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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)

Chapter: APPENDIX D Committee, Expert Adviser, and Staff Biographies

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Suggested Citation:"APPENDIX D Committee, Expert Adviser, and Staff Biographies." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 197
Suggested Citation:"APPENDIX D Committee, Expert Adviser, and Staff Biographies." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 198
Suggested Citation:"APPENDIX D Committee, Expert Adviser, and Staff Biographies." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 199
Suggested Citation:"APPENDIX D Committee, Expert Adviser, and Staff Biographies." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 200
Suggested Citation:"APPENDIX D Committee, Expert Adviser, and Staff Biographies." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 201

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APPENDIX D 197 APPENDIX D Committee, Expert Adviser, and Staff 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. 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 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

APPENDIX D 198 Pharmacology Toxicology Center at the University of Kansas Medical Center, a job 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 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 wrote 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 co-authored 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 co-edited 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 (co-editor, David Fate Norton), a complete electronic edition of Hume's philosophical, political, and literary works. Timothy Stoltzfus Jost, J.D., is the Newton D. Baker-Baker and Hostetler Professor of Law and also a professor of health services management at the College of Medicine and Public Health, Ohio State University. He is the author of a book on comparative health law and a co-author 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 on Legal Problems of the Eld

APPENDIX D 199 erly 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, the Johns Hopkins University, and chair of the board of trustees of Wheaton College. She is the co-author 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 American Law Institute, she is also a fellow of the Hastings Center and a senior research scholar at the Kennedy Institute of Ethics. 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 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. Roderick J. A. Little, Ph.D., is professor and chair of the Department of Biostatistics of the School of Public Health at the 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

APPENDIX D 200 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 a member of the Board of Directors of NAMI National and is 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 position. She also 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, and 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 is a member of the National Advisory Mental Health Council at the National Institutes of Health, and Board of Trustees of the National Institute of Statistical Sciences. 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.

APPENDIX D 201 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 Hospital 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), a member of the congressionally mandated National Science Foundation Committee on Equal Opportunity in Science and Engineering, and 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 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. Ms. Visco is a two-

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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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