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PREPUBLICATION COPY UNCORRECTED PROOFS Conflict of Interest in Medical Research, Education, and Practice Bernard Lo and Marilyn J. Field, Editors Committee on Conflict of Interest in Medical Research, Education and Practice Board on Health Sciences Policy PREPUBLICATION COPY: UNCORRECTED PROOFS THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract No. N01-OD-4-2139, TO # 201 of the National Institutes of Health, the Contract No. 63229 of the Robert Wood Johnson Foundation, The Greenwall Foundation, the ABIM Foundation, the Contract No. S07-2 of the Josiah Macy Jr. Foundation, the Contract No.1007182 of the Burroughs Wellcome Fund, and also the endowment fund of the Institute of Medicine all between the National Academies. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for the project. International Standard Book Number— (prepublication) International Standard Book Number— (prepublication) Library of Congress Cataloging-in-Publication Data Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2009 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2009. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: The National Academies Press. PREPUBLICATION COPY: UNCORRECTED PROOFS PREPUBLICATION COPY: UNCORRECTED PROOFS The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org PREPUBLICATION COPY: UNCORRECTED PROOFS COMMITTEE ON CONFLICT OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE BERNARD LO, (Chair), Professor of Medicine and Director, Program in Medical Ethics, University of California, San Francisco WENDY BALDWIN, Director, Poverty, Gender and Youth Program, Population Council LISA BELLINI, Associate Dean for Graduate Medical Education and Associate Professor of Medicine, University of Pennsylvania LISA A. BERO, Professor, Department of Clinical Pharmacy and Institute for Health Policy Studies, University of California, San Francisco ERIC G. CAMPBELL, Associate Professor, Institute for Health Policy (IHP) and Department of Medicine, Massachusetts General Hospital and Harvard Medical School JAMES F. CHILDRESS, Hollingsworth Professor of Ethics, Department of Religious Studies and Professor of Medical Education and Director, Institute for Practical Ethics, University of Virginia PETER B. CORR, General Partner, Celtic Therapeutics Management Company L.L.P TODD DORMAN, Associate Dean and Director, Continuing Medical Education, and Professor of Anesthesiology, Johns Hopkins Medical Center DEBORAH GRADY, Professor of Medicine and Director, Women’s Health Clinical Research Center and Associate Dean for Translational Research, University of California, San Francisco TIMOTHY S. JOST, Robert L. Willett Family Professor of Law, Washington and Lee University School of Law ROBERT P. KELCH, Executive Vice President for Medical Affairs, University of Michigan and Chief Executive Officer, University of Michigan Health System ROBERT M. KRUGHOFF, President, Consumer CHECKBOOK/Center for the Study of Services GEORGE LOEWENSTEIN, Herbert A Simon Professor of Economics and Psychology, Department of Social and Decision Sciences, Carnegie Mellon University JOEL PERLMUTTER, Elliot Stein Family Professor of Neurology and Professor of Radiology and Physical Therapy, Washington University School of Medicine in St. Louis NEIL R. POWE, Professor of Medicine, Epidemiology, and Health Policy and Management Director, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins School of Medicine and Bloomberg School of Public Health DENNIS F. THOMPSON, Alfred North Whitehead Professor of Political Philosophy Department of Government and Professor of Public Policy, John F. Kennedy School of Government, Harvard University DAVID A. WILLIAMS, Chief of the Division of Hematology/Oncology, Director, Clinical and Translational Research, Children’s Hospital Boston and Leland Fikes Professor of Pediatrics, Harvard Medical School Committee Consultants and Background Paper Authors JASON D. DANA, Assistant Professor, Department of Psychology, University of Pennsylvania v PREPUBLICATION COPY: UNCORRECTED PROOFS MICHAEL DAVIS, Senior Fellow, Center for Study of Ethics in the Professions and Professor of Philosophy, Humanities Department, Illinois Institute of Technology JOSEPHINE JOHNSTON, Research Associate, Hastings Center, Garrison, New York IOM Staff MARILYN J. FIELD, Senior Program Officer FRANKLIN BRANCH, Research Associate ROBIN E. PARSELL, Senior Program Assistant (from January 2008) AFRAH ALI, Senior Program Assistant (unit November 2007) ANDREW POPE, Director, Board on Health Sciences Policy vi PREPUBLICATION COPY: UNCORRECTED PROOFS Acknowledgments In preparing this report, the committee and project staff benefited greatly from the assistance and expertise of many individuals and groups. Important information and insights came from four public meetings that the committee organized to collect information and perspectives from a range of academic, professional, consumer, patient, and other organizations and individuals. A number of speakers at these meetings also shared their knowledge at other times during the course of the study. Appendix A includes the agendas of the public meetings and a list of organizations that submitted written statements of views. The committee appreciates the contributions of the authors of the background papers that appear as Appendix C (Michael Davis at Illinois Institute of Technology and Josephine Johnston at the Hastings Center) and Appendix D (Jason Dana at University of Pennsylvania). Our project officer at the National Institutes of Health, Walter Schaffer, was always helpful in getting our questions answered. We also called on Daniel Wolfson at the American Board of Internal Medicine Foundation for information. In addition, Ariel Winter of the Medicare Payment Advisory Commission helped by answering questions about the commission’s

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