PART II FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS; NOTICES AND RULES

• Document Type: CREST
• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00789R003300220001-1
• Release Decision: RIFPUB
• Original Classification: K
• Document Page Count: 31
• Document Creation Date: November 4, 2016
• Document Release Date: October 21, 1998
• Sequence Number: 1
• Publication Date: June 18, 1991
• Content Type: REGULATION

Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
gin,
Tuesday
June 18 1991
Part II
Federal Policy for the
Protection of Human
Subjects; Notices and
Rules
Office of Science and Technology Policy
Department of Agriculture
Department of Energy
National Aeronautics and Space Administration
Department of Commerce
Consumer Product Safety Commission
International Development Cooperation Agency
Agency for International Development
Department of Housing and Urban Development
Department of Justice
Department of Defense
Department of Education
Department of Veterans Affairs
Environmental Protection Agency
Department of Health and Human Services
Office of the Secretary
Food and Drug Administration
National Science Foundation
Department of Transportation
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 Approved For Release 2000/08/08 ; CIA-RDP96-007$9f~ Q~$300220001-1
2Z:i 2 Federal Register / Vol. 56, No. 117 r Tuesday, lure 18. 1991 ! L Otices
OFFICE OF SCIENCE AND
TECHNOLOGY POLICY
Federal Policy for the Protection of
Human Subjects
AGENCY: Office of Science and
Technology Policy, Executive Office of
the President.
ACTION: Notice of Federal Policy for
Protection of Human Subjects.
SUMMARY: The Office of Science and
Technology Policy has accepted the
Final Federal Policy for the Protection of
Human Subjects in the form of the
common rule promulgated in this issue
of the Federal Register. The common
rule was developed by the Interagency
Human Subjects Coordinating
Committee of the Federal Coordinating
Council for Science, Engineering and
Technology, in response to public
comment on the notice of proposed
policy for Department and Agency
Implementation published in the Federal
Register on November 10. 1988 (53 FR
45660).
Note that the Central Intelligence
Agency is required by Executive Order
12333 to conform to the guidelines
issued by the Department of Health and
Human Services (H'HS).
ADDRESSES: Requests for additional
information should be addressed to Dr.
Joan P. Porter, Interagency Human
Subjects Coordinating Committee,
Building 31. room 5B59. Bethesda.
Maryland 20892. Telephone: (301'J 496-
7005.
D. Allan Bromley,
Director. Office of Science and 1 echnology
Policy. Executive Office of the President.
[FR Doc. 91-14257 Filed 6-17-91: 8:45 amj
BILLING CODE 9170-O1-M
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 C?PARTMENT CF AGRICULTURE
11 CFR Part 1C
DEPARTMENT OF ENERGY
10 CFR Part 745
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
14 CFR Part 1230
DEPARTMENT OF COMMERCE
15 CFR Part 27
CONSUMER PRODUCT SAFETY
COMMISSION
INTERNATIONAL DEVELOPMENT
COOPERATION AGENCY
Agency fcr International Development
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 60
DEPARTMENT OF JUSTICE
26 CFR Part 46
DEPARTMENT OF DEFENSE
32 CFR Part 219
DEPARTMENT OF EDUCATION
34 CFR Part 97
DEPARTMENT OF VETERANS
AFFAIRS
33 CFR Part 16
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 26
o. 1'91 l R'iles and Reguiatlons 23003
CEPART": ENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 46
NATIONAL SCIENCE FOUNDATION
45 CFR Part 690
DEPARTMENT OF TRANSPORTATION
49 CFR Part 11
Federal Policy for the Protection of
Human Subjects
AGENCIES: United States Department of
Agriculture; Department of Energy;
National Aeronautics and Space
Administration: Department of
Commerce; Consumer Product Safety
Commission: International Development
Cooperation Agency, Agency for
International Development: Department
of Housing and Urban Development;
Department of Justice; Department of
Defense; Department of Education:
Department of Veterans Affairs:
Environmental Protection Agency:
Department of Health and Human
Services; National Science Foundation:
Department of Transportation.
ACTION: Final rule.
approved by and on file in the Office fcr
Protection irom Research Risks (OPRR)
in the Department of Health and Human
Services may continue to do so in
accord with the terms and conditions of
their MPAs, See supplementary
Information for further details.
FOR FURTHER INFORMATION CONTACT:
Dr, loan P. Porter. [phone]. Office
for Protection from Research Risks.
National Institutes of Health. Building
31, room 51359, Bethesda. MD 20392.
SUPPLEMENTARY INFORMATION:
Paperwork Reduction Act Requirements:
Sections .103(a): .103(b); 103(b)(4)(i);
103(b)(.1)(iii);
103(b)(5): .103(f);
109(d); --113;
.115(a); .116: and
.117 contain information
collection requirements subject to
approval by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act. HHS has submitted the
request for approval to OMB on behalf
of all Departments and Agencies
governed by this final rule and has
published elsewhere in this issue of the
Federai Register a request for OMB
expedited review and approval of the
information collection requirements.
OMB has assigned OMB control number
9999---0020; however. the information
collection requirements will not become
effective until OMB has approved them.
Unless a notice is published to the
contrary, the public may assume that
01.MB has approved the information
collection requirements during the 60-
day period before the final rule becomes
-Ffective.
For further information regarding
OMB approval of the information
collection, contact Ms. Shannah Koss-
McCallum, OMD. [phone].
Compliance Dates: Institutions that
hold MPAs are permitted and
encouraged to apply all provisions of
this final rule as soon as it is feasible to
do so. They are urged not to wait for the
negotiation and approval of a revised
MPA to begin to function in accord with
this rule. The OPRR, acting on behalf of
the Secretary, Department of Health and
d
SUMMARY: This l Policy sets forth a common Federal Policy for the
Protection of Human Subjects (Model
Policy) accepted by the Office of Science and Technology Policy and
promulgated in regulation by each of the
listed Departments and for thies. A
Proposed of Human Subjects published
November r 10. 1998 (53 FR 45661) has been revised in response revised public
is comments. The Policy as re nowset forth as a common final rule. For
related documents, see other sections of
this Federal Register part. EFFECTIVE DATE: These regulations shall
become effective on August 19. 1901. The Department of Education regulations (34 CFR part 97) take effect
either August 19 ,1991, or later if
Congress takes certain adjournments. If
you want to know the effective date of
the Department of Education regulations
in 34 CFR part 97, call or write Mr. renegotiate and approve IvtYAS in the
Edward Glassman, Office of Planning, normal periodic cycle renewal.
Budget and Evaluation, U.S. Department I
ittions that are not operating
t
u
ns
of Education. room 3127, 400 Maryland under an IVIPA approved by OPRR will
Avenue SW., Washington, DC 20202-
4132. A document announcing the be required to negotiate an Assurance of
effective date of the Department of Compliance with the supporting
Education regulations will be published Department or Agency, prior to initiating
in the Federal Register. Institutions research involving human subjects.
Institutions with MPAs approved by
currently conducting or supporting
research in accord with Multiple Project and on file it oHg S be allowed a
Assurances of Compliance (MPAs) grace period"
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 crqd For ~~~~
o~/p/08 : CjA-RDP96-90R7?9R0P304220001-1
p
o o, rvlesg,20
28L~D4 ra egtster /'V-o. ~. ueaday, one 18. 1991 u es an equ goons
submission date for an application protection of human subjects of
seeking HHS support, to provide biomedical and behavioral research. In
certification of institutional Review carrying out that charge. the President's
Board (IRB) review and approval. Commission was directed to conduct a
Exceptions may occur for reasons of review of the adequacy and uniformity
Congressional mandate or special (1) of the rules, policies, guidelines, and
program or review requirements. In such regulations of all Federal Departments
cases. institutions will be advised that and Agencies regarding the protection of
certification must be sent at an earlier human subjects of biomedical or
time. behavioral research which such
Background Departments and Agencies conduct or
d
f
h
-
i
f
This notice sets forth as a common
rule requirements for the protection of
harnan subjects involved in research
conducted or funded by the following
Federal Departments and Agencies:
United States Department of
Agriculture: Department of Energy:
National Aeronautics and Space
Administration: Oep:irtment of
Commerce: Consumer Product Safety
Commission; International Development
Cooperation Agency} Agency for
International Development: Department
of Housing and 1Jrba'n Development:
Department of justice.. Department of
Defense: Department of Education:
Department of Veterans Affairs:
Environmental Protection Agency:
National Science Foundation:
Department of Health and Human
Services and the Department of
Transportation. Each of these
Departments and Agencies have
adopted the common rule as regulations
to he codified as listed above.
The Food and Drug Administration
(FDA) Final Rule to modify current
regulations to conform to the Federal
Policy are presented' elsewhe.rp in this
issue of the Federal Register. Existing
FDA regulations governing the
protection of human subjects share a
common core with the Federal Policy
and implement the fundamental
principles embodied in that policy. F he
agency is committed, to being as
consistent with the final Federal Pvlii.v
as it can he, given the unique
requirements of the Federal Food, Drug.
and Cosmetic Act under which FDA
operates; and the fact that FDA is a
regulatory agency that rarely supports
or conducts research under its
regulations.
Adoption of the common Policy by
Federal Departments and Agencies in
reguiatory form wlil. implement a
recommendation of 'the President's
Commission for the '',Study of Ethical
Problems in Medicine and Biomedical
and Behavioral Research which was
established on November 9, 1978. by
Public Law 95--622. One of the charges to of the President's Commission. including
the President's Commission was to the recommendation that:
report biennially to the President. the The President should. through appropriate
Congress, and appropriate Federal action. require that all federal departments
Departments and Agencies on the and agencies adopt as a common core the
t
support, an
(2) o
e ..
np
ementauon o
such rules, policies, guidelines, and
regulations by such Departments and
Agencies, such review to include
appropriate recommendations for
legislation and administrative action.
In December 1981 the President's
Commission issued its First Biennial
Report on the Adequacy and Uniformity
of Federal Rules azid Policies. and their
Implementation. for the Protection of
Human Subjects in Biomedical and
Behavioral Research. Protecting Human
Subjects.
In accord with Public Law 95'22.
each Federal Department or Agency
which receives recommendations from
the President's Commission with respect
to its rules, policies, guidelines or
regulations. must publish the
recommendations in the Federal
Register and provide an opportunity for
interested persons to submit written
data, views and arguments with respect
lo adoption of the recommendations. On
March 29, 1982 (47 FR 13262-13305). the
Secretary, HHS, published the
recommendation on behalf of all
affected Departments and Agencies.
In i'vtay 1982 the Chairman of the
Federal Coordinating Council for
Science. Engineering, and Technology
(FCCSET) appointed an Ad Hoc
Committee for the Protection of Human
Research Subjects under the auspices of
the FCCSET. The Committee, chaired by
Dr. Edward N. Brandt. Jr.. Assistant
Secretary for Health. Health and Human
Services (HHS). was composed of
representatives and ex-officio members
of the affected Departments and
Agencies. In consultation with the
Office of Science and Technology Policy
(OSTP) and the Office of Management
and Budget. the Ad Hoc Committee.
after considering all public comments.
developed responses to the
recommendations of the President's
Commission. After further review and
refinement. OSTP responded on behalf
of all the affected Department and
Agency Heads to the recommendations
regulations governing research with human
subjects issued by the Department of Health
and Human Services (codified at 45 CFR Part
46), as periodically amended or revised, while
permitting additions needed by any
department or agency that are not
inconsistent with these core provisions.
The .4d Hoc Committee agreed that
uniformity is desirable among
Departments and Agencies to eliminate
unnecessary regulation and to promote
increased understanding and ease of
compliance by institutions that conduct
federally supported or regulated
research involving human subjects.
Therefore, the Ad Hoc Committee
developed a Model Federal Policy.
which applies to research involving
human subjects conducted. supported or
regulated by Fedoras Departments and
Agencies. In accordance with the
Commission's recommendation. the
Model Federal Policy is based on
subpart A of the regulations of HITS for
the protection of human research
subjects (45 CFR part 46). The Proposed
Model federal Policy developed by the
Ad Hnc Committee was modified by
OSTP to enhance uniformity of
implementation among the affected
Federal Departments and Agencies and
to provide consistency with other
related policies. The revised Model
Federal Policy was concurred in by all
affected Federal Departments and
Agencies in March 1985.
An Interagency Human Subjects
Coordinating Committee was chartered
in October 1983 under the auspices of
FCCSET to provide continued
interagency cooperation in human
subject research once the Ad Hoc
Committee had completed its
assignment. It is chaired by the Director
of the Office for Protection from
Research Risks, HHS, and composed of
representatives of all Federal
Departments and Agencies that conduct.
support or regulate research involving
human subjects. The Committee is
advisory to Department and Agency
Heads and, among other responsibilities.
will evaluate the implementation of the
Federal Policy and recommend
modification as necessary.
On June 3. 1986. OSTP published for
public comment in the Federal Register
(51 FR 20204) a Proposed Model Federal
Policy for Protection of Human Subjects
and Response to the First Biennial
Report of the President's Commission.
Over 200 written comments were
received concerning the publication. Th
Interagency Human Subjects
Coordinating Committee considered
these comments in the revision of a
common Federal Policy proposed as a
common rule on November 10. 1958, for
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 ulatians 28005
adoption by each of the Departments scientific misconduct involving risks to
and Agencies listed. Response to the human subjects and others and that the
more than 60 public comments. scientific fraud and misconduct
discussion of revisions made to that regulations (September 19. 1988.
f TIC A d d
an
P
policy or the requirements or
determination of the IRB: or any
suspension or termination which is
more than minor or temporary.
war ee
publication and the anal common rule R;aponstbtltties o
Response
Naw" follow. Applicant Institutions for Dealing with Summary of Public Co:nments and Reporting Possible Misconduct in In view of the comments and the
Received in Response to the November Science (53 FR 36344)] create duplicate policy concerning fraud and misconduct
10. 1988, Federal Register publication (53 and potentially conflicting requirements. that is now under deliberation. the
FR 45661) of the Notice of Proposed Several suggested that the proposed Interagency Human Subjects
Common Rulemaking, Federal Policy for rules on misconduct should leave Coordinating Committee revised
the Protection of Human Subjects for 16 undisturbed other existing regulatory ? .103(b)(5) as follows:
Federal Departments and Agencies. schemes such as human subjects Written procedures for ensuring prompt
In response to the November 10, 19S8. regulations of the Department of Health reporting to the IRB, appropriate institutional
publication, 66 commentators responded and Human Services at 45 CFR part 46. officials, and the department or agency head
within the comment period. which was Other commentators indicated that the of 10 any unanticipated problems involving
extended to February 8. 1999. The IRB should not have a "police" role and risks to subjects or others or any serious or
source of continents included that its members are potentially legally continuing noncompliance with this policy or
institutional offices of sponsored liable if they did or did not report the requirements or determinations of the IRA
research, departmental deans and chairs certain misconduct activities. Concern and (ii) any suspension or termination of IRB
and other staff of academic institutions. was also noted about additional approval.
institutional review board members and responsibility and work placed on the The President's Commission
staff, principal investigators, and drug [RB. recommended in its 1981 First Biennial
company representatives. Although Several commentators requested Report that institutional assurances
there were 66 separate commentators. clarification of ? .103(b)(5)(i) in should specify how "misconduct" should
several responses were prepared by the terms "misconduct" and be reported and investigated (pp. 77-82.
organizations each representing a "unanticipated" problems. Respondents Recommendations 7 and 8). Since the
consortium of institutions which had suggested that scientific misconduct time of the publication of the 1981
been polled concerning the notice of implies falsification of data. plagiarism. report. however. the issue of
proposed common rulemaking. For abuse of confidentiality, dishonesty in identification and reporting of
example, the Council on Governmental presentirg publications. legal violations misconduct has been deliberated in
Relations. the Association of American and a range of other activities which many other contexts and has included
Medical Colleges, Public Responsibility should be addressed in a separate policy consideration of more than "misconduct
for Medicine and Research. Association involving broader institutional involving risks to human subjects." In
of American Universities. the American considerations than those appropriate August 1969 the Department of Health
Medical Association and the for an iRB. In addition. some and Human Services published a final
Consortium of Social Science respondents suggested that actual rule announcing responsibilities of
f
"
"
"
or
ossible risk
rather than
p to awardee and applicant institutions
Associations offered comment on behalf "harm
of their member institutions. human subjects be reported to dealing with and reporting possible
Ir. general, commentators endorsed Departments and Agencies. misconduct in science (53 CFR 32449j.
the efforts of the Office of Science and Concerning ? .103(b)(5)(iii) The Committee agrees that in the
current context the inclusion of the term
Technology Policy and the Feuerai two commentators suggested that if' Bs
Departments and Agencies to develop a would be reluctant to suspend IRB- misconduct" in the Federal Policy is
Common Rule for the protection of approved research for administrative confusing and misleading because other
human subjects. infractions such as tardiness of policy development efforts giving
The majority of the comments dealt response to an IRD) if such suspension specific meaning to scientific
with three points in the proposed must be reported to an Agency. One misconduct are ongoing. Therefore, the
common rule, as follows: commentator requested that revisions term is deleted from this document.
Section 103(b)(5) concerns be made so that only suspensions or The revised language is closer to that
those procedures set forth in Assurances terminations for serious or continuing of the original provision in the
of Compliance for research conducted or noncompliance with the policy or
Department of Health and Human
supported by a federal Department or determination of the IRD need be epar~s regulations. The Interagency
Agency. As proposed. this section reported to the Department or Agency Committee wishes to clarify that it was
required that an Assurance should head. In that way, IRBs would use
never the intention of the Policy to
include: suspension or termination as a require IRBs to report directly to
administrative tool and continue to keep
Written procedures for ensuring prompt Departments and Agencies informed of Department and Agency Heads.
reporting to the IRB, appropriate institutional serious problems. Assurances of Compliance are
officials, and the department or agency head s negotiated between Departments or
(i) any unanticipated problems or scientific One specific set of comments
misconduct involving risks to human subjects addressed all aspects of this section by Agencies and awardee institutions,
or others (ii) any instance of serious or suggesting deletion of reporting Assurances allow institutions to specify
continuous noncompliance with this policy or requirements to Department and Agency how reporting to Department and
the requirements of determinations of the IRB Heads altog tither. Rather, reports to Agency Heads will take place. Reporting
and (iii) any suspension or termination of IRB IRBs and institutional officials would be is the responsibility of the institutional
approval. required concerning unanticipated official identified in each Assurance.
Some commentators indicated that problems involving risks to human Further, the Committee wishes to
they believed the proposed policy would subjects which are substantial: proven clarify that "unanticipated problems" in
inappropriately require IRBs to notify scientific fraud: instances of substantial this context includes serious and
Department and Agency heads of or continuing noncompliance with the unexpected reactions to biologicals,
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 A r c e ~tL~ a[ e~`~2OOU/O8YOOc CIJytaR~~1Ob~ R@OB8@G O1-1 28031
Executive Order 12291
These regulations have been reviewed
in accordance with Executive Order
,2291.. They are not classified as major
!%nobecause they do not meet the criteria for
major regulations established under the
Order.
Regulatory Flexibility Act Certification
The Secretary certifies that these
interim final regulations will not have a
significant economic impact on a
substantial number of small entities.
The small entities that are affected by
these interim final regulations are small
institutions receiving research grants or
contracts under the programs of the
National Institute on Disability and
Rehabilitation Research. However, the
regulations do not have a significant
economic impact on these entities
because the regulations do not impose
excessive regulatory burdens. These
regulations impose minimal
requirements that are necessary to
ensure the proper treatment of
handicapped children and mentally
disabled persons under the programs of
the National Institute on Disability and
Rehabilitation Research.
Invitation To Comment
Interested persons are invited to
submit comments and recommendations
Nr#'' regarding these interim final regulations.
Comments are specifically invited on
whether other research programs of the
Department should have added
protections for handicapped children
and mentally disabled persons.
All comments submitted in response
to these regulations will be available for
public inspection, during and after the
comment period, in room 3127. 400
Maryland Avenue, SW., Washington,
DC between the hours of 9 a.m. and 4:30
p.m.. Monday through Friday of each
week except Federal holidays.
To assist the Department in complying
with the specific requirements of
Executive Order 12291 and the
Paperwork Reduction Act of 1980 and
their overall requirement of reducng
regulatory burden, the Secretary invites
comment on whether there may be
further opportunities to reduce any
regulatory burdens found in these
interim final regulations.
Assessment of Educational Impact
The Secretary has determined that the
regulations in this document do not
require transmission of information that
is being gathered by or is available from
any other agency or authority of the
United States.
List of Subjects
34 CFA Part 350
Education. Education of the
handicapped. Educational research.
Grant programs-education.
34 CFR Part 356
Education. Education research,
Fellowships.
(Catalog of Federal Domestic Assistance
Number does not apply.)
Dated: lime 6. 1991.
Lamar Alexander.
Secretary of Education.
The Secretary amends titre 34 of the
Code of Federal Regulations by
amending parts 350 and 356 as follows:
PART 350-DISABILITY AND
REHABILITATION RESEARCH:
GENERAL PROVISIONS
3. The authority citation for part 350
continues to read as follows:
Authority: 29 U.S.C. 760-7 62. unless
otherwise noted.
4. Section 350.3 is amended by
revising paragraph (d) and the authority
citation at the end of the section to read
as follows:
1250.3 What regulations apply to these
programs?
. . a . .
(d)(1) The regulations in 34 CFR part
97. PROTECTION OF HUMAN
SUBJECTS, except ? 97.107(a).
(2) Each Institutional Review Board
(IRB) established under part 97 must
have at least five members. with varying
backgrounds to promote complete and
adequate review of research activities
commonly conducted by the institution.
The IRB must be sufficiently qualified
through the experience and expertise of
its members. and the diversity of the
members, including consideration of
race. gender. and cultural backgrounds,
and sensitivity to such issues as
community attitudes, to promote respect
for its advice and counsel in
safeguarding the rights and welfare of
human subjects. In addition to
possessing the professional competence
necessary to review specific research
activities, the IRB must be able to
ascertain the acceptability of proposed
research in terms of institutional
commitments and regulations,
applicable law, and standards of
professional conduct and practice. The
IRB must therefore include persons
knowledgeable in these areas. When an
IRB reviews research that purposefully
requires inclusion of handicapped
children or mentally disabled persons as
research subjects. the IRB must include
at least one person primarily concerned
with the welfare of these research
subjects. if an IRB regularly reviews
another vulnerable category of subjects.
such an non-handicapped children.
prisoners. pregnant women, or
handicapped adults. consideration must
also be given to the inclusion of one or
more individuals who are
knowledgeable about the experience in
working with these subjects.
(Authority, 20 U.S.C. 761 a. 762, 42 U.S.C.
300v-1(b))
PART 356-DISABILITY AND
REHABILITATION RESEARCH:
RESEARCH FELLOWSHIPS
1. The authority citation for part 356
continues to read as follows:
Authority: 29 U.S.C. 761a(d), unless
otherwise noted.
2. Section 356.3 is amended by
revising paragraph (c) and the authority
citation at the end of the section to read
as follows:
? 356.3 What regulations apply to this
program?
(c)(1) The regulations in 34 CFR part
97, PROTECTION OF HUMAN
SUBJECTS. except ? 97.107(a).
(2) Each Institutional Review Board
(IRB) established under part 97 must
have at least five members, with varying
backgrounds to promote complete and
adequate review of research activities
commonly conducted by the institution.
The IRB must be sufficiently qualified
through the experience and expertise of
its members. and the diversity of the
members, including consideration of
race, gender. and cultural backgrounds.
and sensitivity to such issues as
community attitudes. to promote respect
for its advice and counsel in
safeguarding the rights and welfare of
human subjects. In addition to
possessing the professional competence
necessary to review specific research
activities, the IRB must be able to
ascertain the acceptability of proposed
research in terms of institutional
commitments and regulations,
applicable law, and standards of
professional conduct and practice. The
IRB must therefore include persons
knowledgeable in these areas. When an
IRB reviews research that purposefully
requires inclusion of handicapped
children or mentally disabled persons as
research subjects, the IRB must include
at least one person primarily concerned
with the welfare of these research
subjects. If an IRB regularly reviews
another vulnerable category of subjects.
such as non-handicapped children.
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 .9
I4i~rgr~~?~149/4$~ -RTWA99QAPOO1-1
drugs, or medical devices. Institutions
have flexibility to establish channels of
reporting to meet reporting requirements
of Departments and Agencies. In
addition, the Committee believes it is
important that suspension or
termination, for whatever reason, be
reported to the Department and Agency
Heads.
The Sixty Day "Grace''"' Period
Comment
The section of the proposed Policy
and Final Rule eliciting the most
comments was 103(f) regarding
submission of certification. That section
is as follows:
C,.rtification is requires when the research
is supported by a federaldepartment or
agency and not otherwise exempted or
waived under ? ? .1n1 (b) or ii). An
insltution with an approved assurance shall
certify research covered by the assurance
and by ? .103 ofihis policti has been
ievtOwed and approved by Lie iRB. Such
certification must be .submitted with the
application or proposal or by such laier date
as may be prescribed bv'the department or
agency to which the application or proposal
is submitted. Under no condition shall
research covered by ? ___103 of the
policy be supported prior to receipt of the
certification that the research has been
reviewed and approved b.y the LRB.
Institutions without an approved assurance
covering the research shall certify within 30
days after receipt of a request for such a
certification from the department or agency.
that the application or propnsat has been
approved by the IRB. If the certification is not
submitted within these tune knots, die
application or proposal may be returned to
tits institution.
Most of the commentators ti0l
addressed the need for a grac+: period
between the time of submission of an
application for support to a D::partment
and Agency and submission of
certitication by the IRB of review and
approval of the proposal. A 60-day grace
period was allowed in the previuts
Department of Health and Human
S:3rvices Regulatiors'',for the Protection
of Human Subjects. Under this
provision. institutions with Multiple
Project Assurances on file with HHS
had sixty days to complete IRB review
and approval and to notify HHS. This
period of time roughly corresponded to
the time between receipt of the
application and initial scientific merit
review. The groups evaluating the
application for scientific merit need
certification of the fact that an
appropriate IRB has determined that
human subject protections are adequate.
The commentators cited many
reasons why a grace' period is important
for orderly institutional review and for
protection of human' subjects. Many of
the comments on this section requested
that the grace period be reinstated in the
regulations. In brief, respondents noted
that if the grace period is not allowed.
investigators would be required to
submit proposals to IRBs about two
months earlier than at present. IRBs
would be convened into emergency
sessions or required to meet more
f equently. Pressure to grant approval
would increase.
Some commentators noted that
institutions that have no Multiple
Project Assurance on file with HHS are
given 30 days to review and certify upon
HHS request. If Multiple Project
Assurance holders have no grace period.
they may be at a disadvantage in time
permitted for preparation and
institutional review of their applications
as compared to the time permitted
institutions without a Multiple Project
Assurance. Also, data for competitive
renewals is often added just before
'ubmission to HHS so that the most
current urogress under the original
award can be reported. If a grace period
is not offered, applications may not
contain information vital for appropriate
peer review.
Another concern raised was that some
researchers are required to modify their
proposals several times before
submission. The current 90-day period
allows the IRB to review the final
submission carefully.
One commentator indicated that the
proposed provision was acceptable to
the institution.
Response
Many Federal Departments and
Agencies do not have application review
schedules that correspond to those of
HHS. A tit) day grace period is without
relevance to their review systems. At
the time of publication of the proposed
common rule. the lnterag?ncy
Committee noted that HI IS intended to
retain a "grace period" for institutions
that have Multiple Project Assurances
and announce the period through
advisories that are routinely received by
institutions. HIIS has carefully
considered the public comments and
will ordinarily retain the 60-day grace
period in its administrative procedures.
In some programs. such as AIDS-related
research, IIHS has modified the receipt
and review schedules in accordance
with a Congressional mandate.
The Departments and Agencies. other
than HHS, adopting the common rule
are aware of the concerns of the
institutions and will provide as much
flexibility to IRBs as possible in the
orderly processing of applications for
support. To require a 60-day grace
period or any standard grace period for
all Departments and Agencies would
require far-reaching changes in the
review and processing systems of these
organizations. Institutions will be
advised of Department and Agency
procedures through routine publications.
Consequently, the language in the final
rule remains unchanged.
Composition of the IRB
Comments
Section 107 of the Policy
deals with composition of the IRB.
Several points made by commentators
are as follows:
In ? 107(a) there is the
requirement that if an IRB regularly
reviews research that involves a
vulnerable category of subjects, such as
children. prisoners, pregnant women or
mentally disabled persons.
consideration shall be given to the
inclusion of one or more individuals
who are knowledgeable about and
experienced in working with these
subjects. The HHS regulations at 45 CFR
part 46 promulgated in 1981 utilized a
different standard, i.e., "if an IRB
regularly reviews research that involves
a vulnerable category of subjects.
including but not limited to subjects
covered by other subparts of [45 CFR
part 461. the IRB shall include one,or
more individuals who are primarily
concerned with the welfare of these
subjects." The commentator indicated
that his institution would retain previous
standards, because advocates for
special populations have been of great
benefit in the IRB's decision-making
process.
Another commentator wrote that in
her institution, full committee review is
required when a vulnerable population
is involved; all committee members are
advocates for subjects whether or not
they themselves are involved in a
vulnerable population. Adding new
members would make the committee too
large to be workable, she wrote.
The majority of the comments on this
section were directed to the departure
proposed by the Department of
Education at 34 CFR part 97.107(a). The
proposed departure was based on a
concern for protection of mentally
disabled persons and handicapped
children. The departure would have
provided that, for research conducted o,
supported by the Department of
Education." when an IRB reviews
research that deals with handicapped
children or mentally disabled persons,
the IRB shall include at least one person
primarily concerned with the welfare of
the research subject." The remainder of
the departure reiterated the common
Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001-1
 ~_nnr 't M I n~A~t k~s~ ~r ~(~r ~c ~l` QTR Vi ~P 13
rule's provision which required
institutions to consider representation
on the IRE of persons who are
knowiedEeaele about and experienced
in working v.th certain vulnerable
subjects ri the IRB regularly reviews
research involving those vulnerable
subjects. Twenty-one institutions
commented on this proposed departure.
The majority of these comments were
opposed to the proposed departure.
Some commentators. while supporting
the proposed language in ? 107.
stated their belief that the departure
was not necessary because the policy in
? .107 already addresses
representation of the special concerns of
vulnerable subjects on the 1RB. Thus,
the rights of handicapped children and
mentally disabled persons shnuid be
represented on any IRB that regularly
reviews proposals involving those
individuals. and there is no constructive
advantage to emphasizing these two
categories of subjects. Such or. emphasis
was seen as a precedent with the
potentiai for discrimination against
other categories of vulnerable subjects.
When special expertise is required, IRBs
already have the option and the
obligation to seek informed consultants.
respondents noted. One commentator
stated. however, "If in future staffing of
our IRB. someone with expertise in this
area is available and willing to serve.
we would be happy to encourage such
participation."
Some commentators objected to the
lack of consistency among Federal
Departments and Agencies and cited the
Department of Education's proposed
departure as being inconsistent with the
purpose of the common rule.
One commentator suggested that only
when the IKB regularly reviews research
that deals with handicapped children or
mentally r-sabled persons should the
IRE in ciuce at least one person
primarily concerned with the welfare of
the research subjects. Otherwise.
consultation should take place when
appropriate. Another suggestion was
that handicapped children and mentally
disabled persons-be added to the list of
examples of vulnerable subjects for
which an IRB that regularly reviews
research might want to consider
inclusion of one or more members who
are knowledgeable about and
experienced in working with these
subjects.
Response
The Department of Education has
considered these comments carefully
and has decided to withdraw the
departure to the common rule and to
adopt the common rule as promulgated
in this document. The Secretary,
however. continues to believe that there
is a special need to protect handicapped
children and mentally disabled persons.
Thus. the Secretary strongly urges
institutions to included at least one
person who is primarily concerned with
the welfare of the research subjects
whenever the research involved
handicapped children or mentally
disabled persons. Waite the Secretary
agrees to the common rule provision
regarding IRE representation as a
general matter, the Secretary has
decided to address the concerns
underlined by the proposed departure
on a programmatic basis under the
Department of Education's programs of
the National Institute on Disability and
Rehabilitation Research (34 CFR parts
350 and 356). Accordingly, the Secretary
amends the program regulations for
these programs in a document published
in another section of this Federal
Register part.
In light of the concern of the
Department of Education that these
groups were not clearly identified as
vulnerable populations, "handicapped"
has been added to the illustrative list in
? -107.
Comments on Other Sections
Section -101 explains the
application of the Policy. Section
.101(b) describes categories of
research that are exempt from the
Policy.
Comment
Several commentators indicated that
the language and intent of this section
was helpful. One commentator indicated
that he believes the section was written
primarily for medical and health
research and shouid not apply to
involvement of human subjects for
general business interviews or surveys.
The commentators recommended the
exemption of information gathering
related to business. Further comment
suggested that ail minimal risk research
be exempt from the regulations.
Response
The Committee believes that the
exemptions are sufficiently clear so that
all types of research, not just biomedical
or health research, may be reviewed
using the specified criteria. In addition.
the Committee has indicated that the
exemptions of ? .101(b) of the
Policy provides for the exemption of
certain research including much of the
research used by business (e.g., survey
research) in which there is little or no
risk.
Section -
Comment
Section .101(b)(2) is an
exemption for research involving the use
of educational tests, survey procedures
or observation of public behavior. To
paraphrase. this type of research is
exempt unless information is recorded
in a manner such that subjects can be
identified and disclosure of the
responses outside the research could
place the subjects at risk of criminal or
civil liability or be damaging to the
subjects' financial standing.
employability, or reputation. Three
commentators expressed concern that
the additional subparts B. C. and D of
the HHS regulations for the protection of
human subjects are not part of the
Federal policy. They noted that
institutions with assurances with HHS
will be required to apply provisions of
those subparts in research they support
or conduct. while other Federally-
supported research would not be subject
to the subpart requirements.
Others commenting or.
.101(b)(2) indicated that
research that could involve sensitive
data could place the subjects at risk,
even if information is not recorded in
such a manner that human subjects can
be identified and should not be exempt
from provisions of the Policy. One
respondent noted that one IRB reviews
this type of research even if an
exemption is permitted by the
regulations. Another indicated that this
section will exclude from normally
exempt educational. survey, interview
or observational research any instances
wherein disclosure of subjects
responses couid he damaging to the
subject's reputation. Because reputation
is a subjective term that is difficult to
define operationaiiv. the commentator
suggested that the wording be changed
to limit exceptions to specific risks of
"professional and sociological damage."
Response
The Interagency Committee may at a
later date wish to consider incorporation
or provisions of the other subparts of the
HHS regulations into federal policy.
However, such considerations should
not delay publication of basic
protections for all human subjects. At
this time. institutions sponsoring
research under HHS-approved
assurances will adhere to provisions of
all the subparts of 45 CFR part 46. A
footnote has been added to
? .101(b) indicating that
Institutions with NITS-approved
assurances on file will abide by provisions of
45 CF.4 46 subparts A-D. Some of the other
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 28008 IARFtR 1i ?r/ R1 e"0;2OiQQ/A~'i(c8da~CIATRJP196i-QQ R6?30Q0 fl001-1
Departments and Agencies have
incorporated all provisions of 45 CFR
46.101(b) into their polic. es and procedures
as well. However, the exemptions at 45 CFR
46.101(b) do not apply to research involving
prisoners. fetuses. pregnant women. or
human in vitro fertilization. subparts B and
C. The exemption at 45CFR 48.101(b)(2) for
research involving surveyor interview
procedures or observation of public behavior,
does not apply to research with children.
subpart D. except for research involving
observation of public behavior when the
investigator(s) do not participate in the
activities being observed.
A Notice to amend subpart D, 45 CFR
40.401(a)(2)(b) to renumber exemptions
to permitted and not permitted to
conform the subpart':D reference to the
renumbered exemptions in the Common
Rule is published elsewhere in this issue
of the Federal Register.
Under this footnote, for research
involving children, institutions that have
multiple project assurances on file with
OPRR will not be able to use all
provisions in the exemption in
? 101(b)(2), However, the
educational tests basis for the
exemption contained in
? -101(b)(2), will still be
available to institutions conducting
research involving children. In
developing the common rule. a number
of HHS exemptionswere consolidated,
including the HHS educational tests
exemption. The educational tests
exemption has been available for use
under subpart D of the HHS regulations.,
Additional Protections Involving
Children. Thus, the 'footnote to the
common rule continues the provision
that existed under the previous
regulations.
Some institutions do not choose to
permit exemptions even if they are
permitted by the policy. This is their
prerogative, and assurances of
compliance incorporate provisions for
utilizing exemptions.
Section 141(6)(3)
Comment
Section .101(b)(3) described
an exemption for research involving the
use of educational' tests, survey
procedures, interview procedures. or
observation of public behavior that is
not exempt under the exemption in
? -101(b)(2) if human subjects
are elected or appointed public officials
or candidates for public office or if
Federal statute(s) require(s) without
exception that the, confidentiality of the
personally identifiable information will
be maintained throughout the research
and thereafter. Two commentators
recommended deletion of this exemption
because confidentiality considerations
are not the only purpose of IRB review,
Other human subjects protections issues
might need to be considered in research
that is not exempt by the criteria
described in ? 101(b)(2).
Furthermore, the commentators
explained that IRBs and institutions will
not know that Federal statutes afford
these protections, and inconsistency and
confusion is likely.
Response
At present the only statutes that meet
the criteria in ? 101(b)(3)(ii) of
which the Committee is aware are those
for research conducted or supported by
the Department of justice under 42
U.S.C. 3789g. and certain research
conducted or supported by the National
Center for Education Statistics of the
Department of Education under 20
U.S.C.1.221e-1. The Department of
Justice's Office of justice Programs (OJP)
has several constituent offices that
conduct research that would fall under
? 101(b)(3). The law governing
OJP research activities, 42 U.S.C.
3789g(a). provides that
Except as provided by Federal law other
than this chapter. no officer or employee of
the Federal Government. and no recipient of
assistance under the provisions of this
chapter shall use or reveal any research or
statistical information furnished under this
chapter by any person and identifiable to any
specific private person for any purpose other
than the purpose for which it was obtained in
accordance with this chapter. Such
information and copies thereof shall be
immune from legal process. and shall not.
without the consent of the person furnishing
such information. be admitted as evidence or
used for any purpose in any action. suit. or
other judicial, legislative. or administrative
proceedings.
The law governing research
conducted by the National Center for
Education Statistics under 20 U.S.C.
1ZZ1e-1 provides that data collected by
the National Center for Education
Statistics may not be used for any
purpose other than the statistical
purpose for which the data were
collected and establishes further
protections regarding that data,
including a provision that they
shall be immune from legal process, and
shall not without the consent of the
individual concerned. be admitted as
evidence or used for any purpose in any
action. suit. or other judicial or administrative
proceeding. 20 U.S.C. 1221e-1(d)(4)(B).
It Is the responsibility of a Federal
Department or Agency to assist the
institutions proposing to conduct a
research project which it supports in
determining if the research is subject to
the provisions of the Federal statutes
meeting the criteria in
? 101(b)(3)(ii).
Section -101(h)
Comment
Section 101(h) discusses
research that takes place in foreign
countries covered by the policy. One
respondent endorsed this section..
Another found the provision somewhat
ambiguous and suggested that it be
made clear that a researcher may either
comply with the policy provision or may
substitute the foreign procedure in lieu
of the policy only following a
determination by the Department or
Agency Head that the foreign
procedures are at least equivalent to
those required in the policy. Another
comment reflected that it may be
difficult at the time of submitti ng a
research proposal to a supporting
Department or Agency to know If a
foreign country's guidelines provide
protections which are at least equivalent
to the policy; the Interagency Committee
or Department or Agency Heads should
publish regulations or advisories
indicating which are considered
"equivalent."
Response
The Interagency Committee concurs
that evaluation of other country's
protection requirements in comparison
with the policy will be an important
Committee initiative and it will consider
publication of notices that reflet the
decisions of Department and Agency
Heads.
Also in ? 101(h), reference to
Helsinki as amended in 1983 is now
changed to Helsinki as amended in 1969.
Section 102 Definitions
Comment
Section .102 includes the
definition section in the Federal Policy.
In this section, one commentator asked
for a definition of "principal
investigator," since that individual bears
responsibility for human subject
protection. Another commentator
suggested adding a definition of
"scientific fraud."
Another suggestion was to take into
account First Amendment concerns
involving freedom of speech in'
situations where social scientists
Interview foreign and domestic,
government and private individuals to
obtain information. Another
commentator suggested that the
definition of human subject in
g 102(f) should make clear that
with, respect to interview research, a
distinction should be made between
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 i6 lda' .2G0W08YO8 TC i4ARDP?690089RO 338?32O 14
information provided by a person which
relates to past or present events or the
actions of others, as opposed to the
attitudes or actions of the interviewees
themselves: only in the latter case
should the interviewee constitute a
human subject. Also, another letter
explained that in some cultures,
ancestral research would not come
under the definition of "human subject"
because individuals were deceased.
However, this type of research might be
distressing to living family members.
Section 102(b) includes the
definition of "institution." One
commentator proposed that the
definition of "private entity" should also
be included.
Section 102(h) includes the
definition of "1RB approval." Three
commentators suggested that the term
"at the institution" was not appropriate
in the definition of approval as "' . *
determination of the IRB that the
research has been reviewed and may be
conducted at an institution within the
constraints set forth by the IRB and by
other institutional and federal
requirements." Much of the research of
an institution is off-site and thus seemed
to be in technical violation under the
proposed language.
Response
The Interagency Committee agrees
that the principal investigator is a key
person for protection of human subjects
and bears a broad responsibility for
implementation of the requirements. The
term "investigator" is used in the policy,
but not "principal investigator" and no
definition is provided because the
responsibility for protecting human
subjects is shared by the entire research
team. No definition of scientific fraud
has been included, and the term has
been deleted from ? 103(b)(5),
as described previously.
The Committee believes that the
comment on ? 102(f), definition
of "human subject," about interview
content is addressed through application
of exemption criteria in
? 101(b)(2) as well as in the
precise wording of the definition itself.
In response to the comments about the
phrase "at the institution" in the
definition of IRB approval in
? .102(h), the Interagency
Committee responds that there are
instances in which the IRB has approval
authority where the research is not
conducted at the institutional site. The
policy at ? 114, Cooperative
Research, is an important cross-
reference.
Establishment and approval of other
off-site IRBs may be required in some
circumstances in which another
institution is involved in research. The
Department or Agency Heads reserve
the authority to approve cooperative
arrangements. The phrase "at the
institution" in the definition of IRB
approval should be interpreted to mean
field sites and other off-site facilities
over which an institution has
jurisdiction.
Section 203 Assurances
Comment
Section 103 explains how
compliance is assured under this Policy
in research conducted or supported by a
federal Department or Agency. Most of
the comments on this section concerned
reporting and misconduct issues in
? 103(b)(5) or the "grace
period" or timing of certification in
? 103(f), discussed previously.
Several other comments are as follows:
Three respondents asked for
clarification of the rationale for
reporting requirements in
? 103(a). This section requires
that when the existence of an HHS-
approved assurance is accepted in iieu
of requiring submission of a new
assurance, reports required by the
Policy are to be made to the Department
and Agency Heads. Reports (with the
exception of certification) are also to be
made to OPRR.
Another comment was prompted by
review of ? 103(b)(1) which
requires inclusion in the assurance of
principles governing the institution in
protection of human subjects, such as a
statement of ethical principles or
existing codes. The commentator
suggested that a statement as to the
purpose of having regulations which
create an IRB structure should be
explicitly included in the regulations.
A comment concerning
? 103(f) requests clarification
on what type of certification
documentation will be acceptable.
Response
In consideration of these comments,
the Interagency Committee offers the
following information. In
? 103(a) the only reports
required to be made to both the head of
the Department or Agency supporting
the research and the OPRR when the
HHS assurance is utilized are those
required under ? 103(b)(5). The
head of the Department or Agency
supporting a research project must have
information concerning conduct of that
research including instances of
unanticipated problems or serious or
continuing noncompliance with the
Policy or the requirements or
determinations of the IRB and any
suspension or termination of IRB
approval. OPRR requires this
information to ensure that human
subjects protections under the Policy
and under the HII-IS-approved Assurance
are being properly implemented and that
institutions have fulfilled their
requirements in an appropriate and
timely manner.
With regard to the comment
concerning certification requirements in
? 103(f), standardized language
for the certification will be developed.
Certification now used by HI-IS has been
suggested as a basis for development of
the language.
Section 107 IRE Membership
Comment
Most of the commentators on
? 107 address the proposed
departure on IRB membership for the
Department of Education that has been
discussed above [? 107(a)].
Other comments received were as
follows; Reference is made in the Policy
in several places to vulnerable subject
populations. One commentator
indicated that all subject populations
are vulnerable and that the term
"exceptionally vulnerable" would be
better phraseology for those instances
for which additional safeguards are
urged or required.
Section 107(b) requires that
every reasonable nondiscriminatory
effort be made to ensure that no IRB
consists entirely of men or entirely of
women, including the institution's
consideration of qualified persons of
both sexes. One respondent indicated
that the HHS standard in the regulations
published in 1981 requiring that no IRB
shall be constituted entirely of men or
entirely of women should be retained. A
further requirement of ? .107(b)
is that no IRB may consist entirely of
members of one profession. Another
respondent suggested that the word
"discipline" be substituted for
"profession."
Response
The Committee did not believe that
the suggested language changes would
significantly improve the understanding
or implementation of the sections. It
expects that institutions will use good
judgment and diligence in selecting
persons as IRB members who can fulfill
the requirements of ? 107 (a)
and (b) so that persons of both genders
and persons with varying backgrounds
will promote responsible review of the
research activities. in approving
Assurances, the Federal Departments
and Agencies that conduct. support or
regulate research will review IRB
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 211010 tiecaol Re a?r/ a~e 08da C~une Pi~qi 0/O1 t ps tq39t~ 9Q901-1
composition to ensure that the
membership is appropriate for the
research, and may request that
membership be supplemented if
complete and adequate review of the
research does not appear possible.
As regards the gender consideration
in IRB composition the Committee notes
that in seeking diverse membership on
the IRB. the institution must consider
both men and women who can
contribute to the role of the IRB.
110 Expedited Review
"rocedures
Comment
This section sets forth expedited
review procedures for certain kinds of
research involving no more than
minimal risk and for, minor changes in
approved research. Section
110(b) indicates that an IRB
may use the expedited review procedure
under certain specified circumstances
with the approval of Department or
Agency heads. Four respondents noted
that confusion may 'result in institutions
if Departments or Agencies have
different requirements. Furthermore, it
may be burdensome to IRBs and
institutions to seek Department and
Agency approval for use of expedited
review. One respondent recommended
that the phrase "with the approval of
department or agency heads" in
? -110(b) be' deleted because it
will result in bureaucratic delays in
approval to use the "authority.
Furthermore. the authority to restrict use
of expedited review is found in
? _ 110(d) whereby the
Department or Agency head may
restrict, suspend, terminate or choose
not to authorize the; use of the expedited
review procedure.
Response
The Committee agreed that the phrase
in ? 110(b) "with the approval
of department or agency heads," should
be deleted because ? 110(d)
accomplished the intention of the
Committee. As an example of
Department and Agency use of this
authority, note that HHS does not permit
expedited review for institutions that do
not hold Multiple Project Assurances of
Compliance. Note also that some
institutions which have authority to use
expedited procedures choose to use full
IRB review instead.
Note that parentheses have been
added to the word "reviewer(s)" In
? -.110(b)(1) to clarify that one
or more reviewers may carry out the
expedited review procedures in
accordance with ? 110(b).
Section -111 Criteria for IRB
Approval of Research
Comment
Three commentators requested
deletion of the term "economically or
educationally disadvantaged" in the
examples of those who are vulnerable
subjects because of lack of clarity of the
term, difficulty in determining if some
subjects were in this category and
possible exclusion from beneficial
research protocols of those deemed to
be included in this category.
Response
The Committee believes that the
criteria for participation and the
potential vulnerability of some research
subjects are still a very important
consideration for IRBs. In exercising
their responsibilities, IRBs are charged
with evaluating the benefits and the
burdens of the research so that unjust
social patterns do not appear in the
overall distribution of the burdens and
benefits of research. The 1979 Belmont
Report outlining ethical principles and
guidelines for the protection of human
subjects of research written by the
National Commission for the Protection
of Human Subjects of Biomedical and
Behavioral Research makes special note
that some populations are burdened in
many ways by their social
circumstances and environments.
? ? ? when research is proposed that
involves risks and does not include a
therapeutic component, other less burdened
classes of persons should be called on first to
accept these risks of research, except where
research is directly related to the specific
conditions of the class involved.
? certain groups, such as racial
minorities, the economically disadvantaged,
the very sick, and the institutionalized may
continually be sought as research subjects,
owing to their ready availability in settings
where research is conducted. Given their
dependent status and their frequently
compromised capacity for free consent, they
should be protected against the danger of
being involved in research solely for
administrative convenience, or because they
are easy to manipulate as a result of their
Illness or socioeconomic condition.
The Committee expects that in its
review of equitable treatment and
review of benefits and burdens, the
educationally or economically
disadvantaged will not be excluded
from potentially beneficial research to
individuals or to those persons as a
class.
Section 113 Suspension or
Termination of IRB Approval of
Research
Comment
One comment was offered suggesting
that institutions, not IRBs. should report
to Department and Agency Heads.
Another response recommended that
OPRR be designated as the central
coordinating office to which such
notification should be sent. Designation
of OPRR as the single reporting channel
would ensure prompt requisite reporting
to the Government, the commentator
noted.
Response
This section does not require that the
IRB report to the Department or -gency
head. The responsibility for reporting is
specified in the institution's assurance.
OPRR will receive reports if
institutions have an assurance on file
with the HHS which covers the research
in question and will be notified in
accordance with 4 103(b)(3).
OPRR cannot act as a central
information office for other Departments
and Agencies in receiving reports of this
nature because of insufficient resnurces
and regulatory jurisdictional
considerations.
Section 114 Cooperative
Research
Comment
Confusion may result for institutions if
Departments and Agencies have
differing requirements.
Response
The Committee will attempt to advise
Departments and Agencies so that
procedural requirements will be
consistent,
Section 115 IRB Records
Comment
Modified language for this section
was suggested to assure that
confidentiality will be maintained to the
greatest extent possible.
Response
The Committee agreed that
confidentiality considerations are most
important for IRB records. While it
rejected the detailed language suggested
by the commentator, it acknowledged
the importance of maintaining
confidentiality. It believes that the
proposed language is adequate4
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 AnnrovdeF~b~ era>~~'~0OJ/l~8/08':/OIAs~DP$ -OV718l ROOi3&O 9~Qt~ lbns
Section 116 General
Requirements forlnformed Consent: and
Section 117 Documentation of
Informed Consent
Comment
One respondent wrote that the
differences between 4 -in (c)
and (d) and ? .117(c) were
confusing.
Response
Section 116(c) specifies that
an IRB may approve a consent
procedure which alters some or all of
the required elements of informed
consent or waives the requirement to
obtain informed consent in research or
demonstration projects which are
subject to approval of state and local
authorities and which meet certain other
requirements. Section .116(d)
specifies that an IRB may, under limited
circumstances (other than those of
116'c)j approve a consent
procedure which alters some or all of
the elements of informed consent or
waive the requirements to obtain
informed consent for certain types of
research. Section 117(c)
specifies conditions under which an !RB
may waive the requirement for the
investigator to obtain a signed consent
document for some or all subjects in the
research.
Section 123 Early Termination
of Research
Comment
Two commentators expressed concern
the establishment of this section implies
that a "blacklist" composed of
individuals and institutions that, in the
judgment of Department and Agency
Heads, have failed to discharge properly
their responsibilities for the protection
of human subjects. Serious breaches of
confidentiality and due process could be
implied. The inclusion of the
parenthetical phrase "(whether or not
the research was subject to federal
regulations)" was also of concern
because it implies that information
gathering may lead to violations of
confidentiality.
Response
The Committee is aware of concerns
about the need for confidentiality and
due process considerations. The
Committee notes that other federal
regulations deal with the suspension
and termination of funding. These
:egulations provide the requisite due
process. Sources of information and
criteria to be used by Department and
Agency Heads for making decisions are
addressed with more specificity in those
regulations. The federal government
does maintain information that is
pertinent to the exercise of the
discretionary authority to award
funding. Appropriate confidentiality
protections apply to that information.
Section 124 Conditions
Comment
A suggestion was made that
additional considerations of the
Department or Agency head noted in
this section should be limited to those
required by statute.
Response
The Committee, in its ongoing
deliberations, will attempt to maintain
consistency and minimize burdens to
institutions.
Department and Agency-Specific
Comments
Department of Education
The 34 CFR 97.107(a) departure on
composition of the iRB was discussed
earlier in this preamble.
The Department of Education
proposed to amend ?.101(b)(3),
To what does this policy apply, by
revising paragraph (b)(3)(li) to exempt
educational tests and surveys,
interviews, or certain observations from
coverage of the regulations if the
research is conducted under a program
subject to the protections of the General
Education Provisions Act (GEPA). This
departure would have expanded upon
an exception contained in the common
rule that exempted research conducted
under a statute that requires that the
confidentiality of the personally
identifiable information be maintained,
without exception, throughout the
research and thereafter.
Much of the research that would have
been covered by the GEPA exception is
conducted by the National Center for
Education Statistics (NCES). Since
publication of the NPRM for the
common rule, the Department has
developed procedures implementing
new authority under GEPA that
establish absolute confidentiality for
Individuals who are the subjects of the
NCES research which is subject to the
confidentiality requirements of section
406(d)(4) of GEPA. Thus. NCES research
covered by the GEPA confidentiality
requirements now falls within the
exception in the common rule that
excludes from coverage of the
regulations research under a statute that
provides for absolute confidentiality
(? 101(b)(3)(ii)) and an
expanded exception for that research is
unnecessary.
The Secretary has decided to
withdraw the GEPA departure as being
inconsistent with the Department's
overall objective of ensuring that
research conducted or sponsored by the
Department contain the greatest
possible protections consistent with the
common rule. Research of the
Department other than that conducted
under the NCES statute will be covered
by the common rule.
Comment
Four comments were received
regarding the exception from the
common rule requirements for programs
covered by CEPA. Three of the
commentators were concerned that the
proposed departure removed safeguards
or did not provide additional safeguards
for the protection of research subiects,
while possibly increasing administrative
burden on !RBs. One of these three
commentators was concerned that the
proposed departure might prohibit
certain research procedures as applied
to educational practices or programs.
One commentator indicated that the
proposed departure would not pose any
problems.
Response
The departure to
? .1O1(b)(3)(ii) was based on
statutes applicable to the Department
that provide protection for subjects of
the Department's education-related tests
and surveys, interview procedures, and
observation of public behavior. The
protections are found in the CEPA at
section 400A (control of paperwork) (20
U.S.C. 1221-3); section 406(d)(4)
(confidentiality of National Center for
Education Statistics data) (20 U.S.C.
1221e-1); section 438 (Family
Educational Rights and Frivacy Act) (20
U.S.C. 1232g); and section 439
(Protection of Pupil Rights Amendment)
(20 U.S.C. 1232h). The departure was not
intended to create additional burdens
for IRBs but to eliminate the need for
IRB approval of research in those cases
where the research was subject to the
GEPA. The Secretary has withdrawn the
proposed departure because it is
inconsistent with ensuring the greatest
protection under the programs
administered by the Department.
Because the departure is being
withdrawn, there is no need to explain
how the proposed departure would have
affected research practices.
Department of Veterans Affairs (VA)
Concern was expressed that
? .111(a)(4) and ? .116 of
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 ~sfliz 4 fc \f 5ce9r, . Sikc24qp/j0ffilpl, +~rt P1~~1-9~~ ~t X01-1
the Federal Policy would supersede the
Veterans Administration Department of
Medicine and Surgery (VA DYI&S)
Circular 10-813-50 which allows next of
kin to grant consent for incompetent
relatives under specific conditions.
The VA responded. however, that
Federal Policy mandates informed
consent by the subject. or the subject's
"legally authorized representative."
"Legally authorized representative" is
defined to include "individual(s)
authorized under applicable law * '
to consent on behalf of it prospective
subject * * '." Thus, the proposed
consent does not preclude next of kin
consent so long as such consent is
"authorized under applicable law."
38 U.S.C. 4131. and VA policies
promulgated thereunder, do authorize
next of kin consent. According;y, the
Common Federal Policy and current VA
policies are consistent.
Department of justice
The Department of Justice intends to
retain special protections for prison
populations in research it supports or
conducts in accordance with 28 CFR
parts 22 and 512.
Department of Defense
Cornment
One response requested clarification
of how the Federal Policy will extend to
DOD research. Numerous questions
concerning applicability to military and
non-military personnel, voluntary versus
mandated participation situations.
identifiable data and the broad range of
DOD-sponsored research were posed.
The respondent indicated that
formulating guidelines for informed
L:onsent is particularly important in the
military context.
Re& ponse
Questions raised regarding
application of the proposed regulations
to DOD-supported research are
reasonable and appropriate but are
regarded as agency specific. DOD plans
to address these particular issues
through revision of,DOD Directive 32-
18.2. Protection of Human Subjects in
UOD-supported Research.
The text of the common rule is
adopted by the following Department
and Agencies as sot forth below:
Text of the Common Rule
The text of the Common Rule as
adopted by the Department and
Agencies in this document appears
below:
CFR Part -Protection of with ? .-.101. ? 102. and
Human Subjects ? ___.107 through ? -117 of this
policy, by an institutional review: board
Sec. (IRB) that operates in accordance with
__.101 To what does this policy apply? the pertinent requirements of this policy.
-102 Definitions.
..103 Assuring compliance with this (b) Unless otherwise required by
policy-research conducted or supported department or agency heads, research
by any federal department or agency. activities in which the only involvement
_1G4-_106 (Reserved) of human subjects will be in one or more
-.107 IRB membership. of the following categories are exempt
-108 IRB functions and operations. from this policy:
_.109 IRB review of research.
-.110 Expedited review procedures for (1) Research conducted in established
certain kinds of research involving no or commonly accepted educational
more than minimal risk. and for minor settings, involving normal educational
changes in approved research. practices, such as (i) research on regular
-.111 Criteria for IRB approval of and special education instructional
research. strategies, or (ii) research on the:
_112 Review by institution, effectiveness of or the comparison
_.113 Suspension or termination of IRB among instructional techniques.
approval of research. curricula. or classroom management
_____114 Cooperative research.
__115 IRB records. methods.
_._.i16 General requirements for informed (2) Research involving the uselof
consent. educational tests (cognitive, diagnostic.
_--.117 Documentation of informed aptitude. achievement), survey
consent. procedures. interview procedures or
_-__.11d Applications and proposals iackin2 observation of public behavior, iruiess:
definite plans for involvement of human b d d d '
to
subjects.
_._.119 Research undertaken without the
intention of involving human subjects.
.120 Evaluation and dlapositicn of
applications and proposals for research
to be conducted or supported by a
federal department or agency.
_121 (Reserved)
.122 Use of federal funds.
._123 Early termination of research
support: evaluation of applications and
proposals.
,.124 Conditions.
(,) Information o tame is rector a
such a manner that human subjects can
he identified, directly or through
identifiers linked to the subjects;: and (ii)
any disclosure of the human subjects'
responses outside the research could
reasonably place the subjects at risk of
criminal or civil liability or be damaging
to the subjects' financial standing.
employability. or reputation.
(3) Research involving the use of
educational tests (cognitive. diagnostic.
?_101 To what does this policy apply? aptitude, achievement), survey
(a) Except as provided in paragraph procedures, interview procedures. or
exemptbservation under of public behparagraphavio(r r that is
()) of this section, this policy applies to observation
of
all research involving human subjects this section, if:
conducted, supported or otherwise
subject to regulation by any federal (i) The human subjects are elected or
department or agency which takes appointed public officials or candidates
appropriate administrative action to for public office: or (ii) federal statute(s)
make the policy applicable to such require(s) without exception that the
research. This includes research confidentiality of the personally
conducted by federal civilian employees identifiable information will be
or military personnel, except that each maintained throughout the research and
department or agency head may adopt thereafter.
such procedural modifications as may (4) Research, involving the collection
be appropriate from an administrative or study of existing data, documents.
standpoint. It also includes research records. pathological specimen$. or
conducted. supported. or otherwise diagnostic specimens, if these sources
subject to regulation by the federal are publicly available or if the
government outside the United States. information is recorded by the
(1) Research that is conducted or investigator in such a manner that
supported by a federal department or subjects cannot be identified, directly or
agency, whether or not it is regulated as through identifiers linked to the
defined in ? 102(e), must comply subjects.
with all sections of this policy. (5) Research and demonstration
(2) Research that is neither conducted projects which are conducted by or
nor supported by a federal department subject to the approval of department of
or agency but is subject to regulation as agency heads. and which are designed
defined in ? 102(e) must be to study. evaluate, or otherwise
reviewed and approved, in compliance examine:
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 (j) Public benefit or service programs:
('.i) procedures for obtaining benefits or
services under those programs: (iii)
possible changes in or aiterrativec to
those programs or procedures: or (iv)
possible changes in methods or levels of
payment for benefits or services under
those programs.
(6) Taste and food quality evaluation
and consumer acceptance studies, (i) if
wholesome foods without additives are
consumed or (ii) if a food is consumed
that contains a food ingredient at or
below the level and for a use found to
be safe, or agricultural chemical or
environmental contaminant at or below
the le el found to be safe, by the Food
and Dru Administration or approved by
the Environmental Protection Agency or
the Food Safety and Inspection Service
of the U.S. Department of Agriculture.
(c) Department or agency heads retain
,final judgment as to whether a particular
activity is covered by this policy.
(d) Department or agency heads may
require that specific research activities
or classes of research activities
conducted. supported. or otherwise
subject to regulation by the department
or agency but not otherwise covered by
ihis policy, comply with some or all of
the requirements of this policy.
(e) Compliance with this policy
requires compliance with pertinent
federal laws or regulations which
provide additional protections for
human subjects.
(fJ This policy does not affect any
state or local laws or rerilations which
may otherwise be applicable and which
provide additional protections for
human subjects.
(g) This policy does not affect any
foreign laws or regulations which may
otherwise be applicable and which
provide additional protections to human
subjects of research.
(h) When research covered by this
policy takes place in foreign countries,
procedures normally followed in the
foreign countries to protect human
subjects may differ from those set forth
in this policy. (An example is a foreign
institution which compiles with
guidelines consistent with the World
Medical Assembly Declaration
(Declaration of Helsinki amended 1989)
issued either by sovereign states or by
an organization whose function for the
protection of human research subjects is
internationally recognized.] In these
circumstances, if a department or
agency head determines that the
procedures prescribed by the institution
afford protections that are at least
equivalent to those provided in this
policy, the department or agency head
may approve the substitution of the
foreign procedures in lieu of the
procedural requirements provided in
tas policy. Except when otherwise
required by statute. Executive Order. or
the department or aszency head. notices
,,f these actions as they occur will be
rublished in the Federal Register or v. ill
be otherwise published as provided in
department or agency procedures.
(i) Unless otherwise required by law.
department or agency heads may waive
the applicability of some or all of the
provisions of this policy to specific
research activities or classes of research
activities otherwise covered by this
policy. Except when otherwise required
by statute or Executive Order. the
department or agency head shall
forward advance notices of these
actions to the Office for Protection from
Researct Risks, Department of Health
and Human Services (HHS), and shall
also publish them in the Federal Register
or in such cther manner as provided in
department or agency procedures.
-.: 02 Definitions.
(,i) Department or a ency head means
t e head of any federal department or
agency and any other officer or
employee of any department or agency
to whom authority has been delegated.
(b) Institution means any public or
private entity or agency (including
federal, state, and other agencies).
(c) Legally authorized representative
means an individual or judicial or other
body authorized under applicable law to
consent on behalf of a prospective
subject to the subject's participation in
the procedure(s) involved in the
research.
(d) Research means a systematic
investigation, including research
development, testing and evaluation.
designed to develop or contribute to
generalizable knowledge. Activities
which meet this definition constitute
research for purposes of this policy,
whether or not they are conducted or
supported under a program which is
considered research for other purposes.
For example. some demonstration and
service programs may include research
activities.
Institutions with HHS-avproved assurances on
f o will abide by provisions of title 45 CFR part 48
subparts A--D. Some of the other Departments and
regencies have incorporated all provisions of tide 45
CFR part 46 into their policies and procedures as
well. However, the exemptions at 45 CFR part
48.101ib) do not apply to research involving
prisoners, fetuses. pregnant women. or human in
vitro fertilization, subparts B and C. The exemption
at 45 CFR part 48.101(6)(2), for research involving
survey or interview procoaures or observation of
public behavior, does not apply to research with
children, subpart D. except for research involving
observations of public behavior when the
investigator(s) do not participate in the activities
being observed.
(e) Research subject to regulation,
and similar terms are intended to
encompass those research activities for
which a federal department or agency
has specific responsibility for regulatiop
as a research activity. (for example.
Investigational New Drug requirements
administered by the Food and Drug
Administration). It does not include
research activities which are
incidentally regulated by a federal
department or agency solely as part of
the department's or agency's broader
responsibility to regulate certain types
of activities whether research or non-
research in nature (for example. Wage
and Hour requirements administered by
the Department of Labor).
(f) Human subject means a living
individual about whom an investigator
(whether professional or student)
conducting research obtains
(1) data through intervention or
interaction with the individual, or
(2) identifiable private information.
intervention includes both physical
procedures by which data are gathered
(for example, venipuncture) and
manipulations of the subject or the
subject's environment that are
performed for research purposes.
Interaction includes communication or
interpersonal contact between
investigator and subject. "Private
information" includes information about
behavior that occurs in a context in
which an. individual can reasonably
expect that no observation or recording
is taking place, and information which
has been provided for specific purposes
by an individual and which the
individual can reasonably expect will
not be mode public (for example, a
medical record). Private information
rust be individually identifiable (i.e..
the identity of the subject is or may
readii be ascertained by the
invesds;ator or associated with the
information) in order for obtaining the
i iformation to constitute research
involving human subjects.
(g) IRB means an institutional review
board established in accord with and for
the purposes expressed in this policy.
(h) IR3 cpproval means the
determination of the IRB that the
research has been reviewed and may be
conducted at an institution within the
constraints set forth by the IRB and by
other institutional and federal
requirements.
(i) Minima! risk means that the
probability and magnitude of harm or
discomfort anticipated in the research
are not greater in and of themselves
than those ordinarily encountered in
daily life or during the performance of
Approved For Release 2000/08/08 : CIA-RDP96-00789R003300220001-1
 routine physical or psychological
examinations or tests.
(j) Certification means the official
notification by the institution to the
supporting department or agency. in
accordance with the requirements of
this policy, that a research project or
activity involving human subjects has
been reviewed and approved by an IRB
in accordance with an approved
assurance.
__103 Assuring compliance with this
policy-research conducted or supported
by any federal department or agency.
(a) Each institution engaged in
research which is covered by this policy
and which is conducted or supported by
a federal department or agency shall
Provide written assurance satisfactory
to the department or agency head that it
will comply with the,requirements set
forth in this policy. In Lieu of requiring
submission of an assurance. inuiv'.doal
oartment or acencv heads shall
accept the ex;srenceof :rent
assurance, appropriate for the research
in question. on file t%'~..?th the Office for
Protection from Research Risks. Hi-IS,
and approved for federalwide use by
that office. When the existence of an
HHS-approved assurance is accepted in
lieu of requiring submission of an
assurance. reports [d,.,crpt ceit:ficauoni
required by this policy to be made to
department and agehtcv heads shall also
be made to the Office for Prorer.tion
from Research Risks. -HS.
(b) Departments er.d agencies cdi
conduct or support r'--search covered by
.his policy only if the institution has an
assurance app: . ed as nrovided in this
section, and oriy if the institution r.as
cart;fied to the deoattmant or accncv
head that the research has been
-.P viewed and aoaro,i,-ed. Lv on
iPB
provided for u -'a