[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.

[[Page 423]]

    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.