[Weekly Compilation of Presidential Documents Volume 33, Number 13 (Monday, March 31, 1997)]
[Pages 422-424]
[Online from the Government Publishing Office, www.gpo.gov]
<R04>
Memorandum on Protections for Human Subjects of Classified Research
March 27, 1997
Memorandum for the Secretary of Defense, the Attorney General, the
Secretary of Agriculture, the Secretary of Commerce, the Secretary of
Labor, the Secretary of Health and Human Services, the Secretary of
Housing and Urban Development, the Secretary of Transportation, the
Secretary of Energy, the Secretary of Education, the Secretary of
Veterans Affairs, the Director of Central Intelligence,the Administrator
of the Environmental Protection Agency, the Administrator of the Agency
for International Development, the Administrator of the National
Aeronautics and Space Administration, the Director of the National
Science Foundation, the Chair of the Nuclear Regulatory Commission, the
Director of the Office of Science and Technology Policy, the Chair of
the Consumer Product Safety Commission
Subject: Strengthened Protections for Human Subjects of Classified
Research
I have worked hard to restore trust and ensure openness in
government. This memorandum will further our progress toward these goals
by strengthening the Federal Government's protections for human subjects
of classified research.
In January 1994, I established the Advisory Committee on Human
Radiation Experiments (the ``Advisory Committee'') to examine reports
that the government had funded and conducted unethical human radiation
experiments during the Cold War. I directed the Advisory Committee to
uncover the truth, recommend steps to right past wrongs, and propose
ways to prevent unethical human subjects research from occurring in the
future. In its October 1995 final report, the Advisory Committee
recommended, among other things, that the government modify its policy
governing classified research on human subjects (``Recommendations for
Balancing National Security Interests and the Rights of the Public,''
Recommendation 15, Final Report, Advisory Committee on Human Radiation
Experiments). This memorandum sets forth policy changes in response to
those recommendations.
The Advisory Committee acknowledged that it is in the Nation's
interest to continue to allow the government to conduct classified
research involving human subjects where such research
serves important national security interests. The Advisory Committee found,
however, that classified human subjects research should be a ``rare event''
and that the ``subjects of such research, as well as the interests of the
public in openness in science and in government, deserve special
protections.'' The Advisory Committee was concerned about ``exceptions to
informed consent requirements and the absence of any special review and
approval process for human research that is to be classified.'' The
Advisory Committee recommended that in all classified research projects the
agency conducting or sponsoring the research meet the following
requirements:
--obtain informed consent from all human subjects;
--inform subjects of the identity of the sponsoring agency;
--inform subjects that the project involves classified research;
--obtain approval by an ``independent panel of nongovernmental
experts and citizen representatives, all with the necessary
security clearances'' that reviews scientific merit, risk-benefit
tradeoffs, and ensures subjects have enough information to make
informed decisions to give valid consent; and
--maintain permanent records of the panel's deliberations and
consent procedures.
This memorandum implements these recommendations with some
modifications. For classified research, it prohibits waiver of informed
consent and requires researchers to disclose that the project is
classified. For all but minimal risk studies, it requires researchers to
inform subjects of the sponsoring agency. It also requires permanent
recordkeeping.
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The memorandum also responds to the Advisory Committee's call for a
special review process for classified human subjects research. It
requires that institutional review boards for secret projects include a
nongovernmental member, and establishes an appeals process so that any
member of a review board who believes a project should not go forward
can appeal the boards' decision to approve it.
Finally, this memorandum sets forth additional steps to ensure that
classified human research is rare. It requires the heads of Federal
agencies to disclose annually the number of secret human research
projects undertaken by their agency. It also prohibits any agency from
conducting secret human research without first promulgating a final rule
applying the Federal Policy for the Protection of Human Subjects, as
modified in this memorandum, to the agency.
These steps, set forth in detail below, will preserve the
government's ability to conduct any necessary classified research
involving human subjects while ensuring adequate protection of research
participants.
1. Modifications to the Federal Policy for the Protection of Human
Subjects as it Affects Classified Research. All agencies that may
conduct or support classified research that is subject to the 1991
Federal Policy for the Protection of Human Subjects (``Common Rule'')
(56 Fed. Reg. 28010-28018) shall promptly jointly publish in the Federal
Register the following proposed revisions to the Common Rule as it
affects classified research. The Office for Protection from Research
Risks in the Department of Health and Human Services shall be the lead
agency and, in consultation with the Office of Management and Budget,
shall coordinate the joint rulemaking.
(a) The agencies shall jointly propose to prohibit waiver of
informed consent for classified research.
(b) The agencies shall jointly propose to prohibit the use of
expedited review procedures under the Common Rule for classified
research.
(c) The joint proposal should request comment on whether all
research exemptions under the Common Rule should be maintained for
classified research.
(d) The agencies shall jointly propose to require that in classified
research involving human subjects, two additional elements of
information be provided to potential subjects when consent is sought
from subjects:
(i) the identity of the sponsoring Federal agency. Exceptions
are allowed if the head of the sponsoring agency determines
that providing this information could compromise
intelligence sources or methods and that the research
involves no more than minimal risk to subjects. The
determination about sources and methods is to be made in
consultation with the Director of Central Intelligence and
the Assistant to the President for National Security
Affairs. The determination about risk is to be made in
consultation with the Director of the White House Office of
Science and Technology Policy.
(ii) a statement that the project is ``classified'' and an
explanation of what classified means.
(e) The agencies shall jointly propose to modify the institutional
review board (``IRB'') approval process for classified human subjects
research as follows:
(i) The Common Rule currently requires that each IRB ``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.'' For
classified research, the agencies shall define ``not
otherwise affiliated with the institution,'' as a
nongovernmental member with the appropriate security
clearance.
(ii) Under the Common Rule, research projects are approved by the
IRB if a ``majority of those (IRB) members present at a
meeting'' approved the project. For classified research, the
agencies shall propose to permit any member of the IRB who
does not believe a specific project should be approved by
the IRB to appeal a majority decision to approve the project
to the head of the sponsoring agency. If the agency head
affirms the IRB's decision to approve the project, the dis
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senting IRB member may appeal the IRB's decisions to the
Director of OSTP. The Director of OSTP shall review the
IRB's decision and approve or disapprove the project, or, at
the Director's discretion, convene an IRB made up of
nongovernmental officials, each with the appropriate
security clearances, to approve or disapprove the project.
(iii) IRBs for classified research shall determine whether
potential subjects need access to classified information to
make a valid informed consent decision.
2. Final Rules. Agencies shall, within 1 year, after considering any
comments, promulgate final rules on the protection of human subjects of
classified research.
3. Agency Head Approval of Classified Research Projects. Agencies
may not conduct any classified human research project subject to the
Common Rule unless the agency head has personally approved the specific
project.
4. Annual Public Disclosure of the Number of Classified Research
Projects. Each agency head shall inform the Director of OSTP by
September 30 of each year of the number of classified research projects
involving human subjects underway on that date, the number completed in
the previous 12-month period, and the number of human subjects in each
project. The Director of OSTP shall report the total number of
classified research projects and participating subjects to the President
and shall then report to the congressional armed services and
intelligence committees and further shall publish the numbers in the
Federal Register.
5. Definitions. For purposes of this memorandum, the terms
``research'' and ``human subject'' shall have the meaning set forth in
the Common Rule. ``Classified human research'' means research involving
``classified information'' as defined in Executive Order 12958.
6. No Classified Human Research Without Common Rule. Beginning one
year after the date of this memorandum, no agency shall conduct or
support classified human research without having proposed and
promulgated the Common Rule, including the changes set forth in this
memorandum and any subsequent amendments.
7. Judicial Review. This memorandum is not intended to create any
right or benefit, substantive or procedural, enforceable at law by a
party against the United States, its agencies, its officers, or any
other persons.
8. The Secretary of Health and Human Services shall publish this
memorandum in the Federal Register.
William J. Clinton
Note: This memorandum was released by the Office of the Press Secretary
on March 28.