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[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.




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