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Advisory Committee on Human Radiation Experiments NATIONAL IjVSTITi NIHLIBR JAN 2 2 BLDG 10, 10 CENTER DR BETHESDA, MD 20892-1150 Advisory Committee on Human Radiation Experiments Final Report October 1995 Additional copies ofthe Final Report ofthe Advisory Committee on Human Radiation Experiments (stock number 061-000-00-848-9) as well as copies ofthe Executive Summary and Guide to Final Report (stock number 061-000-00849-7) and the three supplemental volumes (061-000-00850-1, 061-000-00851-9, and 061-000-00852-7) may be purchased from the Superintendent ofDocuments, U.S. Government Printing Office. All telephone orders should be directed to: Superintendent ofDocuments U.S. Government Printing Office Washington, D.C. 20402 (202) 512-1800 FAX (202) 512-2250 8 a.m. to 4 p.m., Eastern time, M-F All mail orders should be directed to: U.S. Government Printing Office P.O. Box 371954 Pittsburgh, PA 15250-7954 An Internet site containing ACHRE information (replicating the Advisory Committee's original gopher) will be available at George Washington University. The site contains complete records ofAdvisory Committee actions as approved; complete descriptions ofthe primary research materials discovered and analyzed; complete descriptions ofthe print and non-print secondary resources used by the Advisory Committee; a copy ofthe Interim Report ofOctober 21, 1994, and a copy ofthe Final Report; and other information. The address is http://www.seas.gwu.edu/nsarchive/radiation. The site will be maintained by the National Security Archive at GWU. Printed in the United States ofAmerica 751 1 Contents PREFACE 1 INTRODUCTION The Atomic Century 19 PART I Ethics ofHuman Subjects Research: A Historical Perspective Overview 81 1 Government Standards for Human Experiments: The 1940s and 1950s 83 2 Postwar Professional Standards and Practices for Human Experiments .... 130 3 Government Standards for Human Experiments: The 1960s and 1970s .... 171 4 Ethics Standards in Retrospect 196 PART II CaseStudies Overview 227 5 Experiments with Plutonium, Uranium, and Polonium 233 6 The AEC Program ofRadioisotope Distribution 283 7 Nontherapeutic Research on Children 320 8 Total-Body Irradiation: Problems When Research and Treatment Are Intertwined 366 A 9 Prisoners: Captive Research Population 42 10 Atomic Veterans: Human Experimentation in Connection with Bomb Tests 454 1 Intentional Releases: Lifting the Veil ofSecrecy 506 12 Observational Data Gathering 563 13 Secrecy, Human Radiation Experiments, and Intentional Releases 619 PART III Contemporary Projects Overview 669 14 Current Federal Policies Governing Human Subjects Research 675 1 Research Proposal Review Project 694 16 Subject Interview Study 724 Discussion ofPart III 758 PART IV Coming to Terms with the Past, Looking Ahead to the Future Overview 769 1 Findings 777 18 Recommendations 801 Statement By Committee Member Jay Katz 847 Official Documents Executive Order 857 Charter 862 | Appendices Acronyms and Abbreviations 869 Glossary 878 Selected Bibliography 886 Public Comment Participants 892 A Citizen's Guide to the Nation's Archives: Where the Records Are and How to Find Them 897 iii advisory committee on human radiation Experiments 1726 M STREET, N.W., SUITE 600 WASHINGTON, D.C. 20036 _ Octob.er i1n9n9c5 To the Members ofthe Human Radiation Interagency Working Group: Secretary Hazel O'Leaiy, DepartmentofEnergy Secretary William Perry, Department ofDefense Attorney GeneralJanet Reno, Department ofJustice Secretary Donna Shalala, Department ofHealth and Human Sen-ices SecretaryJesse Brown. DepartmentofVeterans Affairs DirectorAlice Rivlin, Office ofManagement andBudget DirectorJohn Deutch, Central Intelligence Agency Administrator Daniel Goldin, NationalAeronautics andSpace Administration On behalfofthe Advisory Committee on Human Radiation Experiments, it is my privilege to transmit to you our Final Report. Since the Committee's first meeting in April 1994 we have been able to conduct an intensive inquiry into the history ofgovernment-sponsored human radiation experiments and intentional environmental releases ofradiation that occurred between 1944 and 1974. We have studied the ethical standards ofthat time and oftoday and have developed a moral framework for evaluating these experiments. Finally, we have examined the extent to which current policies and practices appear to protect the rights and interests oftoday's human subjects. This report documents our findings and makes recommendations for yourconsideration. The committee listened to the testimony ofmore than 200 public witnesses who appeared before us. We are deeply grateful to all these witnesses, who overcame the obstacles ofgeography and emotions to assist us. Our work and this report would not have been possible without the extraordinary effort the President and you put forward to open the government's records to our inquiry and thus to the nation. We are especially pleased that, through ourjoint efforts, the American people now have access to the tens ofthousands ofdocuments that bear on this important history. None ofour conclusions came easily. We endeavored, both as individuals and as a committee, to live up to the responsibility with which we were entrusted. This report represents the consensus offair-minded people who gave the best they had to offer to their fellow citizens. We thank President Clinton for this opportunity and for his courage and leadership in appointing the Advisory Committee. Ruth R. Faden Chair, Advisory Committee on Human Radiation Experiments ® Printedwithsoyinkonrecycledpaper Advisory Committee on Human Radiation Experiments Ruth R. Faden. Ph.D.. M.RH.-Chair Philip Franklin Wagley ProfessorofBiomedical Ethics and Director The Bioethics Institute Johns Hopkins University Baltimore, Maryland Senior Research Scholar Kennedy Institute ofEthics Georgetown University Washington, D.C. Kenneth R. Feinberg, J.D. NancyL. Oleinick, Ph.D. & Kenneth R. Feinberg Associates ProfessorofRadiation Biochemistry Washington, D.C. Division ofRadiation Biology Case Western Reserve University School ofMedicine Eli Glatstein, M.D. Cleveland, Ohio Professorand Chair DepartmentofRadiation Oncology HenryD. Royal, M.D. The University ofTexas ProfessorofRadiology Southwestern Medical Centerat Dallas Associate Director; Division ofNuclear Medicine Dallas, Texas Mallinckrodt Institute ofRadiology Washington University Medical Center JayKatz, M.D. St. Louis, Missouri Elizabeth K. Dollard Professor Emeritus ofLaw, Medicine and Psychiatry Philip K. Russell, M.D. Harvey L. Karp Professorial Lecturer in Law Professor, Department ofInternational Health and Psychoanalysis Johns Hopkins University Yale Law School School ofHygiene and Public Health New Haven, Connecticut Baltimore, Maryland PatriciaA. King, J.D. MaryAnn Stevenson, M.D., Ph.D. ProfessorofLaw Assistant ProfessorofRadiation Oncology Georgetown University Law Center Joint Center for Radiation Therapy Washington, D.C. Harvard Medical School Boston, Massachusetts Susan E. Lederer, Ph.D. Associate Professor Deputy Chief Department ofHumanities New England Deaconess Hospital The Pennsylvania State University College ofMedicine Department ofRadiation Oncology Hershey, Pennsylvania Boston, Massachusetts Ruth Macklin, Ph.D. Duncan C. Thomas, Ph.D. ProfessorofBioethics Director, Biostatistics Division DepartmentofEpidemiology & Social Medicine DepartmentofPreventive Medicine Albert Einstein College ofMedicine University ofSouthern California School ofMedicine Bronx, New York Los Angeles, California Lois L. Norris Reed V. Tuckson, M.D. Second Vice PresidentofOmahaNational Bank President and Omaha National Corporation (Retired) Charles Drew University ofMedicine and Science Omaha, Nebraska Los Angeles, California Advisory Committee on Human Radiation Experiments Dan Guttman ExecutiveDirector Jeffrey Kahn Anna Mastroianni Associate Director AssociateDirector Stephen Klaidman Sarah Flynn Director ofCommunications Editor Counselor to the Committee Staff* Senior Policy andResearch Analysts Research Associates Barbara Berney Miriam Bowling James David Praveen Fernandes John Harbert Sara Chandros Hull Gregg Herken Valerie Hurt Jonathan Moreno John Kruger Ronald Neumann Ellen Lee Gary Stem Shobita Parthasarathy Jeremy Sugarman Noel Theodosiou Donald Weightman Gilbert Whittemore Information Services David Saumweber, Director Research Analysts Robin Cochran, Librarian Jonathan Engel Tom Wisner, Senior Technology Patrick Fitzgerald Consultant Mark Goodman Deborah Holland Communications andOutreach Denise Holmes Lanny Keller Michael Jasny Kristin Crotty Gail Javitt Wilhelmine Miller Committee andStaffAffairs Patricia Perentesis Jerry Garcia Kathy Taylor Jeanne Kepper Sandra Thomas Faith Weiss Consultants Jeffrey Botkin Suzanne White Junod Allen Buchanan Nancy Kass Gwen Davis Charles McCarthy Gail Geller Monica Schoch-Spana Steve Goodman Patricia Stewart-Henney Jon Harkness John Till Rebecca Lowen E.W. Webster *includes both full-time and part-time staff acknowledgments T the Committee's work over the past year and a halfwould have been impossible without the assistance ofan extraordinary number ofindividuals and We groups from all corners ofthe United States, and beyond. wish to express the depth ofour gratitude to the many people who assisted, informed, and advised us. Some ofthese people are identified by name elsewhere in this report and its supplemental volumes. An appendix in this volume lists the more than 200 witnesses who appeared before the Committee at our public meetings in Washington, D.C., Cincinnati, Knoxville, San Francisco, Santa Fe, and Spokane. The supplemental volumes identify the dozens ofindividuals who agreed to formal, taped interviews in connection with the Committee's oral history projects. We thank all these people and many more: • The hundreds ofpeople who contacted the Committee with information about their own experiences orthe experiences oftheir family members. Many ofthese people shared not only their personal stories but also the information they had collected in the course ofconducting their own research into government archives. • The representatives ofmany groups whose interests coincided with the work ofthe Committee. These include organizations offormer subjects of biomedical radiation experiments (and their families), downwinders, atomic veterans, uranium miners, and workers in and around atomic energy communities. These groups, as well, shared the accumulated information and perspective ofyears ofexperience and research. • The numerous professionals in fields related to our research who gave of their time and expertise to provide information or comment on the myriad factual, technical, and policy questions before the Committee. These experts provided help in understanding areas ranging from military and human rights law to the laws ofthe atom, from the history ofthe government's use ofsecrecy to the history ofradiation science. • The dozens ofuniversities and independent hospitals, located in all regions ofthe country, that willingly provided us with the documents we needed to conduct our Research Proposal Review Project. vn Acknowledgmen(s The nearly 1,900 individuals who graciously participated in our Subject Interview Study, and the university hospitals, veterans hospitals, and community hospitals that permitted us to conduct the study. The numerous chairs ofinstitutional review boards and radiation safety committees who were kind enough to share with us their views about the current status ofhuman subject protections. Archivists at public and private libraries, universities, and research institutions, who assisted the Committee in our search for information. The manyjournalists and scholars who have previously researched and written about the subjects covered in this report, for sharing the knowledge and wisdom embodied in their own many years ofinquiry and reflection. A variety ofstate and local agencies for sharing with the Committee the results oftheir own reviews ofactivities that we explored. Members ofCongress and congressional staff, including the staffs ofthe General Accounting Office and the Office ofTechnology Assessment, for sharing the product oftheir own prior inquiries into many ofthe areas discussed in this report. The members ofthe Human Radiation Interagency Working Group, who provided invaluable assistance. We are particularly grateful to the many employees at the Department ofEnergy, the Department ofDefense, the Department ofHealth and Human Services, the Department ofVeterans Affairs, the National Aeronautics and Space Administration, and the Central Intelligence Agency, who aided us in the search and retrieval of the many thousands ofdocuments that provide the backbone for the Committee's review ofhuman radiation experiments that took place between 1944 and 1974 and the history ofgovernment requirements for the conduct ofthat research. We are also grateful to the staffs ofthe Nuclear Regulatory Commission and the National Archives and Records Administration for their invaluable assistance. Many ofthe same people, as well as others, also provided advice and information as we undertook our evaluation ofthe conduct ofresearch involving human subjects today. We wish to thank both the professional and administrative members ofour staffwho worked so hard and showed such dedication to our task. Their talent, energy, and commitment provided the foundation for our work. It is impossible to overstate our gratitude and appreciation for their extraordinary efforts. Finally, we wish to acknowledge our indebtedness to President Clinton for the honor he bestowed upon us when he selected us to serve on the Advisory Committee. Vlll