RESPONSIBLE SCIENCE

Ensuring the Integrity of the Research Process

VOLUME I

Panel on Scientific Responsibility and the Conduct of Research

Committee on Science, Engineering, and Public Policy

National Academy of Sciences

National Academy of Engineering

Institute of Medicine

NATIONAL ACADEMY PRESS
Washington, D.C. 1992



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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process RESPONSIBLE SCIENCE Ensuring the Integrity of the Research Process VOLUME I Panel on Scientific Responsibility and the Conduct of Research Committee on Science, Engineering, and Public Policy National Academy of Sciences National Academy of Engineering Institute of Medicine NATIONAL ACADEMY PRESS Washington, D.C. 1992

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process National Academy Press 2101 Constitution Ave., NW Washington, DC 20418 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 panel responsible for this report were chosen for their special competences and with regard for appropriate balance. This report is the result of work done by an independent panel appointed by the Committee on Science, Engineering, and Public Policy, which has authorized its release to the public. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee and by the Committee on Science, Engineering, and Public Policy. Both consist of members of the National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. Library of Congress Cataloging-in-Publication Data Committee on Science, Engineering, and Public Policy (U.S.). Panel on Scientific Responsibility and the Conduct of Research. Responsible science : ensuring the integrity of the research process / Panel on Scientific Responsibility and the Conduct of Research, Committee on Science, Engineering, and Public Policy, National Academy of Sciences, National Academy of Engineering, Institute of Medicine. p. cm. Includes bibliographical references and index. ISBN 0-309-04591-6 1. Research—Moral and ethical aspects. 2. Responsibility. I. Title. Q180.55.M67C66 1992 174′.95—dc20 92-10780 CIP Copyright © 1992 by the National Academy of Sciences No part of this book may be reproduced by any mechanical, photographic, or electronic process, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for pubic or private use, without written permission from the publisher, except for the purposes of official use by the United States Government. This book is printed with soy ink on acid-free recycled stock Printed in the United States of America

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process NATIONAL ACADEMY OF SCIENCES 2101 CONSTITUTION AVENUE, NW WASHINGTON. D. C. 20418 OFFICE OF THE PRESIDENT The right to search for truth implies also a duty; one must not conceal any part of what one has recognized to be true. --Albert Einstein These words are inscribed on the statue of Albert Einstein that stands at the front of the National Academy of Sciences building. The search for truth is the vocation of every scientist, a vocation that inspires each of us to pursue exciting and controversial ideas, to engage in spirited exchange with our colleagues and critics, and to counter customary habits of thinking and analysis with new insights and observations. This report, Responsible Science: Ensuring the Integrity of the Research Process thoughtfully examines the challenges posed in ensuring that the search for truth reflects adherence to ethical standards. In recent years, we have learned, sometimes painfully, that not all scientists adhere to this obligation. Reports of falsified research results and plagiarism involving both junior and senior scientists have stimulated doubts and criticism about the ways in which misconduct in science is addressed by the research community. Misconduct in science is now being publicly examined in all of its aspects--how misconduct is defined, the process by which misconduct is discovered, and procedures for judging innocence or guilt and assessing penalties. Also being explored are the appropriate roles of individuals, research institutions, journals, government research agencies, and the legal system. Issues of misconduct and integrity in science present complex questions. These issues require the sustained attention of all members of the research community as well as of leaders in the public and private sector who are concerned with safeguarding the health of science. In this regard, ensuring the integrity of the research process is similar to assuring safety in the workplace: it is a process that requires continued participation from all levels of the entire research enterprise--the practitioners, the host institutions, the sponsors in government, and the legislators who provide the funds.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process The world of science today is an exciting one, filled with tremendous research opportunities and the ability to contribute to the solution of pressing national needs. In the midst of this excitement, however, it is important to reflect on the values and standards that guide responsible research practices. Three years ago, the Council of the National Academy of Sciences prepared a booklet, On Being a Scientist, to stimulate young researchers to identify and uphold the methods that keep science strong and healthy. Responsible Science is another step toward informing discussions among scientists, and between scientists and the general public, of ethical issues that arise in the contemporary research environment. Each major institution of American society is now undergoing scrutiny and examination. It is natural for scientists to affirm and protect the traditions and standards that contribute to a healthy and vigorous research system. However, it is also important for scientists to demonstrate the accountability that accompanies public investment in research. This includes setting in place procedures to identify and adjudicate cases of misconduct and supporting measures that will strengthen the integrity of the research system. Cautioning against proposals that may impose counterproductive restraints is important, but not enough. The report of this panel is the result of intense discussion, analysis, and reflection. It is an important contribution to the national dialogue on integrity in the conduct of research. The broader scientific community knows that ensuring the integrity of the research process is fundamental to the success of science. Scientists must also recognize that it is requisite to the continuing support of science with public funds. This letter of transmittal conveys the basic sentiments expressed in the report. Ensuring the integrity of the research process is one of the fundamental obligations that accompanies the "right to search for truth." Frank Press President National Academy of Sciences

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process PANEL ON SCIENTIFIC RESPONSIBILITY AND THE CONDUCT OF RESEARCH EDWARD E. DAVID, JR. (Chairman), President, EED, Inc. PHILIP H. ABELSON, Deputy Editor of Science and Science Advisor, American Association for the Advancement of Science VICTOR R. BAKER, Regents Professor and Professor of Geosciences and Planetary Sciences, Department of Geosciences, University of Arizona ALBERT BARBER, Vice Chancellor for Research, University of California, Los Angeles MICHAEL BERMAN, President, The Duberstein Group, Inc. JOHN DEUTCH, Institute Professor of Chemistry, Massachusetts Institute of Technology VAL L. FITCH, James S. McDonnell Distinguished University Professor of Physics, Princeton University MARYE ANNE FOX, M. June and J. Virgil Waggoner Regents Chair in Chemistry, University of Texas at Austin PETER GALISON, Co-chairman, History of Science Program, Stanford University BERNARD GERT, Stone Professor of Intellectual and Moral Philosophy, Dartmouth College IRA J. HIRSH, Mallinckrodt Distinguished University Professor of Psychology and Audiology, Washington University JENNY L. McFARLAND, Postdoctoral Fellow, Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology LAURIE E. McNEIL, Associate Professor, Department of Physics and Astronomy, University of North Carolina at Chapel Hill RICHARD A. MESERVE, Partner, Covington and Burling FRANK M. RICHTER, Professor and Chairman, Department of Geophysical Sciences, University of Chicago ARTHUR H. RUBENSTEIN, Professor and Chairman, Department of Medicine, University of Chicago HOWARD K. SCHACHMAN, * Professor, Department of Biochemistry and Molecular Biology, University of California, Berkeley HOWARD E. SIMMONS, JR., Vice President and Senior Science Advisor, E.I. du Pont de Nemours and Company, Inc. ROBERT L. SPRAGUE, Professor in the College of Medicine and Director of the Institute for Research on Human Development, University of Illinois at Urbana-Champaign SHEILA WIDNALL, Associate Provost and Abby Rockefeller Mauze Professor of Aeronautics and Astronautics, Massachusetts Institute of Technology

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process PATRICIA K. WOOLF, Lecturer, Department of Molecular Biology, Princeton University KEITH R. YAMAMOTO,* Professor and Vice Chairman, Department of Biochemistry and Biophysics, University of California, San Francisco Staff ROSEMARY CHALK, Study Director BARRY GOLD, Senior Staff Officer SUSAN MAURIZI, Editor DAVID H. GUSTON, Research Assistant MARYANN SHANESY, Administrative Secretary ELIZABETH BLOUNT, Secretary * Members whose dissent from the panel consensus is expressed in the minority statement following Chapter 8 of the report.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process COMMITTEE ON SCIENCE, ENGINEERING, AND PUBLIC POLICY CORNELIUS J. PINGS (Chairman), Provost and Senior Vice President of Academic Affairs, University of Southern California LAWRENCE BOGORAD, Maria Moors Cabot Professor of Biology, Harvard University STUART BONDURANT, Professor and Dean, School of Medicine, University of North Carolina ROBERT A. BURT, Southmayd Professor of Law, Yale University ALBERT M. CLOGSTON, Member, Center for Material Sciences, Los Alamos National Laboratory RALPH GOMORY, President, Alfred P. Sloan Foundation HARRY B. GRAY, Arnold O. Beckman Professor of Chemistry, Division of Chemistry, California Institute of Technology WILLIAM G. HOWARD, JR., Scottsdale, Arizona RICHARD M. JOHNS,* Massey Professor and Director, Department of Biomedical Engineering, Johns Hopkins University FRANCIS E. LOW, Institute Professor, Department of Physics, Massachusetts Institute of Technology JOHN L. McLUCAS, Aerospace Consultant BEATRICE MINTZ, Senior Member, Institute for Cancer Research, Fox Chase Cancer Center C. KUMAR PATEL, Executive Director of Research, Materials Sciences, Engineering, and Academic Affairs Division, AT &T Bell Laboratories FRANK PRESS (ex officio), President, National Academy of Sciences KENNETH I. SHINE (ex officio), President, Institute of Medicine MAXINE F. SINGER,* President, Carnegie Institution of Washington ROBERT M. SOLOW, Institute Professor, Department of Economics, Massachusetts Institute of Technology H. GUYFORD STEVER, Science Advisor ROBERT M. WHITE (ex officio), President, National Academy of Engineering Staff LAWRENCE E. McCRAY, Executive Director BARBARA A. CANDLAND, Administrative Assistant * Term expired June 30, 1991.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process 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. Frank Press 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. Robert M. White 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. Kenneth I. Shine is president of the Institute of Medicine. The Committee on Science, Engineering, and Public Policy (COSEPUP) is a joint committee of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. It includes members of the councils of all three bodies.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process Preface Concerns about integrity in the conduct of research and misconduct in science raise complex issues. Scientists rely on an honor system based on tradition, and on the operation of self-regulating checks and balances to foster responsible research practices. But following a series of highly publicized cases of misconduct in science in the 1980s, the federal government set into motion policies and procedures that now affect every scientist and research institution seeking funding from the Public Health Service and the National Science Foundation. The problems associated with cases of misconduct in science have not yet been resolved. In addition, new concerns have emerged about the methods that are appropriate to ensure integrity in a dynamic, highly decentralized, and diverse research enterprise. In 1989, the National Academy of Sciences (NAS), the National Academy of Engineering, and the Institute of Medicine (IOM) initiated a major study to examine issues related to scientific responsibility and the conduct of research. The Committee on Science, Engineering, and Public Policy convened a study panel to review factors affecting the integrity of science and the research process as it is carried out in the United States today and to recommend steps for reinforcing responsible research practices. The panel was also asked to review institutional mechanisms that exist for addressing allegations of misconduct in science. Finally, the panel was asked to consider the

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process advantages and disadvantages of formal guidelines for the conduct of research. The panel included junior and senior scientists from various scientific disciplines, public and private universities, and different regions of the United States; attorneys; research administrators; science editors; a philosopher; a historian; a whistle-blower; and individuals experienced with the formulation of governmental policies on misconduct in science. When our panel of 22 members convened, we knew that this would be a difficult and controversial study. We did not expect that our discussions would achieve simple solutions or easy explanations for the ethical problems that are apparent in the modern research environment. Panel members had fundamental disagreements about the nature of the problems to be addressed as well as the appropriateness of potential solutions. With two exceptions, panel members achieved consensus in this report. We believe that the ideas, findings, and recommendations that follow provide a foundation for addressing the complex challenge of ensuring the integrity of the research process. The panel held seven meetings between May 1990 and June 1991. We met with numerous junior and senior scientists, research administrators, government officials, leaders from scientific and educational associations and journals, and congressional representatives. We heard opposing points of view about factors that affect integrity and misconduct in the research environment. We drew on several Academy studies and reports, including the. NAS 's On Being a Scientist (National Academy Press, Washington, D.C., 1989), the IOM's The Responsible Conduct of Research in the Health Sciences (1989), the Government-University-Industry Research Roundtable's Science and Technology in the Academic Enterprise (1989), and the National Research Council's Sharing Research Data (1985). Our report consists of two volumes. Volume I includes the findings and recommendations of the study panel. A minority statement, drafted by the two members of the panel who disagreed with the panel consensus, follows Chapter 8. Volume II includes the six working papers of the study panel as well as selected policy statements, developed by various institutions to address issues related to responsible research practices and misconduct in science, that proved useful in the panel's deliberations. This report recommends specific actions that all scientists, their institutions, and their sponsors can take to preserve and strengthen the integrity of the research process and also to deal with allegations of misconduct. The recommendations provide a blueprint for encouraging and safeguarding the intellectual independence that is es-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process sential to doing the best science while also providing for fundamental accountability to those who sponsor and support scientific research. Edward E. David, Jr., Chairman Panel on Scientific Responsibility and the Conduct of Research

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process Jacobsen, Covington and Burling; Richard Johns, Johns Hopkins University; Edward Korn, National Heart, Lung and Blood Institute; Donald Langenberg, University of Maryland; and Nathan Lewis, California Institute of Technology. Also, David Meyer, University of California, Los Angeles; Barbara Mishkin, Hogan and Hartson; Frederick Mosteller, Harvard University; Robert Park, American Physical Society; John Pierce, Stanford University; William Raub, National Institutes of Health; Arnold Relman, New England Journal of Medicine; Ellis Rubenstein, Science magazine; Paul Russell, Harvard Medical School; Alan Shinn, National Science Foundation; Eleanor Shore, Harvard Medical School; Gregory Simon, House Committee on Science, Space, and Technology; Maxine Singer, Carnegie Institution of Washington; Stephen Smale, University of California, Berkeley; Nicholas Steneck, University of Michigan; Richard Stephens, U.S. Department of Energy; Walter Stewart, National Institutes of Health; Peter Stockton, House Committee on Energy and Commerce; Philip Sunshine, National Science Foundation; Judith Swazey, Acadia Institute; Michael Teitelbaum, the Alfred P. Sloan Foundation; Robert Weinberg, Whitehead Institute; James Wyngaarden, former director, National Institutes of Health; Rosemary Yancik, National Institutes of Health; Larry Zipursky, University of California, Los Angeles; and Diana Zuckerman, House Committee on Government Operations. Although this report represents the work of the panel members, it would not have been produced without the support of professional staff from the Committee on Science, Engineering, and Public Policy of the National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. Rosemary Chalk, the project's study director, drafted the chapters and refined them on the basis of the panel' s discussions and conclusions. Barry Gold, senior staff officer, provided editorial guidance for the report, prepared the material for Chapter 3, and wrote the working paper on congressional activities in Volume II. Dave Guston, research assistant, provided editorial and bibliographic support for the report, prepared contributions for Chapter 2, and wrote the working paper on mentorship in Volume II. Lawrence McCray, executive director of the Committee on Science, Engineering, and Public Policy, provided general guidance and review for the study. The panel is grateful, also, to the secretaries for the project: Maryann Shanesy, Marian Cole, Barbara Candland, and Elizabeth Blount. They prepared manuscripts, arranged travel, and assisted with panel meetings. Others within the National Academy of Sciences (NAS), Institute of Medicine (IOM), and National Research Council (NRC) who were

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process instrumental in the completion of this study are Frank Press, president of NAS; Samuel O. Thier, former president of IOM; Philip Smith, executive director of the NRC; Enriqueta C. Bond, executive officer of IOM; John Campbell, senior program officer, Government-University-Industry Research Roundtable; Michael A. Stoto, deputy division director, IOM Division of Health Promotion and Disease Prevention; Porter Coggeshall, Report Review Committee; Susan Maurizi, editor, Commission on Physical Sciences, Mathematics, and Applications; and Stephen Mautner, National Academy Press.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process Sponsors This study was undertaken with both public and private sector support. The following agencies of the federal government provided support for the study: the Alcohol, Drug Abuse, and Mental Health Administration, the Department of Agriculture, the Department of Energy, the Department of Health and Human Services, the National Institutes of Health, and the National Science Foundation. The William and Flora Hewlett Foundation and the Alfred P. Sloan Foundation also awarded grants in support of the study. Additional support was provided by funds from the National Research Council (NRC) Fund, a pool of private, discretionary, nonfederal funds that is used to support a program of Academy-initiated studies of national issues in which science and technology figure significantly. The NRC Fund consists of contributions from a consortium of private foundations including the Carnegie Corporation of New York, the Charles E. Culpeper Foundation, the William and Flora Hewlett Foundation, the John D. and Catherine T. MacArthur Foundation, the Andrew W. Mellon Foundation, the Rockefeller Foundation, and the Alfred P. Sloan Foundation; from the Academy Industry Program, which seeks annual contributions from companies concerned with the health of U.S. science and technology and with public policy issues with technological content; and from the National Academy of Sciences and the National Academy of Engineering endowments.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process Contents     EXECUTIVE SUMMARY   1  1   INTRODUCTION   17      The U.S. Research Enterprise,   17      The Traditions of Science,   17      Changing Circumstances and Expectations,   18      The Problem of Misconduct in Science,   19      Ensuring Integrity in the Research Process,   20      Acknowledging the Range of Concerns,   20      Taking Constructive Action,   21      Purpose and Scope of This Study,   22      Charge to the Panel,   22      Approach, Audience, Content,   22      Methods, Definitions, and Basic Assumptions,   24      Evaluating Available Data,   24      Defining Terms—Articulating a Framework for Fostering Responsible Research Conduct,   24      Understanding Causes and Evaluating Cures,   30      Starting from Logical Assumptions,   31      Notes,   33

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process  2   SCIENTIFIC PRINCIPLES AND RESEARCH PRACTICES   36      Factors Affecting the Development of Research Practices,   40      Norms of Science,   40      Individual Scientific Disciplines,   41      The Role of Individual Scientists and Research Teams,   42      Institutional Policies,   43      Government Regulations and Policies,   44      Social Attitudes and Expectations,   45      Research Practices,   46      Data Handling,   47      Communication and Publication,   51      Correction of Errors,   56      Research Training and Mentorship,   59      Findings and Conclusions,   62      Notes,   64  3   CONTEMPORARY RESEARCH ENVIRONMENT   67      The U.S. Scientific Research Enterprise,   67      Brief Historical Perspective,   67      Current Concerns,   69      The Changing Research Scene,   69      Increased Size and Scope of the Research Enterprise,   71      Complexity of Collaboration,   72      Organization, Goals, and Management of Research Groups,   72      Regulation and Accountability,   74      Reward System,   74      University–Industry Cooperation,   76      Findings and Conclusions,   77      Notes,   79  4   MISCONDUCT IN SCIENCE—INCIDENCE AND SIGNIFICANCE   80      Incidence of Misconduct in Science—Published Evidence and Information,   81      Government Statistics on Misconduct in Science,   81      Consequences of Confirmed Misconduct,   84

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process      Government Definitions of Misconduct in Science—Ambiguity in Categories,   85      Reports from Local Institutional Officials,   87      International Studies,   88      Analyses, Surveys, and Other Reports,   88      Findings and Conclusions,   95      Notes,   95  5   HANDLING ALLEGATIONS OF MISCONDUCT IN SCIENCE—INSTITUTIONAL RESPONSES AND EXPERIENCE   98      University–Government Approaches,   98      Growing Interaction in the 1980s,   98      General Requirements,   100      More Specific Requirements Related to Misconduct Policies and Procedures,   100      Institutional Responses to Requirements,   101      Findings, Discussion, and Conclusions,   104      Government Regulations and Procedures,   108      Department of Health and Human Services,   108      National Science Foundation,   111      Government–University Efforts—Unresolved Issues,   112      Areas of Disagreement,   112      Observations and Discussion,   114      The Role of the Courts,   115      Special Concerns Prompted by University–Government–Court Interactions,   116      Due Process Requirements,   116      Consequences of Misconduct Inquiries and Investigations,   118      Faculty Participation in Misconduct Investigations,   119      The Role of Whistle-blowers,   120      The Problem of False Accusations,   121      Additional Findings and Conclusions,   121      Current Situation,   121      Balancing Accountability and the Need for Intellectual Freedom,   123      Need for an Independent Body as an Additional Resource,   124      Notes,   125

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process  6   STEPS TO ENCOURAGE RESPONSIBLE RESEARCH PRACTICES   128      Acknowledging Responsibility and Taking Action,   128      Integrating Ethics into the Education of Scientists,   130      Benefits of Education in Ethics,   130      Approaches to Teaching Ethics,   131      Considering Guidelines for Responsible Research Practices,   133      Current Means for Providing Guidance,   133      Scope and Purpose of Institutional Guidelines for the Conduct of Research,   135      Benefits of Institutional Guidelines for the Conduct of Research,   136      Disadvantages of Institutional Guidelines for the Conduct of Research,   136      Conclusions About Institutional Guidelines for the Conduct of Research,   137      A Framework of Subjects to Consider in Encouraging Responsible Research Practices,   138      Discouraging Questionable Research Practices,   142      Notes,   143  7   RECOMMENDATIONS   145      Acting to Define and Strengthen Basic Principles and Practices,   145      Recommendation One,   145      Recommendation Two,   146      Recommendation Three,   147      Dealing with Misconduct—Institutional Roles,   147      Recommendation Four,   147      Recommendation Five,   147      Recommendation Six,   148      Recommendation Seven,   149      Recommendation Eight,   149      Recommendation Nine,   149      Taking Additional Steps,   150      Recommendation Ten,   150      Discussion and Details,   150      Recommendation Eleven,   154      Recommendation Twelve,   155      Note,   155  8   SELECTED BIBLIOGRAPHY   156

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process     MINORITY STATEMENT   180     APPENDIXES       A Biographical Sketches of Panel Members,   185     B Subpanels,   188     INDEX   191

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