[Federal Register: May 13, 1997 (Volume 62, Number 92)]
[Page 26367-26372]
_______________________________________________________________________
Memorandum of March 27, 1997--Strengthened Protections for Human
Subjects of Classified Research
Presidential Documents
___________________________________________________________________
Title 3--
The President
Memorandum of March 27, 1997
Strengthened Protections for Human Subjects of
Classified Research
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, [and] the
Chair of the Consumer Product Safety Commission
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.
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
dissenting 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.
THE WHITE HOUSE,
Washington, March 27, 1997.
