Interim Report of the Advisory Committee on Human Radiation Experiments October 21, 1994

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ADVISORY COMMITTEE ON HUMAN RADI A TIO NEXPERIMENTS ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS NOT FOR PUBLIC RELEASE BEFORE

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ADVISORY COMMITTEE ON HUMANRADIATION EXPERIMENTS TO: Members of the Interagency Working Group Secretary Hazel O'Leary. Department of Energy Secretary IYilliam Perry, Department of Defense Attorney General Janet Reno, Department of Justice Secretary Donna Shalala. Department of Health and Human Services Secretary Jesse Brown, Department of Veterans Again Director Alice Ridin, Office of Management and Budget Director Jumes Woolsey. Central Intelligence Agency Administrator Daniel Goldin. National Aeronautics and Space Administration FROM: The Advisory Committee on Human Radiation Experiments RE: Interim Rcport The Advisory Committee on Human Radiation Experiments is pleased to transmit its Interim Report to the Interagency Working Group. .

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Tasks and Strategies: An Overview of the First Six Months PART I . AREAS OF INQUIRY: THE FRAMEWORK AND PIECES OF THE PUZZLE .............................................. 8 A . The Problem: Widely Dispersed and Fragmentary Information .............. 9 1. Phase I: Mapping Experiments and the World in Which They Were b . Ethics Policies and Practices ................................... 11 d . Scientific Standards Timeline .................................. 14 2 . Phase 11: Focus on Specific Experiments and Their Context ............ 15 b . Institutional Case Studies .................................... 16 1. Subject Interview Study ......................................... 20 2. Research Proposal Review Project ................................. 22 3 . Agency Oversight Review ....................................... 23 PART I1. THE AGENCY SEARCH PROCESS AND OTHER METHODS OF INQUIRY: THE HUNT FOR PIECES OF THE PUZZLE .............. 23 3 . Committee Work with Agencies on Search Strategy ................... 25 2 . Ethics Oral History Project and Interview Project ..................... 30

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PART IV . INFORMATION MANAGEMENT AND PUBLIC ACCESS ............. 32 PART V . TAKMG STOCK: SOME INITIAL OBSERVATIONS ................... 33 1. Government Ethics Debate and Policy .............................. 35 3. Government Rediscovery of its Past ............................... 36 D . Public Access to the Records of our Past ............................... 36 E Challenges to Reconstructing the Past 37 2. Discovery of the Present in the Past ................................ 35 1 . Agency Searches Are Time Consuming ............................. 37 2. Data on Experiments Are Fragmentary 3 . Loss or Destruction of Important Document Collections ................ 37 PART VI . THE NEXT SIX MONTHS ......................................... 39 1. Continuation of Present Tasks .................................... 39 2. Identification of Relevant Ethics Standards .......................... 40 3 . Considerations and Criteria for a Range of Remedies .................. 40 D Meeting Dates and Locations E Summary of Agency Records Retrieval TERMS AND ACRONYMS

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The Advisory Committee on Human Radiation Experiments was created by President Clinton to advise the Human Radiation Interagency Working Group (the "Interagency Working Group") on the ethical and scientific criteria applicable to human radiation experiments carried out or sponsored by the U.S. Government. The Committee is composed of 14 members, including a citizen representative and 13 expens in bioethics, radiation oncology and biology, hstory of science and medicine, epidemiology, nuclear medicine, and law. Human radiation experiments are defined by the Committee's charter to include "( 1) experiments on individuals involving intentional exposure to ionizing radiation. This category does not include common and routine clinical practices. . . . (2) experiments involving intentional environmental releases of radiation that (A) were designed to test human health effects of ionizing radiation; or (B) were designed to test the extent of human exposure to ionizing radiation. The Committee seeks to answer several fundamental questions: (1) What ethics criteria should be used to evaluate human radiation experiments? (2) What was the Federal Government's role in human radiation experiments? (3) What are the criteria for determining appropriate Federal responses where wrongs or harms have occurred? (4) What lessons learned from studying past and present research standards and practices should be applied to the future? As a Federal advisory committee, the Committee asks these questions and seeks to answer them in open public meetings. In addition to meetings in Washington,which contain a period for public comment, and a fhll Committee meeting in San Francisco, the Committee has scheduled at least three other sessions to hear public comment in regions throughout the country. The Committee's ability to tell the story of past radiation experiments requires more than the will to search through hundreds of boxes for documents and the intuition to recognize which ones are important. It depends on the Committee's ability to find a common language to address the technically complex, often highly emotional issues related to human radiation experimentation. The voices to which the Committee must listen speak in the languages of medicine, a multiplicity of sciences, the military, sick patients, healthy subjects, policymakers, and philosophers. The Committee cannot understand, much less tell, the story unless it seeks out all who can aid its understanding, and works to bridge the cultural and linguistic gaps among The Committee is also convinced that an important determinant of its success will be its

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ability to understand the present just as well as, if not better than, it understands the past. Therefore, it has undertaken the task of sampling the ethical practices and standards governing human radiation research today, evaluating them, and deciding whether change is needed. Finally, in order to focus its own inquiry, and the ability of the public to assist it, the Committee has identified a number of common themes that will guide its work, and give structure to its final report. These themes include: 0 Consent standards andprocedures: A cornerstone of modem research ethics is the requirement that research proceed only with the informed consent of a competent subject or with adequate safeguards to protect the interests of a subject who cannot give consent. The Committee must understand when policies and practices of informed consent were adopted, when, if ever, the requirement was disregarded and why. e Risks and benefits of research: It is inherent in most research that subjects are put at risk of harm in order to obtain desired benefits. It is the Committee's charge to determine whether the risks to which subjects were exposed, however low, were justified. The selection of research subjects: The ethics of research turn as much on considerations of justice in the selection of subjects as they do on questions of consent or acceptable risk. The Committee deems it essential that it examine whether particular populations were targeted for participation as research subjects because of their relative lack of economic, social, or political power. e Responsibilityfor experiments: Who decided which experiments were carried out, and who was responsible for assuring that ethics policies, where they existed, were put into practice? The Committee Begins Its Work The Committee was created in tandem with a Presidential directive that the executive branch be open to searching inquiry. When it began its work in April 1994, there were few records in hand; the Committee was embarking on a daunting journey into the past and present with neither stars nor compass to chart its course. For example: e How many human radiation experiments were conducted before 1975? Where could the answer be found? In April it was not clear whether the answer was in the hundreds or the thousands. What codes of conduct, if any, existed before 1975 to govern federally

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sponsored experiments? The prevailing assumption was that until the mid- 1960s Federal agencies. by and large, did not have ethics policies. What institutions planned, funded, and conducted experiments, and who had responsibility for ensuring the integrity of experimentation? Where agency organization charts or other road maps existed to guide the way, the fragments at hand were often physically blurred beyond recognition. Time was short. The Committee therefore had to develop a strategy to quickly gather, organize, and analyze vast mounts of information. Phase I. The Phase I strategy has three components: ( I ) the development of a framework for all the information the Committee hoped to collect--the "big picture" into which pieces of the puzzle could be fit; (2) the development of a strategy to mine all available information sources; and (3) the development of an information infrastructure to house and organize all the data. The components of the "big picture" framework include: 8 An experiment database, to provide a single locale for cataloguing experiments as they are identified; 8 An ethics rimeline, to chart the evolution of Federal and private sector policies and practices pertaining to research ethics; e A scientfidmedical standards timeline, to chart the evolution of these a Institutional maps, to plot the network of public and private institutions that planned, funded, managed, and performed experiments. Phase XI. While Phase I continues, the Committee's brief tenure requires that it turn to the task of evaluating experiments. But on w h c h experiments should it focus? On the one hand, the number of pre-1975 experiments may well be in the thousands, and the number of post-1975 experiments far greater. On the other hand, the Committee may be able to locate only fragments of data about many of these experiments (for example, there is often no information on who subjects were, much less what they were told about the experiment). The working solution, therefore, is a strategy that seeks to address the basic questions of concern to the Committee and the public by an overlapping set of case studies and samples. First, the Committee is focusing on five groups of biomedical experiments, with each group anchored in one or more specific experiments that have received public attention. Second, the Committee is simultaneously focusing on institutions that conducted the experiments, in order to examine the decisionmalung process and determine responsibility. Third, the Committee's inquiry into intentional releases will focus on determining (1) whether (at this late date) the public can learn

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who planned the releases, why, and what precautions i f any were taken; and (2) whether intentional releases, which were often shrouded in secrecy, could take place today in the absence of meaningful public notice. For evaluating the contemporary world of research, the working solution is to conduct three projects: (1) a review of a sample of recently funded research proposals; (2) interviews with subjects of current research; and (3) review of current Federal agency policies for oversight. Phase 111. While Phase I continues, and Phase I1 has just begun, the Committee is simultaneously turning to Phase 111--the tasks of evaluating past and present experiments, recommending policy changes, and developing criteria for a range of remedies that may be appropriate where wrongs or harms have occurred. Taking Srock: Some Accomplkhmenr and Challenges Openness: The President's request that the Federal Government open a substantial portion of its Cold War files to the Committee, and the public, was ambitious. There were many reasons for skepticism, including the enormous number of records, the vast number that remained classified, and the potential for bureaucratic delay. These factors remain real. As detailed in this report and agency-specific appendices, the Committee and agency search terms have retrieved important records collections, some of them previously secret, that will provide a new basis for understanding our past and present. In doing so, these collections are producing a road map that should, as present work continues, permit the completion of a substantial search within the Committee's life, and that will remain as a guide for the public in the years to come. It is now clear to the Committee that, with continued public support and interest, the agency commitment to the opening up of a substantial portion of our Cold War archives can continue to be substantial, even unprecedented. It is the Committee's task to help ensure that this search produces results that merit its continuation when the Committee is no longer in existence. Piecing Together the Secret and Public Worlds of Experiments: The Committee's experiment database presently contains about 400 biomedical experiments conducted before 1975. The Committee possesses at least fragmentary indications of over 1,000 additional experiments. In addition to the 13 intentional releases of ionizing radiation identified in the Charter, the Committee is now aware of hundreds of additional intentional releases. The Committee is learning that secrecy is not always the primary bar to comprehending the past. A vast amount of data already is public, but it is often widely scattered. For example, piecing together the story of human experimentation in connection with atomic bomb tests requires the Committee to combine discrete collections of public data with newly declassified data while continuing to search for further secret and public pieces of the puzzle.

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Piecing Together the Hidden History of Federal Ethics Policy and Practice: Documents delivered by the agencies, and others located by the Committee, have revealed that there was discussion at the highest reaches of government--often in secret--about the need for human experimentation and for policies to govern i t . Committee and agency staff have placed the highest priority on tracking down the twists and turns in these discussions and in the policies and practices that flowed from them. Discovery of the Past in the Present: When the Committee began its work six months ago, i t might reasonably have been assumed that research conducted in the mid-century world was so different from current research that its relevance would be limited. However, the story that is unfolding raises questions of continuing relevance to today. For example: At mid-century, ethics policies were discussed and recorded on paper. A key question then, as today, is the relationship between policy and Even as policies were put on paper, it was not always clear what they covered. Did they cover sick patients as well as healthy volunteers? In cases involving soldiers and workers, for example, what was understood by responsible decisionmakers to be the difference between experimentation with healthy volunteers and occupational safety monitoring? Then, as today, the boundaries of experimentation may not have been fixed. Even with the benefits of openness, basic information on some experiments (notably the intentional releases) remains secret. Could these releases be conducted today without basic public disclosure? Outreach: The Committee has heard from many members of the public who have written, called, visited its offices, or testified at its open meetings. In many cases these communications have brought important insight and information to the Committee's attention. The Committee's public reading room provides access not only to basic Committee material (e.g., transcripts of meetings) but a collection of important documents that were previously classified or not readily available in an organized form. The Committee's experiment and document collection databases should soon be available to the public on Internet. Challenges: The primary challenge to the Committee now, as at the onset, is the overwhelming nature of its tasks. Agency and Committee document and information searches are progressing and should result in substantial new information about known experiments, policies, and practices, and perhaps discovery of heretofore unknown experiments, policies, and practices. However, (1) search efforts are necessarily time consuming and uncertain; (2) data on many experiments will likely continue to remain fiagmentary; (3) it appears that many important collections have been long since lost or destroyed; (4) a great number of relevant collections

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contain classified data; the declassification process may be a substantial bottleneck. Work To Be Done In the next …