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Suggested Citation:"LIAISONS." 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 204
Suggested Citation:"LIAISONS." 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 205

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APPENDIX D 204 ence 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 Science Committee, and a member of the 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 director of 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. 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, Department of Epidemiology and Social Medicine, Montefiore Medical Center, and professor of bioethics at the Albert Einstein College of Medicine. She received a B.A. from Barnard College and an LL.B. from Harvard Law School. Ms. Dubler founded the Bioethics Consultation Service at Montefiore Medical Center in 1978 as a support for analysis of difficult cases presenting ethical issues in the health care setting. 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 jointly by Montefiore Medical Center, the Albert Einstein College of Medicine, and the

APPENDIX D 205 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, published by Vintage in 1993, and Mediating Bioethical Disputes, published in 1994 by the United Hospital Fund in New York City. She consults often with federal agencies, national working groups, and bioethics centers and served as cochair of the Bioethics Working Group 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. 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 of human rights violations and as 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. Pilar Ossorio, Ph.D., J.D., is assistant professor of law and medical ethics at the University of Wisconsin at Madison. Before taking this position, she was director of the Genetics Section at the Institute for Ethics of the American Medical Association. Dr. Ossorio received a Ph.D. in microbiology and immunology in 1990 from Stanford University. She went on to complete a postdoctoral fel

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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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