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. * * * * * STAFF MEMORANDUM * * * * * TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: July 20, 1994 RE: Overview of Briefing Book Materials for July 25-26 Meeting In prior briefing books, we sought to identify threads that could be followed to understand the Big Picture of experiments, and the world in which they were set. Now we begin to look at the Big Picture (at least from the 1940's to the early 1950's) as a whole. To invoke an apt clich, we take snapshots of the same elephant from different perspectives: 1. the policies and standards announced to govern human experiments (Tab F); 2. the body of radiation standards in which experiments were set (Tab M); 3. the public purposes, agencies and personalities that drove research experiments and that may have shaped the kinds of experiments undertaken (Tab F); and 4. the bureaucracies that regulated experimentation (Tab F). (Please note that the staff memoranda found in Tab F that discuss the above perspectives are overlapping in content and should be read together.) 1 The Big Picture brings some questions we have been asking into increasingly meaningful focus. For example, if ethics policies were stated on high, how did they get translated to the investigators in the field? The new documentation on the early AEC bureaucracy begins to fill in the gap between pronouncement and practice in that agency. How did the AEC system compare with that put into place by the Defense Department to implement the 1953 Secretary of Defense policy on human experimentation? The Big Picture permits us to ask new, and hopefully fruitful, questions. For example, how do differing regulatory systems (here, those governing total body irradiation and radioisotope use) affect the kinds of experiments pursued? Similarly, did the regulators define "experiment" consistently? Did they have difficulty defining "experiments", and how did their definitions compare with those in use now? In that, and other cases, the Big Picture indicates that many questions faced by those in the earlier period appear to be of striking contemporary relevance. For example, the documents indicate that 1947 AEC policies on biomedical research were governed not simply by questions of medical risk and national security interest, but also by concerns over lawsuits, public image, and labor discontent. What, for example, can we learn from looking back on the balance struck, in the early days of the AEC, between the AEC's Insurance Department and its Division of Biology and Medicine? The briefing materials are intended to provide the context for discussion and debate by which we can begin to make sense of, and ultimately evaluate, the numerous experiments that have been identified. With policies, standards and institutions in mind, experiments are needed to complete the pictures. In Tab H, therefore, we provide the beginning narrative on a group of experiments--total body irradiation. This is one of the sets of experiments that we hope to research as a group. In Tab I, we provide an "experimental map" that culls the data available on some of the experiments identified by one agency--DOE. In the folders to be provided to you at the meeting, you will also be given briefing materials on the continuing refinement of the proposals to review contemporary protocols and interview contemporary subjects to be filed in Tab E. We look forward to your discussion of these materials.