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Institute of Medicine (US) Committee on Assessing the System for Protecting Human Research Participants; Federman DD, Hanna KE, Rodriguez LL, editors. Responsible Research: A Systems Approach to Protecting Research Participants. Washington (DC): National Academies Press (US); 2002.

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Responsible Research: A Systems Approach to Protecting Research Participants.

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The committee is grateful to the many administrators, investigators, policy makers, professional societies, and in particular, the research participants, their representatives, and their families that contributed their time, energy, and insight to the work and deliberations of this group throughout its two-year course (see Appendix A for listing of contributors to phase 2 activities).

Many thanks to Jeffrey Kahn and Robert J. Levine for their technical review of sections within the report and to Paul S. Appelbaum for his input to the committee's discussion regarding the informed consent process.

The committee also wishes to thank Lee Zwanziger, formerly of the Institute of Medicine, for her assistance and contribution to this project during the transition between Phases 1 and 2. Special gratitude is extended to Virginia deWolf, Constance Citro, and Andrew White of the Committee on National Statistics at the National Research Council and the entire CNSTAT/BBCSS Panel on IRBs, Surveys, and Social Science Research for their efforts to provide specialized insight into the questions facing this committee from the perspective of the social and behavioral sciences. Thanks also to Kenneth Shine, former President of the Institute of Medicine; Susanne Stoiber, Executive Officer of the Institute of Medicine; Clyde Behney, Deputy Director of the Institute of Medicine; and Andrew Pope, Director of the Institute of Medicine Board on Health Sciences Policy, for ongoing advice and guidance as this project progressed.

This report was made possible by the support of the U.S. Department of Health and Human Services (including the National Institutes of Health, the Office for Human Research Protections, the Food and Drug Administration, the Agency for Healthcare Research and Quality and the Centers for Disease Control) and The Greenwall Foundation. Special thanks to Greg Koski, Belinda Seto, and Irene Stith-Coleman for their extra efforts and repeated attention to the ongoing information needs and support of this study.

Copyright © 2003, National Academy of Sciences.
Bookshelf ID: NBK43559
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