The protection of human subjects in research conducted or supported by federal agencies : staff report

R

724
IJ559
1978

Staff Report

The Protection of
Human Subjects in
Research Conducted or
Supported by
Federal Agencies

February 10, 1978

The National Commission for the
Protection of Human Subjects of Biomedical
and Behavioral Research

N

im

Contents

Introduction 1

Summary of Findings 2

Standards and Procedures at DHEW 4

Standards and Procedures at Other

Federal Agencies 9

Problems Identified 14

Appendix: Summary Analyses of Federal
Policies and Procedures for the
Protection of Human Subjects
(by Agency) 22

Introduction

In addition to developing guidelines for the protection of human subjects
of research conducted or supported by DHEW, the Commission for the Protection
of Human Subjects is charged under its mandate to recommend to Congress a
mechanism (if needed) to assure the protection of human subjects in research
not subject to regulation by DHEW, including research conducted or supported
by other federal departments and agencies. This staff report, which was pre-
pared to assist the Commission in fulfilling its mandate, surveys the policies,
regulations, etc. that have been adopted by the various departments and agen-
cies of the federal government to assure the protection of human subjects in
research which they conduct or support.

The survey was conducted by the Commission's staff in 1975 and updated
at the end of 1977. In the first phase, 61 federal departments and agencies*
were queried to determine whether they conduct or support research involving
human subjects and, if so, what policies or regulations are in force to pro-
tect the subjects. Twenty departments and agencies other than DHEW reported
that they conduct or support research involving human subjects.** Four of
these have components that operate under their own policies for the protection

* Of the 77 federal agencies listed in the U.S. Government Manual, 16 were
excluded as there was reason to be confident that they were not conducting
or supporting research with human subjects. Agencies excluded from the
staff survey included, for example, the Federal Property Council, the
American Revolution Bicentennial Commission, the Farm Credit Administra-
tion, and the Overseas Private Investment Corporation.

** In 1975, twenty-one agencies reported that they conduct or support research
with human subjects; however, two of these were subsequently combined in
the Department of Energy, reducing the number of agencies that conduct such
research to twenty.

of human subjects, and, accordingly, the survey reports on 28 federal enti-
ties that conduct or support research involving human subjects outside the
regulatory authority of DHEW.

As a result of the recent update, in which agencies were given the oppor-
tunity to comment on summaries of their original responses and to provide any
revised materials, it is believed that the survey covers all federal policies
and regulations for the protection of human research subjects in effect on
January 1, 1978. All policies, regulations and letters cited in this report
are on file in the office of the Commission.

Summary of Findings

It is clear that DHEW has been preeminent in the area of protection of
human subjects of research. Almost all the other agencies that have formal
policies or regulations governing such activities follow (to a greater or
lesser extent) the standards and procedures of DHEW; roughly half of these
agencies impose additional requirements. The degree to which the other
federal agencies monitor implementation and compliance varies, however; and
nine agencies conducting or supporting research with human subjects have no
formal policies to assure the protection of human subjects. Thus, the degree
of protection afforded subjects of federally funded research varies from non-
existent to standards that exceed those imposed by DHEW. The norm, however,
is substantial conformity with present DHEW regulations.

Since DHEW policies and procedures have served as a model for other
federal agencies, an understanding of the basic elements of the DHEW regula-
tions is essential to an understanding of the state-of-the-art throughout
the federal government. The primary responsibility for protecting human sub-
jects of research supported by DHEW rests with the institution (e.g. , univer-
sity, hospital, research foundation) that is awarded the grant or contract;
and the primary mechanism by which the institution discharges that responsi-
bility is the Institutional Review Board (IRB). Each institution that re-
ceives research funds from DHEW is required to establish an IRB to review
all research involving human subjects and to determine that the benefits
sufficiently outweigh the risks, that the rights and welfare of subjects will
be protected, and that informed consent will be obtained by adequate and appro-
priate methods. The IRB must have a diverse membership and be competent to
deal with scientific considerations, questions of law, institutional regula-
tions, professional standards and community attitudes. Only if DHEW approves
the membership and review procedures of an IRB will it accept the applicant
institution's "assurance" of compliance with applicable DHEW regulations.

Of the 19 other federal entities that have formal policies or regulations
governing research with human subjects, 17 adopt DHEW standards and procedures
to a substantial degree, and most of these cite DHEW regulations or policy as
a reference. Among these 17 are four that follow DHEW regulations strictly,
eight that follow DHEW regulations but impose some additional requirements
(regarding composition of review boards, standards of review, or provisions
for selection of subjects or informed consent) and five that have policies
similar to those of DHEW without adopting DHEW regulations specifically and

in their entirety. In a few instances, there is a different standard for trig-
gering the provisions of the regulations in the first place.

Approximately one-third of the government entities that support or conduct
research with human subjects have no formal policies or procedures to protect
such subjects; however, most of the research supported by those agencies con-
sists of questionnaires and surveys (activities about which there is presently
no uniform understanding with respect to the nature and extent of protective
mechanisms that should be applied). Only two agencies -- the Law Enforcement
Assistance Administration and the Department of Housing and Urban Development --
support research involving active intervention in the lives or behavior of
subjects and have no formal policies or procedures for reviewing the ethical
acceptability of such research or for assuring the adequacy of informed con-
sent.

Standards and Procedures at PHEW

DHEW was the first federal agency to develop formal policies for the pro-
tection of human subjects and has remained the lead agency in this area. From
1966, when the Surgeon General published a policy order requiring institutional
review (to assure ethical acceptability of research with human subjects sup-
ported by DHEW grants) to the present, DHEW's policies and procedures have served
as a model for other federal agencies. That this should be so is not surprising
in view of the department's extensive involvement in support of biomedical and
behavioral research, primarily through the National Institutes of Health (NIH)

and the more recently organized Alcohol, Drug Abuse, and Mental Health Admin-
istration (ADAMHA). In 1975, the Secretary of Health, Education, and Welfare
reported that DHEW was supporting nearly two-thirds of the nation's biomedical
research through grants to institutions and individual scientists. DHEW sup-
ports behavioral research, as well, particularly through ADAMHA and the Educa-
tion Division.

Until 1974 DHEW's standards were in the form of policy applicable to all
research supported by DHEW grants and contracts. Not covered by the policy,
therefore, was a large amount of research conducted intramurally, by scien-
tists employed at NIH or in various outposts of the Public Health Service
such as St. Elizabeths Hospital, the hospitals and clinics of the Indian Health
Service, and the Addiction Research Center in Lexington, Kentucky. Also not
covered by the policy was research in which the investigator determined that
the subjects would not be "at risk." In other words the investigator made
the threshold determination as to whether or not the research would expose
subjects to "the possibility of harm - physical, psychological, sociological,

or other - as a consequence of any activity which goes beyond the application

3
of those established and accepted methods necessary to meet his needs." If

the investigator found no risk to subjects, the research was not subject to
the review and consent procedures set forth in the policy. The reviewers at
DHEW might ultimately determine otherwise, but unless the investigator's deter-
mination was questioned, none of the protective mechanisms set forth in the
policy would be applied.

By contrast, the present regulations (which otherwise are almost identical
to the policy) are applicable to all research involving human subjects (whether

or not the subjects are "at risk"). The present regulations also extend
the protection procedures to intramural research.

The essential mechanism by which DHEW seeks to assure protection of human
subjects is the Institutional Review Board (IRB). Each institution applying
to the department for funds to conduct research involving human subjects must
certify to DHEW that it has established an IRB and that no research involving
human subjects will be undertaken at the institution unless it has been re-
viewed and approved by the IRB. This review is to determine whether or not
the subjects are at risk and, if so, whether: (1) the risks to subjects are
so outweighed by the sum of the benefits to subjects and the importance of
the knowledge to be gained as to warrant a decision to allow subjects to
accept those risks; (2) the rights and welfare of subjects will be adequately
protected; and (3) legally effective informed consent will be obtained by ade-
quate and appropriate methods, according to provisions set forth in the regu-
lations.

The IRB must be composed of at least five members with sufficient diver-
sity of background to enable review of research proposals with respect to
scientific considerations, applicable law, institutional regulations, standards
of professional conduct and community attitudes. No IRB may consist entirely
of officers, employees or agents of the institution served by the board, nor
of members of a single professional group. Board members must be identified
to DHEW by name, earned degrees, position or occupation, representative capa-
city and other pertinent indications of experience.

"Informed consent" is defined by DHEW as:

the knowing consent of an individual or his legally
authorized representative, so situated as to be able
to exercise free power of choice without undue induce-
ment or any element of force, fraud, deceit, duress or
other form of constraint or coercion. The basic ele-
ments of information necessary to such consent include:

(1) a fair explanation of the procedures to be fol-
lowed, and their purposes, including identification
of any procedures which are experimental ;

(2) a description of any attendant discomforts and
risks reasonably to be expected;

(3) a description of any benefits reasonably to be
expected;

(4) disclosure of any appropriate alternative proce-
dures that might be advantageous for the subject;

(5) an offer to answer any inquiries concerning the
procedures; and

(6) an instruction that the person is free to with-
draw his consent and to discontinue participation in
the project or activity at any time without prejudice
to the subject, r

A consent form must be signed by each subject or a legally authorized repre-
sentative; if part of the required information is conveyed orally (and omitted
from the written form), the consent form must also be signed by an "auditor
witness to the oral presentation."

Additional protections and special procedures are imposed for research
involving fetuses, pregnant women or human in vitro fertilization, as well as
for research involving investigational new drugs (as required by the Food and
Drug Administration).

The institution must inform DHEW of the IRB's quorum requirements and
its procedures for initial and continuing review (including procedures for
notifying the board and DHEW of adverse reactions, changes in research de-
sign, or unanticipated problems). In addition, the institution must pro-
vide administrative assistance and support for the IRB's functions and for
implementation of its recommendations. Finally, the IRB must identify to
DHEW a statement of principles (e.g. , Nuremberg Code, Helsinki Code) that
will govern its review of research involving human subjects.

If an institution has a number of concurrent grants from DHEW, it will
submit a "general assurance" of compliance with DHEW regulations, applicable
to all research projects supported by the department. If the institution has
applied for only one grant or contract, it will submit a "special assurance"
which is, in effect, a request for approval of its IRB to review and monitor
the particular activity or project described in the pending application. The
department reviews all of the documents submitted by the institution in its
assurance, and may either approve, request modifications or disapprove the
assurance. Conditions (e.g. , approval only for review of behavioral research)
may be attached by DHEW, which also determines the period during which the
assurance will remain effective. Once an institution has an approved assurance
on file at DHEW, it becomes eligible to receive support for research with human
subjects.

Periodic site visits are made by DHEW staff to examine IRB files and
ascertain whether there are any problems with respect to the functioning
of the IRBs. If the department determines (either through site visits or

otherwise) that an institution has failed materially to protect human subjects,
the department may refuse further research funding or even withdraw current
funds, whether or not DHEW funds were involved in the research in which the
failures of protection occurred. Application of this sanction may be limited
to the investigator involved or may extend to the entire institution, since
DHEW places the major responsibility for protection of human subjects on the
institution that is accountable to DHEW for the funds awarded to support the
research.

Standards and Procedures at Other Federal Agencies

Twenty federal departments or agencies, other than DHEW, reported that
they conduct or support biomedical or behavioral research with human subjects.
Four of these (the departments of Commerce, Defense, Justice and Transportation)
have separate subsidiary components that operate under their own policies or
regulations for the protection of human subjects. Thus, there are a total
of ,28 separate federal entities that conduct or support research with human
subjects outside the regulatory authority of the Secretary, DHEW.

Of the 28 federal entities that conduct or support such research, nine
have no formal policies or regulations for the protection of human subjects.
Three of these are within the Department of Transportation, which is in the
process of developing departmental regulations governing such activities.
Four others are involved primarily in survey research entailing no inter-
vention in the lives or activities of the subjects: the Civil Service

Commission, the Commission on Civil Rights, the Internal Revenue Service
and the United States Information Agency. Although their activities might
fall within the Commission's definition of research with human subjects,
it should be noted that data gathering, in and of itself, has not univer-
sally been considered "research with human subjects." Since the Privacy
Act of 1974 sets forth conditions for maintaining confidentiality of data
and the Office of Management and Budget (0MB) reviews the appropriateness
of all questionnaires sent out by federal agencies, there would appear to be
minimal discernible risk involved to respondents of such surveys. Such would
be the case, as well, with agencies such as the Bureau of the Census and the
Bureau of Labor Statistics that operate under a legislative mandate to col-
lect certain information. Real concern is raised only with respect to the
remaining two agencies that lack formal policies, the Law Enforcement
Assistance Administration (LEAA, part of the Department of Justice) and
the Department of Housing and Urban Development (HUD). Both of these agen-
cies support behavioral or social research involving systematic changes or
interventions in people's lives for the purpose of determining the effects
of an intervention or comparing the effects of one intervention with those
of another. This clearly constitutes research with human subjects. LEAA
states on the record that it does support behavioral research involving human
subjects;* HUD states that it does not. This problem is explored more fully,
below.

LEAA specifically prohibits the use of its funds for biomedical research
except for projects generally recognized and accepted as not involving
physical or psychological risk to subjects, and specifically approved
by the Office of Administration after consultation with DHEW.

10

Three departments have review procedures designed to assure technologi-
cal soundness of the research and safety of the subjects, but have no review
of ethical acceptability of research per se. The National Oceanic and
Atmospheric Administration (NOAA) and the Federal Aviation Administration
(FAA) require technical review, safety provisions, fitness standards and

Q

medical supervision. Similarly, although the Navy adopts DHEW standards
and procedures for its intramural research, it requires of contractors only
that they make adequate safety provisions and conform to the ethical standards
of the American Medical Association.

Five agencies have formal policies or regulations that are substantially
similar to, but not entirely consistent with, those of DHEW. For example,
the Bureau of Prisons requires local review by a board composed of two prison
officials, a research analyst, a psychologist, an inmate, a representative
of the employees union and a representative of the community. Although the
consent provisions adopted by the Bureau are those of DHEW, the review stan-
dards differ. Proposals are reviewed for relevance to the mission of the
Bureau, potential benefits to mankind, professional standing of the investi-
gator, and assurance that the research will not adversely affect ongoing
programs. The Bureau also requires all research involving inmates to be ap-
proved by the Director of Prisons, and it absolutely prohibits medical ex-
perimentation and drug testing. The Bureau is "guided by" the Nuremberg
Code and states that it relies on the investigators to protect the rights and
lives of subjects. Similarly, NASA adopts the review standards and consent
provisions of DHEW, but the IRBs that review research consist entirely of NASA
personnel, primarily staff physicians and scientists. In one research center,
a representative from the office of general counsel is also included; in the

11

other research center, a personnel officer is included. Following review by
the IRB, all research proposals must receive the approval of the installa-
tion's medical officer, general counsel and safety officer before being for-
warded to the director of the installation for final review and approval.^
Other agencies that follow DHEW standards or procedures with some variation
include: the clinical investigation program of the Air Force, the Bureau of
Standards, and the Agency for International Development.

Four agencies adopt DHEW regulations by reference, with no additions or
modifications: the Consumer Product Safety Commission, the Department of
Energy, the National Academy of Sciences, and the National Science Foundation.
Eight agencies adopt DHEW provisions by reference, but add various other pro-
visions relating to applicability, IRB composition, review standards, consent
procedures and selection of subjects. For example, the Environmental Protec-
tion Agency exempts from its regulations opinion polls and questionnaires, pro-
jects involving merely collection of blood, urine, mothers' milk or nonviable
fetal tissue and medical observations that are not preceded by purposeful ex-
posure to chemicals or environmental conditions under investigation. (EPA is
developing a different set of regulations to govern such activities.) The
Environmental Protection Agency also prohibits research involving the testing
for possible carcinogenic effects on human subjects.

With regard to IRB composition, the Army and the Air Force require that the
IRB include a lawyer and a clergyman; the Air Force adds that there should be
three lay members of the IRB but that the chairman should be a physician. The
draft Intelligence Community Directive contains the provision that no more than
one-half of the members of an IRB may be members of the Intelligence Community.

12

Some agencies impose review standards additional to those of DHEW, in-
cluding: prior animal studies , use of minimal number of subjects and avoidance
of unnecessary physical and mental discomfort (Army, Navy and Air Force); per-
formance of adequate physical and psychological examinations before, during
and after participation in research, and provision of compensation that will
be commensurate with the risk involved but not so excessive as to constitute
undue inducement (National Highway Traffic Safety Administration). With respect
to informed consent, the Army, Navy and Air Force require the consent proce-
dure to be witnessed in all cases, and the Red Cross requires investigators
to inform subjects of any abnormalities discovered during the conduct of the
research but to keep such information confidential unless specifically released
from that requirement by the donor (subject) or the donor's legal representa-
tive. The Army, Navy and Air Force also have special consent provisions for
children and the mentally disabled.

In addition, the Department of Agriculture requires that selection of
subjects be made without regard to sex, race, color, religion or national
origin unless these characteristics are factors to be studied, and it
specifically excludes pregnant and lactating women from studies involving
food additives or chemicals not recognized as safe by FDA, EPA or the Animal
and Plant Health Inspection Service. Similarly, the Army and Navy (but not
the Air Force clinical investigation program) exclude prisoners from parti-
cipation in research; Navy also excludes the institutionalized mentally in-
firm. The Air Force aerospace research program excludes children, prisoners,
the mentally incompetent, and females (unless there is reasonable assurance
that there is no concomitant pregnancy and methods adopted for contraception
assure against increased risk).

13

Miscellaneous provisions included requirements that investigators con-
form to the provisions of the Privacy Act of 1974 and, in some instances,
that such fact be disclosed on the consent form. Several agencies require
debriefing following research involving incomplete disclosure, the Veterans
Administration provides a mechanism for appeal from an IRB's decision, and
the Army, Navy and Air Force specifically provide for treatment of injuries
arising as a consequence of participation in research. Finally, a number
of agencies specifically apply their regulations to research conducted out-
side the United States and require that such research conform, in addition,
to the legal and ethical standards of the country in which the research
will be conducted.

Problems Identified

As the preceding discussion makes clear, the protection of human sub-
jects in federally funded research is far from uniform despite the striking
number of agencies that substantially follow the standards and procedures of
DHEW. The extent of protection ranges from nonexistent to a plethora of re-
quirements imposed in addition to those of DHEW regulations. Just as the
lack of formal policies and regulations is a serious problem, so too is the
confusion that results from the many variations on the theme presented by
agencies that have imposed manifestly reasonable but diverse additions or
modifications to the DHEW standards. An IRB that reviews projects funded
by different agencies must face the difficult task of satisfying multiple
(and perhaps incompatible) requirements regarding applicability of the regu-
lations, IRB composition, review standards, consent procedures, selection of

14

subjects, and so forth. To do so requires constant referral to the funding
agency's particular provisions after first identifying the source of support
for each proposed project. The administrative burden imposed thereby can
be immense; and the problem is compounded by the fact that some projects re-
ceive support from two or more federal agencies.

Another problem arises from the lack of a uniform definition of "re-
search with human subjects." Thus, when federal agencies conduct or support
social research, they may not consider it necessary to apply procedures for
the protection of human subjects. For example, the Department of Housing
and Urban Development (HUD) submitted a number of printed materials to the
Commission describing its housing allowance "experiments" in which subjects
are selected according to predetermined criteria, assigned to different
"treatment groups" according to the research "design," and followed for a
period of years through periodic interviews and inspections to determine

the different effects on the recipients' behavior of the various housing

l ?
allowance schemes under study. Nevertheless, despite the fact that HUD,

itself, describes the "experiments" in terms of a systematic intervention

into people's lives in order to gather data by which to answer specific

questions, the department officially responded to the Commission's inquiry

13
that HUD has "never sponsored any human subject or biomedical studies."

Commission staff formally requested clarification of that statement, but

no reply has been received despite numerous attempts to elicit a response.

Similarly, in 1975 Medicaid recipients successfully challenged an experi
ment (supported by DHEW) designed to assess the effects of requiring a co-
payment for medical care, on the grounds that it had not been reviewed by

15

an IRB (Crane v. Mathews) . ^ The Secretary of Health, Education, and Welfare
argued that the project was not "research with human subjects" and that there-
fore the review requirements were not applicable. The court disagreed and
stopped the project pending review and approval by an IRB.*

These examples suggest that the term "biomedical and behavioral research
with human subjects" is not uniformly understood. A clear definition would
be helpful to federal agencies that may be frankly unsure as to whether cer-
tain programs which they support fall within the category of activities to
which procedures for the protection of human subjects should apply.

Another problem is the lack of central coordination of research activi-
ties in some departments, and the absence of high-level staff sufficiently
knowledgeable to supervise the protection of human subjects in projects con-
ducted or supported by various components of the department. For example,
the Environmental Protection Agency reported in 1975 that "it is the policy
of the Environmental Protection Agency to comply fully with the policies and
practices established by the Department of Health, Education, and Welfare to

1 c

protect human subjects in our research program." The EPA official, however,
apparently was referring only to research conducted under the auspices of
EPA's Environmental Research Center at Research Triangle Park, North Carolina.

* An IRB subsequently reviewed the project and determined that the sub-
jects would be at risk of physical harm as a result of being required to
pay for necessary medical care. The IRB further determined that the bene-
fits of the proposed research did not outweigh the risks and that the
research design was "so seriously inadequate that it would be very un-
likely to provide any accurate or reliable information upon which to
base policy decisions regarding Medicaid co-payments." It therefore
disapproved the project., ,-

16

It appears that other components of EPA also supported research involving human
subjects, but without the constraints imposed upon the research conducted at
Triangle Park. It was recently revealed^ that a contract with a Mexican
gynecological hospital to study the effects of ingesting a massive amount
of fungicide narrowly missed being put into effect. The original plan had
been to conduct the tests in the U.S., but the IRB that reviewed the proto-
col found the risks excessive. It was reported that EPA staff therefore agreed
with the contractor to conduct the tests in a Mexican gynecological hospital,
but a fortuitous review prevented approval of the contract. EPA has since
forbidden the testing of carcinogens on human subjects under its auspices
and has required that all future EPA research comply with DHEW regulations

I Q

for the protection of human subjects.

Similarly, although DHEW regulations "are applicable to all Department

of Health, Education, and Welfare grants and contracts supporting research,

19
development, and related activities in which human subjects are involved,"

implementation of the regulations is not uniform within the Department. For

example, the Education Division (which includes the National Institute of

Education, the Office of Education and the National Center for Education

Statistics) takes the position that it is not subject to the Department's

on

regulations because it has statutory authority to write its own regulations.
Therefore, present NIE and OE regulations require that research conducted or

supported by the components of the Education Division comply with the DHEW

21
Grants Administration Manual Chapter 1-40 and the DHEW Procurement Rules.

These both require IRB review only when the investigator determines that the

research subjects will be at risk (as was the case in earlier DHEW policy).

17

Similarly, the Center for Disease Control (CDC) still follows the old Insti-
tutional Guide to DHEW Policy, in which IRB review is not triggered unless
the investigator determines that the subjects of his or her research will be
at risk. (The Commission has been advised that CDC's policies will be updated
"in the near future" to incorporate the provisions of current DHEW regulations
and the Commission's recommendations on research involving children. )

The regulations of the Food and Drug Administration (FDA), governing re-
search regulated by that agency in the course of approving applications for
new drug investigations and licensing, differ from the regulations governing
research supported by DHEW in that IRB review is required by FDA only when the
subjects of the research are institutionalized, or when the investigator al-
ready is "affiliated with an institution which agrees to assume responsibility

23
for the study." Investigators lacking such affiliation apparently may con-
duct research with human subjects without such review. (The Commission has
been informed that FDA is drafting proposed regulations that would extend the
requirement for IRB review to all human experimentation under its regulatory
jurisdiction, thus conforming to regulations governing research conducted or
supported by DHEW.) FDA regulations also permit a waiver of the consent re-
quirement if the investigators "deem it not feasible or in their professional
judgment contrary to the best interests" of the subjects. This is explained
as applying to cases in which (1) the communication of information to obtain
consent would seriously affect the patient's well-being or (2) the patient

is in a coma or is otherwise incapable of giving consent, his representative

25
cannot be reached, and it is imperative to administer a drug without delay.

In summary, most of the departments and agencies of the federal government
that have formal policies or regulations governing research with human subjects
follow the standards and procedures of DHEW, at least to some extent. However,
the nature and extent of the deviations from the DHEW regulations are such
that the protection of human subjects in federally funded research is far
from uniform, and the administrative burden of implementing diverse sets of
standards is unnecessarily great. Further, some agencies have no policies or
regulations governing such research because, in large measure, there is con-
fusion regarding the kinds of activities to which such regulations should
apply. A uniform standard governing all research supported or regulated by
the federal government would assure the protection of human subjects in all
such activities and, at the same time, reduce the administrative complexity
that now exists.

19

Footnotes

1. David Mathews, Secretary, DHEW, in foreward to This is PHEW, Department
of Health, Education, and Welfare Publication No. (OS) 75-126, Wash-
ington, D.C., 1975.

2. The Institutional Guide to DHEW Policy on Protection of Human Subjects,
DHEW Publication No. (NIH) 72-102, Washington, D.C., 1971; DHEW Grant?
Administration Manual , Ch. 1-40.

3. Institutional Guide to DHEW Policy, p. 2.

4. 45 CFR § 46.101.

5. 45 CFR § 46.301.

6. 45 CFR § 46.103(c).

7. 45 CFR § 46.110.

8. National Oceanic and Atmospheric Administration, Department of Commerce,
NOAA Diving Regulations, NOAA Diving Manual , Appendix C, U.S. Government
Printing Office, Washington, D.C., 1975; Federal Aviation Administration
Order 9950. 3A (December 6, 1974).

9. Office of Naval Research, Code 600 Memorandum No. 97A (27 March 1974).

10. Bureau of Prisons, Draft revision of Policy Statement 6110.1 (October 31,
1967) to be published in Spring 1978; Policy Statement 37000.3 (June 10,
1977).

11. NASA, Management Instruction 7100.8 (February 2, 1972); Ames Management
Manual 7170-1 (as revised March 19, 1969); Ames Memorandum 74/200 (Decem-
ber 11, 1974); Johnson Space Center Management Instruction 7100.8A (March
29, 1977).

12. Department of Housing and Urban Development, The Experimental Housing
Allowance Program (1974); Second Annual Report of the Experimental Housing
Allowance Program (1974); and Experimental Housing Allowance Program:
Initial Impressions and Findings (1975).

13. Letter (Nov. 18, 1977) to the Commission's Staff Director from Patricia
M. Worthy, Deputy Assistant Secretary for Regulatory Functions, Depart-
ment of Housing and Urban Development.

14. 417 F.Supp. 532 (N.D. Ga. 1976).

20

15. Clarification Statement Regarding the Georgia Department of Human Re-
sources Human Research Review Board's Review of the Proposal Entitled
"Recipient Cost-Participation in Medicaid Reform," Russell J. Bent,
Chair.

16. Letter (Oct. 20, 1975) from Roy E. Albert, M.D., Acting Deputy Assistant
Administrator for Health and Ecological Affairs, Environmental Protection
Agency.

17. Bob Wyrick, "EPA Officials Devised Cancer Tests on People," Washington
Post, June 22, 1977,

18. Environmental Protection Agency, Order 1000.17, October 25, 1977.

19. 45 CFR § 46.101.

20. General Education Provisions Act, 20 USC § 1221e(3).

21. 45 CFR § 100a. 263; 45 CFR § 1400.

22. Letter (Feb. 6, 1976) from David J. Sencer, M.D., then Director, CDC;
telephone communication (Nov. 14, 1977) from Bruce Dull, M.D.,
Assistant Director of Program, CDC.

23. 21 CFR § 312.1(a)(2) 10C; FDA Compliance Program Guidance Manual,
transmittal 77-39, March 15, 1977.

24. 21 CFR § 310.102(a).

25. Id., subsections (f) and (g).

21

Appendix

Summary Analyses of Federal Policies and Procedures for the
Protection of Human Subjects (by Agency")

Department of Health, Education, and Welfare 24

Other Federal Agencies:

American National Red Cross 34

Civil Service Commission 37

Commission on Civil Rights 38

Consumer Product Safety Commission 39

Department of Agriculture 41

Department of Commerce

Bureau of Standards 44

National Oceanic and Atmospheric

Administration 47

Department of Defense

Army 49

Navy 53

Air Force 58

Department of Energy 65

Department of Housing and Urban

Development 67

Department of Justice

Bureau of Prisons 68

Law Enforcement Assistance

Administration 70

22

Department of State: Agency for

International Development 72

Department of Transportation

Federal Aviation Administration 74

Federal Highway Administration 75

Federal Highway Traffic Safety

Administration 76

Federal Railroad Administration 78

U.S. Coast Guard 78

Department of Treasury: Internal

Revenue Service 79

Environmental Protection Agency 80

Intelligence Community 82

National Academy of Sciences 85

National Aeronautics and Space

Administration 87

National Science Foundation 91

United States Information Agency 92

Veterans Administration 93

23

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE (DHEW)

I. National Institutes of Health (NIH) and Alcohol, Drug Abuse, and Mental
Health Administration (ADAMHA)

NIH and ADAMHA conduct and support extensive biomedical and
behavioral research.

Authority: P.L. 93-348 (1974); 45 CFR 46 revised as of Aoril 1, 1967;
DHEW Grants Administration Manual, Chapter 1-40.

Applicability: Section 474(a) of the National Research Act (P.L. 93-348)
provides that the Secretary, DHEW, must require each institution applying for
a grant or contract that will involve the conduct of biomedical or behavioral
research with human subjects to establish an Institutional Review Board (IRB)
"to review biomedical and behavioral research involving human subjects conducted
at or sponsored by such entity in order to protect the rights of the human sub-
jects of such research." It is unclear from the language of the Act whether
the IRB thus established must review all research involving human subjects that
is conducted under the auspices of such institutions, or whether it must review
only such research supported by DHEW. The implementing regulations (45 CFR 46)
apply only to research, development and related activities conducted or supported
by DHEW; nevertheless, as a practical matter DHEW is now requiring grantees to
assure that all research conducted under their auspices is reviewed by an IRB.
The uncertainty surrounding the applicability of the review requirements is
exacerbated by Section 46.121(b) of DHEW regulations (45 CFR 46) which provides
that the Secretary may withhold research funds from any institution that fails
materially to protect human subjects under its care "whether or not DHEW funds
were involved." The result is that many institutions have required IRB review

24

for all their research involving human subjects as a matter of prudence.

Review Procedures: All research involving human subjects must be re-
viewed by an Institutional Review Board (IRB) having an approved general or
special assurance on file at DHEW. Requirements for such an assurance in-
clude a statement of principles that will govern review of such research (e.g. ,
Helsinki Code, Nuremberg Code), and a membership with sufficient diversity of
background to enable review of research proposals with respect to applicable
law, institutional regulations, standards of professional conduct and practice,
and community attitudes. IRBs must consist of at least five members, none of
whom may have an interest in the research under review. No IRB may consist
entirely of officers, employees or agents of the institution, nor of members
of a single professional group. Board members must be identified to DHEW by
name, earned degrees, position or occupation, representative capacity, and
other pertinent indications of experience. The institution must state the
IRB's quorum requirements (which must be no less than a majority of total
membership) as well as the procedures to be followed for initial and conti-
nuing review of proposals and activities, including procedures for notifying
the board and DHEW of adverse reactions, changes in the research design, or
unanticipated problems that may increase the risk to human subjects. The
institution establishing the IRB must provide administrative assistance and
support for the board's functions and for implementation of its recommendations.

In addition to reviewing applications for general or special assurances
and certifying approval of IRB membership and procedures, NIH and ADAMHA require
that proposals be reviewed by agency staff, scientific advisory committees (study
sections) and interdisciplinary national advisory councils for scientific merit

25

and for further review of such considerations as risk to human subjects, ade-
quacy of protection against those risks, potential benefits to the subjects
and to others, and the importance of the knowledge to be gained. Some proto-
cols are subject to review by a national Ethical Advisory Board and modifi-
cation or waiver of specific requirements are permitted with approval of
the Ethical Advisory Board following opportunity for public comment.

Review Standards: The IRB must review all research involving human sub-
jects to determine whether subjects will be at risk. If so, the IRB must then
determine that: (1) the risk to the subjects is outweighed by the sum of the
benefit to the subjects and the importance of the knowledge to be gained; (2)
the rights and welfare of subjects will be protected; (3) legally effective
informed consent will be obtained by adequate and appropriate methods; and
(4) adequate steps are taken to avoid unintentional involvement of pregnant
women. The conduct of any activity involving risk to human subjects must be
monitored by the IRB at timely intervals.

Consent Provisions: "'Informed consent' is defined as the knowing consent
of an individual or his legally authorized representative, so situated as to
be able to exercise free power of choice without undue inducement or any ele-
ment of force, fraud, deceit, duress or other form of constraint or coercion.
The basic elements of information necessary to such consent include:

"(1) a fair explanation of the procedures to be followed, and their
purposes, including identification of any procedures which are experimental;

"(2) a description of any attendant discomforts and risks reasonably
to be expected;

"(3) a description of any benefits reasonably to be expected;

26

"(4) disclosure of any appropriate alternative procedures that might be

advantageous for the subject;

"(5) an offer to answer any inquiries concerning the procedures; and
"(6) an instruction that the person is free to withdraw his consent and

to discontinue participation in the project or activity at any time without

prejudice to the subject."

A consent form must be signed by each subject or a legally authorized
representative; if part of the required information is conveyed orally (and
omitted from the written form), the consent document must also be signed by
an "auditor witness to the oral presentation." Written copies of the infor-
mation disclosed must be filed with the IRB,

Special Subjects: Additional protections and special procedures are im-
posed for research involving fetuses, pregnant women or human in vitro fertili-
zation, as well as for research involving investigational new drugs as required
by the Food and Drug Administration.

Sanctions: No grant or contract involving human subjects will be awarded
to an individual unless he or she is affiliated with an institution that "can
and does assume responsibility for the subjects involved." The Secretary may
terminate funds or withhold funds from grantees or contractors when either
the institution or the principal investigator has failed materially to protect
human subjects under their care (whether or not DHEW funds were involved).

II. DHEW Components other than NIH and ADAMHA

A. The following DHEW components require compliance with 45 CFR 46:

27

1 . Office of Assistant Secretary for Planning and Evaluation

Authority: Letter (February 2, 1976) from Assistant Secretary
for Planning and Evaluation (William A. Morrill).

2. Office of Human Development Services (includes: Administration
on Aging; Administration for Children, Youth and Families;
Administration for Handicapped Individuals; and Administration
for Native Americans).

Authority: Letter (April 15, 1976) from Jane Lampmann, then
Director, Office of Planning and Evaluation, OHD; Rehabilita-
tion Services Manual, Section 4010.18.

3. Health Services Administration

a. Bureau of Community Health Services

Authority: Letter (January 23, 1976) from Edward D. Martin,
M.D., Director. ("Every project involving human subjects
must have an NIH general or special assurance clearance.")

b. Bureau of Medical Services

Authority: Division of Hospitals and Clinics Operations
Manual Cll.4.6, April 23, 1975. For further information
contact Director, Bureau of Medical Services.

28

c. Indian Health Service

Authority: Indian Health Manual, TN No. 77.5, Part 1,
Chapter 7, July 13, 1977.

B. The following components of DHEW deviate from 45 CFR 46:

1 . Center for Disease Control (CDC)

Authority: Manual Guide - General Administration No. CDC-11 ,
June 8, 1973; letter (February 6, 1976) from David J. Sencer,
M.D., then Director, CDC.

Research conducted or supported by CDC, or performed on a
collaborative basis by CDC employees with other institutions or
agencies, is governed by the Manual Guide No. CDC-11, "Protection
of the Individual as a Research Subject." This guide, in turn,
requires compliance with the 1971 Institutional Guide to DHEW
Policy on Protection of Human Subjects.

Although the informed consent provisions in the Institutional
Guide to DHEW Policy are generally the same as those in DHEW regu-
lations (45 CFR 46), the requirement for review by an Institutional
Review Board (IRB) is not triggered unless the research investigator
determines that the subjects in his or her research will be at risk.
There is no mechanism for reviewing the decision of the investiga-
tor as to whether or not the subjects will be at risk and thus,

29

whether or not there is a need for IRB review. By contrast,
under present DHEW regulations, the IRB must review all research
involving human subjects, and it is the IRB that makes the
threshold determination as to whether or not the subjects will
be at risk. To the extent that the investigator of a project
may not be sensitive to the risks which the research entails,
the protection afforded by the present CDC manual will be less
than that afforded by DHEW regulations (45 CFR 46) which pro-
vide that the initial determination as to whether or not sub-
jects will be at risk will be made by an IRB.

Dr. Sencer indicated in his letter that CDC's policies
will be updated "in the near future" to incorporate the pro-
visions of 45 CFR 46; and the Commission has recently been
informed by Dr. Bruce Dull, Assistant Director for Program,
that CDC is awaiting the Secretary's regulatory response to
the Commission's recommendations on research involving children,
in order to incorporate those provisions into its revisions of
the manual .

2. Education Division (includes: the National Institute of Education
(NIE), the Office of Education (OE), and the National Center for
Education Statistics).

Authority: 45 CFR 100a. 263; 45 CFR 1400; DHEW Procurement Rules,
Title 41, Chapter 3, Subpart 3-4.55; DHEW Grants Administration
Manual, Chapter 1-40, 1974; the General Education Provisions Act,
20 U.S.C. § 1221 et seq.

30

Section 1 221 e(3 ) of the General Education Provisions Act
vests authority in the Commissioner of Education, the Director
of the National Institute of Education (NIE), and the Assistant
Secretary for Education to issue their own regulations. Conse-
quently, it has been the position of the Education Division that
it is not subject to the Department's regulations (45 CFR 46) un-
less and until specifically adopted by the Commissioner, OE, and
the Director, NIE. This was recognized by the Secretary, DHEW, in
his comments to the publication of 45 CFR 46 (Federal Register,
May 30, 1974, p. 18917), although no such exemption appears in
the regulations per se.

Research conducted or supported by the Education Division
must comply with provisions of the DHEW Grants Administration
Manual Chapter 1-40 and the DHEW Procurement Rules. These both
require IRB review only when the investigator of a research pro-
ject determines that the research involves subjects at risk. If
the investigator does not believe his or her subjects will be
at risk, none of the provisions for the protection of human sub-
jects will be applied.

Section 1232 of the General Education Provisions Act requires
parental consent for release of records or identifiable information
of children in public schools, and suggests that the Commissioner
of Education require parental involvement in the planning and con-
duct of programs supported by OE if he believes it would enhance
the effectiveness of the program. Section 1232h requires that all

31

instructional materials to be used in connection with any re-
search or experimental program be open to inspection by the
parents or guardians of the children "engaged in such program
or project."

3. Food and Drug Administration (FDA)

Authority: 21 CFR 310.102, 312.1(a)(2) IOC; FDA Compliance
Program Guidance Manual, transmittal 77-39, March 15, 1977.

The regulations governing investigations of new drugs differ
from 45 CFR 46 with respect to requirements for IRB review and
for informed consent. FDA requires research protocols to be
reviewed by an Institutional Review Committee (analagous to an
IRB) only when the proposed subjects are institutionalized or
when the investigator is "affiliated with an institution which
agrees to assume responsibility for the study." For all other
drug research, no such review is required. Instead, the prin-
ciple investigator must merely attest that the informed consent
of all subjects will be obtained. (In 1975, FDA Commissioner
Schmidt testified before the Senate Health Subcommittee that
FDA was considering extending the committee review requirements
to noninstitutionalized subjects, and we are informed that FDA
is developing such proposed regulations, to be issued for public
comment sometime early in 1978.)

* FDA proposed similar provisions for the testing of medical devices, 41
Federal Register 35282, August 20, 1976.

32

In addition, section 505 ( i ) of the Food, Drug and Cosmetic
Act requires that investigators proposing to test investigational
new drugs on human beings "obtain the consent of such human beings
or their representatives, except where they deem it not feasible
or, in their professional judgment, contrary to the best interests
of such human beings." Thus, under FDA regulations, consent need
not be obtained if "the communication of information to obtain
consent would seriously affect the patient's well-being and the
physician has exercised a professional judgment that under the
particular circumstances of this patient's case, the patient's
best interests would suffer if consent were sought." 21 CFR
310.102(g). The regulations define "not feasible" as situations
"wherein the investigator is not capable of obtaining consent
because of inability to communicate with the patient or his re-
presentative, for example, the patient is in a coma or is other-
wise incapable of giving consent, his representative cannot be
reached, and it is imperative to administer the drug without
delay." 21 CFR 310.102(f).

33

THE AMERICAN NATIONAL RED CROSS

The Red Cross conducts research related to its blood program.
This may include studies of the motivation of volunteers or
clinical trials necessary for the licensure of new products
by FDA.

Authority: Blood Program Directive 4.380-1 (revised July 1975); "Special
Exemption - Previously Collected Blood or Blood Products" (undated); letter
(November 17, 1977) from George M. Elsey, President.

Applicability: The directive is applicable to all research studies in-
volving human subjects or materials of human origin. Exception: Certain pro-
cedures found by the Red Cross Headquarters Committee for the Protection of
Human Subjects not to involve risk may be exempt from local review require-
ments, provided "federal funds are not involved."* Procedures specifically
exempted include the use of blood components derived from units of blood col-
lected from Red Cross donors in the normal course of blood center activities;
blood obtained from commercial sources; removal of up to fifty milliliters
of additional whole blood subsequent to the donation of a unit of blood,
through the same venipuncture; and blood collected previously in the course
of routine clinical procedures, or another approved research project.

* The Directive evidences some confusion regarding applicability of DHEW

regulations: "DHEW requires that any research activity supported in whole
or in part by federal funds and which involves human subjects . . . must
be reviewed by a Human Protection Committee .... In studies involving
federal funding, DHEW will require assurance of compliance with their
regulations directly from the local review committee." (Blood Program
Directive 4.38, p. 2). In fact, DHEW regulations apply only to institu-
tions conducting research supported by the Department of Health, Education,
and Welfare; they do not necessarily extend to research funded by other
federal agencies. In his letter (November 21, 1977) to the Commission,
the president of the Red Cross indicates that future directives will sub-
stitute "DHEW" for "federal funds."

34

Review Procedures: The Red Cross requires that local review boards be
established in conformity with procedures set forth in the DHEW regulations
(45 CFR 46) but permits alternative methods of fulfilling the requirement.
Institutions or Red Cross Centers may either submit proposals for local re-
view to an Institutional Review Board (IRB) with an approved assurance on
file at DHEW or to an IRB with similar composition and duties. (In the latter
case, the Red Cross instructs the regional center to establish an IRB in con-
formity with DHEW regulations, but no assurance is required and no procedures
have been established by the Red Cross for initial review or monitoring for
compliance.) Alternatively, research proposals from the Washington, D.C.,
metropolitan region may be submitted directly to the National Red Cross Com-
mittee for the Protection of Human Subjects for review. The Red Cross has an
approved general assurance on file at DHEW, and its Committee therefore com-
plies with DHEW regulations (45 CFR 46).

Each investigator must submit a form to the National Red Cross Head-
quarters indicating either that the protocol has been reviewed and approved
by an Institutional Review Board or that review by the National Red Cross Com-
mittee for the Protection of Human Subjects is requested. The national commit-
tee obtains documentation of local review, when such is performed.

Review Standards: The Red Cross requires compliance with the review stan-
dards of DHEW regulations (45 CFR 46).

Consent Provisions: IRBs with approved DHEW assurances follow the DHEW
regulations. Those not having approved DHEW assurances are given no formal
guidance by the Red Cross regarding consent procedures except that when abnor-
malities are found in the course of conducting studies on blood obtained from

35

donors, the Red Cross is obliged to inform the donor of such abnormalities
and to keep the information confidential "unless specifically released in
writing by the donor or a legally appointed representative of the donor."

Sanctions: No specific provisions are made for sanctions in the case
of noncompliance.

36

CIVIL SERVICE COMMISSION

The Civil Service Commission conducts research related to
examining programs and personnel management.

Authority: There are no formal regulations or policies for the protection
of human subjects in research conducted or supported by the Civil Service Com-
mission.

In a letter to the National Commission for the Protection of Human Sub-
jects (October 7, 1975), Robert E. Hampton, then Chairman of the Civil Service
Commission, indicated that the staff of the Personnel Research and Development
Center all have copies of the Ethical Principles in the Conduct of Research
with Human Participants issued by the American Psychological Association in
1973, and are guided by those principles.

37

COMMISSION ON CIVIL RIGHTS

The Commission on Civil Rights conducts observational
behavioral research.

Authority: There are no formal regulations or policies for the protection
of human subjects in research conducted by the Commission on Civil Rights.

In a letter to the Commission (November 8, 1977), Louis Nunez, Deputy
Staff Director, U.S. Commission on Civil Rights, indicated that behavioral
research conducted by the Office of Research is guided by the ethical standards
of the American Psychological Association as set forth in Ethical Principles
in the Conduct of Research with Human Participants, 1973, and in Principle 9:
Pursuit of Research Activity, Ethical Standards of Psychologists, January 1977.

38

CONSUMER PRODUCT SAFETY COMMISSION (CPSC)

The Consumer Product Safety Commission supports research to
determine safety standards for consumer products.

Authority: 16 CFR 1028 (42 Federal Register 36819, July 18, 1977).

Applicabil ity: The regulations apply to all grants or contracts or
other agreements supporting research or related activities in which human sub-
jects are involved. Exception: The regulations are not applicable to opinion
surveys, questionnaires, or solicitation of information about past events.

Review Procedures: CPSC adopts the DHEW provisions (45 CFR 46) for esta-
blishment of Institutional Review Boards (IRBs). Grantees or contractors may
utilize an IRB having an approved general assurance on file at DHEW or, alter-
natively, may submit an assurance directly to CPSC for approval, following the
same procedures and requirements as those required by the DHEW regulations.

CPSC reviews applications to determine either that the applicant institu-
tion has an approved general assurance on file at DHEW or, alternatively, to
ascertain compliance with requirements for an assurance negotiated directly
with CPSC. In addition, CPSC submits proposals for further evaluation to such
consultants and staff as it deems appropriate. Such evaluation may take into
account, among other pertinent factors, the apparent risk to subjects, the
adequacy of protection against risks, the potential benefits of the research
to the subjects and to others, and the importance of the knowledge to be gained.
CPSC may impose additional safeguards for the protection of human subjects (such
as restrictions on the use of certain subjects or groups of subjects or the
use of additional procedures for informed consent).

39

Review Standards: CPSC applies the review standards of the DHEW regula-
tions, with the following addition: the IRB must determine that "a qualified
psychologist, doctor of medicine, or other appropriate professional, having
established emergency medical procedures, will oversee each test."

Consent Provisions: CPSC generally follows the consent provisions of
the DHEW regulations.

Sanctions: CPSC may withhold or withdraw grant or contract funds if an
investigator or institution fails materially to discharge its responsibility
for the protection of the rights and welfare of human subjects.

40

DEPARTMENT OF AGRICULTURE

The Department of Agriculture conducts and supports biomedical
and behavioral research related to human nutrition.

Authority: Administrative Memorandum No. 130-2 (November 26, 1976); and
Administrative Memorandum 730 (November 26, 1976).

Applicability: Administrative Memorandum No. 130-2 applies to research con-
ducted or supported by the Department of Agriculture and involving human subjects
It is specifically applicable to "economic, social and behavioral research that
may involve varying degrees of discomfort, irritation, or harassment of persons
or groups and to research in which rights of privacy of persons must be safe-
guarded" in addition to "biological science research." Administrative Memoran-
dum No. 130-2 is applicable to all such research conducted or supported by the
Department of Agriculture, and sets forth departmental review procedures and
responsibilities. Administrative Memorandum 730 sets forth additional require-
ments for certain taste test and quality evaluation studies.

Review Procedures: The Department of Agriculture requires that IRBs be
established in conformity with procedures set forth in the Institutional Guide
to PHEW Policy on Protection of Human Subjects, but requires IRB review of all
studies involving human subjects, thus bringing its policy in conformance with
present DHEW regulations (45 CFR 46).* This requirement may be fulfilled by an

* The major substantive difference between the Guide and the present regula-
tions (45 CFR 46) is that the former applied only to research projects
determined by the investigator to involve subjects at risk, whereas the
latter applies to all research involving human subjects.

41

IRB having an approved general assurance on file with DHEW or, alternatively,
by an IRB with similar composition and duties whose compliance with DHEW regu-
lations is "ascertained" by the Department of Agriculture. (No procedures for
doing so are provided.)

Documentation of IRB review and approval must be forwarded to the Human
Studies Review Committee in the Agriculture Research Service which reviews all
research proposals involving human subjects conducted or supported by the
Department of Agriculture. No medical or biological research involving human
subjects may be initiated without written approval of this committee. Approval
of the committee is also required for taste tests and quality evaluation studies
involving food additives or chemicals not "generally recognized as safe" by
the FDA and for studies involving pesticides or other chemical residues for
which the acceptable level has not yet been established. Exempt from review
by the committee are consumer acceptance tests that require and receive prior
approval by the FDA.

Review Standards: Review standards are those stated in the 1971 Guide to
DHEW Policy on Protection of Human Subjects, with the following addition.
Selection of persons or groups for study must be made "without regard to sex,
race, color, religion, or national origin unless these characteristics are fac-
tors to be studied." Any investigation that includes such characteristics as
factors for classification must be approved in writing by the director of the
responsible agency.

Consent Provisions: The Agriculture Research Service adopts the consent
provisions set forth in the Guide to DHEW Policy on Protection of Human Subjects

42

Special Subjects: No pregnant or lactating women may be included in
studies to evaluate the safety or nutritional qualities of foods or in taste
tests involving food additives or chemicals that are not listed by FDA as
"generally recognized as safe" or that involve residues of pesticides or other
chemicals for which an acceptable level has not been established by FDA, the
Environmental Protection Agency or the Animal and Plant Health Inspection Ser-
vice. Children may participate in taste tests and quality evaluation studies
only with the written approval of their parents.

Sanctions: No provisions are made for sanctions in the case of noncom-
pliance.

43

DEPARTMENT OF COMMERCE

I. National Bureau of Standards

The Bureau of Standards conducts research related to product
safety; environmental measurements and standards for air, water
and noise pollution, and radiation safety; prosthetic devices;
materials for dental research; mine safety; and lead paint
poisoning control. Much of the research conducted by the
Bureau of Standards is at the request of various regulatory
agencies.

Authority: NBS Administrative Manual 3.01 Appendix A (February 2, 1976);
NBS Policy Bulletin No. 12 (February 14, 1975).

Applicability: The policy applies to research conducted by the Bureau of
Standards.

Review Procedures: A Human Research Ethics Committee, appointed by the
Director of the Bureau of Standards, reviews all research proposals involving
human subjects. Members include federal employees both from within the Bureau
and from outside, with a broad range of expertise. Among the five members,
there must be at least one medical doctor, one behavioral scientist, and one
engineer or physical scientist. Two alternate members are appointed to serve
in the absence of a regular member or in cases when a regular member cannot vote
because of conflict of interest. "Line managers" in the divisions performing
human research are excluded from membership. No individual may serve as a com-
mittee member where he or she is a principal investigator or is directly asso-
ciated with the proposed research. The chairman of the committee may request
advice or information from the Office of the Legal Advisor or other organiza-
tions within the Bureau of Standards. Recommendations for approval require con-

44

currence of three of the five committee members (or alternates serving in their
place).

The Bureau of Standards' Human Research Ethics Committee is responsible
for initial review and ongoing monitoring of all research. The committee may
discuss proposed research with the principal investigator, negotiate modifi-
cations with the investigator, and recommend approval or disapproval of the
research to the Director of the Bureau of Standards or his designee. The
authority of the Director or his designee to approve or disapprove research
may not be delegated to a member of the committee.

Review Standards: Review by the Human Research Ethics Committee is limited
to concerns of an ethical nature; review for technical soundness is performed
through other supervisory channels. The ethics review is designed to protect
the physical and psychological well -being of subjects, to assure that Bureau
of Standards' policies are observed, and to protect the Bureau against errors
in ethical judgment that might result either in harm to subjects, law suits
and adverse publicity. Subjects must be protected against an unreasonable
degree of physical danger or psychological distress. Provisions must be made
to protect personal privacy and maintain confidentiality of data. Such provi-
sions include: limiting the information recorded about a subject to that
which is essential, separating subjects' names from their data as soon as possi-
ble, destroying identifiable records as soon as possible, and using data only
for the purpose described in the approved protocol. Adequate preparations must
be made for treatment of injuries that may occur.

Consent Provisions: Subjects must be provided with all the information

that is likely to influence their willingness to participate, as well as with

45

explanations of any other aspects about which they inquire. They must sign
a form which explains the responsibilities of both subjects and investigators
and which makes explicit the subjects' right to withdraw at any time "without
incurring legal liability." Prospective subjects must be free from undue
pressure, coercion or temptation by excessively high rewards of a monetary
or any other nature. Data may not be used for any purpose other than that
described to the subjects without their written consent.

If the "control of the expectations of subjects with respect to the purpose
of the research, the design of the research, or the specific events which will
occur during the course of the research" is necessary in order to obtain useful
data and reach valid conclusions, such "control" is permissible provided the
review committee determines that: (a) it is absolutely necessary to the suc-
cess of the research; (b) the personal safety and dignity of the subjects are
not compromised; (c) there is good reason to believe that it would be irrele-
vant to the subjects' decisions to participate in the research; and (d) the
subjects are debriefed in a manner and at a time that is maximally compatible
with their well-being and with the success of the research.

Special Subjects: If the proposed subjects are not legally, psychologi-
cally or intellectually capable of giving informed consent because of age or
any other reason, the committee must ascertain whether it is appropriate to
use such subjects and, if so, shall insure that lawful consent is obtained
from the parent or legal guardian. In such cases, the committee must consult
with the Bureau of Standards' Legal Advisor.

Sanctions : No provisions are made for sanctions in the case of noncom-
pliance.

46

II. National Oceanic and Atmospheric Administration (NOAA)

NOAA conducts and supports research concerned with the physi-
cal and biological technology involved in deep sea diving and
other underwater activities.

Authority: NOAA Diving Regulations, Appendix C in the NOAA Diving
Manual (1975); letter to the Commission (November 14, 1977) from John M.
Golden, Director of Personnel, Department of Commerce.

Applicability: The diving regulations apply to all diving projects con-
ducted or supported by NOAA.

Review Procedures: There is no review of ethical acceptability of re-
search; rather, NOAA undertakes comprehensive review of safety factors.

Review Standards: Review standards pertain to such safety considerations
as the training of divers, their medical condition, and the adequacy of equip-
ment and personnel to meet the demands of the project and to respond to emer-
gencies.

Consent Provisions : "Each diver has the responsibility and privilege to
refuse to dive if, in his judgment, conditions are unsafe or unfavorable; if
at any specific time he feels he is not in proper physical or mental condition
for diving; or if, by diving, he would violate the dictates of his training
or these regulations. The conditions and reasons for refusing to dive may be
required to be documented. If requested, the incident will be reviewed by
the Unit Director with the Unit Diving Officer and diver, and appropriate ac-
tion may be taken. Any action resulting from this review may be appealed to
the NOAA Diving Safety Board."

47

Sanctions: Violation of any of the applicable regulations may result in
suspension of a diver's certification.

NOTE: In his letter to the Commission, the Director of Personnel, Depart-
ment of Commerce, stated:

In future years there may be some use of human subjects in
tests of decompression or in experimental excursions for
saturation of great depths; NOAA officials are considering
adoption or modification of HEW or NAVY Human Use Rules for
such research efforts, depending on the circumstances of
each project.

48

DEPARTMENT OF DEFENSE

I. Army

The Army conducts and supports extensive biomedical and
behavioral research involving human subjects, including
basic research and clinical investigations.

Authority: U.S. Army Regulation 70-25 (31 July 1974); U.S. Army Medical
Research and Development Command Regulation 70-25 (15 September 1976); Army
Regulation 40-7 (4 April 1975); Army Regulation 40-38 (amended 1 September
1975); Office of the Surgeon General Regulation 15-2 (1 March 1976); and Mem-
orandum of Understanding Between the Food and Drug Administration (FDA) and
the Department of Defense (39 Federal Register 41570, November 27, 1974).

Appl icability: Army Regulation 70-25 is applicable world-wide to intra-
mural research wherever human volunteers are used as subjects. Army Medical
Research and Development Command Regulation 70-25 is applicable world-wide to
all intramural research and to research supported by Army grants and contracts,
regardless of Army appropriation source. Regulation 40-7 applies to the investi-
gational use of drugs and the use of Schedule I controlled drug substances
whether such use occurs intramurally or by grant or contract. The Memorandum
of Understanding Between the Food and Drug Administration and the Department of
Defense applies to clinical investigations involving drugs that are classified
for reasons of national security, and waives the requirement to file a formal
"Claim for Exemption" otherwise imposed by FDA.* Research conducted or supported

In an enclosure to a letter to the Commission (28 November 1977), Gerald P.
Dinneen, Principal Deputy to the Under Secretary for Research and Engineering,
reports that the waiver provision of the Memorandum of Understanding has
never been invoked by the Department of Defense.

49

by Army Intelligence is governed by the directives of the Intelligence Com-
munity (see page 82) .

Review Procedures: The Army adopts the review procedures set forth in the
DHEW regulations (45 CFR 46). Medical centers, grantees or contractors may
utilize an Institutional Review Board with an approved assurance on file at
DHEW, or they may establish an IRB that complies with the provisions of DHEW
regulations and submit assurance of such compliance to the Army. Committees
established to review intramural research must include, whenever possible, at
least one lawyer and one clergyman. Intramural research is reviewed by local
committees prior to submission to the Human Use Review Office in Washington,
just as extramural research is reviewed by IRBs.

A Human Use Review Office, under the direction of the Assistant Surgeon
General for Research Development, is the central Army processing point for all
extramural and intramural research involving human subjects. The staff includes
two pharmacists and a biostatistician. Additional outside review and advice
may be sought, including supervision of the review by a physician.

Local commanders and the Inspector General are responsible for determining
compliance of medical hospitals with directives from the Surgeon General; yearly
site visits by Headquarters personnel ensure compliance of research laboratories.
Annual reports must be submitted to the Human Use Review Office.

All protocols (except those deemed to be of low risk by the Human Use Re-

50

view Office)* are reviewed by a Human Subject Review Board. This board is com-
posed of the Assistant Surgeon General for Research and Development, or his
designee; seven consultants (expert in medicine, surgery, pharmacy, behavioral
science, preventive medicine, allied medical sciences, and infectious disease);
a chaplain; an attorney; and two community representatives. The board's recom-
mendations for approval or disapproval (including any dissenting opinions) are
forwarded to the Surgeon General who makes the final decision regarding each
protocol .

Although most of the intramural research involving human subjects is con-
ducted either in Army hospitals or in Army research laboratories, the regula-
tions are applicable to all components of the Army. The Surgeon General has
encouraged all agencies to construe the language of the regulations broadly,
to include, for example, tests of new uniforms, vehicles and other equipment.
Tests from any Army component that may expose human subjects to risk are re-
viewed by the Human Use Review Office and are processed in the same manner
as research conducted under the auspices of the Medical Research and Develop-
ment Command.

Review Standards: The Army adopts the review standards of the DHEW regula-
tions. In addition to meeting such standards, all studies conducted or supported
by the Army must meet scientific standards including: (1) use of the minimum
number of human subjects necessary to achieve the required results; (2) perfor-

Studies deemed to be of low risk include analysis of hair, nail clippings,
or deciduous teeth; collection of external excretions; recording of data
by physical sensors applied superficially (EEG, EKG); and collection of no
more than 450 ml. of blood within a six week period from subjects who are
over 18 years of age and not anemic.

51

mance of appropriate laboratory and animal studies prior to involving human
subjects; (3) avoidance of all unnecessary physical and mental discomfort;
(4) proper preparations and adequate facilities to handle any foreseeable in-
juries; and (5) appropriate qualifications of principal investigators and
those assisting in the research.

Consent Provisions; Provisions governing informed consent are those of
the DHEW regulations, supplemented as follows. Consent forms must be in non-
technical language so that they can be clearly understood by a subject who
has no particular familiarity with medical terminology. Consent procedures
must be witnessed. Provisions must normally be made for debriefing subjects
following their participation in research; this is mandatory for research in-
volving deception. Additional provisions are made for consent to research in-
volving special subjects, as described below.

Special Subjects: Special protections and restrictions apply to research
involving children, prisoners,* the institutionalized mentally infirm and men-
tally disabled subjects, including: (1) limitation of research to projects that
either will benefit the subjects directly or cannot be conducted on any other
subject population; (2) requirement for consent of children and mentally incom-
petent subjects, in addition to the consent of a legal guardian, when such sub-
jects are able to express an opinion regarding their participation in research;
(3) adequate living conditions, employment opportunities and medical care in
any prison proposed as a research site; and (4) a site visit by a senior medical

* The Assistant Surgeon General for Research and Development has written the
Commission (November 28, 1977) that by current policy, prisoners and others
with restricted civil liberties are not regarded as acceptable subjects of
research.

52

officer and a member of the Army's legal staff to any prison or mental institu-
tion proposed as a research site. Prisoners of war may not be used as research

subjects under any circumstances.

Additional Provisions: The regulations provide that civilian or military
volunteers may be treated for research-related injuries in Army medical facili-
ties and that military personnel are eligible for workman's compensation.

Research conducted abroad must comply with Army regulations as well as
with all laws and customs of the country in which the research will be con-
ducted. If, in exceptional circumstances, the laws or customs of the country
involved would render a particular provision of Army regulations unacceptable,
a waiver may be granted by U.S. Army Medical Research and Development Com-
mand Headquarters following a site visit by a senior medical officer and a
member of the legal staff.

Sanctions : No provision is made for sanctions in the case of noncompliance.

II. Navy

The Navy conducts and supports biomedical and behavioral re-
search related to basic factors underlying health and disease,
effects of environmental stress, methods for studying biologi-
cal systems and for diagnosing, treating and preventing disease
or injury, basic psychological functions, psychological response
to stress, and group behavior.

A. Intramural Research

Authority: Secretary of the Navy Instruction 3900.39 (28 April 1969
under revision); Bureau of Medicine and Surgery Instructions 6000. 4B (15
January 1975), 3900. 3B (1 May 1969), and 3900.6 (2 April 1976); and

53

Memorandum of Understanding Between the Food and Drug Administration and
the Department of Defense (39 Federal Register 41570, November 29, 1974).*

Applicability: Secretary of Navy Instruction 3900.39 applies to
the use of human volunteers in research, development, test and evaluation
activities. Bureau of Medicine Instruction 3900. 3B applies to biomedical
and behavioral research conducted by the Navy Bureau of Medicine and Sur-
gery (intramural). Instruction 3900.6 applies to medical research "per-
formed at BUMED-managed activities irrespective of the source of funding
support" if such research entails risk to subjects as a result of their
participation. Instruction 6000. 4B applies to the intramural Clinical
Investigation Program conducted at regional Navy medical centers with the
exception of "those research proposals that are unique to the operational
mission of the Navy and Marine Corps (militarily relevant), which may be
approved and supported through the Director of Defense Research and Engi-
neering." The Memorandum of Understanding Between the Food and Drug Ad-
ministration and the Department of Defense applies to clinical investiga-
tions involving drugs that are classified for reasons of national security,
and exempts such research from the filing of a formal "Claim for Exemption"
with FDA.**

* The documents reviewed refer to additional documents, copies of which were
not provided: SECNAVINST 3900. 32A (6 August 1968); 0NRINST 3900. 24A (19
Sept. 1968); MANMED Chapter 20; D0D Directive 6000.4 (7 April 1971); BUMEDINST
6320.31 series; BUMEDINST 6710. 49D.

** Defense Department reports that this exemption provision has never been
invoked.

54

Review Procedures: The Navy adopts the review procedures of DHEW regu-
lations (45 CFR 46). Although Navy regulations refer to the 1971 Institu-
tional Guide to PHEW Policy on Protection of Human Subjects, the review
procedures required by the Navy are those of the current DHEW regulations.
(The only substantive difference between the Guide and the regulations, on
the matter of review procedures, is whether IRB review is required for all
research involving human subjects, or only for research involving risk to
human subjects. By requiring that all research involving human subjects
be reviewed by an IRB, the Navy has adopted the standard of the current
DHEW regulations. )

Clinical investigation studies are submitted from local medical depart-
ments, through the Regional Clinical Investigation Center, to the Director
of Clinical Investigation, who serves under the Commanding Officer of the
Naval Health Sciences Education and Training Command. Proposals must be
reviewed for compliance with all applicable directives and approved by the
Regional Clinical Investigation Center prior to submission (with a priority
score) to the Health Sciences Education and Training Command for review,
approval and funding. Annual progress reports are required, and changes
in research personnel, objectives or funding requirements must be reported
within a reasonable amount of time. Reports are also required when a pro-
ject is terminated (explaining the reasons for termination) or when a pro-
ject is completed.

Review Standards: The Navy adopts the review standards of the DHEW
regulations. In addition to meeting such standards, all studies conducted
or supported by the Navy must meet scientific standards including: (1) use

55

of the minimum number of human subjects necessary to achieve the required
results; (2) performance of appropriate laboratory and animal studies
prior to involving human subjects; (3) avoidance of all unnecessary phy-
sical and mental discomfort; (4) proper preparations and adequate facili-
ties to handle any foreseeable injuries; and (5) appropriate qualifications
of principal investigators and those assisting in the research. There must
be no greater intrusion into the privacy of subjects than is absolutely
necessary for the conduct of the study involved.

Consent Provisions: Provisions governing informed consent are those
of the DHEW regulations, supplemented as follows. The subject must be
made aware of the provisions of the Privacy Act of 1974 and an appropriate
Privacy Act statement must be included in the consent form. In addition,
consent forms must be signed by a witness who is not directly involved
with the research.

Special Subjects: Prisoners, prisoners of war, or institutionalized
mentally disabled persons may not be used as research subjects under any
circumstances.

Additional Provisions: Medical or dental treatment, including hospitali-
zation if necessary, must be provided to any subject who requires such treat-
ment or hospitalization as a result of participation as soon as such need
is recognized. The physician-in-charge must have consultants, available
on short notice, who are competent to advise or assist with unexpected com-
plications. Volunteers may not be included if they have any physical or
mental disease that will make participation in the research more hazardous
for them than for normal healthy persons.

56

Sanctions: There are no provisions for sanctions in the case of non-
compliance.

B. Extramural Research

Authority: Code 600 Memorandum No. 97A (27 March 1974).

Appl icability: The memorandum governs the use of human volunteer
subjects in any contract with the Office of Naval Research.

Review Procedures: No provisions are made for the establishment of
an Institutional Review Board or any comparable committee.

Review Standards: The contractor is responsible for ensuring that
the research is conducted under the supervision of a qualified physician
and that there are adequate safety equipment and medical facilities to pro-
tect the volunteer against the possibility of injury, disability or death.
"Adequacy of the medical safety facilities, the supervision of the physi-
cian-in-charge, and of the consultants [must be] consistent with the stan-
dards of medical ethics as enunciated and practiced by the American Medical
Association."

No procedures for implementing or monitoring the provisions of the
memorandum are provided beyond insertion of the provisions in the contract.

Consent Provisions : The contractor is responsible for determining
that the rights and welfare of subjects are adequately protected and that
informed consent is "obtained by methods that are adequate and appropriate."
The contractor is further responsible for assuring that volunteers are in-

57

formed of their right to withdraw or to withhold consent without preju-
dice, and that they are competent to give legally valid consent.

Additional Provisions: Contractors are responsible for ensuring
that volunteers have no physical or mental disease that would make parti-
cipation in research more hazardous for them than for normal volunteers.

Sanctions: There are no provisions for sanctions in the case of
noncompliance.

III. Air Force

The Air Force conducts biomedical and behavioral research in
Medical Service treatment and clinical investigation programs;
it also conducts and supports research in the aerospace re-
search and development program.

A. Clinical Investigation Program

Authority: Air Force Regulation 169-6 (4 November 1977); and Memoran-
dum of Understanding Between the Department of Defense and the Food and
Drug Administration (39 Federal Register 41570, November 29, 1974).

Applicability: These regulations apply to research involving the bio-
logical, behavioral or psychological study of persons, their bodies or
their surroundings conducted by or in collaboration with Air Force Medical
Service personnel. Applicability thus appears to be limited to intramural
research. Such research is generally conducted in Air Force medical faci-
lities and Air Force clinical research laboratories. Exceptions: (1)
studies involving nonidentifiable data collection from medical records,
passive observation, analysis of excreta, diagnostic, surgical, or autopsy

58

specimens; (2) treatment administered with the consent of the Director
of Base Medical Services as a life-sustaining measure; and (3) the use
of human volunteers in the Air Force Biotechnology Research, Development,
Test and Evaluation Program (see Part B, below), provided the diagnostic
and treatment procedures employed conform to accepted professional prac-
tice and all medications used are administered in a manner approved by
the Food and Drug Administration. The Memorandum of Understanding
Between the Food and Drug Administration and the Department of Defense
applies to clinical investigations involving drugs that are classified
for reasons of national security, and exempts such research from the
filing of a formal "Claim for Exemption" to the FDA.*

Review Procedures: Review procedures are similar to those of DHEW
regulations (45 CFR 46) with the following additions: Institutional Re-
view Boards, chaired by a physician, must include at least three lay mem-
bers, including at least one lawyer and one clergyman. A medical or den-
tal officer (as appropriate) other than the investigator must be assigned
responsibility for assuring proper conduct of the experiments and the
professional care of volunteers. The physician or dental officer may
terminate the study at any time.

The medical facility commander is responsible for establishing an
Institutional Review Board (IRB), for approving or disapproving each pro-
posal following the IRB's review, and for assuring compliance with appli-

* Defense Department reports that this exemption provision has never been
invoked.

59

cable Air Force regulations. He is also responsible for submitting ap-
proved proposals to the Air Force Surgeon General, and assuring that
his approval is received before any investigation is initiated. He must
submit progress reports to the Office of the Surgeon General every six
months, and a final report of findings and conclusions upon completion
or termination of each investigation.

A Clinical Investigation Committee, appointed by the Surgeon General,
reviews and approves or disapproves all clinical research not involving
the investigational use of drugs, and serves as the Review Board for pro-
posals that do involve the investigational use of drugs. The Surgeon
General makes final decisions regarding research involving the investiga-
tional use of drugs, and generally monitors the overall clinical investi-
gation program of the Air Force.

Misadventures must be reported by the Director of Base Services
directly to the Surgeon General. If the misadventure is serious, this must
be reported by "electrical means" as quickly as possible, followed by a
complete written narrative within 15 days.

Review Standards: Studies must meet the following standards: (1)
safeguarding the rights and welfare of human subjects; (2) any risks to
subjects outweighed by potential benefits in terms of medical advances;
(3) use of the minimum number of volunteers consistent with the study
objectives; (4) nature of the investigation must require participation
of human subjects; (5) performance of preliminary tests with laboratory
animals and human simulators, as far as possible; and (6) avoidance of

unnecessary physical or mental discomfort,

60

Consent Provisions : Consent provisions generally follow the DHEW
regulations (45 CFR 46) with the following additions. Consent forms must
be signed by at least one witness as well as by the officer who advises
the volunteer of possible consequences of participation in the research.
The completed consent form must be filed in the volunteer's medical re-
cords.

Special Subjects: Minors and mentally disabled or institutionalized
mentally infirm individuals may participate as subjects only if the nature
of the research is such that no other subjects are suitable. Legally
effective informed consent must be given by parents or a guardian, and
the consent of a mentally disabled subject must also be obtained, when
the subject is capable of comprehending what is proposed. Children should
be given the right to refuse to participate "depending upon the circum-
stances" and, as they approach maturity, should be given an opportunity
to consent, as well. It is recommended that the local Staff Judge Ad-
vocate be consulted regarding consent for the participation of children
in research, since no hard and fast rules can be laid down. Prisoners
may participate in research only if it concerns the diagnosis, treatment,
prevention or etiology of the particular impairment with which the
prisoner is afflicted, and there is a direct potential benefit to the
prisoner.

Sanctions : There are no provisions for sanctions in the case of non-
compl iance.

61

B. Aerospace Research, Development, Test and Evaluation Studies
Program

Authority: Air Force Regulation 169-xx (draft, has completed for-
mal Air Staff coordination and is undergoing review by the Air Force
Scientific Advisory Board).

Applicability: This draft regulation applies to both intramural and
contract research and governs aerospace research, development, test and
evaluation procedures in which human subjects are used and in which there
is "inherent risk" of distress, pain, damage to health, physical or emo-
tional injury, invasion of privacy, surrender of autonomy or death. Ex-
ceptions: (1) clinical, biomedical and behavioral research performed
under the provisions of Air Force Regulation 169-6 (see Clinical Investi-
gation Program, above); (2) research that involves exposure to occupa-
tional hazards such as encountered in flight training, jump training,
handling of explosives; (3) human engineering portions of research in-
volving only hazards encountered in normal military duty; and (4) experi-
ments judged to be nonhazardous. To be judged nonhazardous, research
must: (a) be conducted in a normal environment, free from safety hazards;
(b) involve only the application of stimuli to the senses of sight, hear-
ing, touch and smell at levels and durations commonly experienced and
tolerated; and (c) involve neither unusual physical exertion nor applica-
tion of unusual or harmful physical or chemical substances.

Review Procedures: The Air Force adopts the review procedures of
DHEW regulations (45 CFR 46).

62

In addition, a Human Use Committee, established by the Surgeon
General provides additional review of projects, as necessary, and reviews
all applications for modification or waiver of regulatory requirements,
and all reports of misadventures involving human subjects. This committee
is composed of representatives of the staff offices of Research and Develop-
ment, Personnel, the Surgeon General, the Judge Advocate General, the
Inspector General and Chaplain. The Director of Professional Services,
Office of the Surgeon General, serves as Chairman. He also reviews all
proposals submitted by IRBs, determines whether review by the Air Force
Human Use Committee is required, and notifies the Major Command of the
organization submitting a proposal of its approval or disapproval.

Review Standards : The Air Force adopts the review standards of DHEW
regulations. In addition to meeting such standards, all studies conducted
or supported by the Air Force must meet scientific standards including:
(1) use of the minimum number of human subjects necessary to achieve the
required results; (2) performance of appropriate laboratory and animal
studies prior to involving human subjects; (3) avoidance of all unneces-
sary physical and mental discomfort; (4) proper preparations and adequate
facilities to handle any foreseeable injuries; and (5) appropriate quali-
fications of principal investigators and those assisting in the research.
There must be no greater intrusion into the privacy of subjects than is
absolutely necessary for the conduct of the study involved.

Consent Provisions: Generally, to give legally valid consent, subjects
must be 21 years of age except in jurisdictions in which a lesser age is speci-

63

fied.* The Air Force adopts the consent provisions of DREW regulations
(45 CFR 46) with the following addition. Consent must be documented in
writing by each volunteer in the presence of at least one witness who
must also sign the consent form.

Special Subjects: "Participation of females as volunteer subjects
is permitted only when there is reasonable assurance of no concomitant
pregnancy which would place the fetus at risk and if methods adopted for
contraception do not place the female subject at increased risk without
complete disclosure to the female subject. Children, institutionalized
mentally infirm persons, mentally disabled persons, and prisoners must
not participate as human subjects in Department of the Air Force research
projects."

Projects conducted outside the United States must comply with all
laws and customs of the country in which the research will be conducted.
In exceptional circumstances, when the laws or customs of the country
indicate that certain provisions of the regulations would not be accepta-
ble, special permission may be granted by the Surgeon General for a
waiver. Only the Surgeon General may grant such a waiver.

Sanctions: No provision is made for sanctions in the case of non-
compliance.

For active duty personnel participating in intramural studies, there is no
minimum age requirement.

64

DEPARTMENT OF ENERGY (DOE)

(No description of research supported by DOE was provided.)

Authority: 10 CFR 745 (41 Federal Register 52434, November 30, 1975, as
amended in 42 Federal Register 30492, June 15, 1977). (These regulations were
issued by the Energy Research and Development Administration and continue in
effect pursuant to Section 705(a) of the Department of Energy Organization
Act. Authority: letter to the Commission (December 1, 1977) from James L.
Liverman, Acting Assistant Secretary for Environment, DOE.)

Applicability: The regulations are applicable to Department of Energy
(DOE) agreements including, but not limited to, contracts supporting research,
development and related activities in which human subjects are involved. The
regulations, therefore, apply only to extramural research. The requirements
set forth in the regulations are applicable to research conducted outside the
United States and its territories "to the maximum extent practicable as deter-
mined by the Administrator on a case-by-case basis, taking into account the
relevant laws and practices of the foreign nation in which the activity will
be conducted."

Review Procedures: DOE requires that IRBs be established in conformity
with procedures set forth in DHEW regulations (45 CFR 46) but permits alter-
native methods of fulfilling the requirement. The DOE accepts an assurance
approved by DHEW as documentation of such compliance, or alternatively, will
negotiate an assurance directly with an institution receiving DOE support.
DOE staff reviews assurances for general acceptability taking into account,
among other pertinent factors, the adequacy of the proposed Institutional

65

Review Board in light of the anticipated scope of the applicant institution's
activities and the types of subject populations likely to be involved, the
appropriateness of the proposed initial and continuing review procedures in
light of the probable risks, and the size and complexity of the institution.
No provision is made for agency review of individual research proposals.

Review Standards: DOE adopts the review standards set forth in DHEW
regulations (45 CFR 46).

Consent Provisions: DOE adopts the consent provisions of DHEW regula-
tions (45 CFR 46).

Sanctions: DOE adopts the sanctions of DHEW, namely, withholding or
withdrawal of grant or contract funds if an investigator or institution fails
materially to fulfill responsibilities for protection of human subjects.

66

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HUD)

The Department of Housing and Urban Development supports re-
search involving human subjects in projects such as the Experi-
mental Housing Allowance Program and programs related to
reduction of the risk of lead poisoning.

Authority: There are no formal regulations or policies for the protection
of human subjects in research supported by HUD. (Information was supplied in
letters to the Commission by Charles J. Orlebeke (September 17, 1975), then
Assistant Secretary for Policy Development and Research, and by Patricia M.
Worthy (November 18, 1977), Deputy Assistant Secretary for Regulatory Func-
tions.)

In her letter of November 18, 1977, the Deputy Assistant Secretary for
Regulatory Affairs stated that HUD has "never sponsored any human subject or
biomedical studies." It is clear, however, that projects such as the Experi-
mental Housing Allowance Program constitute research with human subjects.

67

DEPARTMENT OF JUSTICE

I. Bureau of Prisons

The Bureau of Prisons conducts and supports research related
to correctional programs.

Authority: Draft revision of Policy Statement 6110.1 (October 31, 1967),
to be published in the Federal Register in Spring 1978; Policy Statement
37000.3 (June 10, 1977).

Applicability: The policy applies to "research activities undertaken by
individuals or organizations either in or out of federal, state or local
governments where the Bureau of Prisons assumes either a host or sponsorship
role." No research involving medical experimentation or drug testing is per-
mitted.

Review Procedures: Research proposals made at the institutional or
regional level must be reviewed by a Research Committee prior to submission
to the Bureau of Prisons Chief of Research. Suggested membership includes the
warden or associate warden, research analyst, chief psychologist, a unit mana-
ger or department head, an inmate, a representative of the employees union and
a representative of the community.

The Director of the Bureau of Prisons must approve all research projects.
This authority may not be delegated. The Chief of Research sets the number
and frequency of progress reports that will be required for each project, de-
pending upon the nature of the research. At a minimum, reports must be sub-
mitted to the prison warden and forwarded to the Chief of Research of the Bureau
of Prisons every six months.

68

Review Standards: Research proposals are reviewed for relevance to the
mission and "collateral objectives" of the Bureau of Prisons, for potential
benefits to mankind or advancement of knowledge, for professional standing
of the investigator, and for assurance that the conduct of the research will
not adversely affect Bureau of Prisons1 programs or operations. Priority
is given to projects holding promise for advancing knowledge and capability
for treatment of offenders. The Bureau of Prisons is "guided by" the Nurem-
berg Code, and relies on the investigators to protect the "rights and lives"
of subjects.

Consent Provisions: The Bureau of Prisons generally follows the consent
provisions of DHEW regulations (45 CFR 46).

Additional Provisions: "Offering inmate incentives of a material nature
seems inappropriate and are prohibited; however, soft drinks and snacks may
be offered to subjects at the test setting."

Investigators must adhere to all requirements of the Privacy Act of 1974
and implementing regulations. They may not report information which can be
used to identify an individual to any party other than to Bureau of Prisons
research personnel without written consent of the subject. Further, no indi-
vidual other than an employee of the Bureau of Prisons may have access to
personally identifiable information without the written consent of the indi-
vidual from whom the information was obtained, unless the information is
already accessible to the general public.

Prospective investigators must also submit an assurance of compliance with

the Civil Rights Act of 1964 and the appropriate regulations of the Department

of Justice (28 CFR 42).

69

Sanctions: The Bureau of Prisons maintains the prerogative to suspend
or terminate any project at any time if there is reason to believe that the
project violates research policy or that continuation of the project will be
detrimental to the inmate population or the functioning of the staff or pro-
gram. Any suspected violations of law must be referred to the Office of Gen-
eral Counsel .

II. Law Enforcement Assistance Administration (LEAA)

The Law Enforcement Assistance Administration supports research
in crime prevention and in treatment of offenders through cate-
gorical grants to individual institutions and block grants to
states.

Authority: There are no formal regulations or policies for the protection
of human subjects in behavioral research; biomedical research is restricted by
LEAA Guideline 6060. 1A (June 18, 1974).

Applicability: Guideline 6060.1 A applies to categorical grants funded
through LEAA Central and regional offices, and block grants provided to states
pursuant to the Omnibus Crime Control and Safe Streets Act of 1968.

Review Procedures: The Office of Administration must specifically approve
in advance any medical research projects, after consultation with the Depart-
ment of Health, Education, and Welfare.

Review Standards: LEAA funds may not be used to support (1) psychosurgery,
(2) medical procedures which seek to modify behavior by aversion therapy, chemo-
therapy (except as part of routine clinical care) or physical therapy; or (3)
projects involving medical research "except in limited types of programs generally

70

recognized and accepted as not involving physical or psychological risk to
the patient, as specifically approved by the Office of Administration after
consultation with and the advice of the Department of Health, Education, and
Welfare." The guideline specifically does not prohibit programs of behavior
modification involving environmental changes or social interaction.

Consent Provisions: There are no provisions governing informed consent.

Sanctions: There are no provisions for sanctions in the case of noncom-
pliance.

71

DEPARTMENT OF STATE:
AGENCY FOR INTERNATIONAL DEVELOPMENT (A.I.D.)

The Agency for International Development supports research
in a variety of fields including agriculture, rural and
urban development, health, population, nutrition, educa-
tion, economics, institutional and social development, and
science technology.

Authority: Manual entitled Contract Program in Centrally Funded Research,
issued by the Agency for International Development, January 1977.

Applicability: A.I.D. policy for the protection of human subjects applies
to all grants, contracts or other awards for the support of research involving
human subjects conducted both within and outside the United States.

Review Procedures: A.I.D. requires initial and continuing review and
approval of each research project by "an appropriate committee of the appli-
cant institution." A.I.D. reviews each institution's assurance for: (1) com-
pliance with requirements for initial and continuing review, (2) adequacy of
the institution's review committee structure, (3) its review procedures, and
(4) the facilities and personnel available to protect the health and safety
of human subjects. In addition, each institution must certify to A.I.D. for
each proposal that its committee has reviewed and approved the proposed re-
search. The Agency may submit research protocols involving human subjects
to independent review by staff, consultants and advisory groups. Where appli-
cable, A.I.D. also requires evidence of compliance with regulations of the
Food and Drug Administration.

72

Review Standards: Review must assure that (a) the rights and welfare
of the individuals involved are adequately protected, (b) the methods used
to obtain informed consent are adequate and appropriate, and (c) the risks
and the potential benefits of the investigation are assessed.

Consent Provisions: The consent procedures must be adequate and appro-
priate. For guidance A.I.D. refers to DREW regulations (45 CFR 46).

Additional Provisions: Research conducted outside the United States must
comply with all the above provisions and, in addition, conform to legal and
other requirements governing human research in the country in which the re-
search will be conducted. For guidance A.I.D. refers to DHEW regulations
(45 CFR 46).

Sanctions: There are no provisions for sanctions in the case of noncom-
pliance.

73

DEPARTMENT OF TRANSPORTATION (DOT)

Except as otherwise noted, information regarding DOT agencies was supplied
to the Commission in a letter (November 24, 1975) from Admiral O.W. Siler, Com-
mandant, U.S. Coast Guard, responding on behalf of all components in the Depart-
ment of Transportation that conduct or support research involving human subjects.
The information provided by Admiral Siler was amended (to reflect subsequent
agency policies) in a letter (December 9, 1977) from Martin Convisser, Acting
Assistant Secretary for Environment, Safety, and Consumer Affairs, DOT.

I. Office of the Secretary of Transportation

Mr. Convisser reports that the Office of the Secretary is
developing a Departmental order to provide uniform procedures
for protecting human subjects of research conducted or sup-
ported by any component of the Department of Transportation.

II. Federal Aviation Administration (F.A.A.)

The F.A.A. conducts and supports aeromedical research to
study factors contributing to accidents, to establish aero-
medical standards for airmen, to maintain fitness and per-
formance of aviation personnel, and to improve the working
procedures and environment of air traffic control personnel.

Authority: Order 9950. 3A (December 6, 1974) - Medical Research Program
Guide; letter to the Commission (July 25, 1975) from Stanley R. Mohler, then
Chief, Aeromedical Applications Division, Office of Aviation Medicine. NOTE:
A more comprehensive order governing research with human subjects is under
development.

Applicability: Order 9950. 3A applies to aeromedical research activities
conducted intramurally under the auspices of the Civil Aeromedical Institute or
supported by contract.

Review Procedures: The Office of Aviation Medicine reviews all research
proposals for scientific merit, program and budget requirements, and to esta-
blish research priorities. All research must be approved by the Federal Air
Surgeon, following technical review by the Research Task Review Panel which is
composed of chiefs of various branches of the F.A.A. Aeromedical Division.

Review Standards: There is no provision for review relative to protection
of human subjects. Dr. Mohler stated in his 1975 letter that: "We never under-
take an experiment in which the likely outcome would be injury or death to a
subject, and for each experiment with humans that would entail any kind of
potential risk, a committee of scientists, including medical scientists, re-
views the experiment. During the conduct of a potentially hazardous experiment,
a physician is in the building on call, in case of a mishap."

III. Federal Highway Administration

The Federal Highway Administration conducts and supports re-
search to study reaction times, vehicular control responses,
choice behaviors, and measures of alertness and performance.

Authority: There are no formal regulations or policies for the protection
of human subjects in research conducted or supported by the Federal Highway Ad-
ministration. (No biomedical research is conducted or supported.)

Staff investigations are performed principally by research psychologists
"who are bound by the American Psychological Association's code of ethics for
the conduct of experiments with human subjects," and work plans for contractor
studies "are carefully reviewed to assure minimum risk to subjects of both
traffic engineering studies and controlled experiments."

75

IV. National Highway Traffic Safety Administration (NHTSA)

The Highway Traffic Safety Administration conducts biomedi-
cal and behavioral research on such topics as the effects of
alcohol and other drugs on judgment and performance, methods
to detect alcohol or drug ingestion, effects of stress on
driving performance, factors in visibility, driver's educa-
tion and training, and prevention of injuries during crashes.

Authority: NHTSA Order 700-1 (December 7, 1977); NHTSA Order 700-2
(September 7, 1976); and letter to the Commission (August 13, 1975) by Fred B.
Benjamin, then Senior Research Physiologist, Office of Driver and Pedestrian
Research.

Applicability: NHTSA Orders 700-1 and 700-2 are applicable to all intra-
mural research and all contracts supporting research with human subjects.

Review Procedures: In any project involving human subjects, the contract
technical manager (or, if intramural research, the investigator) is responsible
for determining whether or not subjects will be at risk and, if so, for pre-
paring a risk/benefit analysis. Such analysis must take into account: the ex-
tent of predictable risk, the extent of benefits to be derived from the program,
the harm to society which might result from not conducting the proposed program,
and "the ethics and standards which are acceptable to the societal segments
having a stake in the human subjects experiments or the ethical guidelines to be
established by the President's [sic] Commission for the Protection of Human Sub-
jects of Biomedical and Behavioral Research." The approval of both the respon-
sible Associate Administrator and the Chief Counsel is required for any project
involving human subjects at risk, and review by the NHTSA Human Use Steering
Panel may be requested by the Associate Administrator, prior to making his

decision.

76

Once a contract proposal is approved by the Assistant Administrator and
the Chief Counsel, it is referred to the contract technical manager and the
Proposal Evaluation Committee for review of procedures for the protection of
human subjects. Intramural research is reviewed by the NHTSA Human Use Steer-
ing Panel, which may also review contract proposals if requested by the Asso-
ciate Administrator.

Review Standards: NHTSA adopts the review standards of DHEW regulations
(45 CFR 46). In addition, review for the protection of human subjects includes
consideration of whether subjects are given adequate physical and psychological
evaluations or monitoring prior to their selection, during the experiments,
and after completion of the research; whether there are trained medical person-
nel and adequate equipment for emergency treatment; whether risks are reduced
as much as possible; whether there are alternate ways of obtaining the desired
information; what the criteria are for selection of human subjects; whether
compensation will be commensurate with the risk involved, but not so excessive
as to constitute undue inducement; and whether there are adequate plans to
ensure privacy and confidentiality according to the provisions of the Privacy
Act of 1974.

Consent Provisions: NHTSA generally follows the consent provisions of
DHEW regulations (45 CFR 46), with the following additions. It is suggested
that subjects be given information regarding (1) medical compensation and/or
liability insurance in force (together with any limits involved); (2) nature
and extent of medical supervision and emergency procedures; and (3) reviews
by the contractor's IRB.

77

Sanctions: No provisions are made for sanctions in the case of noncom-
pliance.

V. Federal Railroad Administration

The Federal Railroad Administration reports that it is sup-
porting only one research project involving human subjects, a
study on cab vigilance.

Authority: There are no formal regulations or policies for the protection
of human subjects in research conducted or supported by the Federal Railroad
Administration.

In one study (on cab vigilance) performed under contract at the Transporta-
tion Systems Center, the Federal Railroad Administration reports that certain
professional guidelines (including DHEW regulations) "are used to insure the
safety and privacy of the human subjects."

VI. U.S. Coast Guard

The Coast Guard supports research relating to safety in both
recreational and maritime vessels, emergency treatment for
hypothermia, and the evaluation of safety procedures and
equipment.

Authority: There are no formal regulations or policies for the protection
of human subjects in research conducted or supported by the Coast Guard; however,
the Coast Guard uses the provisions of DHEW regulations (45 CFR 46) as guidelines.

One contractor adheres to the policies of the American Psychological Associa-
tion; volunteers are fully informed and must provide written consent prior to
participation. No release from liability is contained in either the written or

oral presentations.

78

DEPARTMENT OF THE TREASURY:
INTERNAL REVENUE SERVICE

The Internal Revenue Service conducts research related to
personnel management, motivation and job performance,
typically through questionnaire, interview and work-simu-
lation methods.

Authority: There are no formal regulations or policies for the protection
of human subjects in research conducted or supported by the Internal Revenue
Service. (Information was supplied to the Commission in a letter (November 29,
1977) from Morris A. Simms, Director of Personnel, Department of the Treasury.)

Mr. Simms reports that personnel research follows the guidelines pres-
cribed by the American Psychological Association in Ethical Principles in the
Conduct of Research with Human Participants.

79

ENVIRONMENTAL PROTECTION AGENCY (EPA)

The Environmental Protection Agency conducts and supports
research related to the effects of pollutants on human
beings.

Authority; EPA Order 1000.17 (October 25, 1977); letter to the Commis-
sion (December 19, 1977) from Stephen J. Gage, Acting Administrator for Re-
search and Development.

Applicability: Order 1000.17 applies to all intramural studies, grants,
contracts, Public Law 480 projects, and other research with human subjects
supported in whole or in part by EPA. Exceptions: Order 1000.17 does not
apply to (1) opinion polls, questionnaires or the solicitation of information
about past events; (2) the taking of blood, urine, mothers' milk, "nonviable
fetus tissue" or human tissue samples; or (3) the conduct of any medical observa-
tions where such testing is not preceded or followed by purposeful exposure
to chemicals, physical conditions or other environmental conditions being
tested. EPA is developing orders to address (1) the acquisition of informa-
tion and the collection of tissue or fluid samples (blood, urine and human
milk) for use in epidemiologic studies, and (2) the conduct of research by
industrial laboratories for the purpose of acquiring data required by EPA
for product approval .

Review Procedures: EPA requires compliance with DHEW regulations (45 CFR
46) for the establishment of Institutional Review Boards, and further requires
that grantees, contractors or other parties responsible for the conduct of re-
search with human subjects have an approved general or special assurance on
file at DHEW. Applications for an assurance may be made to DHEW through the
EPA Deputy Administrator for Health and Ecological Effects.

80

Certification of IRB review and approval, and a description of the pro-
cedures to be used in obtaining informed consent (along with a copy of the
consent form to be used), must be submitted to the EPA Deputy Assistant
Administrator for Health and Ecological Effects for review and approval.

Review Standards: EPA requires compliance with the review standards of
DHEW regulations (45 CFR 46). In addition, EPA will not support any research
involving (1) risk of substantial or irreversible injury to a human subject,
or (2) determining whether or not a substance is a carcinogen by testing on
human subjects.

Consent Provisions : EPA requires compliance with the consent provisions
of DHEW regulations (45 CFR 46) and with any subsequent modifications thereto.

Sanctions: The Deputy Assistant Administrator for Health and Ecological
Effects may terminate a grant, contract or other agreement in the case of
noncompliance with approved human testing procedures or if the Secretary, DHEW,
withdraws his approval of the general or special assurance.

81

INTELLIGENCE COMMUNITY

The Intelligence Community has conducted and supported bio-
medical and behavioral research relating to the effects of
drugs on behavior; methods for lie detection, stress detec-
tion and information gathering; hypnosis; motivation; effects
of biologicals on human tissue; and methods of "surreptitious
delivery" of biologicals.

NOTE: At the request of the National Foreign Intelligence Board, the
Commission, in 1977, reviewed a draft directive governing research conducted
or supported by components of the Intelligence Community. In a letter dated
23 December 1977, Walter Elder, Executive Secretary of the Board, reported
that the directive reviewed by the Commission is undergoing substantial revi-
sion and is no longer current. He added that the newest draft, now under-
going review, "will adopt many of the provisions of the Department of Health,
Education, and Welfare regulations (45 CFR 46), and will require agencies of
the Intelligence Community to publish their own regulations." The revised
directive should be available early in 1978. The following summary, based
upon the 1977 draft, is included in this report for purposes of completeness
and to indicate the general approach that is being taken by the Intelligence
Community in this sensitive area.

Authority: Executive Order 11905 (18 February 1976); Draft Director
of Central Intelligence Directive IC-77-4563 (17 May 1977); statement of
Admiral Stansfield Turner, Director of Central Intelligence, before the Senate
Select Committee on Intelligence (3 August 1977).

Applicability: The Executive Order applies to experimentation with drugs
on human subjects conducted or supported by Intelligence Community agencies;

82

the draft Directive applies to all research conducted or supported by Intel-
ligence Community agencies.

Review Procedures: In the draft directive, the Intelligence Community
adopts the provisions of DHEW regulations (45 CFR 46), with the following
addition. No more than half the members of an IRB may represent Intelligence
Community organizations, even when all IRB members must have security clearance
in order to review classified research.

Each component of the Intelligence Community must establish procedures
to implement the directive. One requirement is the appointment of an "agency
expert" who will be responsible for determining that Institutional Review
Boards are established in compliance with the regulations, and who will also
serve as the point of contact for subjects participating in intramural re-
search. The resident expert must remain knowledgeable on matters pertaining
to the protection of human subjects, and maintain contacts with the National
Commission for the Protection of Human Subjects, the Department of Health,
Education, and Welfare, and other appropriate federal agencies, soliciting
guidance and consultation, as necessary, on specific proposals or general issues.

Review Standards: In the draft directive, the Intelligence Community
adopts the review standards of DHEW regulations (45 CFR 46).

Consent Provisions: In the draft directive, the Intelligence Community
adopts the provisions of DHEW regulations (45 CFR 46) with the following addi-
tions. Consent documents must be signed in the presence of a disinterested
third party. In addition, when the research is of a classified nature, sub-
jects may be required to sign an agreement not to disclose information regarding

83

the research to other members of the public, or they may be informed that the
sponsor of the research prefers to remain anonymous. The subject must indi-
cate willingness to participate under such conditions on the consent document.
In no event, however, may security considerations "constitute a basis for con-
travening the informed consent requirements."

Special Subjects: When members of the military, U.S. government employees
or employees of U.S. government contractors are enrolled as research subjects,
"scrupulous attention shall be paid to ensure that no coercion is directed to
the employee as a means of securing his or her participation. Data collected
as a result of the employee participating in the research shall not be incor-
porated in subject's personal file." [Quotation from draft directive.]

Additional Provisions: In the draft directive, the Intelligence Com-
munity requires adherence not only to present DHEW regulations but also to
any future DHEW regulations adopted pursuant to the recommendations of the
National Commission for the Protection of Human Subjects.

Sanctions: Contract funds may be withdrawn in the case of noncompliance.
No sanctions are provided in the case of noncompliance in research conducted
within the Intelligence Community.

84

NATIONAL ACADEMY OF SCIENCES

The National Academy of Sciences occasionally conducts and
supports biomedical and behavioral research involving human
subjects. No description of such research was provided.

Authority: National Academy of Sciences Administrative Guide. (Ad
tional information was supplied in a letter (September 25, 1975) by Phil
Handler, President of the National Academy of Sciences.)

Applicability: The policy of the Academy is to require review by at
approved by DHEW for any research involving human subjects regardless of
potential source of support. This policy applies to all elements of the
Academy complex (including the National Academy of Engineering, the Insti
of Medicine, and the National Research Council).

Review Procedures: The Academy maintains an Institutional Review Bo<
with an approved assurance on file at DHEW; thus the review procedures an
those of DHEW regulations (45 CFR 46). The composition and procedures of
the IRB are reviewed and approved by DHEW. All research proposals must be
submitted to the President of the Academy with documentation of IRB review
and approval .

Review Standards: Research is reviewed according to the provisions o
DHEW regulations (45 CFR 46). The Academy specifically requires review of
proposals involving the use of questionnaires, interviews, photographs, obi
vations, taped records or stored data.

85

Consent Provisions: The IRB adheres to the consent provisions of DHEW
regulations (45 CFR 46).

Sanctions: No sanctions in the case of noncompliance are provided by
the Academy.

86

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION (NASA)

NASA conducts and supports biomedical and behavioral research
in biotechnology, environmental biology, spacecraft simula-
tion and medicine.

Authority: NASA Management Instruction 7100.8 (February 2, 1972); NASA
Management Delegation AD 7100.9 (February 2, 1972); Ames Management Manual
7170-1 (as revised March 19, 1969); Ames Memorandum 74/200 (December 11, 1974);
and Lyndon B. Johnson Space Center Management Instruction 7100.8A (March 29,
1977).

Applicability: NASA Management Instruction 7100.8 applies to "all human
research conducted by NASA, by or under the direct supervision of a NASA offi-
cer or employee or an officer or employee detailed to NASA from another Govern-
ment agency." It specifically does not apply to human research conducted un-
der grant or contract or conducted "under a cooperative arrangement or agree-
ment entered into by NASA and another Government agency, private entity, or
non-Federal public entity." The Management Delegation empowers the Directors
of each NASA field installation and, for NASA Headquarters, the NASA Director
of Life Sciences, to authorize human research and to grant such waivers as
are permitted under the NASA instructions. The Ames Management Manual applies
NASA policy both to all human research conducted at the Ames Research Center
Moffet Field, California, and, to all human research conducted for or on behalf
of Ames by NASA contractors, subcontractors or grantees. The Lyndon B. Johnson
Management Instruction applies to all human research conducted by, or under
the direct supervision of officers or employees of the Johnson Space Center,
Houston, Texas. It specifically does not apply to research conducted under

87

grant or contract or to research conducted under cooperative arrangement with
government agencies or with private entities, but requires that grantees and
contractors comply with the provisions of NASA general policy as set forth
in NASA Management Instruction 7100.8.

Exceptions: Although neither of the two space centers make such excep-
tions, the NASA Management Instruction 7100.8 does not apply to research "as
determined by the principal investigator,* that is (a) performed by or under
the supervision of a physician (who may be the principal investigator) for
the purpose of diagnosing, preventing, curing or alleviating disease in a
particular human subject; (b) performed primarily for the human subject's
benefit; and (c) recognized generally by the medical profession as proper."
Nor does it apply to research involving no risk (as determined by the princi-
pal investigator)* or to (1) evaluative procedures authorized by the Civil
Service Commission or by other government agencies to determine qualifica-
tions of job applicants or to determine the state of an employee's health;
(2) research involving as subjects individuals who are specially trained
for that occupation (e.g. , using test pilots to evaluate air or space flight
equipment); or (3) research involving NASA employees whose regular position
description includes such tests or evaluative procedures.

Review Procedures: The NASA Office of Life Sciences neither conducts nor
directly supports research involving human subjects. All such research is con-
ducted under the auspices of the NASA field centers (primarily Ames and Johnson)
Both Ames Research Center and the Johnson Space Center require (in their own

The investigator's determinations must be approved by "line management."
(Letter dated November 16, 1977 from Robert A. Frosch, Administrator,
NASA.)

88

management directives) that their intramural research be reviewed by a review
board; they require only adherence to general NASA policy, however, for re-
search that they support under contract. Thus it appears that the require-
ment for review by an Institutional Review Board applies only to intramural
research conducted at one of the two research centers. The IRB at the Johnson
center is chaired by the Deputy Director of Life Sciences and includes the
heads of divisions of biomedical research, health services, safety, reliabi-
lity, and quality assurance; and a representative of the Chief Counsel. Three
ad hoc members may also be appointed by the Chairman. The composition of the
review board at the Ames center as set forth in Ames Memorandum 74/200 includes
six staff physicians or scientists and a personnel officer.

Research proposals must be approved by the installation's counsel's office,
safety office and medical officer before being approved by the appropriate
authorized NASA official (i.e., the Director of the Ames Research Center, the
Deputy Director of Life Sciences at the Johnson Center, and the Director of
Life Sciences at NASA Headquarters, respectively). At the Ames Center, the
Director also signs each test participant's certification of medical accepta-
bility forwarded by the physician conducting the medical examination. The
authorized official must also be informed in the event of any injury, illness
or disease that occurs to subjects, any change in the environment or in a sub-
ject's response that could lead to some medical disturbance, and any change
in the research as described in the approved protocol.

Review Standards: Research involving human subjects is reviewed to deter-
mine that: (1) the importance of the research objective outweighs the risk
to the subjects; (2) subjects will not be exposed unnecessarily to risk of

89

injury, discomfort or inconvenience; and (3) the subject or his representa-
tive will be compensated in the event the subject suffers loss, injury,
illness, disease or death as a result of participating in the research. The
review at the two research centers also assesses the scientific merit of the
research, the competence of the investigators, and the adequacy of the facili-
ties for the safe conduct of the research, and for treatment of injuries.

Consent Provisions: NASA consent provisions generally follow those of
DHEW regulations (45 CFR 46), with the following modification. Subjects must
be informed if, for any reason, withdrawal during the conduct of the research
is not an option (because it would be "unwise, dangerous, or impossible").
In exceptional cases, waivers of the consent requirements may be granted by
"the cognizant authorized NASA official" if such requirements are deemed "not
to be necessary, for various reasons, to protect the subjects."

Special Subjects: The Ames Manual provides that no person who is a minor
or who is without legal capacity to give his voluntary informed consent may
be a subject of human research without the specific authorization, in writing,
of the NASA Administrator. (No such provision appears in the other manuals.)

Additional Provisions: The Ames Research Center requires that all human
subjects be examined by a physician, who has been informed of the nature of the
proposed research, for a determination of fitness. Subjects must be re-examined
at the conclusion of the research, and reports of the results of both the exami-
nations must be forwarded to the Director of the research center.

Sanctions: There are no provisions for sanctions in the case of noncompliance.

90

NATIONAL SCIENCE FOUNDATION (MSF)

The National Science Foundation supports research involving
human subjects primarily in the behavioral and social sciences
and in education.

Authority: NSF Grant Policy Manual (October 1, 1977); letter (November 9,
1977) from Richard T. Louttit, Director, Division of Behavioral and Neural
Sciences.

Applicability: The policy applies to research, development and related
activities supported by NSF grants.

Review Procedures: NSF adopts DHEW provisions (45 CFR 46) for establish-
ment of Institutional Review Boards (IRBs).

Review Standards: NSF grantees must comply with review standards of
DHEW regulations (45 CFR 46).

Consent Provisions: NSF grantees must comply with the consent provisions
set forth in DHEW regulations (45 CFR 46).

Special Subjects: NSF specifically applies its policy to research,
development and related activities in which students are involved as subjects.

Sanctions : No provisions are made for sanctions in the case of noncom-
pliance.

91

UNITED STATES INFORMATION AGENCY (USIA)

The agency supports media surveys and attitude research that
is conducted abroad by contractors.

Authority: There are no formal regulations for the protection of human
subjects of such research. (Information was supplied to the Commission in
letters (September 29, 1975) by James Keogh, then Director, U.S. Information
Agency, and (November 7, 1977) by Harold E. Engle, Acting Assistant Director,
Office of Research.)

Mr. Engle writes that "it is the policy of USIA that in keeping with the
need for objective results, contractors be required to assure the respondents
their answers will be kept confidential."

92

VETERANS ADMINISTRATION (VA)

The Veterans Administration conducts biomedical and beha-
vioral research in its hospitals, clinics and centers, and
permits outside investigators to conduct such research at
those facilities.

Authority: Veterans Administration Issue M-3, Chapter 1, Part 1, as
modified by interim issue 10-75-8 (March 10, 1975); Circular 10-75-121
(June 19, 1975).

Applicability: The policy applies to the use of drugs and/or procedures
for research purposes, including prosthetics research.

Review Procedures: The VA generally follows provisions in DHEW regula-
tions (45 CFR 46) for establishment of Institutional Review Boards. Institu-
tions already having established boards may utilize such boards providing the
board conforms to, or exceeds, the requirements set forth by the VA.

The hospital or clinic director is responsible for assuring that the
review board is free from undue pressures in discharging its obligations, and
is also responsible for implementing the board's decisions. No recommendation
of the review board may be modified or reversed, other than by the board itself.
Any appeal must be made in writing to the Assistant Chief Medical Director for
Research and Development with "sufficient detail and background to allow evalua-
tion of the recommendation and its appeal."

Review Standards: The VA generally follows the review standards set forth
in DHEW regulations (45 CFR 46).

93

Consent Provisions: The VA adopts the consent provisions of DHEW regu-
lations (45 CFR 46) with the following additions. Subjects must sign each
page of the information sheets in the consent form; but when the procedure is
simple and the experiment is brief, several or all of the subjects may sign
the same information sheets which are kept separate from the signed consent
forms. The investigator may give subjects their own copies of the informa-
tion sheets; but one copy of each sheet must be signed by the subject and
retained by the investigator. In addition, investigators "must assure that
the consent is given freely without threats, even by implication, without
promises of unrealistic results, and without excessive material reward for
participation."

Additional Provisions: "Experimental procedures must not be added surrep-
titiously to accepted clinical ones; so-called 'bootleg' or 'piggy-back' re-
search is forbidden."

Sanctions: The Institutional Review Board must consider and recommend
action in any instance in which it is claimed that a subject's rights were
violated or the subject's safety unduly jeopardized during research. A writ-
ten report of such findings and recommendations is forwarded to the hospital
or clinic director who then decides what actions are necessary. Copies of the
report, recommendations, and the director's decision are forwarded to the
Assistant Chief Medical Director for Research and Development, to the adminis-
trative officer for research in the institution, and to the investigator.

94

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