Integrity and Misconduct in Research Report of the Commission on Research Integrity To the Secretary of Health and Human Services The House Committee on Commerce The Senate Committee on Labor and Human Resources 1995 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Commission on Research Integrity Membership Kenneth J. Ryan, M.D., Chair Distinguished Kate Macy Ladd Professor Department of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, and Chairman, Ethics Committee Brigham and Women's Hospital Boston, MA Carol A. Aschenbrener, M.D. Drummond Rennie, M.D. Chancellor, Deputy Editor (West), University of Nebraska Journal of the American Medical Association, Medical Center Chicago, IL, Omaha, NE and Adjunct Professor of Medicine, Institute for Health Policy Studies Carolyn Whitfield Broome, Ph.D. University of California, Associate Professor, San Francisco, CA Department of Biochemistry and Molecular Biology Howard University Priscilla A. Schaffer, Ph.D. College of Medicine Professor, Washington, DC Department of Microbiology and Molecular Genetics Harvard Medical School Eugene H. Cota-Robles, Ph.D. Dana-Farber Cancer Institute Professor Emeritus, Biology Boston, MA University of California, Santa Cruz, CA S. Andrew Schaffer, Esq. Senior Vice President and General Counsel, and Thomas M. Devine, Esq. Adjunct Professor of Law Legal Director, New York University Government Accountability Project New York, NY Washington, DC Judith P. Swazey, Ph.D. Linda L. Emanuel, M.D., Ph.D. President, Assistant Director, The Acadia Institute Division of Medical Ethics Bar Harbor, ME Harvard Medical School Boston, MA Staff C. K. Gunsalus, J.D. Associate Vice Chancellor for Academic Affairs, Henrietta D. Hyatt-Knorr, M.A. University of Illinois, Executive Secretary Urbana-Champaign, IL Rockville, MD Karl J. Hittelman, Ph.D. Anne H. Rosenfeld Associate Vice Chancellor, Academic Affairs Science Writer University of California, Rockville, MD San Francisco, CA ii Letters of Transmittal On November 3, 1995, Dr. Kenneth J. Ryan, Chair of the Commission on Research Integrity, sent the following message to the Secretary of Health and Human Services and to the Chairs of the House Committee on Commerce and the Senate Committee on Labor and Human Resources: On behalf of the Commission on Research Integrity, I am pleased to transmit our final report and recommendations: Integrity and Misconduct in Research. The Commission's mandate was established in Section 162 of Public Law 103-43, the NIH Revitalization Act of 1993, in reaction to continuing misconduct in research and retaliation against whistleblowers in spite of federal regulations existing since 1989 and more than a dozen congressional hearings. According to the Commission charter, we were asked to consider: a new definition of research misconduct; an assurance process for institutional compliance with HHS regulation; mechanisms by which to respond to and oversee related administrative functions and investigations; and development of a regulation to protect whistleblowers. In fulfilling its mandate, the Commission held a total of 11 meetings open to the public in the Washington area and 4 regional hearings on university campuses in California, Illinois, Massachusetts, and Alabama. The Commission proved to be an effective forum for soliciting testimony on research integrity from all affected constituencies, including scientists, whistleblowers, attorneys, institutions, scientific organizations, the press, interested citizens, and federal officials. We have listened and deliberated carefully based on the extraordinary outpouring of commentary on the issues. We believe the recommendations unanimously supported by the Commission are realistic and balance the interests of the Federal Government, research institutions, scientists, and the public. We believe that the individual scientists and their research institutions and societies bear the primary responsibility for preserving integrity and dealing with misconduct when it occurs. We are not recommending a bigger federal role, only a more effective one. The creation and functioning of the Commission gave fresh expression and hope to many disillusioned scientists and whistleblowers that their voices could be heard and might make a difference in advancing the cause of scientific integrity and public trust. It is for this reason that the Commission urges that an independent oversight review body with a membership like the Commission's be created to periodically conduct hearings and review regulations and policies that affect federally funded biomedical and behavioral research. The Commission also hopes that the resources needed for effective oversight and timely disposition of investigations be carefully considered. We appreciate the opportunity to have served on this task, which is so important to the public and the scientific community. iii Acknowledgments The Commission on Research Integrity is indebted to the many individuals and institutions who have helped it fulfill its mission. We are grateful to the following consultants for the knowledge and expertise they shared with the Commission: Stephanie J. Bird, Ph.D., Cambridge, MA; Louis M. Guenin, J.D., Boston, MA; David H. Guston, Ph.D., New Brunswick, NJ; and Stephen E. Toulmin, Ph.D., Los Angeles, CA. We give special thanks to Dr. Lyle Bivens, DHHS, and Dr. Donald Buzzelli, NSF, for their dedication and untiring support of the Commission. We are also indebted to the following DHHS employees for sharing professional skills that have immeasurably enhanced the effectiveness and efficiency of our work: Ms. Elaine Alvarez de Benavides, Ms. Doris Campos-Infantino, Ms. Hilda Goldstein, Mr. Chris McNickle, Ms. Maria Mone, Ms. Karen Patrias, Ms. Catherine West, and Andrea Selzer, Esq., as well as Mr. George Getsinger of CASET Associates. Our thanks are extended as well to the four universities that graciously offered to host the Commission's regional meetings: De Paul University, Chicago, IL; Harvard University, Boston, MA; University of Alabama, Birmingham, AL; and University of California, San Francisco, CA. We also deeply appreciate the contributions of all witnesses who generously shared experience, expertise, and advice with the Commission, often at considerable personal expense. The Commission would especially like to acknowledge the extraordinary contributions of its Executive Secretary Henrietta Hyatt-Knorr and science writer Anne Rosenfeld in the organization and conduct of our meetings and the development of this report. iv Contents LETTERS OF TRANSMITTAL iii EXECUTIVE SUMMARY vii I. INTRODUCTION 1 II. COMMISSION DELIBERATIONS AND RECOMMENDATIONS 5 A. Promoting and Maintaining Research Integrity: A Shared Responsibility 5 B. Definition of Research Misconduct and Other Professional Misconduct 6 1. Introduction 6 2. Recommendation 13 3. Uniform Federal Definition 15 4. Recommendation 15 C. Education and Standards for Research Integrity 15 1. Role of Research Institutions and the Federal Government 15 2. Role of Professional Societies and Codes of Ethics 19 D. Responsible Whistleblowing 21 E. Administrative Processes and Investigations in Research Misconduct 24 1. Structures and Procedures of Research Institutions 24 2. Federal Structures and Procedures 26 F. Summary of Recommendations 33 APPENDICES A. Commission Charter 42 B. Commission Meetings/Hearings 45 C. Structure and Function of the DHHS Office of Research Integrity 47 D. Commentary on Offenses Described in Definition of "Research Misconduct" 50 E. Draft Whistleblower Protection Guidelines 56 F. Abbreviations 68 v This is a blank page. vi Executive Summary Commission on Research Integrity: Origins and Charge Congress created the Commission on Research Integrity in 1993 in response to continuing controversy concerning the apparent inability of the scientific community and the Federal Government to deal adequately with misconduct in scientific research. The Commission's task was to advise the Secretary of Health and Human Services and Congress about ways to improve the Public Health Service (PHS) response to misconduct in biomedical and behavioral research receiving PHS funding. Issues to be addressed included: 1) the definition of research misconduct; 2) the assurance process for research institutions' compliance with DHHS regulations; 3) the administrative processes of institutions and the PHS for dealing with allegations of misconduct; 4) and the development of a regulation to protect whistleblowers. The Commission's 12 members, chaired by Dr. Kenneth Ryan of Harvard University Medical School, were selected to include scientists, research misconduct investigators, administrators of research institutions, attorneys, and ethicists. The Commission held public meetings monthly from June 1994 through October 1995, primarily in the Washington, D.C., metropolitan area; regional public hearings were held in San Francisco, Chicago, Boston, and Birmingham. These meetings and hearings elicited a range of opinion and experience regarding weaknesses in current institutional and federal policies and practices related to research misconduct, as well as suggestions for improvement. The Commission also consulted informally with relevant non-PHS federal agencies, and with professional and scientific organizations. Guiding Considerations and Principles In its deliberations, the Commission sought to develop a fair, balanced, and realistic response to its charge, while taking into account the many parties potentially affected