Project Gabriel." 2.

99. The six locales were ( 1 ) northern Utah or southwestern Idaho, (2) Kansas or
Iowa, (3) New England (Boston), (4) South America, (5) England, and (6) Japan. From
each would be drawn twelve human tissue samples, four from each age group: 0-10
years, 10-20 years, over 20 years. Within each age group, two samples would be
epiphysial end or rib and two would be teeth. Rand Corporation, Worldwide Effects, 5 1 .

100. Robert A. Dudley, Biophysics Branch, Division of Biology and Medicine,
to Gertrude Steel c/o Willard Libby, Professor of Chemistry, University of Chicago, 16
October 1953 ("There are several matters which I would like to bring to the attention of
you and Dr. Libby . . .") (ACHRE No. DOE-013195-A), 1.

101. Ibid.

102. Ibid., 2.

103. Robert A. Dudley, Biophysics Branch, Division of Biology and Medicine,
to Shields Warren, Director, AEC Division of Biology and Medicine, 26 October 1953
("We are now starting to make provision for a collection of foreign bones . . .") (ACHRE
No. DOE-013195-A), 1.

104. Robert A. Dudley, Biophysics Branch, Division of Biology and Medicine,
to Raymond A. Dudley, ABCRM, 10 November 1953 ("Thanks for the information in
your letter of November 4. . .") (ACHRE No. DOE-013195-A), 1.

105. DBM Director Bugher wrote to the Rockefeller Foundation, providing the
cover story and asking for help in obtaining specimens "from Brazil, Colombia, Peru, and
Chile or Bolivia." John C. Bugher, Director, Division of Biology and Medicine, to
Andrew J. Warren, Director, Division of Medicine and Public Health, Rockefeller
Foundation, 30 December 1953 ("Herewith I am enclosing a letter to you which might be
used to explain the program of bone collections . . .") (ACHRE No. DOE-013195-A), 1.

106. Robert A. Dudley, Biophysics Branch, Division of Biology and Medicine,
to James K. Scott, Atomic Energy Project, University of Rochester, 9 December 1 953
("This letter will explain in a little more detail . . .") (ACHRE No. DOE-013195-A), 1.

1 07. AEC Division of Biology and Medicine, "Report on Project Gabriel," July
1954, 13.

108. Ibid., 38.

109. Armed Forces Special Weapons Project, undated document ("AFSWP
History, Latter Period: 1955-58") (ACHRE No. DOD-072594-B), 37.

1 10. Walter Reed Army Institute of Research, November 1955 ("Recovery of
Radioactive Iodine and Strontium from Human Urine-Operation Teapot [WRAIR-IS-55
{AFSWP-893}]") (ACHRE No. DOD-092394-C), 1. The substance of the work was
declassified in the late 1950s.

Research continued through the early 1960s, with use of the new body counter
technologies (that permitted measurement of body radiation). U.S. Army Medical
Research and Development Command to the Chief of DAS A, 25 April 1963
("Metabolism of Fission Products from Fallout") (ACHRE No. DOD-020195-A); U.S.
Army Medical Research and Development Command to the Chief of DASA, 26 April

662

1963 ("Ionizing Radiation Combined with Trauma") (ACHRE DOD-020195-A).

111. Major General A. R. Luedecke, Chief, AFSWP, to the Surgeon General,
Department of the Air Force, 16 December 1954 ("Fall-Out Studies") (ACHRE No.
DOD-090994-C), 2.

Another contemporary instance of selective disclosure of fallout-related research,
although not directly involving human beings, is discussed in a February 1955 letter
written in the aftermath of the March 1954 Bravo bomb test. In this letter, Willard Libby,
acting AEC chairman, writes to the chairman of the Congressional Joint Committee on
Atomic Energy to report on a proposed marine radiobiological survey in the Pacific.
Libby explained that it had been determined that the survey itself did not involve
Restricted Data, although the results would involve Restricted Data since they could
reveal weapons information. Libby further explained:

The classification "Secret" Defense Information has been assigned to the
survey in order to avoid, if possible, an unwarranted recrudescence of
fears in Japan of radioactive contamination offish; and because
knowledge by unfriendly interests of bomb-originated debris in the
vicinity of Formosa might be used effectively to embarrass the United
States. The fact of an oceanographic survey in the Pacific, however, is
regarded as unclassified so long as purpose, content, and results are not
revealed.
W. F. Libby, Acting Chairman, AEC, to Honorable Clinton P. Anderson, Chairman, Joint
Committee on Atomic Energy, U.S. Congress, 16 February 1955 ("We would like to
inform the Committee of plans . . .") (ACHRE No. NARA-070595-A), 1-2.

1 12. AEC Division of Biology and Medicine, 18 January 1955 ("Biophysics
Conference") (ACHRE No. NARA-061395-B), 60.

113. Ibid.. 8.

1 14. The researchers had come to recognize the difficult sampling problems;
not only was the stati'stical representativeness of individual subjects a question, but the
representativeness of particular body parts. Ibid., 12.

1 15. Ibid., 81. In 1995, Dr. Kulp recalled that the Columbia researchers
followed legal processes to obtain cadavers. Some states required a special permit to
dispose of human remains outside the state; others required specific approval from
relatives for use of certain organs. At the time there were no restrictions in Houston on
the use of unclaimed bodies for any scientific purpose. As a result of these policies, Dr.
Kulp recalled, "The group supporting our project said they could obtain samples from
virtually every body that came under their jurisdiction (not all of Houston!) that met the
legal criteria." The reference to "poverty cases" was "meant to convey the fact that
among the lower economic group in the city there are many unclaimed bodies." Dr. Kulp
recalled: To the best of my recollection all human bone samples collected for the
Columbia University studies were done legally. They came from medical school
cadavers, morgues or amputation material. In all cases the sources were either bodies
that had been donated for medical use, unclaimed, or residue from necessary
amputations. In all cases the material (with or without Project Sunshine) would have
been ashed after examination or research use and then the ash discarded. Taking a
portion of this ash for the determination of its calcium and strontium-90 concentration
(or for any other trace element such as radium, selenium, arsenic etc.) can hardly be a
moral, ethical or legal issue under these circumstances." Dr. J. Laurence Kulp, letter to

663

Dan Guttman (ACHRE), 21 July 1995.

1 16. DBM, "Biophysics Conference," 185-187.

117. Ibid., 187.

118. Ibid., 12.

1 19. Geochemistry Laboratory, Lamont Observatory, Columbia University, 15
April 1956 ("Project Sunshine: Annual Report, Period March 31, 1955-April 1, 1956")
(ACHRE No. DOE-082294-B), 68-70.

120. U.S. General Accounting Office, Fact Sheet for Congressional Requestors:
Information on DOE's # Human Tissue Analysis Work, GAO/RCED-95-109FS
(Gaithersburg, Md.: GAO, 1995), 3.

121. Dr. Merril Eisenbud to Dan Guttman (ACHRE), 25 June 1995 ("I
appreciate the opportunity you have given me . . . ") (ACHRE No. IND-070395-A).

122. Ibid. From 1948 to 1950 "Official Use Only" was a category in the formal
classification system, but since then it has been used as an informal way of connoting
that information should be protected even if it is not classified. While much information
labeled Official Use Only never makes it to the public, the information does not have to
be protected with formal security measures, readers do not have to be cleared in order to
see it, and officials cannot be criminally prosecuted for disclosing it to members of the
public.

123. Paul F. Foster, Special Assistant to the General Manager for Liaison, to
the AEC General Manager, 9 November 1954 ("Discussion in Office of Secretary of
Defense on 'Change in National Dispersion Policy'") (ACHRE No. DOE-033195-A), 2.
This memo was circulated within the AEC; see W. B. McCool, Secretary, to Distribution,
16 November 1954 ("Atomic Energy Commission National Dispersion Policy: Note by
the Secretary") (ACHRE No. DOE-033195-A), 1.

124. Richard Hewlett and Jack Holl, Atoms for Peace and War: 1953-1961
(Berkeley and Los Angeles: University of California Press, 1989), 264.

125. On the scientific debate, see Carolyn Kopp, "The Origins of the American
Scientific Debate over Fallout Hazards," Social Studies of Science 9 (1979): 403-422.
For a public AEC presentation of fallout at the time, see Gordon M. Dunning, "The
Effects of Nuclear Weapons Testing," Scientific Monthly 81, no. 6 (December 1955):
265-270. (Dunning was a health physicist with the AEC Division of Biology and
Medicine.)

1 26. Robert A. Divine, Blowing on the Wind: The Nuclear Test Ban Debate
1954-1960 (New York: Oxford University Press, 1978), 21 .

1 27. Stannard, Radioactivity and Health, 982.

128. Harold M. Schmeck, Jr., "Study Discounts Risk In Nuclear Fall-Out," New
York Times, 8 February 1957, 1. See J. Laurence Kulp, Walter R. Eckelmann, and Arthur
R. Schulert, "Strontium-90 in Man," Science 125 (8 February 1957): 219-225. Following
the initial declassification of Sunshine in the mid-1950s, the details of the Columbia
work, including the identity of medical professionals who had provided assistance,
became part of the public research report record.

129. Divine, Blowing on the Wind, 106.

130. For a contemporary reaction to the declassification see, Ralph E. Lapp,
"Sunshine and Darkness," Bulletin of the Atomic Scientists 15 (January 1959): 27-29.

131. W. F. Libby, AEC Commissioner, to Herman M. Kalcker, National
Institutes of Health, 10 June 1957 ("I think your idea of using children's milk teeth for
strontium-90 measurement is a good one . . .") (ACHRE No. DOE-041295-D), 1.

664

132. The 1957 and 1959 hearings appear as Joint Committee on Atomic Energy,
Special Subcommittee on Radiation, The Nature of Radioactive Fallout and its Effect on
Man, 85th Cong., 1st Sess., 1957; Joint Committee on Atomic Energy, Special
Subcommittee on Radiation, Fallout from Nuclear Weapons Tests, 86th Cong., 1st Sess.,
5 May 1959.

1 33. The AEC concluded that radiation did not cause any sheep deaths and
consequently did not compensate the Nevada ranchers. Some of the ranchers remained
unconvinced by the AEC's explanation and sued the government. While the court ruled
in favor of the government, controversy over the case continues to this day. Congress
held hearings on the subject in 1979 and concluded that the AEC had suppressed
evidence during the trial. House Committee on Interstate and Foreign Commerce,
Subcommittee on Oversight and Investigations, The Forgotten Guinea Pigs': A Report
on Health Effects of Low-Level Radiation Sustained as a Result of the Nuclear Weapons
Testing Program Conducted by the United States Government, 98th Cong., 2d Sess.,
1980, Committee Print 96-IFC 53, 15. In 1981, the judge who heard the first case ruled
that the AEC fraudulently suppressed evidence in the trial. On appeal, however, this
ruling was overturned. For further discussion of the sheep controversy see Philip L.
Fradkin, Fallout: An American Nuclear Tragedy (Tucson: The University of Arizona
Press, 1989), 147-165; Hacker, Elements of Controversy, 106-130.

134. Committee to Study Nevada Proving Grounds, 1 February 1954 ("Abstract
of Report, Committee to Study Nevada Proving Grounds") (ACHRE No. DOE-040395-
B), 1-2.

135. Ibid., 2.

136. Ibid., 46.

137. Ibid.

138. Ibid., 47.

139. Ibid.

140. Ibid., 50.

141. Ibid., 46.

142. Thomas L. Shipman, Los Alamos Laboratory Health Division Leader, to
Charles Dunham, Director, Division of Biology and Medicine, 5 December 1956
(ACHRE No. DOE-020795-D-2), 3. On Sunshine, Shipman also wrote, "such a program
obviously cannot be carried out with the complete lack of administration which has
characterized past efforts." Ibid, 2.

143. Hal Hollister, Environmental Sciences Branch, Division of Biology and
Medicine, to Dunham et al., 27 February 1958 ("Reporting Sunshine") (ACHRE No.
DOE-012595-B), 2. Other participants in AEC-sponsored biomedical research had a
different perspective on the fallout research.

In 1995, Dr. Kulp recalled that, from the perspective of the researchers at
Columbia, the goals were clear~"defining the amount of SR90 in the stratosphere to its
mechanism of descent in the ground to the movement through the food chain to man."

The work of Sunshine, he recalled, "provided the scientific basis for the
International Treaty banning atmospheric tests." J. Laurence Kulp, letter to Dan Guttman
(ACHRE), 21 July 1995.

Another perspective is contained in a 1973 letter to Dixie Lee Ray, the last
AEC chairman before its separation into agencies responsible for regulating (the Nuclear
Regulatory Commission) and promoting (the Energy Research and Development
Administration) nuclear energy. Dr. William F. Neuman, director of the Atomic Energy

665

Project at the University of Rochester, suggested that the difficulties leading to the
agency's breakup were not limited to the conflict between its responsibilities to promote
and regulate atomic energy. In addition, "the AEC (its Division of Biology and Medicine
in particular) has been put in the position of providing a biological justification for some
other agency's political decision." He explained to Chairman Ray:

Some years back, before the Test Ban, the military
wished to test various weapon designs. The Eisenhower
Administration concurred. Admiral Strauss was
instructed to have the AEC provide the basis for public
acceptance. This meant of course that the Division of
Biology and Medicine was supposed to convince the
public that fallout was good for them and environmental
Sr-90 contamination was accordingly expressed in
'Sunshine Units' if you recall. This very nearly tore the
Division apart and we were rescued from potential
disaster only by the timely signing of the big power Test
Ban Treaty.

Neuman had been a participant in the fallout debate and was the spokesperson
for a panel that included Libby, Eisenbud, Dunham, Langham, and other AEC-connected
experts at the 1959 congressional hearings. William F. Neuman, Wilson Professor and
Director, Atomic Energy Project, University of Rochester, to Dixie Lee Ray, Chairman,
Atomic Energy Commission, 12 November 1973 ("When you visited the Rochester
Biomedical Research Project . . .") (ACHRE DOE-01 1895-B), 1.

144. Dwight Ink, AEC General Manager, to Seaborg, Chairman of the AEC, 9
September 1965, as quoted in House Committee on Interstate and Foreign Commerce,
Subcommittee on Oversight and Investigations, The 'Forgotten Guinea Pigs,' 15.

145. Hacker, Elements of Controversy, 277.

146. Ibid., 278.

147. Ibid.

148. "The worst thing in the world," Harry Truman reportedly once said, "is
when records are destroyed." Merle Miller, Plain Speaking: An Oral Biography of Harry
Truman (New York: Berkley, 1974), 27.

149. The supplemental volumes to this report contain a detailed description of
the record collections reviewed by the Advisory Committee.

1 50. As a 14 February 1995 CIA report concluded:

CIA has found no evidence that Agency offices
sponsored human radiation experiments or deliberately
exposed anyone to ionizing radiation for operational or
experimental purposes. As noted above, at least two
Agency-affiliated contractors [deletion] and [Dr.]
Geschickter [a Georgetown University researcher]) may
have conducted human radiation experiments while
working on other matters for the CIA. Some CIA
officers probably knew of human radiation tests by other
U.S. government agencies, but apparently did not

666

consider these tests particularly relevant to the Agency's
mission.

Circumstantial evidence, however, may not suffice to
overcome suspicions fueled by CIA's contacts with
persons and programs involved in radiation experiments
sponsored by other agencies. The fact that MKULTRA
held the authority to conduct radiological experiments,
combined with the Agency's destruction of the main
MKULTRA files in 1973, has already prompted
speculation about the Agency's "real" role. These
heightened suspicions will not fade any time soon.
Michael Warner, CIA History Staff, 14 February 1995 ("The Central Intelligence Agency
and Human Radiation Experiments: An Analysis of the Findings") (ACHRE No. CIA-
061295-A), 14.

151. This conclusion was arrived at by DOE following an investigation
conducted in response to the Committee's request for the documents. DOE Office of
Human Radiation Experiments, 26 August 1994 ("Destruction of the U.S. Atomic Energy
Commission Division of Intelligence Files") (ACHRE No. DOE-082994-A). The DOE
interviewed DOE employees who stated that they destroyed documents under direction
from supervisors during this period. DOE reported that, shortly after the AEC Division
of Intelligence was abolished in 1971, destruction of older file materials began. "This
first file 'purge' continued until at least May 1 974. Destruction was probably confined to
documents dated prior to 1964." Following the DOE's creation in 1977, a second "purge"
began, reportedly based on limited storage space, "destroying most surviving files." In
1988, DOE implemented rules requiring that documents classified at the Secret level be
inventoried. "Many offices, however, destroyed Secret documents rather than having the
burden of inventorying them. Surviving fragments of the AEC Division of Intelligence
files may also have been destroyed during this third 'purge.'" Ibid., 2-3. The
investigation reported that records that were kept of the documents that were destroyed
had themselves been subsequently destroyed in the routine course of business.

1 52. There was no central location, within agencies, or among them, that
routinely kept anything but the most fragmentary records of human experiments
sponsored by the agencies. During the 1950s, a central "Bio-Science" information
exchange was maintained. Government and nonfederal agencies (such as foundations)
formerly registered descriptions of research projects performed or sponsored by the
federal government with an office of the Smithsonian Institution variously called the
Scientific Information Exchange or the Bio-Sciences Information Exchange. This group,
established at the recommendation of and advised by the National Research Council,
collected abstracts of research in progress reports for the period 1949-1979. The
Department of Commerce's National Technical Information Service began a similar
program two years later.

The abstracts submitted to the Exchange were collected in annual reports and are
available on microfiche in the Smithsonian Institution Archives. Unfortunately, the
indices to the reports are available only on magnetic tape in a 1970s mainframe format
that Smithsonian technologists are currently unable to read. For that reason, Advisory
Committee staff did not review the Exchange's records.

667

153. As noted in chapter 10, the VA concluded that a "confidential" division
contemplated in relation to secret record keeping was not activated.

154. Although, as discussed in chapter 1 1, we must be careful to distinguish the
need to keep secret information, for example, weapons design or a weapon's purpose,
from the need to keep secret a weapons test that may put surrounding populations at risk.

668

PART III

CONTEMPORARY PROJECTS

Part III
Overview

In parts I and II of this report, the Advisory Committee attempted to
come to terms with the past. We told the history of standards for conducting
human subject research in part I, and the history of human radiation experiments
through representative case studies in part II. Here in part III of our final report,
we attempt to assess whether the current protections for human subjects are
better than the prevailing standards and practices during the 1944 to 1974 period
to help recommend what changes, if any, ought to be instituted in current policies
governing human subject research.

The Advisory Committee's study of contemporary research ethics is three-
pronged. It comprises a review of agency policies and oversight practices, a
review of documents from recently funded research proposals (the Research
Proposal Review Project, or RPRP) to examine the extent to which the rights and
interests of the subjects of federally sponsored research appear to be protected,
and the Subject Interview Study (SIS) in which the attitudes and beliefs of
patients about medical research and their decisions and experiences regarding
participation in research are examined. These projects together form the basis of
the Advisory Committee's picture of the protections now afforded the subjects of
biomedical research and, along with findings regarding radiation experiments
during the 1944-1974 period, inform the forward-looking recommendations of the
Advisory Committee, found in part IV.

Chapter 14 reviews the current regulatory structure for human subjects
research conducted or supported by federal departments and agencies, a structure
that has been in place since 1991. This "Common Rule" has its roots in the
human subject protection regulations promulgated by the then-Department of
Health, Education, and Welfare (DHEW) in 1974. The historical developments
behind these regulations are described in chapter 3. Following a summary of the

671

Part 111

essential features of the Common Rule, chapter 14 discusses several subjects of
particular relevance to the Advisory Committee's work, such as special review
processes for ionizing radiation research, protection for human subjects in
classified research, and audit procedures of institutions performing human subject
research.

Chapter 15 describes the Research Proposal Review Project (RPRP), the
Advisory Committee's examination of documents from research projects
conducted at institutions throughout the country, including both radiation and
nonradiation proposals. Documents utilized in the RPRP were those available to
the local institutional review boards (IRBs) at the institutions where the research
was conducted. The goals of the RPRP were to gain an understanding of the
ethics of radiation research as compared with nonradiation research; how well
research proposals address central ethical considerations such as risk,
voluntariness, and subject selection; and whether informed consent procedures
seem to be appropriate.

The RPRP reviewed documents prepared by investigators and institutions
and submitted in IRB applications. This study was complemented by a
nationwide effort to learn about research from the perspective of patients
themselves, including those who were and were not research subjects. The
Subject Interview Study (SIS), described in chapter 16, was conducted through
interviews with nearly 1,900 patients throughout the country. The SIS aimed to
learn the perspectives of former, current, and prospective research subjects by
asking about their attitudes and beliefs regarding the endeavor of human subject
research generally and their participation specifically.

The RPRP tried to understand the experience of human subjects research
from the standpoint of the local oversight process, while the SIS tried to
understand it from the standpoint of the participant. Although the two studies
related to different research projects and different groups of patients and subjects,
some common tensions in the human research experience emerge in both projects,
and they are described in the "Discussion" section of part III. For example, it has
long been recognized that the physician who engages in research with patient-
subjects assumes two roles that could conflict: that of the caregiver and that of the
researcher. The goals inherent in each role are different: direct benefit of the
individual patient in the first case and the acquisition of general medical
knowledge in the second case. The interviews with SIS participants suggest that
at least some patient-subjects are not aware of this distinction or of the potential
for conflict. In our review of documents in the RPRP we found that the written
information provided to potential patient-subjects sometimes obscured, rather
than highlighted, the differences between research and medical care and thus
likely contributed to the potential for patients to confuse the two.

To help complete the picture of current human subject research and its
regulation and oversight, the Committee also gathered limited information in two
areas: (1) the federal system of human subject protection as viewed by those

672

Overview

charged with implementing it at the local level, the chairs of IRBs; and (2) the
particular review process applied to human subject research involving radiation as
viewed by those charged with implementing it at the local level, the chairs of
radiation safety committees.*

A letter was written to forty-one chairs of IRBs and forty chairs of
radiation safety committees at institutions throughout the country, attempting to
gain their perspectives on the current regulatory systems their committees seek to
apply. Many of these letters are reproduced in a supplemental volume to this
report. Most of the replies from IRB chairs indicated a general approval of the
current system, but many also had useful observations and suggestions for
improvement. For example, several expressed concern about what they believed
to be a disparity in the procedures of IRBs from one institution to another. The
chairs of radiation safety committees, on the other hand, reported a nearly
universal confidence in, and approval of, the review process for human subject
research involving the use of radiation. The Committee's recommendations, in
part IV of this report, address some of the concerns outlined in response to our
queries.

As the Committee's work in part III shows, in the discussion section,
contemporary human subject research does not suffer from the same shortcomings
witnessed in the 1940s and 1950s, but poses different issues that need to be
addressed. With a system of human subjects protections comes issues related to
implementation and interpretation of rules and regulations. And with a change in
the culture of medicine comes a change in the relationship between researchers
and subjects. In the historical period of the Committee's review, we found that
subjects needed protections to ensure their basic rights to consent to or to refuse
participation in research. While this need to protect the right of consent
continues, in the current period we found that subjects also need protections to
ensure their interests are served in understanding the distinctions between
research and therapy and the limits of the benefits research may offer. These
findings and conclusions suggest the need for changes in an oversight system
designed to address the concerns of an earlier time, and the Committee makes
recommendations for such change in part IV of this report.

"The Committee also contacted a sample of institutions at which therapeutic
human radiation research involving higher doses of radiation, and therefore imposing
substantial risk, had recently been conducted according to reports in the medical
literature. The Committee was interested in learning whether the research projects
reported in these journal articles had been reviewed by an IRB, and if IRB review had
depended upon whether the research was supported by federal funds. Information was
received from only nine of the sixteen institutions requested. Although the projects about
which we were inquiring were sometimes described as clinical investigations in the
journal reports, these institutions did not always view them as satisfying the definition of
human subject research and thus did not appear to require IRB review for these projects.

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Current Federal policies

Governing Human Subjects

Research

Each year many thousands of people participate in biomedical and
behavioral research projects conducted, sponsored, or regulated by federal
agencies. The federal government invests roughly $3.5 billion annually in
research that involves human subjects.1 The Committee wanted to establish what
the federal government currently does to protect the rights and interests of these
subjects. The answers to this question all emanate from a seminal event in the
history of human subjects research, the adoption of what is widely known as the

"Common Rule."

A single, general set of regulatory provisions governing human subjects
protections was adopted by sixteen federal departments and agencies2 in 1991; the
Common Rule specifies how research that involves human subjects is to be
conducted and reviewed, including specific rules for obtaining informed consent.3
The Common Rule was developed in response to recommendations made by the
President's Commission for the Study of Ethical Problems in Medicine and
Biomedical and Behavioral Research in 1981 calling for the adoption by all
federal agencies of Department of Health and Human Services regulations then in
effect for the protection of human subjects of research.4 In mid- 1982 the
President's science adviser, the head of the Office of Science and Technology
Policy (OSTP), appointed an ad hoc committee that included the federal
departments and agencies engaged in research involving human subjects to
address these recommendations.5 Nine years later, the Common Rule was the
result of this committee's efforts.

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History of the Common Rule Since 1974a

1 974 Title II of the National Research Act (P.L. 93-348)

Required codification of DHEW policy in regulations, imposed a
moratorium on federally funded fetal research, and established
requirements for IRB review of all human subjects research at any
institution receiving DHEW funding.
DHEW regulations for the protection of human research subjects, 45 C.F.R. 46
Established JRB review procedures in accordance with Title II. Later
in the same year DHEW published regulations providing additional
protections for pregnant women and fetuses.

1974-1978 National Commission for the Protection of Human Subjects of Biomedical and

Behavioral Research

Issued reports and recommendations on fetal research; on research
involving prisoners, psychosurgery, children, and the mentally infirm;
on IRBs and informed consent; and, in The Belmont Report, discussed
criteria for distinguishing research from the practice of medicine and
ethical principles underlying the protection of subjects.

1978 Revised DHEW regulations governing protections for pregnant women, fetuses,

in vitro fertilization (subpart B of 45 C.F.R. 46), and prisoners (subpart C)
published

1 980- 1 983 President's Commission for the Study of Ethical Problems in Medicine and

Biomedical and Behavioral Research

Charged with, among other responsibilities, reviewing federal policies
governing human subjects research and determining how well those
policies were being carried out. Recommended that all federal
agencies adopt the DHHS (a successor agency to DHEW) regulations
for the protection of human subjects (1981).

1981 DHHS published a revision of 45 C.F.R. 46, responding to recommendations of

the National Commission

The revision set out in greater specificity IRB responsibilities and the
procedures IRBs were to follow.
FDA regulations at 21 C.F.R. 50, governing informed consent procedures, and at
21 C.F.R. 56, governing IRBs, revised to correspond to DHHS regulations to the
extent allowed by FDA's statute

Tor a brief history of federal protections for human subjects prior to 1974, see chapter 3.

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1982 President's Science Adviser, Office of Science and Technology Policy (OSTP),
appointed an interagency committee to develop a common federal policy for the
protection of human research subjects

1983 DHHS regulation governing protections afforded children in research (subpart D
of45C.F.R. 46) published

1986 Proposed common federal policy for the protection of human research subjects

published

1991 Final common federal policy published on June 18, codified in the regulations of

fifteen federal agencies and adopted by the CIA under executive order.

This common policy, known as "the Common Rule, " is identical to the
basic DHHS policy for the protection of research subjects, 45 C.F.R.
46, subpart A. Other sections of the DHHS regulation provide
additional protections for pregnant women, fetuses, in vitro fertilization
(subpart B), prisoners (subpart C), and children (subpart D). Several
agencies have adopted these additional provisions as administrative
guidelines. The FDA made conforming changes in its informed consent
and IRB regulations.

The promulgation of the Common Rule was a significant achievement.
The ability of the Common Rule to protect the rights and interests of human
subjects is, however, at least partially dependent on how the departments and
agencies to which the Common Rule applies implement and oversee its
provisions. As a foundation for the Advisory Committee's recommendations
concerning contemporary policies and practices regarding human subjects, we
asked the sixteen federal agencies and departments that conduct human subjects
research to provide us with information on the relevant policies and practices
currently in place. In this brief descriptive overview, we focus on six agencies
within the scope of the Advisory Committee's charter: the Department of Defense
(DOD), Department of Energy (DOE), Department of Health and Human Services
(DHHS), Department of Veterans Affairs (VA), National Aeronautics and Space
Administration (NASA), and the Central Intelligence Agency (CIA).
(Information on the ten other agencies covered by the Common Rule is provided
in a supplemental volume to this report.)

The following sections briefly describe the institutional structures, review
mechanisms, and policies prescribed by the Common Rule and the variety of
ways in which federal agencies attempt to ensure that human subjects are
adequately protected in the conduct of research. The chapter closes with a review
of an issue of particular importance to the Advisory Committee-the status of
protections for human subjects of classified research.6

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Part III

THE FEDERAL POLICY FOR HUMAN SUBJECTS
PROTECTIONS (THE COMMON RULE)

The Common Rule applies to all federally funded research conducted both
intra- and extramurally. The rule directs a research institution to assure the
federal government that it will provide and enforce protections for human subjects
of research conducted under its auspices. These institutional assurances
constitute the basic framework within which federal protections are effected.
Local research institutions remain largely responsible for carrying out the specific
directives of the Common Rule. They must assess research proposals in terms of
their risks to subjects and their potential benefits, and they must see that the
Common Rule's requirements for selecting subjects and obtaining informed
consent are met.

As discussed below, central to the process of ensuring that the rights and
well-being of human subjects are protected are institutional review boards (IRBs).
The Common Rule requires that a research institution, as a condition for receiving
federal research support, establish and delegate to an IRB the authority to review,
stipulate changes in, approve or disapprove, and oversee human subjects
protections for all research conducted at the institution. IRBs are generally
composed of some combination of physicians, scientists, administrators, and
community representatives, usually at the local research institution, but
sometimes at an agency that conducts intramural research.7 IRBs have the
authority to suspend the conduct of any research found to entail unexpected or
undue risk to subjects or research that does not conform to the Common Rule or
the institution's additional protections.

A prominent feature of the Common Rule is the informed consent
requirement. The informed consent of a competent subject, along with adequate
safeguards to protect the interests of a subject who is unable to give consent, is a
cornerstone of modern research ethics, reflecting respect for the subject's
autonomy and for his or her capacity for choice. Informed consent is an ongoing
process of communication between researchers and the subjects of their research.
It is not simply a signed consent form and does not end at the moment a
prospective subject agrees to participate in a research project.

The required elements of informed consent stipulated by the Common
Rule are summarized as follows:

• A statement that the study involves research, an explanation of the
purposes of the research, and a description of the procedures to be
followed;

• A description of any reasonably foreseeable risks or discomforts to the
subject;

• A description of any benefits to the subjects or to others that might
reasonably be expected;

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• A disclosure of alternative procedures or courses of treatment;

• A statement describing the extent to which confidentiality of records
identifying the subject will be maintained;

• For research involving more than minimal risk, an explanation of the
availability and nature of any compensation or medical treatment if injury
occurs;

• Identification of whom to contact for further information about the
research and about subjects' rights, and whom to contact in the event of a
research-related injury; and

A statement that participation is voluntary, that refusal to participate will
involve no penalty or loss of benefits to which the subject is otherwise
entitled, and that the subject may discontinue participation at any time.8

The Common Rule includes several additional elements of consent that
may be appropriate under particular circumstances9 and describes the conditions
under which an IRB may modify or waive the informed consent requirement in
particular research projects.10

When an IRB reviews and approves a research project, it must pay
particular attention to the project's plan for obtaining subjects' informed consent
and to the documentation of informed consent. The IRB may require changes in
the investigator's procedure for obtaining informed consent and in the consent
documents. The board also must be allowed to observe the informed consent
process if the IRB considers such oversight important in ascertaining that subjects
are being adequately protected by that process."

RESEARCH INVOLVING IONIZING RADIATION

Beyond the strictures of the Common Rule, research involving either
external radiation or radioactive drugs usually undergoes additional reviews for
safety and risk (including a review of radiation dose) prior to IRB review at the
local research institution. Most medical institutions have a radiation safety
committee (RSC) responsible for evaluating the risks of medical activities
involving radiation, whether for diagnostic, treatment, or research purposes, and
limiting the exposure of both employees and subjects to radiation. In addition,
research and medical institutions that perform basic research involving human
subjects and radioactive drugs must have such studies reviewed and approved by
a radioactive drug research committee (RDRC)-a local institutional committee
approved by the Food and Drug Administration (FDA) to ensure that safeguards,
including limitations on radiation dose, in the use of such drugs are met.12
Notwithstanding the prior review and approval of either or both of these radiation
committees, the IRB must also assess the risks and potential benefits of the
proposed research before approving it.13

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Part III

SCOPE OF PROGRAMS OF RESEARCH INVOLVING
HUMAN SUBJECTS

The six federal departments and agencies (DHHS, DOD, DOE, NASA,
VA, and CIA) all conduct or support research involving human subjects. Each
agency's program is distinctive in terms of its scope, organization, and focus, all
of which reflect the primary mission of the agency.

DHHS is the largest federal sponsor of research involving human subjects,
with approximately $367 million in intramural funding and $2.4 billion in
extramural support for clinical research in fiscal year 1992, the latest year for
which an estimate of extramural research funding is available.14 Intramural
research is usually conducted by agency staff members at various field sites,
while extramural research is conducted outside the agency by contractors or
grantees such as universities. Most of this research is biomedical, and some
involves the use of radiation in experimental diagnostic and therapeutic
procedures or as tracers in basic biomedical research.'5 The U.S. Public Health
Service (PHS) is the operating division of DHHS and the principal health agency
of the federal government.16

The DOD conducts biomedical and behavioral research involving human
subjects within each of the military services and through several additional
defense agencies, primarily in areas that support the mission of the department.
In fiscal year 1994 DOD spent an estimated $77 million on intramural and $107
million on extramural human subjects research.17

The VA operates 1 7 1 inpatient medical centers, including short-term
hospitals, psychiatric and rehabilitation facilities, and nursing homes. The VA's
largely intramural biomedical research program focuses on the health care needs
of veterans. The VA spends approximately $114 million annually in appropriated
research money on human subjects research, along with another $110 million in
staff clinicians' time. Other federal agencies and private entities also support
research in VA facilities.18

The DOE conducts and supports research, both intramurally and
extramurally, involving human subjects that ranges from diagnostic and
therapeutic applications in nuclear medicine to epidemiological and occupational
health studies. DOE laboratories also receive funding from other federal agencies
such as the NIH and from private sponsors of research. DOE spends $46 million
annually on human subjects research, more than $20 million of which is devoted
to the Radiation Effects Research Foundation (RERF) in Japan, which is charged
with studying the health effects of exposure to radiation from atomic weapons.19

Both intramurally and extramurally, NASA conducts ground-based and in-
flight biomedical research involving human subjects related to space life. In
fiscal year 1994 NASA spent approximately $25 million on ground-based human
subjects research.20

The CIA supports or conducts a small number of intramurally and

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extramurally conducted studies involving human subjects each year.21 No figure
for the annual dollar amount spent by the CIA was made available to the
Advisory Committee.

ADMINISTRATIVE STRUCTURES AND PROCEDURES FOR
RESEARCH OVERSIGHT

The following is an overview of the administrative structures and
procedures used by the six departments and agencies to ensure compliance with
human subjects ethics rules, particularly as they relate to the Common Rule. The
Advisory Committee asked each of these agencies to provide the following
information on its program of protections for human subjects involved in
research:

• The scope of its human subjects research programs;

• The organizational structure of its human subjects protection efforts and
the resources devoted to such activities;

The policy issuances and guidances pursuant to the Common Rule that the
department or agency has prepared and provides to subsidiary agencies
and research institutions engaged in human subjects research;
Monitoring and enforcement activities for ensuring that the provisions of
the Common Rule are met;

• Sanctions available for noncompliance with human subjects protections;

• The rules governing classified research involving human subjects; and
The use or potential use of waivers of any of the requirements of the
Common Rule or the agency's human subjects regulations.

In a supplemental volume to this report we provide greater detail on the
departments' and agencies' responses.

Each federal department structures its program of administrative oversight
of human subjects research somewhat differently, despite the fact that all operate
under the requirements of the Common Rule.22 Some departments conduct
reviews of research documentation out of one central departmental office, while
others rely on local review; some provide detailed interpretive guidance on
human subjects protections to subsidiary intramural research offices, contractors,
and grantees, while others simply reference the Common Rule; and some
departments audit or review IRB performance routinely, while others conduct
investigations only when problems emerge.

The Office for Protection from Research Risks (OPRR) at the National
Institutes of Health (within DHHS) serves not only as the locus for that
department's policies for the protection of research subjects but also as the
principal federal agent approving the assurances of research institutions to
conduct human subjects research sponsored by any of a number of departments

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Part III

Scientific peer review of federally sponsored research is one layer of
protection for research subjects. Most federal research programs require that
committees of scientists, expert in the particular subject under consideration and
often from outside the agency (generally known as "study sections"), review both
intramural and extramural research proposals for scientific merit and make
recommendations regarding funding. When these committees of subject-matter
experts review research proposals, they also consider the risks that may be
involved for subjects. They may recommend that the sponsoring agency more
closely consider the potential risks or that the principal investigator make specific
changes in the research protocol prior to any funding.

Local review is a key component of the oversight system. The Common
Rule requires IRB review and approval prior to the granting of federal funding for
research on human subjects. Almost all federal agencies that conduct human
subjects research within their own facilities have intramural IRBs, whose
members include agency staff and at least one member who is not affiliated with
the facility.24 Likewise, extramural research projects must undergo IRB review
prior to agency funding, usually by an IRB at the site of the research activity-for
example, a university, medical school, or hospital. The IRB is an administrative
unit that must itself comply with certain requirements of the Common Rule in
terms of its composition, review procedures, and substantive review criteria; it
must also direct researchers to comply with other requirements of the rule, such as
adequate informed consent and fair subject selection procedures.

A research institution that has assured either OPRR or the federal agency
sponsoring the research that it conducts human subjects research in compliance
with the Common Rule must delegate to its IRB the authority to preclude or halt
the conduct of any federally funded research project that does not conform with
federal human subjects protections.25 This delegation of authority applies to IRBs
within federal research institutions for intramural research and to those at
nonfederal research institutions as well. This authority extends even to research
performed by military organizations, where unit commanders cannot overrule
safeguards adopted by military IRBs.26 Thus the IRB is the enforcing agent of
federal protections that is situated closest to the conduct of research. Much of the
success or failure of the federal regulations governing human subjects research
depends on the effectiveness of IRBs in carrying out their responsibilities:
assessing research proposals prior to their funding; stipulating any changes in the
research protocol or informed consent procedure that strengthen the protections
afforded the subjects; disapproving inadequate or excessively risky research
proposals; minimizing risks to subjects; reviewing ongoing research at least every
twelve months to ascertain that the research poses no undue risks to subjects; and
taking action quickly to correct any failings in safeguarding subjects' rights and
welfare.27

In overseeing human subjects research conducted in-house or supported
extramurally, federal agencies acquire the following responsibilities: (1)

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communication of practice guidelines to research institutions and IRBs based on
the policies of the Common Rule, (2) establishment of a structure whereby
research proposals involving human subjects are peer reviewed for scientific
merit as well as for IRB approval and the adequacy of subject protections, (3)
negotiation of assurances with research institutions that ensure that adequate
protections will be in place for research subjects, (4) verification that institutions,
their IRBs, and researchers are complying with the federal human subjects
regulations, and (5) investigation of complaints of noncompliance and adverse
outcomes for subjects of research.

Table 1, "Human Subjects Research & Protections in Seven Departments
and Agencies" (at the end of this chapter), summarizes information received by
the Advisory Committee about human subjects research programs in DHHS,
DOD, DOE, VA, NASA, CIA, and FDA (a subagency of DHHS). This chart
shows each department's or agency's staffing levels for human subjects protection
activities. Both the size of the departments' research programs and their
investment of staff resources in oversight activities vary widely. A particularly
important distinction in oversight programs is the extent to which they investigate
the performance of research institutions and IRBs in carrying out their
responsibilities under the Common Rule. Some departments rely heavily on the
prospective assurances that research institutions make to the funding agency or to
OPRR, while others audit research institutions and IRB records periodically.

The method, intensity, and frequency of research oversight and inspection
activities depend entirely on how much staff and budget an agency allots them.
OPRR negotiates multiple project assurances (MPAs) with large research
institutions that perform a significant amount of research funded by DHHS. If an
institution is awarded an MPA by OPRR, the federal agency funding the research
must accept that institution's assurance of compliance with federal requirements
and may not impose additional assurance requirements on the institution. This
provision is intended to avoid duplicative and potentially contradictory
enforcement of the federal protections.28

OPRR, in overseeing human subjects protections for DHHS-funded
research and for all institutions to which it has issued an assurance, generally
investigates the conduct of research only in cases where a complaint has been
filed; where an institution, IRB, or researcher has reported a problem or adverse
outcome; or where a problematic audit finding has been referred to it by the
FDA.29 Principal investigators are required to report to the IRB any adverse
outcomes to subjects in the course of their research, and the IRB must have
procedures to ensure that the appropriate institutional officials and the funding
agency are informed as well. The FDA, in its role regulating new drugs,
biologies, and devices for marketing, enforces the somewhat different
requirements for human subjects protections of the Food, Drug, and Cosmetic Act
through periodic on-site investigations of research institutions (e.g.,
pharmaceutical firms, university-based research facilities funded by

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pharmaceutical firms, independent testing laboratories) and their IRBs.30 The
DOD conducts on-site audits of its intramural research programs in addition to
negotiating assurances. The DOD also reports that it is common practice in
DOD-funded research to appoint independent medical monitors— health care
providers qualified by training, experience, or both to monitor human subjects
during the conduct of research as advocates for safety of the subjects.31 The DOE
is now planning to institute periodic audits of the research programs that it funds
in addition to relying on assurances.32

Special Issues Arising in DOD Research

Human subjects research conducted by military agencies and within
military settings entails considerations for subject protections and research
oversight that are unique to the military context. The activities of military
research programs may be difficult to distinguish from innovative training
programs and medical interventions undertaken for the protection of the troops.
In addition to enforcing policies derived from the requirements of the Common
Rule, DOD has in place a parallel set of regulations for managing the risks to
which military personnel are exposed in the course of these routine duties.33
Military leaders are responsible for determining whether human experimentation
protections, in addition to the more general risk-assessment requirements, apply
to particular practices. A further distinction of the military context is the
hierarchical and comprehensive nature of its authority structure, which poses
special issues with respect to voluntariness in the recruitment of experimental
subjects. In some cases, military researchers have excluded unit officers and
senior noncommissioned officers from subject recruitment sessions (e.g., in
vaccine trials conducted by Walter Reed Army Medical Center).34 DOD has
regulations that require most more-than-minimal-risk research proposals to be
subjected to a second level of review by each military medical service at a central
oversight office.35 The Army, for example, requires greater-than-minimal-risk
research protocols to undergo a second level of review at the Human Use Review
and Regulatory Affairs Division (HURRAD) and the Human Subjects Research
Review Board or the Clinical Investigation Regulatory Office (CIRO).36

FEDERAL RESPONSES TO VIOLATIONS OF HUMAN
SUBJECTS PROTECTIONS

In the event that the Common Rule is violated in the conduct of federally
sponsored research involving human subjects, there are various responses that can
affect both investigators and grantee institutions, such as withdrawal or restriction
of an institution's or project's assurance and, with that action, of research funding
and suspension or termination of IRB approval of the research. In addition, an
IRB is authorized by the Common Rule to suspend or terminate its approval of

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research that fails to comply with the IRB's requirements or when a research
subject suffers an adverse event.37 No federal department or agency may continue
to fund a project from which IRB approval has been withdrawn or at an institution
whose assurance has been withdrawn.38

An institution's or investigator's prior performance with respect to human
subjects protections may affect future federal funding as well. If human subjects
protection regulations are willfully violated, the department secretary or agency
head may bar the organization or individual from receiving funding from any
federal source.39 Such debarment must be for a specified length of time and, in
some extreme cases, may be permanent.

Federal agencies may also take disciplinary action against employees
involved in human subjects research for failure to follow human subjects
protection rules. For example, DOD sanctions for noncompliance by intramural
researchers include loss of investigator privileges. For military personnel,
potential sanctions are letters of reprimand, nonjudicial punishment, and sanctions
under the Military Code of Justice; for civilian DOD personnel, sanctions include
reprimands, suspension, or termination of employment.

No requirement of the Common Rule can preempt state and local laws
governing the conduct of human subjects research that are stricter or provide
additional protections for subjects. Of those states with any laws governing
research involving human subjects, only California authorizes sanctions for
failure to obtain a subject's informed consent.40 The California statute authorizes
monetary awards for negligent failure to obtain a subject's informed consent (up
to $1,000), for willful failure to obtain such consent (up to $5,000) and, if a
subject is thereby exposed to "a known substantial risk of serious injury either
bodily harm or psychological harm," jail terms of up to one year and/or fines of
up to $10,000.

PROTECTIONS FOR HUMAN SUBJECTS IN CLASSIFIED
RESEARCH

We were advised that the only classified studies involving human subjects
currently conducted by the six federal agencies are a small number of projects
sponsored by the DOD and the CIA.41 The Common Rule does not distinguish
between classified and unclassified research in terms of the requirements or
procedures it imposes to protect human subjects.

The Department of Defense reported that it currently sponsors a small
number of classified research studies involving human subjects.42 When such
research is proposed, IRBs review classified protocols in one of two ways. The
chair of the IRB may remove the classified portions of the protocol if he or she
judges that those classified portions have no effect on the risks imposed on human
subjects. Alternatively, the IRB may be composed of people with appropriate
security clearances who then review the protocol in its entirety. A person not

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affiliated with the institution but with appropriate security clearance is included as
a voting member of such IRBs.

The CIA indicated that it is currently performing classified human
research projects.43 The agency informed the Advisory Committee that all human
subjects are informed of the CIA's sponsorship and of the specific nature of the
study in which they are participating, even if the general purposes of the research
are classified.44

Although DOE has the authority to conduct or support classified human
subjects research projects, it reports that it is not currently conducting such
research.45 According to DOE guidelines, IRB review of classified research may
take one of two forms.46 If the chair of the IRB determines that none of the
classified information in a proposal is relevant to the protection of human subjects
and that the research can be accurately and fully described to the IRB, the
proposed research will be reviewed at a regular IRB meeting without disclosure
of any classified information. If the proposed research cannot be reviewed in the
foregoing manner, however, the IRB must meet in a secure environment. (The
Advisory Committee was advised that to date this has not occurred.) To review
classified research, each member of the IRB must have the appropriate security
clearance. The member of the IRB who is not affiliated with the institution
conducting the research must also have security clearance to participate in the
review of classified research. DOE guidelines recommend that IRBs expecting to
review classified research obtain clearance for their nonaffiliated members so that
they are not excluded from such reviews.

DHHS neither conducts nor sponsors any classified research. Some FDA
personnel hold security clearances so that they may review classified
investigational new drug or device applications submitted by the DOD, if the
need to study or use these items in secret arises.47 The VA does not now conduct
any classified research and does not have original classification authority.48
NASA currently conducts no classified research that involves human subjects and
has not in the past. NASA does have classification authority, however, and
conducts some classified research that does not involve human subjects.49

Research that involves human subjects and is classified for reasons of
national security raises special issues for IRB review and for the process of
obtaining informed consent, particularly with respect to the level of disclosure
and waivers of informed consent. Specifically, the IRB must consider whether
the prospective research subject will be adequately informed about the nature of
classified research if some aspects of the research will not be disclosed in the
informed consent process, whether security clearances are needed for IRB
members, and whether information about classified studies must be partitioned
from other IRB study reviews. Institutional review boards can determine that
some aspect of a classified research project, if only the identity of the research
sponsor, is irrelevant to the process of obtaining a subject's informed consent to
participate. IRB members can decide that sponsorship information or complete

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disclosure of the purpose of the research need not be provided to potential
subjects (in contrast to information about physical risk).

The Common Rule grants IRBs the authority to approve modifications in,
or to waive entirely, informed consent requirements, but only for research
involving no more than minimal risk.50 A separate provision grants an agency
head the authority to waive any requirement of the Common Rule for any kind of
human subject research as long as advance notice is given to OPRR and the action
is announced in the Federal Register.^ As indicated above, the rule makes no
distinction between classified and unclassified research, so this latter route to an
informed consent exception would appear to pose a tension between duties to
disclose and the need to keep information secret.

CONCLUSION

The Common Rule, adopted by the sixteen federal agencies and
departments that conduct human subjects research, is another step in the evolution
of human subject research protections policies begun in the 1940s. While those
protections are crucial, gaps still remain.

With respect to classified research, the current requirement of informed
consent is not absolute; if consent is waived, the research may proceed in ways
that do not adequately protect the research subject. Also, military research
involves special considerations because of the nature of the subject population,
whose voluntary participation must be especially guarded. In addition,
nonfederally funded research is not subject to the Common Rule, except under the
umbrella of an institution's multiple project assurance.

Further, oversight mechanisms generally are limited to audits for cause
and review of paperwork requirements. These offer little in the way of assurances
that the prospective review process is working and do not give an indication of
the quality or consistency of IRB review, either among IRBs or within a single
board. An effective system of oversight relies on the detection of violations of
policies and the imposition of appropriate sanctions.

The Committee's recommendations for remedying these and other
shortcomings are discussed in chapter 18 of the final report. The remaining two
chapters of part III report what documents used by IRBs suggest about the
protection of human subjects and what patients think about the enterprise of
human subject research.

687

Part HI

Table 1. Human Subjects Research & Protections in Seven Departments and
Agencies

Specific Statutory

Annual Spending

Locus of Human

Staff Resources

Nature of

Original

Additional

Authority for

on Human

Subjects

Devoted to

Research

Classification

Provisions

Human Subjects

Subjects

Research

Human Subjects

Oversight and

Authority/

for Special

Protection

Research t

Sponsored by

Protection

Compliance

Conduct of Classified

Populations

Agencyf

Activities*t

Activitiesf

Research t

DHHS

P.L. 93-348(1974)

$367 million

Intramural and

19 full-time staff

Negotiates

Is not conducting

Pregnant

P.L. 99-158(1985)

intramural, $2.4

extramural

& 38.3 FTEs

institutional

classified research

women.

P.L. 103-43(1993)

billion extramural

(excludes FDA)

assurances;

with human subjects

fetuses and in

fiscal year 1992

Some overseas
research

reviews IRB
performance on
an exceptions
basis only

vitro

fertilization at
subpart B, 45
C.F.R. 46;
prisoners at
subpart C;
children at
subpart D

FDA

Food. Drug, and

(included in

Intramural and

6 full-time staff &

Conducts

No classified research.

Intramural

Cosmetic Act, sec.

DHHS total)

extramural

26.7 FTEs

compliance

Maintains security

research

505(i). 507(d)

inspections on

clearances for

governed by

(1963). and 520(g)

Drug and device

a three-year

coordination with

45 C.F.R. 46

(1976)

research
regulated by
FDA; domestic
and foreign

cycle, annually
if problematic

DOD

subparts B,
C, and D

DOD

I0U.S.C. 980

$77 million for

Intramural and

80 FTEs

Negotiates

Has original

Subparts B.

(1988). Requires

intramural

extramural .

assurances,

classification

C, and D of

informed consent

programs; $ 1 07

relies on OPRR

authority.

45 C.F.R. 46

million for

Some overseas

MPAs; Also

Conducted one

adopted as

extramural

research

conducts on-

classified human

DOD

programs, fiscal

site audits of

subject study in FY

directives

-

year 1994

research
programs

1994. May conduct
other minimal-risk
classified studies

*This estimate includes staff resources devoted to policy development and guidance, negotiating assurances, oversight, and
auditing. It excludes the time of agency staff spent on IRB members or staff and the minimal efforts of grant and contracts
personnel who track IRB-approval status on research applications. Full-time equivalent (FTE) effort represents the cumulative
efforts of several people, who spend part of their time on oversight of human subjects experiments.

/■Information on current human subjects research programs and practices provided by agencies to Advisory Committee staff.

688

Chapter 14

Specific Statutory

Authority for

Human Subjects

Protection

Annual Spending

on Human

Subjects

Research f

Locus of Human

Subjects

Research

Sponsored by

Agencyf

Staff Resources
Devoted to

Human Subjects
Protection
Activities *f

Nature of

Research

Oversight and

Compliance

Activitiesf

Original

Classification

Authority/

Conduct of Classified

Research f

Additional
Provisions
for Special
Populations

DOE

None. Policy
derives from

$46 million in
fiscal year 1 994

Intramural and
extramural

1 - 10.4 FTEs

Negotiates
institutional

Has original
classification

Subparts B.
C. and D of

Common Rule

(S20.4 million of

Program director

assurances.

authority. Is not

45 C.F.R. 46

which is for

Some overseas

devotes 85

relies on

conducting any

adopted as

epidemiological
studies in Japan);

research

percent of time to
human subjects

OPRR MPAs,
reviews IRB

classified research
with humans

agency
guidelines

$10 million from
other federal

protection

performance on
an exceptions

agencies

basis; plans to
conduct
periodic audits

VA

38U.S.C. 7331.

$1 14 million in

Intramural only

0.5 FTE, central

Central office

Does not have

No distinct

7334. Requires

research funds;

office staff

review of IRB

original classification

requirements

informed consent

$1 10 million in

minutes and of

authority. No

and references

clinicians' time;

51.6 FTEs, field

research

classified human

Common Rule

$100 million in
privately
supported
research; $170
million funded by
other federal
agencies

staff

protocols

subject research

NASA

None. Policy

$25 million

Intramural and

0.5 FTE

In-house IRB

Has original

No distinct

derives from

FY 1994 for

extramural

provides a

classification

requirements

Common Rule

ground-based
research

Some overseas
research

second-level
review for all
air/space
human
research;
ground-based
research may
be reviewed by
one or more
IRBs

authority. Conducts
no classified human
subject research

None. DHHS

Funding is a

Intramural and

One senior staff

Director, CIA,

Has original

Subparts B,

regulations
applicable under
Executive Order
12333(1981)

small portion of
research
components of
general budget

extramural

physician (four
hours per month)

approves all
human subjects
research. In-
house IRB also

classification
authority. Conducted
small number of
classified human

C, and Dof
45 C.F.R. 46
adopted as
agency policy

CIA

-

reviews
extramural
projects.
Inspector
general reviews
Human Subject
Research Panel

subject studies FY
1992-1993

689

ENDNOTES

1 . Agency data reported to the Advisory Committee. See table 1 at end of this
chapter and supplemental volume for the individual agency spending estimates that
make up this total figure.

2. The sixteen departments and agencies that adopted a common policy for
human subjects protection are the Department of Agriculture, Department of Energy,
National Aeronautics and Space Administration, Department of Commerce, Consumer
Product Safety Commission, Agency for International Development, Department of
Housing and Urban Development, Department of Justice, Department of Defense,
Department of Education, Veterans Administration (now Department of Veterans
Affairs), Environmental Protection Agency, Department of Health and Human Services,
National Science Foundation, Department of Transportation, and pursuant to an
executive order, the Central Intelligence Agency. The Food and Drug Administration, a
subagency of Health and Human Services, has somewhat different regulations governing
human subjects research, based on its distinct statutory authority to regulate research for
the licensing of new drugs, devices, and biologies (e.g., vaccines).

3. Federal Policy for the Protection of Human Subjects; Notices and Rules, 56
Fed. Reg. 28002 - 28032 (June 18, 1991). Each department and agency subject to the
Common Rule incorporated its provisions within the agency's own regulations (e.g.,
DHHS regulations are reflected in 45 Code of Federal Regulations [C.F.R.] pt. 46, while
DOD regulations are reflected in 32 C.F.R. pt. 219). The June 1991 Federal Register
announcement is the only publication of the Common Rule as such. The Common Rule
is not applicable to nonfederally funded research unless the research is performed at an
institution whose research is subject to a multiple project assurance (MPA), described
later in this chapter.

4. President's Commission for the Study of Ethical Problems in Medicine and
Biomedical and Behavioral Research, Protecting Human Subjects: The Adequacy and
Uniformity of Federal Rules and Their Implementation (Washington, D.C.: GPO, 1981).

5.' Ibid., 140.

6. DHHS regulations specify additional protections for research on certain
subject populations: pregnant women, fetuses, and subjects of in vitro fertilization
research; prisoners; and children. The DHHS regulation is codified at 45 C.F.R. pt. 46
(1991). Subpart A of this regulation is the Common Rule. Subpart B provides additional
protections for research involving pregnant women, fetuses, and in vitro fertilization,
subpart C for research involving prisoners, and subpart D for research involving children.
At their discretion, some of the other federal agencies whose research programs involve
subjects in one of these categories have adopted these regulations as agency guidelines.
See table 1 at the end of this chapter for information on the applicability of special
protections by agency. Some agencies, such as DOD, impose other safeguards in
addition to those of the Common Rule. Information on individual agency policies and
oversight practices at the other ten agencies, and greater detail on the policies of the six
agencies above, are reported in a supplemental volume to this report.

7. The Common Rule directs that IRBs must include at least one member
whose primary concerns are in scientific areas and at least one member whose primary
concerns are in nonscientific areas. They must also include at least one member who is

not otherwise affiliated with the institution (§ .107). (The provisions of the Common

Rule are designated as "§ .000." The " " indicates that these sections are

reproduced within the regulations of various departments. Thus § .107 of the

690

Common Rule is codified for DHHS at 45 C.F.R. § 46.107.)

8. Federal Policy for the Protection of Human Subjects, § . 1 1 6(a).

9. Ibid., § .116(b).

1 0. Common Rule, . 1 1 6(d). Under the Common Rule, four requirements

must be met in order for an IRB to waive the rule's informed consent requirements: "(1)
the research involves no more than minimal risk; (2) the waiver or alteration will not
adversely affect the rights and welfare of the subjects; (3) the research could not
practicably be carried out without the waiver or alteration; and (4) whenever appropriate,
the subjects will be provided with additional pertinent information after participation."

11. Ibid., § .109.

12. Radioactive Drugs for Certain Uses, 21 C.F.R. § 361.1

13. National Institutes of Health, Office for Protection from Research Risks,
Protecting Human Research Subjects (Washington, D.C.: GPO, 1993), 5-23 - 5-28.

14. These figures represent the total amount of funds obligated for projects in
which any human subjects were involved regardless of how minimal such involvement
may be. Since it is virtually impossible to determine, within any given grant, the exact
dollar amount that goes to human subject research, only the funding for the entire project
could be calculated.

15. Lily O. Engstrom, Office of Extramural Research, NIH, to Wilhelmine
Miller, ACHRE, 21 February 1995 ("Response to ACHRE Request No. 013095-E") and
4 April 1995 ("Additional Information in Response to ACHRE Request No. 013095-E").

16. The PHS comprises a number of agencies, including the National Institutes
of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food
and Drug Administration (FDA). The NIH is the world's largest medical research center
and conducts biomedical research (both basic science and clinical) dedicated to the
improvement of the public's health. The CDC focus is primarily on health promotion
and disease-prevention, in addition to basic research in epidemiology, disease
surveillance, laboratory science, and training of disease-prevention officials. The FDA
is responsible for regulating and overseeing the safety and effectiveness of food,
cosmetic, medical device, and human and veterinary drug industries, in addition to
studying and monitoring consumer products and the industries that produce them.
Department of Health and Human Services, Public Health Service, Office of the Assistant
Secretary for Health, January 1993 ("The U.S. Public Health Service Today") (ACHRE
No. HHS-091395-A).

17. Joseph V. Osterman, Environmental and Life Sciences, Office of the
Director of Defense Research and Engineering, DOD, to Principal Deputy Assistant to
the Secretary of Defense (Atomic Energy), 27 February 1995 ("White House Advisory
Committee on Human Radiation Experiments").

18. Richard Pell, Jr., Deputy Chief of Staff, VA, to Jeffrey Kahn, ACHRE, 10
February 1995 ("We have prepared the enclosed fact sheet"), and Richard Pell, Jr., to
Wilhelmine Miller, ACHRE, 19 January 1995 ("In response to your request"), enclosure
pages 9-10.

19. DOE Database, Fiscal Year 1994, reported by David Saumweber, ACHRE,
to Advisory Staff, ACHRE, 17 October 1994 ("DOE Current Research"), and oral
communication by Susan Rose, Office of Health and Environmental Research, Office of
Energy Research, DOE, to Wilhelmine Miller, ACHRE, 13 January 1995. There is
ongoing discussion as to how large the commitment to RERF will be and how it will be
administered.

691

20. J. Stoklosa, NASA Office of Aerospace Medicine, to Wilhelmine Miller,
ACHRE, 14 February 1995 ("Enclosed is the response to"), 2. Figures for in-flight
biomedical research were not provided.

21. Notes of Gary Stern, ACHRE, regarding 7 March 1994 meeting with CIA
inspector general's staff, 8 March 1994. John F. Pereira, CIA, to Gary Stern, Anna
Mastroianni, and Sara Chandros, ACHRE, 7 August 1995 ("Information for Committee's
Final Report"). No additional information on this issue was made available by the CIA
in response to Advisory Committee queries.

22. In addition, several federal agencies have adopted as policy guidelines the
additional provisions of the DHHS regulation, 45 C.F.R. pt. 46, for pregnant women,
fetuses, and in vitro fertilization; prisoners; and children (subparts B, C, and D,
respectively). See table 1 at the end of this chapter for references to such agency policies.

23. Federal Policy for the Protection of Human Subjects, § . 1 03(a).

24. Occasionally, a federal agency may rely on an IRB at an adjacent academic
institution to review research projects conducted at the federal facility. This sometimes
occurs at VA hospitals that are affiliated with teaching hospitals and is the case for the
Environmental Protection Agency, whose own research facility is located at the
University of North Carolina.

25. Federal Policy for the Protection of Human Subjects, § .103 and

§ -113.

26. James M. Lamiel, Chief, Clinical Investigation Regulatory Office,
Consultant to the Army Surgeon General for Clinical Investigation, to Director, Radiation
Experiments Command Center, 28 July 1995 ("Revised Chapter Drafts of the Advisory
Committee").

27. Ibid., § .109 and § .113.

28. Federal Policy for the Protection of Human Subjects, § _. 1 03(a).

29. Gary Ellis, Director, OPRR, to OPRR Staff, 7 December 1993 ("Compliance
Oversight Procedures"), 1-4.

30. FDA Protection of Human Subjects, 21 C.F.R. pt. 50 and Institutional
Review Board Requirements, 21 C.F.R. pt. 56 (1995), § 56.1 15 and § 56.120. See
supplemental volume for further discussion of the FDA's distinctive policies and
oversight practices.

3 1 . Medical monitors are not permitted to be investigators involved in the
protocol. Medical monitors have the authority to terminate an individual volunteer's
participation in the study or suspend the study for review by the IRB. Lamiel, "Revised
Chapter Drafts of the Advisory Committee."

32. DOE, Office of Health and Environmental Research, Progress Report:
Protecting Human Research Subjects (Washington, D.C.: DOE, November 1994), A2.

33. See for example, Department of Defense Instruction 5000.2: "Defense
Acquisition Management Policies and Procedures," 23 February 1991 (Administration);
Army Regulation 40-10, "Medical Service Health Hazard Assessment Program In
Support of the Army Materiel Acquisition Decision Process," 15 September 1983
(Administration and Safety Issues); Army Regulation 70-8: "Research, Development,
and Acquisition, Personnel Performance and Training Program (PPTP), (Research
Guidelines and Procedures; Training and Indoctrination)"; Army Regulation 70-8:
"Research, Development, and Acquisition, Soldier-Oriented Research and Development
in Personnel and Training," 31 July 1990 (Research Guidelines and Procedures Training
and Indoctrination); Donald J. Atwood, Deputy Secretary of Defense, Department of
Defense Directive Number 5000.1: "Defense Acquisition," 23 February 1991.

692

34. Oral communication by Colonel John Boslego, Deputy Director, WRAIR, to
Shobita Parthasarathy (ACHRE Staff), 13 September 1995.

35. Lamiel, "Revised Chapter Drafts of the Advisory Committee."

36. Major Dale Vander Hamm, Chief, Human Use Review and Regulatory
Affairs Division, Headquarters, U.S. Army Medical Research and Materiel Command, to
Shobita Parthasarathy, ACHRE, 27 July 1995 ("Human Volunteers in U.S. Army
Research in 1995").

37. Ibid., § .113.

38. Ibid., § . 103(b) and (f), § .122- .123.

39. Each agency has its own regulations regarding the oversight of compliance.
For example, debarment procedures are specified for DHHS at 45 C.F.R. § 76. These
procedures are summarized in a memorandum from Gary Ellis to OPRR staff, 5 February
1993 ("Compliance Oversight Procedures"), 3.

40. California Health and Safety Code, vol. 40B, § 24176 (1995).

41 . Joseph V. Osterman, Environmental and Life Sciences, Office of the
Director of Defense Research and Engineering, to Principal Deputy, Assistant to the
Secretary of Defense (Atomic Energy), 27 February 1995 ("White House Advisory
Committee on Human Radiation Experiments"). Larry Magnuson, M.D., CIA, in oral
communication to Gary Stern, ACHRE.

42. Osterman to Assistant to the Secretary of Defense (Atomic Energy), 27
February 1995.

43. Notes of Gary Stern (ACHRE staff), regarding meeting with inspector
general's staff, CIA, 7 March 1994 (8 March 1994).

44. Ibid.

45. Ellyn R. Weiss, Office of Human Radiation Experiments, DOE, to Daniel
Guttman, ACHRE, 13 February 1995 ("This letter is in response to . . .").

46. Described in the DOE guidance. Protecting Human Subjects at the
Department of Energy, Human Subjects Handbook, Office of Health and Environmental
Research, 1992, "Review of Classified Research," unpaginated (ACHRE No. DOE-
050694-A).

47. The FDA and DOD, memorandum of understanding of May 1987
("Concerning Investigational Use of Drugs, Antibiotics, Biologies, and Medical Devices
by the Department of Defense"), 4.

48. Veterans Administration, "Policy Manual MP-1" (21 November 1979), part
5, chapter 1, 5-8.

49. Janis Stoklosa, Office of Aerospace Medicine, NASA, in oral
communication to Wilhelmine Miller, ACHRE, February 1995.

50. Federal Policy for the Protection of Human Subjects, § . 1 1 6 (d).

5 1 . Ibid., § . 1 0 1 (i). This provision also allows for a statute or executive

order to override the notification and publication requirements.

693

15

RESEARCH PROPOSAL REVIEW

PROJECT

T\

wo of the biggest differences between research involving human
subjects today and research involving human subjects as it was conducted in the
1940s, 1950s and 1960s, are the presence of applicable federal regulations and
the articulation of rules of professional and research ethics. There is little
question that these developments have had a significant effect on the protection of
the rights and interests of human subjects. At the same time, however, there has
been little systematic investigation of how much protection these developments
have provided. As an Advisory Committee charged both with looking at the past
and making recommendations about the future, we hoped to learn as much as we
could about the state of contemporary human subjects research. We were
particularly interested in exploring the extent to which the rights and interests of
people currently involved as subjects of radiation research conducted or supported
by the federal government appear to be adequately protected and whether the
level of protection afforded these subjects was the same as that afforded the
subjects of nonradiation research. The Advisory Committee's Research Proposal
Review Project (RPRP) was designed to address these questions. By examining
documents from a wide variety of research projects funded by many agencies of
the federal government, we hoped to offer insight into the general state of the
protection of the rights and interests of human subjects.

During the course of the RPRP, the Committee reviewed documents from
a random sample of research proposals involving human subjects and ionizing
radiation that were approved and funded in fiscal years 1990 through 1993 by the

694

Chapter 15

Departments of Health and Human Services (DHHS), Defense (DOD), Energy
(DOE), Veterans Affairs (VA), and the National Aeronautics and Space
Administration (NASA); these are the only federal agencies that currently
conduct human subjects research involving ionizing radiation.1 We also reviewed
a comparison sample of studies that did not involve ionizing radiation funded by
the same agencies during the same period.

In this chapter, we first present the methodology and findings of the
Research Proposal Review Project. We then report the results of an independent
review of research proposals and documents conducted by one member of the
Committee who also acted as a reviewer in the RPRP. The chapter closes with a
discussion of our results in the context of current policies and practices in
research involving human subjects.

METHODOLOGY OF THE RPRP

Obtaining Research Proposal Abstracts to Identify Studies of Interest

The RPRP involved the collection and review of documents related to
recently funded, federally supported human radiation research. This included
research supported or performed by the DOD, DOE, DHHS, NASA, and VA.
Each agency funds intramural research conducted by agency staff members at
various field sites and extramural research conducted outside the agency by
contractors or grantees. The Advisory Committee requested and received
abstracts or similar descriptions from these agencies for all intramural and
extramural studies newly approved and funded between fiscal years 1 990 and
1993 (that is, "new starts" in those fiscal years) that fell within two general
categories: (1) studies involving the exposure of human subjects to research
applications of ionizing radiation (or follow-up studies of such exposures); and
(2) nonradiation research involving human subjects. These abstracts represented
the "universe" of federally funded contemporary human research from which
studies were then selected for review.

Selection of Studies Involving Ionizing Radiation

For purposes of the RPRP, a radiation experiment was defined as any
federally funded or performed investigation where the exposure of human
subjects to ionizing radiation is an element of the research design. In addition,
we included follow-up or epidemiological studies of exposures of humans to
ionizing radiation.2 Any procedures involving radiation incidental to a subject's
enrollment in a study (for example, a diagnostic x ray in research involving
chemotherapy) were not considered experimental for purposes of the review.

To select studies to review from the many abstracts we received, nuclear
medicine experts on the Advisory Committee staff first reviewed and stratified the

695

Part III

Definitions of Biomedical Categories

Tracer/biodistribution studies: Studies involving the measurement of administered radioactive
chemicals within the body (in vivo) using radiation detectors directed at the body from the outside,
or in body fluids such as blood and urine in the test tube (in vitro).

Biodistribution studies are distinct from tracer studies in that their object of study is
radioactive contaminants themselves, in order to understand their distribution and metabolism
within the body. By contrast, tracer studies employ radio-labeled variants of ordinary biological
chemicals to provide information on natural metabolic processes involving those chemicals.
Tracer/biodistribution studies differ from research involving external sources of radiation (such as
x rays), because tracer/biodistribution studies involve the administration of radioactive chemicals
into a subject's body."

Studies involving potential therapeutics: Studies that involve novel or nonvalidated uses of
radiation for therapeutic purposes on sick individuals.

Studies involving potential diagnostics: Studies that involve experimental uses of radiological or
nuclear medicine diagnostics (for imaging) that are experimental in that their efficacy has not been
established. This includes research involving different types of radiation exposure as well as
applications of established radiation imaging techniques (such as diagnostic x-rays or CAT scans),
for new diagnostic purposes.

Epidemiological/observational: Studies of health effects in people who have experienced
exposures to ionizing radiation. This research does not employ radiation, but attempts to
understand health effects on humans exposed to ionizing radiation using follow-up studies,
medical monitoring, and retrospective records reviews.

study abstracts obtained according to the biomedical categories that the Advisory
Committee established for radiation research: tracer/biodistribution studies,
studies involving potential therapeutics, studies involving potential diagnostics,
and epidemiological/observational studies. These categories were intended to
parallel roughly the various types of past radiation experiments identified by the
Advisory Committee. We recognized that placing radiation experiments into
discrete categories was a difficult task. The purpose of the categorization,
however, was to sample proposals across the range of radiation research
conducted on human subjects rather than to identify specific research as falling
into strict categories.3 Definitions of the biomedical categories used in the

aHenry N. Wagner, Jr. and Linda E. Ketchum, Living with Radiation— The Risk, The Promise
(Baltimore: The Johns Hopkins University Press, 1989), 77-78.

696

Chapter 15

Research Proposal Review Project are listed in the accompanying box.

We then selected studies4 to ensure that each funding agency and each
biomedical category of human radiation research (tracer/biodistribution,
therapeutic, diagnostic, and epidemiological/observational) was adequately
represented in the random sample5 of studies to be reviewed. Eighty-four
radiation studies were selected from proposal abstracts provided by the agencies.
These included 3 1 extramural proposals representing nonfederal research
institutions,6 primarily universities, and 53 intramural proposals7 from the DHHS,
DOE, DOD, NASA, and VA.

Selection of a Comparison Group of Nonradiation Studies

For purposes of selecting a comparison sample of nonradiation studies, the
84 radiation studies were reclassified according to the following categories: ( 1 )
federal funding agency, (2) extramural/intramural, and (3)
cardiology /cancer/neither cardiology nor cancer.8 Approximately half as many
studies (41) were selected for the comparison sample and distributed in each of
the three categories in comparable proportion to the distribution of radiation
studies. We drew our sample of nonradiation studies from the same grantee
institutions that were included in the radiation sample.

Data Sources

In total, the Advisory Committee identified for review 125 research
proposals involving human subjects (84 involving ionizing radiation, and 41 not
involving radiation) that were approved and funded by DHHS, DOE, DOD,
NASA, or VA between fiscal year 1990 and fiscal year 1993.9 Long-term
epidemiological studies that were initiated before fiscal year 1990 and continued
through this period were included in the review in cases where the methodology
and/or consent procedures for such studies were found to have been updated in
recent proposal renewals.

The Advisory Committee requested the following documents10 for each of
the 125 studies it identified for review:

1 . Grant proposal submitted by investigator to
federal agency;"

2. Institutional review board (IRB) application;12

3. Original consent form submitted to the IRB;

4. Consent form, as approved by the IRB;'3

5. The IRB's final disposition letter;14

6. Documentation concerning any changes to the
research design, methods, or consent form approved

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Part III

by the IRB after the IRB's initial approval of the
study;15

7. If relevant, the application submitted to and the
official letter of approval from the radioactive drug
research committee (RDRC);'6

8. If relevant, the application submitted to and the
official letter of approval from any institutional
human use committee other than the IRB or RDRC.

All of the relevant federal agencies and the 47 extramural grantee
institutions to which the Advisory Committee submitted a request complied with
this request. The willingness of institutions to voluntarily make available
documents for review indicates their commitment to research ethics, which the
Committee very much appreciates. The openness shown by the biomedical
research community is important evidence of improvement in the ethics of human
subject research over the fifty-year history reviewed by the Committee.

Review Process

Three basic elements were considered in developing a system to review
the research materials supplied to the Advisory Committee: the procedures for
obtaining informed consent, the balance of risks to potential benefits for the
subject, and the selection and recruitment of subjects. An evaluation form was
developed by a subcommittee of Committee members and staff to assist reviewers
in organizing their assessments of the research documents (grant proposal, IRB
application, RDRC application) and the consent form(s).

The documents for each proposal were reviewed by a team of two
individuals, with at least one member of the Advisory Committee placed on each
team, so that documents from every proposal were reviewed by at least one
member of the Committee. Review teams consisted of either two Advisory
Committee members or one Committee member and one staff member. One
member of each team had expertise in research ethics, while the other had
expertise in radiation science, radiation medicine, another branch of medicine, or
epidemiology. Reviewers were never assigned documents from their own
institution; they were also required to recuse themselves if they were well
acquainted with the principal investigator of a proposal.

Documents were first reviewed independently by each reviewer and then
by the reviewers together as a team. At the end of this process, each team
completed a single evaluation form representing a joint assessment.

Limitations

The Research Proposal Review Project was designed to provide insight on

698

Chapter 15

an exploratory basis into the current practice of human subjects research
conducted or supported by the U.S. government. The project was not undertaken
with the expectation that our results would be generalizable to all research
involving human subjects or to research sponsored by nongovernmental agencies.
Of necessity, we reviewed documents from only a small sample of proposals for
human subjects research funded in fiscal years 1990 through 1993. In a given
year, DHHS supported 16,972 projects and subprojects involving human subjects
research.17 At the same time, however, our sample includes examples of both
radiation and nonradiation research funded or sponsored by five different federal
agencies across a variety of biomedical categories and medical specialties.
Moreover, the proposals whose documents we received and reviewed were
selected at random; there was no attempt to identify proposals that appeared from
the outset to pose human subjects problems or high levels of risk and therefore no
reason to suspect that the sample chosen was biased in favor of more problematic
or higher-risk studies.

Within the Committee, reviewers rarely disagreed in their reviews.
Although these reviews are based on interpretation and opinion in the context of
Committee deliberation, it should be noted that so, too, are the evaluations of
IRBs, on which the protection of human subjects now rests.

Perhaps the most significant limitation of this project is that the evaluation
of each proposal was based only on the documents that were provided by the
federal funding agency and grantee institution. The documentation we received
was not always complete. Moreover, IRBs may have had access to sources of
information not available to the Committee. Some IRBs invite principal
investigators to make presentations at IRB meetings; others encourage reviewers
to discuss proposals with principal investigators before IRB meetings. Thus, in
some cases, IRBs may have reviewed the proposals evaluated by the Committee
with a fuller and more accurate understanding of the project than was available to
the Committee. It is therefore possible that some of the research projects that
raised concerns for us based on the documents we reviewed, would, with the
provision of additional information, be deemed unproblematic from a human
subjects perspective. Conversely, it is possible that some of the research projects
whose documents raised no concerns may nevertheless have inadequacies
affecting the rights and interests of human subjects that we could not detect.

From the outset, the Committee neither desired nor thought it possible
(because of our limited tenure and resources) to make judgments about the extent
to which these 125 research projects were in fact being conducted in an ethically
acceptable manner. This would have required a careful evaluation of far more
than the documents that we received.

Neither IRB interactions with principal investigators nor documents speak
to what actually happens between investigators, their assistants, and potential
subjects. What investigators in fact say to potential subjects, the tone with which
they say it, and the conditions under which the interaction takes place are pieces

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of information that were unavailable to the Advisory Committee in its review of
the documents from contemporary human research proposals, just as they are
generally unavailable to IRBs.

The Advisory Committee's review of research proposal documents thus
was not intended to evaluate the performance of particular IRBs or the ethics of
the conduct of particular investigators or specific insitutions. Rather, by
examining documents from a wide variety of research projects funded by many
agencies of the federal government, we hoped to offer insight into the general
state of the protection of the rights and interests of human subjects.

FINDINGS OF THE RPRP

IK

In this section, we present the results of the RPRP. We begin with a
general characterization of our overall assessment of the research documents. We
also provide additional analysis of the impact of the level of risk and kind of
experiment (nonradiation vs. radiation) on our evaluations. Next, we turn to a
discussion of what the Committee found most troubling in these documents,
organized around issues of understanding, voluntariness, and decisional capacity.
Finally, we look at problems that were common in the sample as a whole,
including the readability of consent forms and deficiencies in documentation.

Overall Assessment

Reviewer teams registered their overall assessment of each set of
documents using a scale from 1 to 5, where 1 was taken to indicate no ethical
concerns and 5 was taken to indicate serious ethical concerns. This scoring scale
was used to assist reviewers in organizing their overall evaluations of the set of
documents for each research proposal. These ratings were made in concert by the
two reviewers after each had completed his or her own independent review.
Ratings of 4 and 5 are grouped together in the discussion that follows because
reviewers generally did not differentiate between the two; both ratings were used
when documents raised serious ethical concerns for reviewers.19

For the total sample of documents from 1 25 radiation and nonradiation
research proposals, two-thirds received ratings of either 1 (34%) or 2 (34%),
while 18 percent received a rating of 3 and 14 percent received a rating of 4 or 5.

Level of Risk

Reviewers identified whether the research proposals as described in the
documents involved minimal risk or greater than minimal risk of harm to
subjects; 78 proposals were considered to involve greater than minimal risk
(including 24 proposals that were evaluated as "maybe" greater than minimal
risk20), while 47 proposals were considered to involve minimal risk.

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There was a marked difference in the distribution of ratings between
minimal-risk and greater-than-minimal-risk studies (Figure 1 ). Although a
substantial number of greater-than-minimal-risk studies received ratings of 1 or 2,
all of the studies that received 4s and 5s were considered greater than minimal
risk.

Radiation versus Nonradiation Research

While about 70 percent of both radiation and nonradiation proposals
received ratings of 1 or 2, a somewhat higher proportion of nonradiation studies
than radiation studies received overall ratings of 4 or 5 (Figure 2). This
difference could not be explained by differences in level of risk; the proportion of
studies in the nonradiation subsample and the radiation subsample that involved
greater than minimal risk was essentially the same. Perhaps the lower proportion
of proposals in the radiation sample whose documents were rated as ethically
problematic can be attributed to the second layer of scrutiny that is often afforded
radiation studies during the initial review process. It must be noted, however,
that because there were few studies that received ratings of 4 or 5, differences
between radiation and nonradiation studies may not be significant.

Issues Contributing to the Overall Ratings

In this section we examine the kinds of problems that troubled reviewers
in the documents from the 40 proposals that received ratings of 3, 4, or 5. These
problems fell in to three categories: (1) factors likely to affect the adequacy of
potential subjects' understanding of the research (other than questions of
competence); (2) factors likely to affect the voluntariness of potential subjects'
decisions about participation; and (3) approaches to the inclusion of subjects with
limited or questionable decision-making capacity.

Factors Likely to Affect Understanding

Reviewers were likely to give a 3, 4, or 5 to proposals whose consent
forms did a poor job of describing either what potential subjects stand to gain or
what they stand to lose by participating in research. We looked carefully at how
the consent forms presented the purpose of the study, its potential for direct
benefits to the subject, the distinction between direct benefits and benefits to
medical science, and alternatives to participation. How well consent forms
communicated the realities of what it would be like to participate in the proposed
research, including the likely impact on quality of life, also came under scrutiny.
We were troubled, for example, by consent forms that, when compared with the
information provided in the grant proposal or other research documents, appeared
to overstate the therapeutic potential of research, either explicitly or indirectly.

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Figure 1

Overall Ratings

Greater than Minimal Risk vs. Minimal Risk

60

50

o
0.

40

30

ffi 20

10

Legend

~] Greater than Minimal Risk (n=78)
| Minimal Risk (n=47)

Overall Rating

23

4/5

Figure 2

Overall Ratings

Radiation vs. Non-Radiation

40

35

30

Cfl

1

o

2 25
a.

° 20

0)

I 15

I 10

Legend

Radiation (n=84)
Non-Radiation (n=41)

19

Overall Rating

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This issue was of particular concern to the Committee when the subjects being
recruited were patients with poor prognoses. For example, one study, which was
presented as primarily a toxicity study in the accompanying research documents,
was cast differently in the consent form: "One objective is to find out how well

patients respond to treatment If treatment works in your case, it may shrink

your tumor or cause it to temporarily disappear, and/or prolong your life and/or

improve the quality of your life Another objective of this study is to find out

what kind of side effects this treatment causes and how often they occur."2

There also was significant concern about the use of the word treatment in
consent forms for pharmacological studies. Phase I studies are designed to
establish the maximum tolerated dose (MTD) for new chemotherapeutic agents
and radiation regimens, which are then subjected to limited (Phase II) and then
more extensive (Phase III) clinical trials to determine therapeutic effectiveness.22
Although some Phase I studies contain elements of Phase II research and can
appropriately be characterized as holding out at least a remote prospect of benefit
to the subject, for some Phase I studies even the suggestion that subjects might
benefit is inappropriate.

Reviewers were influenced in their overall assessments by inadequate
descriptions of the physical risks of participating in the research. Reviewers were
concerned, for example, when consent forms did not discuss the risks potential
subjects faced in being removed from their standard treatments to be placed on an
experimental protocol. In one study, patient-subjects were taken off cardiac
medication in order to participate in a diagnostic study that offered no direct
benefit to them. Any risks involved in the removal from this cardiac medication
were not addressed in the consent form. The Advisory Committee also identified
consent forms in which the possible lethality of drug treatments and radiation
exposures was not adequately discussed. This occurred in contexts where patient-
subjects generally faced far greater risks from their underlying illnesses, but,
nevertheless, we felt that the consent forms should have been more forthcoming.
A number of projects that involved combination drug treatments, for example, did
not provide the potential subject with an estimate of the possibilities of death or
major toxicities from a combination of drugs. One study involved a combination
chemotherapy consisting of twelve different drugs but did not address the
uncertainty of risk resulting from this new and investigational combination.
Although the hazards and side effects for each drug were described individually,
there was no discussion of overall risks and harms.

Even where consent forms described the risks of the research, there was
often little mention of how participation would affect the subject's ability to
function in daily life or how ill subjects might be made to feel during the course
of the research. This omission was of particular concern to us when the
implications for quality of life were markedly different depending upon whether a
person decided to participate in the research or accept standard medical
management, such as when standard management included only palliative care or

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watchful waiting. In one end-stage cancer study, for example, the consent form
stated only that there may be "[o]ther general complications which may occur
from combinations of chemotherapy drugs, including weight loss and loss of
energy." The Advisory Committee was troubled that in such studies patient-
subjects may not understand that although the research protocol might offer a
chance to extend life, the time gained might be compromised by additional
limitations in the quality of life resulting from participation in the study.

Reviewers also noted a number of problems in some consent forms for
randomized clinical trials. For example, when some patient-subjects were
randomized to receive the standard treatment while others would undergo an
experimental procedure, reviewers commented that physical risks associated with
the standard treatment or procedure were sometimes not adequately addressed in
the consent forms. In one study of the effectiveness of a new compound for the
decontamination of people who had ingested a radioisotope, although the grant
proposal indicated that subjects would be randomized to receive a placebo, this
information was not included in the consent form. In fact, the consent form only
vaguely discussed the experimental procedures. "I [subject name] authorize
[physician name]. . . to administer decorporation therapy utilizing the drug [name
of drug]."

The Committee recognizes the difficulties facing investigators in
communicating to potential research subjects a complex set of experimental
procedures, side effects, long-term risks, trade-offs relative to alternatives, and
other relevant information. This task is not impossible, however. We reviewed
documents from several complex research proposals that at the same time had
excellent consent forms.

For example, we reviewed documents from a proposal for a Phase I study
of experimental antibody therapy that involved a number of possible risks;
imposed a number of inconveniences including restrictions on sexual activities
and a weeklong time commitment; and, as a Phase I study, offered little prospect
of direct benefit to subjects. The consent form for this study addressed each of
these issues in understandable language, briefly described how the monoclonal
antibodies used in this research were derived, and explained that the U.S. Food
and Drug Administration (FDA) permits experimental, new forms of therapy to be
tested in a limited number of patient-subjects in Phase I studies. This consent
form presented enough useful information to enable potential subjects to make an
informed decision about whether to participate in the research, and it was not
overly optimistic about the prospect of direct benefit to the patient-subject.

Another complex, greater-than-minimal-risk study with a good consent
form involved an investigational radiation treatment, radiosurgery, for patient-
subjects who had vascular disorders of the brain. The consent form for this study
described the experimental procedures step-by-step with a very realistic picture of
what participation would entail. Potential risks, possible benefits, and alternatives
to participation for this experimental therapy were clearly presented.

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Furthermore, information that was likely to discourage some patients from
enrolling--the possibility that participation in this study might limit the
effectiveness of similar types of radiotherapy for the patient in the future—was
disclosed in the consent form.

Factors Likely to Affect Voluntariness

As is discussed later in this chapter, the documents we reviewed often
provided no basis on which to judge whether the participation of potential
subjects was likely to be voluntary or not. In some cases, however, the
information provided was sufficient to raise concerns. One was a neuroscience
study that offered no prospect of medical benefit to potential subjects. Subjects
were being recruited from among former cocaine addicts who were living in a
residential treatment facility. Although compensation was not needed to
reimburse subjects for travel expenses or loss of income, subjects were being
offered $100 to participate. Reviewers were concerned that this cash payment
might make it easier for those people struggling to break an addiction to get
cocaine. Moreover, as part of the study, cocaine was injected into the body in
order to measure brain uptake. Even if this procedure was not likely to have a
physiologic effect upon the subjects, we were concerned that subjects may have
been encouraged to participate because the research involved the injection of
cocaine. We were also concerned about how their receiving cocaine as part of the
research might affect the subjects' perceptions of themselves during the recovery
process.

By contrast, the following text from a consent form for employee-subjects
(colleagues of the investigators) who are smokers illustrates exemplary handling
of the voluntariness issue in a minimal-risk study. The study, which involved no
risk of physical harm to the subjects, was designed to measure environmental
tobacco smoke.

Your participation in the experiments is entirely voluntary
and you are free to refuse to take part. You may also stop
taking part at any time. Because you are a colleague here
at [research institution], we want to be especially clear on
this point. We have approached you about the possibility
of your volunteering for these experiments. Your refusal to
participate or to continue will not be questioned by us, nor
will it (or should it) be discussed further with anyone else.

Inclusion of Subjects With Limited Decisional Capacity

Several issues revolve around how certain factors that influence a subject's
decisional capacity may affect his or her ability to understand the implications of

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participating in research. There is, for example, considerable controversy over
how to conduct research ethically in emergency medicine when, because of the
acute nature of the medical problem, the patient is temporarily incapacitated and
no family members are available for consultation. The documents of one proposal
raised some of these issues. In this example, 5 minutes were allotted to obtain
consent from subjects who were recruited in the emergency room while their
chest x-ray films were being processed. Under the stressful conditions of an
emergency room and while experiencing chest pain, the decisional capacity of
potential subjects was likely to be severely compromised. Reviewers expressed
concern about the subjects' ability, in such a context, to comprehend the study
adequately and then make a voluntary decision about whether or not to
participate. In another study, women in preterm labor were recruited to participate
in a study that involved collecting data about the infants born to these women.
Although the proposal stipulates that "[n]o mother will be approached while
under undo[s/c] stress or in excessive pain," reviewers were nonetheless
concerned about consent having been solicited during preterm labor.

The Advisory Committee also reviewed the documents of studies
involving children and adults with questionable decision-making capacity, several
of which raised serious ethical concerns.

Sixteen of the studies included in the Advisory Committee's review
involved children as research subjects; 1 1 of these 16 studies, according to federal
regulations, should have had assent forms as well as parental permission forms.23
The documents we received on each of these proposals all included parental
permission forms. We received assent forms for 8 of these 1 1 proposals. The 3
studies for which we did not receive assent forms all involved greater than
minimal risk, 1 of which may not have offered any prospect of medical benefit to
the children-subjects.

This last study illustrates a major issue in the ethics of research involving
children. Current regulations permit the use of children as subjects in research
that offers no prospect of direct medical benefit to them when the research poses
no more than minimal risk. Nontherapeutic research on children posing more
than minimal risk is permitted under special circumstances. A central, unresolved
question is whether the administration of tracer amounts of radioactive materials
to children can properly be classified as a minimal-risk intervention.

Eight studies in the project sample sought to recruit adult subjects with
questionable decision-making capacity. 6 of the 8 appeared not to offer potential
medical benefits to the subjects; two of the 6 were epidemiologic studies.

The Committee's concerns focused primarily on the remaining four
studies, all of which involved diagnostic imaging with cognitively impaired
persons, such as those with Alzheimer's disease. The imaging processes required
that the subjects' movements be restricted, yet there was no discussion in the
documents or consent form of the implications for the subjects of these potentially
anxiety-provoking conditions. Nor was there discussion of the subjects' capacity

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to consent or evidence that appropriate surrogate decision makers had given
permission for their participation. We were particularly troubled that two of these
studies exposed subjects to greater than minimal risks. The question of whether
or under what conditions adults with questionable decision-making capacity can
be used as subjects of research that offers no prospect of benefit to them is
unresolved in both research ethics and regulation. When such research puts
potentially incompetent people at greater than minimal risk of harm, it is even
more ethically problematic.

Common Problems With the Documents

We turn now to a discussion of issues that emerged often in the documents
we reviewed, including documents that raised only minor concerns.

Consent Form Language

Although inappropriate reading level in a consent form was generally not
sufficient in and of itself to result in ratings of 3, 4, or 5, it was sufficient for a
rating of 2. A significant majority (nearly 80%) of the proposals receiving a 1
included consent forms that used a reading level appropriate for the study
population. By contrast, the reading level was judged to be appropriate in no
more than half of the remaining consent forms.

Reviewers raised a number of issues that they felt may have contributed to
problematic reading levels in the consent forms. One such issue pertains to the
complexity of the research being proposed. We were disturbed to find that in
their attempts to convey complexities to the subject, investigators often drafted
consent forms that were too lengthy, highly technical, and generally
unintelligible. Consider the following, for example: "The purpose of this study is

to obtain a 'map' of brain cholinergic receptors This is done by administering,

intravenously, small amounts of a radioactive substance that attaches to brain
acetylcholine receptors and then producing a map of these receptors using Single
Photon Emission Computed Tomography (SPECT)."

Still another consent form included language such as "[y]ou will then be
positioned in a recumbent position," and "[a]nother possibility is poor regional
function because of ongoing or intermittent ischemia at rest, resulting in anginal
symptoms and global function that is worse than it can or should be."

A number of the consent forms included standard ("boilerplate") language
that was often in a smaller type and distinct from the rest of the document. The
presentation of information in this manner may have given subjects the
impression that the information was less important and easily skipped.
Sometimes these sections contained the only discussion of such critical topics as
alternatives to participation, costs to the subject, confidentiality, potential benefits
of participation, and voluntariness of participation.

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The Advisory Committee found that intramural institutions often used a
standard consent form that contained boilerplate language provided by their
respective agencies. The following passage is an example of such language. It
appeared in smaller type at the top of consent documents, clearly separated from
the rest of the text:

We invite you (or your child) to take part in a
research study at the [named institution]. It is
important that you read and understand several
general principles that apply to all who take part in
our studies: (a) taking part in the study is entirely
voluntary; (b) personal benefit may not result from
taking part in the study, but knowledge may be
gained that will benefit others; (c) you may
withdraw from the study at any time without
penalty or loss of any benefits to which you are
otherwise entitled. The nature of the study, the
risks, inconveniences, discomforts, and other
pertinent information about the study are discussed
below. You are urged to discuss any questions you
have about this study with the staff members who
explain it to you.

Reliance on Disclosures Not Subject to IRB Review

When patients are being approached to participate in research that has
implications for the medical management of their illness, it is understandable and
indeed desirable that patient-subjects discuss the proposed research with their
treating physician. The Committee was disturbed, however, when consent forms
indicated that the only presentation to potential subjects of key information about
the research was to take place in such undocumented discussions. This suggests
that it is difficult, if not impossible, for IRBs to judge whether potential subjects
were being provided an adequate base of information on which to make an
informed decision. There is no documentary record, either in the consent form or
in other materials submitted to the IRB, of what potential subjects have or will be
told about key aspects of research participation.

In some cases, consent forms indicated that subjects themselves were
responsible for approaching physician-investigators for explanations of the
choices available and guidance on how to compare the experimental protocol to
standard treatment. Consider the following example:

Your (child's) doctor can provide detailed
information about your (child's) disease and the

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benefits and risks of the various options available.
You are (your child is) encouraged to discuss this
with your (child's) doctor.

In this instance, it is unclear whether the phrase your doctor refers to the
patient-subject's personal physician, a physician who is a member of the research
team, or a physician who is both. This passage, as well as passages in several
other consent forms, suggests that conversations between subjects and the doctors
occurred after consent was given. Examples of this follow: "Severe and
sometimes deadly side effects have occured when high doses of this drug have
been given . . . You and your doctor will determine whether the benefits of such
treatment outweigh the risk"; and "You will discuss the options with your
physician and decide between . . . [surgical alternative] ... or [medical
alternative] . . ." Subjects in these studies may have received information critical
to their decision making process only after giving their consent to participate in
the research and without the IRB knowing the content of that information. This is
particularly troublesome because these statements comprise the only discussions
of side effects and alternatives, respectively, in these consent forms.

Other consent forms seemed to rely on disclosures that had already taken
place by the time potential subjects were approached to give their consent, and so
could not be afforded IRB review. One such consent form began, "The following
is a summary of the information your doctors gave you when discussing this
treatment with you. Please read it and ask any questions you may have." The
summary that followed provided little specific detail. The Committee was left
wondering whether the IRB was in a position to make a judgment about the
adequacy of this prior disclosure.

Voluntariness

If an informed consent is to be a meaningful act of decisional autonomy, it
is essential not only that the consent be based on adequate understanding but also
that it be substantially free from coercive or manipulative influences. We found,
however, that many proposal documents, including applications to IRBs, did not
contain enough information to make a judgment about the likely voluntariness of
subjects' consent decisions. For example, there was often insufficient or no
information about who was soliciting a potential subject's consent and under what
conditions.24

Often the only information in the documents reviewed that bore on issues
of voluntariness was the inclusion in consent forms of boilerplate language to the
effect that participation was voluntary. In most cases, the issue of voluntariness
was simply ignored in proposal documents submitted to the IRBs and funding
agencies, precluding us (and, presumably, IRBs) from making any judgments
about the procedures employed to ensure voluntary decision making.

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Scientific Merit

A controversy has long existed over whether the role of IRBs includes
evaluation of the scientific merit of proposed research. Some argue that
evaluation of scientific merit lies outside the scope of IRB review, while their
opponents contend that it is impossible to do a proper assessment of the benefit-
risk ratio without evaluating the potential contribution to science. Based on the
documents we received, it was sometimes difficult to make judgments about
scientific merit. In some cases, reviewers felt that they could not establish from
the documents available to them whether there was sufficient scientific merit to
warrant the exposure of human subjects to risk or inconvenience.

Psychosocial and Financial Risks

In research where psychosocial risks were clearly an issue, these risks
were often inadequately addressed in proposal documents. A number of
proposals that included neuropsychological batteries, for example, failed to
discuss the potential anxieties that may result from participation in the study. The
objective of one research project involved the inducement of sadness in the
subject. Neither the consent form nor the research documents addressed the
possibility that the sadness would not resolve itself quickly and that psychological
counseling or other therapy might be necessary.

Four studies reviewed by the Advisory Committee involved DNA
screening to determine the subjects' carrier status for a particular gene. None of
the proposals for these studies addressed the potential psychosocial impact of
learning about one's carrier status, including possible implications for other
members of the subject's family or the potential for insurance discrimination. The
availability of genetic counseling for these subjects was not mentioned in consent
forms. Reviewers also were concerned that some proposals did not clearly
explicate the types of tests that were included in what was referred to as "chronic
disease screening" in the consent forms. This lack of specificity was particularly
troubling for "chronic disease screens" that included human immunodeficiency
virus (HIV) testing. Although the anxieties and social risks of HIV testing were
likely to be addressed on a separate HIV-specific consent form, any study that
requires HIV screening as part of its eligibility criteria should make that clear to
subjects so that those who do not wish to undergo HIV testing can decline
participation.

Another area that was sometimes inadequately described in both consent
forms and research documents was the financial cost to the subject of
participating in the research. Costs were often briefly addressed in the boilerplate
section of the consent form, but usually no project-specific information about
actual expenses was offered to the subject. Reviewers were concerned that
subjects might not appreciate the real costs and the possibility that insurance

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companies would be very reluctant to cover them. This omission was particularly
troubling in studies involving seriously ill patient-subjects who may be at risk of
spending much of their assets on research interventions at the end of life.

Justice in the Selection of Subjects

Most research documents did not include specific information about the
subject populations that would be involved in the protocol. Unless IRBs are
receiving more information on this topic than that provided in the documents
reviewed by the Advisory Committee, they are clearly ill-equipped to address the
social policy goal25 of including women, minorities, and other groups in research.
The racial and ethnic composition of the subject sample, for example, was
specified in only one-quarter of the proposals whose documents were reviewed by
the Committee.

The only frequently mentioned reason for excluding a person from
participation in research was pregnancy. Pregnant women were explicitly
excluded in 58 percent of the studies (73 of 125) and were explicitly included in
only 5 percent (6 of 125) of the proposals. Pregnancy tests were often included in
the eligibility screening procedures for women who were willing to participate in
research. The RPRP sample also included 13 studies in which women who were
not pregnant were expressly excluded from participation. There was no scientific
reason to exclude women as subjects of research in any of these proposals. In two
of these instances, women were excluded expressly because of the possibility that
they might become pregnant.

The Committee's interpretation of the implications of these findings can be
found in the "Discussion" section at the end of the chapter.

INDEPENDENT REVIEW OF PROPOSALS

One member of the Advisory Committee, Jay Katz, served both as a
reviewer for the RPRP and independently reviewed 93 proposals.26 Katz's
independent sample was drawn from the same pool of proposals from which the
RPRP sample was drawn, included examples of both radiation and nonradiation
research, and was based on the same sets of documents as the RPRP.27 Although
there is considerable overlap between the proposals included in Katz's review and
those in the RPRP, the samples are not identical. Katz reviewed the first 93
proposals for which the Committee received documents, while the RPRP sample
was drawn from the entire pool of proposals for which documents were received
in order to achieve adequate representation by funding agency and type of
research. In addition, a few of the studies reviewed by Katz were eliminated from
eligibility in the RPRP because they did not fall within the biomedical categories
established by the Committee.

Katz's review complements and strengthens the findings of the Research

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Proposal Review Project. Whereas the RPRP sought to investigate several basic
issues regarding the conduct of human subjects research, including balance of risk
to potential benefit, justice in the selection of subjects, the involvement of people
with diminished decisional capacity, and the consent process, Katz focused
exclusively on informed consent. In doing so, he asked himself two interrelated
questions: (1) What can be learned about the contemporary informed consent
process? and (2) How adequately does the process protect the rights and interests
of research subjects? Although Katz appreciated that there was more to the IRB
process than could be ascertained from the protocols and consent forms submitted
to the IRB, he felt that consent forms constituted written documentation not only
of what subjects ultimately agreed to but also what IRBs considered to be
adequate written disclosure for purposes of consent. With respect to these signed
informed consent forms, he echoed a fellow Committee member's observation
that, if such forms are not clearly written or are otherwise flawed in significant
ways, it is likely that the oral interactions are similarly flawed.

Of the 93 proposals Katz reviewed, he identified 41 that posed greater
than minimal risks to subjects and therefore that also raised significant and
complex informed consent issues.28 Of these 41 proposals, Katz found that 1 1
(26%) raised no or only minor ethical concerns and were analogous to those
warranting a Committee rating of 1 or 2. Thirty protocols, however, raised ethical
concerns about the informed consent process (analogous to a Committee rating of
3, 4, or 5). Of the 30 (74%) protocols that raised serious problems, Katz felt that
10 were "borderline" (analogous to a Committee rating of 3), and 20 raised
serious ethical concerns of the sort analogous to those warranting a rating of 4 or
5 in the RPRP. Katz detailed the results of his review of these 20 problematic
proposals for the Committee, and a summary of his findings specific to those
proposals is presented here.

Physician-Investigators

In his review, Katz was struck by evidence of the dedication physician-
investigators brought to their task. They were concerned, and so informed IRBs,
about current treatments that were inadequate in eradicating disease or, at least, in
prolonging life. Moreover, physician-investigators emphasized the importance of
finding cures and not merely temporary or prolonged remissions.

Katz also noted that a number of the troublesome research proposals
appeared to be part of an underlying "grand scientific design" to gain basic
knowledge in such areas as cellular immunology or molecular biology, which
might eventually lead to more clinical research about therapeutic effectiveness.
The primary purpose of these studies was to advance knowledge for the sake of
future patients, not to benefit present patients.

As investigators declared war on cancer and other ills, they often
employed highly toxic agents to treat patients whose prognosis was grave. In

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their scientific protocols, the use of such agents was justified by arguing that only
such aggressive approaches would ultimately lead to cure, although often only for
future patients rather than present patient-subjects.

Katz, like the full Committee, was concerned that, at the same time,
documents from these proposals were devoid of any discussion of the impact of
the research on patient-subjects' quality of life, particularly in situations of
terminal illness. He speculated that in their ultimate quest for finding cures,
physician-investigators often paid more attention to increased longevity for
present patient-subjects than to the quality of remaining life.

Patient-Subjects

To Katz, the ancient but questionable proposition that physicians and
patients share an identity of interest in medical decision making becomes even
more questionable in research settings where physician-investigators have dual
allegiances: to their subject-patients and to their research objectives. As did
those in the RPRP, Katz noted that consent forms for the troublesome proposals
were often written in ways that made it difficult, if not impossible, for patient-
subjects to come to a meaningful decision as to whether they wished to participate
in research. Thus, patient-subjects seemed obliged to fall back on uninformed
trust, based on a belief that physician-investigators will act only to ensure a
patient-subject's therapeutic benefit.

Katz identified five specific problems with the informed consent process:
(1) unclear purpose, (2) incomplete information regarding the consequences of
participation in randomized studies, (3) confusing or incomplete discussion of
risks, (4) exaggerated benefits, and (5) insufficiency of information in consent
forms provided to IRBs. His concerns are elucidated below.

Specific Problems With the Informed Consent Process

Unclarity About Purpose

Katz found that the most striking element of the troublesome consent
forms was the lack of a forthright and repeated acknowledgment that patient-
subjects were invited to participate in human experimentation. All too quickly the
language shifted to treatment and therapy when the latter was not the purpose and
was only, at best, a by-product of the research. Like the other reviewers in the
RPRP, Katz was particularly concerned with Phase I trials. As documented in
some of the protocols in his examination, patient-subjects may suffer life-
threatening toxicities that may, though rarely, kill them. Nevertheless, such
studies are important for subsequent clinical trials and more widespread use in an
attempt to save lives in the future. Katz's examination of consent forms revealed
that investigators often did not take sufficient care to apprise patient-subjects of

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Part III

the purpose of Phase I studies. Although the dangers of the research are often
mentioned, this information was often compromised when the "treatment"
dimension of the research was emphasized. Katz concurred with a fellow
Committee member who observed, through his participation in the RPRP,
"Perhaps the consent form should not repeatedly emphasize that it is treatment,
but I believe that it is the way it is perceived by the researchers themselves." Katz
pointed out that the controversy over when, if ever, Phase I trials are to be
regarded as potentially therapeutic has not been satisfactorily resolved with
respect to the question: What must patient-subjects know? The President's
Commission for the Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research,29 when addressing Phase I trials, recommended that
"patients not be misled about the likelihood (or remoteness) of any therapeutic
benefit they might derive from such participation."30 Katz's review of consent
forms revealed that the Phase I purpose is often dismissed and the therapeutic
benefits are highlighted. Thus, he was concerned that patient-subjects are likely
to be confused about what is being asked of them.

The Consequences of Participation in Randomized Studies

A number of the troublesome proposals identified by Katz involved
randomized clinical studies in which patient-subjects were assigned to two
different experimental regimens to assess their comparative merits. These two
procedures were generally described adequately in the consent forms. Patient-
subjects, however, were generally not apprised of the already accumulated
knowledge about possible therapeutic benefits to be derived from each regimen.
Although protocols submitted to the IRB contained some, but often incomplete,
information about the greater promise of one procedure over the other, patient-
subjects rarely received such information.

In one protocol, for example, investigators clearly indicated that clinical
experiences with the combined administration of chemotherapy and radiation had
demonstrated its effectiveness against cancer. But since no scientific randomized
clinical study had as yet been conducted, the investigators intended to submit half
of the subjects to radiation alone. Consent forms provided no clues about what
had already been learned from clinical experience and nonrandomized trials.

In another randomized trial, the research objective required that half of
the patient-subjects submit to a mild treatment regimen, and the other half to a
more intensive one. Katz noted that quality-of-life impairments imposed by
random assignment to one research arm over another were not addressed in the
consent forms. The consent forms also failed to address the fact that more
intensive treatment regimens went counter to customary clinical practice of
"watching and waiting," as the often slowly progressive nature of the cancers
under investigation had led practitioners to recommend, in most cases, doing
nothing or administering chemotherapy or radiation therapy only in low doses.

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Chapter 15

Moreover, the risks inherent in both the mild and aggressive regimens were
lumped together in the consent forms as if they were one and the same. The
history of clinical experience with these particular cancers also was not discussed
in the consent forms.

Discussion of Risks

The troublesome consent forms identified by Katz customarily listed an
extremely detailed and separate discussion of all risks of the drugs, surgery,
and/or radiation to be administered. Although he felt that federal regulations can
be interpreted to require such detail, Katz, like the Advisory Committee as a
whole, was concerned that such exhaustive treatment may serve only to
overwhelm and numb patient-subjects. Only rarely were risks summarized or
were risks of particular relevance to the research project highlighted. In almost
none of the troublesome consent forms was there any comparative discussion of
the impact on quality of life and toxic consequences of what investigators
sometimes term total therapy (or of the physical and financial hardships imposed
by countless research tests) on the one hand and of less toxic therapeutic
alternatives that promise less but at least provide greater comfort for remaining
life on the other.

For example, one study sought to explore the toxicity /efficacy of a new
drug that may cause irreversible brain damage. That crucial piece of information,
however, was not highlighted as a specific risk of the particular drug under
investigation.

Another research project was designed to treat a cancer with a highly toxic
drug, which had an expected mortality of up to 10 percent when used in a dosage
greater than customary, as was contemplated in this "total therapy" research
project. This fact, however, was not mentioned in the consent form. Although the
patient-subjects had limited life expectancies, they probably would live longer
than when a lethal drug toxicity would occur. Katz noted that another
investigator simultaneously submitted the identical study to the same IRB
(utilizing the same drug to combat the same disease), but with an exemplary
protocol and consent form that discussed the expected 10 percent mortality rate
without equivocation.

Presentation of Benefits

Like the RPRP reviewers, Katz found that benefits were often exaggerated
in the troublesome consent forms. One consent form, for example, stated, "It is
possible that the treatment [emphasis added] will cause the tumor to shrink or
disappear or eliminate any symptoms and thus increas[e] life expectancy."
Although this statement conveys a promise of benefit to the patient-subject, the
protocol clearly indicates that any benefits would be fortuitous since they were

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Part III

•. '^neither an aspect of the research objective nor supported by evidence so far
accumulated.

One consent form for a research project that was designed solely to
establish the maximum tolerated dose of an intensive chemotherapy schedule
stated, "It is not possible to predict whether or not any personal benefit will result
from the use of the treatment program. A possible benefit could be the
achievement of a remission." There was, however, no therapeutic intent in this
proposal; physician-investigators were interested only in learning if it could be
used safely in a subsequent randomized clinical trial. The subjects, however,
could easily be led to believe that there was probable therapeutic benefit. Katz
was particularly alarmed about the overstatement of benefits because patient-
subjects so desperately long for such benefits.

Insufficiency of Information Provided to IRBs

,! In many cases, Katz found discrepancies between information provided in

/the protocol and that provided in the consent forms. This finding was not unlike
that of the full Advisory Committee. Thus, an important question must be posed
and eventually answered: Why was information that was available to IRBs not
disclosed to patient-subjects?
'% According to the documents received, it seemed that even IRBs were often

inadequately apprised of crucial information. In some cases, Katz noted that

.'•proposals were deficient in explicating the available knowledge about standard

'treatments, therapeutic effectiveness, and the impact of experimental procedures
on quality of life. Although research is often a voyage into the unknown,
investigators do possess preliminary guiding data that must be transmitted to
IRBs. Only then can IRBs accurately evaluate consent forms and make certain

. ithat patient-subjects are provided with necessary information in order to make

'•decisions about participation.

In one research project, for example, IRBs and, in turn, parents were
insufficiently informed that the combination of radiation treatment and highly
toxic chemotherapeutic agents used in the project exposed children to
considerable risks that deserved careful scrutiny. The parents or guardians had
two choices: to enroll their children in the study or to opt for standard treatments
of either radiation or chemotherapy alone (depending also on the location of the
cancer), with or without one of the chemotherapeutic agents that had considerable
carcinogenic potential within five years. This example highlighted another, more
general concern: that some patient-subjects may become part of inflexible
research protocols when considerable clinical experience suggests that a patient-
subject's medical condition may deserve an individualized treatment approach.

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'*Kf

Chapter 15

DISCUSSION

We turn now to a consideration of the implications of the results of the
RPRP, as bolstered by Katz's review, for our understanding of the current status
of human subjects protections. It should be reemphasized that these results were
based solely on an evaluation of the documents available to the Committee. It is
therefore possible that some of the research projects that raised concerns for us
based on the documents we reviewed would, with the provision of additional
information, be deemed unproblematic from a human subjects perspective. It is ^
also possible that some of the research projects whose documents raised no
concerns may nevertheless have inadequacies affecting the rights and interests of
human subjects that we could not detect.

There is no evidence in this review that research in which human subjects
are exposed to radiation is any more ethically problematic than other kinds of
research involving human subjects; in fact, our results suggest that human subject
protections may be more effective in radiation research then elsewhere, perhaps
because some radiation research is reviewed by a radiation safety committee as
well as an IRB. Because we failed to find any systematic differences between
radiation research and nonradiation research in our review, our observations
based on the RPRP results are directed at human subjects research generally, not
solely at radiation research.

About 40 percent of the research whose documents we reviewed appeared
to pose no greater than minimal risk to participants. Most of these studies raised
no concerns about ethics, or only minor ones. Many studies that involved greater
than minimal risks to subjects were similarly ethically unproblematic.
Specifically, more than half of the greater-than-minimal-risk studies reviewed
raised no or only minor concerns about ethics. There are important lessons to be > :
learned from these studies. It is possible to conduct complex research that puts >
subjects at greater than minimal risk of harm in an ethically acceptable fashion. It£
is possible to develop good consent forms for this kind of research. Not only is it •
possible, but it appears that this happens frequently.

At the same time, our review suggests that there are significant
deficiencies in some aspects of the current system for the protection of human
subjects. We have evidence that the documents provided to IRBs often do not
contain enough information about topics that are central to the ethics of research
involving human subjects such as voluntariness of participation, fairness in the
selection of subjects, and scientific merit. Although we have already noted that
IRBs do not necessarily rely solely on documents in making their evaluations,
clear, complete written documents are important. These documents form the core
of the information upon which IRBs rely in protecting the rights and interests of
human subjects; in some cases, they are the only source of information available.
These documents also provide a written record of the research subject protection
process for both administrative and historical purposes.

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Part III

In some cases, the Committee found that it was difficult to assess the
scientific merit of a protocol based on the documentation provided. This is
particularly problematic for proposals in which the IRB provides the only
opportunity for peer review, as is sometimes the case for research that is not
funded by the federal government.

The Committee also found evidence suggesting that in some studies
women are being excluded from participation in research, explicitly or
presumably because of the possibility that they might become pregnant during the
course of the study. This finding is disturbing in light of the fact that much of this
research was undertaken after a national policy had been instituted, advocating
the inclusion of women in research, and a general rejection of the mere possibility
of pregnancy as a justifiable reason for not permitting women to become research
subjects.31 The conditions under which pregnant women ought to be included as
research subjects remain controversial. That pregnant women are frequently
excluded from research was clearly evidenced in the RPRP; this occurred in more
than half the studies in our review.

Some of the Committee's most serious concerns focus on informed
consent. The results of the RPRP, as well as of Katz's review, suggest that some
consent forms currently in use are flawed in morally significant respects, not
merely because they are difficult to read but because they are uninformative or
even misleading. These are consent forms that have been approved by an IRB,
and still they are problematic, to the point where Committee reviewers viewed
them as raising serious ethical issues. Most of these concerns centered on
research involving patient-subjects with poor prognoses, people who are
particularly vulnerable to confusion about the relationship of research to
treatment. The consent forms to be used with such patient-subjects sometimes
appeared to suggest a greater prospect of benefit than the research as described in
the documents we reviewed warranted. In a few Phase I studies, any intimation
that subjects would benefit appeared questionable. At the same time, the
disadvantages of participation, particularly as they would affect quality of life,
were sometimes inadequately described or not presented at all. The Committee
recognizes that the consent form is only a document and is never to be confused
with the entire process of soliciting informed consent, which includes far more
than the form itself. It is possible that in some of these cases potential patient-
subjects were provided more balanced and straightforward information in
discussions with investigators or their own physicians. At the same time,
however, the consent form as approved by the IRB is a powerful symbol of what
the system considers an adequate disclosure. Moreover, this may convey to
investigators that meeting ethical obligations to potential subjects requires the
investigators to say nothing different and nothing more than what is approved on
the consent form.

- Our review also raises serious concerns about some research involving
children and adults with questionable decision-making capacity. Although we

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Chapter 15

looked at documents from only 125 proposals, we found examples of three
controversial, unresolved issues in the ethics of research: research with patients in
the midst of a potential medical emergency; research involving children that may
offer them no prospect of direct benefit but that may put them at greater than
minimal risk, depending on how minimal risk is understood; and research on
adults with questionable decision-making capacity that offers them no benefit but
that involves unpleasant procedures and exposes them to greater than minimal
risk of harm.

All told, the documents of almost half the studies reviewed by the
Committee that involved greater than minimal risk raised serious or moderate
concerns. Katz, who focused exclusively on the informed consent process, had
serious concerns about 50 percent of the greater-than-minimal-risk proposals he
evaluated. These are findings that cannot be ignored. At the same time, our
review provides evidence that research involving human subjects, even complex
research, can and often is being conducted in an ethically responsible manner.
The challenge is to identify what needs to be changed to ensure that all research
involving human subjects is conducted in accord with the highest ethical
standards.

719

ENDNOTES

1. From 1988 to 1993, the CIA approved twelve proposals for human subjects
research. However, none of these proposals involved ionizing radiation as an element of
the research design.

2. Studies performed upon human tissue were included in this definition of
radiation experiments only if a subject's exposure to ionizing radiation occurred prior to
the collection of the tissue.

3. The matrix, shown in the chapter on the Research Proposal Review Project in
a supplemental volume to this report, went through several adjustments to account for
classification errors in which research abstracts were assigned to the incorrect biomedical
category (owing largely to inadequate information in the abstracts).

4. The approach we used can be described as a modified quota sampling
methodology. Quota sampling methodology is described briefly in Earl R. Babble,
Swvey Research Methods (Belmont, Calif: Wadsworth Publishing Company, Inc.,
1973), 107-108.

5. The final radiation study sample matrix can be found in the chapter on the
Research Proposal Review Project in a supplemental volume to this report. A matrix of
these categories was constructed and a criterion was established that every cell of the
matrix be filled with no fewer than 3 and no more than 5 studies from the contemporary
period of research (fiscal years 1990 through 1993). Where there were more than 5
eligible studies per cell, a sample of 5 was randomly selected. The original target
number of studies per cell was set at between 3 and 10; studies were identified for
review according to this initial criterion. However, as the Advisory Committee
approached the end of its tenure, the sampling of radiation studies was modified slightly.
The Committee agreed that reviewing only 5 would enable the Research Proposal
Review Project to be completed in enough time for the results to be included in this
report without compromising the meaning of its findings. Accordingly, where 5 studies
had not yet been reviewed in any given cell, the number of studies needed to reach 5 was
randomly selected from those remaining.

6. Of the 225 research proposals originally chosen by the Advisory Committee,
91 were funded at 43 extramural institutions. As a number of these proposals were
deleted during the review process, however, only 32 extramural institutions were
represented in the final total sample. Although 31 extramural institutions were
represented in the radiation sample, one institution was represented only in the
nonradiation sample.

7. We originally believed that the ratio of the number of extramural to intramural
studies would be much closer to 1:1; however, this was not the case with our radiation
sample. The discrepancy can be attributed to the fact that VA studies are all intramural
and that few extramural studies are funded by DOD.

8. The final nonradiation (and radiation) study sample matrix, broken down by
funding agency, funding type, and disease, can be found in a supplemental volume.

9. The Advisory Committee received a total of 225 proposals. A number of
these proposals were eliminated from the sample because they did not fall within the
definitions (for radiation/nonradiation, biomedical category) established by the Advisor}'
Committee. Additionally, approximately 40 proposals were deleted according to the
modified sampling scheme that was conceived in order to pare down the number of

720

studies reviewed to 125.

10. Grant proposals were requested directly from the funding agencies. All
other materials for intramural studies were also requested from the respective agencies,
while other materials for extramural studies were requested from the grantee institution
performing the research.

1 1 . Contains a detailed scientific research proposal including references to
related work and relevant animal models. Descriptions of the informed consent process
and subject selection are not usually well developed in this document. When the
proposal was not available, a detailed protocol and summary of research were used in
lieu of the proposal. Intramural studies often did not include a full research proposal, but
only the IRB application, consent form, and other supporting documents.

12. May sometimes include the grant proposal, but usually contains a more
concise version of the research protocol with greater explanation of and specific attention
to the use of human subjects.

13. The consent form provides a written record of what information is provided
by the investigators to research subjects. The original and approved versions of the
consent form reviewed together give some insight into the IRB review process for the
particular research, the extent to which investigators understand the requirements for
informed consent prior to submitting their study proposal for review by the IRB, and the
IRB's required changes lo the consent form and/or process prior to the approval. In some
cases, only the consent form approved by the IRB was available.

14. Specific changes required for final approval of the proposal are often
indicated in this document. When the disposition letter could not be obtained, a record
of the IRB minutes for the meeting in which the project was approved served as a
substitute.

15. Such documentation, which generally takes the form of correspondence or
annual renewal forms, enabled the Committee to determine if, over time, there were
improvements or further problems with the consent procedures, risks and benefits, and
selection of subjects.

16. The RDRC application provides additional justification regarding the
dosages of radioactive drugs administered to subjects, which helped the Committee
assess risks to which subjects were exposed. The Advisory Committee sometimes
received a radiation safety committee (RSC) application in lieu of or in addition to the
RDRC application.

17. D. A. Henderson, University Distinguished Service Professor, The Johns
Hopkins University School of Hygiene and Public Health, to Ruth Faden, Chair,
ACHRE, 31 July 1995 ("Who would have believed . . .").

18. A more exhaustive report of the quantitative findings can be found in the
Research Proposal Review Project chapter of a supplemental volume of this report.
These findings include additional graphs of overall rating distributions according to
federal agency, biomedical category, disease, and funding type.

19. All proposals receiving an overall rating of 4 or 5 were reviewed a second
time by Advisory Committee and staff reviewers to identify the core ethical concerns
involved in each such proposal.

20. In light of the analysis that showed that inclusion/exclusion of "maybe
greater than minimal risk" studies with those studies that involved "greater than minimal
risk" did not significantly affect the proportion of studies that received each overall
rating, the Advisory Committee decided to evaluate these two groups of studies together.

721

2 1 . In correspondence with RPRP extramural institutions, the Advisory
Committee promised not to link findings in this report to any institution, investigator, or
research proposal. Where individual RPRP proposals are discussed in the final report,
no identifying information is provided.

22. The FDA approval process for the sale and use of drugs and medical devices
proceeds through four phases of testing on humans, after being tested in animal models.
In Phase I the goal is to establish the dose of a drug or treatment at which toxicity in
humans results, in an effort to establish safe levels for human use. In Phase II the goal is
to establish a therapeutically effective dose of a drug or treatment whose toxicity has
been established. Phase III is testing of a drug or treatment whose therapeutic
effectiveness has been shown, to determine its effectiveness as compared with existing
drugs or treatments, in preparation for approval and marketing. Phase IV testing is
postmarketing data collection to determine the longer term effects of the drug or
treatment in a large group of patients, over time.

23. Of the 5 studies involving children that did not require assent forms, 3
involved sixteen- to eighteen-year-olds, and 2 were follow-up studies in which children
were not actively recruited and were not likely to be subjects in the study.

24. It is important to note that the degree of professional expertise of the person
soliciting consent is often considered important to the quality of the consent process. In
some cases, consent is solicited by researchers or nurses working on the project, not by
the principal investigators themselves. Although there is controversy over whether the
influence of the investigator in the consent process is potentially coercive, many argue
that it is the responsibility of the principal investigator to make sure that the subject's
consent is informed and voluntary.

25. Institute of Medicine, Committee on the Ethical and Legal Issues Relating to
the Inclusion of Women in Clinical Studies, Women and Health Research: Ethical and
Legal Issues of Including Women in Clinical Studies (Washington, D.C.: National
Academy Press, 1994).

26. Committee member Katz initiated this independent review of research
proposals. Dr. Katz has been a scholar of the ethics of human experimentation for more
than thirty years.

27. Most of these 100 studies reviewed by Professor Katz also appeared in the
sample of studies "formally" evaluated by the review teams; however, several were cut
from the sample over the course of the review process in the interests of managing the
sample size. The studies included in Professor Katz's independent review sample that
were eliminated from the "formal" reviews were otherwise relevant to the Research
Proposal Review Project and provide additional depth to the scope of the Committee's
review of research proposals.

28. Because Katz reviewed a convenient sample of proposals in the order
received and did not apply the Committee's selection criteria, his sample included a
number of minimal-risk studies that had been eliminated from the Committee's scope of
review. It is, therefore, not surprising that there is a discrepancy between the proportion
of minimal-risk studies assessed by Katz and those assessed by the full Committee.

29. The President's Commission for the Study of Ethical Problems in Medicine
and Biomedical and Behavioral Research was chartered in 1979 to report biennially on
the adequacy and uniformity of the federal rules and policies for the protection of human
subjects in biomedical and behavioral research, as well as the adequacy and uniformity
of their implementation.

722

30. President's Commission for the Study of Ethical Problems in Medicine and
Biomedical and Behavioral Research, Implementing Human Research Regulations: The
Adequacy and Uniformity' of Federal Rules and Their Implementation, for the Protection
of Human Subjects Biennial Report No. 2 (Washington, D.C.: GPO, 1983), 2, 43.

31. The National Institutes of Health (NIH) Revitalization Act of June 1993
introduced new requirements to "ensure that women be included as subjects in each
project of [clinical] research" and "conduct or support outreach programs for the
recruitment of women and members of minority groups as subjects in projects of clinical
research." A copy of this act can be found in Institute of Medicine, Committee on the
Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies Women
and Health Research, appendix B. This report also stresses the need for the inclusion of
pregnant, women in clinical research and recommends "that NIH strongly encourage and
facilitate clinical research to advance the medical management of pre-existing medical
conditions in women who become pregnant (e.g., lupus), medical conditions of
pregnancy (e.g., gestational diabetes) and, conditions that threaten the successful course
of pregnancy (e.g., pre-term labor)." Ibid., 16.

723

16

Subject Interview Study

I,

Ln reporting to the American people what we have learned about the
current status of human subjects research, the Committee wanted to incorporate
the voices and experiences of subjects themselves. What is it like to be a subject
in biomedical research today? Why do people become research subjects, and
what does participating in research mean to them?

To provide answers to these questions, the Advisory Committee
conducted the Subject Interview Study (SIS), a descriptive study in which both
patients who were research subjects and patients who were not research subjects
were interviewed to determine whether they believed that they were participants
in medical research, their general attitudes and beliefs about medical research,
and if applicable, why they did or did not decide to participate in research. The
Committee would have liked to have heard not only from patient-subjects but also
from the many "healthy volunteers" who are critical to the success of much
biomedical research. Unfortunately, time constraints made this impossible.
Clinical research—research involving patients— does account for a large proportion
of contemporary medical research involving human subjects, however, and it was
toward this enterprise that the SIS was directed.

In this chapter, we report what patients and patient-subjects told us about
research and what we learned about their experiences. We begin by describing
the methodology of the SIS: how the patients were selected and how they were
interviewed. Next, we report the results of these interviews, as well as the results
of our review of the records of the patients to whom we talked. We close with a
discussion of the limitations and implications of the SIS.

724

Chapter 16
METHODOLOGY

The SIS included almost 1,900 patients at medical institutions across the
country. To determine whether the experiences people had with radiation
research were any different from those people had with nonradiation research, we
interviewed patients in medical oncology, radiation oncology, and cardiology
clinics. All of these patients participated in a Brief Survey (five to ten minutes).
One hundred three of these patients, all of whom reported in the Brief Survey that
they were research participants, also completed longer (roughly forty-five
minutes) In-Depth Interviews, designed to give patients an opportunity to
elaborate on their perceptions of research and their personal research experiences.
Advisory Committee staff and consultants took primary responsibility for
designing the SIS, recruiting institutions to participate in the study, conducting
some of the interviews, and analyzing the data. Research Triangle Institute, a
nonprofit organization, was hired to perform several tasks including conducting
focus groups, piloting the interview instruments, conducting the majority of
interviews, and performing most of the data entry.

Selection of Institutions

Five areas of the country were selected as sites for the SIS: Ann Arbor,
Baltimore/Washington, Dallas/San Antonio, Raleigh/Durham, and
Seattle/Tacoma. These sites were selected because they include institutions that
receive some of the highest amounts of federal dollars for human subjects
research and because we were trying to balance our sample with respect to
geographic region, rural/urban settings, and expected ethnic mix. At each of
these five sites, a university hospital, a VA hospital, and a community hospital
were selected. If other federal government or military hospitals were present at a
site, the most highly funded of these institutions were included. A total of
nineteen institutions were selected, as presented in table 1 . Interviews were
conducted at sixteen of the nineteen institutions selected. At the University of
Washington Health Services Center and the Seattle Veterans Affairs Medical
Center, the institutional review board (IRB) process could not be completed
within the time constraints of the SIS. Baylor University Medical Center declined
to participate in the study.

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Part III

Table 1. Institutions Selected for the Subject Interview Study

Ann Arbor

Ann Arbor Veterans Affairs Medical Center
1 St. Joseph's Hospital
University of Michigan Medical Center

Baltimore/Washington

Baltimore Veterans Affairs Medical Center
Clinical Center of the National Institutes of Health
Greater Baltimore Medical Center
The Johns Hopkins Hospital
Walter Reed Army Medical Center

Dallas/San Antonio

Baylor University Medical Center *

Dallas Veterans Affairs Medical Center

Parkland Memorial Hospital and the

University of Texas Southwestern Medical Center at Dallas

Wilford Hall Air Force Medical Center

Durham/Raleigh

Duke University Medical Center
Durham Veterans Affairs Medical Center
Rex Hospital

Seattle/ Tacoma

Madigan Army Medical Center

Seattle Veterans Affairs Medical Center *

Swedish Hospital

University of Washington Health Services Center *

* Interviews were not conducted at these institutions.

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Chapter 16
Recruitment of Patients

At each of the participating institutions, patients were recruited from the
waiting rooms of three outpatient departments: medical oncology, radiation
oncology, and cardiology. On the days that patients were seen in each of the
departments, a clinic staff member informed patients arriving at the clinic that a
study was being conducted to examine attitudes and beliefs about participation in
medical research. The staff member also asked patients if they were willing to
have a study interviewer approach them in the waiting room to see if they were
willing to be interviewed. Interviewers approached a systematic sample of these
patients and, following a brief description of the SIS, asked individuals to
participate.

Each patient who agreed to participate in the Brief Survey completed a
written consent form that authorized the SIS staff to consult one or more of the
following sources to ascertain whether the patient was or had been a participant in
a research project: doctors, investigators, research nurses, a research office, a
research database, and their medical/research records. The survey, composed
mostly of multiple-choice questions, was designed to take roughly five to ten
minutes to administer. Patients completing the Brief Survey received $5.00 for
their time and effort devoted to the study. All patients who indicated in the Brief
Survey that they believed they were medical research participants were asked if
they were willing to participate in an In-Depth Interview (roughly forty-five
minutes). These interviews raised many of the topics from the Brief Survey. A
sample of those who agreed to this further participation were contacted to arrange
for an interview at a time and place convenient for them. Patients completing the
In-Depth Interview received $25.00 to compensate them for their time and effort
devoted to the study as well as to pay for any expenses related to participation in
the study, such as transportation and parking.

A target of 150 Brief Surveys (50 each in medical oncology, radiation
oncology, and cardiology) was set for each institution. A target of 100 total
In-Depth Interviews was set for patients selected from all institutions. Both the
Brief Survey instrument and the In-Depth Interview guide appear in a
supplemental volume to this report. Electronic files containing the final data from
the Brief Survey and transcripts from the In-Depth Survey are maintained along
with other records of the Advisory Committee.

Data Collection and Analysis

Brief Survey

The Brief Survey instrument was refined based upon focus groups of
patients conducted at two institutions not participating in the SIS: the University
of North Carolina at Chapel Hill and Georgetown University. The instrument was

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Part III

then further refined based upon pilot testing at these same institutions. The
instrument consisted predominantly of questions with multiple-choice answers
addressing:

1 . General attitudes toward medical research.

2. Any perceived differences in understanding among the
following terms: medical research, medical study, clinical
trial, clinical investigation, and medical experiment.

3. Beliefs about research participation.

4. Reasons for either participating in research or not
participating in research (when applicable).

5. Demographic and other background information (such as
race, sex, age, and employment/insurance status).

All survey forms were labeled with an identification number for each
patient, rather than with patients' names. Data were entered into a computerized
database and analyzed using standard statistical methods.

In-Depth Interview

An In-Depth Interview guide was developed based on the focus groups
and pilot testing at the University of North Carolina at Chapel Hill and
Georgetown University. The In-Depth Interview contained open-ended questions
that allowed participants to speak more extensively about the issues addressed in
the Brief Survey. For example, patients were asked to describe their attitudes
about research generally, their own experience as research participants, how they
arrived at their decision to participate, and the informed consent process for their
particular project. All of the interviews were audiotaped and transcribed. All
cassette tapes and transcripts were labeled with an identification number for each
patient and never with patients' names. All transcripts were read in their entirety
by Advisory Committee staff members, and then data were coded and analyzed
using text analysis software.

Determination of Research Participation

To assess how well patients' reports of their participation in research
matched their documented enrollment in research projects at the participating
institutions, a mechanism for determining research participation was developed
for each institution. In each instance, we sought documentation of participation in
research from sources such as patients' medical or research records. This
information was supplemented by information from investigators and research
nurses.

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Chapter 16

A second level of review was conducted in those cases in which there was
an apparent discrepancy between a patient's own description of having been, or
not having been, a research subject and the documents or other sources of this
information. A physician or a research nurse on the Advisory Committee staff
reviewed the patient's interview, the patient's medical and research records,
institutional databases, and other sources of information at the local institution
for evidence that could either resolve or verify the discrepancy.

Expert Panel Assessments of the Research Projects

To identify some of the basic characteristics of the research projects in
which the patients we interviewed were or had been participating, we convened
an expert panel and asked this panel to make some preliminary judgments based
on the information provided in the consent forms of these research projects. The
panel consisted of eight physicians: specialists in oncology, radiation oncology,
cardiology, nuclear medicine, and radiology, as well as general internists.

We attempted to secure a copy of an unsigned consent form for every
research project in which a respondent in the SIS was a documented participant
and that had been conducted at one of the study institutions. Although 336
consent forms were requested, only 236 were received in time to be reviewed by
the expert panel.

Each consent form received was reviewed by the expert panel, which met
for one day. After agreeing how the forms would be evaluated, the panel broke
into four teams, each consisting of two physicians, one who had content area
expertise in the project being reviewed and another who did not. If a team could
not reach consensus on the evaluation of a particular consent form, it was brought
to the larger group for review. If a consent form was received after this meeting
of the panel it was sent to the panelists for review. The expert panel characterized
the research projects on three dimensions: (1) type of research (therapeutic,
diagnostic, or other); (2) degree of sickness of the population (expressed as a
high burden for those with diseases such as AIDS, a medium burden for those
with conditions such as hypertension, or a low burden for those who generally
were healthy), and (3) incremental risk assumed by those who participated in the
project compared with those who were not participating in the research project
(measured as minimal or more than minimal incremental risk).

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Part III
RESULTS

In this section, we present the results of the SIS. We begin with a
description of the demographic characteristics of the patients we interviewed, as
well as the basic characteristics of the research projects in which some of these
patients were or had been participating. We then review what we learned about
patients' general attitudes toward, and beliefs about, research and their
understanding of some of the terms commonly used to describe research to
potential subjects. This is followed by our results concerning patients'
perceptions of whether they are, or are not, participants in research and the extent
to which we were able to compare these perceptions with documents and other
sources. We then discuss what patients said about the distinctions between
research and treatment, and their reasons for deciding to participate. We also
describe the characteristics of patients who reported that they declined to be
research participants. Our discussion of results closes with what we learned from
the SIS about the consent process and issues of voluntariness of participating in
research.

Demographic Information

Brief Survey

A total of 1,882 patients completed the Brief Survey. The overall
response rate was 95 percent. Patients predominantly were Caucasian (80%),
more than sixty years old (53%), and male (59%). Other relevant demographic
features are found in table 2.

In-Depth Interview

A total of 103 patients, representing fourteen of the sixteen institutions
included in the overall study sample, were interviewed.1 This sample also was
predominantly Caucasian (74%) and male (54%) (see table 2). Due to technical
or administrative difficulties with four interviews, only ninety-nine transcripts
were available for analysis.2

Characteristics of the Research Projects

The characteristics of the projects in which patients participated are
described in table 3. The expert panel categorized the disease burden associated
with the projects reviewed as low (1 1%), medium (38%), and high (51%).
Approximately half (48%) involved minimal incremental risk from research.

730

Table 2. Demographic Characteristics of SIS Patients

Brief Survey

(N = 1882)

Percent

Sex

Male

58.7

Female

41.3

Age Category

Under 30

3.6

30 to 59

43.3

Over 59

53.1

Race/Ethnicity

African-American

16.3

Caucasian

79.7

Latino

3.9

Other

2.9

Education

Less than high school

21.5

High school graduate plus those

with additional schooling

53.7

College graduate plus those with

additional schooling

24.9

Annual Household Income

Greater than $75,000

10.9

$50,000 - $74,999

14.4

$25,000 - $49,999

28.7

Less than $25,000

41.0

Not reported

5.1

Insurance*

Private

87.2

Public

46.4

Veterans Administration

26.6

Not reported

1.4

Type of Institution

Community

37.7

VA Medical

19.7

University

28.5

Government/Military

24.1

In-Depth
Interview
(N = 103)
Percent

54.0
46.0

5.0

53.0

42.0

23.0
74.0
2.0
1.0

9.0

52.0

39.0

21.0
15.0
25.0
34.0
5.0

65.0
36.0
20.0
12.0

34.0
17.0
17.0
32.0

A detailed breakdown, in schematic format, of the procedures and results
reported in this section are found in a supplemental volume to this report.

73]

Type of Research

Patients' Re]

Report

N=,

Therapeutic

65%

Diagnostic

16%

Other

14%

Did not know

3%

Missing/Unreported

2%

Part III

Table 3. Characteristics of Research Projects

* Expert Panel

N = 236+

69%
18%
12%

N/A
1%

* Patients' Report refers to the patient's understanding of the type of research in
which they were participating. Expert Panel Report refers to the expert panel's
assessment of the type of research in which the patient was participating.

t Because of time constraints, the remaining consent forms were not reviewed.

General Attitudes Toward and Beliefs About Biomedical Research
Brief Survey

In the Brief Survey, patients were asked a series of questions concerning
their attitudes toward, and beliefs about, "medical research." Almost all the
patients had positive impressions of medical research. Specifically, 52 percent
reported a "very favorable" attitude toward research and 37 percent a "somewhat
favorable" attitude. Only 5 percent of patients described themselves as having an
unfavorable attitude. Controlling for multiple factors, the characteristics
associated with more favorable general attitudes toward research included being
older (age greater than sixty), being male, being a patient in radiation oncology
rather than cardiology, and having reported currently being or having been a
participant in research.3

More than two-thirds of the patients reported that they believed medical
research usually or always advances science. More than 80 percent of the patients
agreed that medical research does not involve unreasonable risks (86%).
Nevertheless, some patients (9%) believed that research usually or always poses
unreasonable risks to people. Controlling for multiple factors, the characteristics
associated with holding this belief included being younger, being African-
American, not having a college education, being in fair or poor general health,
and not having any experience as a research participant.4 Seven percent of
patients believed that participants in medical research are usually or always
pressured into participating. Patients more likely to believe that people are

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pressured into research were African-American and had an annual income of less
than $25,000.5

Thirty-seven percent of patients believed that patients who participate in
medical research are usually or always better off, medically, than similar patients
who are not in medical research. Patients with a more positive view about
research tended to be older, have incomes of less than $50,000 a year, and have
had some experience as a research participant.6

In-Depth Interview

In the In-Depth Interviews, patients' general attitudes about research often
seemed to be shaped by what their own research experiences had been, and
patients generally had very positive things to say about their own experiences.
Typically, they believed that the projects in which they were or had been
participants had been explained thoroughly, that they had been treated kindly, and
that they had received at least as much benefit as could have been expected.
Moreover, the more experience people had with research, the more positive was
their attitude. In addition, a few patients admitted that they had held a rather
negative impression of research until they themselves had participated, at which
time their impression changed. One respondent said, "I didn't know what to
expect. In the beginning I was worried, you know. I was a little upset, a little
frighten[ed] and everything. Once I got here, I found that the people were very
nice, very professional, and they care about their patients . . . [Y]ou think that you
are going to be a number, that they just may be cold and calculating, they['ll] just
be thinking about just the data itself and you are just a number or something. But
once I got here I found that . . . the doctors and nurses and everybody are very
concerned about the individual and you find that out because they take the time to
know your name."7 These findings are consistent with those from the Brief
Survey, in which patients who currently were, or once had been, research
participants had significantly more positive attitudes about research than those
who had never participated.

When asked for their attitudes and beliefs about medical research
generally (rather than about their own experiences), patients, again, had very
positive things to say. Research was thought of as a promising endeavor,
something that would advance knowledge and help other people: "[Research is]
the only way advancement is made in the medical field particularly. . . [I]t's gotta
be done at some point in time on human beings . . . and there are people who are
alive today because of the people [who] did research projects."8 Another
respondent strongly endorsed research activities: "Overall I have to say clinical
trials, medical experiments are the only way we're going to find any type of
results . . . because you can . . . practice on guinea pigs, monkeys, or whatever,
but the only way you're going to find out if any of these drugs are going to work
is you're going to have to do it on a human being."9 While patients articulated the
necessity of conducting research, a few reiterated the importance of looking out
for the interests of the human participants: "I think that . . . research is awfully

733

Part III

important in all fields and ... the more it involves human life the more guarded
one has to be about it."10

Terminology

Brief Survey

In the Brief Survey, patients were asked to compare the term medical
research with one of four alternative terms: clinical trial, clinical investigation,
medical study, or medical experiment. The term medical experiment evoked the
most striking and negative associations. It was the only term to be evaluated as
worse than the term medical research on all of the dimensions considered.
Specifically, patients who were asked to compare medical experiments with
medical research reported that patients in "medical experiments" were more likely
to get unproven treatments and be at greater risk than patients in "medical
research" and also that they were less likely to do better medically. By
comparison, patients thought those in "medical research" were more likely than
those in either "clinical investigations" or "clinical trials" to get unproven
treatments and to be at greater risk, but they were more likely to do better
medically. The term medical study got better ratings than the term medical
research in every respect; medical studies were viewed as less risky, as less likely
to involve unproven treatments, and as offering a greater chance at medical
benefit.

In-Depth Interview

Distinctions in meaning among different terms for biomedical research
also emerged from the In-Depth Interview. Elaborating on the findings of the
Brief Survey, the terms experiment and experimental, for the vast majority of
participants, meant that something was unproven, untested, or in the first stage of
testing and was thereby riskier and perhaps scary. Some patients said they would
become a participant in an "experiment" only if they were terminally ill. A few
participants described quite explicit images of what experiments involved: "I
envision all kinds of weird things done to the body and I assume that's not true,
but also I envision a medical experiment maybe . . . done in a laboratory sealed up
somewhere where no one even knows what [is] going on."" Another respondent
said, "Medical experiment—almost sounds like Frankenstein to me."12 When
asked to explain the term experiment, patients often invoked the term guinea pig
to convey the sentiment of being the "victim" of an experiment. For example, one
respondent, when asked to define the term medical experiment, said, "That's
where you get down to the human guinea pig . . . where they may be injecting
medication or whatever they want to inject in someone and watching them for a
reaction."13

In comparison with the term experiment, clinical trial and clinical
investigation were not such evocative terms. Some patients gave hesitant or

734

Chapter 16

stumbling definitions or said they were not familiar with these terms. On the
other hand, some patients did attach meaning to these terms, defining them as
endeavors that were at an intermediate stage of inquiry, where researchers already
know something about the topic and they are now trying the next step.

Patients were most likely to consider "study" a benign endeavor, akin to
studying something in school: "Study brings to my mind more of using
documentation for analysis. . . . With a study . . . you're looking at records. You
look at past histories and so forth. ... It is mostly paperwork, documents, or the
books and things."14

Of the four terms offered, patients usually said they would prefer to be in a
study. It was reported to be the least harmful because it was believed to be the
least invasive. In comparison to experiments, which many patients believed
involved "trying things out" on animals and/or humans, "studies," they felt,
usually entailed gathering information and reviewing paperwork.

Personal Experience With Research

Brief Survey

Thirty percent (570) of the 1,882 patients interviewed reported that they
were or had been participants in research (see table 4).15 We were able to review
records or consult other sources for 541 of these 570 cases. By these reviews, we
were able to confirm research participation in 302 of 541 cases (56%). In another
203 of the 541 cases (38%), we were unable to find documentation to suggest
whether or not the patient was participating or had participated in research. In the
remaining 36 cases, the review by health professionals on the Advisory
Committee staff concluded that these patients were probably in error and that they
were not, indeed, research participants.16 In summary, 16 percent (302 of 1,882)
of the total sample, consistent with their reports, were former or current research
participants. Also, assuming that most of the patients for whom research
participation could not be verified but, consistent with their own reports were
probably truly former or current participants (1 1%, or 203 of 1,882), then a total
of 27 percent of the Brief Survey respondents were former or current research
participants. By contrast, 2 percent of the total sample (36 of 1,882), were likely
incorrect in their perception of themselves as being participants in
research.

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Part III

Table 4. Personal Experience With Participation in Research: Results of the
Record Review*

Result of Subjects who reported Subjects who said they

record review they were in research were not in research

N = 570 N = 1,223

In research 53% (302) 5% (69)

Couldn't tell 36% (203) 2% (23)

Probably not in research 6% (36) 88% ( 1 ,080)

No record review 5% (29) 4% (5 1 )

*The numbers in this table should be interpreted in the context of the
explanation and limitations presented in the text (pages 10-12 and 21-24).

Sixty-five percent (1,223 of 1,882) of the patients interviewed reported
that they were not and never had been participants in research. We were able to
review records or consult other sources for 1,1 72 of these cases. In 23 of the
cases, relevant records were unavailable to confirm participation. In our review
of records and other sources, we did not find evidence of research participation
for 1,080 of 1,149 patients. In 69 of these 1,149 cases, however, Advisory
Committee health professional staff was able to confirm patients' participation in
research. In 61 of these 69 cases, the preliminary evidence for participation had
included an informed consent form signed by the patient for enrollment in the
research project. In summary, then, 60 percent of the total sample (1,080 of a
total of 1,882) appear never to have been research participants— in the sense that
there is no evidence to the contrary—and in another 1 percent of the sample (23
out of 1,882) it is unclear. By contrast, 4 percent (69 of 1,882) of the total sample
were apparently incorrect in believing they never had been participants in
research.

Although the Committee could not return to the 69 subjects to determine
whether the apparent discrepancy was due to true lack of awareness or perhaps to
other factors like confusion, misunderstanding of the question, or poor memory,
we did attempt to take a closer look at these cases. These 69 patients came from
all five geographic sites sampled in the SIS and were receiving care at every type
of institution participating in the study (that is, university hospitals, government
or military hospitals, Veterans Affairs medical centers, and community hospitals).
These patients were interviewed in radiation oncology, medical oncology, and

736

Chapter 16

cardiology clinics. Their ages ranged from twenty-one to eighty-nine years of
age; 30 were women and 39 were men; and the majority (53) were white (12 were
African-American and 4 were of other ethnicities). Their educational background
ranged from less than eighth grade to those with graduate or professional degrees.

The records of these 69 patients, who reported that they were not in
research but for whom evidence of research participation was found, were
subjected to extensive review and analysis by Advisory Committee health
professional staff. According to this review, about half of these patients had been
enrolled in research during the previous year.17 The consent forms of 42 of the
studies in which these patients were enrolled had been included in the sample of
consent forms reviewed by our expert panel. According to the panel, the disease
burden for those recruited for these 42 studies ranged from low (5 studies) to high
(18 studies), with the remainder being medium (19 studies). Most of these studies
involved the evaluation of treatment (23 studies), while some were diagnostic
(13) or other types of studies (5). '8 Finally, of these 42 studies, 25 were
determined by our experts as posing minimal incremental risk to subjects and 17
as posing more than minimal incremental risk.

In-Depth Interview

Patients completing the Brief Survey were recruited for the In-Depth
Interview if they reported that they currently were or once had been participants
in research. Through the review process described above, however, research
participation could not be verified for 9 of the 99 In-Depth Interview patients, nor
did the transcripts of these 9 patients suggest that they were research participants.
Two of these 9 patients told stories about research participation that were
confusing or unclear. Another 7 of the 9 seemed to believe that anything new or
unknown, or, in a few instances, any tests, were research. One such respondent,
with a rare medical condition without a known efficacious treatment, described
the interventions she received and said, "Everything is experimental, they don't
know how to cure it."|g These 9 transcripts were excluded from further analysis.

Distinctions Between Research and Medical Care

While the Brief Survey did not address distinctions between medical
treatment and research, this issue arose during the In-Depth Interview. Here,
patients' descriptions of their research experiences often included descriptions of
their physical conditions, their own health care providers, or the hospitals at
which their research projects were conducted. Research experiences, particularly
for those patients who reported being in research evaluating potential treatments,
were inextricably interwoven with their medical care experiences. One
respondent described her research experience "as a means of treating what I
have."20 Another respondent, when asked what she disliked about the project in
which she was a participant, replied: "Nothing other than the fact that nobody
likes to be sick and nobody likes to go to doctors."21

737

Part HI

While patients, if asked, were quite able to identify which procedures,
tests, and staff were associated with their research, they did not themselves
readily make distinctions between research and medical treatment. Particularly
for patients with serious medical diagnoses, research often was viewed as one of
the treatment options for their medical conditions. Not surprisingly, then, some
participants evaluated their research experience in terms of whether they believed
it would provide them with clinical benefit. One respondent noted, "I see results
that indicate that the chemotherapy that I'm taking is working, and therefore, that
is adequate enough to satisfy me."22

Despite the tendency for some patients to fuse discussions of research and
treatment, some clearly differentiated the two.23 This was especially true for
those who reported that they were in diagnostic, epidemiologic, or survey
research.24

Deciding to Participate

Brief Survey

When asked whether specific factors contributed a lot, contributed a little,
or did not contribute to their decision to participate in particular research projects,
patients typically identified multiple motivations. Most patients reported that
they had joined a research project to get better treatment (contributed a lot, 67%;
a little, 1 1%) and because being in research gave them hope (contributed a lot,
61%; a little, 18%). Patients who cited the desire for better treatment as a reason
for agreeing to be in research were more likely than other patients to be in a study
that they viewed as "therapeutic," that related to the patient's medical condition,
and that involved radiation.25

In addition to this emphasis on the possibility of better treatment and the
bolstering of hope, 135 patients agreed with the statement that they "had little
choice" but to participate and that this belief contributed a lot to their decision.
While it is difficult to ascertain precisely what these patients understood this
statement to mean, patients elaborated on this motivation in the In-Depth
interviews, often saying that because of the serious nature of their medical
condition and/or because other interventions had not been successful, they
believed they had "little choice" but to try research. Patients reporting that they
had little choice tended to categorize the projects in which they were subjects as
treatment projects (compared with diagnostic or epidemiological), tended to
report that the projects involved radiation, that they did not feel they had enough
information, and that the research was related to their medical condition.26

Altruistic reasons also played a part in many patients' decisions to
participate in research. Specifically, most patients reported that they looked at
participation as a way to help others (contributed a lot, 76%; a little, 18%) and as
a way to advance science (contributed a lot, 72%; a little, 21%). Patients also
frequently said that they had joined research projects because it seemed like a
good idea (contributed a lot, 48%; a little, 17%), the project sounded interesting

738

Chapter 16

(contributed a lot, 53%; a little, 24%), and they had no reason not to participate in
medical research (contributed a lot, 56%; a little, 15%).

In-Depth Interview

In reporting how they had decided to participate in research, In-Depth
Interview patients described many different processes, ranging from the very
deliberate weighing of risks and benefits to the quicker decision of just taking
action. Doctors (e.g., "my doctor," "the doctor," a particular doctor, or referring
physician) were frequently identified as the key agent in the respondent's decision
to participate in research.

Patients expressed a broad range of reasons they decided to participate in
biomedical research. As in the Brief Survey, for people in therapeutic research,
the primary reason for participating in research was to obtain benefits either
through an experimental treatment they hoped would be better than standard
treatment or through the closer medical attention they believed they would
receive through research. One woman reported that she was participating in a
treatment trial specifically to obtain an experimental drug that she believed
looked promising. Furthermore, she wanted to receive it in a controlled
environment where she could receive good follow-up and where researchers
would document the drug's effects.27 Another respondent commented that since
doctors at the military hospital where he received his care were very busy, he
could receive closer attention and obtain appointments more easily by enrolling in
research.2* Some patients who reported being in therapeutic research hoped that
the research would give them more "time": "[A]ll I wanted at that point was five
years to get my boys through high school";29 "I want longevity ... I don't see
myself wanting to just pass away."30 Some patients decided to be in research
because they believed that newer therapies might inherently be better: "If there's
something new on the market that might be better than the traditional program
they've been using, why not try it?"31

Mirroring the Brief Survey finding that 31 percent of patients felt they had
little choice in joining a research project, many In-Depth Interview patients who
participated in therapeutic research remarked that they had joined because they
believed they had "no choice," meaning they had no medical alternatives: "My
doctor told me if I do not take the drug, in a couple of months I . . . [will] . . . die.
So, I had no choice. Who wants to die? Nobody."32 Another respondent said, "I
had one more option as he [the doctor] put it."33 Hope and desperation pervaded
the remarks of many terminally ill patients. Patients said they wanted to "try
anything" or that this was their "last resort." One man explained, "Well, what was
driving me to say 'yes' was the hope that this drug would work. . . . When you
reach that stage . . . and somebody offered that something that could probably
save you, you sort of make a grab of it, and that's what I did."34 This same patient
noted that he had first declined what he had considered a very aggressive therapy,
"because at that point everything was pretty okay and there was no need for me to

739

Part III

do any wild things."35 Later, when his condition worsened, he decided to
participate in the research.

One of the most influential forces in patients' decisions to enroll was
doctors' recommendations. One patient described the process of her enrollment:
"He [the doctor] asked me if I wanted to go on it, and I said, 'If it's what you
think I should do, yes, because you know more about it than I do.' . . . [H]e said, 'I
think it would be a good idea to try it.'"36

Along these lines, a theme of trust overwhelmingly emerged. Patients
trusted specific physicians, medical professionals more generally, or the overall
research enterprise. Trust in specific physicians was straightforward: "Basically,
y[ou] know, we trust Dr. [So-and-so] . . . [There] was no reason to, . . . get a
second opinion from another doctor."37 Another respondent exclaimed "Oh, I
love that man. He has kept me alive and I obey him and I do what he tells me

to do. . . ."38 Some patients also communicated trust in the medical profession
more generally: "I have this attitude. They know what they're doing. They
wouldn't have you to do this if they didn't know what they were doing and . . .
that's my attitude. . . ."3<) Finally, there were a few patients who expressed trust in
the overall enterprise of medical research as well as its oversight. One respondent
stated: "I do not feel like the drug would be on the market if it were going to harm
me, and if it would help in any way . . . I'm very willing to participate in this and
perhaps other studies."40 Related were patients who said they decided to
participate because of their trust in the institution where the research was being
conducted. "I think I've got the best treatment down there [named hospital]. I
don't think I could get any better."41 Rare were the patients who had less "blind
trust" and considered themselves to be more of a consumer: "I sort of take my
own treatment in my head and tell them that I'm his client. It's not the other way
around. . . ,"42

Elaborating on responses to the Brief Survey, the majority of patients
mentioned altruism as a reason to participate. This desire to help others took
many forms, including helping others who had the same medical condition,
advancing medical science more broadly, and contributing to society. Most
frequently, those in therapeutic research seemed to voice a combined motivation
of seeking benefit for themselves and hoping to achieve benefit for others. Very
representative was the comment, "I was hoping, if not for me, at least for the next
people coming along. . . ,"43

For some patients who faced a life-threatening illness, participating in
research seemed to offer them a greater sense of personal worth, a chance to
contribute something of value to society. One woman said, "[I]f I can help find a
cure for what seems to be so common [that is, cancer] these days, I would love to
think I was part of finding that cure."44 For a small number of patients, this notion
of helping others went further, to be a duty or obligation: "[I thought], well, I
don't have to do this, and then I thought, well, here I am benefiting from literally
thousands and thousands of experiments that have gone before and that are
helping to save my life and this one sounded [very] reasonable to me and I was
happy to participate."45 Similarly, one respondent replied, "I feel like that

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Chapter 16

[participating in research and giving blood] is a moral obligation as a citizen.

You put back into your community [Opportunities to not only help yourself

but other people are real important to me "46 ^

Only three patients cited monetary reasons for participating in research.

Deciding Not to Participate

It is also clear from the Brief Survey that not all patients approached to
participate in a research project agree to do so. In fact, 191 (10%) of the 1,882
patients we spoke with told us that at some point they had made a decision not to
participate in research. While 112 (59%) of these 191 patients had never decided
to be in research, the remainder reported that at some time or other they had (39
were current research participants, and 40 were former research participants),
suggesting that some patients discriminate between projects they are willing to
participate in and those they are not. Patients who declined to participate in
research ranged in age from twenty-one to eighty-three, with a median age of
fifty-six. The patients were of both genders (53% male, 47% female),
predominantly white (69%, with 27% African-American and the remainder being
of other ethnicities), with wide educational backgrounds ranging from less than
eighth grade to those with professional degrees.

We asked the 1 12 patients who had never been in research why, when
they had been offered the chance, they had decided not to participate. The
reasons that "contributed a lot" to their decision were that they wanted to know
what treatment they were getting (64%); they wanted their medical decisions to
be made by their doctors and themselves, not by researchers (56%); they believed
that being in the medical research project was not the best way for them to get
better (45%); and taking part in the medical research project would have been
inconvenient (43%).

Consent and Voluntariness

Brief Survey

Overall, 83 percent of patients who told us they were current or former
research participants remembered signing a consent form agreeing to take part in
research. This was true for 88 percent of current research participants and 80
percent of former research participants. Most (90%) of the patients who believed
that they were current or former participants in research reported that they felt
they had enough information to make a good decision about whether to
participate. This was the case for 95 percent of current research participants and
87 percent of former research participants.

Fewer than 2 percent of current or former research participants felt
pressured by others in making a decision to participate. Six patients specifically
said that they had been pressured by someone in the medical field (e.g., "my

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doctor"; "the hospital"); four patients reported having been pressured by someone
in the military (e.g., "the military"; "Admiral on ship").

When patient-subjects were asked what they thought the policy was for
dropping out of the study in which they were participating, 78 percent thought,
correctly according to current research standards, that they could drop out at any
time. A variety of other responses were also offered, ranging from not knowing
the policy, to expressing that it was irrelevant (e.g., the entire project consisted of
a single survey or blood test), to believing they had to stay in the research project.

In-Depth Interview

On the whole, patients who granted In-Depth Interviews recounted that
the staff involved in conducting research explained research projects, gave
participants time to read over the consent forms and confer with family and
friends, and responded to participants' questions. One patient said explicitly, "It
seemed to me that they were well prepared to answer any questions I would ask
them."48 Asked if research staff had provided her with as much information as
she needed, one patient replied that they used "terminology . . . that I could relate
to. They spoke in my language. That was a plus."49

The consent process, in general, and the consent form, in particular, held
varying degrees of importance for patients. Most patients enrolled in survey or
noninvasive projects did not attach a great deal of meaning to the consent form.
One respondent, whose experimental procedure consisted of "just drawing some
blood," thought, in fact, that his consent form went overboard.50 For those
patients who reported being in research evaluating potential treatments, the value
of the consent form varied. For many, the decision to participate seemed to have
been made before the consent form was given to them, and they signed it almost
as a formality. For a few, signing a consent form symbolized the first step on the
path to getting better. Others, however, relied heavily upon the content of the
form when deliberating about whether to participate. In addition, several patients
noted that they held on to their consent forms, a few even offering them up for the
interviewers' review.

The notion of trust also accompanied accounts of the consent process. For
some participants, the consent form was the means by which patients could
authorize trusted health professionals to do what they think is best. One
respondent remarked, "[W]hatever the doctor was doing, well, that was all right. I
consented to this and let the experts take over then."51 This authorization for
treatment meant abdicating attention to detail for some patients: "I'm the type of
person, I don't read all this fine print and all this stuff and so forth. The lady said
that we would like to experiment on your body to see what can be done . . . and
it's to help me and so far, so good. . . . "52

While patients attached different levels of personal interest to the consent
process, they were clear that the type of information typically conveyed in a
consent process is exactly what they would need in order to decide about
participating in research jn the future. Patients overwhelmingly said that they

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would participate in a research project again if they had enough information and
if the project were explained in sufficient detail by research staff: "I'd have to
know the what fors, ifs, whys, what they're gonna do. . . ."53 Or, "if somebody
can't explain what they're going to do to me good enough, I wouldn't [do] it."54
Furthermore, several patients stated that they would like to know why a particular
study was being conducted and why certain procedures or techniques were
necessary. "Communication," "information," and "honesty" were frequently
identified by participants as essential in considering participation in any future
research project.

For patients who described their own consent process, experiences
generally were positive. A few patients reported problems, however. Three
general problems were identified: ( 1 ) too much technical information that was
difficult to read and understand,55 (2) an overwhelming amount of information,56
and (3) discussions occurring at stressful or inappropriate moments.57 A few
patients reported that during discussions with physicians or investigators they
relied upon family members to help process the information conveyed.58

A few patients remarked upon the importance of contact among
participants in research projects evaluating treatments. One respondent contrasted
the type of information one research participant can provide to another versus that
which a doctor can provide: "[It's] always nice to be able to . . . see somebody in
the same boat or talk to [that person]. . . . because even though a doctor is very
good in explaining thing[s]. . . . there are certain things that . . . only somebody
who's going through the thing can really know what you're talking about."59

Consistent with findings from the Brief Survey in which 98 percent of
patients reported that they were not pressured into participating in research, almost
all the patients who gave In-Depth Interviews believed that the decision about
whether to participate in research had been theirs to make and that they had not
felt pressured into that decision. Indeed, many patients mentioned that they
participated "voluntarily." One respondent said, "They wanted to know if I would
be interested in this. Nobody was pushy. Nobody, they just said, 'Here it is,
would you like to be involved in this program[?]"'60 No one interviewed identified
pressure from family members. More often, patients remarked that while they
conferred with families and friends, the choice was ultimately their own: "My
family. The people I work with . . . [E]verybody tells you you have to make up
your own mind. . . . [Njobody's going to tell you what to do because it wouldn't
work anyway. So nobody tried to influence me one way or the other. . . ."6I

There were only a few patients who suggested that doctors tried to exert
what was viewed as unwelcome or inappropriate influence. One respondent, who
remarked in one portion of the transcript that she did not feel pressured, later
reported, "[The doctor] sorta made a plug. He said, 'you know, if people like you
refuse to get into this . . . we're never going to get anywhere.'"62 Another
respondent indicated that he felt pushed by one doctor to sign a consent form for a
particular type of infusion treatment. "[T]hey say, well ... go ahead and sign
it ... so we can . . . start you on the process, and I said, well, I want to read

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it. . . . And he said, have you signed it yet? And I said, 'I haven't read it yet. Oh,
okay, well ... we need you to sign it and then . . . make a copy and we'll just let
you read it afterwards and I thought, what is going on? I mean, they had never
ever kind of pushed it like that."63

Almost all patients reported that they had been told they could leave the
research project at any time and that they believed that they could leave at any
time. One respondent said, "[T]hey always told us all the way along, anytime you
don't feel happy with this, we can quit . . . they said if you don't feel like you want
to continue, you can quit anytime. There was no pressure on or nothing. . . ."64
Similarly, "[I]t was made very clear up front[,] and then in the original package of
material that they had, at any point in time for any reason in time any reason I
wanted, you know, I didn't even have to have a reason, I could withdraw with no
problem."65 For some participants, the question of withdrawing seemed almost
foreign because there was such trust in the research process. One respondent
said, "[The thought of withdrawing] never entered my mind. I was going to let
them make the decision because they were the ones that were watching the
cancer. ... I wasn't the expert. If they thought it was working, that was fine."66
One respondent who was in the military believed that continued participation was
required.67 Another respondent, about to undergo a bone marrow transplant,
reported being pressured both to enroll and to continue participation in a clinical
trial. "They were really pushing this procedure [a drug to help raise white blood
cell counts]. ... It was very obvious to me that they wanted people to sign up for
this bad, and I did not want to upset my doctor. . . . Y'know I'm totally helpless.
I'm in his hands and, so part of it was, I wanted to keep him happy and, uh, there
was some pressure."61*

As described earlier, several patients in therapeutic research identified an
intense desire to have some type of treatment. This not only influenced their
decision to enroll, but also to remain in a research project. One respondent stated
that participating in research "was through necessity. . . . [T]he thought never
entered my mind that I would withdraw from this program."69 Such sentiments
also seemed to influence patients' desires to find research projects for which they
might be eligible. "I said if something comes up that you think will benefit me,
let me know ... I wanted to be on that trial bad enough to where I gave [in to] the
pressure."70

DISCUSSION

Limitations

Although we were able to involve different types of hospitals from five
different areas across the country in this study, only sixteen hospitals were
included in our sample. We have no way of knowing whether our findings would
have been different if we had interviewed individuals at other hospitals.
Similarly, we interviewed only medical oncology, radiation oncology, and

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cardiology patients who were not hospitalized but were receiving their care at
outpatient clinics. Most of them were white, and many were more than sixty
years of age. It is quite possible that other types of patients would have answered
some questions differently from our patients and that healthy research subjects
might have had different attitudes, beliefs, or motivations for participation than
patients likely to have serious illnesses did. In the In-Depth Interview component
of the study, only people who believed they were or had been research
participants were included. The responses of people who had chosen not to
participate in research, presumably, would be quite different. It should not be
assumed, therefore, that our findings necessarily apply to the entire research
enterprise.

An important research question in this project was the degree to which
present-day patients know whether or not they are research participants. To
answer this question, we interviewed patients and asked them whether they
believed they were, or had been, participants in research, and then, with their
permission, we checked their records for evidence of research participation.
Although this approach provides an estimate of the degree to which present-day
patients know or remember if they are research subjects, this estimate is likely to
be very rough for two sets of reasons. First, interviewing patients in the way we
did may not be the most accurate way of gauging their own understanding of
participation in research. This is because they were often approached in a busy
clinic setting by an interviewer they did not know. It is also likely that these
patients were under stress at the time of the interview, either because of their
upcoming appointment with their doctors or because of the very illnesses that
brought them to the clinic. In addition, because of necessity the Brief Survey was
designed to take only five to ten minutes to complete; we asked patients only
about current or former research participation with single questions, rather than a
series of questions designed to more completely capture those patients who had
experience with research. Moreover, following our review of the medical and
research records we did not go back to patients and ask them questions about
research once we had an understanding of their medical history and documented
research experience.

Second, despite significant attempts to gather information from multiple
sources, the method of abstracting medical and research records we used may not
have been comprehensive enough to locate all relevant evidence of research
participation (e.g., records of research may not be retained at the same institution
in which the Brief Survey was conducted, or research participation may have been
in the distant past and records may no longer be available). A related problem is
that some patients may have been enrolled in studies that purposely do not keep
records of participation (e.g., studies where confidentiality is paramount).
Finally, while trained abstractors examined records for all patients, health
professionals on the Advisory Committee staff only reviewed records where
patients' responses differed from the results of the initial records review
conducted by the trained abstractors. Health professionals had only a one- to two-
day window to perform this confirmatory search of documentation at each

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institution and thus were not always able to review relevant records because they
were unavailable on short notice. Because of these reasons, we do not know the
degree to which our estimates are accurate regarding the proportion of patients
whose responses about research participation differed from what we found in
records.

Implications

A striking finding from this study is the frequency with which people with
cancer and heart disease appear to come in contact with biomedical research in
the course of their medical care. Notably, nearly 40 percent of the patients we
talked with either believed they were or had been subjects in research, had records
that showed that they were, or had reported that they had been offered the
opportunity to be in research but had declined. Moreover, most patients thought
that medical research was a good thing. They had favorable attitudes toward
medical research generally, they believed that research did not involve
unreasonable risks, and they believed that medical research usually or always
advances science. Patients who are or had been participants in research had even
more positive attitudes about research than those who had not.

There was evidence in this study that many patients feel free to refuse
when physicians and researchers ask them to become research subjects. Nearly
200 patients told us that they had been offered an opportunity to participate, but
had declined. Moreover, 40 percent of these patients had chosen at some other
time to participate in research, indicating that at least some patients are
discriminating in terms of the circumstances under which they are willing to
participate in research. There also was little evidence that patients felt coerced or
manipulated by health care providers or scientific investigators to participate in
research. When we asked patients who were subjects if they had felt pressured by
others into becoming research participants, these patient-subjects overwhelmingly
said no. Not only did they give the impression that the initial decision to enter a
research project was theirs, but many also informed us that they had been told
frequently by the investigators that they could drop out of the study at any point,
and the patients believed that this was so.

Although the vast majority of both African-American and white patients
held favorable beliefs about research, such beliefs were held less often by patients
who are African-American. Specifically, as compared with white patients,
African-American patients were more likely to believe that people are pressured
into research and more likely to believe that research poses unreasonable risks.
These findings together suggest that for a small number of patients, distrust as a
result of the troubled historical experience of African- Americans in research, as
exemplified by the Tuskegee syphilis study, may persist.

We learned a great deal from this project about why patients choose to be
in research. The overwhelming majority of the patients we interviewed who were
participants in research were subjects in studies investigating medical treatments.
Almost all of these patients said that they had enrolled in research because they

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thought it offered them their best chance of personal medical benefit. Moreover,
for many of them, their doctors had recommended it. Often these patients had
very serious illnesses and had tried many treatments unsuccessfully; the
opportunity to be in research offered them hope that improvement might still be
possible. Many of these patients specifically said that they had "no choice" but to
participate. They had tried everything else to improve their condition, and
nothing else had worked. These patients felt constrained to participate because of
their medical situation, not by their providers or the research investigators.

Not surprisingly, then, when asked to describe the research project they
were in, most of the patient-subjects we talked with described the project as part
of their therapy. Although, when asked, these patients appeared to clearly
understand which interventions were associated specifically with the research,
they also conceived of the research as their medical treatment. And despite the
recognition by most of these patients that the goal of the enterprise of medical
research generally was to advance science, when asked about their own specific
project, they often believed that the project would benefit them.

It is likely that in some, and perhaps in many, of these cases, it was indeed
in the patient's medical best interest to be enrolled in a research project. As
demonstrated by the recent push for access to investigational drugs on the part of
people with HIV infection and other serious illnesses where there may seem to be
no truly efficacious standard therapies, many patients believe that their best
chance of extending life is to take treatments that are still experimental. In some
cases, patient-subjects were participating in treatment studies involving agents
available only through research because their illnesses may have had no known
efficacious treatments. From the perspective that holds extending life to be the
primary concern, it would be in the patients' best interests to be in the research.

It is a separate issue whether participation in research is in a patient's
overall best interests. Investigational interventions for devastating, life-
threatening illnesses may be a patient's best chance— however small—of extending
life. However, this chance may be at the expense of the person's ability to
function and enjoy life for the time affected by participation in the research.
Furthermore, the history of experimentation demonstrates that such therapies
might also shorten life rather than extend it. Unfortunately, we did not pursue
whether these sorts of trade-offs were clearly understood by the patient-subjects
we interviewed. In chapter 15, we report some data from the RPRP that bear on
this question.

That patients viewed their participation as being in their best interests is
consistent with patients' profound trust in their physicians, on whom they depend
as their lifelines, and who they could not imagine offering something not in their
best interests. We heard from several patients the belief that their doctors are the
experts and that they know best what would be helpful. If a doctor recommended
or even offered research, patients were certainly more inclined to decide to
participate. The trust that patients placed in their physicians often was
generalized to the medical and research community as a whole. Patient-subjects
frequently expressed the belief that an intervention would not even be offered if it

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did not carry some promise of benefit; many certainly assumed that the
intervention would not be offered if it posed significant risks.

It was largely because of this trust that most patient-subjects considered
the consent process somewhat incidental to their decision to participate in
research. When asked, almost all patients reported that they had been provided
with information, their questions had been answered, and they had been satisfied
with the consent process. Nevertheless, doctors' recommendations and patients'
own beliefs that the research was their best chance or even their only hope made
the research an obvious decision for many patients, and the consent process and
consent form were viewed as somewhat of a formality.

This framing of research as therapy is consistent with the very language
used to describe research projects. We learned that patients attach very different
meanings to the different terms associated with medical research. Experiments
are considered by patients to involve unproven treatments of greater risk, often
invoking the image of human beings as "guinea pigs," while terms such as
clinical investigation or study convey less uncertainty to patients and a greater
chance of personal benefit.

The design of this study does not allow us to assess whether patients'
expectations of benefit from their therapeutic trials were appropriate for the
particular studies in which they were enrolled, or whether their expectations were
exaggerated or unrealistic. Moreover, if patients' expectations were exaggerated
in some way, we have no evidence to discern whether patients overestimated the
expected benefit themselves or whether it was investigators who suggested that
the research held more promise than was warranted. It is understandable that
patients with poor prognoses may read hope into even the slimmest possibility of
benefit. It also is understandable that some physicians, uncomfortable with
having little to offer their seriously ill patients, might at such times inadvertently
impart more hope than the clinical facts, strictly speaking, warrant.

Hope is a delicate and precious commodity for those with life-threatening
illnesses. For clinicians, the balance between support of that hope and honesty is
often difficult. At the same time, however, there is a world of moral difference
between a physician emphasizing— even inappropriately—slim chances, in order to
bolster waning hope, and a physician emphasizing slim chances in order to meet a
recruitment goal for a clinical investigation. Feeding hope at the expense of
candor is one thing; exploiting the desperation of those whose lives hang in the
balance is another. Here again, our data are silent. We cannot know, insofar as
physicians contributed to unrealistic expectations among these patient-subjects,
how often this was the result of well-meaning reassurances or self-interested
misrepresentations.

It seems very much related that we found that a small proportion of
patients believed they were subjects in research when it appeared they were not,
and other patients believed they were not research subjects when records
suggested that they were. These confusions about whether a patient was in
research occurred almost exclusively when patients were in (or thought they were
in) research investigating potential therapeutic interventions. However, we found

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that these patients covered the full range in terms of education, income, sex, and
race; they came from all three medical specialties studied and all types of
hospitals.

At least three-quarters of the patients who apparently were mistaken when
they reported they were not research subjects had actually signed consent forms
authorizing participation in research. In addition to the limitations of our methods
described earlier in the chapter, we can only speculate as to why the discrepancy
exists between patients' perceptions and their records. Some patients may not
have understood our question and may in fact have known they were research
subjects all along. Other patients may not have understood what they were doing
when they signed the consent form, perhaps believing that it was a consent for
treatment. Still other patients may have had an adequate understanding that they
were consenting to participate in research at the time they signed the form and
then later forgot. This last explanation is not as troubling as the second, in that it
suggests the possibility that in at least some cases valid consents were initially
obtained, but it does raise questions about the meaningfulness of these patients'
rights to withdraw from research. Such questions are obviously more meaningful
in ongoing projects that involve continuing exposure to potential risk, in contrast
to those studies where research participation is less burdensome, such as studies
involving routine follow-up or only a minor change in a regular therapeutic
regimen.

It is often the case in clinical research that the participation of ill people in
research and the medical treatment they receive for their illnesses are identical.
When this occurs, it is not surprising that some patients conflate their being in
research with therapy to the point that they no longer understand or remember
that they actually are in a research project. Ironically, it may be especially when
patient-subjects feel well cared for that they are most likely to feel like a patient
only, and not like a research subject. At the same time, many patient-subjects
told us of being reminded by research staff that they could leave the project at any
time for any reason. It seems doubtful that the patients we interviewed whose
self-report of participation was not consistent with research records had such an
experience.

Although most of the patients we interviewed listed a chance at medical
benefit as a reason for participating in research, many patients also said that they
had participated in research to help others. Some patients described the
willingness to participate in research as a civic duty; others wanted to help
members of their own families at risk for the same conditions, and still others saw
being in research as a means of making a shortened life expectancy more
meaningful. Participants in survey research and similar research projects were
especially likely to say that they had joined in part because there was no reason
not to do so, but also because they hoped they could help others or advance
science by doing so. Several patients in therapeutic research who appreciated that
there was only a slim chance that the research would provide them with personal
benefit, offered that, as a result of their participation, they hoped at least that
someone down the road would be better off, if not themselves. This willingness

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of patients to be altruistic should be tapped explicitly when recruiting participants
for research, since it might help to underscore for patients that the primary
objective of research is to create generalizable scientific knowledge rather than
simply to offer them a chance for some medical benefit. In the end, it is only the
benefit of furthering knowledge that can be honestly guaranteed to a potential
research subject.

750

ENDNOTES

1 . Because of time constraints, no In-Depth Interviews were conducted with
patients from the University of Michigan or the Baltimore VA Medical Center.

2. One audiotape of poor quality was never transcribed. Transcripts for three
patients who stated clearly during the In-Depth Interview that they had never participated
in research and who were inappropriately selected were also excluded.

3. All models were developed using multiple logistic regression, and the results
are reported here as the baseline probability of a given response along with the
approximate absolute difference due to a given factor. Each factor either adds to or
subtracts from this baseline probability. Note that the baseline probability used in the
models is not equal to the overall probability of corresponding response reported in the
text. It is only a "baseline" within the context of these models.

4. Baseline probability of saying that medical research usually or always
involves unreasonable risks was 19%; Age > 60, -6%; African-American. +1 1%; College
degree, -6%; Good health, -8%; Research participant, -6%.

5. Baseline probability of feeling that potential subjects are usually or always
pressured was 5%; African-American, +9%; Income=$25,000-$50,000, -2%; and Income
> $50,000, -3%.

6. Baseline probability or saying those in research usually or always do better
was 31%; Age > 60, +7%; Income > $50,000, -8%; Research experience, +9%.

7. Subject No. 335216-8, interview by Subject Interview Study staff (ACHRE),
transcript of audio recording, 27 March 1995, lines 40-43, 170-175 (Research Project
Series, Subject Interview Study).

8. Subject No. 551334-6, interview by Subject Interview Study staff (ACHRE),
transcript of audio recording, 14 March 1995, lines 706-714 (Research Project Series,
Subject Interview Study).

9. Subject No. 335213-5, interview by Subject Interview Study staff (ACHRE),
transcript of audio recording, 28 March 1995, lines 1663-1668 (Research Project Series,
Subject Interview Study).

1 0. Subject No. 442 1 07-9, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 29 March 1995, lines 458-460 (Research Project
Series, Subject Interview Study).

1 1 . Subject No. 552106-7, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 14 March 1995, lines 311-315 (Research Project
Series, Subject Interview Study).

12. Subject No. 442107-9, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 29 March 1995, line 432 (Research Project
Series, Subject Interview Study).

13. Subject No. 333208-7, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 6 March 1995, lines 745-748 (Research Project
Series, Subject Interview Study).

14. Subject No. 333256-6, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 16 March 1995, lines 361-366 (Research Project
Series, Subject Interview Study).

15. A detailed breakdown, in schematic format, of the procedures and results
reported in this section is found in a supplemental volume to this report.

1 6. A variety of reasons suggested that although patients reported that they
were research participants, review of their medical records suggested that they were not.

751

For instance, in comparing patients' self-reports with their records, what they had called
"research" actually was standard clinical care that they were receiving.

1 7. Data for this analysis were available for 54 of 69 individuals with discordant
responses: 54% had enrolled after 1 January 1994; 65% after 1 January 1993; and 72%
after 1 January 1 99 1 .

1 8. Data regarding type classification are missing for one study in this group.

19. Subject No. 552212-3, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 13 March 1995, lines 34-35 (Research Project
Series, Subject Interview Study).

20. Subject No. 335227-5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 24 March 1995, lines 226-227 (Research Project
Series, Subject Interview Study).

2 1 . Subject No. 552 1 26-5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 13 March 1995, lines 186-187 (Research Project
Series, Subject Interview Study).

22. Subject No. 221202-5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 14 March 1995, lines 403-405 (Research Project
Series, Subject Interview Study).

23. One respondent remarked, "Wouldn't it be great" if this particular protocol
"that treats you for [a] shorter period of time [with] high doses of chemotherapy" proved
as beneficial as treatment over "years and years" (Subject No. 335215-0, interview by
Subject Interview Study staff [ACHRE], transcript of audio recording, 24 March 1995,
lines 536-539 [Research Project Series, Subject Interview Study]). It was clear that this
respondent conceptualized research as an endeavor aimed at increasing knowledge about
unproven interventions, rather than understanding research as a form of medical care.

24. Research experience for these patients tended to be described more
dispassionately as a one-time event that stood apart from their therapeutic needs. Indeed,
the patients tended to minimize the effect that the research experience had for them
personally: deciding to join required little deliberation, and participating required little
effort. One respondent made it clear repeatedly that her research experience was "just"
an interview (Subject No. 334148-4, interview by Subject Interview Study staff
[ACHRE], transcript of audio recording, 3 March 1995, lines 73, 105, 143-144 [Research
Project Series, Subject Interview Study]). A respondent who participated in survey
research agreed out of a willingness to help: "If I can help on anything, I want to be able
to do it ... . 'course my wife thinks if we can help in any research, we're both willing to
do it" (Subject No. 443321-5, interview by Subject Interview Study staff [ACHRE],
transcript of audio recording, lines 108-109, 125-126 [Research Project Series, Subject
Interview Study]). Finally, in notes kept by interviewers and in debriefing sessions with
interviewers, interviewers reported that most patients who had participated in survey
research simply did not have a lot to say compared with other patients.

25. Groups for which there was marginal statistical evidence for increased
frequency for this belief were African- Americans (versus Caucasians) and those who
were retired or unemployed. In this model, the baseline probability of contributing a lot
to the decision was 13%; Treatment study +27%; Involved radiation 13%; African-
American +8%, Employed -5%; and Research related to condition +20%.

26. Baseline probability of contributing a lot to their decision was 1 1%;
Treatment study +10%; Radiation +6%; Had enough information 7%; Research related to
condition +25%.

27. Subject No. 33521 5-0, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 24 March 1995, lines 1 1-72 (Research Project
Series, Subject Interview Study).

752

28. Subject No. 553 1 09-0, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 10 March 1995, lines 252-269 (Research Project
Series, Subject Interview Study).

29. Subject No. 441227-6, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 10 March 1995, lines 542-544 (Research Project
Series, Subject Interview Study).

30. Subject No. 22 1 202-5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 14 March 1995, lines 350-352 (Research Project
Series, Subject Interview Study).

3 1 . Subject No. 333208-7, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 6 March 1995, lines 30-32 (Research Project
Series, Subject Interview Study).

32. Subject No. 3332 1 5-2, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 3 March 1995, lines 194-195 (Research Project
Series, Subject Interview Study).

33. Subject No. 1 14229-8, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 14 March 1995, line 1 19 (Research Project
Series, Subject Interview Study).

34. Subject No. 332250-0, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 28 March 1995, lines 105-109 (Research Project
Series, Subject Interview Study).

35. Subject No. 332250-0, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 28 March 1995, lines 208-210, 188-193
(Research Project Series, Subject Interview Study).

36. Subject No. 552264-4, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, March 1995, lines 432-434 (Research Project
Series, Subject Interview Study).

37. Subject No. 1 14229-8, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 14 March 1995, lines 194-198 (Research Project
Series, Subject Interview Study).

38. Subject No. 1 14217-3, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 10 March 1995, lines 50-51 (Research Project
Series, Subject Interview Study). A powerful instance of the finding of trust in
physicians' recommendations and requests was the participant who said, "He [a
physician] asked me would I do it and I told him, 'Yeah.' I didn't think that he would
harm me [in] any kind of way, hurt me in any kind of way, so I told him, 'Yeah.' He
couldn't get I don't believe . . . anybody else to do it" (Subject No. 44 1 3 1 1 -8, interview
by Subject Interview Study staff [ACHRE], transcript of audio recording, 28 March
1995, lines 155-158 [Research Project Series, Subject Interview Study]).

39. Subject No. 332324-3, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 24 March 1995, lines 309-31 1 (Research Project
Series, Subject Interview Study). Another reported, "There's not a lot that you can
control when you're sick so you have to rely on your doctor ... if he suggests that you
should go into a research project, I think you should really take his advice or her advice,
whatever it may be . . .[B]ecause if you take the time to get yourself a good doctor and
they're involved in research, they would never steer you wrong" (Subject No. 552244-6,
interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 5
March 1995, lines 617-675 [Research Project Series, Subject Interview Study]).

40. Subject No. 44324 1 -5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 2 March 1995, lines 67-70 (Research Project
Series, Subject Interview Study).

753

41. Subject No. 333208-7, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 6 March 1995, lines 381-383 (Research Project
Series, Subject Interview Study).

42. Subject No. 552143-0, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 15 March 1995, lines 327-329 (Research Project
Series, Subject Interview Study).

43. Subject No. 223212-2, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 16 March 1995, lines 233-234 (Research Project
Series, Subject Interview Study). A few patients had very specific others in mind. One
respondent, for instance, enrolled in a genetic study of colon cancer, said, "Because if it's
hereditary and it sure seems [so] in my situation ... I'm concerned about my daughter.
I'm concerned about her kids, and [it] goes on and on and on ... " (Subject No. 221240-
5, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 15
March 1995, lines 334-337 [Research Project Series, Subject Interview Study]). As
patients became sicker, altruism played a larger note for some. For example, one
respondent explained that over the course of his disease and enrollment in numerous
research projects, his reasons for participating in research had become more altruistic:
"[I]t will never cure me . . . I'll be dead in the next couple of years . . . but if they can find
something that can save someone else [I'll be happy] . . . [W]hen you first go in . . . you're
kind of dealing with whatever . . . disease you're dealing with. . . . There's this hope factor
that's there, that you think, 'Well, maybe this is going to work. Maybe I'm going to—it's
going to help me. . . .' [But now] I don't have the expectations that ... I did . . . seven or
eight years ago ... I'm realistic. It might help. It might not. But, you know, they're
going to find out something that's going ... to help somebody else and you have to think
of it that way" (Subject No. 335213-5, interview by Subject Interview Study staff
[ACHRE], transcript of audio recording, 28 March 1995, lines 598-600, 1234-1238,
1294-1299 [Research Project Series, Subject Interview Study]).

44. Subject No. 443252-2, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 1 March 1995, lines 198-200 (Research Project
Series, Subject Interview Study).

45. Subject No. 442107-9, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 29 March 1995, lines 120-124 (Research Project
Series, Subject Interview Study).

46. Subject No. 443218-3, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 24 February 1995, lines 545-553 (Research
Project Series, Subject Interview Study).

47. Only one respondent noted that he participated simply because he wanted
the money that was being paid to participants in his research project (Subject No.

551 145-6, interview by Subject Interview Study staff [ACHRE], transcript of audio
recording, 1 1 March 1995, line 60 [Research Project Series, Subject Interview Study]).
Another respondent with breast cancer stated plainly that she, as someone without health
insurance, had enrolled in research to get treatment and "didn't have to worry about trying
to pay something back later on" (Subject No. 335216-8, interview by Subject Interview
Study staff [ACHRE], transcript of audio recording, 27 March 1995, lines 30-33
[Research Project Series, Subject Interview Study]).

48. Subject No. 335227-5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 24 March 1995, lines 47-48 (Research Project
Series, Subject Interview Study).

49. Subject No. 333256-6, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 16 March 1995, lines 332-333 (Research Project
Series, Subject Interview Study).

754

50. Subject No. 221240-5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 15 March 1995, lines 359-370 (Research Project
Series, Subject Interview Study).

5 1 . Subject No. 333208-7, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 6 March 1995, lines 407-409 (Research Project
Series, Subject Interview Study). Another respondent had a similar response: "[T]o me
they are the doctors and once I had gotten those doctors and I trusted them. It was pretty
much up them. I wanted to know what I was going to be going through as far as what to
expect . . . physically . . . [b]ut a lot of the little nitty-gritty detail, I did not even want to
know" (Subject No. 1 14250-4, interview by Subject Interview Study staff [ACHRE],
transcript of audio recording, 10 March 1995, lines 274-283 [Research Project Series,
Subject Interview Study]).

52. Subject No. 332324-3, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 24 March 1995, lines 156-161 (Research Project
Series, Subject Interview Study).

53. Subject No. 441204-5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 8 March 1995, lines 171-172 (Research Project
Series, Subject Interview Study).

54. Subject No. 552365-9, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 14 March 1995, lines 399-401 (Research Project
Series, Subject Interview Study).

55. There were a number of people who said that the written material was
difficult to read: "I read some of the literature and it didn't mean a hill of beans to me
because I didn't know anything about medical science . . . but . . . like I say, if it's to help
me, I'll go in . . ." (Subject No. 332324-3, interview by Subject Interview Study staff
[ACHRE], transcript of audio recording, 24 March 1995, lines 189-192 [Research Project
Series, Subject Interview Study]). One respondent drew attention to the overly technical
language used in forms: "You kind of think, 'Hmmmm. What do these things really
mean?'. . . [You hear that] your follicles might fall. . . . you're thinking, 'follicles fall?'
My hair . . . [T]hey're slick at . . . [how] they present stuff. . . " (Subject No. 335213-5,
interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 28
March 1995, lines 742-748 [Research Project Series, Subject Interview Study]). A few
patients said the forms were unnerving: "[I]t'd be more reassuring for the person . . .
that's going to be involved in the research to receive some positive, more positive
language in the protocol itself. . . . [C]ertainly in a way it's good that they let you know
these things. ... on the other hand, it just scares people sometimes" (Subject No. 335227-
5, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 24
March 1995, lines 89-92, 114-116 [Research Project Series, Subject Interview Study]).

56. One respondent noted that cancer patients such as herself receive a deluge of
technical information to digest: "We were sorta bombarded with information and I just
made my mind up at that one appointment to go with the study" (Subject No. 4433 1 1-6,
interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 28
February 1995, lines 212-214 [Research Project Series, Subject Interview Study]).
Another replied, "[T]hey do give you all the available information, almost too much,
because you can't absorb it all at once, and I brought home all these little books and the
books are good and you just get sick of it . . ." (Subject No. 333250-9, interview by
Subject Interview Study staff [ACHRE], transcript of audio recording, 8 March 1995,
lines 84-87 [Research Project Series, Subject Interview Study]).

57. One respondent, approached in his hospital room the night before scheduled
brain surgery to consider enrolling in a clinical trial for anesthesia, felt that the timing of
consent was poor: "... I felt the timing could have been a little better, because I was

755

concerned about sleeping and being rested. . . . [I]t might have been better a day earl[ier]
. . ." (Subject No. 442107-9, interview by Subject Interview Study staff [ACHRE],
transcript of audio recording, 29 March 1995, lines 155-157, 174-175 [Research Project
Series, Subject Interview Study]).

58. One respondent who spoke only broken English reported that she relied
upon her husband to gather and make sense of information that staff relayed about her
therapeutic research project.

59. Subject No. 1 14229-8, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 14 March 1995, lines 481-486. Similarly,
another respondent argued that "it's important that the people who are on the protocol
talk," particularly since in this forum participants can more quickly exchange information
about what "is going to happen. ..." Talking can convey the information "quicker than
if it's on a piece [of paper] . . ." (Subject No. 335213-5, interview by Subject Interview
Study staff [ACHRE], transcript of audio recording, 28 March 1995, lines 1403-1404,
1417-1420 [Research Project Series, Subject Interview Study]).

60. Subject No. 333208-7, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 6 March 1995, lines 27-29. Even when some
patients noted that a doctor's recommendation had influenced them, they did not construe
this as "pressure": "[D]on't misunderstand me, [my doctor] didn't influence me in [any]
way . . . [but] he thought it would be a good program for my type of cancer" (Subject No.
552126-5, interview by Subject Interview Study staff [ACHRE], transcript of audio
recording, 13 March 1995, lines 125-127 [Research Project Series, Subject Interview
Study]). Another respondent noted that she thought that the staff wanted her to enroll,
"but they [were] not pushing anything" (Subject No. 1 13122-6, interview by Subject
Interview Study staff [ACHRE], transcript of audio recording, 1 1 March 1995, line 462
[Research Project Series, Subject Interview Study]).

6 1 . Subject No. 552 1 26-5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 13 March 1995, lines 102-105 (Research Project
Series, Subject Interview Study).

62. Subject No. 223201-5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 13 March 1995, lines 136-138 (Research Project
Series, Subject Interview Study).

63. Subject No. 335213-5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 28 March 1995, lines 687-700 (Research Project
Series, Subject Interview Study). Another respondent, who did not remember signing a
consent form reported, the doctor "just recommended me to go [on the drug]" (Subject
No. 44131 1-8, interview by Subject Interview Study staff [ACHRE], transcript of audio
recording, 28 March 1995, lines 63 [Research Project Series, Subject Interview Study]).
Another respondent reported that although she did not recall signing a consent form, she
later discovered that she had. One procedure to which she had consented in written form
was not something she wanted to go through, however. This respondent explained the
confusion in part to the fact that she . . . "never thought about the study" . . . because she
was worried about . . . "[having] to be cut again . . ." (Subject No. 443226-6, interview by
Subject Interview Study staff [ACHRE], transcript of audio recording, 16 March 1995,
lines 246-255, 348-361, 446-448 [Research Project Series, Subject Interview Study]).

64. Subject No. 2232 12-2, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 16 March 1995, lines 195-200 (Research Project
Series, Subject Interview Study).

65. Subject No. 552143-0, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 15 March 1995, lines 205-208 (Research Project
Series, Subject Interview Study).

756

66. Subject No. 333208-7, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 6 March 1995, lines 250-252, 256-257, 260-261
(Research Project Series, Subject Interview Study).

67. This respondent described that others in the study had been "on orders to
leave here" (i.e., to go to another military base), ... and were "not allowed to [leave].
The doctor told them that they could not . . . [and] ... had the orders changed because
they were enrolled in an intense medical program research program" (Subject No.
333301-0, interview by Subject Interview Study staff [ACHRE], transcript of audio
recording, 9 March 1995, lines 779-783 [Research Project Series, Subject Interview
Study]).

68. The respondent went on to identify sources of overt and covert pressure for
him to remain in the trial: "[T]he response was kind of like trying to convince me to just
finish it up and that was always the response, anytime I had reservations there was
somebody there to . . . talk about those reservations, but in the course of doing it really

trying to convince me that it's ok[ay] " The respondent also said, "When they asked

for a bone marrow biopsy I said I'm not gonna do it, so I just dropped out at that point,
and she says, you know if we don't do that then I mean, it's not valid ... it defeats all
those days . . ." (Subject No. 551334-6, interview by Subject Interview Study staff
[ACHRE], transcript of audio recording, 14 March 1995, lines 303-305, 326-328, 330-
332, 562-566, 652-656, [Research Project Series, Subject Interview Study]).

69. Subject No. 5532 1 5-5, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 10 March 1995, lines 96-99, 205-206. Another
respondent explained, "... I knew that I could stop at any point and time. I was aware of
that ... I knew that I could, but I didn't have anything else ... 1 didn't know what
stopping was going to do either . . . then I thought well, if I stop, what do I do[?]"
(Subject No. 3341 10-4, interview by Subject Interview Study staff [ACHRE], transcript
of audio recording, 28 March 1995, lines 483-488 [Research Project Series, Subject
Interview Study]).

70. Subject No. 552143-0, interview by Subject Interview Study staff
(ACHRE), transcript of audio recording, 15 March 1995, lines 37-38, 217-218 (Research
Project Series, Subject Interview Study).

757

Discussion of Part III

1 he Committee undertook the efforts described in part III of this report
in order to gain insight into the current status of protections in human radiation
research and research with human subjects generally. An important finding of
part III is that with respect to the rights and interests of human subjects there
appear to be no differences between radiation research and other research.

Compared with what we have learned about the 1940s, 1950s, and 1960s,
there have been many changes in the climate and conduct of human subject
research. The most obvious change is the regulatory apparatus described in
chapter 14, which was not in place in that earlier time. The rules of research
ethics are also more articulated today than they were then, as exemplified by the
evolution of the concept of informed consent. Although the basic moral
principles that serve as the underpinning for research ethics are the same now as
they were then, some of the issues of greatest concern to us today are different, or
have taken on a different cast, from those of earlier decades.

In our historical inquiry, for example, we concentrated on cases that
offered subjects no prospect of medical benefit; they were instances of
"nontherapeutic research" in the strictest sense. That is, these were experiments
in which there was never any basis or expectation that subjects could benefit
medically-both the design and the objectives precluded such a possibility. Most
of the human radiation experiments that were public controversies when the
Advisory Committee was appointed were of this type. The basic moral concern
they raised was whether people had been used as mere means to the ends of
scientists and the government; this would have occurred if the subjects could not
possibly have benefited medically from being in the research and they had not
consented to this use of their person.

As we noted in chapter 4, the ethical issues raised by research that is
nontherapeutic in this strict sense are stark and straightforward. Because risks to
subjects cannot be offset by the possibility that they might benefit medically,
there is rarely justification for nontherapeutic research that puts subjects at

758

significant risk. Participation in such research is always a burden and never a
benefit to the individual subject, making questions of justice straightforward as
well. And, at least theoretically, there are no subtleties involved in disclosing to
potential subjects that they cannot possibly benefit medically from participating in
the research, although problems do emerge concerning what incentives are
appropriate to induce people to become research subjects when, considerations of
altruism aside, it is otherwise not in their interests to do so.

Today, we still conduct nontherapeutic medical research on human
subjects. Much research in physiology offers subjects no prospect of medical
benefit, as does every protocol that calls for "normal controls." Although
nontherapeutic research frequently involves subjects who are healthy, it also often
involves patient-subjects as well. It is, of course, still appropriate to be concerned
about the ethics of such research, as it is with all research. For example, we were
particularly troubled in our Research Proposal Review Project by documents that
suggested that adults of questionable competence were being used as subjects of
research from which it appeared they could not benefit medically and where the
authorization for this use was unclear.

Much research involving human subjects does not, however, fit this
nontherapeutic paradigm. Many of our most pressing ethical questions concern
research that raises at least the specter of potential medical benefit to the patient-
subject. For example, unlike the plutonium experiments with hospitalized adults
or the iodine 131 experiments with hospitalized children, in which there was no
possibility that the patient-subjects could have benefited medically, in the modern
Phase I trial, which is conducted to establish toxicity, there is at least the
possibility of therapeutic benefit, however slim. Thus, although Phase I trials
often impose significant burden and risk on subjects, they are not nontherapeutic
in the strict sense. And, in contrast with Phase I trials, in much research involving
patient-subjects there is a real prospect that subjects will benefit medically from
their participation. In many of these cases, being a research subject is clearly in
the medical best interests of the patient.

As Otto Guttentag observed in the 1950s (see chapter 1), it is the
possibility of medical benefit that creates much of the moral tension in human
subject research. Physician researchers are often torn between the demands of a
research project and the needs of particular patients. Today this tension has taken
on special significance, with the immense growth of research at the bedside and
the frequency with which the medical care of seriously ill patients is intertwined
with clinical research. In our Subject Interview Study, for example, at least a
third of the patients interviewed had some contact with medical research.

It is these considerations that led us to focus the efforts reported on in part
III, and particularly the SIS, on research involving patient-subjects. The
Committee regrets that we did not have the resources to conduct a similar study
with subjects who are not also patients. It would have been particularly useful to
have conducted such a study with subjects who are military personnel not
currently in medical care. This would have allowed us to investigate other
important sources of tension in the ethics of research, including the tension

759

Part III

between giving orders and soliciting consent and between occupational
monitoring and research.

Although the SIS and the RPRP employed radically different
methodologies and were directed toward different research questions, both
projects speak to the ethical issues raised by the conduct of human research in a
medical context, a context dominated by the human needs to be healed and to
heal.

The findings of the SIS underscore what other, smaller studies also have
identified— that patient-subjects generally decide to participate in medical research
because they believe that being in research is the best way to improve their
medical condition.1 In the SIS, we could not determine whether the patients had
unrealistic expectations about how likely it was that they might benefit from
being in research, or in what form that benefit might take. Other empirical studies
suggest that some subjects do have an inadequate, sometimes exaggerated
understanding of the potential benefits of the research in which they are
participating.2 In the RPRP, we reviewed consent forms that appeared to
overpromise what research could likely offer the ill patient and underplay the
effect of the research on the patient's quality of life. These were the kinds of
disclosures that could easily be interpreted by a patient desperate for hope as
offering much more than realistically could be expected. Not surprisingly, this
problem was the most acute in certain Phase I trials that, while not being
nontherapeutic in the strict sense, appeared to offer only a remote possibility of
benefit to the patient-subject. In oncology, for example, it is estimated that in
only about 5 percent of subjects enrolled in Phase I chemotherapy studies does
the tumor respond to the drug,3 and it is often unclear even then what the tumor
response means from a patient's point of view.4 To say that there is no prospect
that the patients might benefit medically is questionable; there are enough cases
of patients being helped in Phase I trials to make such a stark claim problematic.
Beneficial effects of Phase I trials have a very low probability, but do occur.5 At
the same time, however, any suggestion of the possibility of benefit has the
potential to be magnified many times over by patients with no good medical
alternatives. It is understandable that physicians, faced with the prospect of little
or nothing to offer seriously ill patients, may sometimes impart more hope than
the clinical facts warrant. At the same time, however, desperate hopes are easily
manipulated.

Consider, for example, a recent report of a small study of patient-subjects
participating in Phase I clinical oncology trials.6 Despite the predictably low
likelihood of medical benefit for subjects in Phase I trials, all of the patient-
subjects surveyed about their reasons for participating said their decision was
motivated in large part by the possibility of therapeutic benefit, and nearly three-
quarters cited trust in their physician as motivating their decision to participate.
Only one-third listed altruism as a major motivating factor. These results support
what we found in the SIS-that patient-subjects view research participation as a

760

Discussion of Part III

way of obtaining the best medical care, even when participating in research holds
out very little prospect of direct benefit. This phenomenon, which is especially
relevant when some subjects receive a placebo as a part of the research, has been
dubbed the therapeutic misconception.7 This phenomenon is not confined to
patient-subjects' perceptions of benefit from research; at least one study has
shown that physician-investigators also overestimate the potential benefits to
subjects participating in Phase I oncology trials.8

One of the most powerful themes to emerge from the SIS is the role of
trust in patients' decisions to participate in research, a finding that has been
observed in other studies as well.9 It was common for patients in the SIS to say
that they had joined a research project at the suggestion of their physician and that
they trusted that their physician would never endorse an option that was not in
their best interest. This trust underscores the much-discussed tension in the role of
physician-investigator,10 whose duties as a healer and as a scientist inherently
conflict. This trust that patients place in their physicians often is generalized to
the medical and research community as a whole. Some patients expressed faith
not only in their doctors but also in the institutions where they were receiving
medical care. These patients believed that hospitals would never permit research
to be conducted that was not good for the patient-subjects. The trust that patients
have in physicians and hospitals underscores the importance of the Committee's
concern, based on our review of the documents in the RPRP, that IRBs may not
always be properly structured to ensure that the medical interests of ill patients
are adequately protected. In some cases, the scientific information to make such
judgments was not included in the documents we received. Even with adequate
information, IRBs may lack sufficient expertise to evaluate the science or
implications for medical care of particular proposals. As we heard from some
IRB chairs, they may also lack the staff or the respect and authority within their
institutions to function adequately to protect subjects.

The theme of trust discerned in the SIS also has implications for how
properly to view the role of informed consent in protecting the rights and interests
of human subjects. For many of the patients who based their decision to be in
research on their trust in their physicians, the informed consent process and the
informed consent form were of little importance. IRBs can serve the interests of
these patients best by being vigilant in their review of risks and benefits and
attending to questions of fairness in the selection of subjects. On the other hand,
we also found in the SIS that sizable numbers of patients had refused offers to
participate in research and that some patients who had consented to be research
subjects had made efforts to learn what they could about the research opportunity.
For these patients, the informed consent process likely served an important moral
function.

From these seemingly conflicting results we can conclude both that the
informed consent requirement is crucial to protect the autonomy rights of those
potential subjects who choose to exercise them, but that it is naive to think that

761

Part III

informed consent can be relied upon as the major mechanism to protect the rights
and interests of patient-subjects. Taken together, the results of our two projects
suggest that it is important to correct the deficiencies identified in the RPRP with
respect to informed consent. Our results also underscore, however, the
importance of an IRB review that focuses on whether the proposed research is a
reasonable, ethically acceptable option to offer the patient, in light of available
alternatives and the risks and potential benefits of the proposed research for the
subject, including impact on quality of life. An alternative, the practice of adding
detail to consent forms as a way of further informing potential subjects who often
have a difficult time understanding risks, benefits, and purposes of research," is
unacceptable; by confusing subjects, it offers less, rather than greater protection.
For the many patients who continue to rely on the expertise and good will of
physicians and hospitals in deciding whether to participate in research, rigorous
review on the part of IRBs and rigorous commitment on the part of physicians to
honor the faith entrusted to them are the important protections.

The SIS and the RPRP also both speak to the current confusion between
research and "standard care" in medical practice.12 The same therapy that is part
of a research protocol, and therefore must receive IRB approval, can proceed
outside of the research setting and not be subject to IRB oversight. This leads to
understandable confusion on the part of subjects as to whether they are
participating in research, receiving standard care, or some combination. It is thus
perhaps not surprising that research subjects occasionally seem unaware of their
participation in research, even when there is evidence they have signed consent
forms.'3 This finding was observed in the SIS, though the methodology of the
study did not allow us to probe the reasons some subjects appeared unaware of
their participation.

The confusion between research and alternative medical interventions is
mirrored in the language used to communicate to patients in the informed consent
process and in the language of patients themselves. In the SIS, the patients
surveyed viewed experiments as involving unproven treatment of greater risk,
while clinical investigation or study conveyed less uncertainty and were perceived
as offering a greater chance of personal benefit. None of the consent forms we
reviewed in the RPRP used the term experiment.

CONCLUSION

In addition to the role they played in helping the Advisory Committee
come to our conclusions, the RPRP and SIS should be understood as adding to the
body of research undertaken to try to understand the strengths and weaknesses of
the system to protect the rights and interests of human subjects.

In the end, patients' reasons for participating in research must more
accurately reflect the benefits they may reasonably expect. Altruistic motivation
can be more fruitfully tapped, both for the benefit it provides to the advancement

762

Discussion of Part III

of science and to underscore for patients that the primary objective of some
research is to create generalizable scientific knowledge rather than to offer
personal benefit to them. Subjects are much more likely to have a positive view
of biomedical research if they feel they understand what prospects research holds
for them. The good news in the endeavor of human subject research is that
subjects are willing to participate, and in the process entrust their care to
researchers; however, that trust cannot be taken for granted as it sometimes has
been in our history.

Increasingly it is being argued that it is generally advantageous for
patients to participate in research; the distinction between standard care and
research, if it was ever clear, is viewed as growing dimmer all the time.14 As a
consequence, the debate over subject selection has changed entirely. As we
discussed in parts I and II, in the past a central concern was that certain
populations, considered vulnerable to exploitation because of their relative
powerlessness, were inequitably bearing the burdens of the risks of research.
Today, the concern is that the same populations may have inequitable access to
research and therefore individuals and the communities of which they are a part
may be denied a fair share of the benefits of research participation. While this is a
valid moral concern, the results of the SIS and the RPRP suggest that it remains
important to be attuned to issues of vulnerability. While patients with serious
illnesses may stand to gain the most from participating in medical research, they
also are among the most vulnerable to its risks.

It also is important to underscore the finding in the RPRP that in both
studies involving minimal risk and those involving greater risk, research with ill
patient-subjects can proceed ethically and consent can be properly obtained. The
research enterprise is too important to jeopardize by inadequate protections for
subjects. Tensions and potential conflicts exist throughout the research process,
and so we must be sure to acknowledge and address them squarely. This is the
goal of the next and final part of the Advisory Committee's report.

763

ENDNOTES

1. Barrie R. Cassileth, Edward J. Lusk, David S. Miller, and Shelley Hurwitz,
"Attitudes Toward Clinical Trials Among Patients and the Public," Journal of the
American Medical Association 248, no. 8 (1982): 968-970; and Christopher Daugherty,
Mark J. Ratain, Eugene Grocowski et al., "Perceptions of Cancer Patients and Their
Physicians Involved in Phase I Trials," Journal of Clinical Oncology 13, no. 5 (1995):
1062-1072.

2. Ira S. Ockene et al., "The Consent Process in the Thrombolysis in Myocardial
Infarction (TIMI-Phase I) Trial," Clinical Research 39 no. 1 (1991): 13-17; Roberta M.
Tanakanow, Burgunda V. Sweet, and Jill A. Weiskopf, "Patients' Perceived
Understanding of Informed Consent in Investigational Drug Studies," American Journal
of Hospital Pharmacy 49 (1992): 633-635; Doris T. Penman et al., "Informed Consent
for Investigational Chemotherapy: Patients' and Physicians' Perceptions," Journal of
Clinical Oncology 2 no.7 (1984): 849-855; Henry W. Riecken and Ruth Ravich,
"Informed Consent to Biomedical Research in Veterans Administration Hospitals,"
Journal of the American Medical Association 248 no. 3 ( 1 982): 344-348; Gail A.
Bujorian, "Clinical Trials: Patient Issues in the Decision-Making Process," Oncology
Nursing Forum 15, no. 6 (1988): 779-783; Niels Lynoe et al., "Informed Consent: Study
of Quality of Information Given to Participants in a Clinical Study," British Medical
Journal 303 (1991): 610-613; and Daugherty et al., "Perceptions of Cancer Patients and
Their Physicians Involved in Phase I Trials."

3. D. D. Von Hoff and J. Turner, "Response Rates, Duration of Response, and
Dose Response Effects in Phase I Studies of Antineoplastics," Investigational New
Drugs 9 (1991): 1 15-122; E. Estey et al., "Therapeutic Response in Phase I Trials of
Antineoplastic Agents," Cancer Treatment Report 70 (1986): 1 105-1 155; and G.
Decoster, G. Stein, and E. E. Holdener, "Responses and Toxic Deaths in Phase I Clinical
Trials," Annals of Oncology 2 ( 1 990): 1 75- 1 8 1 .

4. Decoster, Stein, and Holdener, "Responses and Toxic Deaths in Phase I
Clinical Trials," 175-181.

5. There have been very few occasions reported in the literature of Phase I trials
having medical benefit for patient-subjects. While very rare, that such benefit occurs at
all further complicates the difficulty over what to say to patients at the end of the medical
road who are considering enrolling in a Phase I trial. See, for example, M. Kaminski,
"Radioimmunotherapy of Bcell Lymphoma with 1-131 Anti-Bl," New England Journal
of Medicine 329, no. 7 (1993): 459-465.

6. Daugherty et al., "Perceptions of Cancer Patients and Their Physicians
Involved in Phase I Trials."

7. Paul S. Appelbaum, Loren H. Roth, and Charles Lidz, "The Therapeutic
Misconception: Informed Consent in Psychiatric Research," International Journal of
Law and Psychiatry 5 (1982): 319-329; Paul S. Appelbaum et al., "False Hopes and Best
Data: Consent to Research and the Therapeutic Misconception," Hastings Center Report,
April 1987,20-24.

8. Decoster, Stein, and Holdener, "Responses and Toxic Deaths in Phase I
Clinical Trials."

9. Cassileth et al., "Attitudes toward Clinical Trials among Patients and the
Public"; Susan M. Newburg, Anne E. Holland, and Lesly A. Pearce, "Motivation of

764

Subjects to Participate in a Research Trial," Applied Nursing Research 5, no. 2 (1992):
89-104; Penman et al., "Informed Consent for Investigational Chemotherapy: Patients'
and Physicians' Perceptions"; and Daugherty et al., "Perceptions of Cancer Patients and
their Physicians Involved in Phase I Trials."

10 Nancy M. P. King, "Experimental Treatment: Oxymoron or Aspiration?"
Hastings Center Report 25, no. 4 (1995): 6-15; Jay Katz, "The Regulation of Human
Experimentation in the United States-A Personal Odyssey," IRB 9, no. 1 (1987): 1, 5-6;
and J. R. Maltby, and C. J. Eagle, "Patient Recruitment for Clinical Research [letter,
comment]," Canadian Journal of Anaesthesia 40, no. 9 (1993): 897-898.

11. Ockene et al., "The Consent Process in the Thrombolysis in Myocardial
Infarction (TIMI-Phase I) Trial"; Tanakanow et al., "Patients' Perceived Understanding
of Informed Consent in Investigational Drug Studies"; Penman et al., "Informed Consent
for Investigational Chemotherapy: Patients' and Physicians' Perceptions"; Riecken et al.,
"Informed Consent to Biomedical Research in Veterans Administration Hospitals";
Bujorian et al., "Clinical Trials: Patient Issues in the Decision-Making Process"; Lynoe
et al., "Informed Consent: Study of Quality of Information Given to Participants in a
Clinical Study"; and Daugherty et al., "Perceptions of Cancer Patients and their
Physicians Involved in Phase I Trials."

12. King, "Experimental Treatment: Oxymoron or Aspiration?"

13. Riecken et al., "Informed Consent to Biomedical Research in Veterans
Administration Hospitals."

14. King, "Experimental Treatment: Oxymoron or Aspiration?"

765

PART IV

COMING TO TERMS WITH
THE PAST, LOOKING AHEAD TO THE

FUTURE

Part IV
Overview

In part IV we present the overall findings of the Advisory Committee's
inquiry and deliberations and the recommendations that follow from these
findings.

In chapter 17, findings are presented in two parts, first for the period 1944
through 1974 and then for the contemporary period. These parts, in turn, are
divided into findings regarding biomedical experiments and those regarding
population exposures.

We begin our presentation of findings for the period 1944 through 1974
with a summation of what we have learned about human radiation experiments:
their number and purpose, the likelihood that they produced harm, and how
human radiation experimentation contributed to advances in medicine. We then
summarize what we have found concerning the nature of federal rules and
policies governing research involving human subjects during this period, and the
implementation of these rules in the conduct of human radiation experiments.
Findings about the nature and implementation of federal rules cover issues of
consent, risk, the selection of subjects, and the role of national security
considerations.

Our findings about government rules are followed by a finding on the
norms and practices of physicians and other biomedical scientists for the use of
human subjects. We then turn to the Committee's finding on the evaluation of
past experiments, in which we summarize the moral framework adopted by the
Committee for this purpose. Next, we present our findings for experiments
conducted in conjunction with atmospheric atomic testing, intentional releases,
and other population exposures. The remaining findings for the historical period
address issues of government secrecy and record keeping.

There is an asymmetry in our findings on human radiation experiments
and intentional releases. In both cases, we discuss their number and purpose, the

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Part IV

likelihood that they produced harm, and what is known about applicable
government rules and policies. In the case of human radiation experiments, we
also have a finding on the benefits to medicine-and thus to all of us— that human
radiation research during this period produced. We do not, however, have a
corresponding finding on the benefits of the intentional releases of the period,
benefits that would presumably have been to the national defense and, thus again,
to all of us. Although the members of the Committee are positioned to comment
on contributions to medicine and medical science, we do not have the expertise to
evaluate contributions to the national defense and thus could not speak to this
issue.

Our findings for the contemporary period summarize what we have
learned about the rules and practices that currently govern the conduct of
radiation research involving human subjects, as well as human research generally,
and about the status of government regulations regarding intentional releases.

Chapter 1 8 presents the Committee's recommendations to the Human
Radiation Interagency Working Group and to the American people. The
Committee's inquiry focused on research conducted by the government to serve
the public good— the promotion and protection of national security and the
advancement of science and medicine. The pursuit of these ends— today, as well
as yesterday— inevitably means that some individuals are put at risk for the benefit
of the greater good. The past shows us that research can bear fruits of
incalculable value. Unfortunately, however, the government's conduct with
respect to some research performed in the past has left a legacy of distrust.
Actions must be taken to ensure that, in the future, the ends of national security
and the advancement of medicine will proceed only through means that safeguard
the dignity, health, and safety of the individuals and groups who may be put at
risk in the process.

The needed actions are in four dimensions:

First, the nation must provide for appropriate remedies as it comes to grips
with the past.

Second, the nation must provide improved means to better ensure that
those who conduct research involving human subjects act in a manner consistent
with the interests and rights of those who may be put at risk and consistent with
the highest ethical standards of the practice of medicine and the conduct of
science.

Third, the nation must ensure that special care is taken to prevent abuses
in the conduct of human subject research and environmental releases in a context
where these activities must occur in secret.

Fourth, the nation must ensure that records are kept so that a proper
accounting can be made to those who are asked to bear risks, particularly when
any or all of the risk taking involves secrecy. Moreover, these records should be
made available to the public at large on a timely basis consistent with legitimate

770

Overview

national security requirements.

The Committee's recommendations address these four areas— remedies for
the past, practices to govern the future of biomedical experimentation, practices to
govern the future exposure of citizens to biomedical research or environmental
releases from secret activities, and provisions for record keeping and public
access to records.

We wish to note here the limits of our framework for remedies for past
harms or wrongs for subjects of human radiation experiments.* First, we are
addressing questions of remedies from the perspective of what, ethically, ought
to be done. We recognize that some of the remedies we propose, including
financial compensation, may not be available under current federal law. To the
extent that such remedies are not available under current law, we encourage the
administration to work with Congress to develop such remedies through
legislation or other appropriate means.

Second, the Committee has focused on past experiments in which there
was no possibility that subjects could derive medical benefit from being in the
research or in which the potential for this benefit is in dispute. These were the
experiments that raised the greatest public concern. They were also the
experiments that raised the greatest concern for most members of the Committee
when we considered the 1944-1974 period. This was a time, as noted throughout
this report, when it was common for physicians to use patients as research
subjects without the patients' knowledge or consent. It was also a time, however,
when physicians were ceded considerable moral authority both by patients and by
society to decide for patients what medical treatments they should receive. This
authority extended, as well, to deciding whether a patient should be a subject in
therapeutic medical research, provided that this decision was based on a good
faith judgment by the physician that it was in the patient's medical best interest to
be a subject in the research and thus that any risks of the research were acceptable
in light of the possibilities for medical benefit. Even at the time, however,
physicians did not have the moral authority to use patients, without their
knowledge or consent, as subjects in research in which there was no expectation
that they could benefit medically.

* In accordance with our charter, these recommendations apply to human
radiation experiments conducted from 1944 to 1974 that were supported by the
government, whether the support was in the form of funding (including funding for data
gathering in conjunction with exposure of patient-subjects to radiation) or other means,
such as the provision of equipment or radioisotopes, and regardless of whether the
research was performed by federal employees or nonfederal investigators. Although we
focus here on human research involving exposure to ionizing radiation, the moral
justification for these recommendations is not specific only to experiments involving
radiation.

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Part IV

The Committee appreciates that simply because the moral context of the
doctor-patient relationship during the 1944-1974 period was different from
today's, this does not mean that all therapeutic research was always or even often
conducted in an ethical fashion. We also appreciate that the risks of therapeutic
research were often considerable and that it is likely that some patient-subjects
were harmed unnecessarily as a consequence. However, the moral problems
presented when people in the 1944-1974 period were used as subjects of research
from which they could not benefit medically are both more straightforward and
more compelling. We therefore felt obligated to expend our limited resources on
historical and moral analysis of these kinds of experiments. We do not address
whether or under what conditions remedies should be provided for injuries or
offenses related to research that offered a plausible prospect of medical benefit to
subjects and we leave that work to others.

Third, even in those experiments where there was no prospect of medical
benefit, limited Committee resources, and the overall Committee mandate,
precluded the type of fact-intensive individual investigation that would give rise
to a recommendation of compensation in individual cases. The Committee did
not have the ability to locate and evaluate the research and medical records of
countless individual subjects. As a consequence, for example, we were not able
to make judgments about whether, in individual cases, subjects had suffered
physical harm attributable to their involvement in research.

Fourth, we note that the Committee was not unanimous in its decision to
make a recommendation for remedies for people who were subjects in
experiments that offered them no prospect of medical benefit but who were not
physically harmed as a consequence (recommendation 3). Three Committee
members elected not to support this recommendation.

The entire Committee believes that people who were used as research
subjects without their consent were wronged even if they were not harmed.
Although it is surely worse, from an ethical standpoint, to have been both harmed
and wronged than to have been used as an unwitting subject of experiments and
suffered no harm, it is still a moral wrong to use people as a mere means.
Although what we know about the practices of the time suggests it is likely that
many people who were subjects in nontherapeutic research were used without
their consent or with what today we would consider inadequate consent, in most
of these cases, we have almost no information about whether or how consent was
obtained. Moreover, in most of these cases, the identities of the subjects are not
currently known; even if considerable resources were expended, it is likely that
most of their identities would remain unknown. The Committee is not persuaded
that, even where the facts are clear and the identities of subjects known, financial
compensation is necessarily a fitting remedy when people have been used as
subjects without their knowledge or consent but suffered no material harm as a
consequence; the remedy that emerged as most fitting was an apology from the

772

"

Overview

government.

The Committee struggled with and ultimately was divided on the issue of
whether to recommend that the government extend an apology under the
circumstances just described. While all members agreed that a goal of all the
Committee's recommendations is, in the words of one member, to "bind the
nation's wounds," we disagreed about how best to accomplish that end when
debating whether we should recommend such an apology. Our deliberations were
complicated by what we all agreed was a murky historical record. In the case of
some experiments, there was evidence of some disclosure or some attempt to
obtain consent, and the issue emerged as to how poor these attempts must be for
an apology still to be in order. In other cases, there was simply too little
documentary evidence to draw any conclusions about disclosure or consent. In
most cases, as noted above, the identities of subjects are unknown and are
unlikely to be uncovered even with an enormous expenditure of resources.

The Committee members who concluded that it was not appropriate to
recommend that a government apology be extended did not all reach this
conclusion for the same reasons. Among the reasons put forward were that it
would be impossible to craft a recommendation for an apology in such a way as to
avoid the divisiveness that could result from apologizing to some but not all of
those who view themselves as victims of this kind of human radiation experiment.
There was concern that if the criteria for who should receive an apology were too
narrow, some people would resent not qualifying for an apology; conversely, if
the criteria were too broad and included large numbers of people, the generality of
the apology would diminish its meaningfulness. It was also argued that a
recommendation for an apology should not be made because of the difficulties in
crafting the criteria for eligibility in the face of an incomplete historical record.
Another reason for not recommending an apology was that during the 1944-1974
period many people were used as subjects of research that did not involve
radiation, for which there was no prospect of medical benefit and consent was not
obtained from them, and these people would not be included in a recommendation
from us for an apology.

The Committee members who favored an apology took the position that
justice requires that an apology from the government is due in research that it
sponsored, where it can be determined that an apology is deserved and the
identities of subjects who were wronged can be known. They do not believe that
the recommendation to apologize rests on the likelihood that it will lead to more
healing than divisiveness. Rather, these Committee members hold that an apology
is a just remedy for those who were wronged and that it should not be withheld
only because there are other cases that are likely to have been morally similar but
for which a recommendation of an apology could not be made because the
evidence was unclear or unavailable. Making a specific apology in those cases
where the facts are clear today would not for these Committee members preclude

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Part IV

apologies being extended to other subjects in the future, should new information
come to light.

All Committee members agreed that it was appropriate that the subjects of
the experiments at the Fernald State School in Massachusetts receive an apology,
but divisions within the Committee arose when we tried to determine how to
differentiate them from the subjects of studies similar to those conducted at
Fernald about which less is known in relation to disclosure and consent.

Fifth, the Committee notes that our recommendations for remedies are
directed solely to the executive and legislative branches of the federal
government; they are not recommendations for exclusive remedies intended to bar
the opportunity to seek redress from other parties or the courts. Those who
believe they or their family members have been wronged or injured should be free
also to seek relief from appropriate institutions or from individuals; the
Committee does not intend to suggest the limiting of any rights to do so.

Finally, the framework for remedies for former subjects of human
radiation experiments that the Committee proposes in our recommendations limits
the availability of compensation from the federal government to what is likely to
be a small number of people. In developing the framework we were concerned
about the impact of recommending criteria that would result in compensation in
some cases but not in others. The Committee sought and heard testimony from
hundreds of witnesses, over months of deliberation, many of whom were
emotional and heart-rending in sharing their experiences. Often these witnesses
expressed considerable anguish over the pain that they and their families suffer
because of their belief that they have been or might yet be harmed, and some
advanced the view that compensation is appropriate. It was very painful for the
Committee to recognize that often we had neither the resources nor the mandate
to investigate all these compelling stories. The Committee concluded that an
appropriate service we could render was to shed light on this dark period in our
history by articulating the historical record to the best of our ability. But it is
equally important that, the historical record having been spelled out, we as a
nation move forward. The most fitting way to acknowledge the wrongs and
harms that were done to others in the past, and to honor their contributions to the
nation, is for the government to take steps to ensure that what they experienced
will not happen again.

Thus, many of our recommendations are directed not to the past but
toward the future. The Committee calls for changes in the current federal system
for the protection of the rights and interests of human subjects. These include
changes in institutional review boards; in the interpretation of ethics rules and
policies; in the conduct of research involving military personnel as subjects; in
oversight, accountability, and sanctions for ethics violations; and in
compensation for research injuries. Unlike the 1944-1974 period, in which the
Committee focused primarily on research that offered subjects no prospect of

774

Overview

medical benefit, our recommendations for the future emphasize protections for
patients who are subjects of therapeutic research, as many of the contemporary
issues involving research with human subjects occur in this setting. We also call
for the adoption of special protections for the conduct of human research or
environmental releases in secret, protections that are not currently in place.

We realize, however, that regulations and policies are no guarantee of
ethical conduct. If the events of the past are not to be repeated, it is essential that
the research community come to increasingly value the ethics of research
involving human subjects as central to the scientific enterprise. We harbor no
illusions about the Pollyanna-ish quality of a recommendation for professional
education in research ethics; we call for much more. We ask that the biomedical
research community, together with the government, cause a transformation in
commitment to the ethics of human research. We recognize and celebrate the
progress that has occurred in the past fifty years. We recognize and honor the
commitment to research ethics that currently exists among many biomedical
scientists and many institutional review boards. But more needs to be done. The
scientists of the future must have a clear understanding of their duties to human
subjects and a clear expectation that the leaders of their fields value good ethics as
much as they do good science. At stake is not only the well-being of future
subjects, but also, at least in part, the future of biomedical science. To the extent
that that future depends on public support, it requires the public's trust. There can
be no better guarantor of that trust than the ethics of the research community.

Finally, our examination of the history of the past half century has helped
us understand that the revision of regulations that govern human research, the
creation of new oversight mechanisms, and even a scrupulous professional ethics
are necessary, but are not sufficient, means to needed reform. Of at least equal
import is the development of a more common understanding among the public of
research involving human subjects, its purposes, and its limitations. Furthermore,
if the conduct of the government and of the professional community is to be
improved, that conduct must be available for scrutiny by the American people so
that they can make more informed decisions about the protection and promotion
of their own health and that of the members of their family. It is toward that end
that we close our report with recommendations for continued openness in
government and in biomedical research. It is also toward that end that this report
is dedicated. Some of what is regrettable about the past happened, at least in part,
because we as citizens let it happen. Let the lessons of history remind us all that
the best safeguard for the future is an informed and active citizenry.

775

17

Findings

Findings for the Period 1944-1974

Biomedical Experiments
Finding 1

The Advisory Committee finds that from 1944 through 1974 the
government sponsored (by providing funding, equipment, or radioisotopes)
several thousand human radiation experiments. In the great majority of
cases, the experiments were conducted to advance biomedical science; some
experiments were conducted to advance national interests in defense or space
exploration; and some experiments served both biomedical and defense or
space exploration purposes.

These experiments were conducted by researchers affiliated with
government agencies, universities, hospitals, and other research institutions. Only
fragmentary information survives about most experiments.

Finding 2

The Advisory Committee finds that the majority of human radiation
experiments in our database involved radioactive tracers administered in
amounts that are likely to be similar to those used in research today. Most of
these tracer studies involved adult subjects and are unlikely to have caused

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physical harm. However, in some nontherapeutic tracer studies involving
children, radioisotope exposures were associated with increases in the
potential lifetime risk for developing cancer that would be considered
unacceptable today. The Advisory Committee also identified several studies
in which patients died soon after receiving external radiation or radioisotope
doses in the therapeutic range that were associated with acute radiation
effects.

Review of available information indicates that the majority of the
approximately 4,000 human radiation experiments in the Advisory Committee
database involved the use of radioisotopes as tracers in research designed to
measure physiological processes in either normal or diseased states. These
experiments were not typically aimed at measuring the biological effects of
radiation itself. However, information on the majority of experiments in our
database was fragmentary and thus did not allow for detailed estimates of
dosimetry or examination of issues of experimental design and subject selection.

To supplement the information in our database and provide context to our
analysis, we independently reviewed archival documents from AEC-mandated
institutional local isotope committees. These local use committees were part of a
larger AEC program that facilitated the distribution of radioisotopes for use in
government-sponsored human subjects research in the 1947-1974 period and
involved the review of experimental risk on an individual basis to ensure that
human uses of isotopes were within accepted risk standards of the day. We thus
used these materials as an indicator of isotope use and regulatory practices at that
time.

While we recognize the limitations of the data available to us, our
evaluation suggests that most tracer studies conducted during the period 1944-
1974 likely involved low doses that did not cause any acute or long-term effects.
The Advisory Committee cannot rule out, however, the possibility that some
people were or will be harmed as a consequence of their involvement in these
experiments.

The Committee did identify some nontherapeutic tracer experiments
involving the administration of iodine 131 to children, which may have raised the
subsequent risk of developing thyroid cancer to levels that would be considered
unacceptable today. Based on the average risk estimate for each experiment,
approximatedly 500 individuals were exposed to greater than minimal risk. (The
Committee used a threshold of greater than or equal to one excess case of cancer
per 1,000 subjects for categorizing experiments as greater than minimal risk.)
Combining the average risk estimates for each experiment, this translates into an
expected excess of 1.3 incident cases of thyroid cancer for the entire group.
Fortunately, unlike many other cancers, thyroid cancer is curable in more than 90
percent of cases; therefore, it is unlikely that, even if cancers developed, these

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Chapter 1 7

exposures caused any premature deaths. Furthermore, although there is strong
scientific evidence that radiation doses delivered over a short period of time from
external sources can result in increases in cancer incidence at specific sites,
comparable data suggest that the carcinogenic effects of isotope exposures are
less than those of external irradiation. The difference in carcinogenic effect is
thought to be due to the relatively low dose rate of the isotope exposure, which
allows for effective repair of radiation damage.

One additional isotope study involving the administration of radioiron to
pregnant women has been linked to a possible increase in cancers in children who
were exposed in utero. However, the small number of observed cancers as well
as considerable uncertainties in the amount of radioisotope administered have
made the determination of causality difficult. Finally, the Committee found some
experiments where radioisotope exposures were associated with either acute or
chronic physiologic changes of uncertain clinical significance, pathologic
evidence of kidney damage secondary to chemical and radiation toxicity in some
patients injected with uranium, and radiographic evidence of minimal bone
changes in some long-term survivors of plutonium injections.

Studies that involved radiation doses in the therapeutic range were for the
most part performed on patient-subjects where there was, at least arguably, a
prospect that the subjects might benefit medically from the exposure. However,
the TBI and experimental gallium treatments, in which patients suffered
symptoms of acute radiation sickness and died soon after treatment, raise the
question of whether their deaths were hastened by the radiation treatments.
Resolution of this issue requires review of individual medical histories, which the
Advisory Committee could not undertake.

Finding 3

The Advisory Committee finds that human radiation experimentation
during the period 1944 through 1974 contributed significantly to advances in
medicine and thus to the health of the public.

Human radiation research was essential to the development of new
therapies such as the use of radioactive iodine to treat thyroid cancer; the use of
phosphorus to treat blood diseases such as polycythemia vera; and the use of
radioactive strontium as a palliative in prostate and other cancers metastasized to
the bone. Diagnostic uses of radionuclides developed during this period include
scanning techniques to identify tumors and radiolabeling techniques that help
evaluate a variety of cardiac diseases. The quality of images produced by
external sources of radiation also improved dramatically between 1944 and 1974,
making possible, for example, techniques such as balloon angioplasty to open
occluded arteries.

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PartIV

Finding 4

The Advisory Committee finds that some government agencies
required the consent of some research subjects well before 1944. These
requirements generally did not stipulate what was meant by consent,
however, nor did they generally indicate whether investigators were
obligated to disclose specific information to potential subjects. The
government did not have comprehensive policies requiring the consent of all
subjects of research, including both healthy subjects and patient-subjects,
until 1974.

4a. Research Involving Healthy Subjects: In the 1920s, the Army
promulgated a regulation concerning the use of "volunteers" for medical research.
In 1932, the secretary of the Navy required that subjects of a proposed experiment
be "informed volunteers." In 1942 the requirement that healthy subjects be
informed volunteers was also articulated by the Committee on Medical Research,
which oversaw war-related research for the Executive Office of the President. In

1953, the principle of consent articulated in the Nuremberg Code was adopted by
the Department of Defense in a Top Secret memorandum from Secretary of
Defense Charles Wilson regarding human research related to atomic, biological,
and chemical warfare (this document is known as the Wilson memorandum); in

1954, this application of the Nuremberg Code was expanded by the Army Office
of the Surgeon General as an unclassified policy for all research with "human
volunteers." A policy of requiring researchers to obtain consent was adopted by
the Clinical Center, the research hospital of the National Institutes of Health, in
1953; by the Atomic Energy Commission in 1956; and by the Air Force in 1958.
In the 1960s, all branches of the Department of Defense promulgated regulations
requiring the consent of healthy subjects, and the Isotopes Distribution Division
of the AEC included in its guide for researchers a requirement of consent from all
subjects. In 1966, the surgeon general of the Public Health Service issued a
policy requiring the consent of all subjects of research conducted or funded by
PHS; also in the late 1960s, the Veterans Administration codified in its operating
manual a requirement of consent from all research subjects. In 1972, the National
Aeronautics and Space Administration adopted similar consent requirements,
although exceptions were made for certain subject populations, such as
astronauts. In 1 974, the Public Health Service policy was promulgated as a
regulation for all contracts and grants of the Department of Health, Education,
and Welfare. The CIA did not formally adopt consent requirements until 1976,
when an executive order mandated that it follow the 1974 regulations of DHEW
concerning research involving human subjects.

4b. Research Involving Patient-Subjects: In an April 1947 letter, the AEC
general manager stated the AEC's understanding that AEC contract researchers

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would inform patient-subjects of the risks associated with a research intervention
and that patient-subjects express a willingness to receive the intervention. In a
second letter, written in November 1947, the general manager specifically
stipulated that the AEC require researchers to obtain "informed consent in
writing" from patient-subjects where "substances known to be or suspected of
being poisonous or harmful" were given to human beings. In 1948, the AEC
permitted the administration of "larger doses [of radioisotopes] for investigative
purposes," but only with the patient-subject's consent. In 1953, the NIH Clinical
Center required consent from all patient-subjects and specified that written
consent was to be obtained from patient-subjects involved in high- or uncertain-
risk experiments. In the early 1 960s, several government agencies adopted
consent provisions for investigational drugs; these requirements applied to some
radioisotope experiments with patients. In 1965, the AEC required that consent
be obtained from all subjects, including patient-subjects, who were administered
radioisotopes for experimental purposes, except when it appeared "not feasible"
or not in the patient's "best interest." By 1967, the VA required the consent of all
patient-subjects. As noted in Finding 4a above, in 1965 the AEC required that
consent be obtained from all subjects administered radioisotopes for experimental
or nonroutine uses. In 1966 the surgeon general of the Public Health Service
issued a policy requiring the consent of all subjects of research conducted or
funded by PHS, including patient-subjects. Exceptions to this requirement were
permitted for only certain kinds of social science research posing minimal risk. A
1972 NASA policy applied to all subjects of research, presumably including
patient-subjects. By 1973, all the branches of the military had promulgated
regulations requiring the consent of patient-subjects. In 1974, the PHS policy was
promulgated as a regulation for all contracts and grants of DHEW.

Finding 5

The Advisory Committee finds that government agencies did not
generally take effective measures to implement their requirements and
policies on consent to human radiation research.

Evidence of the implementation of the AEC's consent requirements stated
in April and November 1947 letters from the general manager is slim. A
document suggests that the April 1947 requirement for a signed statement from
two physicians testifying to consent was satisfied in at least one case. However,
the Advisory Committee did not find evidence that this or other requirements
stated in the 1947 letters were embodied as a provision of AEC contracts
involving human subject research or otherwise routinely communicated to
contract researchers. Further, there was no reference to the requirements stated in
these letters or to the letters themselves in the written material disseminated to

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researchers by the AEC's program for distributing radioisotopes for "human uses."
Moreover, requests for guidance concerning human use policies from
investigators at AEC-operated research facilities suggest that the 1947
requirements were not routinely disseminated. Subsequent requirements that
healthy subjects be informed volunteers and that consent be obtained from
seriously ill patients receiving higher doses of radioisotopes were more widely
communicated; we have not been able to determine the extent to which they were
actually implemented.

Secretary of Defense Wilson's February 1953 Top Secret memorandum
detailing requirements for research with human subjects was rewritten as an
unclassified June 1953 directive from the secretary of the Army. It is difficult to
determine why these requirements were applied to some activities and not to
others. For example, elements of some of these requirements appear to have been
implemented in some experiments conducted in conjunction with atomic bomb
tests and not in others. In 1954, these requirements were adopted by the Army
surgeon general as applicable to all research involving "human volunteers." This
1954 statement was transmitted to contractors as a "nonmandatory guide."
However, there is some evidence that the Army sought to include this statement
as a condition in at least some contracts.

Evidence of implementation of the NIH Clinical Center's 1953 policy
requiring that information be provided to and consent obtained from all subjects is
difficult to find; in most cases involving patient-subjects, documentation would
not have been required in writing. By contrast, the use of healthy subjects in the
Clinical Center required written consent and the "normal volunteer program"
appears to have involved greater supervision to ensure that consent was obtained
from these subjects.

Finding 6

The Advisory Committee finds that from at least 1946 some
government agencies had in place procedural mechanisms for reviewing the
acceptability of risks to human subjects from exposure to radioisotopes. By
1974, the government had policies requiring review of the acceptability of
risks to human subjects in other forms of research, including research
involving exposure to external radiation.

Beginning in 1946 the Manhattan Project, and from 1947 onward the
AEC, required some investigators seeking to conduct experiments using
radioisotopes supplied by the government to have the risks to subjects reviewed
by a committee at the irtstitution where the work was to be conducted and in some
cases by the AEC's Subcommittee on Human Applications as well. The AEC
required that local committees be composed of at least three physicians or

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researchers with relevant expertise regarding radiation safety and medical
applications. By 1949, it was clear that this policy applied to all investigators
using radioisotopes supplied by the AEC.

In 1953 prior group review for risk was also begun at the NIH Clinical
Center for proposed human research that involved unusual hazard. No such
requirement applied to research funded by NIH but conducted at universities and
other nongovernmental research facilities until 1966, when the PHS required that
all institutions establish a local peer review committee to evaluate the adequacy of
the protection provided to human subjects in each proposal. This requirement
was promulgated as an institutional policy by the DHEW in 1971.

In 1953, by adopting the Nuremberg Code, the secretary of defense and
the Department of the Army endorsed several principles intended to minimize risk
in research with human subjects, at least in regard to the atomic, biological, and
chemical warfare experiments that were subject to this policy. In the DOD, both
the purpose of proposed research and the level of risk were subjected to prior
review through the military chain of command. This was previously required by
the Navy at least from 1943, and the Air Force from 1952. However, the extent to
which these requirements covered particular research activities (such as healthy
subjects vs. patients; radioisotopes vs. external radiation) and particular
institutions (such as contractors vs. in-house research) differs and is difficult to
reconstruct. Also difficult to reconstruct is the extent to which the risk protection
principles of the Nuremberg Code were implemented. In the mid-1960s,
concurrent with the adoption of regulations related to investigational drug testing,
the DOD and each military service adopted provisions requiring the establishment
of a "review board" or committee to oversee proposed research projects involving
new drugs. In some cases, such as with the Air Force beginning in 1965, this
committee also served to evaluate all other proposals involving human subjects.
During this period, the VA also established a review board mechanism for
research involving new drugs and investigational procedures.

Finding 7

The Advisory Committee finds that the government program of
distributing radioisotopes for use in human subject research included
procedures for the review of risk. These were widely implemented by
researchers and institutions that used isotopes obtained from the AEC for
human experimentation. However, there is no evidence that a parallel
mechanism for reviewing the risks of research involving external radiation
was in place.

From its 1947 birth, the AEC, as part of its policy to promote the peaceful
use of radioisotopes, required private institutions that wished to obtain

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radioisotopes for "human uses" (including human experimentation as well as
patient treatment) to establish local review committees. These committees
reviewed proposed human uses under guidelines provided by the AEC's own
Subcommittee on Human Applications of the Advisory Committee on Isotope
Distribution Policy. This AEC subcommittee reviewed these applications,
providing a second level of oversight of risk. By 1949, the AEC's own labs were
required to establish local committees and to have human use applications,
reviewed by the same AEC Subcommittee on Human Applications. The control
of risk, and the assurance of safety to all those involved (including doctors and
other health care workers), was a primary purpose of the reviews. The Advisory
Committee lacked sufficient evidence to determine whether the system was
implemented in all of the many institutions that used government-supplied
radioisotopes for human subjects research or whether the system was always
adhered to in any particular institution.

In addition to providing for the review of research proposals, the AEC
dramatically increased the number of qualified personnel by offering training
courses in the safe handling and use of radioisotopes. As individual procedures
became routine, the degree of review was lessened; as specific institutions
became more experienced, more reviewing authority was delegated to them.

The primary function of the system was to reduce the physical hazards of
using radioisotopes, not to enforce any policies regarding consent of subjects.
(See chapter 6.)

Finding 8

The Committee finds that for the period 1944 to 1974 there is no
evidence that any government statement or policy on research involving
human subjects contained a provision permitting a waiver of consent
requirements for national security reasons.

Neither the AEC nor the DOD included national security exceptions in
their written rules on human subjects research. For example, the 1953 Wilson
memorandum adopting the Nuremberg Code was expressly applicable to human
experimentation related to atomic, biological, and chemical warfare and did not
provide for any "national security" exception.

The Committee notes that much documentation related to the CIA's
program of secret experimentation, including MKULTRA, has long since been
destroyed, and, therefore, we cannot state with certainty what policy(ies) underlay
human experiments in these programs or whether such policies included national
security exceptions.

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Finding 9

9a. The Advisory Committee finds that government agencies had no
requirements or policies to ensure equity in the selection of subjects for
research conducted or funded by the federal government during the period
1944 through 1974.

The only reference during this period to issues of equity in the selection of
subjects in agency documents reviewed by the Advisory Committee is in an
influential DHEW guide to recipients of federal research funds published in 1971,
popularly known as the Yellow Book. The Yellow Book notes a "particular
concern" about research involving "groups with limited civil freedom."

9b. Because of the limited data available on the universe of
experiments identified by the Committee, the Committee was unable to
determine whether during the period 1944 through 1974 people who were
socially disadvantaged were more likely than more socially advantaged
people to be used as subjects in human radiation experiments generally or in
those experiments that offered no prospect of medical benefit or posed
greater risks. The Advisory Committee finds, however, that some of the
biomedical experiments reviewed by the Committee that were ethically
troubling were conducted on institutionalized children, seriously ill and
sometimes comatose patients, African-Americans, and prisoners.

The Committee was troubled by the selection of subjects in many of the
experiments we reviewed. These subjects often were drawn from relatively
powerless, easily exploited groups, and many of them were hospitalized patients.
As noted in Finding 9a, there were during this period no federal rules or policies
directed at fairness in the selection of research subjects, and no norms or practices
within the biomedical research community specifically addressing considerations
of fairness. This silence on questions of justice in the conduct of human research
was characteristic not only of radiation research but also of the entire research
enterprise. While we note here cases that provoked concern, we were unable to
determine the extent to which there were systemic injustices in the selection of
research subjects in human radiation research because in most cases we were
unable to determine any of the characteristics of the subjects involved in the
experiments we catalogued.

Finding 10

The Advisory Committee finds that even as early as 1944 it was
conventional for physicians and other biomedical scientists to obtain consent

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from healthy subjects of research. By contrast, during the 1944-1974 period
but especially through the early 1960s, physicians engaged in clinical
research generally did not obtain consent from patient-subjects for whom the
research was intended to offer a prospect of medical benefit. Even where
there was no such prospect, it was common for physicians to conduct
research on patients without their consent. It also was common, however, for
physicians to be concerned about risk in conducting research on patient-
subjects and, in the absence of a prospect of offsetting medical benefit, to
restrict research uses of patients to what were considered low- or minimal-
risk interventions.

Perhaps the best-known example of the use of informed volunteers in
research conducted at the turn of the century is the yellow fever research by
military scientist Walter Reed. In the Advisory Committee's Ethics Oral History
Project, several of Reed's military successors who were active in the 1940s and
1950s gave similar examples of voluntary consent from healthy subjects in the
context of work on typhus and malaria. In 1946, the American Medical
Association (AMA) articulated the principle that human subjects must give
"voluntary consent." In 1947, the prosecution's expert witness at the Nuremberg
Medical Trial, Dr. Andrew Ivy, who had helped shape the AMA principle in
conjunction with his role at Nuremberg, asserted that this was a standard by
which physicians were guided in the use of human beings in medical experiments
and that this standard was in "common practice" prior to its articulation by the
AMA in 1946. Precisely what Ivy meant by this claim is unclear. Although there
are doubtless instances in which this standard of voluntary consent was not
followed, it does seem to have been widely recognized and adhered to among
investigators whose research involved healthy subjects.

By contrast, various sources confirm that it was not conventional to obtain
consent from patient-subjects. These sources include documents from the period
in which the conduct of clinical research was discussed as well as the
Committee's Ethics Oral History Project, in which physicians active in research in
the 1940s and 1950s agreed that consent played little or no role in research with
patient-subjects, even where there was no expectation that the patient would
benefit medically from the research. At the same time, however, there was also
agreement that, where patients were used as subjects in nontherapeutic research,
the research usually posed little or no risk to the patients.

Finding 11

11a. The Advisory Committee finds that the government and
government officials are morally responsible in cases in which they did not
take effective measures to implement the government's policies and

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requirements, and the medical profession and biomedical scientists are
morally responsible for instances in which they failed to adhere to the
professional norms and practices of the time.

The Advisory Committee was concerned that our conclusions about
actions taken in the past be rendered fairly. Clearly, if government agencies had
rules or requirements for the use of human subjects at the time, and if these
requirements were sound from our point of view and consistent with basic moral
principles, then agencies and agency officials had just as much moral
responsibility to implement those requirements as those in analogous positions
would have today, or in any day, with respect to current sound government
requirements.' We have found that some government agencies did in fact have
such requirements (see Findings 4 and 6).

Similarly, if the medical profession and the research community generally
had recognized norms and practices for the conduct of research with human
subjects, and if these norms and practices were sound, then physician-
investigators and other scientists operating in the past had just as much
responsibility to adhere to those norms and practices as those in analogous
positions would have today with respect to current norms and practices that are
morally sound. The Committee found evidence that the medical profession had
such norms with respect to obtaining consent from healthy subjects, although
physicians engaged in clinical research did not generally seek consent from
patient-subjects. The Committee also found evidence of professional norms
concerning acceptability of risk to subjects (see Finding 10).

lib. The Advisory Committee finds that by today's standards we
consider it wrong that our government did not take effective measures to
adequately protect the rights and interests of all human subjects of research.
We also find that by today's standards we consider it wrong that medical and
other professions engaged in human research did not have norms and
practices of consent for all subjects of research.

There is today a well-established consensus about the basic principles that
should govern the use of human subjects of research. There is also wide
agreement that the government has an obligation to protect the rights and interests
of all human research subjects and that the medical and other professions engaged
in research are obligated to have norms and practices of consent for all human
subjects of research. The failure to have such conditions in place would today be
considered wrong.

lie. The Advisory Committee finds that government officials and
investigators are blameworthy for not having had policies and practices in

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place to protect the rights and interests of human subjects who were used in
research from which the subjects could not possibly derive medical benefits
(nontherapeutic research in the strict sense). By contrast, to the extent that
there was reason to believe that research might provide a direct medical
benefit to subjects, government officials and biomedical professionals are
less blameworthy for not having had such protections and practices.

We also find that, to the extent that research was thought to pose
significant risk, government officials and investigators are more
blameworthy for not having had such protections and practices in place. By
contrast, to the extent that research was thought to pose little or no risk,
government officials and biomedical professionals are less blameworthy for
not having had such protections and practices.

Today we consider policies and practices to protect the rights and interests
of human subjects to be as important in research that offers participants a
prospect of medical benefit as in research that does not. Government regulations
and the rules of professional and research ethics apply equally to both kinds of
research. In the 1940s, 1950s, and 1960s, however, patients and society generally
accorded doctors more authority to make decisions for their patients than they do
today. It was both commonplace and considered appropriate for a physician to
determine what treatments a patient should receive without necessarily consulting
the patient, provided that the decision was based on the physician's judgment
about what would be in the patient's best interest. This authority generally
extended to decisions about whether a patient's interest would be served by being
a subject in medical research. Judgments about the blameworthiness of officials
and physician-investigators for not having had policies and practices to protect
the rights of human subjects in research that offered a prospect of medical benefit,
such as requirements of consent, are mitigated by this historical context.

However, even at the time, government officials and biomedical
professionals should have recognized that when research offers no prospect of
medical benefit, whether subjects are healthy or sick, research should not proceed
without the person's consent. It should have been recognized that despite the
significant decision-making authority ceded to the physician within the doctor-
patient relationship, this authority did not extend to procedures conducted solely
to advance science without a prospect of offsetting benefit to the person. This
finding is supported by the moral principle, deeply embedded in the American
experience, that individuals may not be used as mere means toward the ends of
others. We also note that at its 1947 beginning, officials of and biomedical
advisers to the AEC were clearly aware of the issues raised when patients, as well
as healthy people, were used as subjects in nontherapeutic research without their
consent.

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The Advisory Committee has also determined that government officials
and scientific investigators at the time recognized that research could put subjects
at risk of harm, that they had an obligation to determine that the risks imposed
were reasonable, and that research that posed greater or more uncertain risks was
more problematic than research whose risks were lower. Sometimes government
officials and investigators took steps to protect subjects from unnecessary or
unacceptable risks. These steps included in some cases a requirement of group
review of research proposals and the obtaining of consent of the subjects,
particularly where risks were considered worrisome. But these steps were not
consistently or uniformly taken.

Population Exposures

Finding 12

The Advisory Committee finds that some service personnel were used
in human experiments in connection with tests of atomic bombs. The
Committee finds that such personnel were typically exposed to no greater
risks than the far greater number of service personnel engaged in similar
activities for training or other purposes. The Committee further finds that
there is little evidence that the 1953 secretary of defense Nuremberg Code
memorandum was transmitted to those involved with human experiments
conducted in conjunction with atomic testing. However, some of the
requirements contained in the memorandum were implemented in the case
of a few experiments, apparently independently of the memorandum. The
Committee also finds that the government did not create or maintain
adequate records for both experimental and nonexperimental participants.

More than 200,000 service personnel participated in nuclear weapons tests
from 1946 to the early 1960s. The vast majority of those who participated were
engaged in management of the tests, training maneuvers, or data-gathering
activities. In the range of 2,000 to 3,000 of these participants were research
subjects. In many cases these research subjects engaged in activities, and were
subjected to risks, essentially identical to those engaged in by many more people
who were not research subjects. The purpose of this human subject research was
not to measure the biological effects of radiation. Rather, for example,
researchers sought to measure the psychological and physiological effects of
participation in bomb tests, the levels of radiation to which individuals who flew
in and around atomic clouds were exposed, and the effects of intense light from
the bomb blast on the eyes.

The Advisory Committee found little evidence that the 1953 Wilson
memorandum on human experimentation in connection with atomic, biological,

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and chemical warfare (or an Army implementing document) was transmitted to
those involved in bomb-test-related experimentation. In interviews with
Committee staff, some of those involved in the experimentation stated that they
were unaware of the memorandum. However, there is evidence that in some of
the experiments consent was provided for, but this was likely independent of the
1953 policy.

The military took successful precautions against exposure to radiation
levels that were likely to produce acute effects. However, bomb-test participants
were exposed to lower levels of radiation, which might conceivably have effects
on some participants over the longer term. The evidence shows that those who
managed the tests were aware of the potential, however small, that injury might
result years later from such exposures. In recent years, as the government and
veterans have sought to reconstruct the extent of exposure and resulting injury, it
has become apparent that the government did not uniformly create records that
would permit all individuals to efficiently and confidently know the extent of
their exposure, did not create records that would permit reconstruction of the
identity and location of all those who participated at the tests, did not adequately
undertake to link medical and exposure records, and did not adequately maintain
those records that were initially created.

Finding 13

The Advisory Committee finds that during the 1944-1974 period the
government intentionally released radiation into the environment for
research purposes on several hundred occasions. In only a very few of these
cases was radiation released for the purpose of studying its effect on humans.

The Advisory Committee's charter identified thirteen releases: one related
to the testing of intelligence equipment (the "Green Run"), eight radiological
warfare tests, and four releases of radioactive lanthanum ("RaLa") to test the
mechanism of the atomic bomb. The Advisory Committee received information
on more than sixty radiological warfare releases that took place in the period
1949-1952 and on the nearly 250 RaLa releases that took place in the period
1 944- 1961. We identified further intentional releases of a kind that were not
described in the charter. These included the release of radiation to study its
environmental pathways and the release of radiation in connection with outdoor
safety tests and tests related to the development of nuclear reactors, as well as to
the development of nuclear-powered rockets and airplanes.

Most releases took place in and around the sites that constitute the nation's
nuclear weapons complex, notably Oak Ridge, Tennessee; Hanford, Washington;
Los Alamos, New Mexico; the Nevada nuclear weapons test site; and the Idaho
National Engineering Laboratory. Releases related to radiological warfare tests

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took place primarily at the Dugway Proving Ground in Utah. Radioactive material
was also released into the environment for research purposes at other locations;
for example, fallout from the Nevada Test Site was inserted into the tundra of
Alaska.

Finding 14

The Advisory Committee finds that for both the Green Run (at
Hanford) and the RaLa tests (at Los Alamos), where dose reconstructions
have been undertaken, it is unlikely that members of the public were
directly harmed solely as a consequence of these tests.

It is impossible to distinguish any harm due to these releases from other
sources of exposure, particularly at Hanford, where the amount of radioactivity
intentionally released by the Green Run was 1 percent of the amounts released by
routine operations of the Hanford facility in the 1945-1947 period. The risks of
thyroid disease from all past operations of the Hanford plant are currently under
study; however, the Advisory Committee estimates that the contribution of the
Green Run to any such risks amounts to substantially less than one case. No dose
reconstruction has been undertaken for the radiological warfare field tests at the
Dugway Proving Grounds. Most of the intentional releases the Advisory
Committee has studied, including all those identified in our charter, involved
radioactive materials with short-enough half-lives that they quickly decayed and
therefore pose no risk to health from continuing exposure.

Finding 15

The Advisory Committee finds that during the period from 1944 to
about 1970 there was no system of environmental laws and regulations
governing the conduct of intentional releases analogous to that currently in
place. However, those responsible for intentional releases during this period
recognized the possible health risks from environmental releases and that
risks had to be considered in making policy decisions about such releases.

In the case of the Green Run, guidelines existed for routine (or normal
operating) environmental releases of radioactive iodine but were exceeded; in the
case of radiological warfare tests, a safety panel was created. These and other
releases specified in the Advisory Committee's charter were conducted in secret
because of a combination of concerns about national security and public reaction.
The Atomic Energy Act of 1954 began the formal public system of safety
regulation of environmental releases of radiation. It was not until the National

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Environmental Policy Act of 1969 that public review of federal actions likely to
have a significant impact on the environment was institutionalized.

Finding 16

The Committee finds that, as a consequence of exposure to radon and
its daughter products in underground uranium mines, at least several
hundred miners died of lung cancer and surviving miners remain at elevated
risk. As a consequence of a U.S. hydrogen bomb test conducted in 1954,
several hundred residents of the Marshall Islands and the crew of a Japanese
fishing boat developed acute radiation effects. Some of the Marshall
Islanders subsequently developed benign thyroid disorders and thyroid
cancer as a result of the radiation exposure. Surviving Marshallese also may
remain at elevated risk of thyroid abnormalities.

The miners, who were the subject of government study as they mined
uranium for use in weapons manufacturing, were subject to radon exposures well
in excess of levels known to be hazardous. The government failed to act to
require the reduction of the hazard by ventilating the mines, and it failed to
adequately warn the miners of the hazard to which they were being exposed, even
though such actions would likely have posed no threat to the national security.

Some Marshallese exposed during the 1954 bomb test received radiation
doses substantially in excess of those considered safe, both at the time and today.
One Marshallese exposed as a baby died of leukemia in 1972, which may have
been as a consequence of exposure during the test. In 1954, twenty-eight U.S.
servicemen manning a weather station on Rongerik Atoll also received doses of
radiation substantially in excess of those considered safe at the time and today.
The Advisory Committee does not know whether any of the servicemen suffered
long-term harm as a result of their exposure. Twenty-three Japanese fishermen
were irradiated as a result of the fallout from the 1954 bomb test. The exposed
Marshallese population received additional doses of radiation from later bomb
tests and residual radiation in the food chain, which continues to this day. The
U.S. government— initially the Navy and then the AEC and its successor agencies-
has provided care to the Marshallese ever since for radiation-related illnesses
while conducting research on this population to determine radiation effects. For
many years the distinction between research and clinical care was not adequately
explained to the Marshallese.

Finding 17

The Committee finds that since the end of the Manhattan Project in
1946 human radiation experiments (even where expressly conducted for

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military purposes) have typically not been classified as secret by the
government. Nonetheless, important discussions of human experimentation
took place in secret, and information was kept secret out of concern for
embarrassment to the government, potential legal liability, and concern that
public misunderstanding would jeopardize government programs. In some
cases, deception was employed. In the case of the plutonium injection
experiments, government officials and government-sponsored researchers
continued to keep information secret from the subjects of several human
radiation experiments and their families, including the fact that they had
been used as subjects of such research. Some information about the
plutonium injections, including documentation showing that data on these
and related human experiments were kept secret out of concern for
embarrassment and legal liability, was declassified and made public only
during the life of the Advisory Committee.

Human experimentation conducted during the Manhattan Project was
carried out in secret. Since 1947 (when the Atomic Energy Commission began
operations and the military services were unified under a secretary of defense)
human radiation experiments have rarely been protected as classified secrets.
However:

In 1947 AEC biomedical advisers publicly urged that biomedical research
be kept secret only where required by national security. At the same time, AEC
officials and advisers secretly determined that reports on human radiation
experiments should not be declassified where they contained information that was
potentially embarrassing or a cause of legal liability. Upon requests for
declassification, research reports involving human radiation experiments and
other human radiation exposures were reviewed for their effects on public
relations, labor relations, and potential legal claims.

In 1947 AEC officials and advisers conducted discussions about human
subject research policy; some of these discussions were conducted in secret
meetings, and the statements of requirements that were articulated, while not
secret, evidently were little disseminated. Similarly, 1949-1950 AEC/DOD
discussions of the terms on which human radiation experiments could be
conducted were either secret or the substance of the discussions was given limited
public distribution. In 1952, Department of Defense biomedical advisory groups
also engaged in secret or restricted discussions of policy, which led to the 1953
issuance of the Wilson memorandum, which was itself issued in Top Secret.

Government officials and experts did not squarely and publicly address
the existence and scope of government-supported human radiation
experimentation. For example, in the late 1940s and early 1950s the AEC denied
to the press and citizens that it engaged in human experimentation, even though

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the AEC's highly visible radioisotope distribution program had been created to
provide the means for, among other things, human experimentation.

Project Sunshine, a worldwide program of data gathering, including
human data gathering to measure the effects of fallout, was kept secret from its
1953 inception until 1956, and AEC officials and researchers employed deception
in the solicitation of bones of deceased babies from intermediaries with access to
human remains. It appears that concern for public relations played a key role in
keeping the human data gathering, and the very existence of Project Sunshine,
secret.

Finding 18

All the intentional releases identified in the Advisory Committee's
charter, as well as the several hundred other releases that were essentially of
the same types, were conducted in secret and remained secret for many years
thereafter. All involved some stated national security purpose, which may
have justified some degree of secrecy. Despite continued requests from the
public that stretch back well over a decade, however, some information
about intentional releases was declassified and made publicly available only
during the life of the Advisory Committee.

The Committee's review indicates that internal proposals that the public be
informed about the existence of the radiological warfare program were rebuffed
on grounds that public misunderstanding might jeopardize the program.

Citizens learned of the 1949 Green Run in 1986, and then only following
close review of documents requested from the government by members of the
public. Portions of a key surviving report on the Green Run were not declassified
until 1994. Similarly, although 250 intentional releases near the land of the
Pueblo Indians in New Mexico took place between 1944 and 1961, the Pueblo do
not appear to have been informed of the full scope of the program until 1994.
Documentation on these midcentury tests is only now being declassified.

Finding 19

The Advisory Committee finds that the government did not routinely
undertake to create records needed to ensure that secret programs could be
understood and accounted for in later years and that it did not adequately
maintain such records where they were created. The Committee further
finds that many important record collections (including records that were
not initially classified) have been maintained in a manner that renders them
practically inaccessible to those who need them, thereby limiting the utility of

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the records to the government itself, as well as the public's rights under the
Freedom of Information Act.

Where citizens are exposed to potential hazards for collective benefit, the
government bears a burden of collecting data needed to measure risk, of
maintaining records, and of providing the information to affected citizens and the
public on a timely basis. The need to provide for ultimate public accounting, as
was recognized by early AEC leadership, is particularly great where risk taking
occurs in agencies that do much of their work in secret. The government did not
routinely or adequately create and maintain such records for relevant human
radiation experiments, intentional releases, and service personnel exposed in
conjunction with atomic bomb tests.

Where records were initially created, important collections have been lost
or destroyed over the years. These include the classified records of the Atomic
Energy Commission's Intelligence Division; secret records that were kept in
anticipation of potential liability claims from service personnel exposed to
radiation;2 records relating to the secret program of experimentation conducted by
the CIA (MKULTRA); nonclassified records of VA hospitals regarding the
thousands of experiments that, the VA told the Advisory Committee, were
conducted there; and nonclassified files of the AEC's Isotope Distribution
Program relating to the many licenses for "human use" it granted in the period
1947 to 1955. The Committee notes that laws governing government records
provide for routine destruction of older records; however, we also found that
some records documenting the destruction of records had been lost or destroyed.

Public witnesses and others repeatedly expressed doubt to the Advisory
Committee about the credibility of the government's efforts to respond to requests
for documents. The Advisory Committee's experience indicates that
shortcomings in government response to Freedom of Information Act requests,
which may be interpreted by citizens as deliberate nondisclosure, may often occur
because the agencies themselves lack adequate road maps to the records that still
exist and lack records needed to determine whether collections of importance to
the public have been lost or destroyed. In the absence of the efforts put forth by
the Human Radiation Interagency Working Group, thousands of documents that
have now been made public would not have been located.

795

Part IV

Findings for the Contemporary Period

Biomedical Experiments

Finding 20

The Advisory Committee finds that human research involving
radioisotopes is currently subjected to more safeguards and levels of review
than most other areas of research involving human subjects. The Advisory
Committee further finds that there are no apparent differences between the
treatment of human subjects of radiation research and human subjects of
other biomedical research.

Today, research involving either external radiation or radioactive drugs
usually undergoes an additional layer of review for safety and risk. Most medical
institutions have a radiation safety committee (RSC) responsible for evaluating
the risk of radiation research and other medical activities and limitation of
radiation exposure of both employees and subjects. Research and medical
institutions that perform basic research involving human subjects and radioactive
drugs must also have studies reviewed and approved by a radioactive drug
research committee (RDRC), a local institutional committee approved by the
Food and Drug Administration, to ensure that safeguards in the use of such drugs
are met. These steps are in addition to the review of risks and benefits undertaken
for all research, whether radiation or nonradiation, by local institutional review
boards.

In the Advisory Committee's two empirical projects examining current
practices in human subject research, we found no meaningful differences between
radiation research and human research in other fields.

Finding 21

The Advisory Committee finds that today research involving human
subjects sponsored by the government may be classified and conducted in
secret, but it must comply with the provisions of the Common Rule.

It is permissible today to perform classified research on human subjects,
although it is our understanding that classified research occurs relatively rarely.
Like unclassified research, such research is covered by the protections enunciated
in the Common Rule. There may be significant problems in the application of the
Common Rule to classified research, however. One problem concerns the
possible need for security clearances if institutional review boards are to
appropriately protect the interests of human subjects. Written guidance on this

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Chapter 1 7

question differs among the agencies. Of particular concern is whether only those
members of the IRB who are employees of the agency will possess security
clearances and thus be able to participate in reviewing classified projects.

Another issue of concern is that for classified research involving no more
than minimal risk, as with any such research, the Common Rule allows IRBs to
waive any or all elements of informed consent if, among other things, it is not
practicable for the research to be carried out without such a waiver.* The
Committee believes, however, that research conducted in secret should never be
permitted on human subjects without the subjects' informed consent. The question
of what must be disclosed to potential subjects in order for them to make an
informed decision about participating in classified research, including whether an
adequate disclosure can be made to people who do not have security clearances, is
an important issue not addressed in the Common Rule.

Finding 22

The Advisory Committee finds that, in comparison with the practices
and policies of the 1940s and 1950s, there have been significant advances in
the protection of the rights and interests of human subjects of biomedical
research. However, we also find that there is evidence of serious deficiencies
in some parts of the current system for the protection of the rights and
interests of human subjects.

Based on the Advisory Committee's review, it appears that about 40 to 50
percent of human subjects research poses no more than minimal risk of harm to
subjects. In our review of research documents that bear on human subjects issues,
we found no problems or only minor problems in most of the minimal-risk studies
we examined. In our review of documents we also found examples of
complicated, higher-risk studies in which human subjects issues were carefully
and adequately addressed and that included excellent consent forms. In our
interview project, there was little evidence that patient-subjects felt coerced or
pressured by investigators to participate in research. We interviewed patients
who had declined offers to become research subjects, reinforcing the impression
that there are often contexts in which potential research subjects have a genuine
choice.

'Common Rule, . 1 1 6(d). Under the Common Rule, four requirements must

be met for an IRB to waive the rule's informed consent requirements: "(1) the research
involves no more than minimal risk; (2) the waiver or alteration will not adversely affect
the rights and welfare of the subjects; (3) the research could not practicably be carried
out without the waiver or alteration; and (4) whenever appropriate, the subjects will be
provided with additional pertinent information after participation."

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PartIV

At the same time, however, we also found in our review of documents
examples in which human subjects issues were carelessly and inadequately
addressed. These disparities suggest that there is substantial variation in the
performance of institutional review boards.

We found serious deficiencies in our review of research proposal
documents in several areas central to the ethics of research involving human
subjects. Specifically, these documents often failed to provide sufficient
information with which judgments could be made about the likely voluntariness
of participation and about the characteristics of and justification for the subjects
selected for study. It also was often difficult to assess, again because of
insufficient information, whether the likely merits of the research warranted the
imposition of risk or inconvenience on human subjects. We also found serious
deficiencies in many of the consent forms we reviewed, including the consent
forms of some minimal-risk studies.

Most of the Advisory Committee's concerns focus, however, on research
that exposes subjects to greater than minimal risk. We found evidence of
confusion over the distinction between research and therapy in interviews with
patients, in the research documents reviewed, and in public testimony. This
confusion appears to be borne out of a combination of trust in physicians and an
inadequate understanding of the differences among innovative practice,
therapeutic research, and accepted modes of therapy. The Advisory Committee's
empirical studies suggest that there is reason to worry that patient-subjects who
have serious illnesses may have unrealistic expectations both about the possibility
that they will personally benefit by being a research subject and about the
discomforts and hardships that sometimes accompany research.

The Advisory Committee is also concerned about research we reviewed
involving adult subjects of questionable capacity. In the documents made
available to the Advisory Committee, there was little discussion of the
implications of diminished capacity for the process of consent and authorization
to participate in research, even in studies that appeared to offer no prospect of
medical benefit to subjects. In addition, the Advisory Committee is concerned
about the failure of federal regulations to address the conduct of research
involving institutionalized children.

Population Exposures

Finding 23

The Advisory Committee finds that events that raise the same
concerns as the intentional releases in the Advisory Committee's charter

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Chapter 1 7

could still take place in secret under current environmental laws and
regulations.

Today the law provides that environmental reviews may be conducted in
part or even in whole in secret, thereby eliminating provision for public notice
and comment. In classified programs, the government must still comply with
environmental standards, and the Environmental Protection Agency must oversee
and review environmental compliance. However, the EPA has not maintained
records of environmental releases where the reviews were conducted in whole or
in part in secret. Environmental laws and regulations that limit quality or quantity
of a release also contain provisions allowing exemptions for national security. In
principle, the President or the secretary of energy (in the case of the Atomic
Energy Act) could invoke these exemptions to permit releases that would
otherwise exceed risk standards.

799

ENDNOTES

1. The qualification of agency officials' responsibility to implement "sound"
requirements refers to the moral quality of the requirements. There may be other reasons
for a society to hold its government officials responsible for implementing duly
authorized rules, such as prudential needs for orderliness and predictability. But we
would not hold an official morally blameworthy for failing to implement a requirement
that is morally unsound. In that case his or her role-related responsibilities are
superseded by basic ethical principles.

2. As discussed in chapter 10, the precise nature of all the records that were kept
remains to be determined.

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18

RECOMMENDATIONS

Recommendations for Remedies Pertaining to Experiments and
Exposures During the Period 1944-1974*

Biomedical Experiments

Recommendation 1

The Advisory Committee recommends to the Human Radiation
Interagency Working Group that the government deliver a personal,
individualized apology and provide financial compensation to the subjects
(or their next of kin) of human radiation experiments in which efforts were
made by the government to keep information secret from these individuals
or their families, or from the public, for the purpose of avoiding
embarrassment or potential legal liability, or both, and where this secrecy
had the effect of denying individuals the opportunity to pursue potential
grievances.

The Advisory Committee has found three cases to which the above
applies. These are the surviving family members of:

*In preparing these recommendations, the Advisory Committee addressed only
the question of whether the federal government owes remedies to subjects or their
surviving immediate family members. The remedies identified below are not intended to
preclude any remedies that subjects or their family members may otherwise be entitled to
from nonfederal institutions or from individuals.

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Part IV

1 . The eighteen subjects of the plutonium injection experiments;

2. The subject of a zirconium injection experiment, known only as
Cal-Z; and

3. Several subjects of total-body irradiation experiments conducted
during World War II.1

Deliberate attempts by public officials in trusted and often sensitive
government positions to conceal the fact of participation from subjects or their
families, particularly in the absence of sufficient national security justification
and for the declared purpose of avoiding potential liability and public
embarrassment, are assaults upon the foundations of individual privacy and self-
determination. Such actions violate an individual's right to information about
him- or herself and must be taken with the utmost seriousness.

In the cases listed above, this secrecy served to prevent people who may
have been wronged from seeking redress within their lifetimes. Secrecy
regarding the participation of particular subjects was maintained until as late as
1974. Documents showing that the government kept information secret about
particular 1940s experiments on grounds of potential liability and embarrassment
remained secret until retrieved by the committee in 1994. Even though at the time
justice might not have required financial compensation for the failure to disclose
information in the absence of direct physical harm, the fact that the government's
actions limited the opportunity of these subjects to seek justice is undeniable.
Because of the offensiveness of the government's actions, justice today warrants a
remedy of financial compensation.

Moreover, efforts to cover up governmental wrongdoing are assaults upon
the polity itself, and not just upon the directly affected individual, because such
efforts undermine the ability of a civil society to ensure that the government and
its agents act within the rule of law. Such a situation warrants the extension of
compensation to the next generation.

Implementation:

Congress may need to consider legislation to provide compensation for the
immediate families of the subjects in the plutonium injection experiments whose
identities are known. The identities of the subject known as Cal-Z, as well as the
subjects in the wartime total-body irradiation experiments, are not now known.
Should their identities come to light, they or their families also should be
compensated. In addition, should additional cases be identified that satisfy the
criteria outlined above, further legislation should be enacted or other steps taken
to provide those individuals or their family members with similar compensation.

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Chapter 18

Recommendation 2

The Advisory Committee recommends to the Human Radiation
Interagency Working Group that for subjects of human radiation
experiments that did not involve a prospect of direct medical benefit to the
subjects, or in which interventions considered to be controversial at the time
were presented as conventional or standard practice, and physical injury
attributable to the experiment resulted, the government should deliver a
personal, individualized apology and provide financial compensation to cover
relevant medical expenses and associated harms (pain, suffering, loss of
income, disability) to the subjects or their surviving immediate family
members.*

The Advisory Committee has identified several experiments that are
candidates for remedies to former subjects under this recommendation; these are
described below in the section on implementation.

When the government puts an individual at risk in order to serve some
collective national interest, it must take steps to ensure that the rights and interests
of the individual are adequately protected. The Advisory Committee presumes,
however, based on our understanding of the historical context, that such steps
were not uniformly undertaken. As a consequence, it is possible that a citizen
who was harmed as a result of participation in nontherapeutic research did not
adequately consent to this use of his or her person. That the government did not
have a system in place to ensure that individuals were not wronged by their use as
research subjects in nontherapeutic research without their adequate consent, when
that use resulted in harm, warrants a personal, individualized apology and
financial compensation to subjects or to their surviving immediate family
members.

Analogous cases exist to support this recommendation. In awarding
substantial compensation to victims (or their families) of the CIA's MKULTRA
experiments who were killed or suffered other serious harm, Congress and the

* The Advisory Committee was convened in response to concerns about human
radiation experiments that offered no prospect of medical benefit to human subjects. In
our historical analysis, the experiments we investigated either offered no prospect of
medical benefit or they involved interventions alleged to be controversial at the time (see
Overview to Part II). As a consequence, the Advisory Committee focused its
consideration of remedies for subjects of human radiation experiments only on those
experiments that fit these descriptions. The Committee makes no recommendations
about whether, or under what conditions, remedies are appropriate for subjects of human
radiation experiments that were considered at the time to offer a plausible prospect of
medical benefit to subjects.

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Part IV

courts recognized that individuals used for government purpose without direct
benefit to the experimental subject and without their consent deserved substantial
awards.2

Nothing in this recommendation should be taken as having implications
for how future policies governing compensation for research injuries should be
constructed.

Implementation:

Of the experiments that the Advisory Committee studied in detail, we
have identified several that are candidates for remedies under this
recommendation. These are as follows: the total-body irradiation (TBI)
experiments (should it be determined that TBI was considered at the time to be a
controversial treatment for patients with "radioresistant" tumors, and it was not
presented as such to potential subjects, and should a determination of harm
attributable to the experiments be made); the testicular irradiation experiments
using prisoners as subjects (should a determination of harm attributable to the
experiments be made); the uranium injection experiments at Rochester and
Boston (should a determination of harm attributable to the experiments be made);
and some of the iodine 131 experiments involving children (should a
determination of harm attributable to the experiments be made). Because of the
scope of the Advisory Committee's charge and our limited tenure, we were not in
a position to undertake the individualized and detailed fact-finding required to
resolve the uncertainties in each of these cases, including the evaluation of
medical and research records of all the patients or subjects involved.

In addition, two experiments that the Committee did not study in detail,
the iodine 131 experiment in Alaska and the Vanderbilt radioiron nutrition
experiments, are currently in legal proceedings in which claims of harm have
been made.

If an appropriate forum such as the courts or a properly constituted review
committee determines that subjects were harmed as a consequence of
nontherapeutic research, or as a consequence of research in which controversial
treatments were presented to patients as conventional or standard therapy, it is the
Advisory Committee's view that the government should take steps to ensure that
the remedies of apology and financial compensation are awarded.

The question of causation is key to any such determination. The Advisory
Committee has heard from many public witnesses regarding the standards of
proof and presumptions involved in the administration of existing radiation
compensation statutes, which cover atomic bomb testing and uranium mining. In
those cases the nature of the exposure for all applicants is relatively uniform and
well defined, and the exposures have been the subject of a relatively large amount
of study; by contrast, in the case of human radiation experiments, each
experiment may present a different set of circumstances. In some cases, as in the

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Chapter 18

administration of iodine 131, there is considerable knowledge of the relation
between exposure and subsequent injury. In many other situations, less is known.

A decision should be made about how strict a causal association ought to
be required, with a more strict standard making financial compensation available
to fewer individuals. Whether the standard for presuming "causation" should be
strict or loose is a policy decision that depends on values, not science. The
standards/values problem speaks both to what should be done about whether the
illness should be treated as experiment-related for purposes of compensation if (1)
it is impossible to determine the likely range of association between the exposure
and the illness (because the facts about dose or method of exposure are not
available); and (2) the likely range of association is broad or the probability of
association between the exposure and the illness is low.

To determine reasonable medical expenses, a schedule of projected
medical costs appropriate for reimbursement could be created for specific
diagnoses, rather than compensating for actual costs incurred. This approach
would relieve the burden on the subject or immediate family members to prove
actual costs, streamline the process for determining level of compensation, and
allow for compensation for costs not yet incurred.

Recommendation 3

The Advisory Committee recommends to the Human Radiation
Interagency Working Group that for subjects who were used in experiments
for which there was no prospect of medical benefit to them and there is
evidence specific to the experiment in which the subjects were involved that
(1) no consent, or inadequate consent, was obtained, or (2) their selection as
subjects constituted an injustice, or both, the government should offer a
personal, individualized apology to each subject.*

The Committee believes that people who were used as research subjects
without their consent were wronged even if they were not harmed. Although it is
surely worse, from an ethical standpoint, to have been both harmed and wronged
than to have been used as an unwitting subject of experiments and suffered no
harm, it is still a moral wrong to use people as a mere means without their
consent. Although what we know about the practices of the time suggests it is
likely that many people who were subjects in nontherapeutic research were used
without their consent or with what today we would consider inadequate consent,
in most of these cases we have almost no information about whether or how

*For a discussion of the Committee's deliberations about this recommendation,
see "Overview to Part IV."

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PartIV

consent was obtained. Moreover, in most of these cases, the identities of the
subjects are not currently known; even if considerable resources were expended,
it is likely that most of their identities would remain unknown.

The Committee is not persuaded that, even where the facts are clear and
the identities of subjects known, financial compensation is necessarily a fitting
remedy when people have been used as subjects without their knowledge or
consent but suffered no material harm as a consequence; the remedy that emerged
as most fitting was an apology from the government.

The Committee struggled with the issue of whether to recommend that the
government extend such an apology. Our deliberations were complicated by what
we all agreed was a murky historical record. In the case of some experiments,
there was evidence of some disclosure or some attempt to obtain consent, and the
issue emerged as to how poor these attempts must be for an apology still to be in
order. In the great majority of cases, there was simply too little documentary
evidence to draw any conclusions about disclosure or consent. In most cases, as
noted above, the identities of subjects are unknown and are unlikely to be
uncovered even with a substantial expenditure of resources.

What kind of evidence is necessary to determine that an apology is
warranted? In the preceding recommendation, the remedy is linked to evidence of
harm to particular individuals. While requiring evidence of harm specific to
individuals, we did not require such specific evidence of lack of consent. Rather,
in that recommendation, we presumed that the government did not uniformly
undertake steps to ensure that the rights and interests of individual subjects were
adequately protected, and thus that it is possible that people who were harmed as
a result of participation in research did not adequately consent to this use of their
person. In this recommendation, by contrast, a remedy is linked to a showing that
people were wronged, not harmed. Thus the Committee believes that an apology
should be offered only where there is evidence specific to an experiment or
subject that no consent, or inadequate consent, was obtained, or the subject's
selection constituted an injustice, or both.

The Committee believes that, among those experiments we have had the
opportunity to review in depth, there is sufficient evidence that wrongs were
committed against the children who participated in the experiments at the Fernald
School. This case is discussed in detail in chapter 7.*

In recommending an apology to individuals who were subjects of these
experiments, the Committee wishes to emphasize that there are likely many other

* Several other experiments studied by the Committee are candidates for
remedies under Recommendation 2. Where it is determined that subjects in these
experiments were not harmed, they may be due an apology under this recommendation if
it is determined that they were wronged.

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Chapter 18

instances in which an apology is warranted but for which experiment-specific
factual support is not currently available.3

Recommendation 4

In the research that we reviewed for this recommendation, the
Advisory Committee has found no subjects of biomedical experiments for
whom there is a need to provide notification and medical follow-up for the
purpose of protecting their health. In the event that other experiments of
concern come to light in the future, we recommend to the Human Radiation
Interagency Working Group that subsequent decisions for notification be
based on evaluation of both the level of risk from radiation exposure and the
potential medical benefit from medical follow-up in exposed individuals.

Additionally, the Advisory Committee has found no evidence to
indicate that the subjects of human radiation experiments we reviewed
would have had greater likelihood of incurring heritable (genetic) effects
than the general population and thus does not recommend notification or
medical follow-up for descendants of subjects of human radiation
experiments.

In formulating this recommendation, the Advisory Committee considered
those subjects for whom there is a significant risk of developing a radiation-
related disease that has not yet occurred, or has occurred but may still be
undetected or untreated, and in whom there might be an opportunity to prevent or
minimize potential health risks through detection and treatment. In considering
notification, we focused only on biomedical experiments, as stated in our charter.

The Advisory Committee based its present recommendation on the
specific guidelines stated below and recommends that future decisions for
medical notification and follow-up of subjects of government-sponsored human
radiation experiments not examined by the Committee, or that have not yet come
to light, be based on these same guidelines, as follows:

1 . The subject was placed at increased lifetime risk for development

of a fatal radiation-induced malignancy. The level of increased
risk was set by the Advisory Committee at 1/1,000 remaining
lifetime risk and an excess relative risk of greater than 10 percent
(organ specific). This level of risk was arbitrarily chosen by the
Advisory Committee. When compared with the normal risk of
dying of cancer (220 out of 1,000), this level of risk is small. The
Advisory Committee chose this small remaining lifetime risk as a
reasonable initial criterion to decide if an analysis of the utility of
screening and intervention (criterion 2 below) was needed.

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PartIV

2. There is a recognized medical benefit from early detection and
treatment of the cancer, which outweighs whatever medical risks
are associated with detection and treatment interventions. In
addition, the government should consider the public health and
financial costs as well as the potential benefits before making a
decision to offer such a notification and screening program.

Eligible subjects for whom medical follow-up to protect health is
recommended should be notified of their participation in a human radiation
experiment, and voluntary screening programs offered to them. Such a program
should include adequate disclosure of both the nature of the potential benefits as
well as the potential risks of medical follow-up, which might include some of the
following aspects:

• medical harm, discomfort, inconvenience, or anxiety from the screening
test itself or subsequent follow-up exams;

• the possibility of incorrect test results, either false positive or false
negative;

• the possibility of stigmatization by friends, family, employers, or
life/health insurance carriers;

• the costs to themselves of the screening program (if any) and subsequent
medical tests and treatments.

Thus the Advisory Committee's recommendations for notification and
medical follow-up of individuals who were subjects of a human radiation
experiment depend equally on risk estimates and the medical utility of early
detection and treatment for changing the course of disease or the quality or length
of life in such an exposed individual, as shown in the accompanying table.

The Advisory Committee database includes articles and other documents
describing approximately 4,000 government-sponsored human radiation
experiments. Because of the limited data available on most of these, and the
Advisory Committee's limited resources, it has not been feasible for the Advisory
Committee to systematically apply the two criteria described above to the
majority of experiments identified within its database. The Advisory Committee
therefore selected for review types of experiments that seemed most likely to
include subjects who might still be alive and meet the risk criteria chosen by the
Committee and who might medically benefit from notification and medical
follow-up.

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DETERMINATION OF THE NEED FOR NOTIFICATION
AND MEDICAL FOLLOW-UP

Risk Analysis
(For Development of Fatal Cancer)

Remaining Lifetime Risk
* 1/1,000 AND RRa 10%

Remaining Lifetime Risk
< 1/1,000 OR RR< 10%

Medical Benefit from
Early Detection and
Treatment

Yes

RECOMMEND
NOTIFICATION AND
MEDICAL FOLLOW-UP

NO NOTIFICATION

No

NO NOTIFICATION

NO NOTIFICATION

Specifically, the Advisory Committee has reviewed twenty one studies
involving three types of experiments:

1 . Children who received iodine 131;

2. Prisoners subjected to testicular irradiation; and

3. Children and military personnel exposed to nasopharyngeal radium
treatments.

Following this detailed analysis, the Advisory Committee concluded that
none of the experiments examined satisfied both of the guidelines identified in
this recommendation. If in the future new methods of screening are developed or
new information about increased risk is discovered, then these experiments
should be reevaluated to assess whether they meet the criteria. (For a full
discussion, see the addendum on medical notification and follow-up at the end of
this chapter.)

Though it was beyond the scope of the Advisory Committee to evaluate
individually all the experiments in our database, the results of our review of these
carefully selected studies suggest that the remaining experiments would be
unlikely to meet the proposed criteria for notification and medical follow-up.
However, another important group of studies not considered in detail by the
Advisory Committee were tracer studies in pregnant and nursing women.

It is possible that experiments that would satisfy the Committee's criteria
for notification and medical follow-up will be identified. Implementation of a
notification and medical follow-up program would have to be done carefully if a
follow-up program is to provide former research subjects with greater health
benefit than harm. Considerable effort would be needed to educate both subjects
and physicians about the realistic benefits and the possible harms of medical

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PartIV

follow-up, as well as the specific screening modalities and follow-up care that
would be indicated. It is particularly important to distinguish follow-up that is
intended to benefit medical science from follow-up that is intended to medically
benefit patients. An additional concern is that, for most experiments, no list of
subjects exists. Performing screening tests in people who are incorrectly
identified as having an increased risk is unlikely to result in any benefit and may
result in harm.

The Advisory Committee also recognizes that individuals who have
received therapeutic radiation treatments, either in a purely clinical setting or
research setting, may have been exposed to substantially higher doses of radiation
and should seek medical follow-up pursuant to the advice of their treating
physician.

With regard to the need to notify descendants of subjects of human
radiation experiments of potential genetic effects, it is likely that the risk of
radiation-induced mutations is small in relation to natural rates. Thus it would be
impossible to distinguish whether the condition was caused by the parent's
radiation exposure or by other factors. Based on these considerations, the
Advisory Committee does not recommend notification and medical follow-up for
descendants of subjects of radiation experiments.

In the event that specific genetic effects attributable to radiation exposure
could be identified in a particular population of descendants at some future time,
the guidelines would be the same as those previously outlined for subject
populations— there would need to be evidence to indicate that early intervention
would change the course of a particular disease before notification and follow-up
would be recommended.

Population Exposures

In recent years Congress has enacted a body of laws to provide relief to
service personnel exposed to radiation in connection with atmospheric nuclear
tests, citizens who lived downwind from the tests, and workers who mined
uranium to be used by the government in nuclear weapons production. These
include the Veterans Dioxin and Radiation Exposure Compensation Standards
Act of 1984, the Radiation-Exposed Veterans Compensation Act of 1988, and the
Radiation Exposure Compensation Act of 1990.

In the Committee's view, these existing laws provide the framework on
which to base continued provision for relief. In the interim since these laws were
passed, experience with the laws and more current scientific knowledge strongly
suggest the need for revisiting the laws and their administration and for extending
their coverage to similarly situated groups—such as those exposed to intentional
releases— who are not now covered.

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Chapter 18

The following recommendations address the circumstances of groups
exposed to intentional releases, service personnel who were exposed in
connection with nuclear weapons tests, and workers who mined uranium for use
in government programs. We also address the circumstance of the citizens of the
Republic of the Marshall Islands, for whom a different framework of remedies
has been fashioned.

Recommendation 5

The Advisory Committee recommends to the Human Radiation
Interagency Working Group that it, together with Congress, give serious
consideration to amending the provisions of the Radiation Exposure
Compensation Act of 1990 to encompass other populations environmentally
exposed to radiation from government operations in support of the nuclear
weapons program, should information become available that shows that
areas not covered by the legislation were sufficiently exposed that a cancer
burden comparable to that found in populations currently covered by the
law may have resulted.

The Advisory Committee did not have the time or resources to undertake
our own epidemiologic studies of the cancer burden surrounding the Hanford
facility in Washington state, where the Green Run took place. The preliminary
radioiodine dose estimates now available raise the issue of whether the releases
from Hanford may have caused cancers. The Advisory Committee found that the
Green Run itself contributed only a very small portion of that cancer burden, so
small that it would be impossible to attribute any cancers to the Green Run as
opposed to other sources (including routine Hanford releases). The Advisory
Committee believes that in addressing the Green Run intentional release, the
appropriate response is to redress injury without regard to whether exposures
were in the course of routine or research activities. There would be no practical
way to make this distinction, if it were desired. We also note that the Radiation
Exposure Compensation Act provides relief for downwinders and uranium miners
without regard for whether they were subjects of research (and in many cases they
were not).

Recommendation 6

The Advisory Committee recommends to the Human Radiation
Interagency Working Group that it, together with Congress, give serious
consideration to reviewing and updating epidemiological tables that are
relied upon to determine whether relief is appropriate for veterans who
participated in atomic testing so that all cancers or other diseases for which

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PartIV

there is a reasonable probability of causation by radiation exposure during
active military service are clearly and unequivocally covered by the statutes.

Congress has provided for compensation for veterans who participated in
atmospheric atomic tests or the American occupation of Hiroshima or Nagasaki,
Japan. The provision of compensation depends on evidence that the veteran has
sustained disability from a disease that may be related to radiation exposure.

The Veterans Dioxin and Radiation Exposure Compensation Standards
Act of 1984 required the Veterans Administration to write a rule governing
entitlement to compensation for radiation-related disabilities. The resulting
regulation contains criteria for adjudicating radiation claims, including
consideration of a radiation-dose estimate and a determination as to whether it is
at least as likely as not that the claimed disease resulted from radiation exposure.
The Radiation-Exposed Veterans Compensation Act of 1988 provides that a
veteran who was present at a designated event and subsequently develops a
designated radiogenic disease may be entitled to benefits without having to prove
causation.4

The Committee recommends that the radioepidemiological tables prepared
by the National Institutes of Health in 1985, which identify diseases that may be
causally connected to radiation exposures, be updated. The Committee
understands that the Department of Veterans Affairs agrees with this
recommendation.

The Advisory Committee further recommends to the Human
Radiation Interagency Working Group that it review whether existing laws
governing the compensation of atomic veterans are now administered in
ways that best balance allocation of resources between financial
compensation to eligible atomic veterans and administrative costs, including
the costs and scientific credibility of dose reconstruction.

While the Committee's inquiry focused on participants at atmospheric
testing who were subjects of experimentation, the Committee found that the risks
to which experimental subjects were exposed were typically similar to those to
which many other test participants were subjected. Those service members who
were participants in the experiments reviewed by the Advisory Committee would,
as veterans of atmospheric atomic tests, be eligible for relief under the laws
enacted in 1984 and 1988, as amended, concerning radiation-exposed veterans.

The Committee found that the government did not create or maintain
adequate records regarding the exposures of all participants, the identity and test
locale of all participants, and the follow-up, to the extent it took place, of test
participants. Witnesses before the Advisory Committee, and others who
communicated with us by mail, telephone, and personal visit, expressed strong

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concerns about the adequacy and operation of the current laws, including,
specifically, record-keeping practices. Although the Committee did not have the
time or resources to pursue these concerns to the degree they merit, we believe
that the concerns expressed by veterans and their family members deserve
attention, and we urge the Human Radiation Interagency Working Group in
conjunction with Congress to address these concerns promptly. The concerns
reported to us include the following:

1 . The listing of diseases for which relief is automatically provided-
the "presumptive" diseases provided for in the 1988 law— is
incomplete and inadequate.

2. The standard of proof for those without a presumptive disease is
impossible to meet and, given the questionable condition of the
exposure records retained by the government, inappropriate.

3. The statutes are limited and inequitable in their coverage; for
example, the inclusion of those exposed at atmospheric tests does
not protect those who were exposed to equal amounts of radiation
in activities such as cleanup at Enewetak atoll.

4. The time and expense needed to prosecute a claim is too great. For
example, veterans whose claims are initially denied at the VA
regional offices and are seeking appeal of the initial decision
receive a form letter stating that it will take at least twenty-four
months to process their appeal.

5. Time and money spent on contractors and consultants in
administering the program would be better spent on directly aiding
veterans and their survivors.

Recommendation 7

The Advisory Committee recommends to the Human Radiation
Interagency Working Group that it, together with Congress, give serious
consideration to amending the provisions of the Radiation Exposure
Compensation Act of 1990 relating to uranium miners in order to provide
compensation to all miners who develop lung cancer after some minimal
duration of employment underground (such as one year), without requiring a
specific level of exposure. The act should also be reviewed to determine
whether the documentation standards for compensation should be
liberalized.

The uranium miners were exposed to extremely high levels of radon
daughters, which were recognized at the time to be hazardous yet were not
controlled by the government, despite the availability of feasible means to

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ventilate the mines. Furthermore, the government studied the miners without
disclosing the purposes of the examinations or warning them of the hazards to
which they were exposed. As a result of their continued exposure, hundreds of
miners developed lung cancer or nonmalignant respiratory diseases that could
have been prevented, and many of them have died.

In recognition of this tragedy, Congress included provisions for
compensating certain uranium miners in the Radiation Exposure Compensation
Act of 1990 (RECA). However, the criteria for compensation set in this act were
far more stringent than for the two other groups (atomic veterans and
downwinders of the Nevada Test Site) for which compensation was provided,
despite the fact that the risks were far higher for the uranium miners.

Since 1990, additional scientific information has become available to
support the view that radon exposure is responsible for a much higher proportion
of the lung cancer cases among the miners than had been previously thought. In
particular, the act's current requirement of a minimum of 200 WLM (working
level months) exposure for nonsmokers or 300 to 500 WLM (depending on age)
for smokers translates to quite large probabilities of causation, according to a
recent report by the National Cancer Institute.5 That analysis finds little evidence
to support a distinction between smokers and nonsmokers and suggests that a
majority of lung cancer deaths among Colorado white miners and New Mexico
Navajo miners are attributable to radon exposure. Furthermore, it finds that the
lung cancer risk is strongly modified by a number of factors and uncertainties that
are not accounted for in the total dose; thus, for many miners, the level of
exposure that would merit compensation on the basis of the principle of "balance
of probabilities" might be far lower than the present criteria. In particular, no
exposure measurements are available for 90 percent of the years in most mines, so
that any requirement to reconstruct exposure histories is likely to require some
degree of extrapolation or estimation and be quite uncertain. Furthermore, many
mines have since gone out of business, so that records needed to establish an
exposure history are simply unavailable.

Also since 1990, there has been considerable experience with the
administration of the act, and apparently much of it has been negative. The
Advisory Committee took extensive testimony regarding the difficulties faced by
miners in meeting the documentation requirements, particularly those related to
the requirement to provide a reconstruction of their radon dose. For these
practical reasons, and in light of the additional information, we suggest that the
requirement that a miner demonstrate that he had been exposed to a certain
minimum cumulative dose be replaced by a simple requirement that he worked
underground for a certain minimum length of time. Since more than half the lung
cancer deaths in the cohort who worked at least one month underground appear to
be attributable to radon, we suggest that minimum length of service be set quite
low, preferably not more than a year. At most this should then lead to

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compensation being awarded to twice as many miners as would be entitled to it
under the balance of probabilities principle, while not denying it to any who are
entitled to it.

The grave injustice that the government did to the uranium miners, by
failing to take action to control the hazard and by failing to warn the miners of the
hazard, should not be compounded by unreasonable barriers to receiving the
compensation the miners deserve for the wrongs and harms inflicted upon them as
they served their country.

Recommendation 8

The Advisory Committee supports the Department of Energy's
program of medical monitoring and treatment for the exposed inhabitants of
the Marshall Islands atolls of Rongelap and Utirik and recommends that this
program be continued as long as any member of the exposed population
remains alive. Furthermore, the Advisory Committee recommends that the
program be reviewed to determine if it is appropriate to add to the program
the populations of other atolls to the south and east of the blast whose
inhabitants may have received exposures sufficient to cause excess thyroid
abnormalities. The Advisory Committee also recommends that
consideration be given to the involvement of the Marshall Islanders in the
design of any further medical research to be conducted upon them and the
Advisory Committee recommends that the Human Radiation Interagency
Working Group consider establishing an independent panel to review the
status and adequacy of the current program of medical monitoring and
medical care provided by the United States to the exposed population of the
Marshall Islands.

The 1 954 Bravo hydrogen bomb test caused the populations of several
Marshall Islands atolls to be exposed to hazardous levels of radiation. The United
States has provided a medical follow-up program that combines research on
radiation effects with treatment for radiation-related illnesses. It is noteworthy
that as a result of the ongoing program to study radiation effects, many cases of
thyroid disease were detected and treated, but not all exposed Marshallese
received the benefits of the program. The people of Ailuk, for example, who
according to early reports received about the same exposure as the people of
Utirik, were never evacuated from their atoll and were not followed up medically,
even though they received a radiation dose of more than six roentgens.
Moreover, an epidemiological study reported in the Journal of the American
Medical Association in 1987 demonstrated that inhabitants of several atolls to the
east and south of Bikini had elevated levels of thyroid disease and that there was a
"strong inverse linear relationship" between incidence of thyroid nodules and

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distance from the blast. It should also be noted that the exposed populations
received additional doses of radiation over the years from later bomb tests and
residual radiation on the atolls. The medical program is ongoing, but Congress
has the authority to reduce or eliminate funding.

Available evidence indicates that many Marshallese~it is impossible to
identify specific individuals—were not adequately informed about the purposes of
the medical tests to which they were subjected. There is also evidence in the
documentary record that the Marshallese often did not understand the relationship
between the research and medical care components of the medical follow-up
program. For example, Dr. Robert A. Conard headed the program, and according
to his report on twenty years of medical treatment and monitoring, "the people did
not always understand the need for the examinations, or their results." Although
this situation has improved in recent years, it would nevertheless be appropriate to
consult with the Marshallese in the design and implementation of further medical
research so as to minimize any possibility of misunderstanding and to ensure that
the priorities of the Marshallese are a consideration in the planning of such
research.

The Advisory Committee supports the continuation of the Department of
Energy's program of medical monitoring and medical care for the exposed
inhabitants of the Marshall Islands. Questions have been raised during the course
of our deliberations as to whether this program is running as well as it should,
both with respect to the research and monitoring activities conducted by
Brookhaven National Laboratory (BNL) and with respect to the medical care
provided. In particular, the issue has emerged whether the medical care ought to
be expanded to include treatment for conditions that are not radiogenic as a
further remedy to Marshallese people who were exposed, however inadvertently,
as a result of weapons tests. The Advisory Committee did not have the resources
to pursue these issues, but we believe that they deserve serious consideration.
One mechanism through which this could be accomplished is the establishment of
an independent panel to review the program with input from the Marshallese as to
the panel's composition.

Recommendations for the Protection of the
Rights and Interests of Human Subjects in the Future

While we were constituted to consider issues related to human radiation
experiments, in critical (but not all) respects, the government regulations that
apply to human radiation research do not differ from those that govern other kinds
of research. In comparison with the practices and policies of the 1940s and
1950s, there have been significant advances in the protection of the rights and
interests of human subjects. These advances, initiated primarily in the 1970s and
1980s, culminated in the adoption of the Common Rule throughout the federal

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government in 1991 . Although the Common Rule now affords all human subjects
of research funded or conducted by the federal government the same basic
regulatory protections, the work of the Advisory Committee suggests that there
are serious deficiencies in some parts of the current system. These deficiencies
are of a magnitude warranting immediate attention.

The Committee was not able to address the extent to which these
deficiencies are a function of inadequacies in the Common Rule, inadequacies in
the implementation and oversight of the Common Rule, or inadequacies in the
awareness of and commitment to the ethics of human subject research on the part
of physician-investigators and other scientists. We urge that in formulating
responses to the recommendations that follow, the Human Radiation Interagency
Working Group consider each of these factors and subject them to careful review.

Recommendation 9

The Advisory Committee recommends to the Human Radiation
Interagency Working Group that efforts be undertaken on a national scale to
ensure the centrality of ethics in the conduct of scientists whose research
involves human subjects.

A national understanding of the ethical principles underlying research and
agreement about their importance is essential to the research enterprise and the
advancement of the health of the nation. The historical record makes clear that the
rights and interests of research subjects cannot be protected if researchers fail to
appreciate sufficiently the moral aspects of human subject research and the value
of institutional oversight.

It is not clear to the Advisory Committee that scientists whose research
involves human subjects are any more familiar with the Belmont Report6 today
than their colleagues were with the Nuremberg Code forty years ago. The
historical record and the results of our contemporary projects indicate that the
distinction between the ethics of research and the ethics of clinical medicine was,
and is, unclear. It is possible that many of the problems of the past and some of
the issues identified in the present stem from this failure to distinguish between
the two.

The necessary changes are unlikely to occur solely through the
strengthening of federal rules and regulations or the development of harsher
penalties. The experience of the Advisory Committee illustrates that rules and
regulations are no guarantee of ethical conduct. The Advisory Committee has
also learned, in responses to our query of institutional review board (IRB) chairs,
that many of them perceive researchers and administrators as having an
insufficient appreciation for the ethical dimensions of research involving human
subjects and the importance of the work of IRBs. The federal government must

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Part IV

work in concert with the biomedical research community to exert leadership that
alters the way in which research with human subjects is conceived and conducted
so that no one in the scientific community should be able to say "I didn't know" or
"nobody told me" about the substance or importance of research ethics.

The Advisory Committee recommends that the Human Radiation
Interagency Working Group institute, in conjunction with the biomedical
community, a commitment to the centrality of ethics in the conduct of research
involving human subjects. We urge that careful consideration be given to the
development of effective strategies for achieving this change in the culture of
human subjects research, including, specifically, how best to balance policies that
mandate the teaching of research ethics with policies that encourage and support
private sector initiatives. It may be useful to commission a study or convene an
advisory panel charged with developing and perhaps implementing
recommendations on how best to approach this challenge for the research
community.7

The Committee suggests that such an examination include consideration
of the following:

• Extending to all federal grant recipient institutions and all students and
trainees involved or likely to be involved in human subject research the
current federal requirement that institutions receiving NIH National
Research Service Award training grants offer programs in the responsible
conduct of research.

• The role of accrediting bodies such as the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO).

• Establishing competency in research ethics as a condition of receipt of
federal research grants, both for institutions and individual investigators.

• Incorporating of research ethics, and the differences between the ethics of
research involving human subjects and the ethics of clinical medical care,
into curricula for medical students, house staff, and fellows.

• Encouraging the nation's leaders in biomedical research to spearhead
efforts to elevate the importance of research ethics in science.

Recommendation 10

The Advisory Committee recommends to the Human Radiation
Interagency Working Group that the IRB component of the federal system
for the protection of human subjects be changed in at least the five critical
areas described below.

1. Mechanisms for ensuring that IRBs appropriately allocate their
time so they can adequately review studies that pose more than minimal risk

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to human subjects. This may include the creation of alternative mechanisms
for review and approval of minimal-risk studies.

The majority of the Advisory Committee's concerns in its Research
Proposal Review Project centered on research that exposed subjects to greater
than minimal risk of harm. If human subjects are to be adequately protected, such
research must be carefully scrutinized. However, higher risk research is often
complex, and careful review is time-consuming and difficult. The Advisory
Committee heard from several chairs of IRBs who underscored the difficulties
their committees experience in finding the time to adequately review such
research. Members of IRBs have only so many hours they can devote to review
of proposals. This problem of inadequate time appears to have worsened in
recent years. Institutional review boards are required to review research
proposals prior to their review for funding by the National Institutes of Health.
As the probability that a proposal will be approved for funding has decreased over
time, due to increasing competition for limited research monies, the number of
proposals being submitted to NIH from many institutions has significantly
increased. This has resulted in a substantial increase in the workload of some
IRBs, whose members are spending considerable time reviewing proposals that
are never implemented. Without guidance from the federal government, and
perhaps regulatory relief, IRBs may not have the flexibility necessary to
concentrate their efforts where subjects are in greatest need of protection— on the
proposals that pose the greatest risks to subjects and that are actually
implemented.

2. Mechanisms for ensuring that the information provided to potential
subjects (1) clearly distinguishes research from treatment, (2) realistically
portrays the likelihood that subjects may benefit medically from their
participation and the nature of the potential benefit, and (3) clearly explains
the potential for discomfort and pain that may accompany participation in
the research.

The Advisory Committee's empirical studies and public testimony
suggests that there may be considerable confusion in the minds of many members
of the public concerning what is "research" or "experimentation," and what is
simply an application of a new technology or even standard medical care. There
is reason to worry that participants in research may have unrealistic expectations
both about the possibility that they will personally benefit from participation and
about the discomfort, pain, and suffering that sometimes accompany some
research. This seemed particularly to be the case in Phase I and Phase II drug
trials. It is important that in the informed consent process it is clearly
communicated to the potential subject, particularly the potential patient-subject,

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Part IV

that the primary intent of "research" is to advance medical knowledge and not to
advance the welfare of particular subjects. Inadequate and potentially misleading
information about potential benefits and harms, and about the trade-offs between
enrollment in research and standard or conventional treatment, was one of the
major problems identified by the Advisory Committee in our Research Proposal
Review Project.

3. Mechanisms for ensuring that the information provided to potential
subjects clearly identifies the federal agency or agencies sponsoring or
supporting the research project in whole or in part and all purposes for
which the research is being conducted or supported.

A morally complicating factor in several of the human radiation
experiments the Advisory Committee has studied is the tendency to disclose to
subjects only the medical purpose of the research (if that) and not those purposes
of the research that advance interests other than medical science or the
sponsorship of agencies other than DHEW/DHHS. For example, in the case of
the total-body irradiation experiments, the data gathered from the research had a
military purpose quite distinct from questions of cancer therapy. The purpose and
funding source may be relevant to a person's decision to participate in human
subject research and should be disclosed.

4. Mechanisms for ensuring that the information provided to potential
subjects clearly identifies the financial implications of deciding to consent to
or refuse participation in research.

Many of the consent forms that the Committee reviewed as part of the
Research Proposal Review Project were silent on the subject of financial costs.
However, knowing whether being in research costs or saves them money may be
necessary for potential subjects to make an informed decision about whether to
participate. Potential subjects need to know whether the interventions that are part
of the research are free or must be paid for and~if there are any financial costs-
what they are, the likelihood that third-party payers will pay for these research-
related medical services, and the extent to which the research institution will
assist patient-subjects in securing third-party payment or reimbursement.

5. Recognition that if IRBs are to adequately protect the interests of
human subjects, they must have the responsibility to determine that the
science is of a quality to warrant the imposition of risk or inconvenience on
human subjects and, in the case of research that purports to offer a prospect
of medical benefit to subjects, to determine that participating in the research
affords patient-subjects at least as good an opportunity of securing this

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medical benefit as would be available to them without participating in
research.

In research involving human subjects, good ethics begins with good
science. In our Research Proposal Review Project, the Advisory Committee was
unable to evaluate the scientific merit of a significant number of proposals based
on the documents provided by institutions. We suspect that this occurred in part
because there is ambiguity about the role that IRBs should play with respect to
evaluation of scientific merit and, thus, that documents submitted to IRBs may be
inadequate in this area. The Advisory Committee also heard dissatisfaction with
this ambiguity in our interviews and oral histories of researchers and from chairs
of IRBs. If the science is poor, it is unethical to impose even minimal risk or
inconvenience on human subjects. Although the fine points of the relative merit
of research proposals are best left to study sections and other review mechanisms
specially constituted to make such judgments, IRBs must be situated to assure
themselves that the science they approve to go forward with human subjects
satisfies some minimal threshold of scientific merit. In some cases, the IRB may
be the only opportunity for this kind of scientific review.

In our Subject Interview Study interviews with patient-subjects, we
confirmed that patient-subjects often base their decisions to participate in research
on the belief that physicians, and research institutions generally, would not ask
them to enter research projects if becoming a research subject was not in their
medical best interests. For these patients, even the most candid, clearly written
consent form affords little protection, for both the consent form and the consent
process are of little interest to them. For patient-subjects whose decisions to
participate in research are based on trust, and not on an assessment of disclosed
information, the IRB review is of special importance. It is the only source of
protection in the federal system for regulating human research positioned to
ensure that their participation in research does not compromise their medical
interests. Such a determination, however, often requires more specialized clinical
expertise than any one IRB can possess. Federal policy must make it clear that
IRBs have the responsibility to make this determination, but it must also allow
mechanisms to be devised at the local level that permit this responsibility to be
satisfied in an efficient and effective manner.

Recommendation 11

The Advisory Committee recommends to the Human Radiation
Interagency Working Group that a mechanism be established to provide for
the continuing interpretation and application of ethics rules and principles
for the conduct of human subject research in an open and public forum.
This mechanism is not provided for in the Common Rule.

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Issues in research ethics are no more static than issues in science.
Advances in biomedical research bring new twists to old questions in ethics and
sometimes raise new questions altogether. No structure is currently in place for
interpreting and elaborating the rules of research ethics, a process that is essential
if research involving human subjects is to have an ethical framework responsive
to changing times. Also, for this framework to be effective, any changes or
refinements to it must be debated and adopted in public; otherwise, the framework
will fail to have the respect and support of the scientific community and the
American people, so necessary to its success.

Three examples of outstanding policy issues in need of public resolution
that the Advisory Committee confronted in our work are presented below:

1. Clarification of the meaning of minimal risk in research with healthy
children, including, but not limited to, exposure to radiation.

2. Regulations to cover the conduct of research with institutionalized
children.

3. Guidelines for research with adults of questionable competence. Of
particular concern is more-than-minimal-risk research that offers adults of
questionable competence no prospect of offsetting medical benefit.

Current regulations permit the involvement of children as subjects in
research that offers no prospect of medical benefit to participants when the
research poses no more than minimal risk. An important question that has come
to the Advisory Committee's attention, both in the literature and in our Research
Proposal Review Project, is whether research proposing to expose healthy
children to tracer doses of radiation constitutes minimal risk. The uncertainty
surrounding this issue calls into question the adequacy of the federal regulations,
as currently formulated, in providing guidance for this category of research. This
is a policy question that ought to be discussed and resolved in a public forum at
the national level, not left to the deliberations of individual IRBs.

Current regulations do not provide any special protections for children
who are institutionalized unless they are also wards of the state. Thus,
researchers and IRBs have no more guidance from the federal government on the
ethics of conducting such research than was available at the time of the Fernald
and Wrentham experiments, decades ago.

The Advisory Committee also confronted in its Research Proposal Review
Project another issue of research policy deserving public debate and resolution in
a public forum. This is the issue of whether and under what conditions adults of
questionable capacity can be used as subjects in research that puts them at more
than minimal risk of harm and from which they cannot realize direct medical
benefit. It is important that the nation decide together whether or under what
conditions it is ever permissible to use a person toward a valued social end in an
activity that puts him or her at risk but from which the person cannot possibly
benefit medically.

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Recommendation 12

The Advisory Committee recommends to the Human Radiation
Interagency Working Group that at least the following four steps be taken to
improve existing protections of the rights and interests of military personnel
with respect to human subject research.

1. Review of policies and procedures: Policies and procedures
governing research involving human subjects should be reviewed to ensure
that they (1) clearly state that participation as research subjects by members
of the armed services is voluntary and without repercussions for those who
choose not to participate; and (2) clearly distinguish those activities that are
research and therefore discretionary on the part of members of the armed
services from other activities that are obligatory, such as training maneuvers
and medical interventions intended to protect the troops.

2. Appreciation of regulations: Education in applicable human
subjects regulations should be a component of the training of all officers and
investigators who may be involved in decisions regarding research on human
subjects. Mechanisms are needed to ensure that officers expected to have
command responsibilities and all officers engaged in research, development,
testing, and evaluation have an adequate appreciation of the regulations
(including DOD regulations and directives, and service regulations) that bear
on the conduct of research involving human subjects, including an
appreciation of the conditions under which such regulations apply, the role
of officers in interpreting such regulations, and how such regulations are to
be implemented.

3. Maximizing voluntariness: The service secretaries should consider
the situations under which it would be appropriate to make obligatory two
practices for maximizing voluntariness that have been employed on an ad
hoc basis in some military research: first, that unit officers and senior
noncommissioned officers (NCOs) who are not essential as volunteers in the
research be excluded from recruitment sessions in which members of units
are informed of the opportunity and asked to participate in research by
investigators; and second, that an ombudsman not connected in any way
with the proposed research be present at all such recruitment sessions to
monitor that the voluntariness of participation is adequately stressed and
that the information provided about the research is adequate and accurate.

The Advisory Committee recommends consideration of steps 1 through 3
above in light of our examination of history that makes plain how difficult it often
is in a military context to distinguish an order from a request for voluntary
participation and to distinguish research from training. (These tensions are
similar in many respects to tensions in the clinical context between research and

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treatment.) Although the military has a long tradition of commitment to the use
of volunteers in research and has introduced significant advances in the military's
system of protection for human subjects since the 1940s and 1950s, without
constant attention to these inherent tensions, the potential for confusion and
inappropriate practice continues.

The military setting, with its strict hierarchical authority structure and
pervasive presence in the lives of its members, poses special problems for
ensuring the voluntariness of participation in research activities. Thus, although
the DOD has adopted and implemented the consent requirements of the Common
Rule, additional procedural safeguards and educational activities for officers may
be warranted to counteract the generalized deference to authority inherent in
military culture. Also, because the opportunity to serve the nation as subjects in
defense-oriented research projects is closely akin to the demands placed on
members of the military in their routine duties, it is desirable to emphasize the
distinction between research and course-of-duty risks both in consent procedures
and in officer training programs.

The Advisory Committee recognizes that additional procedural
requirements in soliciting research volunteers and augmenting already demanding
training curricula would have administrative costs and, to a limited extent, would
shift organizational priorities. It is the Advisory Committee's understanding that
the DOD is preparing to revise its directive implementing the Common Rule and
that the Advisory Committee's recommendations with respect to steps 1 through 3
above are a timely contribution to the department's deliberations.

Military personnel are exposed to both short- and long-term risks in the
course of training and regular duty activities as well as when they participate in
biomedical or behavioral experiments. The demarcation of those activities that
are research in contrast with those that constitute routine duty assignments and
medical care in the military context is not always easy to discern from the
standpoint of the potential subject-member of the military. Indeed, except in
medical settings where research studies are regularly performed and military
testing sites that conduct weapons, materiel, and performance trials routinely,
officers as well as their troops may be uncertain as to whether the status of
particular exercises is research or training. Greater clarity in communications to
potential subjects about the genuinely voluntary nature of participation in
research projects and procedural safeguards in recruiting volunteers could
improve their understanding of what they are being asked (rather than required) to
do. Likewise, educating officers throughout the military services who may be in a
position to solicit volunteers for research studies as to the distinctive rights of
research subjects and the particular duties to protect subjects of research from
both harm and violations of rights would make the Common Rule protections of
subjects more effective.

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4. Maintenance of a registry: The secretaries of the Navy and the Air
Force should be directed to adopt the policy of the Army, as detailed in Army
Regulation 70-25, to maintain a registry of all volunteers in human studies
and experiments conducted under research and development programs.
Such registries make it easier to confirm participation in research by
subjects and facilitates their long-term follow-up.

In analyzing the record of atomic bomb testing, the Advisory Committee
has found that military personnel were exposed to radiation and nonradiation risks
as participants in experiments that were conducted in conjunction with the tests,
and as participants in other activities connected to the testing. While these
activities were not intended to measure biological effects of ionizing radiation, the
exposure to radiation risk was incurred without adequate provision for the
maintenance of records to document exposures or in order to allow for monitoring
and follow-up of those who were exposed. Army regulations now provide for a
registry of participants in experiments conducted under the authority of the
Army's research and development program. This tool for long-term monitoring
and follow-up in the case of exposures to risks unknown at the time of
participation should be employed by the other services as well.

Recommendation 13

The Advisory Committee recommends that the Human Radiation
Interagency Working Group take steps to improve three elements of the
current federal system for the protection of the rights and interests of human
subjects-oversight, sanctions, and scope.

1. Oversight mechanisms to examine outcomes and performance. In

most federal agencies, current mechanisms of oversight of research involving
human subjects are limited to audits for cause and a review of paperwork
requirements. These strategies do not provide a sufficient basis for ensuring that
the current system is working properly. The adequate protection of human
subjects requires that the system be subjected to regular, periodic evaluations that
are based on an examination of outcomes and performance and that include the
perspective and experiences of subjects of research as well as the research
community. The Committee recommends that the Human Radiation Interagency
Working Group consider new methods of oversight that focus on outcomes and
performance of the system of protection of human subjects. The Committee's
Subject Interview Study and Research Proposal Review Project, for example,
yielded important and heretofore unavailable information about the current status
of human subjects protections that could never be obtained from either an
oversight policy that audits only "for cause" or a review that determines only

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whether paperwork requirements have been satisfied.

We realize that resources available for oversight are limited and that there
may be real constraints on what, practically, can be achieved. At the very least,
we urge that in the setting of priorities for limited oversight dollars, a premium be
placed on methods that permit an examination of what the system is actually
producing with respect to the outcome of human subjects protections, in contrast
to methods that focus on process.

2. Appropriateness of sanctions for violations of human subjects
protections. The Committee recommends that the Human Radiation Interagency
Working Group review and evaluate the options available to the government
when it is determined that there has been a violation of the Common Rule in the
conduct of federally sponsored research involving human subjects. The object of
this review is to determine whether the current structure of sanctions that can be
imposed on investigators and grantee institutions is appropriate to the seriousness
with which the nation takes violations of the rights and interests of human
subjects. This structure includes mechanisms for detecting violations (including
issues of oversight discussed above), severity of sanctions, and dissemination of
policies on sanctions to investigators and institutions. We are particularly
concerned that, even in the absence of research-related injury, there be clear and
severe penalties for investigators who use human subjects without their consent.
Although at least one state authorizes civil and criminal penalties for failure to
obtain a subject's consent,8 in most jurisdictions civil litigation is unlikely to
result in penalties to investigators for failing to obtain consent from subjects if the
subjects have not been physically injured. The Committee is aware that the
Common Rule provides for sanctions of violations of its provisions, including the
withdrawal of multiple project assurances and, with that action, research funding.
It is not clear, however, that this system of sanctions functions well; nor is it clear
that it adequately addresses the public's concerns that those who abuse the trust of
research subjects be dealt with accordingly.

3. Extension of human subjects protections to nonfederally funded
research. While some nonfederally funded research is performed voluntarily in
accordance with the Common Rule, there is a need to assess the level of research
performed outside its requirements and to consider action to ensure that all
subjects are afforded the protections it offers. The Committee was charged with
reviewing only federally funded research, and we limited our inquiries
accordingly. However, we are aware that important areas of research are
conducted largely independently of federal funding— for example, some research
on reproductive technologies. We recommend that the Human Radiation
Interagency Working Group take steps to ensure that all human subjects are
adequately protected.

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Recommendation 14

The Advisory Committee recommends that the Human Radiation
Interagency Working Group review the area of compensation for research
injuries of future subjects of federally funded research, particularly
reimbursement for medical costs incurred as a result of injuries attributable
to a subject's participation in such research, and create a mechanism for the
satisfactory resolution of this long-standing social issue.

A system of compensation for research injuries has been contemplated
since at least the late 1940s, when the Army debated, but ultimately rejected,
suggestions to establish a "uniform" program for compensating prisoner
volunteers who were injured during experiments involving malaria and hepatitis.
Beginning in the 1970s, a number of government-sponsored ethics panels
endorsed the provision of compensation for research injuries, culminating with
the President's Commission for the Study of Ethical Problems in Medicine and
Biomedical and Behavioral Research (President's Commission) in 1982. Since
then, experts and commentators have continued to support this position.9

In our deliberations concerning retrospective remedies for injured research
subjects, the Advisory Committee was unable to reference a federal policy or
guide for a fair system of compensation of research subjects, as no policy exists
even today. So that years from now others do not have to revisit and struggle
with this issue, the federal government must take steps now to address the issue of
compensation for injured research subjects. These steps should include
consideration of the approach recommended by the President's Commission in its
report, Compensating for Research Injuries: The Ethical and Legal Implications
of Programs to Redress Injured Subjects. w

The President's Commission summarized the basic argument for
compensation as follows:

Medical and scientific experimentation, even if
carefully and cautiously conducted, carries certain
inherent dangers. Experimentation has its victims,
people who would not have suffered injury and
disability were it not for society's desire for the
fruits of research. Society does not have the
privilege of asking whether this price should be
paid; it is being paid. In the absence of a program
of compensation of subjects, those who are injured
bear both the physical burdens and the associated
financial costs. The question of justice is why it
should be these persons, rather than others, who are

827

Part IV

to be expected to absorb the financial, as well as the
unavoidable human costs of the societal research
enterprise which benefits everyone."

The Advisory Committee urges not only consideration of a compensation
policy for physical injuries attributable to research but also that consideration be
given to appropriate remedies for subjects who have suffered dignitary harms,
even in the absence of physical injury. Subjects so wronged have little recourse in
the current system; litigation in the absence of physical injury is unlikely to
provide relief to people who have been used as subjects without their adequate
consent. If it is determined that financial compensation is not generally an
appropriate remedy in the absence of physical injury, consideration should be
given to other remedies that would be fitting.

Recommendations for Balancing National Security Interests and

the Rights of the Public

Recommendation 15

15a: The Advisory Committee recommends to the Human Radiation
Interagency Working Group the adoption of a federal policy requiring the
informed consent of all human subjects of classified research and that this
requirement not be subject to exemption or waiver. In all cases, potential
subjects should be informed of the identity of the sponsoring federal agency
and that the project involves classified information.

15b: The Advisory Committee recommends to the Human Radiation
Interagency Working Group the adoption of a federal policy requiring that
classified research involving human subjects be permitted only after the
review and approval of an independent panel of appropriate
nongovernmental experts and citizen representatives, all with the necessary
security clearances. This panel should be charged with determining (1) that
the proposed experiment has scientific merit; (2) that risks to subjects are
acceptable and that the balance of risk and potential benefit is appropriate;
(3) that the disclosure to prospective subjects is sufficiently informational
and that the consent solicited from subjects is sufficiently voluntary; and (4)
whether potential subjects must have security clearances in order to be
sufficiently informed to make a valid consent decision, and if so, how this can
be achieved without compromising the privacy and voluntariness of potential
subjects. Complete documentation of the panel's deliberations and of the
informed consent documents and process should be maintained permanently.
These records should be made public as soon as the national security concern
justifying secrecy no longer applies.

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Although the Advisory Committee believes that the interests of both
science and potential subjects are best served when research involving human
subjects is conducted in the open, a public policy prohibiting the conduct of
human subject research in secret is unwise. Important national security goals may
suffer if human subjects research projects making unique and irreplaceable
contributions were foreclosed. More citizens may suffer harms for lack of such
information than would be harmed if adequately safeguarded human subjects
research was conducted in secret.

It also is possible that a prohibition on classified human subjects research
would be circumvented through redefinition of activities or disregarded outright.
If this were to occur, the participants in such activities could end up less well
protected than if they were bona fide research subjects.

The Advisory Committee believes, however, that the classification of
human subject research ought properly to be a rare event and that the subjects of
such research, as well as the interests of the public in openness in science and in
government, deserve special protections. The Advisory Committee does not
believe that continuing with the current federal policy governing the protection of
human subjects, which does not provide any special safeguards or procedures for
classified research, is adequate.

In the current political context, classified human subjects research occurs
relatively rarely. Existing policy may prove an inadequate safeguard of
individual rights and welfare, however, if in the future national security crises
occur that generate a perceived need for classified research. The history of
human experimentation conducted in the interests of strengthening and protecting
national security that the Advisory Committee has examined demonstrates how
the rights and interests of citizens can be violated in secret research. The
convergence of elements of secrecy, urgent national purposes, and the essential
vulnerability of research subjects, owing to differentials in information and power
between those conducting research and those serving as subjects, could again lead
to abuses of individual rights and, upon subsequent revelation, the erosion of
public distrust in government.

The Advisory Committee is particularly concerned about two aspects of
current policy— exceptions to informed consent requirements and the absence of
any special review and approval process for human research that is to be
classified. The current requirement for the informed consent of research
participants is not absolute, leaving open the possibility that subjects may serve as
mere tools of the state in the interests of national security if consent is waived. A
strengthened requirement for the informed consent of research subjects in
classified research should safeguard against the merely instrumental use of
individual people to serve national purposes.

Institutional review boards of government agencies are not sufficiently
independent of the interests of the organizations of which they are a part to set

829

8

PartIV

aside considerations of organizational mission when considering research
construed as having the greatest national priority. Thus, determination by an
agency IRB that a waiver of informed consent is warranted, or that sufficient
information about a study remains in a censored protocol description for a
potential subject's review, inadequately protects subjects' interests and rights and
does not adequately safeguard the public's trust. By contrast, an independent
panel should be less subject to unintended bias than that of an IRB of a federal
agency whose mission is to protect and promote national security.

Although the Advisory Committee acknowledges that both the formation
of an independent review panel and an absolute informed consent requirement
create opportunities for information leaks or security breaches and delays in the
progress of urgent research, these disadvantages are surmountable and are more
than balanced by the increased vigilance afforded the rights and interests of
citizens and the safeguarding of the public's trust in government.

Recommendation 16

The Advisory Committee recommends to the Human Radiation
Interagency Working Group that improvements be made in the protections
of the public's rights and interests with respect to intentional releases.

16a. The Advisory Committee recommends to the Human Radiation
Interagency Working Group that an independent review panel review any
planned or intended environmental releases of substances in cases where the
release is proposed to take place in secret or in circumstances where any
aspect of the environmental review process required by law is conducted in
secret.

In conducting its review, the independent panel should ensure that (1)
secrecy is limited to that required for reasons of national security; (2) records will
be kept on the nature and purpose of the release, the rationale for not informing
the public (including workers and service personnel, as well as affected citizens),
and alternative means of gathering data that were considered; (3) actions to
mitigate risk were considered and will be taken; and (4) actions will be taken to
measure the actual effect of the release on the environment and human health and
safety, to the extent that measurements are deemed needed and feasible. The
panel should also review the conditions on which any information kept secret
should be made public, with a view toward ensuring the release of information as
soon as practicable, consistent with any legitimate national security restrictions.
The panel should report to Congress periodically on the number and nature of
releases it has reviewed.

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The Advisory Committee does not conclude that intentional releases can
never be conducted in secret. It does conclude that, to the extent that the
government proposes to conduct an intentional release that involves elements of
secrecy there must be independent review to ensure that the action is needed, that
risk is minimized, and that records will be kept to make sure a proper accounting
is made to the public at the earliest date consistent with legitimate national

security concerns.

The Advisory Committee found that the government has sponsored
numerous intentional environmental releases of radiation for research purposes.
In many cases these releases were conducted in secret, without warning to the
surrounding populations. While the risks posed by these releases appear to have
been relatively small, in many cases little data remain on the precise measure ot
these risks or on actions taken to minimize risk and to ensure that unknowing
citizens did not inadvertently expose themselves to greater risks than necessary.
In addition the Committee found that the risks and concerns posed by intentional
releases for research purposes-in terms of both the magnitude of radiation
exposure and the consequences of secret keeping-sometimes did not differ
qualitatively from those posed by "routine" operational releases of radiation. Most
notably the radiation risk posed by the Green Run, a relatively large intentional
release, was a fraction of that posed by radiation released in the normal course of
operation of Hanford in the mid- 1 940s.

This recommendation is intended to apply to all secret releases ot
substances into the environment, not merely to substances determined to be
hazardous The Committee believes that the operative concern is secrecy; even it
the substance released is entirely harmless, the backdrop of secrecy is sufficient to
create a climate of distrust. The Committee did not have the expertise, however,
to determine whether so broad a sweep was feasible. At minimum, the
Committee recommends that any secret release of a substance that would
necessitate an environmental impact statement be required to have a review by an

independent panel.

Today, federal environmental laws and rules provide for environmental
impact statements, which are subject to review, in instances in which the federal
government proposes actions with a substantial effect on the environment.
However, the rules also provide that part-or even all-of such reviews may be
conducted in secret. In fact, reviews that are secret in whole or part do take place.

The Environmental Protection Agency has the authority and responsibility
to oversee all environmental impact reviews, including those conducted in secret.
However the Advisory Committee's inquiries indicate that EPA's role in the
review of secret impact statements has been limited. Moreover, the decades of
secret keeping regarding intentional releases have created a basis for distrust,
particularly among those living in potentially affected communities. Even today,
there is little practical means by which the public can know the full extent

831

PartIV

(whether or not great) of environmental decision making and action that is being
kept secret. The location of responsibility for review of these activities in a single
panel that is itself accountable and that is independent of agencies that conduct
releases should be a means to restoring lost trust.

16b. The Advisory Committee recommends to the Human Radiation
Interagency Working Group that an appropriate government agency,
currently the Environmental Protection Agency, maintain a program
directed at the oversight of classified programs, with suitably cleared
personnel. This program should maintain critical records, such as
environmental impact statements and environmental permits, permanently.
The agencies subject to regulation should ensure the timely consideration of
environmental impacts and oversight and the timely provision of all
necessary clearances. EPA should provide regular unclassified reports to
Congress describing the extent of its activities as well as any significant
problems.

The requirements of environmental law apply to activities of the federal
government, regardless of whether those activities are classified. However,
classification complicates the process of regulatory oversight by the EPA or any
other regulatory agency and limits the ability to report to the public and for the
public to express its own concerns. Furthermore, secrecy has been used to shield
activities that raise public health concerns.

For these reasons, the responsibility for environmental oversight is
magnified for secret programs. There is no fundamental barrier to effective
oversight— at least some regulators can be given the necessary clearances.
However, ensuring timely and effective oversight requires cooperation between
the regulated agency and the regulatory agency to establish the necessary
oversight procedures. These mechanisms are not fully in place. For example, the
EPA office with the statutory responsibility to review environmental impact
statements maintains no records of classified environmental impact statements
and has not historically had individuals cleared to review the most highly
classified defense programs. The EPA office responsible for overseeing federal
compliance with environmental regulations has just begun to establish
mechanisms for overseeing secret programs.

Recommendations on Openness

Recommendation 17

The Advisory Committee recommends that the Human Radiation
Interagency Working Group take steps to ensure the continued application
of the lessons learned from the Human Radiation Interagency Working

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Chapter 18

Group's efforts to organize and make accessible to the public, and the
government itself, the nation's historical records.

The Committee's experience confirms that with presidential directive and
the strong and continued support of a multiagency records search team,
substantial amounts of the nation's documentary heritage can be located and
retrieved. Through the research process, important lessons were learned about
ways in which to improve the accessibility and usefulness of this documentary
record to both the public and the government.

We are aware that government resources are stretched thin and may well
be diminishing. However, the nation's records are a precious asset that the
government created, and holds in trust, for its citizens. This asset, and the
commitment made to the public through the enactment of the Freedom of
Information Act, is of limited value if the government itself cannot access its
records as citizens rightfully expect it should. The Committee's experience
confirms that there is an intense public interest in using these records, a public
willingness to volunteer time and intelligence needed to help organize and
research them, and great opportunity to make them available in ways that will

permit citizens to do so.

The Committee recommends that the Human Radiation Interagency
Working Group effect the following five steps to increase both government and
citizen access to information about the past. The implementation of these steps
might best be accomplished by the designation of an individual or entity with
responsibility and appropriate authority for their effectuation.12

1. The most important historical collections should be entrusted to
the National Archives. The agencies and the National Archives should
review the extent to which this is now being done and develop policies to
hasten the transfer of agency records to the National Archives.

Federal law basically requires that permanent records be transferred to the
National Archives when (1) they are more than thirty years old; or (2) earlier if
the originating agency no longer needs to use the records for the purpose for
which they were created or in its regular current business, or if agency needs will
be satisfied by use of the records at the National Archives.

Nonetheless, many portions of older collections have been appraised as
permanently valuable but are not at the National Archives. For example, the
Committee found that a great number of AEC headquarters records of substantial
interest to the Committee and the public are still held by DOE either at its
headquarters or at the Washington National Records Center (these include the
only collection of general manager files, the post- 1958 Executive Secretariat files,
virtually all the Division of Military Application files, and most of the files of the
Division of Biology and Medicine). In the case of the Department of Defense, the

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Part IV

records of the Office of the Secretary of Defense largely remain at the
Washington National Records Center or with the Office of the Secretary of
Defense.13

The public's ability to access records held by agencies is limited because
(1) most agencies do not know in detail what records they still hold, and even if
folder listings exist, they are not publicly available for the most part; (2) there has
generally been little declassification review of these records; (3) there is no
requirement that agencies permit access to even completely unclassified or
declassified collections; and (4) most agencies have very limited facilities to
accommodate researchers. The public's ability to gain access to documents in
federal records centers is also limited because (1) the task of examining the basic
inventory forms (SF-135s)14 to determine what is in a record group is time-
consuming, and in many cases, the SF-135s do not adequately describe the
records; (2) there has generally been very little declassification review of these
records; and (3) permission must be obtained from the appropriate agencies to
review even completely unclassified or declassified collections; this permission
process can be time-consuming and agencies can impose restrictions, such as
permitting review but not copying.

Locating records at the National Archives has the following advantages:
(1) there is generally at least some type of finding aid and, in some cases, folder
listings prepared by the National Archives or the agencies when the records were
sent; (2) archivists are available to assist researchers; (3) there is complete access
to unclassified and declassified collections (unless Privacy Act or similar
restrictions apply); and (4) many classified records at the National Archives
(among the exceptions are Restricted Data records and records dealing with
intelligence) are properly the subject of an informal and usually very quick in-
house declassification review process called Special Declassification Review.
Under Special Declassification Review, records are often reviewed within
months, versus the years it takes under the Freedom of Information Act or
Mandatory Declassification Review.

2. Agencies should make readily available all existing inventories,
indices, folder listings, and other finding aids to record collections now under
agency control. Classified finding aids should undergo declassification
review, and declassified versions of these finding aids should also be made
available.

Finding aids or indices to federal government records holdings are an
invaluable tool, without which it would be practically impossible to locate
documents of interest from among the hundreds of thousands of boxes of records
maintained by the government.

Many collections of records still held by agencies have finding aids or
indices that have been inaccessible to the public, either because they simply have

834

Chapter 18

never been made available or because they are classified. Finding aids should be
made available to the public in a headquarters office, regional offices (including
all field site reading rooms), and ultimately, on the Internet. (This
recommendation does not call for the creation of indices where they do not
currently exist.)

For example, folder listings (which provide the titles of records files) exist
for many of the AEC headquarters record collections that are still at DOE or at
the Washington National Records Center. These include, among others, the only
known collection of general manager's files from 1947 through 1974, all of the
Division of Military Applications files from 1947 through 1974, all of the
Executive Secretariat files from 1959 through 1974, and most of the Division of
Biology and Medicine files from 1947 through 1974. Without the folder listings
it would have been difficult for the Advisory Committee to locate particular
collections of interest and, even if located, to determine the documents to be
reviewed. The folder listings, however, have not been generally available to the
public.

Similarly, the DOE's Oak Ridge Operations Office vault contains more
than 7,000 cubic feet of classified records. The Committee found that the
Records Holding Task Group (RHTG) collection in this vault (about 300 cubic
feet) contained many documents of interest to the Committee, which were
typically readily declassifiable. This collection has an index; however, the index
is classified.

In the case of the National Archives, finding aids are generally available.
However, there are fifteen National Archives facilities around the country.
Currently, the only means of determining exactly what records are at a particular
branch is to contact that branch directly. This is a time-consuming process, and
there are understandable limits on the number of pages of finding aids archivists
can copy and send to any person (a single finding aid can total hundreds of
pages). It would be much simpler and easier for the public to be able to review
the finding aids from all fifteen branches at any one of them.

3. The Human Radiation Interagency Working Group should ensure
the development of policies to improve public access to records held by
agencies or deposited in federal records centers.

In the case of a vast amount of records, particularly those not yet
transferred to the National Archives, the available descriptions are often too broad
or incomplete to provide meaningful clues to the contents of boxes. Thus, a
Freedom of Information Act request that seeks all information on a given topic
may well receive a response that ignores information located in boxes or files that
are not clearly labeled or indexed. Under these circumstances, searches may be
more fruitfully conducted by citizens with an interest in, and understanding of, the
subject of the search. However, because so many of the nation's records

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Part IV

collections are off-limits to the public, even citizens who are willing to help are
often precluded from lending a hand.

Many collections of interest to citizens contain no classified documents
and can be made directly accessible to them. However, the Committee reviewed
collections, particularly those containing decades-old records, where the entire
collection was classified because it housed a small number of classified
documents. For example, Record Group 326 at the College Park National
Archives has approximately 160 feet of Metallurgical Laboratory /Argonne
National Laboratory documentation that should be of significant historical
interest. The collection itself is classified and currently inaccessible to citizens.
The Committee's examination of large portions of the collection found very few
classified documents, and when found, these documents were immediately
declassified.

Executive Order 12958, issued by President Clinton on April 17, 1995
("Classified National Security Information"), provides broadly for the automatic
declassification (with specific exceptions) of all records that are more than
twenty-five years old. In implementing the order, agencies should target
collections that can be relatively quickly reviewed and made available to the
public in their entirety.

4. Agencies should maintain complete records, available to the public,
of document destruction.

Government records management rules provide for the destruction at
varying dates in the future of all records that are appraised as temporary (that is,
nonpermanent). They also provide that records be kept where certain collections,
including classified records, are destroyed. But the Committee found that records
of destruction are themselves routinely destroyed.

For example, upon Committee inquiry, DOE investigation revealed that
the files of the AEC's Intelligence Division had been substantially destroyed
during the 1970s and as late as 1989. (These files may have contained data on
intentional releases, experimentation performed by the AEC for other agencies,
and on the rules and practices of secret keeping regarding human data gathering).
The DOE's inquiry found individuals who stated that they destroyed substantial
records and that records of destruction were made. However, in accordance with
DOE rules, the "certificates of destruction" were themselves later destroyed.15 As
another example, documents provided by the Department of Veterans Affairs and
the Department of Defense indicate that, in 1 947, the government contemplated
the keeping of secret records in anticipation of potential liability claims from
service personnel exposed to radiation and that some such records were kept.
However, despite substantial search efforts by the DOD and the VA, the specific
identity of the records referred to has not yet been determined.16

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Chapter 18

The Committee presumes that the vast majority of these records were
destroyed in the routine course of business. Nonetheless, where records recording
the destruction of important collections of records are themselves destroyed, the
public cannot know whether important records have been destroyed (or merely
are lost) and cannot be easily assured that destruction was in the routine course of
business.

5. The Human Radiation Interagency Working Group should review
and develop policies concerning public access to records generated or held by
private contractors and institutions receiving federal funding.

Since World War II, the government has relied on contractors and grantees
to perform an increasing number of governmental activities, including
government-sponsored biomedical research. When the Advisory Committee
undertook to locate information on particular government-sponsored radiation
experiments, it was often told by federal agencies that, if such information was
created, it would have been maintained only by nonfederal entities or
investigators and not the government itself.

Where an activity is conducted by government employees (for example,
researchers working in the facilities of the National Institutes of Health's Clinical
Center), citizens have a right to seek access to information relating to that activity
under the Freedom of Information Act. A similar right of access often does not
apply, however, where a similar or even identical activity is conducted, also on
federal funds, at nonfederal facilities.17

From the citizen's vantage point, the right to know about a government-
funded activity should not depend on whether that activity is conducted directly
by the government or by a government-funded private institution. At the same
time, nonfederal institutions are not governmental agencies, and there may be
good reasons they should not be burdened with identical obligations to retain
records and to provide information to the public.

Rules are needed that accommodate both the citizen's right to know about
the conduct of the government and the relevant differences between nonfederal
and federal institutions with respect to duties to create and maintain publicly
accessible records.18 To ensure consistent and informed governmentwide
treatment of the question, the Human Radiation Interagency Working Group may
wish to call on the Office of Management and Budget (OMB) and the Office of
Federal Procurement Policy (OFPP) to review the current right of members of the
public to gain access to the records of government grantees and contractors.

Recommendation 18

18a: The Advisory Committee recommends to the Human Radiation
Interagency Working Group that the CIA's record-keeping system be

837

Part IV

reviewed to ensure that records maintained by that agency are accessible
upon legitimate request from the public or governmental sources. This
review could be performed by the CIA inspector general or an oversight
panel.

18b: The Advisory Committee recommends that all records of the
CIA bearing on programs of secret human research, such as MKULTRA
and the related CIA human behavior projects from the late 1940s through
the early 1970s, including Bluebird, Artichoke, MKSEARCH, MKDELTA,
Naomi, Chance, Often, and Chickwit, become a top priority for
declassification review with the expectation that most, if not all, of these
documents can be declassified and made available to the public.

These recommendations are intended to ensure that the public and the
government have practical access to historical records of the CIA (where access is
otherwise appropriate) and to address long-standing public interest and concerns
regarding secret human experiments conducted or sponsored by the CIA.

The framework of the records collections of all the Human Radiation
Interagency Working Group agencies, save the CIA, is visible to the public. This
is the case even in agencies, such as the Defense Nuclear Agency, where
historical research records are largely classified.

While documents showing CIA participation in midcentury DOD-
sponsored discussions of human experimentation were obtained from DOD, DOE,
and the public National Archives, the CIA was not able to locate such documents
in its own files and states that the CIA's role in these discussions was sufficiently
minor that such records would not have been kept. The Advisory Committee also
notes the recent report to the attorney general of the BNL Task Force, which was
investigating a bank-related scandal: "While we benefited from extensive
cooperation and assistance from the CIA's Office of General Counsel, the CIA's
ability to retrieve information is limited. Records are 'compartmentalized' to
prevent unauthorized disclosure; only some of those records are retrievable
through computer databases; no database encompasses all records; and not all
information is recorded. In the course of our work, we learned of 'sensitive'
components of information not normally retrievable and of specialized offices
that previously were unknown to the CIA personnel assisting us."19

In addition, while the Advisory Committee has found no evidence to show
that the CIA conducted or sponsored human radiation experiments, numerous
documents, some of which remain partially classified, make reference to possible
CIA interest in this area. Although Advisory Committee staff has reviewed all of
the available classified information concerning human radiation experiments and
requested that it be declassified, the public does not as yet have the benefit of
such access.

Twenty years after they were first revealed to the public, there continues
to be a strong public interest in the CIA's "mind control" programs. The Advisory

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Chapter 18

Committee received numerous queries about MKULTRA and the other related
programs from scholars, journalists, and citizens who have been unable to review
the complete record. Although these CIA projects were the subject of significant
governmental inquiry in the mid to late 1970s~by the Senate and House
committees and by the presidentially appointed Rockefeller Commission-and a
substantial portion of the records have been declassified and released to the
public, a number of documents remain classified, and many of the documents that
have been released contain numerous redactions. This has made it extremely
difficult to understand the full context of the activities or to clarify discrepancies
or uncertainties in the record.

A number of the declassified documents make reference to radiation
experiments. However, because of the redactions, it is impossible for the public
to determine from these documents whether there is additional, secret information
about radiation activities. (Advisory Committee staff have reviewed the full text
of these documents.) For example, the 1963 CIA inspector general report on the
inspection of MKULTRA, which was declassified in redacted form in 1975,
stated that "radiation" was one of the avenues explored under MKULTRA. But
because so much of that document was redacted, the public reader might
reasonably suspect that there is more information about radiation in the report. At
the request of the Advisory Committee, the CIA re-released this document, and a
handful of others, with minimal redactions.

However, few other such documents have been re-reviewed for
declassification in almost twenty years. Since most of the classified CIA
documents concerning MKULTRA and related programs that Advisory
Committee staff reviewed were declassified upon request, the Advisory
Committee believes that if the rest of these records were reviewed for historical
declassification, most, if not all, of the records could be declassified without
harming the national security.

So long as documents about secret human experiments are withheld from
the public, it will be impossible to put to rest distrust with the conduct of
government. The rapid, public release of the remaining documents about
MKULTRA and other secret programs would be a fitting close to an unhappy
chapter in the nation's history.

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Part IV

ADDENDUM TO RECOMMENDATION 4: MEDICAL
NOTIFICATION AND FOLLOW-UP

The Advisory Committee's charter requires that we consider the issue of
notice to experimental subjects of potential health risk and the need for medical
follow-up:

If required to protect the health of individuals who
were subjects of a human radiation experiment, or
their descendants, the Advisory Committee may
recommend to the Human Radiation Interagency
Working Group that an agency notify particular
subjects of an experiment, or their descendants, of
any potential health risk or the need for medical
follow-up [Sec. 4.c.].

The basic intent of this provision is not directed at subjects who have
already died, or at subjects who have already become ill and been treated. It is
primarily aimed at asymptomatic subjects who remain at significant risk for the
development of radiation-induced cancers. Because at least two and as many as
five decades have passed since the experiments took place, most of those who
may eventually develop cancer as a result of the experiment will already have
developed symptoms and sought treatment. However, some subjects may still be
at risk and thus arguably might benefit from medical follow-up.

The initial consideration in deciding whether to implement a program of
active notification and medical follow-up is the identification of populations of
subjects who have been put at significant risk for the development of radiogenic
cancers. The magnitude and focus of these risk estimates are driven by the
specific organs placed at highest risk from the particular radiation exposure (for
example, thyroid being the organ at greatest risk in the iodine 1 3 1 experiments,
testes in the Oregon and Washington prisoner experiments, and the brain for the
nasopharyngeal radium experiments). Risk estimates are calculated for each
target organ according to a number of assumptions that may include adjustments
for variables such as age at exposure, sex, or type of radiation (isotope vs.
external beam) and are generally expressed in terms of excess cancer
incidence/mortality for a given population over a specified period at a specified
dose.

The Advisory Committee adopted an excess site-specific cancer mortality
(death) greater than 1 case in 1,000 (lifetime) as a criterion for determining that a
subject had been placed at increased risk. However, because of the substantial
passage of time since the initial exposure, the criteria for consideration of active
notification were set at 1/1,000 future or remaining lifetime risk and an excess

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Chapter 18

relative risk of greater than 10 percent (organ specific). This level of risk was
arbitrarily chosen by the Advisory Committee. When compared with the normal
risk of developing cancer (220 out of 1,000), this level of risk is small. The
Advisory Committee chose this small remaining lifetime risk as a reasonable
initial criterion to decide if a more in-depth analysis of the effectiveness of
screening and intervention was needed.

Once a population has been determined to have an increased remaining
lifetime risk for radiogenic cancer mortality, a second criterion must be satisfied
before a government- funded medical follow-up program is recommended, namely
whether the exposed individuals would likely benefit from a program of early
detection or early treatment of the malignancy. Effective screening procedures
for the detection of an early-stage cancer exist only for a limited number of cancer
sites. Moreover, the lack of specificity of all diagnostic screening tests results in
a significant number of "false positives" (a positive test result in an individual
who in truth is not affected), resulting in unnecessary and potentially hazardous
medical procedures that may cause health problems in and of themselves. On the
other hand, most diagnostic tests are also imperfectly sensitive, meaning that
some individuals who actually have the disease will be falsely reassured that they
are cancer free and may thereby delay seeking attention when it becomes
symptomatic. To this end the Advisory Committee has adopted the following
criteria for assessing the value of screening, preventive, or therapeutic measures
for exposed subjects of biomedical experiments:20

1 . The condition must have a significant effect on
the quality or length of life.

2. The condition must have an asymptomatic
period during which it can be detected by available
screening methods.

3. These screening methods must have high
sensitivity and specificity.

4. Treatment in the asymptomatic phase must yield
a therapeutic result superior to that obtained by
delaying treatment until symptoms appear.

5. The medical benefits of screening and early
treatment must outweigh any detrimental medical
effects or risks.

These criteria were applied to each exposed population at significant risk
for development of a malignancy and evaluated according to the organ(s) at risk

841

PartIV

from radiation exposure. In each case, the conditions enumerated above must be
satisfied before specific medical follow-up would be recommended.

Details of the Advisory Committee's risk calculations can be found in
chapters 7 and 9. To summarize, the Advisory Committee found no experiments
involving iodine 131 administration to children that met our 1/1,000 criterion for
remaining lifetime risk of dying of cancer; even in the most highly exposed
individuals, risks were estimated to be 1/2,000 (remaining lifetime risk). In
addition, the U.S. Preventive Services (USPS) Task Force concluded that "routine
screening for thyroid disorders is otherwise not warranted in asymptomatic adults
or children." Although it has been suggested that people placed at risk for
development of thyroid carcinoma following high-dose external irradiation to the
upper body may benefit from regular physical examination of the thyroid, there
are no data to support a similar risk or benefit for those who have been exposed to
diagnostic or therapeutic doses of iodine 13 1.21

The Advisory Committee recognizes that in addition to the very small risk
of a fatal thyroid cancer, individuals exposed as children to iodine 131 also have a
larger risk of a nonfatal thyroid cancer or benign tumor, a lifetime risk that in
many of the experiments we considered exceeded 1/1,000 and in a few
individuals exceeded 1/100. We recognize that such conditions may require
medical treatment and may be associated with considerable anxiety and
discomfort. After considerable discussion, however, the Committee concluded
that notification was not warranted for the purpose of detecting such conditions
early, on several grounds. First, the prognosis for such conditions under standard
clinical care is excellent, and there is no evidence that early detection improves
the outcome. Second, even among the subgroup of about 200 children exposed to
this level of risk, the number of excess cancers expected is less than one, whereas
the normal prevalence in an unexposed population is about 20 to 30 percent.
Third, many thyroid cancers that are detectable by screening may have no clinical
significance. Finally, the most effective means of screening for thyroid cancer
remains palpation, which has low sensitivity and low specificity.

For the prisoners subjected to testicular irradiation, the Advisory
Committee estimates that even the most heavily exposed individual (600 rad to
the testicles) would have a risk of only 0.4/l,00022 of developing a fatal cancer,
which does not attain our stated criterion. Furthermore, the USPS Task Force has
concluded that "there is insufficient evidence of clinical benefit or harm to
recommend for or against routine screening of asymptomatic men [other than
those with a history of cryptorchidism, orchiopexy, or testicular atrophy] for
testicular cancer."23 These considerations lead the Advisory Committee to
recommend against any program of active notification of these subjects.
However, subjects who voluntarily request medical check-up or counseling
should have such provided in a standard clinical setting.

For the children who received nasopharyngeal radium treatments, the
Advisory Committee has estimated that the lifetime risk of tumors to the central

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Chapter 18

nervous system (brain), head, and neck regions is approximately 4.35/1,000 and
the excess relative risk is about 62 percent, both with considerable uncertainties.24
Although these experiments were conducted in the 1940s and much of the risk has
probably already been expressed, it is still possible that the future risk is greater
than or equal to our arbitrary 1/1,000 risk criterion. However, at greatest risk are
the brain, and head and neck tissues, for which there is neither an accepted nor
recommended screening procedure.25 Thus, while the subjects in these
experiments meet the Advisory Committee's arbitrary 1/1,000 criterion for
consideration for notification and medical follow-up (criterion 1 in
Recommendation 4, above), the utility of such a program has not been
demonstrated, so criterion 2 of Recommendation 4 is not satisfied. Adult military
personnel who participated in trials of this procedure received significantly lower
radiation exposures, did not attain our arbitrary 1/1,000 criterion for risk, and
would similarly fail to meet the criteria in guideline 2. Therefore, the Advisory
Committee does not recommend notification and medical follow-up of children or
adults in this group of experiments.

The Advisory Committee's charter also requires that we consider the need
for notification of descendants of experimental subjects for purposes of health
protection. The rationale for considering notification in this instance derived
from the assumption that the offspring of former subjects might be at risk for
disease or disability as a consequence of inherited mutations resulting from their
parent's previous radiation exposure. The weight of evidence suggests that the
risk of heritable genetic effects from the radiation exposures in the experiments
we reviewed is very small, although it is possible that some offspring of exposed
individuals might carry mutations that were caused by radiation.26 Moreover, in
most medical experiments involving external sources of radiation, efforts are
made to shield the gonads (ovaries/testes) as much as possible. With the
exception of the testicular irradiation experiments, where subjects agreed to
undergo vasectomy to prevent transmission of any mutations that might have
occurred, experiments involving external irradiation are likely to have produced
relatively small gonadal doses, as would those experiments involving tracers.
Even therapeutic studies involving internal radionuclides would generally involve
only modest gonadal doses. Thus, in the vast majority of experiments, it is likely
that the risk of radiation-induced mutations is small in relation to natural rates.

In addition to cancer and genetic effects, there are only a small number of
well-established effects of radiation, including severe mental retardation among
those exposed in utero (particularly between eight and fifteen weeks of gestation),
sterility, cataracts, and hypothyroidism. Unlike cancer and genetic effects,
however, these other endpoints appear to be "deterministic" effects that appear
only after high doses that are unlikely to have been received by subjects in the
experiments under consideration for notification. The Advisory Committee heard
extensive public testimony about a range of other conditions that those testifying
thought might be related to radiation exposures. However, the Advisory

843

Part IV

Committee believes that a program of active notification must be grounded on
currently accepted scientific evidence concerning the conditions that are likely to
be caused by radiation.

844

ENDNOTES

1 . AEC documents reveal that in order for one researcher to publish a report on
his TBI research, he had to respond to the AEC's concerns about potential public relations
and legal liability consequences and did so by deleting information that might permit
identification of patients. See chapter 8.

2. These awards included $750,000 in 1976 by Congress to the Olson family,
$703,000 in 1987 by court order to the Blauer family, and $750,000 in 1988 by court
order to nine Canadians for nonfatal brainwashing experiments. See chapter 3.

3. For example, based on facts available to the Committee, those Alaskans who
were subjects of Air Force-sponsored radioisotope research (see chapter 12) and the
pregnant women who were subjects of radioisotope research at Vanderbilt University
(see chapter 7) may also be owed an apology. However, the Committee conducted only
limited inquiry into these cases. The Advisory Committee did not attempt a full factual
inquiry into the Alaskan research, which is the subject of an inquiry by a committee of
the Institute of Medicine and the National Research Council, whose report is pending.
The Vanderbilt research is currently the subject of litigation that may provide for fuller
development of the facts.

4. Veterans who participated in weapons tests are also eligible for relief under
the Radiation Exposure Compensation Act of 1990, which, however, requires claimants
to elect the monetary remedy to the exclusion of other benefits to which a veteran may be
eligible. We also note the Veterans Exposure Amendments of 1992.

5. National Cancer Institute, National Institutes of Health, Radon and Lung
Cancer Risk: A Joint Analysis of 1 1 Underground Miner Studies (Washington, D.C.:
National Institutes of Health Publication No. 94-3644, January 1994).

6. The Belmont Report: Ethical Principles and Guidelines for the Protection of
Human Subjects of Research, Report of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research (Washington, D.C.: GPO,
1979).

7. The convening of a national panel could assist as well with the
implementation of Recommendations 10 and 1 1 .

8. California Health and Safety Code, vol. 40B, sec. 24 1 76 ( 1 995).

9. For example, in 1994, the Institute of Medicine's Committee on the Ethical
and Legal Issues Relating to the Inclusion of Women in Clinical Studies recommended
that the National Institutes of Health review the area of compensation for research injury.
See Women and Health Research (Washington, D.C.: National Academy Press, 1994),
169 and appendix D to that volume titled "Compensation for Research Injuries."

10. President's Commission for the Study of Ethical Problems in Medicine and
Biomedical and Behavioral Research, Compensating for Research Injuries: The Ethical
and Legal Implications of Programs to Redress Injured Subjects, Vol. I, Report
(Washington, D.C.: GPO, June 1982).

11. Ibid., 50.

12. While lessons such as those identified above have been learned, by the same
token, it seems unlikely that they will be fully taken advantage of unless some individual
or entity is designated with responsibility to ensure that this takes place.

13. The post- World War II records of the Army Office of the Surgeon General
are also located primarily either at the Washington National Records Center or with the
Office of the Surgeon General. Similarly, very few of the post-World II records of the

845

Chemical Corps and its successors are located at the National Archives but are mostly
found at the Washington National Records Center or the successors.

14. Standard Form 135 (SF-135) is the transmittal form agencies use when
shipping records to a federal records center. A folder listing is supposed to accompany
all shipments of records, with the exception of the relatively rare classified SF-135, the
forms are available for examination by the public.

15. "Destruction of the U.S. Atomic Energy Commission Division of
Intelligence Files," report by the Office of Human Radiation Experiments, 26 August
1994.

16. As noted in chapter 10, an investigation by the VA concluded that the
"confidential Atomic Medicine Division" evidently contemplated was not activated;
nonetheless, remaining documents indicate that certain records were kept in anticipation
of potential liability claims. As noted further in chapter 10, the precise nature of all
records at issue cannot be conclusively determined.

,17. Government contractor records have been found to be beyond the reach of
the Freedom of Information Act because contractors are not "agencies" who maintain
"agency records," a condition required by the act. However, regulations that govern
contractors may bring records that contractors maintain under the act. For example, a
recent Department of Energy regulation (10 C.F.R. § 1004.3[e], 59 Fed. Reg. 63883 [12
December 1994]), provides that even if a contractor-held document fails to qualify as an
"agency record" it may be subject to the act if the contract provides that the document in
question is the property of DOE. For a discussion of the application of this rule, see
Cowles Publishing Company, Decision and Order of the Department of Energy, Case No.
VFA-0018, 28 February 1995.

1 8. In making this recommendation, the Advisory Committee emphasizes that
we do not intend to alter privacy restrictions that currently limit access to records related
to biomedical research (such as personal medical records).

19. 21 October 1994 Addendum to the BNL Task Force-Final Report from John
Hogan, Acting Assistant U.S. Attorney, Northern District of Georgia and Counselor to
the Attorney General to the Attorney General (ACHRE No. CORP-060595-A), 2-3.

20. Adapted from U.S. Preventive Services Task Force, Guide to Clinical
Preventive Services: An Assessment of the Effectiveness of 169 Interventions (Baltimore:
Williams & Wilkins, 1989), xxix-xxxii; and P. S. Frame, "A Critical Review of Adult
Health Maintenance," Journal of Family Practice 22 (1986): 341, 417, 51 1.

21. National Research Council, Board on Radiation Effects Research,
Committee on the Biological Effects of Ionizing Radiations, Health Effects of Exposure
to Low Levels of Ionizing Radiation: BEIR V (Washington, D.C.: National Academy
Press, 1990), 5, 287-294.

22. See footnote on testicular risk analysis in chapter 9.

23. U.S. Preventive Services Task Force, Guide to Clinical Preventive Sei-vices,

77.

24. See footnote on children's risk analysis in chapter 7.

25. U.S. Preventive Services Task Force, Guide to Clinical Preventive Services.

26. See "The Basics of Radiation Science" section of the Introduction.

846

Statement by Individual
Committee Member

STATEMENT BY
COMMITTEE MEMBER JAY KATZ

We were assigned two tasks: to examine the past and to examine the
present. Telling the full story of government sponsored Cold War human
radiation experiments serves many important purposes—remembrance, warning,
healing. Ultimately, however, the value of knowing the past resides in the lessons
it can teach us for the present and future. Thus, the central question is this: Do
current regulations of human experimentation adequately protect patient-subjects?
Here I have the most serious reservations about our Report.

In summary, my conclusions are these: (1) In the quest to advance
medical science, too many citizen-patients continue to serve, as they did during
the Cold War period, as means for the sake of others. (2) The length to which
physician-investigators must go to seek "informed consent" remains sufficiently
ambiguous so that patient-subjects' understanding of the consequences of their
participation in research is all too often compromised. (3) The resolution of the
tensions inherent in the conduct of research--/. e., respect for citizen-patients'
rights to, and interest in, self-determination on the one hand and the imperative to
advance medical science, on the other— confronts government officials with policy
choices that they were unwilling to address in any depth during the Cold War or
for that matter in today's world. (4) Our Recommendations only touch on these
problems and at times make too much of the safeguards that have been introduced
since 1974. The present regulatory process is flawed. It invites in subtle, but
real, ways repetitions of the dignitary insults which unconsenting citizen-patients
suffered during the Cold War.

Medical research is a vital part of American life. The Federal government
allocates billions of dollars to human research, and the pharmaceutical industry
spends many more billions to develop new drugs and medical devices. And
research is by and large conducted with patients. Since all of us at one time or
another will be patients, we are readily available subjects for research. Thus, the
protection of the rights and interests of citizen-research subjects in a democratic
society is a major societal concern.

Let me introduce my Reservations by offering some preliminary remarks
about the current regulatory scheme and the history of consent. The
contemporary regulatory scheme provides insufficient guidance for addressing
one basic question: When, if ever, should conflicts between advancing medical
knowledge for our benefit and protecting the inviolability of citizen-subjects of
research be resolved in favor of the former? Inviolability, unless patient-subjects
agree to invasions of mind and body, requires punctilious attention to disclosure
and consent and, in turn, imposes considerable burdens on physician-
investigators-be it taking the necessary time to converse with patient-subjects or,

849

Statement

if necessary, making discomforting disclosures. Moreover, taking informed
consent seriously may slow the rate of medical progress with painful
consequences to investigators' work and to society. These dilemmas must be
resolved forthrightly, instead of allowing them to be "resolved" by discretionary
subterfuge.

Neither the drafters of the 1974 Federal Regulations nor the members of
the research community were willing to respond to the reality that taking
informed consent seriously in this new age of informed consent confronted them
with problems that required sustained and thoughtful exploration.
Implementation would also turn out to be a most formidable task because of
physicians' low regard for patient consent throughout medical history. The
Committee's analysis of the informed consent requirements in existence during
the Cold War and earlier in the 20th century acknowledges, but not sufficiently
so, that the millennia-long history of medical custom casts a dark shadow over
what transpired during the Cold War.

Patient consent, until most recently, has not been enshrined in the ethos of
Hippocratic medicine. As I once put it, the idea of patient autonomy is not to be
found in the lexicon of medicine. It is important to be aware of this history; for it
explains why our Findings on contemporary research practices, which time
constraints prevented us from probing in sufficient depth, revealed deficiencies in
the informed consent process, both at the levels of physician-investigator
interactions with their patient-subjects and of IRB review. This is not surprising;
for not only does it take time to change historical practices, it also requires more
thoughtful rules and procedures than currently exist.

My reading of the Cold War record suggests that governmental officials in
concert with their medical advisers at best paid lip service to consent. Whenever
they considered it, they worried mostly about legal liability and embarrassment.
They were not worried or embarrassed about their willingness to conscript
unconsenting patient-subjects to serve as means in plutonium and whole body
radiation experiments. All this is a frightening example of how thoughtlessly
human beings, including physicians, can treat human beings for "noble" purposes.
Most references to consent (with rare exceptions) that we uncovered in
governmental documents or in exchanges between officials and their medical
consultants were meaningless words, which conveyed no appreciation of the
nature and quality of disclosure that must be provided if patient-subjects were
truly to be given a choice to accept or decline participation in research. Form, not
substance, punctuated most of the policies on consent during the Cold War
period. The drafters of the Federal Regulations would eventually build their rules
on this shaky historical foundation, disregarding in the process that the
imprecision of their policies invited physician-investigators not to alter decisively
customary Hippocratic practices.

The long established tradition of obtaining consent from healthy subjects

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Statement

is a separate story; for this tradition did not extend to patients or patient-subjects.
Put another way, the latter were quarantined from disclosure and consent. In our
Finding 10, this was clearly stated: "[DJuring the 1944-1974 period . . .
physicians engaged in clinical research generally did not obtain consent from
patient-subjects for whom the research was intended to offer a prospect of
medical benefit." Therefore, it should come as no surprise, as noted in our
Report, that when a decision was reached in 1951 not to pursue radiation research
with prisoners or healthy subjects in connection with an important defense
project, "the military immediately contracted with a private hospital to study
patients being irradiated for cancer treatment." Patients have always been the
most vulnerable group for purposes of research.

From the perspective of history no significant conclusions can be drawn
about ethical consent standards that "should" have existed for research with
patients by drawing attention to consent requirements that existed for healthy
volunteers. When persons became patients, the rules of consent changed. This
observation also has relevance for the impact of the Nuremberg Code on the
conduct of research. The Code emerged from contexts not only of research with
non-patients but also of sadistic and brutal disregard for the sanctity of human
life, unparalleled in the annals of Western research. American physician-
investigators, therefore, found it doubly easy to consider the pronouncements of
the Allied Military Tribunal irrelevant to their practices.

Let me interject here a few brief remarks about risks: Taking risks is
inevitable in research. After all, research is by its nature a voyage into the
unknown. To pierce uncertainty, to gain scientific knowledge requires risk
taking. And, as our Report makes clear, physician-investigators and government
officials as well have generally been attentive, whenever physical risks needed to
be taken, to minimize them. But such care notwithstanding, research requires
taking risks; for example, research with highly toxic agents affects the quality and
extent of remaining life. In our review of contemporary research we identified
many instances where patient-subjects were unknowingly exposed to such risks,
which have both physical and emotional dimensions.

Scientific studies in today's world often involve patient-subjects whose
prognosis is dire-the most vulnerable of all disadvantaged groups-and for whom
no effective or curative treatments exist. In these situations hope can readily be
exploited by intimating that research interventions may also benefit patient-
subjects, even though the experiment's objectives are in the service of gaining
scientific knowledge. Embarking on this slippery slope begins with investigators'
rationalizations which justify experimental interventions on grounds of "possible"
therapeutic benefits; it continues with apprising patient-subjects insufficiently of
the slings and arrows of the experimental component; and it ends with feeding
into patient-subjects' own dispositions to deny the truth. In sum, by obliterating
vital distinctions between therapy and research, investigators invite subjects to

851

Statement

collude with them in the hazy promise of therapeutic benefits. Put another way,
the "therapeutic illusion," as one commentator felicitously called it, can lead
physician-investigators to emphasize the possible (though unproven) therapeutic
benefits of the intervention and, in turn, to minimize its risks, particularly to the
quality of (remaining) life. Such considerations played a role in the total body
radiation experiments discussed in our Report.

In my Reservations I want to emphasize, however, the centrality of
dignitary, not physical, injuries in any appraisal of the ethics of research. This is
the uncompromising message of the Nuremberg Code's first principle on
voluntary consent, a message which during the Cold War period physician-
investigators found impossible to accept. But the problem goes deeper than that.
The Code, without extensive exegesis, could not serve as a viable guide for the
conduct of medical research. This made its disregard easy and in the process, the
central message which the judges tried to convey in their majestic first principle
was also lost. Thus too much can be made, as our Report does, of Secretary of
Defense Wilson's memorandum endorsing the Nuremberg Code. To hold him
culpable for not implementing the Code makes little sense. If he is culpable of
anything, it is for promulgating it without first having sought thoughtful advice
about what needed to be explicated to make it a viable statement for research
practices. Merely embracing the Code invited, indeed guaranteed, neglect.

Finally, from the perspective of history I want to note that only since the
early 1960's was the importance of consent given greater attention. Among the
social forces that contributed to this development two stand out: Judges'
promulgation of a new legal doctrine of informed consent, based on the Anglo-
American premise of "thoroughgoing self-determination." And the explorations
by a new breed of bioethicists, recruited from philosophy and theology, of the
relevance of such principles as autonomy, self-determination, beneficence, and
justice to medical decision-making. Their novel and powerful arguments, so alien
to the medical mind, disturbed the sleep of the medical community. Physicians
had a particularly hard time in coming to terms with the idea of patient autonomy.
To this day, I believe, this principle has only gained a foothold in the ethos of
medical practice and research.

In our Report we emphasize the primacy of patient-subject autonomy in
research. It led us to conclude in our Interim Report that "[a] cornerstone of
modern research ethics [is] informed consent." I agree with this statement of
principle. From the 1963 beginnings of my work in human experimentation, I
have championed the idea of respect for autonomy and self-determination in all
interactions between physician-investigators and patient-subjects. But I
introduced one major qualification when I wrote that only when the Nuremberg
Code's first principle on voluntary consent

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Statement

is firmly put into practice can one address the claims of science
and society to benefit from science. Only then can one avoid the
dangers that accompany a balancing of one principle against the
other that assigns equal weight to both; for only if one gives
primacy to consent can one exercise the requisite caution in
situations where one may wish to make an exception to this
principle for clear and sufficient reasons.

I mention this here because the final and most far-reaching
recommendation for change that I shall soon propose is based on two premises:
(1) that any exception to the principle of individual autonomy, since it tampers
with fundamental democratic values, must be rigorously justified by clear and
sufficient reasons; and (2) that such exception cannot be made by investigators or
IRBs but only by an authoritative and highly visible body.

I now turn to our Research Proposal Review Project. The Committee's
review of contemporary research reveals that of the greater-than-minimal-risk
studies (which are the ones that raise complex informed consent issues) 23% were
ethically unacceptable and 23% raise ethical concerns. My own independent
review tells a grimmer story: 50% raise serious ethical concerns and an
additional 24% raise ethical concerns that cannot be taken lightly. Since I
focused exclusively on the informed consent process, the differences in our
Findings can perhaps in part be explained on that basis. My data, like the
Committee's, were the protocols submitted to IRBs and the informed consent
forms signed by patient-subjects. I appreciate that the evidence available to us
does not reflect what patient-subjects might have been told during oral
communications. But if the protocols and patient-subject consent forms are
flawed in significant ways, it is likely that the oral interactions are similarly
flawed. Moreover, since IRBs are charged to pay particular attention to the
informed consent process, I contend that IRBs should not have approved the
problematic consent forms in the form they were submitted. The forms often
seem to "sell" research rather than to convey a sense of caution that invites
reflective thought.

I had expected to discover problems, but I was stunned by their extent.
Consider what we observed in Chapter 15 and what is described there in greater
detail: The obfuscation of treatment and research, illustrated most strikingly in
Phase I studies, but by no means limited to them; the lack of disclosure in
randomized clinical trials about the different consequences to patient-subjects'
well being if assigned to one research arm or the other; the administration of
highly toxic agents, in the "scientific" belief that only the knowledge gained from
"total therapy" will eventually lead to cures, but without disclosure of the impact
of such radical interventions on quality of life or longevity. I do not wish to
minimize the impact of making total disclosure on patient-subjects' and physician-

853

Statement

investigators' hopes and fears. Yet, nagging questions remain: What are "clear
and sufficient reasons" which permit tampering with disclosure and consent; and,
if permissible, who decides?

Our Recommendations do not go far enough in remedying the flawed
nature of our current regulations which appear to rely so heavily on informed
consent, but which in practice I contend, bypass true informed consent. Here I
can only make a few comments about the changes required if we wish to protect
adequately the rights and interests of subjects of research:

( 1 ) Informed consent is central to such protections. The drafters of the
Federal regulations have acknowledged that fact. They have failed, however, to
take responsibility for making these requirements meaningful ones. Thus,
patient-subjects now all too often give a spurious consent; a "consent" that can
readily mislead physician-investigators into believing that they have received the
authority to proceed when in fact they have not.

(a) The Federal regulations imply that the principle of respect for patient-
subjects' autonomy is central to the regulatory scheme. Leaving it at that is not
enough; for the principle requires commentary so that physician-investigators will
have a more thoroughgoing appreciation of the moral issues at stake whenever
they ask human beings to serve as means for the ends of others. Only then will
they learn, for example, that to take informed consent seriously requires them to
spend considerable time with prospective patient-subjects and to engage them in
searching conversations. In these conversations they must disclose (a) that their
subjects are not patients or, to the extent they are patients, that their therapeutic
interests will be subordinated in specified ways to scientific interests; (b) that it is
problematic (and in what ways) whether their welfare will be better served by
placing their medical fate in the hands of a practitioner rather than a physician-
investigator; (c) that in opting for the care of a physician they may be better or
worse off and for such and such reasons; (d) that research is governed by a
research protocol and a research question and therefore patient-subjects' interests
and needs have to yield (and to what extent) to the claims of science; etc.

Such disclosure obligations are formidable ones. They need to be fulfilled
in a manner that will give patient-subjects a clear appreciation of the difference
between research and therapy, and in the spirit that disabuses them of the belief,
so widely held-as our Subject Interview Study demonstrates- that everything the
investigator proposes serves their best therapeutic interests.

The Cold War experiments teach us that misplaced trust can deceive; that
trust must be earned by prior disclosures of what research participation entails. I
agree, as our Recommendation 9 proposes, that scientists should be educated "to
ensure the centrality of ethics in [their] conduct." To accomplish that educational
task, however, requires policies that more clearly delineate the ambit of discretion
which investigators can exercise in the conduct of research.

(b) Current criteria for informed consent encourage, perhaps even

854

Statement

mandate, overwhelming patient-subjects with information on every conceivable
risk and benefit as well as on the scientific purpose of the study. Adherence to
these mandates has led, and justifiably so, to concerns about the
incomprehensibility of the informed consent forms that patient-subjects must
sign. Much thought, and then guidance, has to be given to IRBs and investigators
as to the essential information they most provide; e.g., alternatives, uncertainties,
essential risks, realistic benefits as well as the impact of participation—known and
conjectured—on the quality of future (or remaining) lives. Many of the informed
consent forms I have examined fail to emphasize the risks germane to the research
protocol; instead they go into numbing detail on risks that can be summarized. To
put it bluntly: Informed consent criteria in today's world, at least in the ways they
are communicated to patient-subjects, often serve purposes of obscuring rather
than clarifying what participation in research entails.

(2) Though IRBs serve important functions, they do not have the capacity,
if only by virtue of composition and lack of time, either to modify consent
standards (including the ones I have just proposed) or, more generally, to make
any other decisions that could affect the fundamental constitutional rights and
personal interests of subjects of research. IRBs should not have the authority to
decide how to balance competing principles in situations where the competence of
subjects' consent is in question, or where consent cannot be obtained because
patient-subjects suffer from a life-threatening condition, or where other complex
issues need to be resolved, as illustrated in our Chapter on the total body radiation
experiments. Such fateful decisions are beyond their competence.

Moreover, IRBs work in a climate of low visibility, another species of
secrecy about which we expressed so much concern in Chapter 13. These and
other complex ethical problems should only be resolved by an accountable and
highly visible national Body. That Body then can provide IRBs with guidelines
that will better inform their deliberations. I would like to note here, but only in
passing, that the Body I envision will lighten IRBs' tasks; for example, by
fashioning policies for cursory review of the many minimal/no risk studies, or by
being available for advisory opinions whenever IRBs are confronted with new
ethical problems. (IRBs now spend an inordinate amount of time on such
problems which they should not resolve in the first place.) The national Body
should not review individual research projects except when investigators and
IRBs disagree. Finally, a national Body is needed for another reason as well: The
considerable pressure for approval of protocols to which IRBs are subjected by
the scientists at their institutions.

(3) Already in 1973, when I served on HEW's Tuskeegee Syphilis Study
Ad Hoc Advisory Panel, we proposed in our Final Report that Congress establish
a permanent body— we called it the National Human Investigation Board—with
the authority to regulate at least all Federally supported research involving human
subjects. We recommended that this Board should not only promulgate research

855

Statement

policies but also administer and review the human experimentation process.
Constant interpretation and review by a Body whose decisions count by virtue of
the authority invested in them can protect both the claims of science and society's
commitment to the inviolability of subjects of research.

A most important task which such a Board would face in formulating
research policies is to delineate exceptions to the informed consent requirement
when competing principles require it. For example, when might it be permissible
for IRBs to "defer consent" (or more correctly, to allow physician-investigators to
proceed without consent) with patient-subjects suffering from acute head trauma?
Conscripting citizen-patients to anything they have not consented to is deeply
offensive to democratic values and, if necessary, requires public approval.
Greater public participation in the formulation of research policies is vital, and the
Board must therefore establish procedures for the publication of all its major
policy and advisory decisions, particularly those where compromises seem
warranted between the advancement of science and the protection of subjects of
research. Publication of such decisions would not only permit their intensive
study both inside and outside the medical profession but would also be an
important step toward the case-by-case development of policies governing human
experimentation. If we are truly concerned about the baneful effects of secrecy
on public trust, what I propose here could restore trust.

There is, of course, much more to consider, and I have written about it
elsewhere. I hope, however, that I have said enough to suggest that the problems
inherent in research with human subjects—advancing science and protecting
subjects of research-are complex. Society can no longer afford to leave the
balancing of individual rights against scientific progress to the low-visibility
decision-making of IRBs with regulations that are porous and invite abuse. The
important work that our Committee has done in its evaluation of the radiation
experiments conducted by governmental agencies and the medical profession
during the Cold War once again confronts us with the human and societal costs of
too relentless a pursuit of knowledge. If this is a price worth paying, society
should be forced to make these difficult moral choices in bright sunlight and
through a regulatory process that constantly strives to articulate, confront, and
delimit those costs.

We have judged the past and judgments of the past become most relevant
when they teach us lessons for the present and future. Yet, we did not judge the
present with sufficient care. If the problem was time, I wanted to take the time to
offer my judgments. I also took the time and "took [the road] less traveled by"
because much is at stake in the quest for advancing medical science that speaks
not only to progress in the conquest of disease but to other moral values as well.

856

Official documents

Federal Register / Vol 59. No. 13 / Thursday. January 20, 1994 / Presidential Documents 2935

Presidential Documents

Executive Order 12891 of January IS, 1994

Advisory Committee on Human Radiation Experiments

By the authority vested in me as President by the Constitution and the
laws of the United States of America, it is hereby ordered as follows:

Section 1. Establishment, (a) There shall be established an Advisory Commit-
tee on Human Radiation Experiments (the "Advisory Committee" or "Com-
mittee"). The Advisory Committee shall be composed of not more than
15 members to be appointed or designated by the President. The Advisory
Committee shall comply with the Federal Advisory Committee Act, as amend-
ed. 5 U.S.C. App. 2.

(b) The President shall designate a Chairperson from among the members
of the Advisory Committee.

See. 2. Functions, (a) There has been established a Human Radiation Inter-
agency Working Group, the members of which include the • Secretary of
Energy, the Secretary of Defense, the Secretary of Health and Human Services,
the Secretary of Veterans Affairs, the Attorney General, the Administrator
of the National Aeronautics and Space Administration, the Director of Central
Intelligence, and the Director of the Office of Management and Budget.
As set forth in paragraph (b) of this section, the Advisory Committee shall
provide to the Human Radiation Interagency Working Group advice and
recommendations on the ethical and scientific standards applicable to human
radiation experiments carried out or sponsored by the United States Govern-
ment. As used herein, "human radiation experiments" means:

(1) experiments on individuals involving intentional exposure to
ionizing radiation. This category does not include common and
routine clinical practices, such as established diagnosis and treat-
ment methods, involving incidental exposures to ionizing radiation;

(2) experiments involving intentional environmental releases of radi-
ation that (A) were designed to test human health effects of ionizing
radiation; or (B) were designed to test the extent of human exposure
to ionizing radiation.

Consistent with the provisions set forth in paragraph (b) of this section,
the Advisory Committee shall also provide advice, information, and rec-
ommendations on the following experiments:

(1) the experiment into the atmospheric diffusion of radioactive
gases and test of detectability, commonly referred to as "the Green
Run test," by the former Atomic Energy Commission (AEC) and
the Air Force in December 1949 at the Hanford Reservation in
Richland, Washington;

(2) two radiation warfare field experiments conducted at the AEC's
Oak Ridge office hi 1948 involving gamma radiation released from
non-bomb point sources at or near ground level;

(3) six tests conducted during 1949-1952 of radiation warfare ballis-
tic dispersal devices containing radioactive agents at the U.S. Army's
Dugway. Utah, site;.

(4) four atmospheric radiation-tracking tests in 1950 at Los Alamos,
New Mexico; and

(5) any other similar experiment that may later be identified by
the Human Radiation Interagency Working Group.

2936 Federal Register / Vol. 59, No. 13 / Thursday, January 20, 1994 / Presidential Documents

The Advisory Committee shall review experiments conducted from 1944
to May 30, 1974. Human radiation experiments undertaken after May 30
1974 the date of issuance of the Department of Health, Education, and
Welfare ("DHEW") Regulations for the Protection of Human Subjects (45
C.F.R. 46), may be sampled to determine whether further inquiry into experi-
ments is warranted. Further inquiry into experiments conducted after May
30, 1974, may be pursued if the Advisory Committee determines, with
the concurrence of the Human Radiation Interagency Working Group, that
such inquiry is warranted.

(b)(1) The Advisory Committee shall determine the ethical and scientific
standards and criteria by which it shall evaluate human radiation experi-
ments, as set forth in paragraph (a) of this section. The Advisory Committee
shall consider whether (A) there was a clear medical or scientific purpose
for the experiments; (B) appropriate medical follow-up was conducted; and
(C) the experiments' design and administration adequately met the ethical
and scientific standards, including standards of informed consent, that pre-
vailed at the time of the experiments and that exist today.

(2) The Advisory Committee shall evaluate the extent to which human
radiation experiments were consistent with applicable ethical and scientific
standards as determined by the Committee pursuant to paragraph (b)(1)
of this section. If deemed necessary for such an assessment, the Committee
may carry out a detailed review of experiments and associated records
to the extent permitted by law.

(3) If required to protect the health of individuals who were subjects
of a human radiation experiment, or their descendants, the Advisory Commit-
tee may recommend to the Human Radiation Interagency Working Group
that an agency notify particular subjects of an experiment, or their descend-
ants, of any potential health risk or the need for medical follow-up.

(4) The Advisory Committee may recommend further policies, as needed,
to ensure compliance with recommended ethical and scientific standards
for human radiation experiments.

(5) The Advisory Committee may carry out such additional functions
as the Human Radiation Interagency Working Group may from time to
time request.

Sex:. 3. Administration, (a) The heads of executive departments and agencies
shall, to the extent permitted by law, provide the Advisory Committee
with such information as it may require for purposes of carrying out its
functions.

(b) Members of the Advisory Committee shall be compensated in accord-
ance with Federal law. Committee members may be allowed travel expenses,
including per diem in lieu of subsistence, to the extent permitted by law
for persons serving intermittently in the government service (5 U.S.C. 5701-
5707).

(c) To the extent permitted by law, and subject to the availability of
appropriations, the Department of Energy shall provide the Advisory Commit-
tee with such funds as may be necessary for the performance of its functions.

Sec. 4. General Provisions, (a) Notwithstanding the provisions of any other
Executive order, the functions of the President under the Federal Advisory
Committee Act that are applicable to the Advisory Committee, except that
of reporting annually to the Congress, shall be performed by the Human
Radiation Interagency Working Group, in accordance with the guidelines
and procedures established by the Administrator of General Services.

(b) The Advisory Committee shall terminate 30 days after submitting its
final report to the Human Radiation Interagency Working Group.

Federal Register / Vol. 59, No. 13 / Thursday, January 20, 1994 / Presidential Documents 2937

(c) This order is intended only to improve the internal management of
the executive branch and it is not intended to create any right, benefit,
trust, or responsibility, substantive or procedural, enforceable at law or
equity by a party against the United States, its agencies, its officers, or
any person.

ll'R Doc. 94-1531
Filed 1-18-94: 4:37 pml
Billing code 3195-01-P

0^nAJ^AAA<T^MAd^^

THE WHITE HOUSE,
January 15, 1994.

CHARTER
ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS

1. Committee' s Official Designation

Advisory Committee on Human Radiation Experiments (the
"Advisory Committee" or "Committee").

2. Authority

Executive Order No. 12891.

Objectives and Scope of Activities

There has been established a Human Radiation Interagency
Working Group (the "Interagency Working Group") , the members
of which include the Secretary of Energy, the Secretary of
Defense, the Secretary of Health and Human Services, the
Secretary of Veterans Affairs, the Attorney General, the
Administrator of the National Aeronautics and Space
Administration, the Director of Central Intelligence, and
the Director of the Office of Management and Budget. As set
forth in section 4 of this Charter, the Advisory Committee
shall provide to the Interagency Working Group advice and
recommendations on the ethical and scientific standards
applicable to human radiation experiments carried out or
sponsored by the United States Government. As used herein,
"human radiation experiments" means:

(1) Experiments on individuals involving intentional
exposure to ionizing radiation. This category does not
include common and routine clinical practices, such as
established diagnosis and treatment methods, involving
incidental exposures to ionizing radiation.

(2) Experiments involving intentional environmental
releases of radiation that (A) were designed to test
human health effects of ionizing radiation; or (B) were
designed to test the extent of human exposure to
ionizing radiation.

Consistent with the provisions set forth in section 4 of
this Charter, the Advisory Committee also shall provide
advice, information and recommendations on the following
experiments:

(1) The experiment into the atmospheric diffusion of
radioactive gases and test of detectability , commonly
referred to as "the Green Run test," by the former
Atomic Energy Commission (AEC) and the Air Force in
December 1949 in Hanford, Washington;

(2) Two radiation warfare field experiments conducted at
the AEC's Oak Ridge office in 1948 involving gamma
radiation released from non-bomb point sources at or
near ground level;

(3) Six tests conducted during 1949-1952 of radiation
warfare ballistic dispersal devices containing
radioactive agents at the U.S. Army's Dugvay, Utah
site;

(4) Four atmospheric radiation-tracking tests in 19 50 at
Los Alamos, New Mexico; and

(5) Any other similar experiments which may later be
identified by the Interagency Working Group.

The Advisory Committee shall review experiments conducted
from 1944 to May 30, 1974. Human radiation experiments
undertaken after May 30, 1974, the date of issuance of the
Department of Health, Education and Welfare Regulations for
the Protection of Human Subjects (45 C.F.R. 46), may be
sampled to determine whether further inquiry into
experiments is warranted. Further inquiry into experiments
conducted after May 30, 1974, may be pursued if the Advisory
Committee determines, with the concurrence of the
Interagency Working Group, that such inquiry is warranted.

4. Description of Duties for Which
Committee is Responsible

The duties of the Advisory Committee are solely advisory and
shall be:

a. The Advisory Committee shall determine the ethical and
scientific standards and criteria by which it shall _
evaluate human radiation experiments, as set forth in
section 3 of this Charter. The Advisory Committee
shall consider whether (A) there was a clear medical or
scientific purpose for the experiments; (B) appropriate
medical follow-up was conducted; and (C) the
experiments' design and administration adequately met
the ethical and scientific standards, including
standards of informed consent, that prevailed at the
time of the experiments and that exist today.

b. The Advisory Committee shall evaluate the extent to
which human radiation experiments were consistent with
applicable ethical and scientific standards as
determined by the Committee pursuant to paragraph (a)
of this section. If deemed necessary for such an
assessment, the Advisory Committee may carry out a
detailed review of experiments and associated records
to the extent permitted by law.

c. If required to protect the health of individuals who
were subjects of a human radiation experiment, or their
descendants, the Advisory Committee may recommend to
the Interagency Working Group that an agency notify
particular subjects of an experiment, or their
descendants, of any potential health risk or the need
for medical follow-up.

d. The Advisory Committee may recommend further policies,
as needed, to ensure compliance with recommended
ethical and scientific standards for human radiation
experiments.

e. The Advisory Committee may carry out such additional
functions as the Interagency Working Group may from
time to time request.

5. To Whom the Advisory Committee Reports

The Advisory Committee shall report to the Interagency
Working Group.

The Advisory Committee shall submit its final report to the
Interagency Working Group within one year of the date of the
first meeting of the Advisory Committee, unless such period
is extended by the Interagency Working Group. The Advisory
Committee shall issue an interim report not more than six
months after the date of the first meeting of the Advisory
Committee. That interim report shall advise the Interagency
Working Group on the status of the Advisory Committee's
proceedings and the likelihood that the Committee will be
able to complete its duties within one year of the date of
the first meeting of the' Advisory Committee.

6. Duration and Termination Date

The Advisory Committee shall terminate thirty days after
submission of its final report to the Interagency Working
Group. This Charter shall expire one year plus thirty days
after the first meeting of the Advisory Committee, subject
to renewal and extension by the President.

7. Agency responsible for providing financial and
administrative support to the Advisory Committee

Financial and administrative support shall be provided by
the Department of Energy.

8. Estimated Annual Operating Costs
$3 million.

9. Estimated Number and Frequency of Meetings

The Advisory Committee shall meet as it deems necessary to
complete its functions.

10. Subcommittee ( s )

To facilitate functioning of the Advisory Committee,
subcommittee (s) may be formed. The objectives of the
subcommittee (s) are to make recommendations to the Advisory
Committee with respect to matters related to the
responsibilities of the Advisory Committee. Subcommittees
shall meet as the Advisory Committee deems appropriate.

11. Members

Up to a maximum of fifteen Advisory Committee members shall
be appointed by the President for a term of one year, which
may be extended by the President. Committee members shall
be compensated in accordance with federal law. Committee
members may be allowed travel expenses, including per diem
in lieu of subsistence, to the extent permitted by law for
persons serving intermittently in the government service (5
U.S.C. §§ 5701-5707) .

12 . Chairperson

The President shall designate a Chairperson from among the
members of the Advisory Committee.

Appendices

Acronyms and Abbreviations

ACBM Advisory Committee for Biology and Medicine (a civilian

advisory panel established in late 1947 to advise AEC's DBM on
various aspects of biomedical research; dissolved in 1974)

ACR American College of Radiology (professional society)

AEB Army Epidemiological Board (established in 1942; through a

series of various commissions, whose members were civilian
health professionals, sponsored studies of infectious diseases of
interest to military; succeeded by Armed Forces Epidemiological
Board in 1949)

AEC Atomic Energy Commission (established by the Atomic Energy

Act of 1946 and inherited most functions of the MED; succeeded
in 1974 by ERDA and NRC)

AFEB Armed Forces Epidemiological Board ( 1 949 successor to AEB)

AFMPC Armed Forces Medical Policy Council (established by the

secretary of defense in January 195 1; formerly the Office of
Medical Services [OMS]; members included a civilian physician
as chairman, other civilians from medicine or related fields, and
the surgeons general of the three services; developed basic medical
and health policies for DOD and reviewed the medical and health
aspects of the policies, plans, and programs of other DOD
agencies; succeeded by the ASD [H&M] in late 1953)

AFPC Armed Forces Policy Council (established under National Security

Act of 1947, this panel advised the secretary of defense on broad
policy matters and specific issues as requested; its initial members

869

Appendices

AFSWP

AMA
ANL

AR

ASD (H&M)

ASD (R&D)

ASD (R&E)

BNL

included the secretary and deputy secretary of defense; the
secretaries of the Air Force, Army, and Navy; the chairman of the
JCS; chiefs of staff of the Air Force and the Army; and chief of
naval operations)

Armed Forces Special Weapons Project (established by the
secretaries of war and the Navy in January of 1947; inherited
certain functions of the MED in the areas of nuclear weapons
development, testing, storage, and training of personnel; succeeded
byDASAin 1958)

American Medical Association (professional society)

Argonne National Laboratory (established in 1946 and operated by
the University of Chicago; inherited many of the facilities and
functions of Met Lab; one of the three original national
laboratories, the others are BNL and ORNL, established in 1946
and 1947, respectively)

Army regulation (policy directive)

assistant secretary of defense (health and medicine) (succeeded the
AFMPC in 1953; provided advice and assistance on health and
medical aspects of DOD policies, plans, and programs and
collaborated with ASD [R&D] in the development of policies and
the review of requirements for biomedical research by DOD)

assistant secretary of defense (research and development)
(replaced the RDB in 1953; provided advice and assistance to the
secretary of defense on R&D policies, plans, and programs,
developed an integrated DOD R&D program, assigned specific
responsibilities for R&D programs where unnecessary duplication
would be eliminated by such action, examined the interaction of
R&D and strategy and advised the JCS, and reviewed proposed
R&D budgets and made recommendations thereon; succeeded by
ASD [R&E] in 1957)

assistant secretary of defense (research and engineering)
(combined the offices of ASD [R&D] and the assistant secretary of
defense [engineering]; succeeded by the director of defense
research and engineering [DDR&E] in 1958)

Brookhaven National Laboratory (established by the MED in 1946

870

Acronyms and Abbreviations

and operated by the Associated Universities; created to facilitate
cooperation between universities and the federal government in
performing research in physics and nuclear science)

BuMed Bureau of Medicine and Surgery (operates Navy's hospitals and

medical research centers, as well as sponsoring most of its outside
biomedical research)

CDC Centers for Disease Control and Prevention

CEQ Council on Environmental Quality (three-member panel within

EOP, established by National Environmental Policy Act; has
environmental oversight responsibilities)

C.F.R. Code of Federal Regulations (compilation of federal regulations

available from the Government Printing Office and in many public
and private libraries)

CHR Center for Human Radiobiology (created within Argonne National

Laboratory in the late 1 960s)

CMR Committee on Medical Research (established in 1942 under OSRD

to sponsor nonradiation-related biomedical research of interest to
the military; disestablished in late 1946)

CMS Committee on Medical Sciences (RDB committee in existence

from 1948 to late 1953 that reviewed, evaluated, and made
recommendations on all biomedical research conducted by or for
DOD entities; members included both civilian and military health
professionals; from late 1953 to 1957, an advisory group to ASD
[R&D] and ASD [R&E], functions transferred to the Committee on
Science in 1957)

DASA
DBM

Defense Atomic Support Agency (1958 AFSWP successor)

Division of Biology and Medicine (established in early 1948 to
direct and coordinate all AEC biomedical research activities;
became the Biological and Environmental Research Division with
the creation of ERDA in 1974)

DDR&E director of defense research and engineering (succeeded ASD

[R&E] in 1958, reviewing, evaluating, and directing all R&D
conducted by or for DOD)

871

Appendices
DHEW

DHHS

DNA
DOD

DOE
EOP
EPA

ERDA

FDA

HEDR

HEW
HHS

Department of Health, Education, and Welfare (DHHS
predecessor, established in 1953)

Department of Health and Human Services (1980 DHEW
successor; the principal federal agency charged with advancing the
health of Americans and providing essential human services)

Defense Nuclear Agency (1971 successor to DAS A)

Department of Defense (new name established in 1949 for the
National Military Establishment, which had been created under the
National Security Act of 1947 to replace the War and Navy
Departments)

Department of Energy (1977 successor to ERDA)

Executive Office of the President

Environmental Protection Agency (federal agency charged with
monitoring the quality of the environment)

Energy Research and Development Administration (succeeded
AEC in 1974, with responsibilities for civilian nuclear power and
isotope licensing and distribution transferred to the newly created
Nuclear Regulatory Commission; succeeded by DOE in 1977)

Food and Drug Administration (established as part of the
Department of Agriculture in 1862; became a regulatory agency in
1906; transferred to Federal Security Agency in 1940, which
became HEW in 1953; became part of PHS in 1968; enforces laws
to ensure the safety and efficacy of foods, food additives, drugs,
biologies, cosmetics, and medical devices)

Hanford Environmental Dose Reconstruction (established by DOE,
later transferred to Centers for Disease Control, this project
assesses human exposures to ionizing radiation due to radioactive
emissions from the Hanford, Washington, plutonium-production
plant)

See DHEW

See DHHS

872

Acronyms and Abbreviations

HURB

ICRP

IG

INEL

IRB
JCAE

Human Use Review Board (within Army surgeon general's office,
reviews proposed research involving greater than minimal risk)

International Commission on Radiological Protection
(international body of scientific experts, created in 1928, which
functions on an international basis as the NCRP does within the
United States)

inspector general (office in federal departments and agencies that
conducts and supervises audits, investigations, and inspections of
department and agency operations)

Idaho National Engineering Laboratory (originally named the
National Reactor Testing Station, INEL was established in 1 949 as
a remote site to work with experimental civilian and military
reactors)

institutional review board (See Glossary)

Joint Committee on Atomic Energy (congressional committee
established under the Atomic Energy Act of 1946 to oversee AEC;
disestablished in 1974).

JCS Joint Chiefs of Staff

LANL Los Alamos National Laboratory (established as Los Alamos

Scientific Laboratory by the MED in 1943; operated by the
University of California since it was established; originally created
to design and build a fission bomb; designated a national
laboratory in 1977)

LBL Lawrence Berkeley Laboratory (1971 successor to UCRL)

LLNL Lawrence Livermore National Laboratory (successor to the

Livermore weapons lab which had been established in 1952 as the
second weapons lab and had been operated by UCRL)

MED Manhattan Engineer District, also popularly known as the

Manhattan Project (established in 1942 within the U.S. Army to
build the atomic bomb; functions transferred to AEC and AFSWP
in 1947)

MetLab Metallurgical Laboratory (University of Chicago-based MED

873

Appendices

laboratory established in 1 942; most functions transferred to ANL
in 1946)

MKULTRA A domestic CIA program in the 1950s and 1960s involving human
experimentation to investigate control of human behavior through
the use of chemical, biological, and other means (including
psychoactive drugs, psychology, and possibly radiation)

MLC Military Liaison Committee (established under the Atomic Energy

Act of 1946; chaired by a civilian, its other members included two
senior officers from each of the three services; advised the
secretary of defense and Joint Chiefs of Staff on priorities for DOD
atomic energy R&D, which component should conduct it, and
liaisoned with the AEC on DOD activities)

MPA multiple-project assurance (research institution's assurance,

covering a number of different research projects, to OPRR or the
funding agency that the institution will comply with federal human
subjects protection policy)

MPBB maximum permissible body burden (amount of radioactivity that,

if deposited in the body, is estimated to deliver the highest
allowable dose rate to the most critical organ over a defined period
of time)

NASA National Aeronautics and Space Administration (established in

1958; agency responsible for the development of space aviation,
technology, and exploration)

NCI National Cancer Institute (established in 1937, part of NIH)

NCRH National Center for Radiological Health (1967 successor to PHS's

radiological health and safety program; conducted biological and
epidemiological research on radiation effects)

NCRP National Committee on Radiological Protection and Measurements

( 1 946 successor to Advisory Committee on X-ray and Radium
Protection, known after 1964 as National Council on Radiation
Protection and Measurements; an independent body of scientific
experts, it recommends limits for occupational exposure that are
widely followed and periodically issues reports on special topics)

NEPA ( 1 ) Nuclear Energy for the Propulsion of Airplanes ( 1 946- 1 96 1 Air

874

Acronyms and Abbreviations

NIH

NIOSH

Force program for developing nuclear-powered bomber)
(2) National Environmental Policy Act of 1969 (Federal statute
requiring that the U.S. government consider and publicize the
environmental impact of its actions)

National Institutes of Health (part of PHS; begun as a one-room
Laboratory of Hygiene in 1887, now the world's largest biomedical
research facility; based in Bethesda, Maryland; conducts and
sponsors research dedicated to health promotion and the discovery
of causes, prevention, and cure of diseases)

National Institute for Occupational Safety and Health (part of
CDC)

NRC Nuclear Regulatory Commission (established in 1974 as a

successor to AEC to run civilian nuclear power program and
radioisotope licensing and distribution program)

NTPR Nuclear Test Personnel Review (DNA program established in

1978 to, among other things, compile unclassified histories of
atmospheric nuclear weapons tests, determine which DOD civilian
and military personnel were present at these tests, and establish
their exposure levels at the tests)

NYOO New York Operations Office (AEC regional office)

OPRR Office for Protection from Research Risks (established within NIH

in 1966 to educate investigators and others about research ethics
and to implement regulations for the protection of human and
animal subjects)

ORAU Oak Ridge Associated Universities (1966 successor to ORINS)

ORINS Oak Ridge Institute of Nuclear Studies (established in 1946, and

operated initially by a consortium of fourteen Southeastern
universities under AEC contract beginning in 1947; a research and
training site for users of radioisotopes in medicine and site of
biomedical research)

ORISE Oak Ridge Institute for Science and Education ( 199 1 successor to

ORAU)

ORO Oak Ridge Operations Office (AEC/ERD A/DOE regional office)

875

Appendices
ORNL

OSG

OSRD

PBI
PHS

R&D
RDB

RDRC
RSC

RW

SAM

TBI
UCRL

Oak Ridge National Laboratory (established in 1947, succeeding
Clinton Labs; has conducted a wide range of research for AEC,
ERDA, and DOE)

Army Office of the Surgeon General (operates Army's hospitals
and medical research centers, as well as sponsoring most of its
outside biomedical research)

Office of Scientific Research and Development (through numerous
committees, coordinated and directed all nonatomic energy R&D
of the War and Navy Departments from 1942 to 1946; succeeded
by the Joint Research and Development Board)

partial-body irradiation

Public Health Service (the federal government's principal health
agency, restructured three times since World War II, now one of
five operating divisions of DHHS; functions to improve public
health through the promotion of physical and mental health and the
prevention of disease, injury, and disability)

research and development

Research and Development Board (reviewed, evaluated, and
directed all research and development conducted by or for DOD;
functions transferred to ASD [R&D] and ASD [R&E] in late 1953)

radioactive drug research committee (reviews proposed use of
radioactive drugs within an institution)

radiation safety committee (monitors radiation safety within an
institution)

radiological warfare

School of Aviation Medicine (Air Force component; conducted
radiobiology research beginning in the late 1940s; coordinated
efforts with other government agencies)

total-body irradiation

University of California Radiation Laboratory (lab established in
1936 by Ernest Lawrence on the Berkeley campus; conducted a

876

Acronyms and Abbreviations

wide range of research for the MED and AEC; operated the
Livermore weapons lab from its establishment in 1952;
redesignated the Lawrence Berkeley Laboratory in 1 97 1 )

UCSF University of California at San Francisco (biomedical research

site)

U.S.C. United States Code (compilation of congressionally enacted laws

available in many public and private libraries)

VA Department of Veterans Affairs (successor to 1 930- 1 989 Veterans

Administration)

WMA World Medical Association (professional organization; issued

Helsinki Declaration in 1964)

877

Glossary

Terms in italics appear in the Glossary as separate entries.

Alpha radiation See Ionizing radiation.

Association In statistics, the correlation or relationship between one factor and
one or more other pertinent factors as demonstrated by experimental data.

Atomic bomb An explosive device in which a large amount of energy is
released through the nuclear fission of uranium or plutonium. The first atomic
bomb test, known as the Trinity Shot, took place in the desert north of
Alamogordo, New Mexico, on July 16, 1945. Several weeks later, an atomic
bomb was used for the first time as an instrument of war, detonating over the
Japanese cities of Hiroshima (August 6) and Nagasaki (August 9).

Atomic pile See Nuclear reactor.

Becquerel See Units of radioactivity.

Beta radiation See Ionizing radiation.

Biodistribution The pattern and process of a chemical substance's distribution
through the body.

Biological dosimeter See Dosimeter.

Biopsy The removal and/or examination of tissues, cells, or fluids from a living
body for the purposes of diagnosis or experimental tests.

878

Glossary

Biophysics The application of physical principles and methods to the study of
the structures of living organisms and the mechanics of life processes.

Body burden The amount of a radioactive material present in a body over a
long time period. It is calculated by considering the amount of material initially
present and the reduction in that amount due to elimination and radioactive decay.
It is commonly used in reference to radionuclides having a long biological half-
life. A body burden that subjects the body's most sensitive organs to the highest
dose of a particular radionuclide that regulators allow is known as a maximum
permissible body burden (MPBB).

Bone marrow infusion The injection of bone marrow (an essential tissue
producing red and white blood cells and platelets) into the body, used primarily to
replace bone marrow destroyed by disease or in the course of radiation and other
therapies for certain types of cancer.

Carcinogen A material that can initiate or promote the development of cancer.
Well-known carcinogens include saccharine, nitrosamines found in cured meat,
certain pesticides, and ionizing radiation.

Chain reaction The process by which the fission of a nucleus releases neutrons,
causing other nuclei to undergo fission in turn. Both the atomic bomb and the
nuclear reactor use a chain reaction to generate energy.

Clinical trial A research study involving human subjects, designed to evaluate
the safety and effectiveness of new therapeutic and diagnostic treatments.

Common Rule The 1991 federal regulation that provides the basic procedures
and principles that are to be followed in the conduct of human subject research
sponsored by federal agencies.

Critical mass The amount of fissionable material (uranium 235 or plutonium
239) sufficient to sustain a nuclear chain reaction.

Curie See Units of radioactivity.

Cyclotron A device that uses alternating electric fields to accelerate subatomic
particles (a particle smaller than an atom, such as an alpha particle or a proton).
When these particles strike ordinary nuclei, radioisotopes are formed. For his
work in developing the cyclotron in the early 1930s, Ernest Lawrence of the
University of California received the 1939 Nobel Prize in Physics.

Deterministic effect An effect, such as kidney damage, whose severity

879

Appendices

increases with increasing dose of radiation or other agent.

Diagnostic procedure A method used to identify a disease in a living person.

Dosage The prescribed amount of medicine or other therapeutic agent
administered to treat a given illness.

Dose In radiology, a measure of energy absorbed in the body from ionizing
radiation, measured in rad.

Dose reconstruction The process of using information about an individual's past
exposures to ionizing radiation as well as general knowledge about the behavior
of radioactive materials in the human body and in the environment to estimate the
dose of radiation that someone has received.

Dosimeter An instrument that measures the dose of ionizing radiation. A
biological dosimeter is a biological or biochemical indicator of the effects of
exposure, such as a change in blood chemistry or in blood count. A highly
accurate biological dosimeter has yet to be found.

Dosimetry The measurement and calculation of radiation doses.

Endocrinology The study of the body's hormone-producing glands, such as the
thyroid, pituitary, and adrenal glands, and the functions of the hormones they
synthesize and secrete.

Epidemiology The study of the determinants (risk factors) and distribution of
disease among populations.

Fallout Radioactive debris that falls to earth after a nuclear explosion.

Fission The division of an atomic nucleus into parts of comparable mass.
Generally speaking, fission may occur only in heavier nuclei, such as isotopes of
uranium and plutonium. Atomic bombs derive energy from the fission of uranium
or plutonium.

Fission product An atom or nucleus that results from the fission of a larger
nucleus.

Fusion The combining of two light atomic nuclei to form a single heavier
nucleus, releasing energy. Hydrogen bombs derive a large portion of their energy
from the fusion of hydrogen isotopes.

880

Glossary
Gamma radiation See Ionizing radiation.

Genetic effects Changes in a person's germ calls (sperm or ova) that are
transmissible to future generations. Such changes result from mutations in genes
within the germ cells.

Gray see Units of radioactivity.

Half-life The average time required for one-half of the amount of radioactivity
of a radionuclide to undergo radioactive decay. For material with a half-life of
one week, half of the original amount of activity will remain after one week; half
of that (one-quarter of the original amount) will remain after two weeks; and so
on.

Health physics A branch of physics specializing in accurate measurement of
agents, such as ionizing radiation, which can have effects on human health.

Hydrogen bomb (also known as a thermonuclear weapon) An explosive
weapon that uses nuclear fusion to release energy stored in the nuclei of hydrogen
isotopes. The high temperatures essential to fusion are attained by detonating an
atomic bomb placed at the H-bomb's structural center. The United States tested
the first hydrogen bomb in 1954 at the Pacific Test Site.

Institutional review board (IRB) Under the Common Rule, a local review
board convened by any institution conducting federally sponsored human subject
research, vested with the responsibility to review research proposals to ensure
compliance with federal research regulations.

Internal emitter A radioisotope incorporated into a tissue in the body that
decays in place and continuously exposes that tissue to ionizing radiation.

Ionization The process by which a neutral atom or molecule loses or gains
electrons, thereby acquiring a net electrical charge. When charged, it is known as
an ion.

Ionizing radiation Any of the various forms of radiant energy that causes
ionization when it interacts with matter. The most common types are alpha
radiation, made up of helium nuclei; beta radiation, made up of electrons; and
gamma and x radiation, consisting of high-energy particles of light (photons).

Irradiation Exposure to radiation of any kind, especially ionizing radiation.

Isotope A species of nucleus with a fixed number of protons and neutrons. The

881

Appendices

term isotope is usually used to distinguish nuclear species of the same chemical
element (i.e., those having the same number of protons, but different numbers of
neutrons), such as iodine 127 and iodine 131.

Latency period The time between when an exposure occurs and when its effects
are detectable as an injury or illness.

Maximum Permissible Body Burden (MPBB) see Body burden

Metabolism The manner in which a substance is acted upon (taken up,
converted to other substances, and excreted) by various organs of the body.

Natural background radiation Ionizing radiation that occurs naturally. Its
principal sources are cosmic rays from outer space, radionuclides in the human
body, and radon gas (a decay product of natural uranium in the earth's crust).

Nuclear medicine A branch of medicine specializing in the use of radionuclides
for diagnostic and therapeutic purposes.

Nuclear reactor A device containing fissionable material in sufficient quantity
and suitable arrangement to maintain a controlled, self-sustaining nuclear chain
reaction.

Nuclide A type of nucleus with a fixed number of protons and neutrons. The
term nuclide is usually used to distinguish nuclear species of different chemical
elements (i.e., those having different numbers of protons and neutrons), such as
iodine 127 and uranium 235.

Partial-Body Irradiation (PBI) Exposure of part of the body to external
radiation.

Permissible dose In the judgment of a regulatory or advisory body, such as the
National Committee on Radiation Protection, the amount of radiation that may be
received by an individual within a specified period.

Principal investigator The scientist or scholar with primary responsibility for
the design and conduct of a research project.

Protocol The formal design or plan of an experiment or research activity;
specifically, the plan submitted to an institutional review board for review and to
a government agency for research support. Protocols include a description of the
research design or methodology to be employed, the eligibility requirements for
prospective subjects and

882

Glossary

controls, the treatment regimen(s), and the methods of analysis to be performed
on the collected data.

Rad See Units of radiation

Radiation The emission of waves transmitting energy through space or a
material medium, such as water. Light, radio waves, and x rays are all forms of
radiation.

Radiation biology See radiobiology.

Radiation oncology A branch of medicine specializing in the treatment of
cancer with radiation. Radiation therapy and radiotherapy are equivalent terms.

Radiation sickness Acute physical illness caused by exposure to doses of
ionizing radiation large enough to cause toxic reactions. This can include
symptoms such as nausea, diarrhea, headache, lethargy, and fever.

Radioactive decay The process by which the nucleus of a radioactive isotope
decomposes and releases radioactivity. For example, carbon 14 (a radioisotope
of carbon) decays by losing a beta particle, thereby becoming nitrogen 14, which
is unstable.

Radioactivity The decay of unstable nuclei through the emission of ionizing
radiation. The resulting nucleus may itself be unstable and undergo radioactive
decay. The process stops only when the decay product is stable.

Radiobiology Branch of biology specializing in the study of the effects of
radiation on biological molecules, cells, tissues, and whole organisms, including
humans. Radiobiology seeks to discover the molecular changes responsible for
radiation effects such as cancer induction, genetic changes, and cell death.

Radiogenic A term used to identify conditions observed to be caused by
exposure to ionizing radiation, such as certain kinds of cancer.

Radioisotope A radioactive isotope. Radioisotopes are used in medical research
as tracers. See also isotope, nuclide, and radionuclide.

Radiological weapons Weapons that use radioactive materials to cause
radiation injury.

Radionuclide A radioactive nuclide. Often used to distinguish radioisotopes of
different chemical elements, such as iodine 131 and uranium 239.

883

Appendices

Radiopharmaceuticals Drugs (compounds or materials) that may be labeled or
tagged with a radioisotope. In many cases, these materials function much like
materials found in the body and do not produce special pharmacological effects.
The principal risk associated with these materials is the consequent exposure of
the body or certain tissues to radiation.

Radioresistance The degree of resistance of organisms or tissues to the harmful
effects of ionizing radiation.

Radiosensitivity The degree of sensitivity of organisms or tissues to the harmful
effects of ionizing radiation.

Radiotherapy See radiation oncology.

Rem See Units of radiation.

Rep See Units of radiation.

Roentgen See Units of radiation.

Tolerance dose See Permissible dose.

Total-Body Irradiation (TBI) Exposure of the entire body to external
radiation.

Tracer A distinguishable substance, usually radioactive, administered to
determine the distribution and/or metabolism of materials in the body. In 1923,
George Hevesy was the first investigator to use an isotope (radioactive thorium)
in metabolic studies, exploring lead transport in the bean plant. Metabolic studies
proliferated after World War II, when with the development of the cyclotron,
radioisotopes of various atoms became more widely available. Isotopes
commonly used as tracers today include carbon 14, iodine 131 and phosphorus
32.

Transuranic elements Radioactive elements with atomic numbers (i.e., the
number of protons in the nucleus) greater than 92. Only two of these elements
(plutonium in minute amounts and neptunium) occur in nature; the others are
produced in minute amounts through the radioactive decay of uranium. The first
transuranic elements were discovered as synthetic radioisotopes at the University
of California at Berkeley and the Argonne National Laboratory in the 1930s and
1940s.

884

Glossaiy

Units of radiation The basic unit of radiation exposure is the roentgen, named
after Wilhelm Roentgen (discoverer of x rays). It is a measure of ionization in air,
technically equal to one ESU (electrostatic unit) per cubic centimeter, due to
radiation. A rep (roentgen equivalent physical) is an archaic measure of skin
exposure to a dose of beta radiation having an effect equivalent to 1 roentgen of
x rays. The basic unit of radiation absorbed by the body is the rad, technically
equal to 100 ergs (energy unit) per gram of exposed tissue. One roentgen
corresponds to roughly 0.95 rad. The rem (roentgen equivalent in man) is a unit
of effective dose, a dose corrected for the varying biological effectiveness of
various types of ionizing radiation. The currently accepted unit of radiation is the
gray (Gy), the International System unit of absorbed dose, equal to the energy
imparted by ionizing radiation to a mass of matter corresponding to one joule per
kilogram.

Units of Radioactivity The becquerel (Bq), named after the physicist Henri
Becquerel (the discoverer of radioactivity), is a measure of radioactivity equal to
one atomic disintegration per second. The curie (Ci), whose name honors the
French scientists Marie and Pierre Curie (the discoverers of radium), is a standard
based on the radioactivity of 1 gram of radium. It is equal to 3.7 x 1010
becquerels.

X rays Invisible, highly penetrating electromagnetic radiation of a much shorter
wavelength than visible light, discovered in 1895 by Wilhelm C. Roentgen. Most
applications of X rays are based on their ability to pass through matter. They are
dangerous in that they can destroy living tissue, causing severe skin burns on
human flesh exposed for too long a time. This property is applied in x-ray
therapy to destroy diseased cells. See Ionizing radiation.

885

Selected Bibliography

The books and articles listed below provide additional reading in scientific,
ethical, and historical literature. A comprehensive bibliography of primary and
secondary sources used in this report appears in the supplemental volume Sources
and Documentation.

RESEARCH ETHICS

Annas, George J., and Michael A. Grodin, eds., The Nazi Doctors and the
Nuremberg Code: Human Rights in Human Experimentation. New York:
Oxford University Press, 1992.

Beecher, Henry K. "Ethics and Clinical Research." New England Journal of
Medicine 214 (1966): 1354-1360.

Bok, Sissela. Secrets: On the Ethics of Concealment and Revelation. New York:
Vintage Books, 1989.

Couglin, Steven S., and Tom L. Beauchamp. Ethics in Epidemiology. New York:
Oxford University Press, forthcoming.

Faden, Ruth, and Tom L. Beauchamp. A History and Theory of Informed
Consent. New York: Oxford University Press, 1986.

Gray, Bradford H. Human Subjects in Medical Experimentation: A Sociological
Study of the Conduct and Regulation of Clinical Research. New York: John
Wiley and Sons, 1975.

Grodin, Michael A., and Leonard H. Glantz, eds., Children as Research Subjects:
Science, Ethics, and Law. New York: Oxford University Press, 1994.

886

Selected Bibliography

Institute of Medicine, Committee on the Ethical and Legal Issues Relating to the
Inclusion of Women in Clinical Studies. Women and Health Research: Ethical
and Legal Issues of Including Women in Clinical Studies. Vol. 1. Washington,
D.C.: National Academy Press, 1994.

Katz, Jay. Experimentation with Human Beings: The Authority of the

Investigator, Subject, Professions, and State in the Human Experimentation
Process. New York: Russell Sage Foundation, 1972.

Katz, Jay. The Silent World of Doctor and Patient. New York: Free Press, 1984.

Lederer, Susan. Subjected to Science: Human Experimentation in America after
the Second World War. Baltimore: Johns Hopkins University Press, 1995.

Levine, Robert J. Ethics and Regulation of Clinical Research. 2d ed. Baltimore:
Urban and Schwarzenberg, 1986.

Lifton, Robert Jay. Nazi Doctors: Medical Killing and the Psychology of
Genocide. New York: Basic Books, 1986.

Orlans, F. Barbara. In the Name of Science: Issues in Responsible Animal
Experimentation. New York: Oxford University Press, 1993.

Rothman, David J. Strangers at the Bedside: A History of How Law and
Bioethics Transformed Medical Decision Making. New York: Basic Books,
1991.

Veatch, Robert M. The Patient as Partner: A Theory of Human-Experimentation
Ethics. Bloomington: Indiana University Press, 1987.

RADIATION-RELATED SCIENCE

Brucer, Marshall. A Chronology of Nuclear Medicine. St. Louis, Mo.: Heritage
Publications, 1990.

Committee on the Biological Effects of Ionizing Radiation. Board on Radiation
Effects Research. Commission on Life Sciences. National Research Council.
Health Risks of Radon and other Internally Deposited Alpha-Emitters: BEIR
IV. Washington, D.C.: National Academy Press, 1988.

Committee on Biological Effects of Ionizing Radiation, Board on Radiation
Effects Research, National Research Council. Health Effects of Exposure to

887

Appendices

Low Levels of Ionizing Radiation: BEIR V. Washington, D.C.: National
Academy Press, 1990.

Conklin, James J., and Richard I. Walker, eds., Military Radiobiology. Orlando,
Fla.: Academic Press, 1987.

Eisenberg, Ronald L. Radiology: An Illustrated History. St. Louis: Mosby-Year
Book, 1992.

Gofman, John W. Radiation and Human Health. San Francisco: Sierra Club
Books, 1981.

Hennekens, Charles H., and Julie E. Buring. Epidemiology in Medicine. Edited
by Sherry L. Mayrent. Boston: Little, Brown and Company, 1987.

Martin, Alan, and Samuel A. Harbison, eds., An Introduction to Radiation
Protection. 3d ed. New York: Chapman and Hall, 1986.

McAfee, J. G., R. T. Kopecky, and P. A. Frymoyer. "Nuclear Medicine Comes of
Age: Its Present and Future Roles in Diagnosis." Radiology (1990): 609-620.

Mettler, Fred A., Jr., and Arthur C. Upton. Medical Effects of Ionizing Radiation.
2d ed. Philadelphia: W. B. Saunders, 1995.

Schapiro, Jacob. Radiation Protection: A Guide for Scientists and Physicians. 3d
ed.; Cambridge, Mass.: Harvard University Press, 1990.

United Nations Scientific Committee on the Effects of Atomic Radiation.
"Sources and Effects of Ionizing Radiation." UNSCEAR 1993 Report to the
General Assembly, with Scientific Annexes. New York: United Nations, 1993.

Upton, Arthur C. "The Biological Effects of Low-Level Ionizing Radiation."

Scientific American (February 1982): 41-49.

HISTORY AND BIOGRAPHY

Bradley, David. No Place to Hide. Boston: Little, Brown and Company, 1948.

Bush, Vannevar. Pieces of the Action. New York: William Morrow, 1970.

Conard, Robert A. Fallout: The Experiences of a Medical Team in the Care of a
Marshallese Population Accidently Exposed to Fallout Radiation. New York:

888

Selected Bibliography

Brookhaven National Laboratory, 1992. Available from National Technical
Information Service, U.S. Department of Commerce, 5285 Port Royal Road,
Springfield, VA 22161.

D' Antonio, Michael. Atomic Harvest: Hanford and the Lethal Toll of America's
Nuclear Arsenal. New York: Crown Publishing, 1993.

Divine, Robert A. Blowing on the Wind: The Nuclear Test Ban Debate 1954-
1960. New York: Oxford University Press, 1978.

Eichstaedt, Peter H. If You Poison Us: Uranium and Native Americans. Santa
Fe, N.M.: Red Crane Books, 1994.

Eisenbud, Merril. An Environmental Odyssey: People, Pollution and Politics in
the Life of a Practical Scientist. Seattle: University of Washington Press,
1990.

Fradkin, Phillip L. Fallout: An American Nuclear Tragedy. Tucson: University
of Arizona Press, 1989.

Gallagher, Carole. American Ground Zero: The Secret Nuclear War. Boston:
MIT, 1993.

Gerber, Michele Stenehjem. On the Home Front: The Cold War Legacy of the
Hanford Nuclear Site. Lincoln: University of Nebraska Press, 1992.

Glasser, Otto. Wilhelm Conrad Roentgen and the Early History of the Roentgen
Rays. San Francisco: Norman Publishing, 1993.

Hacker, Barton C. The Dragon s Tail: Radiation Safety in the Manhattan Project,
1942-1946. Berkeley: University of California Press, 1987. A history of
radiation safety in the Manhattan Project, 1942-1946.

. Elements of Controversy: The Atomic Energy Commission and Radiation

Safety in Atomic Weapons Testing, 1947-1974. Berkeley: University of
California Press, 1994.

Hershberg, James. Harvard to Hiroshima and the Making of the Nuclear Age.
New York: Alfred A. Knopf Publications, 1993.

Hewlett, Richard G., and Oscar E. Anderson, Jr. The New World: A History of
the United States Atomic Energy Commission, Volume 1: 1939-1946.

889

Appendices

University Park: Pennsylvania State University Press, 1962.

■ — and Francis Duncan. Atomic Shield: A History of the Unites States Atomic
Energy Commission, Volume II: 1947-1952. University Park: Pennsylvania
State University Press, 1969.

and Jack M. Moll. Atoms for Peace and War: Eisenhower and the Atomic

Energy Commission: 1953-1961. Berkeley: University of California Press,
1989.

Johnson, Charles W., and Charles O. Johnson. City Behind a Fence: Oak Ridge,
Tennessee, 1942-1946. Knoxville: University of Tennessee Press, 1981.

Kathren, Ronald L., Jerry B. Gough, and Gary T. Benefiel, eds. The Plutonium
Story: The Journals of Professor Glenn T. Seaborg, 1939-1946. Columbus,
Ohio: Battelle Press, 1994.

Kevles, Daniel J. The Physicists: The History of a Scientific Community in
Modern America. New York: Vintage Books, 1979.

Lindee, Susan. Suffering Made Real: American Science and the Survivors of
Hiroshima. Chicago: University of Chicago Press, 1994.

Mazuzan, George T., and J. Samuel Walker. Controlling the Atom: The
Beginnings of Nuclear Regulation, 1946-1962. Berkeley: University of
California Press, 1992.

Price, Don K. The Scientific Estate. New York: Oxford University Press, 1965.

Quinn, Susan. Marie Curie: A Life. New York: Simon & Schuster, 1995.

Rhodes, Richard. The Making of the Atomic Bomb. New York: Simon &
Schuster, 1986.

. Dark Sun: The Making of the Hydrogen Bomb. New York: Simon &

Schuster, 1995.

Rosenberg, Howard L. Atomic Soldiers: American Victims of Nuclear
Experiments. Boston: Beacon Press, 1980.

Smyth, Henry DeWolf. Atomic Energy for Military Purposes: The Official
Report on the Development of the Atomic Bomb under the Auspices of the

890

Selected Bibliography

United States Government: 1940-1945. Stanford, Calif.: Stanford University
Press, 1989.

Stannard, J. Newell. Radioactivity and Health: A History. Oak Ridge, Tenn.:
Office of Scientific and Technical Information, 1988.

Starr, Paul. The Transformation of American Medicine. New York: Basic Books,
1982.

Taylor, Telford. The Anatomy of the Nuremberg Trials: A Personal Memoir.
New York: Alfred A. Knopf, 1992.

Udall, Stewart L. The Myths of August: A Personal Exploration of Our Tragic
Cold War Affair with the Atom. New York: Pantheon Books, 1994.

Walker, J. Samuel. Containing the Atom: Nuclear Regulation in a Changing
Environment, 1962-1971. Berkeley: University of Califonia Press, 1992.

Weart, Spencer R. Nuclear Fear: A History of Images. Cambridge, Mass.:
Harvard University Press, 1988.

Weisgall, Jonathan. Operation Crossroads. Annapolis, Md.: Naval Institute
Press, 1994.

891

Public Comment Participants

Unless otherwise noted, full committee meetings, with opportunity for public
comment, took place in Washington, D.C. There was also one full committee
meeting in San Francisco. In addition, the Committee convened panels of its
members to take testimony in Cincinnati, Spokane, Sante Fe, and Knoxville on
the dates listed. Where known, cities and affiliations are noted.

April 21-22, 1994

Gwendon Plair, Concerned Relatives of
Cancer Study Patients

May 18-19, 1994

E. Cooper Brown, Executive
Commission, Task Force on Radiation

and Human Rights
H. W. Cummins, Human Radiation

Experiments Litigation Project
Fred Allingham, National Association of

Radiation Survivors
Daryl Kimball, Physicians for Social

Responsibility

June 13-14, 1994

Tod Ensign, Citizen Soldier, NY
John McCarthy, Sacramento Radiation

Survivors Group
Thomas Smith, National Association of

Radiation Survivors
Pat Broudy, National Association of

Atomic Veterans

July 5-6, 1994

Wilfred Kendall, Representative of the

Embassy of the Republic of the

Marshall Islands
Tony deBrum, Representative of the

Embassy of the Republic of the

Marshall Islands
Jonathan Weisgall, Attorney representing

Bikini Islands
E. Cooper Brown, Executive

Commission, Task Force on Radiation

and Human Rights*

July 25-26, 1994

Stewart Udall, former U.S. Secretary of

the Interior
Eugene Trani, Virginia Commonwealth

University
Hermes Kontos, Virginia Commonwealth

University
John Jones, Virginia Commonwealth

University
Chris Zucker, Disability Advocates of

New York, Inc., Albany, NY
Pat Broudy, National Association of

Atomic Veterans*
Dr. Oscar Rosen, National Association of

Atomic Veterans
Catherine Variano, South Bend, ID
Janet Gordon, Citizen's Call, UT

September 12-13, 1994

Ruth Blaz, Hollywood, FL

Cliff Honicker, Environmental Health

Studies Project, Knoxville, TN
Francis Brown, Southwick, MA
Tod Ensign, Citizen Soldier, NY*
Pat Broudy, National Association of

Atomic Veterans*

San Francisco, October 11-13, 1994

Nancy Lynch, Santa Barbara, CA
Jackie Maxwell, Menlo Park, CA
Vernon Sousa, San Francisco, CA
Gwynne Borroughs, Chico, CA
Israel Torres, Niporno, CA
Audrey Hack, Union City, CA
Richard Harley, Bakersfield, CA

* indicates that the participant spoke at a previous meeting

892

San Francisco, October 11-13, 1994
(cont.)

Donald Arbitlit, San Francisco, CA
Geoffrey Sea, International Radiation

Survivors, Oakland, CA
Harold Bibeau, Portland, OR
Cheri Anderson, Placerville, CA
Tom Wilson, Placerville, CA
Michael Yesley, Los Alamos National

Laboratory
Lynn Stembridge, Hanford Education

Action League, Spokane, WA
Trisha Pritikin, Berkeley, CA
Lois Camp, Hanford Downwinder Health

Effects Group
Darcy Thrall, Richland, WA
Dr. Bernard Lo, San Francisco, CA
Jackie Cabasso, Oakland, CA
Marylia Kelley, Livermore, CA

Cincinnati, October 21,1994

U.S. Representative Rob Portman (OH)
Gwendon Plair, Concerned Relatives

of Cancer Study Patients*
Doris Baker, Cincinnati, OH
Gloria Nelson
Richard Casey
Lisa Crawford, Fernald Residents for

Environmental Safety and Health
Herbert Varin
Leslie Lynch
Professor Martha Stephens, University of

Cincinnati
Bob Phillips
Lillian Pagano
Sherry Brabant
Otisteen Goodwin
Clifford Tidwell
Owen Thompson
Dr. Joseph Steger, President, University

of Cincinnati
Stan Chesley, Former Chairman of the

Board, University of Cincinnati
David Thompson, Attorney, Cincinnati

lawsuits
Kenneth Kendall

Cincinnati, October 21, 1994 (cont.)

Tom Wilkenson

Tom Row, Oak Ridge National

Laboratory
Joe Larkins
Monica Ray
Gene Branham
Dorothy Sweety
Pat Wheeler
Katherine Hager
Robert Hager
H. W. Cummins, Radiation Health

Effects Public Law Group*
Ruth Blaz, Hollywood, FL*
Manuel Blaz, Hollywood, FL
Jackie Kitrell, American Environmental

Health Studies Project
Ann Hopkins
Mary Mueller
Daryl Kimball, Physicians for Social

Responsibility*
Vina Colley, Portsmouth/Piketon

Residents or Environmental Safety

and Security
Diana Salisbury, Portsmouth/Piketon

Residents for Environmental Safety

and Security
Geoffrey Sea, International Radiation

Survivors, Oakland, CA*

November 14-15, 1994

Marcia Haggard, Silver Spring, MD
Dr. Kathy Platoni, Beaver Creek, OH
Dr. Dennis Nelson, Kensington, MD
Mayor George Ahmaogak, North Slope

Borough Assembly, AK
Rossman Peetok, North Slope Borrough

Assembly, AK

Spokane, November 21, 1994

Leonard Schroeter, Seattle, WA

Gertie Hanson, Citizens Against Nuclear

Weapons and Exterminations
Al Conklin, Department of Health, WA
Harold Bibeau, Portland, OR*

* indicates that the participant spoke at a previous meeting

893

Spokane, November 21, 1994 (cont.)

Catherine Knox, Department of

Corrections, OR
Jim Thomas, Seattle, WA
Trisha Pritikin, Berkeley, CA*
Fred Larson, Ocean Park, WA
Brenda Weaver, Spokane, WA
Tom Bailie, Mesa, WA
Lynn Grover, Mesa, WA
Michelle Grover, Mesa, WA
Geoffrey Sea, International Radiation

Survivors, Oakland, WA*
Kathy Jacobovitch, Vashon Island, WA
JoAnne Watts, Grants Pass, OR
Theresa Potts, Couer d'Alene, ID
Tom Cooper, Couer d'Alene, ID
Kay Sutherland, Walla Walla, WA
Beverly Aleck, Anchorage, AK
Sherri Lozon, Nez Pierce Tribe
Jeanne Haycraft, Enterprise, OR
Darcy Thrall, Benton City, WA*
Lynne Stembridge, Hanford Education

Action League*
Lois Camp, LaCrosse, WA*
Lynn Horn, Spokane, WA
Charlie Miller, Spokane, WA
Charles Lombard, Spokane, WA
Curt Leslie, Wallua, WA
Rex Harter, Mesa, WA
David Vanderbilt, lone, WA
Wendell Ogg, Knoxville, TN
Iris Hedman Othello, WA

December 15-16, 1994

Doris Baker, Cincinnati, OH*
Vina Colley, Portsmouth/Piketon

Residents for Environmental Safety

and Security*
Diana Salisbury, Sardinia, OH*
Lenore Fenn, Lexington, MA
Peter Lewis, Uniontown, PA

December 15-16, 1994 (cont.)

Professor Robert Proctor, Pennsylvania

State University
William Jackling, Honeye Falls, NY
Fred Boyce, Norwell, MA
Pat Broudy, National Association of

Atomic Veterans*

Santa Fe, January 30, 1995

Stewart Udall, Former U.S. Secretary of

the Interior*
Ray Michael, Truth or Consequences,

NM
Darcy Thrall, Benton City, WA*
Tyler Mercier, Santa Fe, NM
DH Bob Hofmann, Mountain Home, AR
Theodore Garcia, Las Cruces, NM
Bill Holmes, Fulsom, CA
Manuel Pino, Mesa, AZ
Alvino Wacanda, Laguna-Acoma

Delegation, Paguato, NM
Curtis Francisco, Laguna-Acoma

Delegation, Pueblo, NM
Dorothy Purley, Laguna-Acoma

Delegation, Paguato, NM
Harry Lester, Albuquerque, NM
Milton Stadt, Victor, NY
Clyde Gardner, Edgewood, NM
Stanley Paytioma, Pueblo of Acoma,

Acoma, NM
John Taschner, Los Alamos National

Laboratory
Don Petersen, Los Alamos National

Laboratory
George Voelz, Los Alamos National

Laboratory
Joe Nardella

Timothy Benally, Shiprock, NM
Carlos Pacheco, Santa Fe, NM
Rosalie Jones, West Jordan, UT
Bernice Brogan, West Valley City, UT
Barney Bailey, Lovington, NM
Robert Stapleton, Ventura, CA
Linda Terry, Albuquerque, NM
Sue Dayton, Tijares, NM

* indicates that the participant spoke at a previous meeting

894

Santa Fe, January 30, 1995 (cont.)

Ernest Garcia, Chair, National
Contaminated Veterans of America,

Albuquerque, NM
Dale Howard, Las Lunas, NM
Coy Overstreet, Dickens, TX
Denise Nichols, USAF Major, Retired
Langdon Harrison, Albuquerque, NM
Ray Koonuk, Mayor, Point Hope, AK
Jack Schaefer, Point Hope, AK
Caroline Cannon, Point Hope, AK
Dr. Chellis Glendinning, Chimayo, NM
John Sheahan, Albuquerque, NM
Damacio Lopez, Bernalillo, NM
Phil Harrison, Uranium Radiation

Victims Committee, Shiprock, NM
John Fowler
Renda Fowler
Bill Tsosie

Glenn Stuckey, Albuquerque, NM
Robert McConaghy

January 19-20, 1995

Joan McCarthy

Charles McKay, Severna Park, MD
Pat Broudy, National Association of
Atomic Veterans*

February 15-16, 1995

Alex Reinhart, Braintree, MA
Wilfred Kendall, Embassy of the

Republic of the Marshall Islands*
Senator Henchi Balos, Republic of the

Marshall Islands
Holly Barker, Embassy of the Republic of

the Marshall Islands
E. Cooper Brown, Executive Commission

Task Force on Radiation and Human

Rights*
Cliff Honicker, Environmental Safety

Studies Project, Knoxville, TN*
Pat Broudy, National Association of

Atomic Veterans*
Jonathan Weisgall, Attorney representing

the Bikini Islands*

Knoxville, March 2, 1995

Paul White, Oak Ridge, TN

Dorothea Gay Brown, Knoxville, TN

Betty Freels, Clinton, TN

Mary Bunch, Clinton, TN

Margaret Jacobs, Harriman, TN

Dorothy McRight, Nashville, TN

David Lee, Knoxville, TN

Gary Litton, Oak Ridge, TN

Dr. Karl Morgan, Oak Ridge, TN

Dr. Gary Madsen, Utah State University

Richard Sheldon, Knoxville, TN

Janice Stokes, Clinton, TN

Shirley Rippletoe, Old Hickory, TN

Bill Clark, Knoxville, TN

Dr. Helen Vodopick, Oak Ridge, TN

Claudia Soulyarette, Oak Ridge, TN

Dick Smyser, The Oak Ridger

Gertrude Copeland, Brentwood, TN

Dr. William Burr, Oak Ridge, TN

Dr. Bill Bibb, Oak Ridge, TN

Dr. Shirley Fry, Oak Ridge, TN

Acie Byrd, Washington, D.C.

Reba Neal, Coalfield, TN

Emma Craft, White Bluff, TN

Mary Hamm, Goodletsville, TN

Ron Hamm, Goodletsville, TN

Venia Lazenby, Mt. Juliet, TN

Dot McLeod, Lake Park, GA

Mary Lynn Stanley, Wrightsville, GA

Richard Vaughn, Franklin, TN

Dr. Frank Comas, Knoxville, TN

Ann Sipe, Oak Ridge, TN

Freda Jo Burchfield, Morristown, TN

Barbara Humphreys, Louisville, TN

Wilton McClure, Tony, AL

Earl McClure, Nashville, TN

Irene Sartain, Nashville, TN

Bruce Lawson, Oak Ridge, TN

Jeff Hill, Oak Ridge, TN

Patricia Jedlica, Spring City, TN

Carolyn Szetela, Nashville, TN

Doris Baker, Cincinnati, OH*

Gloria Nelson, Cincinnati, OH

Ann Marie Harrod, Nashville, TN

* indicates that the participant spoke at a previous meeting

895

March 15-17, 1995

U. S. Senator Paul Wellstone (MN)
Ernest Sternglass, University of

Pittsburgh
Elmerine Whitfield Bell, Dallas, TX
E. Cooper Brown, Executive

Commission, Task Force on Radiation

and Human Rights*
Dr. Oscar Rosen, National Association

for Atomic Veterans*
Glenn Alcalay, New York, NY
Denise Nelson, Bethesda, MD
Chris DeNicola, New Orleans, LA
Valerie Wolfe, New Orleans, LA
Claudia Mullen, New Orleans, LA
Suzanne Starr, Chimayo, NM
Steven Schwartz, Washington, D.C.

April 10-12, 1995

Gwendon Plair, Concerned Relatives of

Cancer Study Patients, Cincinnati,

OH*
James Tidwell, Cincinnati, OH
Barbara Tatterson, Cincinnati, OH
Joseph Peterson, Carson City, NV
Banny deBrum, Acting Ambassador,

Embassy of the Republic of the

Marshall Islands
Rebecca Harrod Stringer, St. Augustine,

FL

Phil Harrison, Uranium Radiation
Victims Committee, Albuquerque,
NM*

Rachel Greene, Hyattsville, MD

Zina Greene, Washington, DC

Julie Boddy, Tacoma Park, MD

July 17-19

Senator Tony deBrum, (w/ Ambassador

Wilfred Kendall, Phillip Muller),

Marshall Islands*
Dr. Bernard Aron, Cincinnati, OH
Dr. David Egilman, Braintree, MA*
Dr. Oscar Rosen, National Association of

Atomic Veterans*
Dr. Dennis Nelson, Bethesda, MD
Ms. Mary Mueller, Task Force on

Radiation and Human Rights
Mr. Acie Byrd, Task Force on Radiation

and Human Rights*

May 8-10, 1995

Doris Baker, Cincinnati, OH*
Barbara Tatterson, Cincinnati, OH*
Herbert Varin, Cincinnati, OH*
Clifford Tidwell, Cincinnati, OH*
Beatrice Tidwell, Cincinnati, OH
Zettie Smith, Cincinnati, OH
Pat Broudy, National Association of
Atomic Veterans*

June 21-23, 1995

Anthony Roisman, National Committee
of Radiation Victims, Washington, DC

Geoffrey Sea, Task Force on Radiation
and Human Rights, Oakland, CA*

* indicates that the participant spoke at a previous meeting

896

A Citizen's Guide to the Nation's

Archives

where the records are and
how to find them

SOME INITIAL QUESTIONS AND ANSWERS

How can I find out if I or my relative was in a radiation experiment?

This was one of the most commonly asked questions from the hundreds of individuals who
contacted the Committee. There is no simple answer. Medical records are the place to start.
They should provide information on what condition you or your relative was treated for, what
treatment was actually given, and who administered this treatment. See part III. A for further
details.

How can I obtain medical records? What should I do with them once I have them?

You have a legal right to your own medical records and, with the proper authorization, to a
relative's medical records. By contacting the facility where the treatment occurred, you should
be able to request and obtain the records. The next step is to have a qualified medical
professional review the records to ascertain whether the treatment administered was acceptable
for the patient's condition. See part III.B for further details.

What A CHRE materials are available to the public? Where are they stored and who can look at
them?

All documents obtained by and produced by the Advisory Committee are public information,
available to anyone. A large portion of Committee materials is available through the Internet.
Hard copies of all materials will be stored at the National Archives and Records Administration
in Washington, D.C. See part IV. A for further details.

Whom should an individual call to request an investigation into his or her particular case?

This was another very common question. No office currently exists that is specifically
chartered to investigate individual cases with respect to human radiation experiments. That is one
reason for this guide: to provide individual citizens with enough guidance to begin their own
investigations. See part II for details.

Where should an individual researcher turn to learn more about radiation experiments with
government involvement?

Researchers can use a number of resources, including the ACHRE collection. If more
information is desired, the federal agencies have reported to the Advisory Committee that the
public may contact their designated offices. See part II for details.

Whom should the public work through after the Advisory Committee is disbanded?

No extant government body is chartered to provide such guidance. It is the purpose of this
appendix to provide individuals with enough direction to begin their own investigations.

CONTENTS

Introduction

Part I: Finding Federal Records

Types and Sources of Federal Information

Aids for Focusing Research

Where Federal Records Are

Access to Information: Rights and Restrictions

Part II: Agency Information and Services
Department of Energy
Department of Defense
Department of Health and Human Services
Department of Veterans Affairs
National Aeronautics and Space Administration
Central Intelligence Agency
Nuclear Regulatory Commission

Part III: Personal Medical Records
A Basic Distinction

Personal Medical Records Created by Physicians and Hospitals
Where Else Could the Information Be?

Part IV: Using the ACHRE Collection as a Place to Start
What's in the Collection and What Is Not
Experiments
Finding Aids
How to Go From the ACHRE Collection to Agency Records

... I have been to Oak Ridge, Tennessee, and Washington,
D.C. I have seen a lot of documents. I have learned some of
the codes, so please don't try to shaft me. I know a lot. The
records are not here in Cincinnati, all of them on my
grandmother. And I have been trying to find them. And I just
would like to know where the rest of them are. So please, will
you help me find them?

--Citizen at the ACHRE public forum in Cincinnati
21 October 1994

As the Advisory Committee traveled across the country taking public testimony, it
heard citizens describe many of the same experiences over and over. One common
thread that struck a particularly responsive chord with the Committee was the sheer
frustration felt by many, even experienced researchers, who had tried to find their own
records or to find out the details of government programs. The difficulty we have all
faced in doing this research yields an important lesson: The government must be honest
about the nature and purposes of the studies it sponsors and conducts; in sponsoring
human experimentation, it has an even higher obligation to keep a fair record and provide
those involved with meaningful access. The Advisory Committee has done what it can to
open the door to our nation's archives. We all must see that it remains open.

This appendix is intended to help. For those who want to know whether a relative was
involved in an experiment, and for historians, journalists, and others with a more general
interest in human radiation experiments (HREs) and the general topic of government-
sponsored research, the following pages discuss what to ask for, whom to write to, and
where to go.

The Advisory Committee's records are one important place to turn (see part IV). It
should be understood, though, that the Advisory Committee did not find everything there
is to find about human radiation experiments, nor could we review what we did find in
the detail we would have preferred. Moreover, neither the Advisory Committee nor the
agencies, generally speaking, sought the medical records of individuals. But there is
much information that we did recover, and the efforts of the Advisory Committee and the
agencies have increased the likelihood that citizens will be able to find the personal
documents they need.

This Guide has four parts: part I is an introduction to finding and using federal
records; part II covers agency facilities and services, including what information is
available at which agencies, and where to go and how to get it; part III focuses on finding
medical records. And part IV is an introduction to the records collected and created by
the Advisory Committee.

901

Appendices

PART I: FINDING FEDERAL RECORDS

Finding the most general information about the activities of the federal government
can be as easy as picking up the telephone or looking in a reference book, but those
approaches do not provide the detail necessary to understanding how a program operates
or why it does what it does. Finding information like this requires research, and research
in government documents may require time and effort. The government's records are
stored in a sprawling, decentralized, and sometimes haphazard system, and particular
records are often hard to locate. It may be difficult simply to determine whether the
records still exist. Federal records laws and rules provide for the periodic review and
destruction of certain categories of records. However, the Committee found that the
documents that recorded the destructions of other documents were themselves often later
destroyed. Thus, it is often difficult to know for certain whether particular documents
have been destroyed or are simply hard to locate.

This part of the Citizen's Guide provides information that will allow the researcher to
focus more quickly on where the desired information may be or, that being determined,
how to go about retrieving it.

Types and Sources of Federal Information

Although there are many ways to categorize the types of information citizens seek, the
one that will have the most profound effect on what to look for and where to look for it is
whether the citizen is interested in records of individual experience or in program
records. Records of individual experience are those that document the history of a
particular person— medical records, personnel records, tax returns, memberships, and so
forth—and are usually kept for the private use of that person and the institution whose
relationship they record. Such records will only rarely include information about a
program in which the individual participates. For example, an individual's medical
records will not likely contain information on the government program that funded the
medical research or the ethical guidelines applicable to the use of human subjects in the
program.

Program records, on the other hand, document the purposes, organization, staffing,
and funding of an activity-minutes, proceedings, memorandums, proposals, contracts,
and so forth— and are likely to be available to the public in some form. Such records will
only rarely contain information about individuals. For example, agency records on a
biomedical research program will not contain the names of the patients involved in it or
their medical histories.

As is obvious from these descriptions, records of individual experiences and program
records hold very different types of information.1 The significance for the researcher is
that the two types of records are kept in different places, and his or her approach to
finding the information must reflect this fact. For example, if information about the
physical condition and treatment of an individual is what is wanted— that is, medical
facts— a search for medical records is likely to be more useful than a search for records of
experiments. Medical information about the condition and treatment of experimental
subjects is generally contained in medical records and not in the scientific records of
experiments.2 On the other hand, information about a study in which citizens participated

902

A Citizen's Guide

is unlikely to be found in their medical records, but in the investigator's records and those
of his institution and the study's sponsors.

Further information on finding program records, which are generally publicly
available in large repositories, may be found in the remainder of part I and in parts II and
IV. Those sections also provide information on government-held records of personal
experience. For information on finding medical records, see part III.

Aids for Focusing Research

Because the federal government is vast, it is vitally important to identify as quickly as
possible the government components whose records may contain the needed information;
as will be discussed in the section below on the National Archives, that understanding is
also important to using the records once they are found. Unfortunately, one of the things
that the Advisory Committee learned in our research is that many government agencies
do not have complete information on all the programs they sponsored through the years
or on the records that were created or preserved or where they are located. And,
furthermore, there is no central, comprehensive source of information for the history of
the federal government: Even the collections of the National Archives do not reflect the
full and complete history of the government and its programs. In some cases extensive
research was required to discover or to understand the histories of certain parts of the
agencies in order to identify the organizational components whose work was potentially
relevant to the Advisory Committee's research. Only then could the search for records
begin.

Fortunately, however, much unearthing of the histories of government organizations
and locating of pertinent records has been done by agency personnel and Advisory
Committee staff. The fruits of these efforts are available in three resources that may
assist the citizen researcher in finding agency information. First, the relevant
organizational components; the location, classification, and review of their records; and
what records were never located are all described in great detail on an agency-by-agency
basis in the supplemental volume, Sources and Documentation. This volume serves as an
excellent guide for those doing their own research.3 The second is the ACHRE collection
itself; as explained in more detail in part IV below, most records in the ACHRE
collection can be traced to the agency collection and repository from which they came.
The third is the February 1995 Department of Energy publication, Human Radiation
Experiments: The Department of Energy Roadmap to the Story and the Records and its
July 1995 supplements (see part II, below).4 This work describes in considerable detail
many relevant DOE record collections that are located at various repositories in the
Washington, D.C., area and the national laboratories around the nation (see part II,
below, for further information about the laboratories). We note that, in addition to
resources created during the life of the Committee, agencies may have created other
guides to agency history and records collections. See, for example, "A Guide To
Resources on the History of the Food and Drug Administration," Food and Drug
Administration, History Office.

903

Appendices

Where Federal Records Are

Unless they have been lost or destroyed, almost all federal records5 created since the
founding of the Republic are in agency files, stored at a federal records center, or
preserved in the National Archives.6 Generally, agencies are required to transfer to the
National Archives records that are of sufficient historical or other value to warrant
preservation. Documents are transferred when they are thirty years old or, regardless of
age, when the originating agency no longer needs them for its regular business and will
be satisfied accessing them through the National Archives.

In actual practice, few, if any, agencies have fully complied with these requirements.
Most records are still under the control of the agencies that created them, though some
are stored with the National Archives and Records Administration (NARA). Even for
quite old records, therefore, the citizen will often find it necessary to look beyond the
National Archives into the federal record centers and the agencies. The use of these three
repositories is described below; further information on the agencies is contained in part
II.

National Archives

Collections

NARA does not refile the records it receives according to some grand theoretical
scheme but, rather, preserves them in as close to their original order as is practical,
arranging them according to provenance J This means that the structure and organization
of records in the National Archives reflects the structure and organization of the office
that created them, using the same divisions and titles that were used by the office
originally. For this reason, all records of an individual agency— or in the cases of very
large agencies such as the military services, the records of various commands,
headquarters, and other major organizational units—are placed by the National Archives
in a separate record group with a distinctive title and number. The approximately 475
record groups at the National Archives vary in size from less than 100 cubic feet to tens
of thousands of feet. Record groups are divided into subdivisions called entries that often
hold the records of a single division, department, bureau, or office. The access tool
generally used to find basic information in a record group (e.g., brief descriptions of
individual entries) is the finding aid created by the National Archives. Not all record
groups have finding aids, however, and some older ones have not been kept up to date.
The archivists who work with the record groups are often an invaluable source of
information as well.

Services

The National Archives is the one repository holding agency records specifically
charged with accommodating the public. In addition to a staff of professional archivists,
the Archives provide large research rooms, copiers, and complete access to unclassified
and declassified collections.

The National Archives has two major public facilities in the Washington area: the

904

A Citizen's Guide

National Archives, Pennsylvania Avenue between 7th and 8th Streets, N.W.,
Washington, D.C., and the National Archives at College Park ("Archives II"), 8601
Adelphi Road, College Park, Maryland 20740-6001. (Telephone 202-501-5400 to
request reference help, or write Reference Services Branch, National Archives and
Records Administration, Washington, D.C. 20408.) Research hours at both the
downtown Washington and College Park facilities are 8:45 a.m. to 9:00 p.m., Tuesday,
Thursday, and Friday; 8:45 a.m. to 5:00 p.m., Monday and Wednesday; and 8:45 a.m. to
4:45 p.m. on Saturday, except federal holidays.

Records that are generated by regional offices are maintained in regional archives:

Anchorage, Alaska: 654 W. 3rd Avenue, 99501; 907-271-2441

Chicago, Illinois: 7358 S. Pulaski Road, 60629; 312-581-7816

Denver, Colorado: Building 48, Denver Federal Center, 80225;

303-236-0817

East Point, Georgia: 1557 St. Joseph Avenue, 30344; 404-763-7477

Fort Worth, Texas: 501 W. Felix Street, 761 15; 817-334-5525

Kansas City, Missouri: 2312 E. Bannister Road, 64131; 816-926-6272

Laguna Niguel, California: 24000 Avila Road, 92677; 714-643-4241

New York, New York: 201 Varick Street, 10014; 212-337-1300

Philadelphia, Pennsylvania: 9th and Market Streets, 19107;

215-597-3000

San Bruno, California: 1 000 Commodore Drive, 94066; 4 1 5-876-90 1 8

Seattle, Washington: 6125 Sand Point Way N.E., 981 15; 206-526-6507

Waltham, Massachusetts: 380 Trapelo Road, 02 1 54; 6 1 7-647-8 1 00

For Freedom of Information Act (FOIA) and Privacy Act requests, speak with the
archivists who work with the record group concerned, or write: Office of the National
Archives, National Archives and Records Administration, Washington, D.C. 20408;
telephone 202-501-5300. For further information see the section on Rights and
Restrictions on Access to Information, below.

Federal Records Centers

When an agency determines that it no longer needs to house a group of records it can
transfer them to a federal records center in its geographical area. Federal records centers
have been established solely to assist the agencies in the storage and processing of their
records. There is no requirement that any agency transfer its records to a records center.
Although the records centers are managed by NARA, the agencies retain legal custody
and control of the records.

Collections

Records held in federal records centers are also organized into record groups (using
the same titles and numbers as at the National Archives), but are not further broken down
into entries. Instead, a record group at a records center consists simply of a series of
accessions, the shipments of records added to it. Record groups may contain from a few

905

Appendices

to thousands of accessions, and an individual accession may hold one to many hundreds
of boxes of records. Unfortunately, there are no archivists or finding aids at federal
records centers to assist the public. The only means of determining what is in a record
group is by examining the Standard Form 135 (SF-I35) prepared by the agency for each
individual shipment. These forms contain a great deal of information, including the
accession number, name and address of the office shipping the records, point of contact,
security classification of the records, quantity of records in cubic feet, and a description
of the records that often includes a folder listing.8 The examination of SF-135s can be a
very tedious process, for they may total many thousands of pages.

Services

The public does not have free access to records at a federal records center, not even to
completely unclassified or declassified accessions. Permission first must be obtained
from the agency that owns the records, and this can be a time-consuming process.
Personnel at the federal records centers will provide information on who should be
contacted at an agency about obtaining such permission.

The one federal records center in the Washington, D.C., area is the Washington
National Records Center, 4205 Suitland Road, Suitland, Maryland 20409; telephone 301-
763-7000. The hours are 8:00 a.m. to 4:30 p.m., Monday through Friday except federal
holidays. There are thirteen regional federal records centers, which hold records
generated by federal offices in that particular geographical region of the nation. Many,
but not all, are located in the same place as the regional National Archives:

Bayonne, New Jersey: Building 22, Military Ocean Terminal, 07002;

201-823-7161

Chicago, Illinois: 7358 S. Pulaski Road, 60629; 312-352-0164

Dayton, Ohio: 3 1 50 Springboro Road, 45439; 5 1 3-225-2878

Denver, Colorado: Building 48, Denver Federal Center, 80225; 303-236-0804

East Point, Georgia: 1 557 St. Joseph Avenue, 30344; 404-763-7476

Fort Worth, Texas: Building 1, Fort Worth Federal Center, 761 15; 817-334-5515

Kansas City, Missouri: 2312 E. Bannister Road, 64131; 816-926-7271

Laguna Niguel, California: 24000 Avila Road, 92677; 714-643-4420

Philadelphia, Pennsylvania: 5000 Wissahickon Avenue, 19144; 215-951-5588

San Bruno, California: 1 000 Commodore Drive, 94600; 4 1 5-876-90 1 5

Seattle, Washington: 6125 Sand Point Way N.E., 981 15; 206-526-6501

St. Louis, Missouri: National Personnel Records Center, 9700 Page Boulevard,

63132; 314-263-7201

Waltham, Massachusetts: 380 Trapelo Road, 02154; 617-647-8745

FOIA requests for records in the custody of the federal records centers must be
submitted to the federal agency that transferred the records to the federal records center.
Records center personnel will provide addresses and contacts. For further information,
see the section "Access to Information: Rights and Restrictions," below.

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A Citizen's Guide

Records Still Held by Agencies

Several agencies retain great volumes of records that have never been sent to the
National Archives or a federal records center. Such records may be stored at any number
of places, including internal record storage facilities and history offices. With a few
exceptions, these collections are generally less well organized and described than those at
the National Archives or federal records centers. Furthermore, most agencies have only a
limited ability to accommodate researchers. The names, addresses, and telephone
numbers of the locations where the agencies store records are available in part II, below.

Access to Information: Rights and Restrictions

This section addresses some government policies that control access to information—
on privacy, freedom of information, and national security classification-and some of a
citizen's rights to information and how to exercise them.

Privacy and Freedom of Information

The Privacy Act and the Freedom of Information Act (FOI A)9 are the most critical
components of the legal framework that supports public access to federal records. The
Privacy Act defines certain types of information as privileged to the individual, and
during his or her lifetime it prevents their public dissemination or their use for purposes
other than those originally authorizing their collection. This means, for example, that one
agency may not share personal information about citizens with another government
agency, and it means that one person may not have access to such information about any
other person without authorization. This protection of privacy extends to records in the
National Archives as well. The Freedom of Information Act guarantees, with some
categories of exceptions, that all records created by the executive branch of the federal
government are available to citizens. Among those exemptions are a privacy clause that
broadens the scope of the Privacy Act by extending protection to personnel and medical
files by category rather than limiting protection to the lifetime of individuals, and a
national defense and foreign policy clause that precludes one from obtaining certain
classified information under FOIA.

The next two sections discuss the effect of these laws on obtaining information based
on the names of individuals, and the procedures and requirements for making Freedom of
Information Act Requests.

Name Searches

Access by citizens to federal records that are retrievable by the names of individuals or
other personal information are controlled by the Privacy Act and by the privacy clause of
the Freedom of Information Act. The Privacy Act restricts access to information
contained in what are called Privacy Act systems of records, records arranged by the
names of individuals or other personal information. In general, during an individual's
lifetime, records retrieved by the use of personal information are available only to that
person or with his or her authority,10 although redacted copies of such documents— that is,

907

Appendices

copies from which private information has been removed-may be available if the records
are retrievable in some other way." If, therefore, a citizen is interested in obtaining
records that concern him or her or, with the appropriate authority, those that concern a
close relative, there should be no legal restrictions on access; to the extent, however, that
a citizen wishes more information about other individuals who are mentioned in those
records, there may be considerable difficulty. In such cases one would probably have
greater success identifying the program in which he or she participated, determining
where the records of that program are housed, and extracting information from those
records.

FOIA Requests

In general, the Freedom of Information Act requires that the individual12 make inquiry
in writing13 directly to the appropriate agency, in conformity with the established
procedures of the agency, and that agreement on the payment or inapplicability of fees is
reached between the requester and the agency. The first requirement usually is
understood to include identification of the records in which the information is to be
found. Agencies are not required to do research for the citizen but only to conduct
"reasonable searches" of their records in an attempt to meet the request.14 The second
requirement recognizes that different agencies may have different procedures for
handling public inquiry.15 The third requirement permits the agency to determine before
accepting the request that the requestor will pay all the applicable fees or, in the
alternative, that there are valid grounds for waiving the fees.16

Once an agency has accepted a FOIA request, the law establishes very short periods of
time for the agency to respond. If the request is accepted, the agency is obligated to
decide within ten working days of acceptance whether or not it will provide the
information within a reasonable length of time,17 and if the request is denied and an
appeal is made, it must provide a response within twenty working days. In actual
practice, however, agencies rarely meet these time limits. Depending on the backlog of
requests, the number of other agencies that must be contacted, and other factors, a FOIA
can take one to five years to process.

Agencies are most likely to reproduce and mail copies of records to requesters, but
they are not required to do so and are permitted to provide access to the records at a
central location (see also the information on the FOIA reading rooms and offices at the
agencies in Part II).

If an agency denies a request in whole or in part, the requester then has the right to
make one administrative appeal. If after these the requester is still not satisfied, the only
recourse is federal court.

Classified Records

There is a vast number of records at the National Archives, in the federal records
centers, and at the agencies that are still classified and therefore unavailable to the public.
The government is obliged by executive order to review its records periodically for
declassification, but citizens may request a review on their own initiative. Submitting a
request, of course, does not guarantee that the records will be declassified either in whole

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A Citizen's Guide

or in part. The government authorities conducting the review may conclude that the
documents should remain classified.

There are three methods under which the public can request that documents at the
National Archives be reviewed for declassification. The first is under FOIA, and the
second is under the Mandatory Declassification Review (MDR) provisions of Executive
Order 12958 of April 17, 1995. I8 Under both methods, a request is submitted to the
National Archives (rather than to the agency that generated the records), whose archivists
will provide information on how the request should be handled further. The third method
for requesting declassification is under the Special Declassification Review procedure.
This informal procedure, which is only applicable to records at the National Archives, is
much quicker than either FOIA or MDR, but there are some records-intelligence records,
for example-that cannot be reviewed in this way. The archivists working with the
records should be consulted to determine whether a Special Declassification Review may
be used.

To access classified collections at federal records centers or agencies, either a FOIA or
an MDR request must be submitted to the agency. Classified records that turn up in the
course of a document search are sent through declassification review. There is no Special
Declassification Review procedure at federal records centers or agencies.

PART II: AGENCY INFORMATION AND SERVICES

As part of the Advisory Committee's effort to improve citizen access to information,
we asked the agencies providing information to the Committee-chiefly the members of
the Interagency Working Group and the Nuclear Regulatory Commission-to respond to a
series of questions concerning the handling of private information requests. We asked
how citizens should make requests, what services the agencies would provide, what
information resources were available, and how agencies would handle requests for
information held by agency contractors and grantees. Each agency's response is
summarized in its section, below. Those sections also include general information
obtained from the U.S. Government Manual,19 including the location of FOIA reading
rooms and offices.20

Department of Energy

General

DOE maintains a Freedom of Information Act Reading Room at its headquarters in
Washington. The address is FOIA Reading Room, Forrestal Building, Room IE- 190,
Department of Energy, 1000 Independence Avenue, S.W., Washington, D.C. 20585;
telephone 202-586-6020. The reading room is open 9:00 a.m. to 4:00 p.m., Monday
through Friday, except federal holidays. General information on filing FOIA requests
may be obtained from the FOIA office, 202-586-5955.

As described both in Sources and Documentation and in Human Radiation
Experiments: The Department of Energy Roadmap to the Story and the Records, the
History Division at DOE headquarters has custody of many collections of records. The
relatively few unclassified and declassified collections that the division maintains can be

909

Appendices

examined at its office in DOE's Germantown facility: U.S. Department of Energy,
History Division, HR-76, Room F031, 19901 Germantown Road, Germantown,
Maryland 20874-1290; telephone 301-903-5431. The hours are from 8:00 a.m. to 4:00
p.m., Monday through Friday, except federal holidays. An appointment must be made, as
there is limited space to accommodate the public.

In addition, the national laboratories around the nation hold a huge volume of records.
Information at those locations is available as follows:

Argonne National Laboratory: There is no reading room at Argonne, but citizens may
write: Argonne National Laboratory, Office of Public Affairs, 9700 South Cass
Avenue, Argonne, Illinois 60439; 708-252-5575.

Brookhaven National Laboratory: There is no reading room at Brookhaven, but citizens
may write: Brookhaven National Laboratory, Office of Public Affairs, Building 134,
P.O. Box 5000, Upton, New York 22973; 516-282-2345.

Hanford: DOE Public Reading Room, P. O. Box 999 - Mail Stop H2-53, Richland,
Washington 99352; 509-376-8583. This facility is in the library at Washington State
University - Tri-Cities Campus, 100 Sprout Road, Richland, Washington. The hours
are 8:00 a.m. -noon and 1:00-4:30 p.m., Monday through Friday.

Los Alamos National Laboratory: Public Reading Room, 1350 Central Avenue - Suite
101, Los Alamos, New Mexico 87544; 505-665-2127 or 800-343-2342. The reading
room is open 9:00 a.m. - 5:00 p.m.. Monday through Friday, except federal holidays.

Idaho National Engineering Laboratory: DOE Idaho Operations Public Reading Room,
1776 Science Center Drive, Idaho Falls, Idaho 83415-2300; 208-526-9162. The hours
are 8:00 a.m. - 5:00 p.m., Monday through Friday, except federal holidays.

Lawrence Livermore National Laboratory: There is no reading room at Lawrence
Livermore, but citizens may write: Area Relations - Mail Stop L404, Lawrence
Livermore National Laboratory, P.O. Box 808, Livermore, California 94550.

Oak Ridge National Laboratory: Oak Ridge Operations (ORO) Public Reading Room,
55 Jefferson Circle, Oak Ridge, Tennessee 37831; 615-241-4780. The hours are
8:00 - 1 1:30 a.m. and 12:30 - 5:00 p.m., Monday through Friday, except federal
holidays. In addition to the laboratory itself (ORNL), the Oak Ridge complex also
encompasses the regional DOE office (ORO) and an independent research institute
(ORISE) operated by a consortium of universities. The regional office may be
contacted by writing: Oak Ridge Operations Office (ORO), P.O. Box 2001, Oak
Ridge, Tennessee 3783 1 . The research institute may be contacted by writing: Oak
Ridge Institute for Science and Education (ORISE), P.O. Box 117, Oak Ridge,
Tennessee 37831-01 17.

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A Citizen's Guide

Information on Human Radiation Experiments

In response to the Advisory Committee's request, the Department of Energy has
provided the following information about its resources and services for citizens inquiring
about human radiation experiments.

General Department of Energy information about human radiation experiments
sponsored by DOE and its predecessors, and referrals, may be requested through the
Radiation Research Helpline (1-800-493-2998) or by writing to the Department of
Energy, Office of Human Radiation Experiments (OHRE), EH-8, 1 000 Independence
Avenue, S.W., Washington, D.C. 20585.

The largest body of pertinent records is maintained by the Coordination and
Information Center (CIC).21 All CIC material is declassified, screened, and redacted for
public dissemination. The CIC may be contacted by writing to the Coordination and
Information Center, 3084 South Highland Street, Las Vegas, Nevada 89109, or by calling
702-295-073 1 . Although generally equivalent for DOE-related human radiation
experiment records, the ACHRE and CIC collections are not identical: The ACHRE
collection contains most but not all of CIC's Human Radiation Experiments records series
and has some DOE records not represented in CIC collections. For further information
on CIC documentation, see "How to Go From the ACHRE Collection to Agency
Records" in part IV, below.

Medical records should be requested from the facility where the medical services were
performed. Current or former DOE employees may obtain their medical records from the
site where they worked or from the National Personnel Record Center in St. Louis,
Missouri, which may be contacted directly (314-538-3882).22 Dosimetry records
documenting occupational radiation exposures are maintained for both government and
contractor personnel; they should be requested from the DOE manager at the site where
exposure may have occurred. DOE also maintains a consolidated collection of dosimetry
records related to weapons testing, including both civilian and military information.
Information may be requested by writing to the Dosimetry Research Program (DRP),
P.O. Box 98521, Las Vegas, Nevada 89193-8521, or by calling 702-295-0731. DOE will
also help to identify and locate records that are not in the custody of the department,
although citizens must contact those institutions or individuals themselves.

Several DOE departments have created finding aids that may be useful in finding HRE
records: (1) As mentioned above, the report Human Radiation Experiments: The
Department of Energy Roadmap to the Story and the Records, prepared by the Office on
Human Radiation Experiments, provides summaries of that office's findings and
descriptions of some relevant record collections. (2) An electronic index to pertinent CIC
holdings is available at the CIC and OHRE offices and at DOE's reading rooms. Citizens
may request searches or do their own at those locations. (3) For those with Internet
access, recently declassified documents are available from DOE's Office of Scientific and
Technical Information through its World Wide Web" presence, Opennet
(http://www.doe.gov/html/osti/opennet/opennetl.html). And another group of databases
on the Internet, created by OHRE, provide full access to the documents in the CIC
collection. (Further information about OHRE and this complex of databases [called
HREX] may be obtained from its World Wide Web site, http://www.ohre.doe.gov.)
Finally, OHRE issued a supplement to its February 1995 report in July 1995 entitled

911

Appendices

Human Radiation Experiments Associated with the U.S. Department of Energy and Its
Predecessors.24 This volume adds to the information reported in the February 1995
volume, and also includes summaries of the nearly 150 HREs reported by DOE.

Department of Defense

General

The Department of Defense's Freedom of Information Act offices may be contacted as
follows: DOD, 703-697-1 180; Army, 703-607-3452; Navy, 703-697-1459; Air Force,
703-697-3467.

Information on Human Radiation Experiments

In response to the Advisory Committee's request, the Department of Defense has
provided the following information about its resources and services for citizens inquiring
about human radiation experiments.

Information concerning human radiation experiments sponsored or conducted by the
Department of Defense is available chiefly through the Radiation Experiments Command
Center (RECC), the DOD equivalent of DOE's Office of Human Radiation Experiments.
RECC is operated under contract by Science Applications International Corporation
(SAIC). The primary method of contacting RECC is by referral from the DOE Radiation
Research Helpline (l-800-493-2998)--RECC does not provide direct telephone
assistance. Citizens may also write directly to RECC: Radiation Experiments Command
Center, 6801 Telegraph Road, Alexandria, Virginia 22310-3398. Individuals contacting
RECC will be requested to fill out a survey form to facilitate the search for records
responsive to their requests. The RECC collection and the ACHRE collection of DOD
materials are generally equivalent. For further information on RECC documentation, see
"How to Go From the ACHRE Collection to Agency Records" in part IV, below.

RECC does not keep medical records but will assist those who request them by
contacting the appropriate facility and referring the individual there. Active duty military
personnel will find their complete medical records at their current duty stations; upon
retirement or discharge, their files are transferred to the National Personnel Records
Center in St. Louis. Former military personnel may contact the center directly (3 14-538-
3882).25

RECC maintains a database of information on human radiation experiment documents
identified during DOD's search and a database of secondary information concerning the
history and policy behind the activities. Case files on individuals exposed to radiation are
being created and categorized by exposure. RECC will also help citizens contact private
institutions involved in DOD-sponsored programs, within the limits of the Privacy Act.

Another DOD resource is the Nuclear Test Personnel Review Program (NTPRP)
operated by the Defense Nuclear Agency (DNA), which has obtained a considerable
volume of records and information related to military and civilian participants in
atmospheric nuclear tests between 1 945 and 1 962. Unclassified and declassified records
that do not contain privacy information can be reviewed by the public at a special library
at DNA headquarters. The program also provides certain informational and referral

912

A Citizen's Guide

services to participants. The address is Defense Nuclear Agency, Nuclear Test Personnel
Review Program, 6801 Telegraph Road, Alexandria, Virginia 22310; telephone
1-800-462-3683. Additional services may be available through the VA's Ionizing
Radiation Registry Examination Program (see VA section, below).

Department of Health and Human Services

General

There is no general reading room for the Department of Health and Human Services,
nor for its research divisions, the Public Health Service and the National Institutes of
Health.26 Each institute of NIH27 maintains its own information facilities, including its
own office of public affairs. For help in identifying the sort of information needed and
how to obtain it, a good place to start is the National Library of Medicine, 8600 Rockville
Pike, Bethesda, Maryland. The general information line for NIH is 301-496-4000.

Information on Human Radiation Experiments

In response to the Advisory Committee's request, the Department of Health and
Human Services has provided the following information about its resources and services
for citizens inquiring about human radiation experiments.

DHHS sponsors two types of research— intramural ("within the walls"), research
conducted by DHHS staff members, and extramural ("outside the walls"), research
conducted outside DHHS by contractors or grantees. DHHS keeps medical records only
for individuals who participated in intramural research. Inquiries concerning such
records should be directed in writing to the Deputy Assistant Secretary for
Health/Communications, Department of Health and Human Services, Hubert Humphrey
Building - Room 70 1H, 200 Independence Avenue, S.W., Washington, D.C. 20201 .

There are four DHHS databases that may help identify potential human radiation
experiments. The first is the Clinical Center intramural protocol database (also called the
Protocols by Institute database), which was created at the Advisory Committee's request
to index information about NIH intramural research. This database was completed in
February 1995 and contains more than 5,000 entries for the period 1953 through
November 1994. More recent information on extramural research is included in the
CRISP (Computer Retrieval of Information on Scientific Projects) database, which
contains records for all PHS extramural projects and for NIH and Food and Drug
Administration (FDA) intramural projects. The most comprehensive database is called
IMPAC and includes information on awards as far back as 1944, although not all
programs are included for their entire tenure and the information on early awards is
limited. Finally, the National Library of Medicine (NLM) is creating a database with
entries for all articles written by investigators whose human radiation experiments were
supported by NIH. (Thus the database will contain citations for both radiation and
nonradiation research.) NLM expects the database will eventually contain approximately
100,000 entries.

DHHS has a contractual relationship with its contractors and grantees that limits its
access to the records they create to those occasions required by agency functions.

913

Appendices

Consequently, although DHHS will help citizens identify the independent researchers and
institutions that hold their medical records, it asks that the initial contact be made by the
citizen. If that approach is unsuccessful, DHHS will attempt to obtain the records.
Citizens are encouraged to contact DHHS to make a precise determination of whom to
contact and what information to include in their inquiries.

Department of Veterans Affairs

General

The VA maintains a reading room at its central office in Washington, D.C., where
citizens may inspect or copy VA records available to the public. The address is Room
170, 810 Vermont Avenue, N.W., Washington, D.C. 20420; telephone 202-233-2356.
For further information, contact the Office of Public Affairs, Department of Veterans
Affairs, 810 Vermont Avenue, N.W., Washington, D.C. 20420; telephone 202-273-5700.

Information on Human Radiation Experiments

In response to the Advisory Committee's request, the Department of Veterans Affairs
has provided the following information about its resources and services for citizens
inquiring about human radiation experiments.

The VA is continuing to look for information on human radiation experiments in its
own records and will assist citizens in identifying nongovernment records related to their
case histories. It has also published a fact sheet, "Information for Veterans Exposed to
Radiation" (November 1994). Requests for information about participation in
experiments may be made directly to the director of the appropriate VA medical center or
to the director of the regional VA office (toll-free 1-800-827-1000). The VA maintains
an Ionizing Radiation Registry Examination Program for veterans who may have been
exposed to the ionizing radiation while on active duty in the period 1945-1962.
Information about the program may be requested in writing from: Director,
Environmental Epidemiology Service (103E), Department of Veterans Affairs, 1 120 20th
Street, Suite 950, Washington, D.C. 20036-3406, telephone 202-606-5420. Additional
information may be requested from DOD's Nuclear Test Personnel Review Program (see
DOD section, above).

National Aeronautics and Space Administration

General

The NASA Headquarters Information Center is in Room 1H23, 300 E Street, S.W.,
Washington, D.C. 20546, and is open 8:00 a.m. to 4:30 p.m., Monday through Friday,
except federal holidays. For information about holdings, telephone 202-358-1000.

Information on Human Radiation Experiments

In response to the Advisory Committee's request, the National Aeronautics and Space

914

A Citizen 's Guide

Administration has provided the following information about its resources and services
for citizens inquiring about human radiation experiments.

NASA's records concerning human radiation experiments are generally limited to
summary reports from principal investigators and do not contain medical information on
individuals, apart from the records of astronauts. Information about individual
participation may be requested in writing under the Privacy Act using FOIA procedures
and NASA's standard Human Radiation Exposure Log form. Inquiries should be directed
to: NASA Johnson Space Center, Freedom of Information Coordinator, Public Affairs
Office, Mail Code AP2, Houston, Texas 77058, Attn.: Director, Space and Life Sciences
Directorate. NASA's information retrieval systems in this area are limited, and success
will largely depend on the quality and detail of the information provided to NASA.
NASA will refer requests for information requiring access to non-NASA records to the
appropriate individual or institution.

Central Intelligence Agency

General

The CIA does not maintain a public reading room but does issue several publications
that may be of interest. For information, write: Central Intelligence Agency, Public
Affairs Office, Washington, D.C. 20505, or telephone 703-351-2053.

Information on Human Radiation Experiments

In response to the Advisory Committee's request, the Central Intelligence Agency has
provided the following information about its resources and services for citizens inquiring
about human radiation experiments.

The CIA has no special facilities for handling requests concerning human radiation
experiments nor any information resources specifically concerned with them. Privacy
Act and Freedom of Information Act requests should be filed in the usual ways. The CIA
is not prepared to facilitate the identification or the retrieval of nongovernment records
that may be associated with government activities. Requests should be addressed in
writing to: Information and Privacy Coordinator, CIA, Washington, D.C. 20505.

Nuclear Regulatory Commission

General

The Nuclear Regulatory Commission (NRC) Headquarters Public Document Room
maintains an extensive collection of documents related to NRC licensing proceedings and
other significant decisions and actions, and documents from the regulatory activities of
the former Atomic Energy Commission. The reading room is located at 2120 L Street,
N.W., Washington, D.C; telephone 202-634-3273, toll-free 800-397-4209 or fax 202-
634-3343. The Public Document Room is open Monday through Friday from 7:45 a.m.
to 4: 1 5 p.m., except on federal holidays. Reference librarians are available to assist
users with information requests. A bibliographic database is available for on-line

915

Appendices

searching twenty-four hours a day. For additional information call the above telephone
number or write: Nuclear Regulatory Commission, Public Document Room,
Washington, D.C. 20555.

The commission also maintains eighty-eight local public document rooms in libraries
in cities and towns near commercially operated nuclear power reactors and certain
nonpower reactor facilities. A list of local public document rooms is available from the
Director, Division of Freedom of Information and Publications Services, Nuclear
Regulatory Commission, Washington, D.C. 20555-0001. To obtain specific information
about the availability of documents at the local public document rooms, NRC's Local
Public Document Room Program staff may be contacted directly by calling, toll-free,
800-638-8081. Citizens may also request the publication Users' Guide for the NRC
Public Document Room (NUREG/BR-0004, Rev. 2).

Freedom of Information Act inquiries should be directed in writing to the Director,
Division of Freedom of Information and Publications Services, Nuclear Regulatory
Commission, Washington, D.C. 20555-0001. For further information, call 301-415-
7175.

For general information, contact the Office of Public Affairs, Nuclear Regulatory
Commission, Washington, D.C. 20555-0001; telephone 301-415-8200. Citizens may
request the publication Citizen's Guide to U.S. Nuclear Regulatory Commission
Information (NUREG/BR-0100, Rev. 2).

Information on Human Radiation Experiments

In response to the Advisory Committee's request, the Nuclear Regulatory Commission
has provided the following information about its resources and services for citizens
inquiring about human radiation experiments.

Although the NRC and its predecessor, the regulatory division of the Atomic Energy
Commission (AEC), have not conducted or sponsored human radiation experiments, their
license files do contain some relevant information about the radioactive materials that
were distributed and the purposes to which they were put, human radiation experiments
among them. AEC and NRC records do not contain names or other identifying
information about the subjects of such experiments and only rarely contain detailed
information about the experiments themselves. The NRC also collects information about
occupational exposures, medical misadministrations, and other cases of overexposure.
This information is available to the public, subject to the restrictions of the Privacy Act
and FOIA. Citizens may request agency documents under the Freedom of Information
Act and/or the Privacy Act by writing to: Director, Division of Freedom of Information
and Publication Services, Office of Administration, Nuclear Regulatory Commission,
Washington, D.C. 20555-0001.

The agency will search all agency records, if requested to do so, and can search
license files by institution.

PART III: PERSONAL MEDICAL RECORDS

Citizens who participated in experiments have medical records of the same type as
those created by their personal physicians, whether the experiments were conducted in

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A Citizen's Guide

doctors' offices, research laboratories, or medical facilities such as hospitals and
sanatoria. As discussed in part I, these records are distinct from the scientific records of
the experiments and must be sought in different places. Medical records, unlike scientific
records, will contain most of the information necessary to finding out what medical
actions were taken and why specific procedures were followed.

Citizens share ownership of their medical records with their physicians and the
medical facilities where they were treated and have the right to copies of these records.
The records should be available to the individual or an authorized relative for the asking
(though there may be a copying charge). In this part, we discuss how to find personal
medical records and where those records may be located.

A Basic Distinction

Many individuals who contacted the Advisory Committee were understandably
confused by the difference between the broad array of medical interventions involving
radiation and the "human radiation experiments" that the Committee was chartered to
review. The difference is this: While medical interventions are not expressly intended to
accomplish anything more than therapy, "experiments" are designed to yield
generalizable scientific knowledge. This is not to imply that experiments offer no
therapeutic benefit (many do), only that they are organized in a different way, taking
place in a controlled setting and potentially involving thousands of subjects.

It is not always easy for a patient to tell from circumstances whether he or she is
involved in a larger study. One reason for the difficulty is semantic. Some ad hoc
medical interventions are loosely called "experimental," meaning that they have not been
proven effective or generally accepted as safe by the medical community. Experiments,
meanwhile, are commonly known by another name: "human subject research."2* Matters
are complicated by the dual role many doctors play, rapidly switching hats between
physician and investigator. Given all this potential for misunderstanding, those who
conduct human research are under an acute ethical responsibility to clearly explain the
purposes of a procedure in obtaining the subject's consent.

A citizen who believes that he or she or a relative may have been a subject in
government-sponsored human research should begin the search for facts in the medical
records, which provide the details of the patient's condition and the treatment
administered for it. A medical professional should be asked to review these records and
check for signs of a research purpose. In many cases, having the records reviewed by a
professional will answer most questions and concerns. The next two sections give advice
on finding one's records.

Personal Medical Records Created by Physicians and Hospitals

Physicians and medical facilities should be approached directly by the individual or by
an authorized relative. As with any request for private information, a request for medical
records should be formal, direct, and clear, and it should include significant personal
details to assure the identity of the correspondent and, thus, the legitimacy of the request.
These details are similar to those needed to request a birth certificate-date and place of
birth, parent's names, and so forth. The letter should also include as many details as

917

Appendices

possible about the circumstances of interest, such as the dates of treatment, the names of
the physicians, and any other information that will help locate the records. Institutions
may have standard forms that need to be used; if the request occurs at some distance in
time or geography, the identity of the correspondent may have to be certified in some
way. These are common procedures, designed to protect an individual's privacy by
preventing the unauthorized release of information.

If the name of the physician or medical facility that conducted the procedure in
question is known but the address is unknown, one of the indexes of physicians and
facilities available at a public library should be useful.29 If the names are unknown, one
place to start is with the individual's current physician and local hospital. They may have
copies of older medical records because they were authorized to obtain medical histories.
They are also likely to have (or to be able to get) information about how to contact
physicians or medical facilities in other locations.

If the names of the physician and facility are not readily found, more extensive
research in family papers and a broader correspondence with individuals who may have
information will be necessary. Former friends, neighbors and co-workers, extended
family members, clergy, and any other associates are all potential sources of information,
as is the patient's health insurance company. Without the names of the medical personnel
and facilities involved it will be very difficult to find records at nongovernmental
facilities. If the treatment received occurred in a government facility, see part II of this
appendix, which describes how to find those records. Outside the military services and
large government research and social benefit programs, however, there are no large lists
of individual citizens matched to their medical experiences that would provide the needed
information.

Where Else Could the Information Be?

In general, unless there are regulations or legal obligations that require other
arrangements, records stay where they are created. For example, if a patient was treated
at Hospital X, Hospital X is likely to be where those records are kept. It is possible that
Hospital X destroys all records that are, say, thirty years old; it is also possible that
Hospital X stores those records with a firm that specializes in document storage. In either
case, the disposition and location of the records will be known to Hospital X and possibly
to no one else.

Physicians and institutions, however, create records other than patient medical records
that may also contain important medical information. When asked for medical records,
Hospital X may not think of all the records that an individual might find valuable in
reconstructing his or her medical history, other records that reflect activities under its
sponsorship.

These records may not be coordinated or housed with any of the others. Departmental
records at a hospital may be retired with those of the hospital generally or they may not.
Departmental records at a university are typically retired to the university archives,
usually housed in the university library; a hospital department's records at a university
with a medical school may be retired to the medical school library. The academic records
of faculty members are treated similarly. Records of private research and personal
papers, however, are often given to the faculty member's alma mater rather than to the

918

A Citizen 's Guide

university where the research was done, so that both locations need to be searched. If the
faculty member was a physician, it is also possible that such records were given to the
institution where he or she attended medical school rather than to an undergraduate
school (and then to the medical school, rather than to the university itself). In either case,
it is unlikely that actual patient records would be included in an institution's archives.
Many retiring physicians offer former patients (or their successor physicians) their files
or may destroy these records if the patients cannot be reached.

As reported to the Advisory Committee, in some cases (see part II of this appendix)
federal agencies will help citizens locate or retrieve records that were created or are held
by nongovernment organizations or individuals.

PART IV: USING THE ACHRE COLLECTION AS A PLACE
TO START

What Is in the Collection and What Is Not

The ACHRE research collection, which will be deposited in its entirety at the National
Archives as part of Record Group 220, Presidential Committees, Commissions, and
Boards,30 is composed primarily of documents identified through agency search processes
or selected by the Advisory Committee through requests or site visits to forty-five
nonfederal as well as federal institutions. These efforts have not exhausted all research
possibilities, but the volume of materials now identified and available to the public is
very large. The Advisory Committee has not attempted to collect everything that might
be pertinent, but has emphasized primary materials of wide importance. The resulting
collection is rich in its breadth and variety, but frequently limited in the depth to which
individual events or people are documented. Most records in the collection do not
contain information about the individual subjects of human radiation experiments.

ACHRE records can make two significant contributions to the efforts of the individual
researcher. First, there is no other collection in which pertinent materials from so many
different sources are available in a scholarly arrangement with a substantial finding aid.
Second, the collection deposited with the National Archives also includes the Advisory
Committee's own research documents, including substantial unpublished notes, histories,
analyses, and findings. The comprehensiveness of the collection and the added value of'
the Advisory Committee's scholarship make the ACHRE records a good starting point for
citizens researching the public and private histories of human radiation experiments.

Experiments

The Advisory Committee's general charge was to provide advice on the character of
historical and present-day policies and practices in human radiation research. The scope
of such activities and the difficulty in identifying and retrieving relevant records were
initially underestimated, but agency and Advisory Committee staff sought out and
documented as many experiments as resources permitted. Two points should be
emphasized here. First, the agencies and the Advisory Committee collected and recorded
information about every experiment that could be documented. The inclusion of an

919

Appendices

experiment should not be taken as an indication that the experiment was ethically
improper or likely to have caused harm to those involved.

Second, there was never an expectation that this effort would succeed in assembling a
complete list of experiments or that full documentation for any large proportion of those
identified could be discovered and retrieved within the time permitted. The Advisory
Committee's research interest was focused on understanding the scope of activity (for
example, the number and types of subjects typical for experiments of a certain character)
and the policy context (for example, institutional procedures for the review of informed
consent practices), than on accumulating the details of particular cases. As a result,
although the Advisory Committee's log of such experiments is the most comprehensive
and detailed assembled to date, the records of particular experiments are incomplete.
Many experiments are documented entirely through a publication of results and many
others are documented by references to even briefer descriptions of experiments in
records reviewed by the Interagency Working Group or ACHRE.

The chief value of the Advisory Committee's experiment record series is in providing
identifying information such as location, dates, and researchers' names— a good place to
start. The experiment records are indexed by location, financial sponsorship, principal
investigator (and his or her home institution), and other key pieces of information that
could support extended research. Such information may be used to find additional
information either in the ACHRE collection or elsewhere.

Finding Aids

There are two sets of finding aids for the Advisory Committee's records. The first is
entitled Sources and Documentation, a supplement to this final report. The two-volume
supplement features accounts of the agency and ACHRE research processes, descriptions
of the record collections assembled by the Advisory Committee and of individual
documents identified as significant, a complete bibliography of the published sources
used in the Advisory Committee's research, brief descriptions of individual experiments,
lists of testifiers and interviewees, indexes, collections of documents, and other research
aids.

The second aid is the electronic record upon which much of the supplemental volume
is based. Unfortunately, the National Archives is unable to make this information
available in its original format, although it will be available there in simplified electronic
formats with explanatory documentation. Copies of the original databases,
documentation, and operating instructions will be available at the National Security
Archive, an independent research institute whose offices are in the Gelman Library at
George Washington University.31 In addition to these facilities, both the National
Archives and the National Security Archive provide access to the electronic records
contained in the Advisory Committee's original gopher.32 The gopher materials include
electronic copies of the Advisory Committee meeting documents (briefing books,
minutes, and transcripts), condensed descriptions of record collections and experiments,
and other information.

920

A Citizen 's Guide

How to Go From the ACHRE Collection to Agency Records

There are two sources of information that connect records contained in the ACHRE
collection with those of the agencies and the National Archives. The first are document
identifiers provided by the agencies; the second are transmittal records that identify the
origins of the records.

Agency Document Identifiers

Most Department of Energy and a large proportion of Department of Defense
documents are marked with unique identifiers that will allow location of those documents
in DOE and DOD retrieval systems. Those retrieval systems include provenance
information,33 that is, information that identifies the record's office of origin and other
information about its creation and current location.

DOE documents are stamped with a CIC number,34 a six-digit accession number that
uniquely identifies a document or document set (that is, documents described as a group
rather than individually) that can be used to retrieve CIC records with their attendant
provenance and other information management information. DOE's Internet facility can
be used to identify these documents. Information is also available directly from the CIC,
which also provides its index on CD-ROM using Folio Views text retrieval software.

Beginning in the fall of 1994, DOD documents supplied to the Advisory Committee
were assigned accession numbers by the Radiation Experiments Command Center
(RECC). These numbers denote a document's origin and the date it was sent to ACHRE.
For example, records bearing numbers beginning "ARM" originated with the U.S. Army.
Later in 1994 the RECC began to assign accession numbers retroactively to documents
transmitted earlier. These accession numbers are available in the RECC library catalog,
which was converted by ACHRE staff and is available among the Advisory Committee's
records in both hard copy and electronic formats.35

Records of Agency Transmittal

Most records accessioned into the ACHRE collection were transmitted or deposited
with documents indicating their origins. For example, materials obtained from the
National Archives usually have notations indicating record group, series, and box
numbers; agency records have accompanying documents indicating where materials were
obtained; and donations from individuals include such information as the address of the
donor. This information is collected in a ACHRE Records Management Series, Records
Accession and Disposition File. Summaries of this information are included in the
electronic records kept in the Document Collection database. Additional information
concerning specially requested information is contained in the Agency Data Requests
records file, which includes the Agency Data Requests Tracking database.

921

ENDNOTES

1 . There are intersections, naturally, as in contracts and grants, applications and
responses, and so forth, but program history is not constituted of cumulative accounts of
individual program experiences but, rather, summary accounts of overall program
performance.

2. The scientific records of an experiment contain various medical facts about
an individual subject, but generally only information pertinent to the conduct of the
experiment and not the subject's medical history. The complete records of an experiment
may include the medical records, but they will be handled separately from the scientific
records. This may or may not mean that the medical records and the scientific records are
the responsibility of different individuals and are stored in different places; it will
certainly mean that they are created, controlled, and preserved under different guidelines.

3. For example, Sources and Documentation describes the contents and
classifications of the record groups and entries examined at the various National Archives
facilities, the record groups and accessions reviewed at the various federal records
centers, and the record collections examined at various agency record storage facilities,
history offices, and other locations.

4. Department of Energy, Office of Human Radiation Experiments, Human
Radiation Experiments: The Department of Energy Roadmap to the Story and the
Records (Washington, D.C.: Department of Energy, February 1995). For ordering
information, write: U.S. Department of Commerce, Technology Administration,
National Technical Information Service, Springfield, Virginia 22161; or telephone: 703-
487-4650.

5. Although the National Archives and Records Administration (NARA) system
includes records of the judicial and legislative branches of the federal government, most
citizen researchers are looking for records created by agencies of the executive branch,
and so the following information is generally limited to those records. A brief discussion
of judicial and legislative records is included in Sources and Documentation.

6. Because the National Archives was not established until 1934 and the records
centers only came into existence in 1950, there are some instances where the records of
federal officials and agencies are outside the "physical control" of the government. Also,
unfortunately, no general rule can be applied to contractor records. The handling of the
records of contract work is controlled by the terms of the contract, which may require
anything from deposit of complete records with the contracting agency to complete
retention of all records by the contractor. The citizen will need to research such
situations on a case-by-case basis. Agency records should include copies of the contract
or grant instruments, however, and research should begin with those.

7. Provenance refers to the origin, creation, and ownership (or chain of custody)
of records or other items.

8. A folder listing is a list of the titles of the file folders (that is, what is on their
labels) that are contained in the shipment. Because it reproduces the file labels more or
less exactly, such a listing, while invaluable, is only as informative as the labels. SF-135s
are unlikely to contain information on individual documents.

9. The most practical resource is A Citizen's Guide on Using the Freedom of
Information Act and the Privacy Act of 1974 to Request Government Records, House
Report 104-156 (Washington, D.C.: GPO, 1995), prepared by the Committee on

922

Government Management, Information, and Technology of the House of
Representatives. Another important resource (for those interested in the administrative
and legal details) is the annual Department of Justice publication Freedom of Information
Act Guide & Privacy Act Overview. Both volumes are available from the U.S.
Government Printing Office, Superintendent of Documents, Mail Stop: SSOP,
Washington, D.C. 20401-9328. The American Civil Liberties Union (ACLU) also
publishes an annual guide to FOIA and the Privacy Act; for information call (202) 544-
1681.

1 0. These sorts of records are subject to Privacy Act controls whether they are
in the keeping of the originating agency or the National Archives.

1 1 . This is an area in which there is not agreement among the agencies. For
example, the Advisory Committee was assured by one agency that records retrievable by
the names of principal investigators were not subject to the Privacy Act-after all,
officials said, these individuals were government contractors and grantees who had a
practical relationship with the federal government that had to be substantiated by reports
under the law. Under similar circumstances, however, another agency provided the
Advisory Committee with information that it said could not be made public because it
had been retrieved by the name of a principal investigator.

12. The act uses the phrase "any person," so that inquiry is not restricted to U.S.
citizens.

13. "There are three basic elements to a FOIA request letter. First, the letter
should state that the request is being made under the Freedom of Information Act.
Second, the request should identify the records that are being sought as specifically as
possible. Third, the name and address of the requester must be included." A Citizen's
Guide on Using the Freedom of Information Act, 8.

14. The Department of Justice's Overview, 32 fn. 103, cites a Federal District
Court decision: "FOIA creates only a right of access to records, not a right to personal
services." Hudgins v. IRS, 620 F.Supp. 19, 21 (D.D.C. 1985), affd, 808 F.2d 137 (D.C.
Cir.), cert, denied, 484 U.S. 803 (1987).

15. The agencies concerned with human radiation experiments have provided
information on their procedures for filing FOIA requests, and these are included in part II
of this appendix.

1 6. A Citizen 's Guide on Using the Freedom of Information Act, 1 0, should be
consulted on how fees may be waived.

1 7. The effect of this provision is potentially highly elastic because, under the
act, the agency may lengthen the time it takes to provide records in order to look for the
records, search through the records, or consult with another agency or office.

18. The requirements for MDRs under Executive Order 12958 are very similar
to those of the FOIA described in the previous section, and accordingly, there is no
separate discussion of this alternative procedure. Among the few differences are that
only U.S. citizens may file MDRs, and that if there is a denial of an MDR in whole or in
part there is a right to an administrative appeal, but no right of judicial redress.

1 9. The U.S. Government Manual, published annually as a special edition of the
Federal Register, is available by writing: Superintendent of Public Documents, P.O. Box
317954, Pittsburgh, Pennsylvania 15250-7954; telephone (202) 783-3238.

20. A FOIA reading room is a publicly accessible facility that houses
information that has been released to the public by the agency, either voluntarily or as a
result of a citizen's FOIA request. Almost without exception, however, these repositories

923

contain only a small fraction of the records that have been released over the years. FOIA
reading rooms are generally managed and staffed by the agency library. But access to
agency libraries varies, and many agencies do not have FOIA reading rooms. Most
agencies, however, have an office of public affairs that may be contacted for general
information about the agency and its programs. An agency's FOIA office handles all
FOIA requests and is the primary source of information about the agency's FOIA
procedures.

2 1 . CIC is a records center operated by the Reynolds Electrical & Engineering
Co., under contract with DOE. Reynolds's address is P.O. Box 98521, Las Vegas,
Nevada 89 1 93-852 1 . The CIC is the major source of the documents made available by
DOE through the Internet and provides reference services and copies of documents to
help the public.

22. Some records transferred to the St. Louis facility were destroyed in a fire in
1973.

23. The World Wide Web is a network of Internet sites using graphical and
hypertext formats permitting access to images and linking distant and diverse information
sources.

24. Department of Energy, Assistant Secretary for Environment, Safety and
Health, Human Radiation Experiments Associated with the U.S. Department of Energy
and Its Predecessors (Washington, D.C.: U.S. Department of Energy, July 1995).

25. Some records transferred to the St. Louis facility were destroyed in a fire in
1973.

26. The operations of the Department of Health and Human Services (DHHS)
are diverse and decentralized and include several large components, such as the Food and
Drug Administration (FDA), the Public Health Service (PHS), and the National Institutes
of Health (NIH), which are so well known that they sometimes may appear to be
independent. PHS is one of the major subdivisions of the department; FDA and NIH are
components of PHS.

27. The "institutes" that make up the National Institutes of Health are organized
around medical specialties such as cancer and mental health, and physiological topics
such as the heart and the kidneys. They are based in Bethesda, Maryland.

28. The Common Rule governing human experimentation in most federal
government agencies uses this phrase. See 56 Fed. Reg. 28,012 (1991) (§ 101 [a]).

29. Some reference books that might be useful: (1) Directory of Physicians in
the United States, issued by the American Medical Association; (2) Official ABCS
Director}' of Board Certified Medical Specialists, issued by the American Board of
Medical Specialties; (3) The World of Learning, which contains entries for major
universities that include medical center faculty lists and addresses; and (4) Directory of
U.S. Hospitals, published by Health Care Investment Analysts, Inc.

30. These records will be available at the National Archives in late 1995.

31. The National Security Archive, Gelman Library, Suite 70 1 , 2 1 30 H Street,
N.W., Washington, D.C. 20037; telephone, 202-994-7000; fax, 202-994-7005; e-mail,
archive@cap.gwu.edu.

32. A gopher is a software application that provides menu-driven access to
electronic files, frequently over the Internet. The Advisory Committee maintained both
a gopher and a World Wide Web home page.

33. For additional information on provenance, see the section on the National
Archives in part I.

924

34. CIC numbers are assigned by the Coordination and Information Center.
The CIC document number identifies the records series in which a document is indexed.
The records of concern to the Advisory Committee are primarily from the human
radiation series, which uses numbers 700,000-799,999. Other series cover such related
topics as Enewetak Atoll, fallout, and Glenn T. Seaborg.

35. Hard copy format is available in the transmittal documents (see next
section).

925

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