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Suggested Citation:"CONSULTANT." 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 207
Suggested Citation:"CONSULTANT." 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 208

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APPENDIX D 207 she moved to Washington, D.C., to work for an international newsletter before joining the Institute of Medicine. Natasha S. Dickson is a senior project assistant with the National Academy of Sciences' Institute of Medicine in Washington D.C. 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 United States 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 those studies include injury control, disability prevention, biological 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. 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

APPENDIX D 208 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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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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