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Ethical and Policy Issues in Research Involving Human Participants Ethical and Policy Issues in Research Involving Human Participants Volume I Report and Recommendations of the National Bioethics Advisory Commission Bethesda, Maryland August 2001 The National Bioethics Advisory Commission (NBAC) was established by Executive Order 12975, signed by President Clinton on October 3, 1995. NBAC’s functions are defined as follows: a) NBAC shall provide advice and make recommendations to the National Science and Technology Council and to other appropriate government entities regarding the following matters: 1) the appropriateness of departmental, agency, or other governmental programs, policies, assignments, missions, guidelines, and regulations as they relate to bioethical issues arising from research on human biology and behavior; and 2) applications, including the clinical applications, of that research. b) NBAC shall identify broad principles to govern the ethical conduct of research, citing specific projects only as illustrations for such principles. c) NBAC shall not be responsible for the review and approval of specific projects. d) In addition to responding to requests for advice and recommendations from the National Science and Technology Council, NBAC also may accept suggestions of issues for consideration from both the Congress and the public. NBAC also may identify other bioethical issues for the purpose of providing advice and recommendations, subject to the approval of the National Science and Technology Council. National Bioethics Advisory Commission 6705 Rockledge Drive, Suite 700, Bethesda, Maryland 20892-7979 Telephone: 301-402-4242 • Fax: 301-480-6900 • Website: www.bioethics.gov ISBN 1-931022-16-X Ethical and Policy Issues in Research Involving Human Participants Volume I Report and Recommendations of the National Bioethics Advisory Commission Bethesda, Maryland August 2001 Table of Contents Letter of Transmittal to the President Chapter 5: Ensuring Voluntary Informed Consent and National Bioethics Advisory Commission Protecting Privacy and Confidentiality 97 National Bioethics Advisory Commission Staff and Consultants Introduction 97 Voluntary Informed Consent 97 Prologue i Privacy and Confidentiality 104 Summary of Recommendations xi Summary 107 Chapter 1: Introduction—The Need for Change 1 Notes 108 Introduction 1 References 108 The Value of Research 1 Chapter 6: Conduct of Research—Selected Issues for The Need for Oversight of Research Involving Human Participants 2 Local Institutions 111 Current Factors Influencing the Research Enterprise 4 Introduction 111 Major Challenges Facing the Current Oversight System 8 Monitoring of Ongoing Research 111 Consequences of a Flawed System 16 Review of Cooperative Research Studies 117 Notes 16 Compensation for Research-Related Injuries 123 References 18 Summary 126 Notes 127 Chapter 2: A Proposal for Oversight 21 References 128 Introduction 21 Chapter 7: Implications of This Report 131 Purpose of Oversight 21 Introduction 131 Functions and Responsibilities of the Oversight System 23 Resources 131 Scope and Structure of a Revised Oversight System 26 Future Research 133 The Need for a Unified, Comprehensive Federal Policy 28 The New System as a Dynamic and Responsive Structure 134 Definition of Research Involving Human Participants 32 General Themes in the Recommendations 135 Summary 42 What This Report Means to Those Who Use the System 136 Notes 42 How This Report Will Affect Institutional Review Boards, References 43 Investigators, and Institutions 136 How This Report Will Affect Research Participants 137 Chapter 3: Methods for Ensuring Protection: Summary 137 Education, Certification, and Accreditation 45 Notes 137 Introduction 45 References 138 Education and Competence in Conducting Research Involving Human Participants 45 Appendices Mechanisms to Ensure Institutional, Institutional Review Board, A. Acknowledgments 139 and Investigator Compliance 50 B. May 1999 Letter from Harold T. Shapiro to Conflicts of Interest 58 President William J. Clinton and President Clinton’s Response 141 Summary 64 C.The Current Oversight System: History and Description 151 Notes 64 D.The Belmont Report 161 References 65 E. Code of Federal Regulations, Title 45 Part 46 169 F. Code of Federal Regulations, Title 21 Parts 50 and 56 187 Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability 69 G.Statutory Authority for Agency Human Subjects Protection Regulations (Common Rule) 205 Introduction 69 H.Food and Drug Administration Regulations Requiring Institutional Review Board Approval of Research 69 Reporting of Adverse Events 213 Risks of Harms and Potential Benefits to Participants and to Society 71 I. Public Comments on NBAC’s December 19, 2000, Draft 217 Vulnerability 85 J. Public and Expert Testimony 221 Summary 93 K. Commissioned Papers and Staff Analysis 225 Notes 93 References 95 Index 227 National Bioethics Advisory Commission Harold T. Shapiro, Ph.D., Chair President Emeritus and Professor of Economics and Public Affairs The Woodrow Wilson School of Public and International Affairs Princeton University Princeton, New Jersey Patricia Backlar Laurie M. Flynn* Research Associate Professor of Bioethics Senior Research and Policy Associate Department of Philosophy Department of Child and Adolescent Psychiatry Portland State University Columbia University Assistant Director New York, New York Center for Ethics in Health Care Oregon Health Sciences University Carol W. Greider, Ph.D. Portland, Oregon Professor of Molecular Biology and Genetics Department of Molecular Biology and Genetics Arturo Brito, M.D. Johns Hopkins University School of Medicine Assistant Professor of Clinical Pediatrics Baltimore, Maryland University of Miami School of Medicine Miami, Florida Steven H. Holtzman Chief Business Officer Millennium Pharmaceuticals, Inc. Alexander Morgan Capron, LL.B. Cambridge, Massachusetts Henry W. Bruce Professor of Law University Professor of Law and Medicine Bette O. Kramer Co-Director, Pacific Center for Health Policy and Ethics Founding President University of Southern California Richmond Bioethics Consortium Los Angeles, California Richmond, Virginia Eric J. Cassell, M.D., M.A.C.P. Bernard Lo, M.D. Clinical Professor of Public Health Director Weill Medical College of Cornell University Program in Medical Ethics New York, New York Professor of Medicine University of California, San Francisco R. Alta Charo, J.D. San Francisco, California Professor of Law and Bioethics Law School and Medical School Lawrence H. Miike, M.D., J.D. University of Wisconsin Kaneohe, Hawaii Madison, Wisconsin Thomas H. Murray, Ph.D. James F. Childress, Ph.D. President Kyle Professor of Religious Studies The Hastings Center Professor of Medical Education Garrison, New York Director, Institute for Practical Ethics Department of Religious Studies William C. Oldaker, LL.B. University of Virginia Senior Partner Charlottesville, Virginia Oldaker & Harris, L.L.P. Washington, D.C. Co-Founder and General Counsel David R. Cox, M.D., Ph.D. NeuralStem Biopharmaceuticals Ltd. Scientific Director College Park, Maryland Perlegen Sciences Santa Clara, California Diane Scott-Jones, Ph.D. Professor Rhetaugh Graves Dumas, Ph.D., R.N. Psychology Department Vice Provost Emerita, Dean Emerita, and Boston College Lucille Cole Professor of Nursing Chestnut Hill, Massachusetts University of Michigan Ann Arbor, Michigan *Resigned on May 10, 2001 National Bioethics Advisory Commission Staff and Consultants Executive Director Eric M. Meslin, Ph.D.* Project Director Marjorie A. Speers, Ph.D. Research Staff Douglas Berger, M.Litt., Program Analyst** Glen Drew, M.S., J.D., Senior Research Policy Analyst Elisa Eiseman, Ph.D., Senior Research Analyst Ellen L. Gadbois, Ph.D., Senior Policy Analyst Stu Kim, J.D., Program Analyst*** Kerry Jo Lee, Program Analyst* Ayodeji Marquis, Intern (June–August 2000) Debra McCurry, M.S., Information Specialist Alice K. Page, J.D., M.P.H., Senior Policy Analyst* Consultants Burness Communications, Communications Consultant Sara Davidson, M.A., Editor Liza Dawson, Ph.D., Research Consultant (December 2000–March 2001) Debra DeBruin, Ph.D., Bioethics Consultant (July–December 2000) Kathi E. Hanna, M.S., Ph.D., Editorial Consultant The Hill Group, Meeting Consultant Tamara Lee, Graphic Designer Administrative Staff Nicole Baker, Administrative Technician Jody Crank, Assistant to the Executive Director Evadne Hammett, Administrative Officer Margaret C. Quinlan, Office Manager Sherrie Senior, Secretary * Until July 2001 ** Until June 2001 *** Until November 2000 Prologue Protecting Research Participants—A Time for Change Introduction are under way,1 it will take the efforts of both the executive and legislative branches of government to put rotecting the rights and welfare of those who volun- in place a streamlined, effective, responsive, and com- teer to participate in research is a fundamental tenet P prehensive system that achieves the protection of all of ethical research. A great deal of progress has been human participants and encourages ethically responsible made in recent decades in changing the culture of research. research to incorporate more fully this ethical responsi- bility into protocol design and implementation. In the Clearly, scientific investigation has extended and 1960s and 1970s, a series of scandals concerning social enhanced the quality of life and increased our under- science research and medical research conducted with standing of ourselves, our relationships with others, and the sick and the illiterate underlined the need to
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