The Department of Energy last month issued new guidance on the conduct of classified scientific research involving human subjects.
While all human subject research is governed by federal regulations, the new DOE policy imposes several additional requirements whenever such research is to be performed on a classified basis.
For example, the proposed classified research must be reviewed and approved in advance by an Institutional Review Board, and the Board must include a non-scientist member and a member who is not a governmental employee (though he or she must hold a security clearance for this purpose). Also, the normal requirement for informed consent by the human subject cannot be waived.
See Protection of Human Subjects in Classified Research, DOE Notice N 443.1, approved January 21, 2016.
The nature of any such classified human subject research was not described. Speculatively, it might include certain types of research related to polygraph testing or other deception detection techniques. In the past, the Atomic Energy Commission notoriously carried out radiation experiments on unwitting human subjects, and the Central Intelligence Agency conducted behavior modification experiments involving drugs and other stimuli.
It seems that DOE today does little classified human subject research at its own initiative. Rather, “Almost all of the classified [DOE] human subjects research is done on behalf of other Federal sponsors under full cost recovery,” according to a related 2015 DOE memorandum.
The new DOE guidance was prepared after Department attorneys determined last year that a 1997 policy issued by President Bill Clinton was still in effect and applicable to DOE and its contractors. See Strengthened Protections for Human Subjects of Classified Research, March 27, 1997.
Department of Defense policy on classified research involving human subjects is set forth in Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, DoD Instruction 3216.02, November 8, 2011.
Of possible related interest, the National Declassification Center announced today that 37 cubic feet of classified subject files from the Director of the Office of Science and Technology Policy (OSTP) had been declassified and made available to researchers.
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