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Presidential Memorandum

Strengthened Protections for Human Subjects of Classified Research

This 1997 presidential memorandum strengthens ethical protections for human subjects in classified government research by implementing recommendations from the Advisory Committee on Human Radiation Experiments. It prohibits waiver of informed consent for classified research, requires disclosure of sponsoring agencies and classification status to subjects, mandates special institutional review board procedures including nongovernmental members and appeals processes, requires annual public disclosure of secret research projects, and bars agencies from conducting such research without first adopting modified Common Rule regulations.

Federal Register Open PDF 62 FR 26369

Impact dates

  1. First annual disclosure of classified research projects to OSTP Director

  2. Final rules on protection of human subjects of classified research

  3. No agency may conduct classified human research without having proposed and promulgated modified Common Rule

Key directives

  • Prohibit waiver of informed consent for classified research
  • Prohibit expedited review procedures for classified research
  • Require disclosure of sponsoring agency identity to subjects (with national security exception)
  • Require disclosure that project is classified and explanation of what classified means
  • Require IRBs for classified research to include nongovernmental member with security clearance
  • Establish appeals process from IRB majority decisions to agency head, then to OSTP Director
  • Agency heads must personally approve each classified human research project
  • Annual public disclosure of number of classified research projects and subjects via OSTP to Congress and Federal Register
  • Joint proposed rulemaking to be led by HHS OPRR with OMB coordination
  • Final rules due within 1 year of memorandum

Who is ordered

Timeline

Immediate

  • Memorandum issued; agencies directed to begin joint rulemaking process

Near term (90d)

  • HHS Office for Protection from Research Risks to coordinate joint proposed rulemaking with OMB consultation

Long term

  • Final rules due within 1 year; annual disclosure cycle begins September 30, 1998; one-year moratorium on new classified research without Common Rule adoption expires March 27, 1998

Risks & tensions

  • Tension between national security secrecy requirements and informed consent transparency obligations
  • Intelligence sources/methods exception for agency identity disclosure creates potential loophole
  • OSTP Director's discretionary authority to convene alternate IRB may politicize review process
  • One-year implementation timeline may be ambitious for complex interagency rulemaking
  • Annual disclosure limited to aggregate numbers, not project details, limiting public accountability
Presidential Memorandum: Strengthened Protections for Human Subjects of Classified Research · Executive Orders