DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. Tab F-3 MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: January 7, 1995 RE: Experiments to Which Atomic Energy Commission Ethics Policies Would Have Applied (1947-1974) In December the Committee asked for a summing, with examples of experiments, that would be subject to the 1947 AEC ethics statements (assuming they were to be applied). The AEC was the primary, although not the sole, supplier of radioisotopes to research institutes throughout the U.S., indeed the world. Thousands of experiments of various types were conducted with these radioisotopes.1 [The Veteran's Administration alone reports over 3,000 in the pre-1974 period.] The ethics statements contained in the AEC General Manger Wilson's letter to university researchers were at the time that the AEC was enacting a program which it hoped, correctly, would result in the essentially universal use of radioisotopes for research, diagnosis, and therapeutic purposes. In general, all users had to follow the AEC's Isotopes Division rules, including those of the Subcommittee on Human Applications. The extent to which these rules covered situations where isotopes were obtained from non-AEC sources (e.g. private cyclotrons) is being investigated. In addition to distributing isotopes, the AEC funded many research projects. The constantly growing ACHRE experiments database indicates that approximately 207 human studies involving numerous individual subjects occurred with AEC funding from 1947 to 1974. These AEC funded experiments would include: 1. The vast majority involved tracer doses of radioisotopes, such as gallium. Examples of these experiments will be examined in the chapter on radioisotopes. 1 2. There were injections of transuranics, including uranium, zirconium, and americium in the late 1940s and early 1950s at the University of California, San Francisco (UCSF) and Massachusetts General Hospital. These will be examined in the chapter on Biodistribution and were discussed in the staff memorandum on Plutonium Injections, Briefing Book 7, Tab G. 3. Many instances of the use of pregnant women and children, including, for example, experiments at the Fernald School. In some cases, such as the late 1940s Vanderbilt "nutrition" experiments , it is not yet clear where particular isotopes came from (although it is clear that in the mid-1940s Vanderbilt researchers were recipients of AEC isotopes). This research will be examined in the chapter on children. 4. External irradiation experiments with non-therapeutic goals, as with prisoners in Washington and Oregon. This will be examined in the chapter on healthy subjects/prisoners, and is discussed in the prisoners memorandum, Briefing Book 8, Tab E. 2