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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
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Federal Register
Vol. 56. No. 117 7 Tuesday, June 18. 1991 / Notices
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 (HHS).
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) 496-
7005.
D. Allan Bromley,
Director, Office of Science and Technology
Policy. Executive Office of the President.
[FR Doc. 91-14257 Filed 6-17-91: 8:45 amj
BILLING CODE 3170-01-M
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Rules and Regulations
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DEPARTMENT OF AGRICULTURE
7 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
16 CFR Part 1028
INTERNATIONAL DEVELOPMENT
COOPERATION AGENCY
Agency for International Development
22 CFR Part 225
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 46
NATIONAL SCIENCE FOUNDATION
45 CFR Part €90
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.
SUMMARY: This document 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 Agencies. A
Proposed Federal Policy for the
Protection of Human Subjects published
November 10. 1988 (53 FR 45661) has
been revised in response to public
comments. The Policy as revised is now
set 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.
Edward Glassman, Office of Planning,
Budget and Evaluation, U.S. Department
of Education. room 3127, 400 Maryland
Avenue SW., Washington, DC 20202-
4132. A document announcing the
effective date of the Department of
Education regulations will be published
in the Federal Register. Institutions
currently conducting or supporting
research in accord with Multiple Project
Assurances of Compliance (MPAs)
approved by and on file in the Office for
Protection from 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. Joan P. Porter. (301) 496-7005. Office
for Protection from Research Risks.
National Institutes of Health, Building
31, room 5B59, Bethesda. MD 20892.
SUPPLEMENTARY INFORMATION:
Paperwork Reduction Act Requirements:
Sections
.103(a):
103(b);
103(b)(4)(i);
.103(b)(4)(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
Federal 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
OMB has approved the information
collection requirements during the 60-
day period before the final rule becomes
effective.
For further information regarding
OMB approval of the information
collection. contact Ms. Shannah Koss-
McCallum, OMB. (202) 395-7316.
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
Human Services (HHS), will continue to
renegotiate and approve MPAs in the
normal periodic cycle of renewal.
Institutions that are not operating
under an MPA approved by OPRR will
be required to negotiate an Assurance of
Compliance with the supporting
Department or Agency, prior to initiating
research involving human subjects.
Institutions with MPAs approved by
and on file with HHS will be allowed a
"grace period" of sixty days after the
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Federal Register / Vol. 56. No. 117 / Tuesday, June 18. 1991 / Rules and Regulations
submission date for an application
seeking HHS support, to provide
certification of Institutional Review
Board (IRB) review and approval.
Exceptions may occur for reasons of
Congressional mandate or special
program or review requirements. In such
cases. institutions will be advised that
certification must be sent at an earlier
time.
Background
This notice sets forth as a common
rule requirements for the protection of
human 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: 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:
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 be codified as listed above.
The Food and Drug Administration
(FDA) Final Rule to modify current
regulations to conform to the Federal
Policy are presented elsewhere 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. The
agency is committed to being as
consistent with the final Federal Policy
as it can be, 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
regulatory form will 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
the President's Commission was to
report bienmally to the President. the
Congress, and appropriate Federal
Departments and Agencies on the
protection of human subjects of
biomedical and behavioral research. In
carrying out that charge. the President's
Commission was directed to conduct a
review of the adequacy and uniformity
(1) of the rules, policies. guidelines, and
regulations of all Federal Departments
and Agencies regarding the protection of
human subjects of biomedical or
behavioral research which such
Departments and Agencies conduct or
support, and (2) of the implementation of
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 and Policies, and their
Implementation. for the Protection of
Human Subjects in Biomedical and
Behavioral Research. Protecting Human
Subjects.
In accord with Public Law 95-622.
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
to 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 May 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
of the President's Commission, including
the recommendation that:
The President should, through appropriate
action, require that all federal departments
and agencies adopt as a common core the
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 Ad 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 Federal Departments and
Agencies. In accordance with the
Commission's recommendation. the
Model Federal Policy is based on
subpart A of the regulations of HHS for
the protection of human research
subjects (45 CFR part 46). The Proposed
Model federal Policy developed by the
Ad Hoc 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, 1988, for
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adoption by each of the Departments
and Agencies listed. Response to the
more than 60 public comments.
discussion of revisions made to that
publication and the final common rule
follow.
Summary of Public Comments
Received in Response to the November
10. 1988. Federal Register publication (53
FR 45661) of the Notice of Proposed
Common Rulemaking, Federal Policy for
the Protection of Human Subjects for 16
Federal Departments and Agencies.
In response to the November 10, 1958.
publication, 66 commentators responded
within the comment period, which was
extended to February 8, 1989. The
source of comments included
institutional offices of sponsored
research, departmental deans and chairs
and other staff of academic institutions.
institutional review board members and
staff. principal investigators. and drug
company representatives. Although
there were 66 separate commentators.
several responses were prepared by
organizations each representing a
consortium of institutions which had
been polled concerning the notice of
proposed common rulemaking. For
example, the Council on Governmental
Relations. the Association of American
Medical Colleges, Public Responsibility
for Medicine and Research. Association
of American Universities, the American
Medical Association and the
Consortium of Social Science
Associations offered comment on behalf
of their member institutions.
In general, commentators endorsed
the efforts of the Office of Science and
Technology Policy and the Fegerai
Departments and Agencies to develop a
Common Rule for the protection of
human subjects.
The majority of the comments deait
with three points in the proposed
common rule, as follows:
Section
103(b)(5) concerns
those procedures set forth in Assurances
of Compliance for research conducted or
supported by a federal Department or
Agency. As proposed. this section
required that an Assurance should
include:
Written procedures for ensuring prompt
reporting to the IRB. appropriate institutional
officials, and the department or agency head
(i) any unanticipated problems or scientific
misconduct involving risks to human subjects
or others (ii) any instance of serious or
continuous noncompliance with this policy or
the requirements of determinations of the IRB
and (iii) any suspension or termination of IRB
approval.
Some commentators indicated that
they believed the proposed policy would
inappropriately require IRBs to notify
Department and Agency heads of
scientific misconduct involving risks to
human subjects and others and that the
scientific fraud and misconduct
regulations [September 19, 1988.
Responsibilities of PHS Awardee and
Applicant Institutions for Dealing with
and Reporting Possible Misconduct in
Science (53 FR 36344)] create duplicate
and potentially conflicting requirements.
Severai suggested that the proposed
rules on misconduct should leave
undisturbed other existing regulatory
schemes such as human subjects
regulations of the Department of Health
and Human Services at 45 CFR part 46.
Other commentators indicated that the
IRB should not have a "police" role and
that its members are potentially legally
liable if they did or did not report
certain misconduct activities. Concern
was also noted about additional
responsibility and work placed on the
IRB.
Several commentators requested
clarification of §
.103(b)(5)(i) in
the terms "misconduct" and
"unanticipated" problems. Respondents
suggested that scientific misconduct
implies falsification of data. plagiarism.
abuse of confidentiality, dishonesty in
presenting publications, legal violations
and a range of other activities which
should be addressed in a separate policy
involving broader institutional
considerations than those appropriate
for an IRB. In addition, some
respondents suggested that actual
"harm" rather than "possible risk" to
human subjects be reported to
Departments and Agencies.
Concerning §
103(b)(5)(ili)
two commentators suggested that IRBs
would be reluctant to suspend IRB-
approved research for administrative
infractions (such as tardiness of
response to an IRB) if such suspension
must be reported to an Agency. One
commentator requested that revisions
be made so that only suspensions or
terminations for serious or continuing
noncompliance with the policy or
determination of the IRB need be
reported to the Department or Agency
head. In that way, IRBs would use
suspension or termination as a
administrative tool and continue to keep
Departments and Agencies informed of
serious problems.
One specific set of comments
addressed all aspects of this section by
suggesting deletion of reporting
requirements to Department and Agency
Heads altogether. Rather. reports to
IRBs and institutional officials would be
required concerning unanticipated
problems involving risks to human
subjects which are substantial: proven
scientific fraud: instances of substantial
or continuing noncompliance with the
policy or the requirements or
determination of the IRB: or any
suspension or termination which is more
more than minor or temporarv.
Response
In view of the comments and the
policy concerning fraud and misconduct
that is now under deliberation. the
Interagency Human Subjects
Coordinating Committee revised
§
.. 103(b)(5) as follows:
Written procedures for ensuring prompt
reporting to the IRB. appropriate institutional
officials, and the department or agency head
of (i) any unanticipated problems involving
risks to subjects or others or any serious or
continuing noncompliance with this policy or
the requirements or determinations of the IRB
and (ii) any suspension or termination of IRB
approval.
The President's Commission
recommended in its 1981 First Biennial
Report that institutional assurances
should specify how "misconduct" should
be reported and investigated (pp. 77-82.
Recommendations 7 and 8). Since the
time of the publication of the 1981
report. however. the issue of
identification and reporting of
misconduct has been deliberated in
many other contexts and has included
consideration of more than "misconduct
involving risks to human subjects." In
August 1989 the Department of Health
and Human Services published a final
rule announcing responsibilities of
awardce and applicant institutions for
dealing with and reporting possible
misconduct in science [53 CFR 32446].
The Committee agrees that in the
current context the inclusion of the term
"misconduct" in the Federal Policy is
confusing and misleading because other
policy development efforts giving
specific meaning to scientific
misconduct are ongoing. Therefore, the
term is deleted from this document.
The revised language is closer to that
of the original provision in the
Department of Health and Human
Services regulations. The Interagency
Committee wishes to clarify that it was
never the intention of the Policy to
require IRBs to report directly to
Department and Agency Heads.
Assurances of Compliance are
negotiated between Departments or
Agencies and awardee institutions.
Assurances allow institutions to specify
how reporting to Department and
Agency Heads will take place. Reporting
is the responsibility of the institutional
official identified in each Assurance.
Further, the Committee wishes to
clarify that "unanticipated problems" in
this context includes serious and
unexpected reactions to biologicals.
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Executive Order 12291
These regulations have been reviewed
in accordance with Executive Order
2291. They are not classified as major
because 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
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 CFR 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: June 6, 1991.
Lamar Alexander.
Secretary of Education.
The Secretary amends title 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. 760-762. 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:
§ 350.3 What regulations apply to these
programs?
.
-
(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 ir.
working with these subjects.
(Authority: 20 U.S.C. 761a. 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.
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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:
Certification is required when the research
is supported by a federal department of
agency and not otherwise exempted or
waived under § §
.. 101 (b) or ji). An
institution with an approved assurance shall
certify research covered by the assurance
and by ģ
.. 103 of this policy has been
reviewed and approved by the IRB. Such
certification must be submitted with the
application or proposal or by such later date
as may be prescribed by the department of
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 by the IRB.
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 proposal has been
approved by the IRB. If the certification is not
submitted within these nme limits. the
application or proposal may be returned to
tha institution.
Most of the commentators (50)
addressed the need for a grace period
between the time of submission of an
application for support to a Department
and Agency and submission of
certification by the IRB of review and
approval of the proposal. A 60-day grace
period was allowed in the previous
Department of Health and Human
Services Regulations 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
frequently, 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
submission to HHS so that the most
current progress 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
proposais 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 60 day grace period is without
relevance to their review systems. At
the time of publication of the proposed
common rule. the Interagency
Committee noted that HH 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. HHS 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 shail be given to the
inclusion of one or more individuais
who are knowledgeable about and
experienced in working with these
subjects. The HIS 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 46]. the IRB shail 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
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rule's provision which required
institutions to consider representation
on the IRB of persons who are
knowledgeable about and experienced
in working with certain vulnerable
subjects if 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 IRB. Thus.
the rights of handicapped children and
mentally disabled persons should be
represented on any IRB that regularly
reviews proposals invoiving those
individuals. and there is no constructive
advantage to emphasizing these two
categories of subjects. Such an emphasis
was seen as a precedent with the
potential for discrimination against
other categories of vulnerable subiects.
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 ruie.
One commentator suggested that only
when the IRB regularly reviews research
that deals with handicapped children or
mentally disabled persons should the
IRB include at least one person
primariy 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. While the Secretary
agrees to the common rule provision
regarding IRB 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 should 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
cortain research including much of the
research used by business (e.g., survey
research) in which there is little or no
risk.
Section
101(b)(2)
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 on
.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 could be damaging to the
subject's reputation. Because reputation
is a subjective term that is difficult to
define operationaliv. 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 HHS-approved
assurances on file will abide by provisions of
45 CFR 46 subparts A-D. Some of the other
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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 45 CFR 46.101(b)(2) for
research involving survey or 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
46.401(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 exemptions were 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
101(b)(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. 1221e-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.
1221e-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 submitting 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 reflect 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 1989.
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
102(f) should make clear that
with, respect to interview research, a
distinction should be made between
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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 cuitures,
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 "IRB 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
103 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 lieu
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 HHS-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 HHS has been
suggested as a basis for development of
the language.
Section
107 IRB 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
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Rules and Regulations
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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.
Section
110 Expedited Review
Procedures
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 of
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 Agency
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 §
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 resources
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 adequate.
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Section
116 General
Requirements for Informed Consent: and
Section
117 Documentation of
Informed Consent
Comment
One respondent wrote that the
differences between §
.116 (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)
specities that an IRB may, under limited
circumstances [other than those of
.116(c)| 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 IRB
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
regulations 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)(ii) 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 GEPA. 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 IRBs. One of these three
commentators was concerned that the
proposed departure might prohibit
certein 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
101(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 GEPA 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 Privacy 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
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the Federal Policy would supersede the
Veterans Administration Department of
Medicine and Surgery (VA DM&S)
Circular 10-88-50 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 a 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. Accordingly, 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
Comment
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
consent is particularly important in the
military context.
Response
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-
16.2, Protection of Human Subjects in
DOD-supported Research.
The text of the common rule is
adopted by the following Department
and Agencies as set 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
Human Subjects
Sec.
__. 101
To what does this policy apply?
.. 102 Definitions.
.. 103 Assuring compliance with this
policy-research conducted or supported
by any federal department or agency.
_104 -____ 106 [Reserved]
.. 107
IRB membership.
_. 108
IRB functions and operations.
.. 109 IRB review of research.
.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
.111 Criteria for IRB approval of
research.
_112 Review by institution.
.113 Suspension or termination of IRB
approval of research.
.. 114
Cooperative research.
_. 115 IRB records.
.. 116 General requirements for informed
consent.
.117 Documentation of informed
consont.
.118 Applications and proposais lacking
definite plans for involvement of human
subjects.
119 Research undertaken without the
intention of involving human subjects.
.120 Evaluation and disposition 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.
§ __
_101 To what does this policy apply?
(a) Except as provided in paragraph
(b) of this section, this policy applies to
all research involving human subjects
conducted, supported or otherwise
subject to regulation by any federal
department or agency which takes
appropriate administrative action to
make the policy applicable to such
research. This includes research
conducted by federal civilian employees
or military personnel, except that each
department or agency head may adopt
such procedural modifications as may
be appropriate from an administrative
standpoint. It also includes research
conducted. supported, or otherwise
subject to regulation by the federal
government outside the United States.
(1) Research that is conducted or
supported by a federal department or
agency, whether or not it is regulated as
defined in §
___. 102(e), must comply
with all sections of this policy.
(2) Research that is neither conducted
nor supported by a federal department
or agency but is subject to regulation as
defined in § _. 102(e) must be
reviewed and approved, in compliance
with § ___ 101. §
__. 102. and
§ ___ 107 through §.
.117 of this
policy, by an institutional review board
(IRB) that operates in accordance with
the pertinent requirements of this policy.
(b) Unless otherwise required by
department or agency heads, research
activities in which the only involvement
of human subjects will be in one or more
of the following categories are exempt
from this policy:
(1) Research conducted in established
or commonly accepted educational
settings, involving normal educational
practices, such as (i) research on regular
and special education instructional
strategies, or (ii) research on the
effectiveness of or the comparison
among instructional techniques.
curricula. or classroom management
methods.
(2) Research involving the use of
educational tests (cognitive, diagnostic,
aptitude. achievement), survey
procedures, interview procedures or
observation of public behavior, unless:
(i) Information obtained is recorded in
such a manner that human subjects can
be 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.
aptitude, achievement). survey
procedures, interview procedures. or
observation of public behavior that is
not exempt under paragraph (b)(2) of
this section, if:
(i) The human subjects are elected or
appointed public officials or candidates
for public office: or (ii) federal statute(s)
require(s) without exception that the
confidentiality of the personally
identifiable information will be
maintained throughout the research and
thereafter.
(4) Research, involving the collection
or study of existing data, documents.
records, pathological specimens. or
diagnostic specimens. if these sources
are publicly available or if the
information is recorded by the
investigator in such a manner that
subjects cannot be identified, directly or
through identifiers linked to the
subjects.
(5) Research and demonstration
projects which are conducted by or
subject to the approval of department of
agency heads. and which are designed
to study, evaluate, or otherwise
examine:
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(i) Public benefit or service programs:
(li) procedures for obtaining benefits or
services under those programs: (iii)
possible changes in or alternatives 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 level found to be safe, by the Food
and Drug 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
this 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.
(f) This policy does not affect any
state or local laws or regulations 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 complies 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
this policy, Except when otherwise
required by statute. Executive Order. or
the department or agency head. notices
of these actions as they occur will be
published in the Federal Register or will
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
Research Risks, Department of Health
and Human Services (HHS), and shall
also publish them in the Federal Register
or in such other manner as provided in
department or agency procedures.
___ 102 Definitions.
(a) Department or agency head means
the head of any federal department of
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-approved assurances on
file will abide by provisions of title 45 CFR part 48
subparts A-D. Some of the other Departments and
Agencies have incorporated all provisions of title 45
CFR part 46 Into their policies and procedures as
well. However. the exemptions at 45 CFR part
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 45 CFR part 46.101(b)(2), for research involving
survey or interview procedures 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 regulating
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 of 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 made public (for example, a
medical record). Private information
must be individually identifiable (i.e ..
the identity of the subject is or may
readily be ascertained by the
investigator or associated with the
information) in order for obtaining the
information to constitute research
involving human subjects.
(8) IRB means an institutional review
board established in accord with and for
the purposes expressed in this policy.
(h) IRB approval 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) Minimal 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
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examinations or tests.
(j) Certification means the official
notification by the institution to the
supporting department of 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, individual
department or agency heads shall
accept the existence of a current
assurance, appropriate for the research
in question. on file with the Office for
Protection from Research Risks, HHS,
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 (except certificadon}
required by this policy to be made to
department and agency heads shall also
be made to the Office for Protection
from Research Risks, HHS.
(b) Departments and agencies will
conduct or support research covered by
this policy only if the institution has an
assurance approved as provided in this
section. and only if the institution has
certified to the department or agency
head that the research has been
reviewed and approved by an IRS
provided for in the assurance, and will
be subject to continuing review by the
IRB. Assurances applicable to tederally
supported er conducted research shall at
a minimum include:
(1) A statement of principles
governing the institution in the discharge
of its responsibilities for protecting the
rights and welfare of human subjects of
research conducted at or sponsored by
the institution. regardless of whether the
research is subject to federal regulation.
This may include an appropriate
existing code. declaration. or statement
of ethical principles, or a statement
formulated by the institution itself. This
requirement does not preempt
provisions of this policy applicable to
department- or agency-supported or
regulated research and need not be
applicable to any research exempted of
waived under §
____. 101 (b) or (i)
(2) Designation of one or more IRBs
established in accordance with the
requirements of this policy, and for
which provisions are made for meeting
space and sufficient staff to support the
IRB's review and recordkeeping duties.
(3) A list of IRB members identified by
name: earned degrees: representative
capacity: indications of experience such
as board certifications. licenses, etc ..
sufficient to describe each member's
chief anticipated contributions to IRB
deliberations; and any employment or
other relationship between each
member and the institution: for example:
full-time employee, part-time employee,
member of governing panel or board.
stockholder, paid or unpaid consultant.
Changes in IRB membership shall be
reported to the department or agency
head. unless in accord with § _. 103(a)
of this policy, the existence of an HHS-
approved assurance is accepted. In this
case, change in IRB membership shall be
reported to the Office for Protection
from Research Risks. HHS.
(4) Written procedures which the IRB
will follow (i) for conducting its initial
and continuing review of research and
for reporting its findings and actions to
the investigator and the institution; (ii)
for determining which projects require
review more often than annually and
which projects need verification from
sources other than the investigators that
no material changes have occurred since
previous IRB review: and fiii) for
ensuring prompt reporting to the IRB of
proposed changes in a research activity,
and for ensuring that such changes in
approved research. during the period for
which IRB approval has already been
given, may not be initiated without IRB
review and approval except when
necessary to eliminate apparent
immediate hazards to the subject.
(5) Written procedures for ensuring
prompt reporting to the IRB. appropriate
institutional officials, and the
department or agency head of (i) any
unanticipated problems involving risks
to subjects or others or any serious or
continuing noncompliance with this
policy or the requirements or
determinations of the IRB and (#) any
suspension or termination of IRB
approval.
(c) The assurance shall be executed
by an individual authorized to act for
the institution and to assume on behalf
of the institution the obligations
imposed by this policy and shall be filed
in such form and manner as the
department or agency head prescribes.
(d) The department or agency head
will evaluate all assurances submitted
in accordance with this policy through
such officers and employees of the
lepartment or agency and such experts
Cor consultants engaged for this purpose
as the department or agency head
determines to be appropriate. The
department or agency head's evaluation
will take into consideration the
adequacy of the proposed IRB in light of
the anticipated scope of the institution's
research 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.
(e) On the basis of this evaluation. the
department or agency head may
approve or disapprove the assurance, or
enter into negotiations to develop an
approvable one. The department or
agency head may limit the period during
which any particular approved
assurance or class of approved
assurances shall remain effective or
otherwise condition or restrict approval.
(f) Certification is required when the
research is supported by a federal
department or agency and not otherwise
exempted or waived under § __
1.101 (b)
or ti). An institution with an approved
assurance shall certify that each
application or proposal for research
covered by the assurance and by
___... 03 of this Policy has been
reviewed and approved by the IRB. Such
certification must be submitted with the
application or proposal or by such later
date as may be prescribed by the
department or agency to which the
application or proposal is submitted.
Under no condition shail research
covered by &_
.. 103 of the Policy be
supported prior to receipt of the
certification that the research has been
reviewed and approved by the IRB.
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 proposal has been
approved by the IRB. If the certification
is not submitted within these time limits.
the application or proposal may be
returned to the institution. (Approved by
the Office of Management and Budget
under Control Number 9999-0020.)
.104
(Reserved]
105 [Reserved]
§
106 [Reserved]
§
107 IRB membership.
(a) Each IRB shall have at least five
members, with varying backgrounds to
promote complete and adequate review
of research activities commonly
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conducted by the institution. The IRB
shall 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 shall 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 shail therefore include persons
knowledgeable in these areas. If an IRB
regularly reviews research that involves
a vulnerable category of subjects, such
as children. prisoners, pregnant women.
or handicapped 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.
(b) Every nondiscriminatory effort will
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, so
long as no selection is made to the IRB
on the basis of gender. No IRB may
consist entirely of members of one
profession.
(c) Each IRB shall include at least one
member whose primary concerns are in
scientific areas and at least one member
whose primary concerns are in
nonscientific areas.
(d) Each IRB shall include at least one
member who is not otherwise affiliated
with the institution and who is not part
of the immediate family of a person who
is affiliated with the institution.
(e) No IRB may have a member
participate in the IRB's initial or
continuing review of any project in
which the member has a conflicting
interest. except to provide information
requested by the IRB.
(f) An IRB may, in its discretion. invite
individuals with competence in special
areas to assist in the review of issues
which require expertise beyond or in
addition to that available on the IRB.
These individuals may not vote with the
IRB.
.. 108 IAB functions and operations.
In order to fulfill the requirements of
this policy each IRB shall:
(a) Follow written procedures in the
same detail as described in
§ __. 103(b)(4) and. to the extent
required by, § __. 103(b)[5].
(b) Except when an expedited review
procedure is used (see § _. 110),
review proposed research at convened
meetings at which a majority of the
members of the IRB are present.
including at least one member whose
primary concerns are in nonscientific
areas. In order for the research to be
approved. it shall receive the approval
of a majority of those members present
at the meeting.
8_109 IRB Review of Research.
(a) An IRB shall review and have
authority to approve, require
modifications in (to secure approval), or
disapprove all research activities
covered by this policy.
(b) An IRB shall require that
information given to subjects as part of
Informed consent is in accordance with
§ ___. 118. The IRB may require that
information, in addition to that
specifically mentioned in § ___ 116. be
given to the subjects when in the IRB's
judgment the information would
meaningfully add to the protection of the
rights and welfare of subjects.
(c) An IRB shall require
documentation of informed consent or
may waive documentation in
accordance with § __._. 117.
(d) An IRB shall notify investigators
and the institution in writing of its
decision to approve or disapprove the
proposed research activity, or of
modifications required to secure IRB
approval of the research activity. If the
IRB decides to disapprove a research
activity. it shall include in its written
notification a statement of the reasons
for its decision and give the investigator
an opportunity to respond in person or
in writing.
(e) An IRE shall conduct continuing
review of research covered by this
policy at intervals appropriate to the
degree of risk, but not less than once per
year, and shall have authority to
observe or have a third party observe
the consent process and the research.
(Approved by the Office of Management and
Budget under Control Number 9999-0020.)
§ ___. 110 Expedited review procedures
for certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
(a) The Secretary, HHS, has
established, and published as a Notice
in the Federal Register, a list of
categories of research that may be
reviewed by the IRB through an
expedited review procedure. The list
will be amended. as appropriate after
consultation with other departments and
agencies. through periodic republication
by the Secretary, HHS. in the Federal
Register. A copy of the list is available
from the Office for Protection from
Research Risks. National Institutes of
Heaith, HHS. Bethesda, Maryland 20892.
(b) An IRB may use the expedited
review procedure to review either or
both of the following:
(1) Some or all of the research
appearing on the list and found by the
reviewer(s) to involve no more than
minimal risk.
(2) Minor changes in previously
approved research during the period (of
one year or less) for which approval is
authorized.
Under an expedited review procedure.
the review may be carried out by the
IRB chairperson or by one or more
experienced reviewers designated by
the chairperson from among members of
the IRB. In reviewing the research. the
reviewers may exercise all of the
authorities of the IRB except that the
reviewers may not disapprove the
research. A research activity may be
disapproved only after review in
accordance with the non-expedited
procedure set forth in § ____. 108(b).
(c) Each IRB which uses an expedited
review procedure shall adopt a method
for keeping all members advised of
research proposals which have been
approved under the procedure.
(d) The department or agency head
may restrict, suspend, terminate, or
choose not to authorize an institution's
or IRB's nse of the expedited review
procedure.
§ ___. 111 Criteria for IRB approval of
research.
(a) In order to approve research
covered by this policy the IRB shall
determine that all of the following
requirements are satisfied:
(1) Risks to subjects are minimized: (i)
By using procedures which are
consistent with sound research design
and which do not unnecessarily expose
subjects to risk, and (il) whenever
appropriate, by using procedures
already being performed on the subjects
for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable in
relation to anticipated benefits. if any, to
subjects, and the importance of the
knowledge that may reasonably be
expected to result. In evaluating risks
and benefits, the IRB should consider
only those risks and benefits that may
result from the research (as
distinguished from risks and benefits of
therapies subjects would receive even if
not participating in the research). The
IRB should not consider possible long-
range effects of applying knowledge
gained in the research (for example, the
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Federal Register
Vol. 56. No. 119"
Regulations
possible effects of the research on public
policy) as among those research risks
that fall within the purview of its
responsibility.
(3) Selection of subjects is equitable.
In making this assessment the IRB
should take into account the purposes of
the research and the setting in which the
research will be conducted and should
be particularly cognizant of the special
problems of research involving
vulnerable populations. such as
children, prisoners. pregnant women.
mentally disabled persons, or
economically or educationally
disadvantaged persons.
(4) Informed consent will be sought
from each prospective subject or the
subject's legally authorized
representative, in accordance with, and
to the extent required by § ___... 116.
(5) Informed consent will be
appropriately documented, in
accordance with, and to the extent
required by §_
_. 117.
(6) When appropriate, the research
plan makes adequate provision for
monitoring the data collected to ensure
the safety of subjects.
(7) When appropriate, there are
adequate provisions to protect the
privacy of subjects and to maintain the
confidentiality of data.
(b) When some or all of the subjects
are likely to be vulnerable to coercion or
undue influence, such as children.
prisoners, pregnant women, mentally
disabled persons, or economically or
educationally disadvantaged persons.
additional safeguards have been
included in the study to protect the
rights and welfare of these subjects.
___. 112 Review by institution.
Research covered by this policy that
has been approved by an IRB may be
subject to further appropriate review
and approval or disapproval by officials
of the institution. However, those
officials may not approve the research if
it has not been approved by an IRB.
§ ____ 113 Suspension or termination of
IAB approval of research.
An IRB shall have authority to
suspend or terminate approval of
research that is not being conducted in
accordance with the IRB's requirements
or that has been associated with
unexpected serious harm to subjects.
Any suspension or termination of
approval shall include a statement of the
reasons for the IRB's action and shall be
reported promptly to the investigator.
appropriate institutional officials. and
the department or agency head.
(Approved by the Office of Management and
Budget under Control Number 9999-0020.)
§ _114 Cooperative research.
Cooperative research projects are
those projects covered by this policy
which involve more than one institution.
In the conduct of cooperative research
projects, each institution is responsible
for safeguarding the rights and welfare
of human subjects and for complying
with this policy. With the approval of
the department or agency head. an
institution participating in a cooperative
project may enter into a joint review
arrangement, rely upon the review of
another qualified IRB, or make similar
arrangements for avoiding duplication of
effort.
§ ___. 115 IRB records.
(a) An institution, or when
appropriate an IRB, shall prepare and
maintain adequate documentation of
IRB activities, including the following:
(1) Copies of all research proposals
reviewed, scientific evaluations, if any,
that accompany the proposals, approved
sample consent documents. progress
reports submitted by investigators. and
reports of injuries to subjects.
(2) Minutes of IRB meetings which
shall be in sufficient detail to show
attendance at the meetings; actions
taken by the IRB; the vote on these
actions including the number of
members voting for, against, and
abstaining: the basis for requiring
changes in or disapproving research;
and a written summary of the discussion
of controverted issues and their
resolution.
(3) Records of continuing review
activities.
(4) Copies of all correspondence
between the IRB and the investigators.
(5) A list of IRB members in the same
detail as described is §_
.103(b)(3).
(6) Written procedures for the IRB in
the same detail as described in
-. 103(b)(4) and § ___. 103(b)[5).
(7).Statements of significant new
findings provided to subjects, as
required by § ____. 116(b)(5).
(b) The records required by this policy
shall be retained for at least 3 years, and
records relating to research which is
conducted shall be retained for at least 3
years after completion of the research.
All records shall be accessible for
inspection and copying by authorized
representatives of the department or
agency at reasonable times and in a
reasonable manner. (Approved by the
Office of Management and Budget under
Control Number 9999-0020.)
§ __. 116 General requirements for
Informed consent.
Except as provided elsewhere in this
policy, no investigator may involve a
human being as a subject in research
covered by this policy unless the
investigator has obtained the legally
effective informed consent of the subject
or the subject's legally authorized
representative. An investigator shall
seek such consent only under
circumstances that provide the
prospective subject or the representative
sufficient opportunity to consider
whether or not to participate and that
minimize the possibility of coercion or
undue influence. The information that is
given to the subject or the
representative shall be in language
understandable to the subject or the
representative. No informed consent.
whether oral or written. may include
any exculpatory language through which
the subject or the representative is made
to waive or appear to waive any of the
subject's legal rights. or releases or
appears to release the investigator. the
sponsor. the institution or its agents
from liability for negligence.
(a) Basic elements of informed
consent. Except as provided in
paragraph (c) or (d) of this section. in
seeking informed consent the following
information shall be provided to each
subject:
(1) A statement that the study
involves research, an explanation of the
purposes of the research and the
expected duration of the subject's
participation, a description of the
procedures to be followed, and
identification of any procedures which
are experimental:
(2) A description of any reasonably
foreseeable risks or discomforts to the
subject:
(3) A description of any benefits to the
subject or to others which may
reasonably be expected from the
research:
(4) A disclosure of appropriate
alternative procedures or courses of
treatment, if any, that might be
advantageous to the subject:
(5) A statement describing the extent,
if any, to which confidentiality of
records identifying the subject will be
maintained;
(6) For research involving more than
minimal risk, an explanation as to
whether any compensation and an
explanation as to whether any medical
treatments are available if injury occurs
and, if so. what they consis of, or where
further information may be obtained;
(7) An explanation of whom to contact
for answers to pertinent questions about
the research and research subjects'
rights, and whom to contact in the event
of a research-related injury to the
subject: and
[8) A statement that participation is
voluntary. refusal to participate will
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invoive no penalty or loss of benefits to
which the subject is otherwise entitled.
and the subject may discontinue
participation at any time without
penalty or loss of benefits to which the
subject is otherwise entitled.
(b) Additional elements of informed
consent. When appropriate, one or more
of the following elements of information
shall also be provided to each subject:
(1) A statement that the particular
treatment or procedure may involve
risks to the subject (or to the embryo or
fetus. if the subject is or may become
pregnant) which are currently
unforeseeable:
[2) Anticipated circumstances under
which the subject's participation may be
terminated by the investigator without
regard to the subject's consent:
(3) Any additional costs to the subject
that may result from participation in the
research:
(4)The consequences of a subject's
decision to withdraw from the research
and procedures for orderly termination
of participation by the subject:
(5) A statement that significant new
findings developed during the course of
the research which may relate to the
subject's willingness to continue
participation will be provided to the
subject; and
(6) The approximate number of
subjects involved in the study.
(c) An IRB may approve a consent
procedure which does not include. or
which alters, some or all of the elements
of informed consent set forth above. or
waive the requirement to obtain
informed consent provided the IRB finds
and documents that:
(1) The research or demonstration
project is to be conducted by or subject
to the approval of state or local
government officials and is designed to
study, evaluate, or otherwise examine:
(i) Public benefit of service programs: (ii)
procedures for obtaining benefits or
services under those programs: (iii)
possible changes in or alternatives to
those programs or procedures: or (iv)
possible changes in methods or levels of
payment for benefits or services under
those programs: and
(2) The research could not practicably
be carried out without the waiver or
alteration.
(d) An IRB may approve a consent
procedure which does not include, or
which alters, some or all of the elements
of informed consent set forth in this
section, or waive the requirements to
obtain informed consent provided the
IRB finds and documents that:
(1) The research involves no more
thar minimal risk to the subjects:
(2) The waiver or alteration will not
adversely affect the rights and welfare
of the subjects;
(3) The research could not practicably
be carried out without the waiver or
alteration: and
(4) Whenever appropriate, the
subjects will be provided with
additional pertinent information after
participation.
(e) The informed consent
requirements in this policy are not
intended to preempt any applicable
federal, state. or local laws which
require additional information to be
disclosed in order for informed consent
to be legally effective.
(f) Nothing in this policy is intended to
limit the authority of a physician to
provide emergency medical care, to the
extent the physician is permitted to do
so under applicable federal, state, or
local law. (Approved by the Office of
Management and Budget under Control
Number 9999-0020.)
§ __. 117. Documentation of informed
consent.
(a) Except as provided in paragraph
(c) of this section, informed consent
shall be documented by the use of a
written consent form approved by the
IRB and signed by the subject or the
subject's legally authorized
representative. A copy shall be given to
the person signing the form.
(b) Except as provided in paragraph
(c) of this section, the consent form may
be either of the following:
(1) A written consent document that
embodies the elements of informed
consent required by § _116. This
form may be read to the subject or the
subject's legally authorized
representative, but in any event, the
investigator shall give either the subject
or the representative adequate
opportunity to read it before it is signed:
or
(2) A short form written consent
document stating that the elements of
informed consent required by § _
.116
have been presented orally to the
subject or the subject's legally
authorized representative. When this
method is used. there shall be a witness
to the oral presentation. Also, the IRB
shall approve a written summary of
what is to be said to the subject or the
representative. Only the short form itself
is to be signed by the subject or the
representative. However, the witness
shall sign both the short form and a copy
of the summary, and the person actually
obtaining consent shall sign a copy of
the summary. A copy of the summary
shall be given to the subject or the
representative. in addition to a copy of
the short form.
(c) An IRB may waive the requirement
for the investigator to obtain a signed
consent form for some or all subjects if
it finds either:
(1) That the only record linking the
subiect and the research would be the
consent document and the principal risk
would be potential harm resulting from
a breach of confidentiality. Each subject
will be asked whether the subject wants
documentation linking the subject with
the research, and the subject's wishes
will govern; or
(2) That the research presents no more
than minimal risk of harm to subjects
and involves no procedures for which
written consent is normally required
outside of the research context.
In cases in which the documentation
requirement is waived, the IRB may
require the investigator to provide
subjects with a written statement
regarding the research. (Approved by
the Office of Management and Budget
under Control Number 9999-0020.)
§ ___. 118 Applications and proposals
lacking definite plans for involvement of
human subjects.
Certain types of applications for
grants, cooperative agreements. or
contracts are submitted to departments
or agencies with the knowledge that
subjects may be involved within the
period of support, but definite plans
would not normally be set forth in the
application or proposal. These include
activities such as institutional type
grants when selection of specific
projects is the institution's
responsibility; research training grants
in which the activities involving subjects
remain to be selected: and projects in
which human subject's involvement will
depend upon completion of instruments.
prior animal studies. or purification of
compounds. These applications need not
be reviewed by an IRB before an award
may be made. However, except for
research exempted or waived under
$ _. 01 (b) or (i), no human subjects
may be involved in any project
supported by these awards until the
project has been reviewed and approved
by the IRB. as provided in this policy,
and certification submitted, by the
institution, to the department or agency.
___. 119 Research undertaken without
the Intention of involving human subjects.
In the event research is undertaken
without the intention of involving human
subjects, but it is later proposed to
involve human subjects in the research.
the research shall first be reviewed and
approved by an IRB, as provided in this
policy, a certification submitted. by the
institution, to the department or agency,
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and final approval given to the proposed
change by the department or agency.
§ _._. 120 Evaluation and disposition of
applications and proposals for research to
be conducted or supported by a federal
department or agency.
The department or agency head will
evaluate all applications and proposals
involving human subjects submitted to
the department or agency through such
officers and employees of the
department or agency and such experts
and consultants as the department or
agency head determines to be
appropriate. This evaluation will take
into consideration the risks to the
subjects, the adequacy of protection
against these risks. the potential
benefits of the research to the subjects
and others, and the importance of the
knowledge gained or to be gained.
(b) On the basis of this evaluation. the
department or agency head may
approve or disapprove the application or
proposal. or enter into negotiations to
develop an approvable one.
__ 121 [Reserved]
122 Use of federal funds.
Federal funds administered by a
department or agency may not be
expended for research involving human
subjects unless the requirements of this
policy have been satisfied.
§ ____ 123 Early termination of research
support; evaluation of applications and
proposals.
(a) The department or agency head
may require that department or agency
support for any project be terminated or
suspended in the manner prescribed in
applicable program requirements, when
the department or agency head finds an
institution has materially failed to
comply with the terms of this policy.
(b) In making decisions about
supporting or approving applications or
proposals covered by this policy the
department or agency head may take
into account. in addition to all other
eligibility requirements and program
criteria, factors such as whether the
applicant has been subject to a
termination or suspension under
paragarph (a) of this section and
whether the applicant or the person or
persons who would direct or has have
directed the scientific and technical
aspects of an activity has have, in the
judgment of the department or agency
head, materially failed to discharge
responsibility for the protection of the
rights and welfare of human subjects
(whether or not the research was subject
to federal regulation).
.. 124 Conditions.
With respect to any research project
or any class of research projects the
department or agency head may impose
additional conditions prior to or at the
time of approval when in the judgment
of the department or agency head
additional conditions are necessary for
the protection of human subjects.
DEPARTMENT OF AGRICULTURE
7 CFR Part 1c
RIN 0518-AA00
List of Subjects in 7 CFR Part 1c
Human subjects, Research, Reporting
and record keeping requirements. Title 7
of the Code of Federal Regulations is
amended by adding part 1c as set forth
at the end of this document.
PART 1c PROTECTION OF HUMAN
SUBJECTS
Sec.
1c.101 To what does this policy apply?
1c.102
Definitions.
1c.103 Assuring compliance with this
policy-research conducted or supported
by any Federal Department or Agency.
1c.104 [Reserved]
1c.105
[Reserved]
1c.106 [Reserved]
1c.107
IRB Membership.
1c.108 IRB functions and operations.
1c.109 IRB review of research.
1c.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
1c.111 Criteria for IRB approval of research.
1c.112 Review by institution.
1c.113 Suspension or termination of IRB
approval of research.
1c.114 Cooperative research.
1c.115 IRB records.
1c.116 General requirements for informed
consent.
1c.117 Documentation of informed consent.
1c.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
1c.119 Research undertaken without the
intention of involving human subjects.
1c.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency.
1c.121 [Reserved]
1c.122 Use of Federal funds.
1c.123 Early termination of research
support: Evaluation of applications and
proposals.
1c.124 Conditions.
Authority: 5 U.S.C. 301: 42 U.S.C. 300v-1(b)
Dated: December 13, 1990.
Charles E. Hess.
Assistant Secretary, Science & Education.
DEPARTMENT OF ENERGY
10 CFR Part 745
RIN 1901-AA13
List of Subjects in 10 CFR Part 745
Y
Human subjects, Research, reporting,
and Record-keeping requirements. Title
10 of the Code of Federal Regulations is
amended by revising part 745 as set
forth at the end of this document
PART 745 PROTECTION OF HUMAN
SUBJECTS
Sec.
745.101 To what does this policy apply?
745.102 Definitions.
745.103 Assuring compliance with this
policy-research conducted or supported
by any Federal Department or Agency. !
745.104 [Reserved]
745.105
[Reserved]
745.106
[Reserved]
745.107
IRB Membership.
745.108
IRB functions and operations.
745.109
IRB review of research.
745.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk. and for minor
changes in approved research.
745.111 Criteria for IRB approval of
research.
745.112 Review by institution.
745.113 Suspension or termination of IRB
approval of research.
745.114 Cooperating research.
745.115 IRB records.
745.116 General requirements for informed
consent.
745.117 Documentation of informed consent.
745.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
745.119 Research undertaken without the
intention of involving human subjects.
745.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency.
745.121 [Reserved]
745.122 Use of Federal funds.
745.123 Early termination of research
support: Evaluation of applications and
proposals.
745.124 Conditions.
Authority: 5 U.S.C. 301: 42 U.S.C. 7254; 42
U.S.C. 300v-1(b).
--
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Federal Register
Dated: December 21. 1990.
James D. Watkins.
Secretary of Energy.
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
14 CFR Part 1230
RIN 2700-AA76
List of Subjects in 14 CFR Part 1230
Human subjects. Research. Reporting
and Record-keeping requirements. Title
14 of the Code of Federal Regulations is
amended by adding part 1230 as set
forth at the end of this document.
PART 1230 PROTECTION OF HUMAN
SUBJECTS
Ser.
1230.101
To what does this policy apply?
1230.102
Definitions.
1230.103
Assuring compliance with this
policy-research conducted or supported
Ly any Federal Department of Agency.
1230.104
[Reserved!
1230.105
[Reserved]
!230.106
[Reserved]
1230.107
IRB Membership.
1230.108
[RB functions and operations.
1230.109 [RB review of research.
1230.110
Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
1230.111 Criteria for IRB approval of
research.
1230.112 Review by institution.
1220.113 Suspension or termination of IRB
approval of research.
1230.114 Cooperaave research.
1200.115
IRB records.
:230.116
General requirements for wiformed
consent.
: 233.117 Documentation of informed
consent.
12:1.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
1200.119 Research undertaken without the
intention of involving human subjects.
1230.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency.
1230.121 (Reserved]
1230.122
Use of Federal funds.
1230.123 Early termination of research
support: Evaluation of applications and
proposals.
1230.124 Conditions.
Authority: 5 J.S.C. 301: 42 U.S.C. 300v-1(b).
Dated: january 21. 1991.
Richard H. Truly
Administrator.
DEPARTMENT OF COMMERCE
15 CFR Part 27
RIN 0690-AA17
List of Subjects in 15 CFR Part 27
Human subjects. Research, Reporting
and recordkeeping requirements. Title
15 of the Code of Federal Regulations is
amended by adding part 27 as set forth
at the end of this document.
PART 27 PROTECTION OF HUMAN
SUBJECTS
Sec.
27.101
To what does this policy apply?
27.102
Definitions.
27.103
Assuring compliance with this
policy-research conducted or supported
by any Federal Department or Agency.
27.104
[Reserved}
27.105
[Reserved}
27.106
[Reserved}
27.107
IRB Membership.
27.108
IRB functions and operations.
27.109
IRB review of research.
27.110
Expedited review procedures for
certain kinds of research involving no
more than minimal risk. and for minor
changes in approved research.
27.111 Criteria for IRB approval of research.
45.112 Review by institution.
27.113 Saspension or termination of IRB
approval of research.
7.114 Cooperative research.
25.115 IRB records.
4.116 General requirements for intormed
consent.
25.117 Documentation of informed consent.
27.118 Applications and proposais lacking
definite plans for involvement of human
subjects.
`7.119 Research undertaken without the
intention of involving human subjects.
27.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency.
27.121 [Reserved!
27.122 Use of Federal funds.
27.123 Early termination of research
support: Evaluation of applications and
proposais.
27.124 Conditions.
Authority: 5 U.S.C. 301: 42 U.S.C. 300v-1(b).
Dated: December 21. 1990.
Robert Mosbacher.
Secretary of Commerce.
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1028
RIN 3041-AA95
List of Subjects ir 16 CFR Part 1028
Human subjects, Research. Reporting
and recordkeeping requirements. Title
16 of the Code of Federal Regulations is
amended by revising part 1028 as set
forth at the end of this document.
PART 1028 PROTECTION OF HUMAI
SUBJECTS
Sec.
1028.101
To what does this policy apply?
1028.102
D.Finitions.
1028.103
Assuring compliance with this
policy-research conducted or supporte
by any Federal Department or Agency.
1028.104
! Reserved!
1028.105
(Reserved]
:028.106
¡Reserved]
1028.107
IRD Membership.
1028.108
IRB functions and operations.
1028.109
IFB review of research.
1028.110 Expedited review procedures for
Certain kinds of research involving no
more than minimal risk. and for miner
changes in approved research.
1028.111 Criteria for IRB approval of
research.
1028.112 Review by institution.
1028.113 Suspension or termination of IRB
approval of research.
1028.114
Cooperative research.
1028.115
(RB records.
1028.110
General requirements for infora:ec
consent.
:228.117 Documentation of informed
consent.
1028.118 Applications and proposals lackin
definite plans for involvement of human
subiects.
1028.119 Research undertaken without the
intention of involving human subiects.
!028.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federel Department or Agency.
1028.121 (Reserved]
1028.122 Use of Federal funds.
1028.123 Early termination of research
support: Evaluation of applications and
proposals.
1028.124 Conditions.
Authority: 5 U S C. 301: 42 U.S.C. 300v-1[h].
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28020
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Dated: January 11. 1991.
Sheldon D. Butts,
Acting Secretary.
INTERNATIONAL DEVELOPMENT
COOPERATION AGENCY, AGENCY
FOR INTERNATIONAL DEVELOPMENT
22 CFR Part 225
RIN 0412-AA17
List of Subjects in 22 CFR Part 225
Human subjects. Research, Reporting
and record keeping requirements. Title
22 of the Code of Federal Regulations is
amended by adding part 225 at set forth
at the end of this document.
PART 225 PROTECTION OF HUMAN
SUBJECTS
Sec.
225.101 To what does this policy apply?
225.102 Definitions.
225.103 Assuring compliance with this
policy-research conducted or supported
by any Federal Department or Agency.
225.104
[Reserved]
225.105
[Reserved]
225.106
[Reserved]
225.107
IRB Membership.
225.108
IRB functions and operations.
225.109 IRB review of research.
225.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
225.111 Criteria for IRB approval of
research.
225.112 Review by institution.
225.113 Suspension or termination of IRB
approval of research.
225.114
Cooperative research.
225.113
IRB records.
225.116 General requirements for informed
consent.
225.117 Documentation of informed consent.
225.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
225.119 Research undertaken without the
intention of involving human subjects.
225.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency,
225.121 [Reserved)
225.122 Use of Federal funds.
225.123 Earlv termination of research
support: Evaluation of applications and
proposals.
225.124 Conditions.
Authority: 5 U.S.C. 301: 42 U.S.C. 300v-1(b).
Dated: December 13. 1990.
Richard E. Bissell,
Assistant Administrator for Science and
Technology.
Dated: january 16. 1991.
Jack Kemp,
Secretary. U.S. Department of Housing and
Urban Development.
Department of Housing and Urban
Development
24 CFR Part 60
RIN 2501-AA15
List of Subjects in 24 CFR Part 60
Human subjects, Research, Reporting
and record-keeping requirements. Title
24 of the Code of Federal Regulations is
amended by adding part 60 as set forth
at the end of this document.
PART 60 PROTECTION OF HUMAN
SUBJECTS
Sec.
60.101 To what does this policy apply?
60.102 Definitions.
60.103 Assuring compliance with this
policy-research conducted or supported
by any Federal Department or Agency.
60.104 [Reserved]
60.105
[Reserved]
60.106
[Reserved]
60.107
IRB Membership.
80.108
IRB functions and operations.
60.109
IRB review of research.
60.110
Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
60.111 Criteria for IRB approval of research.
60.112 Review by institution.
60.113 Suspension or termination of IRB
approval of research.
60.114 Cooperative research.
60.115 IRB records.
60.116 General requirements for informed
consent.
60.117 Documentation of informed consent.
60.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
60.119 Research undertaken without the
intention of involving human subjects.
60.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency.
60.121 [Reserved]
60.122 Use of Federal funds.
60.123 Early termination of research
support: Evaluation of applications and
proposals.
60.124 Conditions.
Authority: 5 U.S.C. 301: 42 U.S.C. 300v-1(b).
DEPARTMENT OF JUSTICE
28 CFR Part 46
RIN 1105-AA13
List of Subjects in 28 CFR Part 46
Human subjects, Research. Reporting
and record-keeping requirements.
Title 28 of the Code of Federal
Regulations is amended by adding part
46 as set forth at the end of this
document.
PART 46-PROTECTION OF HUMAN
SUBJECTS
Sec.
46.101 To what does this policy apply?
46.102 Definitions.
46.103 Assuring compliance with this
policy-research conducted or supported
by any Federal Department or Agency.
46.104 {Reserved]
46.105
[Reserved]
46.106
[Reserved]
46.107
IRB Membership.
40.108 IRB functions and operations.
46.109 IRB review of research.
48.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
46.111 Criteria for IRB approval of research.
46.112 Review by institution.
46.113 Suspension or termination of IRB
approval of research.
46.114 Cooperative research.
46.115 [RB records.
46.116 General requirements for informed
consent.
46.117 Documentation of informed consent.
46.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
46.119 Research undertaken without the
intention of involving human subjects.
46.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency.
46.121
[Reserved]
46.122 Use of Federal funds.
46.123 Early termination of research
support: Evaluation of applications and
proposals.
46.124 Conditions.
Authority: 5 U.S.C. 301: 28 U.S.C. 509-510:
42 U.S.C. 300v-1(b).
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/ Tuesday, june 18, 1991 / Rules and Regulations
28021
Dated: December 24. 1990.
Dick Thornburgh,
Attorney General.
DEPARTMENT OF DEFENSE
32 CFR Part 219
RIN 0790-AC80
List of Subjects in 32 CFR Part 219
Human subjects, Research, Reporting
and record-keeping requirements.
Title 32 of the Code of Federal
Regulations is amended by revising part
219 as set forth at the end of this
document.
PART 219-PROTECTION OF HUMAN
SUBJECTS
Sec.
219.101
To what does this policy apply?
219.102
Definitions.
219.103
Assuring compliance with this
policy-research conducted or supported
by any Federal Department of Agency.
219.104 [Reserved]
219.105
[Reserved]
219.106
[Reserved]
219.107
IRB Membership.
219.108
IRB functions and operations.
219.109 IRB review of research.
219.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
219.111 Criteria for IRB approval of research
219.112 Review by institution.
219.113 Suspension or termination of IRB
approval of research.
219.114 Cooperative research.
219.115 IRB records.
219.116 General requirements for informed
consent.
219.117 Documentation of informed consent.
219.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
219.119 Research undertaken without the
intention of involving human subjects.
219.120 Evaluation and disposition of
applications and proposais for research
to be conducted or supported by a
Federal Department of Agency.
219.121 [Reserved]
219.122
Use of Federal funds.
219.123 Early termination of research
support: Evaluation of applications and
proposals.
-19,124 Conditions.
Authority: 5 U.S.C. 301: 42 U.S.C. 300v-
1(b) .-
Dated: january 9. 1991.
Linda M. Bynum.
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
DEPARTMENT OF EDUCATION
34 CFR Part 97
RIN 1875-AA07
List of Subjects in 34 CFR Part 97
Human subjects, Research. Reporting
and record-keeping requirements.
Title 34 of the Code of Federal
Regulations is amended by adding part
97 as set forth at the end of this
document.
PART 97-PROTECTION OF HUMAN
SUBJECTS
Sec.
97.101
To what does this policy apply?
97.102
Definitions.
97.103
Assuring compliance with this
policy-research conducted or supported
by any Federal Department or Agency.
97.104
{Reserved]
97.105
[Reserved]
97.106
[Reserved]
97.107
IRB Membership.
97.108
IRB functions and operations.
97.109
IRB review of research.
97.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
97.111 Criteria for IRB approval of research.
97.112 Review by institution.
97.113 Suspension or termination of IRB
approval of research.
97.114
Cooperative research.
97.115
IRB records.
97.116 General requirements for informed
consent.
97.117 Documentation of informed consent.
97.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
97.119 Research undertaken without the
intention of involving human subiects.
97.120 Fvaluation and disposition of
applications and proposais for research
to be conducted or supported by a
Federal Department or Agency.
97.121 [Reserved|
97.122 Use of Federal funds.
97.123 Early termination of research
support: Evaluation of applications and
proposais.
97.124 Conditions.
Authority: 5 U.S.C. 301: 42 U.S.C. 300v-1(b).
Dated' June 6, 1991.
Lamar Alexander.
U.S. Secretary of Education.
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 16
RIN 2900-AE29
List of Subjects in 38 CFR Part 16
Human subjects. Research. Reporting
and record-keeping requirements.
Title 38 of the Code of Federal
Regulations is amended by adding part
16 as set forth at the end of this
document
PART 16-PROTECTION OF HUMAN
SUBJECTS
Sec.
16.101
To what does this policy apply?
16.102
Definitions.
10.103
Assuring compliance with this policy-
research conducted or supported by any
Federal Department or Agency.
16.104
{Reserved]
16.105
[Reserved]
18.106
[Reserved]
16.107
IRB Membership.
16.108
IRB functions and operations.
16.109
IRB review of research.
16.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
16.111 Criteria for IRB approval of research.
16.112 Review by institution.
16.113 Suspension or termination of IRB
approval of research.
16.114 Cooperative research.
16.115 IRB records.
16.116 General requirements for informed
consent.
16.117 Documentation of informed consent.
16.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
16.119 Research undertaken without the
intention of involving human subjects.
16.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency
16.121
{Reserved]
16.122 Use of Federal funds.
16.123 Early termination of research
support: Evaluation of applications and
proposals.
16.124 Conditions.
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Authority: 5 U.S.C. 301: 38 U.S.C. 210(c)(1).
4131. 4134: 42 U.S.C. 300v-1(b).
Dated: February 19, 1991.
Edward j. Derwinski
Secretary of Veterans Affairs.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 26
RIN 2080-AA04
List of Subjects in 40 CFR Part 26
Human subjects. Research, Reporting
and record-keeping requirements.
Title 40 of the Code of Federal
Regulations is amended by adding part
26 as set forth at the end of this
document.
PART 26-PROTECTION OF HUMAN
SUBJECTS
Sec.
26.101 To what does this policy apply?
26.102 Definitions.
26.103 Assuring compliance with this
policy-research conducted or supported
by any Federal Department or Agency.
26.104
[Reserved]
26.105
[Reserved]
26.106
[Reserved]
26.107
IRB Membership.
26.108
IRB functions and operations.
26.109 IRB review of research.
26.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
26.111 Criteria for IRB approval of research.
26.112 Review by institution.
26.113 Suspension or termination of IRB
approval of research.
26.114 Cooperative research.
26.115 IRB records.
26.116 General requirements for informed
consent.
26.117 Documentation of informed consent.
28.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
26.119
Research undertaken without the
intention of involving human subjects.
26.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency.
26.121
[Reserved]
26.122 Use of Federal funds.
26.123 Early termination of research
support: Evaluation of applications and
proposals.
26.124 Conditions.
Authority: 5 U.S.C. 301: 42 U.S.C. 300v-1(b).
Dated: January 28, 1931.
William K. Reilly,
Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 46
RIN 0991-AA71
List of Subjects in 45 CFR Part 46
Human subjects. Research, Reporting
and record-keeping requirements.
Title 45 of the Code of Federal
Regulations part 46 is amended, as
follows:
1. An authority citation for subpart A
is added to read as follows:
Authority: 5 U.S.C. 301: 42 U.S.C. 289. 42
U.S.C. 300v-1(b).
2. Subpart A is revised to read as set
forth at the end of this document.
PART 46-PROTECTION OF HUMAN
SUBJECTS
Subpart A-Basic HHS Policy for Protection
of Human Research Subjects
Sec.
46.101 To what does this policy apply?
46.102 Definitions.
46.103 Assuring compliance with this
policy-research conducted or supported
by any Federal Department or Agency.
46.104 [Reserved]
46.105
[Reserved]
48.100
[Reserved]
48.107
IRB Membership.
46.108
IRB functions and operations.
46.109
IRB review of research.
46.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
46.111 Criteria for IRB approval of research.
46.112 Review by institution.
46.113 Suspension or termination of IRB
approval of research.
46.114 Cooperative research.
46.115 IRB records.
4.116 General requirements for informed
consent.
46.117 Documentation of informed consent.
46.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
46.119 Research undertaken without the
intention of involving human subjects.
46.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency.
48.121
[Reserved]
46.122
Use of Federal funds.
46.123 Early termination of research
support: Evaluation of applications and
proposals.
46.124 Conditions.
Dated: March 29. 1991.
Louis W. Sullivan.
Secretary of Health and Human Services.
NATIONAL SCIENCE FOUNDATION
45 CFR Part 690
RIN 3145-AA18
List of Subjects in 45 CFR Part 690
Human subjects, Research, Reporting
and record-keeping requirements.
Title 45 of the Code of Federal
Regulations is amended by adding part
690 as set forth at the end of this
document.
PART 690-PROTECTION OF HUMAN
SUBJECTS
Sec.
690.101 To what does this policy apply?
690.102 Definitions.
690.103 Assuring compliance with this
policy-research conducted or supported
by any Federal Department or Agency.
690.104 [Reserved]
690.105
[Reserved]
890.106
[Reserved]
690.107
IRB Membership.
690.108 IRB functions and operations.
690.109 IRB review of research.
690.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
690.111 Criteria for IRB approval of
research.
690.112 Review by institution.
690.113 Suspension or termination of IRB
approval of research.
690.114 Cooperative research.
690.115 IRB records.
690.116 General requirements for informed
consent.
690.117 Documentation of informed consent
690.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
690.119 Research undertaken without the
intention of involving human subjects.
690.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency.
890.121 [Reserved]
690.122 Use of Federal funds.
690.123 Early termination of research
support: Evaluation of applications and
proposals.
690.124 Conditions.
Dated: December 17, 1990.
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28023
Authority: 5 U.S.C. 301: 42 U.S.C. 300v-1(b).
Frederick M. Bernthal.
Acting Director.
DEPARTMENT OF TRANSPORTATION
49 CFR Part 11
RIN 2105-AB74
List of Subjects in 49 CFR Part 11
Human subjects, Research. Reporting
and record-keeping requirements.
Title 49 of the Code of Federal
Regulations is amended by adding part
11 as set forth at the need of this
document.
PART 11-PROTECTION OF HUMAN
SUBJECTS
Sec.
11.101 To what does this policy apply?
11.102 Definitions.
11.103 Assuring compliance with this
policy-research conducted or supported
by any Federal Department or Agency.
11.104
[Reserved]
11.105
[Reserved]
11.106
(Reserved)
11.107
IRB Membership.
11.108
IRB functions and operations.
11.109
IRB review of research.
11.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
11.111 Criteria for IRB approval of research.
11.112 Review by institution.
11.113 Suspension or termination of IRB
approval of research.
11.114 Cooperative research.
11.115 IRB records.
Sec.
11.116 General requirements for informed
consent.
11.117 Documentation of informed consent.
11.118
Applications and proposals lacking
definite plans for involvement of human
subjects.
11.119 Research undertaken without the
intention of involving human subjects.
11.120 Evaluation and disposition of
applications and proposals for research
to be conducted or supported by a
Federal Department or Agency.
11.121 [Reserved]
11.122 Use of Federal funds.
11.123 Early termination of research
support: Evaluation of applications and
proposais.
11.124 Conditions.
Authority: 5 U.S.C. 301: 42 U.S.C. 300v-11b).
Dated: February 4, 1991.
Samuel K. Skinner,
Secretary of Transportation.
[FR Doc. 91-14258 Filed 6-17-91: 8:45 am}
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28024
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Federal Register / Vol. 56. No. 117 / Tuesday, June 18, 1991 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Health Service
Agency Forms Submitted to the Office
of Management and Budget for
Clearance
The following request has been
submitted to the Office of Management
and Budget (OMB) for clearance in
compliance with the Paperwork
Reduction Act (44 U.S.C. chapter 35).
Expedited review by OMB has been
requested as described below.
(Call PHS Reports Clearance Officer
on 202-245-2100 for copies of
submission)
Federal Policy for the Protection of
Human Subjects-New-This
submission is for approval of the
information requirements associated
with the common rule for the protection
of hunan subjects of research
conducted. supported or regulated by
the following Federal departments and
agencies: Department of Agriculture,
Department of Energy, National
Aeronautics and Space Administration,
Department of Commerce, Consumer
Product Safety Commission, Agency for
International Development, Department
of Housing and Urban Development,
Department of Justice, Department of
Defense, Department of Education,
Department of Veterans' Affairs,
Environmental Protection Agency,
Department of Transportation, Central
Intelligence Agency, and Department of
Health and Human Services.
Adoption of the common Federal
policy by these departments and
agencies will implement a
recommendation of the President's
Commission for the Study of Ethical
Problems in Medicine and Biomedical
and Behavioral Research. The Office of
Science and Technology Policy
established an Interagency Human
Subjects Coordinating Committee under
the Federal Coordinating Council for
Science Engineering and Technology.
This group prepared a proposed Model
Federal Policy for the Protection of
Human Subjects that was published as a
proposed policy in 1986 and again as a
proposed common rule on November 10,
1988. After revision of the proposed
common rule in response to public
comments, the final common rule is
being published elsewhere in this issue
of the Federal Register. The common
rule is based on Department of Health
and Human Services (DHHS)
regulations (45 CFR part 46, subpart A),
the basic HHS Policy for the Protection
of Human Subjects.
Respondents: Individuals or
households, State or local governments,
businesses or other for-profit. Federal
agencies or employees, non-profit
institutions, small businesses or
organizations.
The total number of respondents
affected by these information
requirements is estimated at 3,831. The
total annual response burden for these
requirements including all Federal
departments and agencies subject to the
common rule, is estimated at 187,408
hours divided as follows: 22,982 hours
for recordkeeping requirements and
164.426 hours for reporting and
disclosure requirements.
Additional Information:
DHHS has submitted this request for
approval to OMB on behalf of all
Departments and Agencies governed by
this final rule. It is critical to receive
OMB review and approval for the
information requirements so that the
common rule for the Protection of
Human Subjects may be effective 60
days after publication. Federal
Departments and Agencies have
ongoing research programs to which the
common rule will apply, and they are
seeking the most expeditious time frame
in which to begin protection of human
subject policies and procedures. In
addition, institutions supported or
regulated by the involved Departments
and Agencies have requested
implementation of the final rule as soon
as possible to lessen burden of
compliance with numerous, sometimes
inconsistent, procedures for the
protection of human subjects required
by the various Federal Departments and
Agencies.
OMB has been requested to review
and approve the information
requirements in the common rule on an
expedited basis no later than August 2,
1991. In keeping with the requirements
for expedited review, we are publishing
this announcement in the same issue as
the proposed final rule. The information
requirements are separately identified in
the preamble to the rule, printed
elsewhere in this issue. There are no
separate forms or instructions for which
approval is being sought.
OMB Desk Officer: Shannah Koss-
McCallum.
Because of the time frame in which
OMB has been asked to act on this
request, any comments and
recommendations for the proposed
information collection should be
provided directly to the OMB Desk
Officer designated above by telephone
at (202) 395-7316 or by express mail at
the following address: Human Resources
and Housing Branch, New Executive
Office Building, room 3002. Washington,
DC 20503.
Dated: May 31, 1991.
Sandra K. Mahkorn,
1Deputy Assistant Secretary for Public
Health Policy.
[FR Doc. 91-14259 Filed 6-17-91: 8:45 am}
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28025
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 50 and 56
[ Docket No. 87N-00321
RIN 0905-AC52
Protection of Human Subjects;
Informed Consent; Standards for
Institutional Review Boards for Clinical
Investigations
AGENCY: Food and Drug Administration.
HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending its
regulations on institutional review
boards (IRB's) and on informed consent
to conform them to the "Federal Policy
for the Protection of Human Research
Subjects" (Federal Policy) published
elsewhere 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.
EFFECTIVE DATE: August 19, 1991.
FOR FURTHER INFORMATION CONTACT:
Richard M. Klein. Office of Health
Affairs (HFY-20). Food and Drug
Administration, 5600 Fishers Lane.
Rockville, MD 20357, 301-443-1382.
SUPPLEMENTARY INFORMATION:
1. Background
FDA is charged by statute with
ensuring the protection of the rights.
safety, and welfare of human subjects
who participate in clinical investigations
involving articles subject to section
505(i), 507(d), or 520(g) of the Federal
Food. Drug. and Cosmetic Act ( the act)
(21 U.S.C. 355(i), 357(d), or 360j(g)), as
well as clinical investigations that
support applications for research or
marketing permits for products regulated
by FDA, including food and color
additives, drugs for human use, medical
devices for human use, biological
products for human use. and electronic
products.
in the Federal Register of January 27.
1981. FDA adopted regulations
governing informed consent of human
subjects (21 CFR part 50; 46 FR 8942)
and regulations establishing standards
for the composition, operation, and
responsibilities of IRB's that review
clinical investigations involving human
subjects (21 CFR part 56; 46 FR 8958). At
the same time. the Department of Health
and Human Services (HHS) adopted
regulations on the protection of human
research subjects (45 CFR part 46: 46 FR
8366). The FDA and HHS regulations
share a common framework.
In December 1981. the President's
Commission for the study of Ethical
Problems in Medicine and Biomedical
and Behavioral Research (the
commission) issued its "First Biennial
Report on the Adequacy and Uniformity
of Federal Rules and Policies, and their
Implementation, for the Protection of
Human Subjects in Biomedical and
Behavioral Research. Protecting Human
Subjects." The commission
recommended that all Federal
departments and agencies adopt the
HHS regulations (45 CFR part 46).
In May 1982. the President's Science
Advisor, Office of Science and
Technology Policy (OSTP), appointed an
ad hoc Committee for the Protection of
Human Research Subjects (the
committee), under the auspices of the
Federal Coordinating Council for
Science. Engineering, and Technology
(FCCSET), to respond to the
recommendations of the commission.
The committee, composed of
representatives and ex officio members
from departments and agencies that
conduct, support, or regulate research
involving human subjects. developed
responses to the commission in
consultation with OSTP and the Office
of Management and Budget (OMB).
The committee agreed that uniformity
of Federal regulations on human subject
protection is desirable to eliminate
unnecessary regulations and to promote
increased understanding by institutions
that conduct federally-supported or
regulated research. The committee
developed a model policy which OSTP
later modified and. with the concurrence
of all affected Federal departments and
agencies, published as a proposal in the
Federal Register of June 3. 1986 (51 FR
20204). More than 200 comments were
submitted in response to the proposal.
Published elsewhere in this issue of the
Federal Register is the final rule on the
Federal Policy.
FDA concurs in that final rule. In the
Federal Register of November 10, 1988
(53 FR 45678), the agency proposed to
amend its regulations in 21 CFR parts 50
and 56 to conform them to the Federal
Policy to the extent permitted by the act.
The agency is committed to being as
consistent with the final Federal Policy
as it can be, given the unique
requirements of the act and the fact that
FDA is a regulatory agency that rarely
supports or conducts research under its
regulations. However, as explained in
the proposed rule. FDA must diverge
from § § .
.101(h) and
.116(d)
of the Federal Policy.
FDA received 22 comments on the
proposed rule from sponsora of
regulated research. institutional review
board members and staff, academic
institutions, medical societies, and
lawyers. Several comments were
prepared by organizations, each
representing a consortia of institutions
that had been polled concerning the
proposed rule.
A. General Comments
1. The majority of comments
supported the agency's efforts to
conform to the Federal Policy.
2. The majority of comments received
concerned the proposal to amend
§ 56.108(b) to require that IRB's follow
written guidelines for ensuring the
reporting of scientific misconduct and of
unanticipated problems to the IRB,
institutional officials, and FDA. Two
comments noted that this provision
would make the IRB the institutional
body that investigates alleged fraud
severely damaging the IRB/investigator
relationship and possibly diminishing
the effectiveness of the IRB in protecting
human subjects. Several comments
noted that the proposed additional
reporting requirements would duplica e
investigator and sponsor reporting
requirements and would be difficult for
the IRB to enforce. One comment said
that this section may adversely affect
the IRB/institution relationship and
asked how FDA intended to ensure that
reporting occurred. One comment
interpreted the provision as applicable
to animal studies and wondered
whether IRB's would be responsible for
contacting sponsors. One comment
expressed concern that the workload of
the IRB would increase and adversely
affect the recruitment of new members.
One comment sought to exclude
Adverse Drug Reaction reports. One
comment argued that the reporting
requirement was unauthorized by law.
Two comments from sponsors
requested that sponsor notification be
added under proposed § 56.108(b),
noting that an investigator engaged in
misconduct is unlikely to report that
misconduct to the IRB, and that the
sponsor is the entity that frequently
detects misconduct through its extensive
monitoring practices. In addition, these
comments requested clarification of the
office in FDA to which scientific
misconduct should be reported. Several
comments requested that FDA define or
clarify "scientific misconduct" and
"unanticipated problems."
Since the proposed model policy was
published, the Public Health Service
published a final rule concerning fraud
and misconduct in science (54 FR 32446.
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Federal Register / Vol. 56 No. 117 / Tuesday, June 18, 1991 / Rules and regulations
August 8, 1989). Because that rule directs
institutions to establish provisions for
the investigation of alleged scientific
fraud and misconduct, the mention of
"scientific misconduct" has been
deleted, as unnecessary, from the model
policy. Because FDA only proposed to
require that IRB's report scientific
misconduct to be consistent with the
model policy, it has deleted this
requirement from its final rule. This
action should allay many of the
concerns expressed in the comments.
Moreover. FDA believes that the
comments misconstrued the intent of
§ 56.108(b). This section requires simply
that an IRB have procedures by which it
checks to ensure in reviewing each
study presented. that provision has been
made in the study to notify the IRB.
appropriate institutional officials, and
FDA in the specified circumstances.
Section 56.108(b) does not require that
the IRB itself provide the notification to
either the institution or to FDA, unless
such reporting would not otherwise
occur. Although FDA's regulations
include reporting requirements for
certain types of investigational articles
(see. e.g., 21 CFR parts 312
(investigational drugs) and 812
(investigational devices)), there are no
such provisions for other articles that
may be the subject of an investigation
(e.g. food additives). Because all
regulated research to be conducted at an
institution will come before the IRB.
FDA finds that the IRB is the
appropriate entity to charge with the
responsibility for ensuring that reporting
of the specified problems to the IRB. the
institution, and the agency will occur.
3. One comment urged FDA to move
toward the adoption of an assurance
system as established for the other
agencies within HHS to guarantee
compliance with regulations for the
protection of human subjects.
FDA continues to believe that it
would be inappropriate for it to adopt
this mechanism. As stated in the final
rule in the Federal Register of January
27. 1981 (46 FR 8959, comment 2). the
benefits of assurance from IRB's that are
subject to FDA jurisdiction, but not
otherwise to HHS jurisdiction. do not
justify the increased administrative
burdens that would result from an
assurance system. FDA relies on its
Bioresearch Monitoring Program. along
with its educational efforts. to assure
compliance with these regulations.
4. One comment expressed concern
over FDA's proposed divergences from
sections 101(h) and 116(d) of the Federal
Policy. The comment contended that it is
sometimes impossible to obtain
informed consent. as defined by FDA's
regulations, in foreign clinical trials.
As stated in the proposed rule (53 FR
45679), FDA does not have the authority
to accept the procedures followed in a
foreign country in lieu of informed
consent as required by the act for
studies that are conducted under a
research permit that it grants. The
comment did not provide any
information that would compel a
different conclusion.
B. Comments on Definitions
5. One comment suggested that the
word "discomfort" used in proposed
§ § 50.3(i) and 56.102(i) is difficult to
define and is subjective.
FDA believes that the meaning of
"discomfort" is sufficiently clear. FDA
interprets this term to have its ordinary
meaning: that is, to mean the extent to
which a subject may be made
uncomfortable by the article that is the
subject of the research.
6. One comment asserted that
proposed § 56.102(m), the definition of
"IRB approval," suggests an intent to
change the procedural requirements of
IRB approval.
FDA proposed to add this definition to
make the regulations conform to the
Federal Policy and to clarify the
meaning of the phrase "IRB approva!"
under this rule. The addition of this
definition is not intended to effect a
substantive change in part 56. In the
preamble to its August 8, 1978 proposal
of the IRB regulation (43 FR 35186 at
35197), FDA presented a thorough
discussion of its authority to require IRB
review.
7. One comment stated that the
reference to "other institutional and
Federal requirements" in proposed
§ 56.102(m) goes beyond FDA's ability to
determine other institutional
requirements and may be
counterproductive where there is
conflict between the institutional
requirements and FDA of HHS
requirements. The suggestion is made to
delete "and other institutional'
requirements."
This definition is intended to make
clear that IRB approval is to be based on
a determination that the proposed
research is acceptable under any
applicable institutional requirements.
applicable law, and standards of
professional conduct and practice. If
there are conflicts between the
institutional requirements and Federal
law, those conflicts obviously must be
resolved in favor of the Federal law.
However, institutional requirements
often address matters not addressed by
Federal law. Therefore, FDA finds it
appropriate to mention both institutional
and Federal requirements in this
definition.
8. One comment suggested
substituting "clinical investigation" for
the word "research" in § 56.102(m).
FDA rejects the suggestion. FDA has
defined "clinical investigation" in
§ 56.102(c) to be synonymous with
"research" (46 FR 8976). Because FDA
desires to conform to the Federal Policy
and in the absence of a compelling
argument to diverge from it, FDA is
using the word used in the Federal
Policy.
9. Several comments suggested
deleting "at an institution" from
§ 56.102(m), contending that this phrase
may confuse the original intent of the
meaning of IRB approval. Another
comment noted that much research
today is conducted outside the
institutional setting.
FDA reiects the comments. In 1981,
when FDA adopted the IRB regulations.
FDA intentionally defined "institution"
broadly to include "any public or private
entity or agency" (§ 56.102(f); 46 FR
8963, comment 27). Thus, § 56.102(m) is
consistent with the original intent of the
IRB regulations.
10. One comment suggested revising
§ 56.102(m) to read "IRB approval means
+
* * that the research has been
reviewed for undue risk to the subject
and may be conducted
*
*
FDA rejects the suggestion. The
suggested change does not adequately
describe the role of the IRB. The IRB's
review of studies and informed consent
documents includes numerous
considerations in addition to whether
the study presents undue risks to the
human subjects invoived.
C. Comments on Exemptions From IRB
Requirements
11. One comment requested that no
exemptions from IRB requirements be
granted for those populations already
identified as vulnerable.
FDA did not propose that studies
involving vulnerable populations be
exempt from IRB review. The only
exemptions from the IRB review
requirements were established in the
1981 final rule (46 FR 8942: 21 CFR
56.104). The use of an investigational
article is exempt from IRB review if the
investigation started before july 27.
1981, before the requirement of IRB
review was in effect, or if it involves an
emergency use of the test article, in
which case there is not time for IRB
review before the article is used. The
agency found that in these
circumstances, the considerations that
support granting an exemption outweigh
those that would support denying it (46
FR 8965. comment 48). The comment did
not provide any basis for reconsidering
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. or revising this judgment. The agency
points out that the latter consideration
'emergency use), which is the only basis
on which a new study would be exempt.
applies only to particular uses of an
article and would not provide the basis
for an exemption for the use of an article
in a particular population. Therefore.
FDA finds that this comment provides
no basis for modifying its regulations.
12. One comment suggested that FDA
completely exempt "minimai risk"
studies from IRB review.
FDA rejects the comment. The
determination of minimal risk can be
made only by members of the IRB, not
the investigator or the sponsor. The
burden of an expedited review of a
protocol to determine if it presents
unimal risk is not so great as to justify
the requested exemption.
D. Comments on IRB Membership
13. Three comments suggested that
FDA define in § 56.107 the specific
members to be included on an IRB.
Several comments suggested that FDA
define. in new § 56.107(c). "non-
scientific" and "scientific." Two
comments suggested that the IRB
¡escludo "one member who has an
uncierstanding of the medical risks
involved." Another comment suggested
that § 56.107(c) be clarified to include a
statement requiring that at least one
member of the IRB have an
understanding of the scientific method.
FDA rejects these comments. FDA has
chosen not to prescribe professional
membership requirements for IRB
members. The regulations allow for
Bexibility in the makeup of the IRB (see
43 FR 8966, comment 35). They require.
however, that there be at least one
member whose concerns are in
nonscience areas and one member who
`as the professional competency to
review the proposed research, such as a
physician. FDA interprets "competency"
in this context to include the ability to
understand the scientific method. The
agency believes that the membership
requirements that it has adopted are
adequate to ensure that an IkB will be
abis to fully consider the issues
presented by a study.
14. One comment suggested that the
proposed change in § 56.107(a), allowing
IRB's that regularly review studies that
involve vulnerable categories of subjects
to consider including as a member an
individual knowledgeable about, and
experienced in, working with vulnerable
populations, will afford less human
subject protection than the current
regulation.
The current regulation states that an
IRB that regularly reviews research
involving vulnerable populations should
include as members individuais who are
primarily concerned with the welfare of
vulnerable subjects. Revised § 56.107(a)
lists categories of subjects who are
considered vulnerable and requires that
the institution, or other authority.
consider including individuals
knowledgeable and experienced in
working with these types of subjects as
voting members on the IRB. This
revision is not intended to lessen in any
way the protections for vulnerable
populations under FDA's regulations. As
explained in the proposal (53 FR 45679).
FDA is making this change only to
conform to the language of the Federal
Policy.
FDA on its own initiative is adding
parenthesis to the word "reviewers" in
§ 56.110(b!(1) to permit a continuance of
existing IRB review procedures.
E. Comments on IRB Functions and
Operations
15. Several comments sought
clarification of new $ 50.108(b)(1) with
regard to the definition and
Interpretation of "any unanticipated
problems involving risks to human
subiects and others" and the level of
risk to be reported.
FDA interprets this phrase to mean an
unexpected adverse experience that is
not listed in the labeling for the test
article. Such experience includes an
event that may be symptomatically and
pathophysiologically related to an event
I'sted in the labeling but that differs
from the event because of greater
specificity or severity. The word
"others" has previously been defined as
persons who are participating in clinical
trials under the same or similar
protocols os who may be affected by
products or procedures developed in
those trials (see 53 FR 45061, 45665;
November 10, 1988).
F. Comments on Expedited Review
Procedures
16. One comment read the
parenthetical change in § 56.110(b). "uf
one year or less," as affecting a change
from the current regulations.
FDA disagrees with the comment.
Under current regulations. the IRD may
approve a study that will continue
beyond 1 year, such as a longitudinal
followup study. The IRB is obligated.
however, under § 56.109(e) (21 CFR
56.109(e)), to conduct continuing review
of the research at intervals appropriate
to the degree of risk that it presents but
not less than once a year.
17. One comment stated that
expedited review procedures should
never be used in research that involves
vulnerable populations.
FDA disagrees with the comment.
Expedited review procedures may only
be used to review research that involve
minimal risk as defined in § 56.102(i) o1
to review minor changes in previously
approved research (§ 56.110(b)). The
determination that such conditions
apply must be made by the chairperson
of the IRB. or by one or more
experienced members of the IRB
designated by the chairperson. Thus.
research involving vulnerable
populations will not be subject to
expedited review unless a member of
the IRB has affirmatively determined
that the subjects will not be exposed to
any greater risk of harm than they
encounter in daily life or during routin
physical or psychological examination
or tests. or that a change in research
that has been reviewed by the whole
IRB is minot. Obviously, in making the
determinations, the IRB member must
consider the nature of the subject
population. Moreover, if expedited
review is undertaken. the reviewer ma
exercise all the authority of the IRB.
including the authority under
§ 56.111(a)[3] to ensure that any specht
problems of vulnerable populations
have been addressed. Thus. FDA
believes that vulnerable populations
will not be involved in research that h.
been subject to expedited review
procedures without full consideration
whether such research should be subje
to expedited review at all and. if so. 0'
their interests. Therefore, FDA does n
agree with the comment.
G. Comments on Criteria for IRB
Anproval cf Research
18. One comment suggested deleting
". . . economically or educationally
disadvantaged persons * * * " from ni
3 56.111(al(3), stating that it would be
impossible for the IRB or the clinical
Investigator to make that determinatic
FDA disagrees with the comment. A
stated in § 56.111(b), FDA expects the
IRB to make sure that adequate
protections are included in those clini
investigations in which vulnerable
subjects will be participating. There is
no requirement for the IRB to make a
determination that individual subjects
are disadvantaged. However, the IRB
required to determine whether it is
likely that vulnerable individuals will
involved in the study, and. if so. whet!
adequate safeguards have been incluc
to protect the study subjects or wheth
additional safeguards are necessary.
II. Environmental Impact
The agency has determined under 2
CFR 25.24(a)(8) that this action is of a
type that does not individually or
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cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
III. Economic and Regulatory
Assessments
FDA has examined the economic
consequences of the final amendments
to its regulations pertaining to IRB's and
to informed consent in accordance with
the criteria in section 1(b) of Executive
Order 12291 and found that these
amendments would not be a major rule
under the Executive Order. The agency
also has considered the effect that the
final rule would have on small entities
including smell businesses in
accordance with the Regulatory
Flexibility Act (Pub. L. 96 -- 354). The
agency certifies that there will not be a
significant economic impact on a
substantial number of small entities.
FDA explained the basis for these
conclusions in the proposal (53 FR
45681). The agency did not receive any
comments that suggest contrary
conclusions. This final rule contains
information collections subject to the
Paperwork Reduction Act of 1930. These
information collections have been
approved under OMB control number
0910-0130.
List of Subjects in
21 CFR Part 50
Prisoners, Reporting and
recordkeeping requirements. Research.
Safety.
21 CFR Port 56
Reporting and Recordkeeping
requirements, Research. Safety.
Therefore. under the Federal Food,
Drug. and Cosmetic Act and the Public
Health Service Act. 21 CFR parts 50 and
56 are amended as follows:
PART 50-PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for 21 CFR
part 50 continues to read as follows:
Authority: Secs. 201. 408. 406. 409, 502. 503,
505. 508. 507, 510. 513-516, 518-520. 701. 706.
B01 of the Federal Food. Drug, and Cosmetic
Act (21 U.S.C. 321, 348. 346a. 349. 352. 353,
355. 356. 357, 350, 300c-360f, 360h-3601. 371.
376. 381): sec8. 215. 301. 351, 354-360F of the
Public Health Service Acl (42 U.S.C. 216. 241.
202. 263b-263n).
2. Section 50.3 is amended by revising
paragraph (I) to read as follows:
§ 50.3 Definitions.
.
(1) Minimol 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
routine physical or psychological
examinations or tests.
*
PART 56-INSTITUTIONAL REVIEW
BOARDS
3. The authority citation for 21 CFR
part 56 continues to read as follows:
Authority: Secs. 201. 406. 408. 409, 501. 502.
503, 505. 506. 507. 510, 513-516. 518-520. 701,
706. 801 of the Federal Food. Drug, and
Cosmetic Act (21 U.S.C. 321. 346. 346a. 343,
351, 352. 353. 355. 356. 357, 360, 360c-360f.
360h-360j. 371. 376. 361): secs. 215. 301. 351.
354-360F of the Public Health Service Act (42
U.S.C. 216. 241. 202. 2635-2631).
4. Section 58.102 is amended by
revising paragraph (i) and by adding
new paragraph (m) to read as follows:
§ 56.102 Definitions.
*
(i) Minimal 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
routine physical or psychological
examinations or tests.
·
(m) IRB approval means the
determination of the IRB that the clinical
investigation 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.
5. Section 56.104 is amended by
adding new paragraph (d) to read as
follows:
§ 56.104 Exemptions trom IRB
requirement.
.
+
.
(d) Taste and food quality evaluations
and consumer acceptance studies, if
wholesome foods without additives are
consumed or 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 level found to be safe. by the Food
and Drug Administration or approved by
the Environmental Protection Agency or
the Food Safety and Inspection Service
of the U.S. Department of Agriculture.
6. Section 56.107 is amended by
revising paragraphs (a), (b), and (c) to
read as follows:
§ 56.107 IRB membership.
(a) Each IRB shall have at least five
members, with varying backgrounds to
promote complete and adequate review
of research activities commonly
conducted by the institution. The IRB
shall be sufficiently qualified through
the experience and expertise of its
members. and the diversity of the
members, including consideration of
race, gender, 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 the
specific research activities. the IRB shall
be able to ascertain the acceptability of
proposed research in terms of
institutional commitments and
regulations, applicable law, and
standards or professional conduct and
practice. The IRB shall therefore include
persons knowledgeable in these areas. If
an IRB regularly reviews research that
involves a vulnerable catgory of
subjects, such as children. prisoners,
pregnant women. or handicapped of
mentally disabled persons.
consideration shall be given to the
inclusion of one or more individuals
who are knowledgeable about the
experienced in working with those
subjects.
(b) Every nondiscriminatory effort will
be made to ensure that no IRB consists
entirely of men or entirely of women,
including the instituton's consideration
of qualified persons of both sexes, so
long as no selection is made to the IRB
on the basis of gender. No IRE may
consist entirely of members of one
profession.
(c) Each IRB shall include at least one
member whose primary concerns are in
the scientific area and at least one
member whose primary concerns are in
nonscientific areas.
+
7. Section 56.108 is amended by
Levising paragraph (a), by removing
paragraph (c), by redesignating
paragraph (b) as paragraph (c). by
adding a new paragraph (b). and by
adding a parenthetical statement to the
end of the section to read as follows:
§ 56.10S IRB functions and operations.
(a) Follow written procedures: (1) For
conducting its initial and continuing
review of research and for reporting its
findings and actions to the investigator
and the institution; (2) for determining
which projects require review more
often than annually and which projects
need verification from sources other
than the investigator that no material
changes have occurred since previous
IRB review; (3) for ensuring prompt
reporting to the IRB of changes in
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28029
mosearch activity: and (4) for ensuring
that changes in approved research.
Juring the period for which IRB
approval has already been given, may
not be initiated without IRB review and
approval except where necessary to
eliminate apparent immediate hazards
to the human subjects.
(b) Follow written procedures for
ensuring prompt reporting to the IRB.
appropriate institutional officials, and
the Food and Drug Administration of: (1)
Any unanticipated problems involving
risks to human subjects or others: (2)
any instance of serious or continuing
noncompliance with these regulations or
the requirements or determinations of
the IRB; or (3) any suspension or
termination of IRB approval.
.
.
+
(Information collection requirements in this
section were approved by the Office of
Management and Budget (OMB) and assigned
OMB control number 0910-0130)
8. Section 56.110 is amended by
revising paragraph (b) to read as
follows:
§ 55.110 Expedited review procedures for
certain kinds of research involving no more
than minimal risk, and for minor changes in
approved research.
.
-
.
(b) An IRB may use the expedited
review procedure to review either or
both of the following: (1) Some or all of
the research appearing on the list and
found by the reviewer(s) to involve no
more than minimal risk, (2) minor
changes in previously approved
research during the period (of 1 year or
less) for which approval is authorized.
Under an expedited review procedure.
the review may be carried out by the
(RB chairperson or by one or more
experienced reviewers designated by
the IRB chairperson from among the
members of the IRB. In reviewing the
research, the reviewers may exercise all
of the authorities of the IRB except that
the reviewers may not disapprove the
research. A research activity may be
disapproved only after review in
accordance with the nonexpedited
review procedure set forth in § 56.108(c).
.
9. Section 56.111 is amended by
revising paragraphs (a)(3) and (b) to
read as follows:
§ 56.111 Criteria for IRB approval of
research.
(a) '
*
(3) Selection of subjects is equitable.
In making this assessment the IRB
should take into account the purposes of
the research and the setting in which the
research will be conducted and should
be particularly cognizant of the special
problems of research involving
vulnerable populations. such as
children. prisoners. pregnant women.
handicapped, or mentally disabled
persons, or economically or
educationally disadvantaged persons.
.
+
.
.
(b) When some or all of the subjects.
such as children, prisoners. pregnant
women. handicapped, or mentally
disabled persons, or economicaily or
educationally disadvantaged persons,
are likely to be vuinerable to coercion or
undue influence additional safeguards
have been included in the study to
protect the rights and welfare of these
subjects.
10. Section 56.115 is amended by
revising paragraph (a)(6) and by adding
a parenthetical statement to the end of
the section to read as follows:
§ 56.115 198 records.
(a)
(5) Written procedures for the IRB as
required by § 56.108 (a) and (b).
·
(Information collection requirements in this
section were approved by the Office of
Management and Budget (CME) and assigned
OMB control number 0910-0130)
Dated: March 29. 1991.
David A. Kessler,
Commissioner of Food and Drugs.
Louis W. Sullivan.
Secretary of Health and Human Services.
[FR Doc. 91-14260 Filed 0-17-01: 8:45 amį
BILLING CODE 4180-01-M
DEPARTMENT OF EDUCATION
34 CFR Parts 350 and 356
Protection Of Human Subjects-
Disability and Rehabilitation Research:
General Provisions, Disability and
Rehabilitation Research: Research
Fellowships
AGENCY: Department of Education.
ACTION: Interim final regulations with an
opportunity to comment.
SUMMARY: The Secretary amends
program regulations for the National
Institute on Disability and
Rehabilitation Research to add certain
protections for handicapped children
and mentally disabled persons who are
the subjects of research conducted or
sponsored by those programs.
Specifically, the program regulations
would require that when an institutional
review board (IRB) reviews research
involving these research subjects. the
IRB must include at least one person
who is primarily concerned with the
welfare of the research subjects. The
regulations are necessary as the result
of the Department of Education's
(Department) withdrawal of a departure
from the common regulations for the
protection of human research subjects.
DATES: Comments must be received on
or before August 2. 1991. These
regulations take effect either August 19.
1991. or later if the Congress takes
certain adjournments. if you want to
know the effective date of these
regulations. cail or write the Department
of Education contact person. A
document announcing the effective date
will be published in the Federal
Register.
ADDRESSES: All comments concerning
these interim final regulations should be
addressed to Mr. Edward Glassman;
Office of Planning. Budget and
Evaluation: U.S. Department of
Education. Federal Building #0. room
3127. 400 Maryland Avenue SW ..
Washington, DC 20202-4132.
FOR FURTHER INFORMATION CONTACT:
Edward B. Glassman. Telephone: (202)
401-3132. Deaf and hearing impaired
individuals may call the Federal Dual
Party Relay Service at 1-800-877-8339
(In the Washington DC area, 202 708-
9300) between 8 a.m. and 7 p.m. Eastern
Time.
SUPPLEMENTARY INFORMATION: The
Office of Science and Technology
Policy. Executive Office of the President
(OSTP), published a "Proposed Model
Policy for the Protection of Human
Subjects" in the Federal Register on Junt
3. 1986 (51 FR 20204). OSTP adopted a
final policy for the protection of human
research subjects on November 10. 1988
(53 FR 45660). The Final Policy adopted
by OSTP was included in proposed
common regulations published in the
Federal Register on November 10. 1938
(53 CFR 45661) by sixteen departments
and agencies in the Executive Branch of
the Federal Government, including the
Department of Education. The final
common regulations are published in
another section of this Federal Register
part.
The notice of proposed rulemaking
(NPRM) for the common regulations
specifically asked for comments
addressing what effect promulgation of
the Model Policy would have on each of
the agencies involved in the proposed
rulemaking. The Secretary proposed a
departure from the common regulations
that would require representation on an
Institutional Review Board (IRB) of at
least one person primarily concerned
with the welfare of the research subject:
whenever the research involves
handicapped children or mentally
disabled persons. As discussed below.
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the Secretary has decided to withdraw
this across-the-board departure in favor
of program-specific regulations under
those programs of the Department that
are likely to support covered research
that involves these research subjects.
Composition of the IRB
Comment
The Department proposed a departure
to § __. 107(a) of the common
regulations that would have required
that, for ali programs of the Department,
"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 subjects." The remainder of the
departure reiterated the common rule's
provision, which required institutions to
consider representation on the IRB of
persons who are knowledgeable about
and experienced in working with certain
vulnerable subjects if the IRB regularly
reviews research involving those
vulnerable subjects. Twenty-one
institutions focused on this proposed
departure in their comments. The
majority of these comments were
opposed to the proposed departure.
Some commenters, while supporting
the proposed general 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
IRB. Thus, the rights of handicapped
children and mentally disabled persons
should be represented on any IRB that
regularly reviews proposals involving
those individuals and there is nothing to
be gained by emphasizing these two
categories of subjects. Such an emphasis
was seen as a precedent with the
potential for discrimination against
other categories of vulnerable subjects.
When special expertise is required. IRBs
already have the option, and, they
believed. the obligation to seek informed
consultants. However, one commenter
stated "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."
One commenter suggested that only
when an IRB regularly reviews research
that deals with handicapped children or
mentally disabled persons should the
IRB include 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 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.
Some commenters objected to the lack
of consistency among Federal agencies
and cited the Department of Education's
proposed departure as inconsistent with
the purpose of the common rule. One
commenter indicated that the departure
would not pose any problem.
Response
The language of the proposed
departure was rooted in the Secretary's
concern that the welfare of research
subjects who are handicapped children
or mentally disabled persons be
adequately protected because of the
diminished capacity of such persons to
protect their own interests and their
corresponding greater potential for
harm. It should be noted that, while the
common rule does, in general, protect
the interests of vulnerable populations.
it does not specifically command
representation of their interests in all
cases. For example, the common rule
only requires that when an IRB regularly
reviews research involving vulnerable
subjects, consideration should be given
to including on the IRB a researcher
experienced in working with such
subjects. Thus, the Department believes
it is appropriate to offer special
protection for handicapped children and
mentally disabled persons, and the
protection proposed in the departure
would have satisfied that need.
The comments also appear to
misunderstand the intent of the
Department's proposed departure. Some
commenters believed that the departure
would require that an IRB include a
permanent member to represent the
special populations covered by the
departure. Others appeared to believe
that the departure would apply to all
research of the institution that involved
the special populations covered by the
departure. The proposed departure
would have produced neither of these
results. Instead, the proposed departure
would have required the addition of one
member on an ad hoc basis only when
the research is sponsored or funded by
the Department of Education and
purposefully requires the inclusion of
handicapped children or mentally
disabled persons.
As explained above, the Secretary
believes that there is a special need to
protect handicapped children and
mentally disabled persons. However,
given the broad policy objective of
providing consistent treatment through
common regulations, the Secretary has
decided that the IRB special
representation requirements contained
in the proposed departure are not
necessary for most of the programs of
the Department, because most programs
of the Department do not support
research likely to involve those persons.
Thus, the Secretary has decided to
withdraw the departure. However, the
Secretary believes that the concerns
addressed by the proposed departure
have a particular urgency in those
programs of the Department that support
a significant amount of research
involving handicapped children and
mentally disabled persons. Therefore,
the Secretary is amending the
regulations for the programs of the
National Institute on Disability and
Rehabilitation Research (34 CFR parts
350 and 356) to ensure that the
protections that would have been
afforded under the departure are
implemented in those specific programs.
Although the Secretary has decided to
publish this regulation in final form. due
to the strong public interest created by
the proposed departure, and because a
number of commenters appeared to
misunderstand the effect of the
proposed rule, the Secretary has also
decided to offer the public an additional
opportunity to comment on the final
rule. The address to which commenters
should send their comments and the
date by which those comments must be
received is stated at the beginning of
this preamble.
Changes
In the notice of proposed rulemaking.
the proposed departure was stated as
follows: "When an IRB reviews research
that deals with handicapped children or
mentally disabled persons, the IRB must
include at least one person primarily
concerned with the welfare of the
research subjects." The Secretary has
decided to change this language in the
program-specific regulations adopted in
this document to make clear that the
regulation specifically protects
handicapped children and mentally
disabled persons when those persons'
are purposefully included in a research
protocol. rather than incidentally.
Therefore, the language has been
changed to state: "When an IRB reviews
research that purposefully requires
inclusion of handicapped children or
mentally disabled persons in the
research sample, the IRB must include at
least one person primarily concerned
with the welfare of the research
subjects."
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