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HUMAN SUBJECT EXPERIMENTATION biectives: Identify the magnitude, possible impact, and government actions to address problems resulting from experiments sponsored or conducted by federal agencies for national security purposes in which humans were deliberately exposed to hazardous or potentially hazardous chemical, biological, and/or nuclear material. Specifically, summarize available information on (1) the experiments and the approximate number of human subjects involved, (2) the potential effects of these experiments on human subjects, (3) the government's efforts to notify the participants and provide medical care and/or compensation, and (4) current laws, policies and procedures to ensure that the government obtains informed consent from participants in experiments. Potential Aaencies to Contact: OSD: Assistant to the Secretary of Defense (Atomic Energy) Defense Nuclear Agency National Security Agency Defense Intelligence Agency Other Government Aaencfes Central Intelligence Agency Department of Energy Presidential Advisory Committee on Human Radioactive Audit S t e m : Contact appropriate officials in the above listed agencies, use prior GAO reports and other existing studies and documents to meet the following OBJECTIVE (1) Identify program, experiments, and number of
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Purpose: To meet this objective we will gather information to support a testimony section in which we discuas, in general t e r m s , the 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 some 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 experiments were conducted by each agency. Describe the purpose, experimental agent(s) used, the number of subjects, and the dates of the c. Determine efforts taken or being taken by each agency to identify the experiments 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 participants. 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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$7I subjects. Prior work in this area has shown that agencies are generally ignorant of any potential long-term effects related to the agents or contaminants used in their experiments. This, in 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 to determine the extent of those efforts. From the list identified in step lb above, determine: a. What were the risks of the experiments to the human subjects identified at the time of the experiments? b. What studies have been done or are currently underway to identify the possible long term health effects of the experimental agents (including radioactive material) used in the experiments? OBJECTIVE (3) Government's Efforts to Notify Participants, and Provide Medical Care and/or Compensation PurDose: To meet this objective we will gather information to support a testimony section that summarizes federal agencies' efforts to locate and provide assistance to experiment subjects. From prior work in this area, we know that agencies do not always have comprehensive lists of experiment participants. This causes 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 both civilian and military subjects of the experiments?
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b. What criteria must the subjects meet in order to c. What is the level of compensation that human subjects d. What barriers do the agencies perceive participants face in getting compensation? e. Identify private bills introduced by Congressional Representatives to obtain compensation for constituents (may be obtained from legislative searches rather than f. Identify agency points of contact that interested parties can contact to obtain information about their participation in human subject experiments. (4) Current Laws, Policies, etc. to Ensure Informed Consent of Human Test Subjects Purpose: This audit step will develop a testimony section that briefly summarizes the history of informed consent requirements, and current requirements designed to ensure that current human subjects are informed of the risks of their participation in an a. Summarize current Code of Federal Regulations requirements, laws, etc. b. Identify milestones in the legislative history of informed consent (Nurenburg Guidelines, 1975 Law,