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Interim Report of the Advisory Committee . on Human Radiation Lxperzments October 21,1994 DISCLAIMER This report was prepared as an account of work sponsored by an agency of the United States Government. Neither the United States Government nor any agency thereof, nor any of their employees, makes any warranty, express or implied. or assumes any legal liability or responsi- bility for the accuracy, completeness, or usefulness of any information, apparatus, product, or process disclosed, or represents that its use would not infringe privately owned rights. Refer- ence herein to any specific commercial product, process, or service by trade name. trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement, ram- mendation, or favoring by the United States Government or any agency thereof. The views and opinions of authors expressed herein do not necessarily state or reflect those of the United States Government or any agency thereof. DISTRIBUTION OF THIS DOCUMENT IS LINUMITm , . _. -.-,..- DISCLAIMER Portions of this document may be illegible in electronic image products. Images are produced from the best available original document. ADVISORYCOMMITTEE ON HUMANRADIATION EXPERIMENTS 1726 M STREET,N.W., SUITE 600 WASHINGTON,D.C. 20036 WMORANDUM TO: Members of the Interagency Working Group Secretary Hazel O'Leary, Department of Energy Secretary William 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 VeteransAflairs Director Alice Rivlin, Ofice of Management and Budget Director James Woolsey, Central Intelligence Agency Administrator Daniel Goldin, National Aeronautics and Space Administration FROM: The Advisory Committee on Human Radiation Experiments DATE: October 21,1994 RE: Interim Report The Advisory Committee on Human Radiation Experiments is pleased to transmit its Interim Report to the Interagency Working Group. @ Printed with soy ink on recycled paper ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS Ruth R. Faden. Ph.D.. M.P.H.-Chair Lois L. Norris Director, Program in Law, Ethics and Health Second Vice President of Omaha National Bank Professor, Dept. of Health Policy & Management and Omaha National Corporation (Retired) The Johns Hopkins University Omaha, NE School of Hygiene and Public Health Baltimore, MD Nancv L. Oleinick. Ph.D. Professor of Radiation Biochemistry Senior Research Scholar Division of Radiation Biology Kennedy Institute of Ethics Case Western Reserve University Georgetown University School of Medicine Washington, DC Cleveland, OH Kenneth R. Feinberp, J.D. Henrv D. Roval, M.D. Kenneth R. Feinberg & Associates Professor of Radiology Washington, DC Associate Director Division of Nuclear Medicine Eli Glatstein. M.D. Mallinckrodt Institute of Radiology Professor and Chair Washington University Medical Center Department of Radiation Oncology St. Louis, MO The University of Texas Southwestern Medical Center at Dallas PhiliD K. Russell. M.D. Dallas, TX Professor, Department of International Health The Johns Hopkins University Jav Katz. M.D. School of Hygiene and Public Health Elizabeth K. Dollard Professor Emeritus of Law, Baltimore, MD Medicine and Psychiatry Harvey L. Karp Professorial Lecturer in Law Maw Ann Stevenson. M.D.. Ph.D. and Psychoanalysis Assistant Professor of Radiation Oncology Yale Law School Joint Center for Radiation Therapy New Haven, CT Harvard Medical School Boston, MA Patricia A. Kinp. J.D. Professor of Law Deputy Chief Georgetown University Law Center New England Deaconess Hospital Washington, DC Department of Radiation Oncologi Boston, MA Susan E. Lederer. Ph.D, Associate Professor Duncan C. Thomas. Ph.D. Department of Humanities Professor The Pennsylvania State University University of Southern California College of Medicine School of Medicine Hershey, PA Department of Preventive Medicine Los Angeles, CA Ruth Macklin. Ph.D. Professor of Bioethics Reed V. Tuckson. M.D. Departtpent of Epidemiology & Social Medicine President Albert Einstein College of Medicine Charles Drew University of Medicine & Science Bronx, NY Los Angeles, CA CONTENTS EXECUTIVE SUMMARY .................................................. 111... INTRODUCTION .......................................................... 1 Charge and Mandate .................................................. 1 How the Committee Functions .......................................... 2 The Committee's Approach ............................................. 3 Tasks and Strategies: An Overview of the First Six Months and the Interim Report ............................................. 6 PART I . AREAS OF INQUIRY: THE FRAMEWORK AND PIECES OF THE PUZZLE .............................................. 9 A . The Problem: Widely Dispersed and Fragmentary Information .............. 9 B . Biomedical Experiments: 1944-1974 ................................. 10 1. Phase I: Mapping Experiments and the World in Which They Were Set ....................................................... 10 a . Experiment Database ......................................... 10 b . Ethics Policies and Practices ................................... 12 c . Institutional Mapping ........................................ 14 d . Scientific Standards Timeline .................................. 15 2 . Phase 11: Focus on Specific Experiments and Their Context ............ 15 a . Biomedical Experiments .................................... 16 b . Institutional Case Studies .................................... 16 C. Intentional Releases ............................................... 17 D . ANoteonScope ................................................. 19 E . The Contemporary Story ........................................... 20 1. Subject Interview Study ......................................... 20 2 . Research Proposal Review Project ................................. 21 3 . Agency Oversight Review ....................................... 23 PART I1 . THE AGENCY SEARCH PROCESS AND OTHER METHODS OF INQUIRY: THE HUNT FOR PIECES OF THE PUZZLE .............. 23 A . The Agency Search Process ......................................... 23 1. InitialReports ................................................. 24 2. Committee Assessment ......................................... 25 3 . Committee Work with Agencies on Search Strategy ................... 25 4 . Classified Documents .......................................... 28 B . Additional Methods of Inquiry ...................................... 29 1. Documentary Search ............................................ 29 2 . Ethics Oral History Project and Interview Project ..................... 30 i ........... -r.--.-. .... .I........ --... -_.- . I............. ............ PART I11 . OUTREACH .................................................... 3 1 PART IV . INFORMATION MANAGEMENT AND PUBLIC ACCESS .............. 33 PART V . TAKING STOCK. SOME INITIAL OBSERVATIONS ..................34 A . Openness ....................................................... 34 B . Organizing the Secret and Public Worlds of Human Radiation Experiments ... 35 C . Historical Discovery ............................................... 35 1. Government Ethics Debate and Policy .............................. 35 2. Discovery of the Present in the Past ................................ 35 3 . Government Rediscovery of its Past ............................... 36 D . Public Access to the Records of our Past ............................... 37 E . Challenges to Reconstructing the Past ................................. 37 1. Agency Searches Are Time Consuming ............................. 37 2 . Data on Experiments Are Fragmentary ............................. 37 3 . Loss or Destruction of Important Document Collections ................ 37 4 . Classification .................................................. 39 PART VI . THE NEXT SIX MONTHS ......................................... 39 A.WorktobeDone .................................................. 39 1. Continuation of Present Tasks .................................... 39 2 . Identification of Relevant Ethics Standards .......................... 40 3 . Considerations and Criteria for a Range of Remedies .................. 40 4 . Recommendations on Policies for Future Research .................... 41 B.TimingofFina1Report ............................................. 41 APPENDIXES A Executive Order B Charter C Committee Roster D Meeting Dates and Locations E Summary of Agency Records Retrieval F Information Management TERMS AND ACRONYMS .. 11 EXECUTIVE SUMMARY 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 experts in bioethics, radiation oncology and biology, history of science and medicine, epidemiology, nuclear medicine, and law. Human radiation experiments are defined by the Committee's charter to include 'I( 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
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