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Whistleblowing in Biomedical Research : Policies and Procedures For Whistleblowing Policies and Procedm'es for Responding to in Biomedical Reports of Misconduct Research Proceedings of a Workshop President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research American Association for the Advancement of Science, Committee on Scientific Freedom and Responsibility Medicine in the Public Interest Library of Congress card number 82-600605 For sale by the Superintendent of Documents U.S. Government Printing Office Washington, D.C. 20402 yyhistleblowing in Biomedical Research Policies and Procedures for Responding to Reports of Misconduct Proceedings of a Workshop September 21-22, 1981 Edited by Judith P. Swazey and Stephen R. Scher President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research American Association for the Advancement of Science, Committee on Scientific Freedom and Responsibility Medicine in the Public Interest O^M \^s \ Table of Contents Preface i Sponsoring Organizations ii Participants v Part I: The Institutional Context of IRBs 1 Chapter 1: Thinking About Institutional Review Boards (Jerry L. Mashaw) 3 Chapter 2: Autonomy, Academic Freedom, and Accountability: The University, The Individual, and The State (Virginia Davis Nordin) 23 Chapter 3: Commentary: The Conflicting Missions of IRBs (Spencer Foreman) 41 Chapter 4: Commentary: Teaching Hospitals, IRBs, and the Protection of Individual Rights (J. Richard Gaintner) 47 Chapter 5: Discussion 51 Part II: Fraud and Whistleblowing: Local Institutional Roles and Responses 59 Chapter 6: Misconduct by Research Investigators, Breach of Rules for Protecting Human Subjects, and the Institutional Review Board (Herman S. Wigodsky) 61 Chapter 7: Commentary: The Role of the IRB in Monitoring Research (Leonard H. Glantz) 75 Chapter 8: Commentary: Responses to Whistleblowing: The Experience of Yale University School of Medicine (Robert J. Levine) 79 Chapter 9: Investigating Fraud in Clinical Research: The Role of Hospitals, State Licensing Boards, and Professional Societies (Charlotte B. Cloutier) 85 Chapter 10: Commentary: Problems in Investigating Fraud 99 in Clinical Research (Frank P. Grad) 191 Chapter 11: Discussion Part III: Fraud and Whistleblowing: The Federal Government’s Role 109 Chapter 12: Protecting the Rights of Whistleblowers and the Accused in Federally Supported Biomedical Research (Andra N. Oakes) 111 Chapter 13: Commentary: Whistleblowing, Due Process, and “Institutional Tarpaper” (Alan F. Westin) 143 Chapter 14: The National Institutes of Health’s Perspective on Misconduct by Grantees (William F. Raub) 151 Chapter 15: Whistleblowing in Biomedical Research: The Role of the Food and Drug Administration (Stuart L. Nightingale) 155 Chapter 16: Commentary: Whistleblowing and the Role of the Federal Government (John A. Robertson) 159 Chapter 17: Discussion 161 Part IV: Fraud, Whistleblowing, and Professional Norms 171 Chapter 18: The Whistleblower as a Deviant Professional: Professional Norms and Responses to Fraud in Clinical Research (Judith P. Swazey and Stephen R. Scher) 173 Chapter 19: Commentary: Bureaucratized Science and Resistance to Whistleblowing (Deena Weinstein) 193 Chapter 20: Discussion 199 Chapter 21: Workshop Recommendations 207 i Preface The purpose of this two-day workshop was to examine the response of research institutions and federal agencies to reports of fraud or misconduct in federally supported biomedical research and to develop suggestions for improving such responses in the future. Incomplete or inaccurate research data, as well as violations of applicable regulations, may pose serious risks to research sub- jects. In addition, fraud in research may place future patients at risk if decisions to adopt or abandon a particular therapy are based upon incomplete or inaccurate data. More fundamentally, of course, fraud in research deeply affects the structure and conduct of sci- ence. Scientists may waste years of work building on false leads, and the scientific enterprise as a whole may lose the confidence and support of the general public. Each of the groups sponsoring the workshop is committed to maintaining the integrity of biomedical research through a delicate balance of informal and formal systems of control. This balance should foster creative research while maintaining individual ac- countability for the accuracy of scientific work — and safeguarding the rights and welfare of human subjects. The challenge is in de- termining how to accomplish these objectives in the context of large research institutions and complex government bureaucracies. The rights and responsibilities of several parties must be rec- ognized and dealt with in the face of competing interests. Individu- als who report or “blow the whistle” on the wrongdoing by their colleagues or superiors may face retaliatory actions by their em- ployers or superiors in the academic hierarchy; they may also en- counter difficulties in having their charges taken seriously Indi- viduals accused of misconduct may believe the allegations to be spurious and may deeply resent disruption of their research during the conduct of an investigation. The federal agencies that disburse public monies to support the research have an obligation to protect the public’s interests. These agencies also have an obligation to protect persons who report serious abuses, on the one hand, and not to overreact to unsubstantiated charges, on the other. How can whistleblowers, scientists accused of misconduct, human subjects, and the public interest best be protected? We be- lieve that an informed discussion will assist both the federal gov- ernment and the research community in developing policies and procedures for responding to the problem. This volume of work- shop papers, commentaries, and summaries of discussion sessions has been prepared to encourage such a discussion. Barbara Mishkin, Deputy Director Rosemary Chalk President’s Commission for the Program Head, Committee Study of Ethical Problems in on Scientific Freedom and Medicine and Biomedical and Responsibility, American Behavioral Research Association for the Advancement of Science Judith Swazey, Executive Director Medicine in the Public Interest 11 President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research The commission was established by Public Law 95-622 and held its first meeting on January 15, 1980. It is authorized through the end of 1982. Its work continues and expands upon the work of predecessor bodies, such as the National Commission for the Pro- tection of Human Subjects of Biomedical and Behavioral Research. In response to part of its statutory mandate, the Commission issued a report in December 1981, Protecting Human Subjects, on the adequacy and uniformity of Federal rules for the protection of human subjects and on the adequacy of their actual implementa- tion. The Commission’s sponsorship of the Workshop on Whistle- blowing was part of its inquiry into present practices for respond- ing to reports of misconduct in Federally supported research. Most of the suggestions coming out of the workshop were adopted by the Commission as formal recommendations for improving both in- stitutional and agency responses to such reports. The Report was submitted to the President, the Congress, and each Federal agency to which its recommendations applied. The Commission Morris B. Abram, M.A., J.D., LL.D., Chairman, New York, N.Y. Renee C. Fox, Ph.D., D.H.L.* Donald N. Medearis, Jr., M.D.* University of Pennsylvania Harvard University Mario Garcia-Palmieri, M.D. Arno G. Motulsky, M.D. University of Puerto Rico University of Washington Frances K. Graham, Ph.D.* Anne A. Scitovsky, M.A. University of Wisconsin Palo Alto Medical Research Albert R. Jonsen, Foundation S.T.M., Ph.D. Charles J. Walker, M.D. University of California, Nashville, Tennessee San Francisco Carolyn A. Williams, Ph.D. Mathilde Krim, Ph.D.** University of North Carolina, Sloan-Kettering Institute for Chapel Hill Cancer Research *Term expired January 1982. **Resigned December 1981. Executive Director, Professor Alexander Morgan Capron Ill Medicine in the Public Interest, Inc. Medicine in the Public Interest (MIPI) is a nonprofit organiza- tion involved in research and education relating to medicine, sci- ence, and society in the United States. Chartered in 1973, MLPFs central purpose is to provide a forum for conducting and dis- seminating independent, objective studies at the federal, state, or local level that will help to inform the general public and to aid the work of policymakers and those in the health care professions. MIPI’s cosponsorship of the Workshop on Whistleblowing in Biomedical Research grew out of and was partially supported by its Project on Social Controls and the Medical Profession. Funded by a grant from the National Science Foundation and the National En- dowment for the Humanities (No. OSS-8016832) this two-year project is concerned with processes of self-governance within the medical profession and attempts to control medical practice through laws and regulations. Board of Directors Dana L. Farnsworth, M.D. Charles O. Galvin, J.D., S.J.D. (Honorary Chairman) Professor, School of Law Henry K. Oliver, Professor of Southern Methodist University Hygiene, Emeritus Robert J. Levine, M.D. Harvard University Professor of Medicine and Daniel X. Freedman, M.D. Lecturer in Pharmacology (Chairman) Yale University School of Professor and Chairman Medicine Department of Psychiatry Dorothy Nelkin,
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