Appendix D
Committee Biographies

Daniel D. Federman, M.D., Chair, is senior dean for alumni relations and clinical teaching and the Carl W. Walter Distinguished Professor of Medicine and Medical Education at Harvard Medical School. He graduated from Harvard College and Harvard Medical School and completed his internship and residency at Massachusetts General Hospital. Dr. Federman conducted research and trained in endocrinology at the National Institutes of Health, the University College Hospital Medical School in London, and Massachusetts General Hospital, where he served as a physician, chief of the Endocrine Unit, and associate chief of medical services. During his 4-year tenure at Stanford University Medical School, he was physician-in-chief, the Arthur F. Bloomfield Professor of Medicine, and chair of the Department of Medicine. In 1977, Dr. Federman returned to Harvard Medical School, where he has held the posts of dean for students and alumni, dean for medical education, and professor of medicine. He has served as chair of the Board of Internal Medicine and president of the American College of Physicians. He is a member of the Institute of Medicine and served on the Committee on Understanding the Biology of Sex and Gender Differences. In 2001, Dr. Federman received the Abraham Flexner Award of the Association of American Medical Colleges.

Daniel L. Azarnoff, M.D., is president of D. L. Azarnoff Associates and senior vice president of Clinical and Regulatory Affairs of Cellegy Pharmaceuticals. He has more than 20 years of academic experience in research and clinical medicine. For 8 years Dr. Azarnoff served as president of



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Responsible Research: A Systems Approach to Protecting Research Participants Appendix D Committee Biographies Daniel D. Federman, M.D., Chair, is senior dean for alumni relations and clinical teaching and the Carl W. Walter Distinguished Professor of Medicine and Medical Education at Harvard Medical School. He graduated from Harvard College and Harvard Medical School and completed his internship and residency at Massachusetts General Hospital. Dr. Federman conducted research and trained in endocrinology at the National Institutes of Health, the University College Hospital Medical School in London, and Massachusetts General Hospital, where he served as a physician, chief of the Endocrine Unit, and associate chief of medical services. During his 4-year tenure at Stanford University Medical School, he was physician-in-chief, the Arthur F. Bloomfield Professor of Medicine, and chair of the Department of Medicine. In 1977, Dr. Federman returned to Harvard Medical School, where he has held the posts of dean for students and alumni, dean for medical education, and professor of medicine. He has served as chair of the Board of Internal Medicine and president of the American College of Physicians. He is a member of the Institute of Medicine and served on the Committee on Understanding the Biology of Sex and Gender Differences. In 2001, Dr. Federman received the Abraham Flexner Award of the Association of American Medical Colleges. Daniel L. Azarnoff, M.D., is president of D. L. Azarnoff Associates and senior vice president of Clinical and Regulatory Affairs of Cellegy Pharmaceuticals. He has more than 20 years of academic experience in research and clinical medicine. For 8 years Dr. Azarnoff served as president of

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Responsible Research: A Systems Approach to Protecting Research Participants research and development for the Searle Pharmaceutical Company, and for the past 14 years he has served as a consultant in drug development. Before joining Searle he was Distinguished Professor of Medicine and Pharmacology and director of the Clinical Pharmacology Toxicology Center at the University of Kansas Medical Center, a position he held for 16 years. He has published more than 175 articles in scientific and medical journals. Dr. Azarnoff is a member of the Institute of Medicine and a fellow of the American Association of Pharmaceutical Scientists, the New York Academy of Sciences, and the American College of Physicians and is chair-elect of the Pharmaceutical Section of the American Association for the Advancement of Science. He maintains a teaching appointment at the schools of medicine of the University of Kansas and Stanford University. Dr. Azarnoff has been on the editorial boards of several journals and on committees of the U.S. Food and Drug Administration, World Health Organization, American Medical Association, National Academy of Sciences, Institute of Medicine, and National Institutes of Health, advising them on drugs and drug development. Tom L. Beauchamp, Ph.D., is professor of philosophy and senior research scholar at the Kennedy Institute of Ethics. He was born in Austin, Texas. He received graduate degrees from Yale University and the Johns Hopkins University, where he received a Ph.D. in 1970. He then joined the faculty of the Philosophy Department at Georgetown University and in the mid-1970s accepted a joint appointment at the Kennedy Institute of Ethics. In 1976, he joined the staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, where he drafted the bulk of The Belmont Report (1978). Dr. Beauchamp’s research interests are in Hume and the history of modern philosophy and practical ethics, especially biomedical ethics and business ethics. Publications include the following coauthored works: Hume and the Problem of Causation (Oxford University Press, 1981), Principles of Biomedical Ethics (Oxford University Press, 1979; 4th ed., 1994), A History and Theory of Informed Consent (Oxford University Press, 1986), and Philosophical Ethics (McGraw-Hill, 1982; 2nd ed., 1991). Publications also include a number of edited and coedited anthologies and more than 100 scholarly articles in journals and books. Dr. Beauchamp is the General Editor—with David Fate Norton and M. A. Stewart—of The Critical Edition of the Works of David Hume, Clarendon Press, Oxford University Press. He is also the editor of an electronic edition called HUMETEXT (coeditor, David Fate Norton), a complete electronic edition of Hume’s philosophical, political, and literary works. Timothy Stoltzfus Jost, J.D., holds the Robert L. Willett Family Professorship at the Washington and Lee University School of Law. Prior to coming

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Responsible Research: A Systems Approach to Protecting Research Participants to Washington and Lee in 2001, Professor Jost taught at the Ohio State University for twenty years in the Colleges of Law and of Medicine and Public Health. He is the author of a book on comparative health law and a coauthor of casebooks in health law and in property law and has published a number of articles concerning health care regulation and comparative health law. Professor Jost has served as a consultant to the Institute of Medicine, the Administrative Conference of the United States, and the American Bar Association’s Commission of Legal Problems of the Elderly and was a member of the State of Ohio Medical Board. A recipient of a Western European Regional Research Fulbright Grant, Professor Jost spent the winter and spring of 1989 at the Oxford University Centre for Socio-Legal Studies. He was also a guest professor at the University of Goettingen in Germany on a Fulbright grant in 1996–1997. In 2000, Professor Jost received the Jay Healey Distinguished Health Law Teacher Award from the American Society of Law, Medicine, and Ethics. He earned a B.A. in history at the University of California, Santa Cruz, and a J.D. from the University of Chicago. Patricia A. King, J.D., is the Carmack Waterhouse Professor of Law, Medicine, Ethics and Public Policy at Georgetown University Law Center. She is also an adjunct professor in the Department of Health Policy and Management, School of Hygiene and Public Health, Johns Hopkins University, and chair of the board of trustees of Wheaton College. She is the coauthor of Cases and Materials on Law, Science, and Medicine and an area editor of the Encyclopedia of Bioethics (MacMillan Publishing Company). A member of the Institute of Medicine and the American Law Institute, she is also a fellow of the Hastings Center. She has served on numerous committees of the Institute of Medicine. Her work in the field of bioethics has included service as cochair for policy of the Embryo Research Panel, National Institutes of Health; the U.S. Department of Health, Education, and Welfare, Recombinant DNA Advisory Committee; the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research; the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; and the Ethics, Legal and Social Issues Working Group of the Human Genome Project. She is also a member of the boards of the Henry J. Kaiser Family Foundation, the National Partnership for Women and Families, and the Hospice Foundation. Before joining Georgetown University, she was the deputy director of the Office of Civil Rights at the U.S. Department of Health, Education, and Welfare and special assistant to the chair of the Equal Employment Opportunity Commission. She also served as a deputy assistant attorney general in the Civil Division of the U.S. Department of Justice. Ms. King received a B.A. from Wheaton College and a J.D. from Harvard Law School.

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Responsible Research: A Systems Approach to Protecting Research Participants Roderick J. A. Little, Ph.D., is the Richard D. Remington Collegiate Professor of Biostatistics at the School of Public Health, University of Michigan. He has also been a professor in the Department of Biomathematics at the University of California, Los Angeles, School of Medicine and a scientific associate for the World Fertility Survey. Little has been an American Statistical Association/U.S. Bureau of the Census/National Science Foundation research fellow and has held faculty positions at the George Washington University and the University of Chicago. He is a fellow of the American Statistical Association and an elected member of the International Statistical Institute. He received a Ph.D. in statistics from London University’s Imperial College. He is currently a member of the National Research Council’s Committee on National Statistics. He has expertise in the areas of survey sampling and statistical analysis of incomplete data and has broad experience with applications of statistics to demography, the social sciences, and biomedical research. James McNulty serves on the board and the Executive Committee of the National Alliance for the Mentally Ill (NAMI), Rhode Island, as well as the Mental Health Consumer Advocates of Rhode Island, a statewide organization for mental health consumers. Having experienced the full impact of mental illness personally, he has been active in involving patient and family advocates in all aspects of treatment of mental illness. Mr. McNulty is President of the Board of Directors of NAMI National and also serves as president of the Manic Depressive & Depressive Association of Rhode Island. He served on the Protection and Advocacy Program for Persons with Mental Illness advisory committee for Rhode Island, as well as the board of the Rhode Island Protection Advocacy Services Agency. For several years, Mr. McNulty served on the Institutional Review Board of Butler Hospital, a freestanding psychiatric teaching hospital affiliated with the Brown University School of Medicine. He began his service with the Human Subjects Research Council Workgroup of the National Advisory Mental Health Council in 1999. He is a member of the Executive Committee of the Clinical Antipsychotic Trials of Intervention Effectiveness Project, a National Institute of Mental Health-funded multisite research protocol evaluating the efficacy of atypical antipsychotics in schizophrenia and Alzheimer’s disease. Mr. McNulty also serves on the Governor’s Council on Mental Health in Rhode Island and the National Advisory Mental Health Council. Anne C. Petersen, Ph.D., has been senior vice president for programs at the W. K. Kellogg Foundation since 1996. Dr. Petersen was deputy director and chief operating officer of the National Science Foundation from 1994 to 1996, the first woman in the agency’s 45-year history to serve in that

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Responsible Research: A Systems Approach to Protecting Research Participants position. She served as the vice president for research, as well as dean of the Graduate School, at the University of Minnesota. Dr. Petersen has authored many books and articles on adolescence, gender, and research methods and is a fellow of the American Association for the Advancement of Science, the American Psychological Association, the Institute of Medicine, and is on the Executive Committee of the International Society for the Study of Behavioral Development, among other societies. In addition, she was a member of the Board of Trustees of the National Institute of Statistical Sciences, among other boards and councils. She holds a bachelor’s degree in mathematics; a master’s degree in statistics; and a doctorate in measurement, evaluation, and statistical analysis, all from the University of Chicago. Bonnie W. Ramsey, M.D., is director of the Pediatric General Clinical Research Center and Cystic Fibrosis Research Center at Children’s Hospital and Regional Medical Center in Seattle. She is a professor in the Department of Pediatrics and program director, Core Center for Gene Therapy, University of Washington School of Medicine. She also is the director of the Cystic Fibrosis Foundation’s newly formed Therapeutics Development Network Coordinating Center. Dr. Ramsey is an active member of several national professional societies including the American Thoracic Society and the American Academy of Pediatrics, serves on the Board of Trustees of the Cystic Fibrosis Foundation, and is chair of the Medical Advisory Committee for the National Cystic Fibrosis Foundation. She also serves as an ad hoc reviewer for the New England Journal of Medicine, Journal of Pediatrics, Human Gene Therapy, Pediatric Pulmonology, and American Journal of Respiratory and Critical Care Medicine. Dr. Ramsey has served on several government agency advisory panels including the Pulmonary Advisory Board, U.S. Food and Drug Administration, and advisory review groups for the National Heart, Lung, Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, and National Center for Research Resources. Dr. Ramsey earned an undergraduate degree from Stanford University and a medical degree from Harvard Medical School. Lydia Villa-Komaroff, Ph.D., is professor of neurology and vice president for research at Northwestern University, where she is responsible for policy formulation, strategy design, and operational oversight of the research infrastructure. She received an A.B. in biology from Goucher College and a Ph.D. in cell biology from the Massachusetts Institute of Technology. During her research career, she gained international recognition as a molecular biologist and was a key member of the team that first demonstrated that bacterial cells could produce insulin. Dr. Villa-Komaroff was an associate professor of neurology at Harvard Medical School and Children’s Hospital and associate director of the Division of Neuroscience at Children’s Hospi-

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Responsible Research: A Systems Approach to Protecting Research Participants tal in Boston. She has published more than 60 articles and reviews and has served on a number of review committees for the National Institutes of Health. She was a member of the Advisory Committee for the Biology Directorate of the National Science Foundation (chair from 1997 to 1998), was a member of the congressionally mandated National Science Foundation Committee on Equal Opportunity in Science and Engineering, and was an invited participant in the Forum on Science in the National Interest sponsored by the White House Office of Science and Technology Policy. She is currently a member of the National Advisory Neurological Disorders and Stroke Council and the Board of Directors of the American Association for the Advancement of Science. She is a founding member of the Society for the Advancement of Chicanos and Native Americans in Science and has served as a board member and vice president. Frances M. Visco, J.D., has served as president of the National Breast Cancer Coalition (NBCC), an organization dedicated to eradicating breast cancer through action and advocacy, since its inception in 1991. NBCC is a coalition of 600 organizations and 60,000 individuals. Ms. Visco is a three-term member of the President’s Cancer Panel, past chair of the National Action Plan on Breast Cancer and member of the National Cancer Policy Board, and immediate past chair of the Integration Panel of the U.S. Department of Defense Peer-Reviewed Breast Cancer Research Program. After her own successful battle with breast cancer, she began her crusade as a breast cancer activist with the Linda Creed Breast Cancer Foundation. She continues to serve on the board of that foundation and is active in many of its programs. Until April 1995, Ms. Visco was a commercial litigator and partner at the law firm of Cohen, Shapiro, Polisher, Shiekman & Cohen in Philadelphia. Ms. Visco graduated from St. Joseph’s University and Villanova Law School. EXPERT ADVISERS Kay Dickersin, Ph.D., is associate professor, Department of Community Health, Brown University School of Medicine, and is codirector of the New England Cochrane Center within the Cochrane Collaboration, which aims to facilitate systematic reviews of randomized controlled trials across all areas of health care. Her primary academic interests are evidence-based medicine, clinical trial design, and meta-analysis. Dr. Dickersin directs the coordinating center for two federally funded, multicenter randomized trials: the Ischemic Optic Neuropathy Decompression Trial and the Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding, and has served on a number of national and international data and safety monitoring boards. She is on the Board of Directors for the Society for Clinical

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Responsible Research: A Systems Approach to Protecting Research Participants Trials (1997-2000) and has served on the Institutional Review Board at the Johns Hopkins School of Hygiene and Public Health. From 1994 to 2000 she served on the National Cancer Advisory Board. She received a B.A. and an M.A. in zoology at the University of California, Berkeley, and earned a Ph.D. in epidemiology at the Johns Hopkins University. Alberto Grignolo, Ph.D., is Senior Vice President and General Manager of Worldwide Regulatory Affairs at PAREXEL International Corporation, a Contract Research Organization headquartered in the United States, with offices in 35 countries. He has held this position for nearly a decade and is responsible for PAREXEL’s regulatory services, including worldwide registration strategies and submissions, regulatory compliance and clinical quality assurance for pharmaceuticals, biologicals and medical devices. He consults with clients in the areas of drug development strategy, regulatory negotiation and best regulatory practices. Prior to joining PAREXEL, Dr. Grignolo served as President of FIDIA Pharmaceutical Corporation and held regulatory positions at SmithKline & French Laboratories. Having completed his undergraduate degree at Duke University, he earned a doctorate in Experimental Psychology from the University of North Carolina and conducted postdoctoral research in neuropharmacology at Duke University Medical Center. He is a past Chairman of the Board of the Regulatory Affairs Professionals Society (RAPS), has been involved in the advancement of the regulatory profession for most of his career, and was the recipient of the 1995 Richard E. Greco Professional of the Year Award from RAPS. Dr. Grignolo is currently an elected member of the Board of Directors of the Drug Information Association (DIA). He is the Chair of the Regulatory Track of the 2001 and 2002 DIA Annual Meetings, and serves on the Steering Committee of the Americas, the Regulatory Special Interest Area Committee, the Marketing Committee and the Regulatory Training Faculty. A native European who has also lived in Latin America, Dr. Grignolo is a regular speaker, instructor and participant at international conferences, seminars and workshops on Regulatory Affairs and Good Clinical Practice. Mary Faith Marshall, Ph.D., B.S.N., is professor of medicine and bioethics at Kansas University Medical Center, where she also holds joint appointments in the School of Nursing and Allied Health and the Department of History and Philosophy of Medicine. She is principal investigator of the Research Integrity Project at the Midwest Bioethics Center. At the U.S. Department of Health and Human Services she serves as chair of the National Human Research Protections Advisory Committee and as a special expert consultant to the Secretary on research involving children and prisoners. She has been a member of on-site evaluation teams for the Office for

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Responsible Research: A Systems Approach to Protecting Research Participants Human Research Protections. She sits on the Council of Academic Societies of the Association of American Medical Colleges. At the National Institutes of Health, Dr. Marshall served on the first special research ethics review panel advisory to the director and sits on the Cardiology and Hematology Data Safety and Monitoring Boards of the National Heart, Lung, and Blood Institute. She has served on multiple special emphasis panels, review panels and study sections in the public and private sectors. She is a past president of the American Society for Bioethics and Humanities and the American Association for Bioethics. She is an elected fellow of the American College of Critical Care Medicine and a former fellow of the Kennedy Institute of Ethics. She received the Trailblazer Award from the NAACP (Charleston Chapter) in 1999 for her work in perinatal substance abuse and has testified on this subject before Congress and in US District Court. She serves on the Life Sciences Research Committee for the State of Missouri. Dr. Marshall received a B.S.N. and a Ph.D. in religious studies (applied ethics) from the University of Virginia. She is a coauthor of the best selling text Introduction to Clinical Ethics. She has published numerous books, chapters, and articles in the fields of research and clinical ethics as well as on perinatal substance abuse. Carol Saunders, R.N., is president and chief executive officer of the Center for Clinical Research Practice, a corporation that produces and publishes educational and management resources for institutions, sponsors, and clinical research professionals. She is executive director of the New England Institutional Review Board, which provides ethical review services for sponsors and investigators of drug and device studies. Coeditor of Research Practitioner, she has published extensively and lectured on a broad range of research-related topics and has been recognized for excellence in medical communications by the American Medical Writers Association. She has coauthored several textbooks on clinical research and human subject protection, including standard operating procedures for both investigative sites and sponsors. She earned a B.S.N. from Boston College and was elected a community leader Alpha Chi Chapter, Sigma Theta Tau International. Dennis Tolsma, M.P.H., is associate director of Clinical Affairs and director of research at Kaiser Permanente in Atlanta. He is chair (2001–2002) of the Board of HMO Research Network, chair of the Science Steering Committee for a Centers for Disease Control and Prevention research contract with the Alliance for Community Health Programs and America Association of Health Plans, and a member of Kaiser Permanente Research Advisory Council. From 1994 to 1998, he was director of prevention and practice analysis for Kaiser Permanente and chaired the company’s Institutional Review Board from 1995 to 1999. Before joining Kaiser, he was associate

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Responsible Research: A Systems Approach to Protecting Research Participants director for public health practice at the Centers for Disease Control and Prevention. He received an A.B. in mathematics and English from Calvin College and an M.P.H. from Columbia University. LIAISONS Richard J. Bonnie, L.L.B., is John S. Battle Professor of Law at the University of Virginia School of Law and director of the University’s Institute of Law, Psychiatry, and Public Policy. He previously served as associate director of the National Commission on Marijuana and Drug Abuse, a member of the National Advisory Council on Drug Abuse, chair of Virginia’s State Human Rights Committee responsible for protecting the rights of persons with mental disabilities, adviser for the American Bar Association’s Criminal Justice Mental Health Standards Project, and a member of the John D. and Catherine T. MacArthur Foundation Research Network on Mental Health and the Law. He was a member of a delegation of the U.S. State Department that assessed changes in the Soviet Union relating to political abuse of psychiatry and is a member of the Board of Directors of the Geneva Initiative on Psychiatry. Mr. Bonnie is a member of the Institute of Medicine and has also served on and chaired numerous Institute of Medicine committees. He recently chaired an NRC committee on research on elder abuse and neglect. In addition, he serves as an adviser to the American Psychiatric Association’s Council on Psychiatry and Law and received the American Psychiatric Association’s prestigious Isaac Ray Award in 1998 for contributions to forensic psychiatry and the psychiatric aspects of jurisprudence. Mr. Bonnie is a liaison from the IOM Board on Neuroscience and Behavioral Health. Nancy Neveloff Dubler, L.L.B., is the director of the Division of Bioethics, Montefiore Medical Center, and Professor of Epidemiology and Social Medicine at the Albert Einstein College of Medicine. She received a B.A. from Barnard College and an L.L.B. from Harvard Law School. Ms. Dubler founded the Bioethics Consultation Service at Montefiore Medical Center in 1978. She lectures extensively and is the author of numerous articles and books on termination of care, home care and long-term care, geriatrics, prison and jail health care, and AIDS. She is codirector of the Certificate Program in Bioethics and the Medical Humanities, conducted with The Hartford Institute of Geriatric Nursing at New York University. Her most recent books are Ethics on Call: Taking Charge of Life and Death Choices in Today’s Health Care System (Vintage Books, 1993), and Mediating Bioethical Disputes (The United Hospital Fund, 1994; Second Edition, 2002). She consults often with federal agencies, national working groups, and bioethics centers and served as co-chair of the Bioethics Working Group

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Responsible Research: A Systems Approach to Protecting Research Participants at the National Health Care Reform Task Force. Ms. Dubler is a liaison from the Board on Health Sciences Policy. Elena Ottolenghi Nightingale, M.D., Ph.D., is a scholar-in-residence at the National Research Council and the Institute of Medicine (IOM) and adjunct professor of pediatrics at both Georgetown University Medical Center and George Washington University Medical Center. She is a member of the Institute of Medicine. Dr. Nightingale serves as liaison or adviser to several IOM activities and is a member emerita of the IOM Board on Health Promotion and Disease Prevention. For more than 11 years she was special adviser to the president and senior program officer at Carnegie Corporation of New York and lecturer in social medicine at Harvard University. She retired from both positions at the end of 1994. Dr. Nightingale earned an A.B. degree in zoology, summa cum laude, from Barnard College of Columbia University, a Ph.D. in microbial genetics from the Rockefeller University, and an M.D. from New York University School of Medicine. She is a fellow of the American Association for the Advancement of Science, the New York Academy of Sciences, and the Royal Society of Medicine. She has authored numerous book chapters and articles on microbial genetics, health (particularly child and adolescent health and well-being and health promotion and disease prevention), health policy, and human rights. Her current research interest is in improving the safety and security of young adolescents in the United States. Dr. Nightingale continues to be active in the protection of human rights, particularly those of children. She also continues to work on enhancing the participation of health professionals and health professional organizations in the protection of human rights. She has lectured and written widely on these topics, particularly on the role of physicians as perpetrators and protectors of human rights. Currently she serves on the Advisory Committee of the Children’s Rights Division of Human Rights Watch. She has also served on the Board of the Children’s Research Institute of the Children’s National Medical Center in Washington, D.C., and is on the Institutional Review Board of that institution. Dr. Nightingale is a liaison from the IOM Board on Children, Youth, and Families and is a member of the joint IOM/NRC Committee on Adolescent Health and Development. Pilar N. Ossorio, Ph.D., JD, is Assistant Professor of Law and Bioethics at the University of Wisconsin at Madison. She is also Associate Director at the Center for the Study of Cultural Diversity in Health Care. Prior to taking her position at UW, she was Director of the Genetics Section at the Institute for Ethics at the American Medical Association, and taught as an adjunct faculty member at the University of Chicago Law School. Dr. Ossorio received her Ph.D. in Microbiology and Immunology in 1990

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Responsible Research: A Systems Approach to Protecting Research Participants from Stanford University. She went on to complete a post-doctoral fellowship in cell biology at Yale University School of Medicine. Throughout the early 1990s, Dr. Ossorio also worked as a consultant for the federal program on the Ethical, Legal, and Social Implications (ELSI) of the Human Genome Project, and in 1994 she took a full-time position with the Department of Energy’s ELSI program. In 1993, she served on the Ethics Working Group for President Clinton’s Health Care Reform Task Force. Dr. Ossorio received her JD from the University of California at Berkeley School of Law (Boalt Hall) in 1997. While at Boalt she was elected to the legal honor society Order of the Coif and received several awards for outstanding legal scholarship. Dr. Ossorio is a fellow of the American Association for the Advancement of Science (AAAS), a past member of AAAS’s Committee on Scientific Freedom and Responsibility, a past member of the National Cancer Policy Board at the National Academy of Sciences, and has been a member or chair of several working groups on genetics and ethics. She has published scholarly articles in bioethics, law and molecular biology. STUDY STAFF Laura Lyman Rodriguez, Ph.D., is a senior program officer in the Board on Health Sciences Policy at the Institute of Medicine and is the study director for Assessing the System for Protecting Human Research Participants. She came to the Institute of Medicine from the Office of Public Affairs at the Federation of American Societies for Experimental Biology (FASEB), where she was a policy analyst covering human subjects research and institutional review board issues, bioethics, and federal funding priorities. Before her tenure at FASEB, Dr. Rodriguez was a congressional fellow in the office of Representative Vernon J. Ehlers (MI), where she focused on national science policy issues and K-12 math and science education. Dr. Rodriguez has expertise in cell biology and genetics and is particularly interested in clinical research issues and the policy implications of genomics. Robert Cook-Deegan, M.D., is director of the Center for Genome Ethics, Law, and Policy at Duke University. Until June 2002, he directed the Robert Wood Johnson Health Policy Fellowship Program at the Institute of Medicine and was a senior program officer for IOM’s Health Sciences Policy Board. Outside IOM, he is also a Robert Wood Johnson Health Policy Investigator at the Kennedy Institute of Ethics, Georgetown University, where he is writing a primer on how national policy decisions are made about health research. He is also a seminar leader for the Stanford-in-Washington program.

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Responsible Research: A Systems Approach to Protecting Research Participants Jessica Aungst is a research assistant in the Division of Health Sciences Policy of the Institute of Medicine. She received a degree in English with a minor in sociology from the State University of New York, Geneseo. Previously, she worked for the Maldon Institute, researching and writing about international affairs. Natasha S. Dickson is a senior project assistant with the National Academies’ Institute of Medicine in Washington DC. She is a graduate of St. Augustine Senior Comprehensive Secondary School in Trinidad and Tobago. She gained most of her administrative experience while working as a clerical assistant at the University of the West Indies, St. Augustine, Trinidad. She also worked as an advertising sales representative and freelance reporter for the Trinidad Express Newspapers before moving to the U.S.A. in March 2000. She became an administrative receptionist for telecommunications lobbyists Simon Strategies LLC before joining the National Academies in March 2001. IOM BOARD ON HEALTH SCIENCES POLICY STAFF Andrew Pope, Ph.D., is director of the Board on Health Sciences Policy at the Institute of Medicine. With expertise in physiology and biochemistry, his primary interests focus on environmental and occupational influences on human health. Dr. Pope’s previous research activities focused on the neuroendocrine and reproductive effects of various environmental substances on food-producing animals. During his tenure at the National Academy of Sciences, and since 1989 at the Institute of Medicine, Dr. Pope has directed numerous studies. The topics of these studies include injury control, disability prevention, biologic markers, neurotoxicology, indoor allergens, and the enhancement of environmental and occupational health content in medical and nursing school curricula. Most recently, Dr. Pope directed studies on priority-setting processes at the National Institutes of Health, fluid resuscitation practices in combat casualties, and organ procurement and transplantation. Charles H. Evans, Jr., M.D., Ph.D., is a Scholar-in-Residence at the Institute of Medicine (IOM). During 1998-2001, he served as Head of the Health Sciences Section and as senior Adviser for Biomedical and Clinical Research at the IOM. He was the study director for the IOM-NAS-NAE National Town Meeting for Discussion of the Common Federal Definition of Research Misconduct, Procedures and Policies, and the IOM Committees on Creating a Vision for Space Medicine during Travel Beyond Earth Orbit and on Strategies for Small Number Participant Clinical Research Trials. A pediatrician and immunologist, Dr. Evans received his B.S. in

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Responsible Research: A Systems Approach to Protecting Research Participants biology from Union College, and his M.D. and Ph.D. from the University of Virginia. His advanced training in pediatrics was at the University of Virginia Medical Center. Following his postgraduate training he was appointed to the National Institutes of Health intramural staff as a principal investigator and during 1975-1998 he served as Chief of the Tumor Biology Section at the National Cancer Institute. Dr. Evans’s research interests are carcinogenesis (the etiology of cancer) and the normal immune system defenses to the development of cancer. Dr. Evans is an author of more than 125 scientific articles and is the recipient of numerous scientific awards including the Outstanding Service Medal from the U.S. Public Health Service and the Wellcome Medal and Prize. He is a Fellow of the American Association for the Advancement of Science, the American Institute of Chemists and a credentialed Fellow in Health Systems Administration of the American Academy of Medical Administrators. An active advisor to community medicine and higher education, he has served on several health system and university Boards of Trustees. CONSULTANT Kathi E. Hanna, M.S., Ph.D., is a science and health policy consultant specializing in biomedical research policy and bioethics. She has served as research director and senior consultant to the National Bioethics Advisory Commission and as senior adviser to the President’s Advisory Committee on Gulf War Veterans Illnesses. In the 1980s and early 1990s, Dr. Hanna was a senior analyst at the now defunct congressional Office of Technology Assessment, contributing to numerous science policy studies requested by committees of the U.S. House and U.S. Senate on science education, research funding, biotechnology, women’s health, human genetics, bioethics, and reproductive technologies. In the past decade she has served as a consultant to the Howard Hughes Medical Institute, the National Institutes of Health, the Institute of Medicine, and several charitable foundations. In the early 1980s, Dr. Hanna staffed committees of the American Psychological Association that were responsible for oversight of policies related to the protection of human participants in research and animal research. Before coming to Washington, D.C., she was the genetics coordinator at Children’s Memorial Hospital in Chicago, where she directed clinical counseling and coordinated an international research program investigating prenatal diagnosis of cystic fibrosis. Dr. Hanna received an A.B. in biology from Lafayette College, an M.S. in human genetics from Sarah Lawrence College, and a Ph.D. from the School of Business and Public Management, George Washington University.

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