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Suggested Citation:"STUDY STAFF." 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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APPENDIX D 206 lowship 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 U.S. Department of Energy's ELSI program. In 1993, she served on the Ethics Working Group for President Bill Clinton's Health Care Reform Task Force. Dr. Ossorio received a J.D. from the University of California at Berkeley School of Law (Boalt Hall) in 1997. 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, and a member of the National Cancer Policy Board 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. Dr. Ossorio is a liaison from the IOM National Cancer Policy Board. STUDY STAFF Laura Lyman Rodriguez, Ph.D., is a senior program officer for the Board on Health Sciences Policy at the Institute of Medicine and is the study director for Assessing the System for Protecting Human Research Subjects. 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 (R-MI), where she focused on national science policy issues and math and science education from kindergarten through grade 12. 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 a senior program officer for the National Cancer Policy Board, Institute of Medicine (IOM), and Commission on Life Sciences (National Academy of Sciences), and for IOM's Health Sciences Policy Board. 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, and a seminar leader for the Stanford-in- Washington program, for which he recently directed a world survey of genomics research. Jessica Aungst is a research assistant for the Board on 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. Upon graduating,

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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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