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Ideas and Opinions |

Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals

Ezekiel J. Emanuel, MD, PhD; Anne Wood, MA; Alan Fleischman, MD; Angela Bowen, MD; Kenneth A. Getz, MBA; Christine Grady, RN, PhD; Carol Levine, MA; Dale E. Hammerschmidt, MD; Ruth Faden, PhD, MPH; Lisa Eckenwiler, PhD; Carianne Tucker Muse, MPH; and Jeremy Sugarman, MD, MPH, MA
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From the National Institutes of Health, Bethesda, Maryland; New York Academy of Medicine, New York, New York; Western IRB, Olympia, Washington; Thomson CenterWatch, Boston, Massachusetts; United Hospital Fund, New York, New York; University of Minnesota, Minneapolis, Minnesota; Phoebe R. Berman Bioethics Institute, Johns Hopkins University, Baltimore, Maryland; Old Dominion University, Norfolk, Virginia; Booz, Allen Hamilton, Atlanta, Georgia; Duke University Medical Center, Norfolk, Durham, North Carolina.

Disclaimer: This paper reflects the deliberations of the Consortium to Examine Clinical Research Ethics. The opinions expressed are the authors' own. They do not reflect any position or policy of the National Institutes of Health, the Public Health Service, the Department of Health and Human Services, the Doris Duke Charitable Foundation, or any of the authors' affiliated institutions.

Grant Support: Work on this manuscript was made possible by a grant to the Consortium to Examine Clinical Research Ethics from the Doris Duke Charitable Foundation.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Ezekiel J. Emanuel, MD, PhD, Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 20892-1156; e-mail, eemanuel@nih.gov.

Current Author Addresses: Drs. Emanuel and Grady: Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 20892-1156.

Ms. Wood: Boalt Hall, University of California, School of Law, Berkeley, California 94720-7200.

Dr. Fleischman: New York Academy of Medicine, 1216 Fifth Avenue, New York, NY 10029-5293.

Dr. Bowen: Western IRB, 3535 7th Avenue, SW, Olympia, Washington 98502.

Dr. Getz: Thomson CenterWatch, 22 Thompson Place 36T1, Boston, MA 02210.

Dr. Levine: United Hospital Fund, 350 Fifth Avenue, 23rd Floor, New York, NY 10118.

Dr. Hammerschmidt: Department of Medicine, University of Minnesota, PO Box 480, Mayo Building, Minneapolis, MN 55455.

Drs. Faden and Sugarman: Phoebe R. Berman Bioethics Institute, Johns Hopkins University, Hampton House 351, 624 N. Broadway, Baltimore, MD 21205.

Dr. Eckenwiler: Department of Philosophy, Old Dominion University, Batten Arts and Letters, Room 401, Norfolk, VA 23529-0083.

Dr. Tucker Muse: Booz, Allen Hamilton, 230 Peachtree Street, Atlanta, GA 30303.

Ann Intern Med. 2004;141(4):282-291. doi:10.7326/0003-4819-141-4-200408170-00008
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The oversight of research involving human participants is widely believed to be inadequate. The U.S. Congress, national commissions, the Department of Health and Human Services, the Institute of Medicine, numerous professional societies, and others are proposing remedies based on the assumption that the main problems are researchers' conflict of interest, lack of institutional review board (IRB) resources, and the volume and complexity of clinical research. Developing appropriate reform proposals requires carefully delineating the problems of the current system to know what reforms are needed. To stimulate a more informed and meaningful debate, we delineate 15 current problems into 3 broad categories. First, structural problems encompass 8 specific problems related to the way the research oversight system is organized. Second, procedural problems constitute 5 specific problems related to the operations of IRB review. Finally, performance assessment problems include 2 problems related to absence of systematic assessment of the outcomes of the oversight system. We critically assess proposed reforms, such as accreditation and central IRBs, according to how well they address these 15 problems. None of the reforms addresses all 15 problems. Indeed, most focus on the procedural problems, failing to address either the structure or the performance assessment problems. Finally, on the basis of the delineation of problems, we outline components of a more effective reform proposal, including bringing all research under federal oversight, a permanent advisory committee to address recurrent ethical issues in clinical research, mandatory single-time review for multicenter research protocols, additional financial support for IRB functions, and a standardized system for collecting and disseminating data on both adverse events and the performance assessment of IRBs.





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