Advisory Committee on Human Radiation Experiments Public Meeting April 21-22, 1994 Briefing Book (Volume 1)

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Search Grow Meeting Steven Gal son Dan Guttman, Executive Di rector Anna Mastroianni, Director Committee Affairs, Deputy Staff Director, Jeff Kahn, Acting Staff Director Steve Klaidman, Pub1 ic Affairs Director Senior Policy and Research Analyst Interactions with Advi s o w Committee A meeting i s needed between Search Group and Advisory Committee staff and Ruth Fad& before the Advisory Committee’s first meeting on April 21, 22, Congressional and press briefings by the Search Group are needed before the public meeting (no date i s yet set). Number o f documents examined Number o f documents relevant to human radiation experimentation Any alarming findings What agencies are doing to ensure no conflict o f interest, What agencies are doing with the documents comprehensiveness and integrity o f search Tentative activities for Advisory Committee public meeting: April 21: Breakfast greetings with Cabinet Secretaries and Interagency Working Group Press Avai 1 abi 1 ity Evening reception with the President L April 22: Search group briefings on records collection activities Advisory Committee meetings are open to the public.

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Advisory Committee may not make specific compensation decisions. They can make broad recommendations on compensation strategies, relevant to groups Advisory Committee plans to meet monthly. Committee staff will d o most o f the research and review. Who will “charge” the Committee, if Vice President Gore does not? O‘Toole will find out. Packages containing information in a uniform format must be prepared for the press, public and others who attend the public meeting. O‘Toole will provide. Could include: Status o f records collections activities at each agency Interactions with Advisory committee Briefinq materials, oral and written, f o r the Advisory Committee Briefing materials must be in a uniform format.e We should ask Advisory Committee to help us with specific problems we are Each agency must provide a coherent, comprehensive status of ongoing information gathering activities and the information retrieved. (Soper) Agencies should have a reasonable number o f records to give to the Advisory Committee on April 21, 1994 at t h e public meettng. Also consider giving Advisory Committee materials they can sink their teeth into, such as articles which may involve experiments. Defense and possibly information on native Alaskan - Soper offered University of Cincinnati experiment records from O’Toole offered plutonium experiments and Markey records.- O’Toole will discover what Advisory Committee wants for their briefing Advisory Committee/Ruth Faden is in charge o f public meeting agenda. - Spokespersons could be assigned on each topic or each agency can make a presentation.a

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O‘Toole prefers individual agency presentations on paper in briefing book and spokespersons for oral presentations. Agencies should not orally discuss experiments because of 1 iabil i ty issues and agencies should not second guess the Advisory Committee. - Soper prefers individual agency oral presentations. Another possibility is that the primary four agencies (DOE, DOD, V A , HHS) could each speak, for brevity’s sake. or oral presentations: agencies have done, found agencies need from Advisory Committee agencies face in their records searches Toll free teleDhone number stratesies Problems existed with the referral decision tree and HHS received the lion’s share o f the referrals. Now, algorithms have been changed and all Military calls are divided: VA - Callers who have filed or want to file claims for benefits or DOD - Any other military callers were exposed while a patient in a VA hospital Q u a lit v Assurance stratesies for document search techniques Need integrity o f documents and comprehensiveness of search. (Wisely) Search Group must find out how Advisory Committee will know the study is Quality Assurance should be top item for meeting between Advisory Committee and Search Group. Three needs to be met to create a database: Reporting formats need to be standardized. Reported information needs to be as complete and comprehensive as possible given time, money, and personnel constraints, and the condition o f the records .serving as the basis o f the 3. The reporting format has to be compatible with existing hardware and software, and easily transferable by electronic means to facilitate reporting and information management.

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Technical staff on Advisory Committee should contact Defense for demonst rat i on. Additionally, Defense i s sorting their information by various populations. Timinq of information releases to public and Dress DOE has problems with timing. Defense problems include investigative reporters knowing more than the agency does. Defense not getting many Freedom o f Information Act (FOIA) Search Group should discuss this issue with Advisory Committee staff, so no FOIA violations or other legal violations occur. Advisory Committee should be in close contact with other investigating committees, such as those at universities (eg, MIT and UCSF). Nothing to report. * Has located University of Cincinnati medical files search. Advisory Comm ttee will want these files. - University wi 1 not release. - Defense must talk to their General Counsel because Mi scell aneous White House must coordinate between Search Group and Interagency Working Phil Caplan o f White House Cabinet Affairs will begin attending Search Group meetings to aid communication.

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O’Toole: Information kit for press, pub1 i c , Congressional staff Discuss public meeting agenda with Ruth Faden Ask Advisory Committee staff t o contact Admiral Wisely for Set up Search Group meeting with Advisory Committee staff and Determine Advisory Committee needs for briefing book General information on benefits o f radiation in medical Ell i s : General information on informed consent

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INTERAGENCY SEARCH GROUP WEEKLY MEETING - APRIL 13,1994 Briefing book materials for Advisory Committee members in preparation for Advisory Committee public meeting Oral presentations by agency representatives at Advisory Committee public, Debrief on Cincinnati hearings and lessons leanred Working level contacts on records searches Update on Advisory Committee public meeting agenda Proposed agenda and dmte for next Search Group meeting

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Advisory Committee on Human Radiation Experiments Senior Policy and Research Analyst Director of Communications Director of Committce Affairs Depuh Staff Director Senior Policy and Research Analyst Senior Policv and Research Analyst Director of Information Services Public Mairs Oficer ADMINISTRATIVE AND SUPPORT

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Director, Program in Law, Ethics and Health, Department of Health Policy and Management, Johns Hopkins University, Baltimore, Maryland; Senior Research Scholar, Kennedy Institute of Ethics, Georgetown, University, Washington, District of Columbia. Ruth Macklin, Ph-D. - Head, Division of Philosophy and History of Medicine, Professor of Bioethics, Shoshanah Trachtenberg Frackman Faculty Scholar in Biomedical Ethics, Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine, Bronx, New York. Washington, District of Columbia; Adjunct Professor, Department of Health Policy and Management, School of Hygiene and Public Health, Johns Hopkins University, Psychiatry, Harvey L Karp Professorial Lecturer in Law and Psychoanalysis, Yale University, New Haven, Connecticut. Hershey Medical Center, Pennsylvania State University, Hershey, Pennsylvania. At t om ev Columbia; Adjunct Professor of Law,Georgetown University Law Center, Washington; Member, PresidentiaI Commission on Catastrophic Nuclear Accidents, 1989-90. Dunan Thomas, Ph.D. - Professor, Preventive Medicine, University of Southern California School of Medicine, Los Angeles, California.

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Eli J. Glatstein, M.D. - Professor and Chairman, Department of Radiation Oncology, Simmons Cancer Center, Southwestern Medical Center, University of Texas, Dallas, Henry D. Royal, M.D. - Associate Director, Division of Nuclear Medicine, Mallinckrodt Institute of Radiology, Professor of Radiology, Washington University School of Medicine, St. Louis, Missouri. Mary Ann Stevenson, M.D.,Ph.D. - Assistant Professor of Radiation Oncology, Joint Center for Radiation Therapy, Deputy Chief, Department of Radiation Oncology, New England Deaconess Hospital, Haward Medical School, Boston, Massachusetts. Reed V. Tuckson, M.D. - President, Charles R. Drew University of Medicine and Science, Los Angeles, California. Militarv Medicine Specialist Philip K. Russell, M.D. - Professor of International Health, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, Maryland. Nancy L. Oleinick, Ph.D. - Professor of Radiation Biology and Biochemistry, Environmental Health Science and Oncology, School of Medicine, Director, Division of Biochemistry and Oncology, Department of Radiology, Case Western Reserve University, Frank Press, Ph.D. - Fellow, Cecil and Ida Green Fellowship, Carnegie Institution of Washington, Washington, District of Columbia; former President, National Academy of -- h i s L. Norris - Community Representative, Institutional Review Board, University of Nebraska; retired Second Vice President, Omaha National Bank and Omaha National Corporation, Omaha. Nebraska.

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CHAIR, ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS Ruth R. Faden, Ph.D., M.P.H., is Professor of Health Policy and Management in the School of Hygiene and Public Hcalth, Johns Hopkins University. Dr.Faden is also Senior Research Scholar at the Kennedy Institute of Ethics, Georgetown Dr. Faden is Director of the Program in Law,Ethics, and Health of Johns Hopkins’ School of Public Health. She is the author of many books and journal articles on biomedical and research ethics, health policy, and health behavior, including A Historv and Theorv of Informed Consent, co-authored with Tom L Beauchamp, Ph.D. In addition to her extensive publications, Dr. Faden has served on numerous national task forces and committees. Dr. Faden holds a Bachelor of Arts in American Civilization from the University of Pennsylvania and a Master of A r t s in Humanities from the University of Chicago. She received a Masters in Public Health (M.P.H.)and a Doctorate (PbD.) in Attitudes and Behavior from the University of California-Berkeley.

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ON HUMAN RADIATION EXPERIMENTS STAFF Dan Guttman has been a partner at Spiegel & McDiarmid, a Washington, D.C. law firm which represents public agencies, workers and consumers in cncrgy, communication and environmental matters, and human rights issues. He has assisted local governments and worker representatives in the ongoing conversion of the nuclear weapons complex, and Nye County, Nwada, the site of the proposed nuclear waste repository. - Foilowing graduation in 1971 from Yale Law School, he co-authored the Ralph Nader sponsored book, The Shadow Government: The GwerrrepJ;et's Multibillion Dollar Giveawav of its Decisionmah'np: Powers to Private Manqgmcnt Consultants. "ExDerts."and Think Tanks. H e served as special counsel to Senator David Pxyor in the oversight and investigation of the Federal use of private expertise in the performance of the basic work of government. He participated on the National Academy of Public Administration's Standing Panel on Executive Organization and Management, and was the recipient of a German Marshall Fund grant to advise on energy conservation in Czechoslovakia. He has written for publications including The New Rembl ic. The WashinPtoq Monthlv, Public Power, and The Harvard Journal on Lern.'slation. He served as research assistant to Andy Rooney in the production of "Mr. Rooney Goes to Washington," an award winning CBS news documentary. He was graduated phi beta kappa with highest honors from the University of

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ON HUMAN RADIATION EXPERIMENTATION Director of Committee Affairs Deputy Staff Direcror Senior Policy and Research Analysr Before joining the Advisory Committee staff, Ms. Mastroianni was a study director in the Division of Health Sciences Policy of the National Academy of Sciences' Institute of Medicine. In that position, she most recently directed a study evaluating legal and ethical issues relating to the inclusion of women in clinical studies. Ms. Mastrioanni practiced hedth care law in Washington, DC, in addition to serving as a legal consultant to the National Research Council's Committee on Contraceptive Development. She received her Juris Doctor and undergraduate degrees fromthe University of Pennsylvania. Her research interests include legal and ethical issues in the "right to die" area. She currently studies health policy at the Johns Hopkins University School of Hygiene and Public Health, and is a member of the Department of Health and Human Services Advisory Workshop on Women in Medicine. Achg Staf Director Senior Poliq and Reseadt Analyst In addition to his Committee duties, Jeffrey Kahn is Assistant Professor of Bioethics and Associate Director for Graduate Studies in the Center for the Study of Bioethics of the Medical College of Wisconsin (MCW). His administrative responsibilities at MCW include directing the College's Master's program in Bioethics. Before joining the faculty at MCW, Dr. Kahn was Assistant Professor of Medical Humanities at East Carolina University School of Medicine, in Greenvie, North Carolina. Dr. Kahn's background includes study in both science and the humanities, with a Bachelor degree in Microbiology from the University of California Los Angeles, a Masters in Public Health from the Johns Hopkins University School of Hygiene and Public Health (Health Policy), and a Doctorate (Ph.D.) in Philosophy from Georgetown University, where he studied Bioethics at the Kennedy Institute of Ethics. Dr. Kahn does research and publishes in a variety of areas, including theoretical bioethics, ethics and genetics, dental ethics, ethical issues in health policy, and research ethics. His experience outside the academic setting includes hospital ethics committee memberships and consultations, along with review of proposed human and animal research.--

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ON HUMAN RADIATION EXPERIMENTATION Director of Communications In addition to his Committee duties, Stephen Klaidman is currently a visiting professor of journalism at the Pennsylvania State University and a fellow of the Kennedy Institute of Ethics,Georgetown University. He b e w his career in academia after 23 years as a journalist with The New York Times, The Washington Post, and the International Herald Tniune. Mr. Klaidman has been a columnist, editorial writer, reporterm, and editor. He has been a senior associate of the Institute for Health Poliq Analysis at Georgetown, director of the Undergraduate Values Project also at Georgetown, and is currently an Associate in the Department of Health Policy and Management at Johns Hopkins University. He is the author of Health in the Hea Virtuous Journalist (oxford, 1987, with Tom L Beauchamp). Mr.Klaidman has been a Guest Scholar at the Woodrow Wilson Center, where he won First Prize in the Media Studies competition in 1989. In 1992 he won the Lowell Mellett Award for improving journalism through critical evaluation. Senior Policy and Research Anuiyst In addition to his Committee duties, Jeremy Sugarman is an Assistant Professor and Co-Director of the Program in Medical Ethics in the Division of General Internal Medicine, Senior Fellow in the Center for the Study of Aging and Human Development, and Assistant Research Professor in the Center €or Health Policy Research and Education at Duke University Medical Center. He received his medical degree and residency training at Duke and went on to pursue formal training in medical ethics at Georgetown University, where he received his Master of Arts in Philosophy. Dr. Sugarman also received training in ernpirid research at the Johns Hopkins University School of Hygiene and Public Health,where he received a Masters in Public Health. Dr. Sugarman is boardartified in Internal Medicine and is a practicing physician at the Duke Medical Center. He has consulted for the U.S. Congress’ Office of Technology Assessment on its Defensive Medicine and Use of Medical Technologies Project. His p r i m w research interests relate to the moral issues associated with physician-patient communication, such as advance directives, informed consent, and shared medical

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Advisory Committee on Human Radiation Experiments Before she joined the Advisory Committee staff: Ms.Bulger practiced environmental law for three years with Vinson and Elkins L.L.P. in Houston, Texas. As an associate, she worked with many state and Federal environmental statutes and regulatory schemes. Her practice developed into predominantly toxic tort litigation. Ms. Bulger served as a legal intern at both the …