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. MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: September 7, 1994 RE: Overview of Briefing Book Materials for September 12-13 Meeting In the last Briefing Book, we looked at the post-World War II creation of Atomic Energy commission and Defense Department bureaucracies with responsibility of biomedical research and human experimentation. We followed AEC and Defense Department experts in the debate over human experimentation in connection with the nuclear powered airplane (NEPA). In this Briefing Book (Number 6), we increasingly focus on the organization of responsibility for experimental programs, with attention to the need to locate particular experiments (or groups of them) in their institutional settings. The presentations on this topic include: * Memos on the planning and conduct of human experimentation by various departments in connection with the atomic bomb tests; * Memos on the beginning of case studies of government research institutions in which human experimentation involving radiation was conducted and sponsored; * A memo adding to the story of the history of policies related to human subject research; and * An update of the Advisory Committee database of experiment. The documents are part of a developing Cold War story of far greater contemporary relevance than might have been anticipated. At the onset of our inquiries, the 1953 Defense Department Nuremberg Code directive (and similar AEC-originated documents), indicated that ethical debate was occurring, and that key principles had earlier, higher level and more formal recognition than might have been suspected. The presence of the policy(ies) indicated that a basic question, then, as today, was the relation between rule and practice. As discussed at the last meeting, it now appears that the workings of bureaucracy, but also on the meaning given the term "experiment." On paper, the NEPA debate concluded with the determination that a program of human experimentation would not be conducted. nonetheless, some seemingly NEPA-related experimentation did proceed. Was this because the left hand of the bureaucracy did not know what the right was doing, or because the debate was defined by reference to research involving healthy volunteers, but did not encompass research involving patients undergoing therapy? The evidence of experimentation in connection with atomic bomb tests poses the question of the boundaries of such experimentation, but from another powerful vantage. If, as documents indicate, the discussions that preceded the 1953 Nuremberg Code policy and atomic bomb-related human testing involved the same biomedical experts and groups, how were the two discussions connected? The Committee's discussion of the story, and the questions it poses, should be of contemporary, as well as of historical relevance. We look forward to the Committee's discussion.