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Suggested Citation:"EXPERT ADVISERS." 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 202
Suggested Citation:"EXPERT ADVISERS." 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 203

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APPENDIX D 202 term member of President Bill Clinton's Cancer Panel, chair of the National Action Plan on Breast Cancer, past chair of the National Action Plan on Breast Cancer, 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. She is serving on the National Cancer Policy Board. EXPERT ADVISERS Kay Dickersin, Ph.D., is associate professor, Department of Community Health, Brown University School of Medicine, and 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. She is also adjunct associate professor in the Department of Epidemiology and Preventive Medicine at the University of Maryland School of Medicine, at the Johns Hopkins University Department of Epidemiology, and at the division of clinical care at Tufts University Department of Medicine. Her primary academic interests are evidence- based medicine, clinical trial design, and metaanalysis. Dr. Dickersin directs the coordinating center for two federally funded, multicenter randomized trials: the Ischemic Optic Decompression Trial and the Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding. She is on the Board of Directors for the Society for Clinical Trials 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 then earned a Ph.D. in epidemiology at the Johns Hopkins University. Alberto Grignolo, Ph.D., is senior vice president and general manager for Worldwide Regulatory Affairs at PAREXEL International, a contract research organization, where he is responsible for the company's regulatory services, including worldwide registration strategies and submissions, regulatory compliance, and clinical quality assurance for pharmaceuticals, biologicals, and medical devices. An internationally recognized regulatory professional and public speaker, Dr. Grignolo joined PAREXEL in 1992 as head of worldwide regulatory consulting services. Before going to PAREXEL, he held a series of regulatory and executive management positions at SmithKline Beecham and Fidia Pharmaceutical. A long-standing member of the Regulatory Affairs Profession

APPENDIX D 203 als Society, he was president and chairman of the board from 1991 to 1992. Dr. Grignolo is currently a member of the Board of Directors of the Drug Information Association (DIA). He is chair of the Regulatory Track of the 2001 DIA Annual Meeting and serves on the Steering Committee of the Americas, the Regulatory Special Interest Advisory Committee, the Marketing Committee, and the Regulatory Training Faculty. Dr. Grignolo holds a Ph.D. in experimental psychology from the University of North Carolina and a B.S. in psychology from Duke University. 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 and serves on the Institutional Review Board and the Conflict of Interest Committee. 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 an expert adviser to the Office for Human Research Protections on research involving children and prisoners. 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 is a past president of the American Society for Bioethics and Humanities. Dr. Marshall received a B.S.N. and a Ph.D. in religious studies (applied ethics) from the University of Virginia. She has published numerous books, chapters, and articles in the fields of perinatal substance abuse as well as clinical and research ethics. 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. Co-editor 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 co-authored several textbooks on clinical research and human subject protection, including standard operating procedures for investigative sites. She earned a B.S.N. from Boston College and serves as consulting faculty at Duke University. Dennis Tolsma, M.P.H., is director of the Division of Clinical Quality Improvement and director of research at Kaiser Permanente in Atlanta. He is chairelect (2001–2002) for the Board of HMO Research Network, chair of the Sci

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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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