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FIRE H)R CLINICAL INVE~[IGAl:C~ Purport of a Sway by a ~nit~e of me ]:NSmUTE OF MEDICINE Division of Health Scier~; Polity National Academy Press Warn, D. C. 1988

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FORCE: me project Flat is We subject of this report was approved tar the Gowning Board of We National l~r~ ~;1, Rose I; are dram from We councils of We National Academy of Sciences, the National Academy of Er~ineerir~, arm the ~i~e of Medicine. the no of We Unit responsible for the retort were chosen for their menial ~?e~ies and wit regard for appropriate h~arx~e. This report has been reviewed by a group other than We authors ascorbic to pours approved be a Presort Preview Soiree _ _ , ~ . ~ consistir~ of no; of the Nations Acad~r of Science;, We National Academy of Engineering, and We Aspire of Medicine. ISe Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an advisor to the federal government and its own initiative in identifying issues of medical, research, and education. Support for this project was provided by the National Institutes of Health, Department of Health and Human Services, pursuant to Contract No. N01-OD-8-2108. 2101 Constitution Avenue, N.W. Washington, D.C. 20418 (202) 334-3300 Publication IOM-88-07

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INSTITUTE OF MEDICINE Division of Health & fences Policy Committee for the Study of Rescurcrs for Clinical Investigation PALL A. MARKS, Chair, President and Chief Executive Officer, Memorial Sloan-Ketbering Cancer Center, New York, New York J. CLAUDE BENNETT, Vice Chair Professor and Chairman, Department of Medicine, The University of Alabama & hood of Medicine, University Station, Binning ham, Alabama ROTH S. HANFT, Research Professor and Health Policy Consultant, George Washington University' Department of H~=lth Administration, Was hingtonl D.C. WILLL~M N. KEILEY' John G. Searle Professor and Chairman Department of Internal Medicines The University of Michigan Medical Center' Ann Arbors Michigan ELAINE L. IARSoN' M. Adelaide Nutting Chair m Clinical Nursing Jams Hopkins University, School of Ming, Baltimore, Maryland AS BASAL, Dean, Sackler School of Graduate Biomedical Sciences' Tufts Un~versi~r, Boston/ Massachusetts GERALD D. IAI~C2I~ President, Pfizer, Tr~c. J New York New York AVID Me, Jr. ~ Vi~ President' Getter' Sac. SO San FTarx~isco, - 1ifornia T9oMAS C. MERIGAN, Jr., Becker Professor of Medicine and Head Division of Infectious Diseases, Stanford University School of Medicine, Stanford, California DAVID G. NATHAN, Physician-in Chief and Stranahan Professor of Pediatrics, Harvard Medical Schools Boston, Massachusetts Mn]KI3~1L T. RABKIN/ President and Physician, Beth Israel Hospital, Boston, Massachusetts RDBkXU' ROSE, Chairman and Professor, Department of Psychiatry and Behavioral Sciences, University of Texas Medical Branch, Galveston, Texas PAUL S1oL[EY, Professor, Department of Medicine, Clinical Epidemiology Unit, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

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SPA A. DELIS, Jr., Bixby Professor of Surgery and Chairman, Art of Surgery, Wa~irqt~n University, School of Medicine, St. lo, Mini JOHN A;, Professor of Epidemiology, Orbs of Anita and Easily Medicine, I~wu~ Medical School, Hover, New 1~1~ GAPS AND ~E;Cr OFFAL Ed BICK, Dusty Director for Oral P~ear=, National =;tit~; of Health, Bethesda, Maryland PAL End, Director, African college of Surgeons, Chicago, Illinois JAMES F. O'DONNELL, Deputy Director, Division of Research RescLraes, National Institute of Health, BethfcA~' Maryland CARL C. PECK, Dire cLor, Center for Drug Evaluation and Research Food and Drug Administration, Rockville, Maryland KAREN M. RICHARrS, Special Assistant to the President, Memorial Sloan-Kettering Cancer Center, New York, New York ROk~ TEMPLE, Dire cLor, Office of Drug Evaluation I, Center for Drug Evaluation and Research, Food and Drug Administration, P0lnrille, Maryland JUDO Ems, Director, General Clinical Research Centers, Division of E~r=h Recurs, National Instituter of Health, Beth~n, Maryland INSl~IUl~ OF MEDICINE Samuel O. Tier, ~;ident SELF Division of Health Sciences Policy Red Ellen Burger, Director Indwell Hi, Project Officer Naomi H. Hudson, Administrative Assistant Chrome Fields, Senior Secretary Consultant - Laurie Airman iv