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ACHRE Report

Part III

Chapter 14


The Federal Policy for Human Subject Protections (The Common Rule)

Research Involving Ionizing Radiation

Scope of Programs of Research Involving Human Subjects

Administravtive Structures and Procedures for Research Oversight

Federal Responses to Violations of Human Subjects Protections

Protections for Human Subjects in Classified Research


Chapter 14: Protections for Human Subjects in Classified Research

We were advised that the only classified studies involving human subjects currently conducted by the six federal agencies are a small number of projects sponsored by the DOD and the CIA.[41] The Common Rule does not distinguish between classified and unclassified research in terms of the requirements or procedures it imposes to protect human subjects.

The Department of Defense reported that it currently sponsors a small number of classified research studies involving human subjects.[42] When such research is proposed, IRBs review classified protocols in one of two ways. The chair of the IRB may remove the classified portions of the protocol if he or she judges that those classified portions have no effect on the risks imposed on human subjects. Alternatively, the IRB may be composed of people with appropriate security clearances who then review the protocol in its entirety. A person not affiliated with the institution but with appropriate security clearance is included as a voting member of such IRBs.

The CIA indicated that it is currently performing classified human research projects.[43] The agency informed the Advisory Committee that all human subjects are informed of the CIA's sponsorship and of the specific nature of the study in which they are participating, even if the general purposes of the research are classified.[44]

Although DOE has the authority to conduct or support classified human subjects research projects, it reports that it is not currently conducting such research.[45] According to DOE guidelines, IRB review of classified research may take one of two forms.[46] If the chair of the IRB determines that none of the classified information in a proposal is relevant to the protection of human subjects and that the research can be accurately and fully described to the IRB, the proposed research will be reviewed at a regular IRB meeting without disclosure of any classified information. If the proposed research cannot be reviewed in the foregoing manner, however, the IRB must meet in a secure environment. (The Advisory Committee was advised that to date this has not occurred.) To review classified research, each member of the IRB must have the appropriate security clearance. The member of the IRB who is not affiliated with the institution conducting the research must also have security clearance to participate in the review of classified research. DOE guidelines recommend that IRBs expecting to review classified research obtain clearance for their nonaffiliated members so that they are not excluded from such reviews.

DHHS neither conducts nor sponsors any classified research. Some FDA personnel hold security clearances so that they may review classified investigational new drug or device applications submitted by the DOD, if the need to study or use these items in secret arises.[47] The VA does not now conduct any classified research and does not have original classification authority.[48] NASA currently conducts no classified research that involves human subjects and has not in the past. NASA does have classification authority, however, and conducts some classified research that does not involve human subjects.[49]

Research that involves human subjects and is classified for reasons of national security raises special issues for IRB review and for the process of obtaining informed consent, particularly with respect to the level of disclosure and waivers of informed consent. Specifically, the IRB must consider whether the prospective research subject will be adequately informed about the nature of classified research if some aspects of the research will not be disclosed in the informed consent process, whether security clearances are needed for IRB members, and whether information about classified studies must be partitioned from other IRB study reviews. Institutional review boards can determine that some aspect of a classified research project, if only the identity of the research sponsor, is irrelevant to the process of obtaining a subject's informed consent to participate. IRB members can decide that sponsorship information or complete disclosure of the purpose of the research need not be provided to potential subjects (in contrast to information about physical risk).

The Common Rule grants IRBs the authority to approve modifications in, or to waive entirely, informed consent requirements, but only for research involving no more than minimal risk.[50] A separate provision grants an agency head the authority to waive any requirement of the Common Rule for any kind of human subject research as long as advance notice is given to OPRR and the action is announced in the Federal Register.52 As indicated above, the rule makes no distinction between classified and unclassified research, so this latter route to an informed consent exception would appear to pose a tension between duties to disclose and the need to keep information secret.

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