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HUMAN SUBJECT EXPERIMENTATION Oblectivee: Identify the magnitude, possible impact, and government action8 to address problems resulting from experiment8 eponaored or conducted by federal agenciee for national security purposes in which humane were deliberately exposed to hazardous ox: potentially hazardous chemical, biological, and/or nuclear material. Specifically, summarize available information o n ( 1 ) the experiment8 and the approximate number of human subjects involved, (2) the potential effects of these experiments on notify the pacticipanta and provide medical care andlor comgenaation, and (4) current laws, policies and procedures to ensure that the government obtains informed consent from Potential Agencies to Contact: OSD: Assistant to t h e Secretary of Defense (Atomic Energy) Defense Nuclear Agency National Security Agency other Government Acrenciea Central Intelligence Agency Department of Energy Presidential Advisory Committee on Human Radioactive Contact appropriate officials in the above listed agencies, use prior GAO reports and other existing Btudies and document8 to meet t h e following Identify program, experiments, and number of
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Purpose: To meet t h l e objective we will gather information to support a testimony eection in which we diecuae, in general terms, t h e scope of tests that have been conducted by the federal government for national security purposes. It is not designed to develop an all-inclusive list, but to give the Committee as much information as possible within the time available concerning the extent and nature of experiments conducted. It will define "experiment", identify 80me of the more egregious examples, and summarize agencies' efforts to identify experiments and Specific audit steps are: a. Determine how each agency defines human use b. Determine what experimente were conducted by each agency. Describe the purpose, experimental agent(s) used, t h e number of subjects, and the dates of the c. Determine efforts taken or being taken'by each agency to identify the experimente and the participants. ( 3 ) resources dedicated to these efforts (4) search methodology (e.g. archival research, outreach programs to identify participants, etc.) d, Identify the difficulties agencies are encountering in identifying experiments and participante. OBJECTIVE ( 2 ) Potential Effects of Experiments on Subjects Purpose: To meet this objective we will gather information to develop a testimony section that summarizes federal agencies' efforts to identify the effects of their experiments on human
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subjects, Prior work in this 8rea ha6 t3hOwn that agencies are generally ignorant of any potential long-term effect6 related to t h e agent6 or Contaminants used in their experfmente. This, i n turn,leads to problems when participants allege their current medical problems are the result of experiments conducted many years ago. Where these questions exist, it appears agencies have an obligation to determine whether, in fact, people have suffered negative health effects. These audit steps are meant t o determine the extent of those efforts. From t h e list identified in step lb above, determine: a. What were the risks of t h e experiments to the human subjects identified a t the time of the experiments? b. What studiee have been done or are currently underway to identify t h e poeaible long term health effects of t h e experimental agents (including radioactive material) used in the experiments? OBJECTIVE (3) Government's Efforta t o Notify Participants, and Provide Medical Care and/or Compensation Pumose: To meet this objective we will gather information to aupport a testimony section that summarizes federal agencies' efforts to locate and provide assistance to experiment 8ubjeCtB. From prior work in t h i s area, we know that agencies do not always have comprehensive lists of experiment participants. This cause8 problems when experiment participants are required to prove participation in the experiments in order to receive medical care From the list identified in step lb above, determine: a. What efforts have the agencies taken to locate b o t h civilian and military subjects of the experiments?
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What criteria must the subjects meet in order to What is the level of cornpensation that human subjects What barriers do the agencies perceive participants face in getting cornpensation? Identify private bills introduced by Congressional Representatives t o obtain compensation for constituents (may be obtained from legislative searches rather than Identify agency points of contact that interested parties can contact to obtain information about their participation in human aubject experiments. ( 4 ) Current Laws, Policiea, e t c . to Ensure Informed Consent o f Human Test Subjects Purpose: This audit s t e p will develop a testimony section that briefly summarizes t h e hietory of informed consent requirements, and current requirements designed to ensure that current human subjects are informed of the r i s k s of their participation in an a. Summarize current Code of Federal RegUlatiOn8 requirements, laws, etc, b. Identify milestones in the legislative history of informed consent (Nurenburg Guidelines, 1975 Law,