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Committee on Assessing Integrity in Research Environments Board on Health Sciences Policy and Division of Earth and Life Studies THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu
THE NATIONAL ACADEMIES PRESS â¢ 500 Fifth Street, N.W. â¢ 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. Support for this project was provided by the Office of Research Integrity, U.S. Department of Health and Human Services. The views presented in this report are those of the Institute of Medicine and National Research Council Committee on Assessing Integrity in Research Environments and are not necessarily those of the funding agencies. International Standard Book Number: 0-309-08523-3; 0-309-08479-2 (pbk.) Library of Congress Control Number: 20021102-17 Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, N.W., Box 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 2002 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.
The National Academy of Sciences is a private, nonprofit, self-perpetuating soci- ety of distinguished scholars engaged in scientific and engineering research, dedi- cated 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. Bruce M. Alberts 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 mem- bers, sharing with the National Academy of Sciences the responsibility for advis- ing 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. Wm. A. Wulf 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 Sci- ences in 1916 to associate the broad community of science and technology with the Academyâs purposes of furthering knowledge and advising the federal gov- ernment. 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 pro- viding 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org
COMMITTEE ON ASSESSING INTEGRITY IN RESEARCH ENVIRONMENTS ARTHUR H. RUBENSTEIN (Chair), Executive Vice President, University of Pennsylvania for the Health System, and Dean, School of Medicine, University of Pennsylvania School of Medicine, Philadelphia MURIEL J. BEBEAU, Professor, School of Dentistry, University of Minnesota, Minneapolis STUART BONDURANT, Professor of Medicine and Dean Emeritus, University of North Carolina at Chapel Hill DAVID R. COX, Professor of Genetics and Pediatrics, Stanford University School of Medicine, Stanford ROBERT C. DYNES, Chancellor and Professor of Physics, University of California, San Diego MARK S. FRANKEL, Program Director, American Association for the Advancement of Science, Washington, D.C. PENNY J. GILMER, Professor of Chemistry and Biochemistry, Department of Chemistry and Biochemistry, Florida State University, Tallahassee FREDERICK GRINNELL, Professor of Cell Biology and Director, Program in Ethics in Science and Medicine, University of Texas Southwestern Medical Center, Dallas JOYCE M. IUTCOVICH, President, Keystone University Research Corporation, Erie, Pennsylvania STANLEY G. KORENMAN, Associate Dean for Ethics and the Medical Scientist Training Program and Professor of Medicine, University of California at Los Angeles School of Medicine, Los Angeles JOSEPH B. MARTIN, Dean, Harvard Medical School, Boston ROBERT R. RICH, Executive Associate Dean and Professor of Medicine and Microbiology/Immunology, Emory University School of Medicine, Atlanta LOUIS M. SHERWOOD, Senior Vice President for Medical and Scientific Affairs, Merck & Co., Inc., West Point, Pennsylvania MICHAEL J. ZIGMOND, Professor of Neurology and Psychiatry, University of Pittsburgh, Pittsburgh Health Sciences Policy Board Liaison ADA SUE HINSHAW, Dean, School of Nursing, University of Michigan, Ann Arbor v
Project Staff THERESA M. WIZEMANN, Study Director, Board on Health Sciences Policy MEHREEN N. BUTT, Senior Project Assistant, Board on Health Sciences Policy FREDERICK J. MANNING, Senior Program Officer, Board on Health Sciences Policy ROSEMARY CHALK, Senior Program Officer, Board on Health Care Services Auxiliary Staff ANDREW POPE, Director, Board on Health Sciences Policy DALIA GILBERT, Research Assistant, Board on Health Sciences Policy ALDEN CHANG, Administrative Assistant, Board on Health Sciences Policy CARLOS GABRIEL, Financial Associate ROBIN SCHOEN, Program Officer, Board on Life Sciences, Division on Earth and Life Sciences Consulting Writer KATHI E. HANNA Copy Editors TOM BURROUGHS MICHAEL K. HAYES vi
Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with pro- cedures approved by the National Research Councilâs (NRCâs) Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: JOHN F. AHEARNE, Sigma Xi Center, The Scientific Research Society PAUL J. FRIEDMAN, University of California, San Diego C. KRISTINA GUNSALUS, University of Illinois at Urbana- Champaign, RUSSEL E. KAUFFMAN, The Wistar Institute DAVID KORN, Association of American Medical Colleges JEFFREY D. KOVAC, University of Tennessee MARCEL C. LAFOLLETTE, George Washington University MARY FAITH MARSHALL, Kansas University Medical Center RICK ANTONIO MARTINEZ, Johnson and Johnson JUDITH P. SWAZEY, The Acadia Institute vii
viii REVIEWERS Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclu- sions or recommendations, not did they see the final draft of the report before its release. The review of this report was overseen by BERNARD LO, University of California, San Francisco, appointed by the Institute of Medicine, and HAROLD C. SOX, Annals of Internal Medicine, appointed by the NRCâs Report Review Committee, who were responsible for mak- ing certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this re- port rests entirely with the authoring committee and the institution.
Acknowledgments The committee is indebted to the researchers and administrators who presented informative talks to the committee and participated in lively discussions at the open meetings, including Melissa Anderson, Stephanie Bird, Ruth Fischbach, Peter Fiske, Barbara Mishkin, Howard Schachman, Joan Schwartz, Harold Varmus, Bart Victor, and Peter Yeager (see Appen- dix A for affiliations and discussion topics). The committee is grateful to Barbara Brittingham, Steven Crow, Beth Fischer, Alasdair MacIntyre, Jean Morse, George Peterson, James Rogers, David Smith, David Stevens, and Naomi Zigmond, who graciously made themselves available by phone and e-mail for consultation and technical advice, and to Kenneth Pimple and David Guston, who were commissioned to prepare technical litera- ture reviews and historical reviews (see Appendix A). Thanks to Diane Waryold and the Center for Academic Integrity for kindly providing their Academic Integrity Assessment Guide. The committee also thanks the Institute of Medicine and National Research Council staff who presented overviews of previous Academy work on integrity in research, including Rosemary Chalk, Robin Schoen, and Debbie Stine. Many thanks to Bruce Alberts, president of the National Academy of Sciences and chair of the National Research Council, Kenneth Shine, then president 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 advice and guidance in addressing the task. Thanks also to Kathi Hanna, Michael Hayes, and Tom Burroughs for assistance with editing the text of the report. ix
x ACKNOWLEDGMENTS The committee also wishes to thank Nicholas Steneck, University of Michigan, for his contributions during the early stages of the study, and Jennifer Rietfors, an intern at the American Association for the Advance- ment of Science, for assistance with information on accrediting bodies. This report was made possible by the generous support of the Office of Research Integrity, U.S. Department of Health and Human Services. Thanks to Chris Pascal and Larry Rhoades for providing background information, advice, and encouragement throughout the course of the study.
Contents EXECUTIVE SUMMARY 1 1 INTRODUCTION 16 2 INTEGRITY IN RESEARCH 33 3 THE RESEARCH ENVIRONMENT AND ITS IMPACT ON INTEGRITY IN RESEARCH 49 4 INSTITUTIONAL APPROACHES TO FOSTERING INTEGRITY IN RESEARCH 72 5 PROMOTING INTEGRITY IN RESEARCH THROUGH EDUCATION 84 6 EVALUATION BY SELF-ASSESSMENT 112 7 CONCLUDING REMARKS AND RECOMMENDATIONS 124 xi
xii CONTENTS APPENDIXES A DATA SOURCES AND LITERATURE REVIEW FINDINGS 135 B OUTCOME MEASURES FOR ASSESSING INTEGRITY IN THE RESEARCH ENVIRONMENT 143 C DEVELOPMENTS IN MISCONDUCT AND INTEGRITY POLICIES SINCE PUBLICATION OF THE 1992 COSEPUP REPORT 167 D ADDITIONAL RESOURCES REGARDING PROFESSIONAL SKILLS 178 E COMMITTEE AND STAFF BIOGRAPHIES 184 INDEX 195
Tables, Figures, and Boxes TABLES 1-1 Grants Funded by ORI in the First Round of Research on Integrity in Research, 23 1-2 NSF Awards Directly Related to Integrity in Research, 1989 to Present, 24 1-3 NSF Awards Indirectly Related to Integrity in Research, 1989 to Present, 24 1-4 Addressing the Charge, 29 A-1 Search Terms, 136 A-2 Number of Relevant Articles, by Journal, 137 A-3 Number of Relevant Articles, by Category, 138 FIGURES 1 Open systems model of the research organization, 7 2 Environmental influences on research integrity that are external to research organizations, 8 3-1 Open systems model of the research organization, 51 3-2 Environmental influences on research integrity that are external to research organizations, 64 xiii
xiv TABLES, FIGURES, AND BOXES BOXES 1 Integrity in Research, 5 2 Recommendations, 12 1-1 Glossary of Terms Used in This Report, 30 2-1 Definition of Institutional Conflict of Interest, 44 5-1 The Four-Component Model of Morality, 88 A-1 Invited Presentations, 140 C-1 Time Line of Some Significant Events in Research Integrity, 1991 to Present, 174