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Notice of Intent to Develop Notice 443.1, Protection of Human Subjects in Classified Research

The purpose for developing this Notice will be to specify additional requirements for the conduct and protection of human subjects, specifically for classified research. This is necessary to ensure legal compliance with the Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March 27, 1997, commonly referred to as the "Clinton Memo," which the DOE and NNSA offices of General Counsel determined in June 2015 is still in effect and applicable to DOE federal and contractor organizations. The requirements outlined in the Clinton Memo are in addition to those specified in the Federal regulations (10 CFR Part 745) and DOE Order 443.lB, Protection of Human Research Subjects.

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