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402-4242 • Fax: 301-480-6900 • Website: RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS: ETHICAL ISSUES and POLICY GUIDANCE RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS: ETHICAL ISSUES AND POLICY GUIDANCE VOLUME I Report and Recommendations of the National Bioethics Advisory Commission Rockville, Maryland August 1999 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 6100 Executive Boulevard, Suite 5B01, Rockville, Maryland 20892-7508 Telephone: 301-402-4242 • Fax: 301-480-6900 • Website: www.bioethics.gov RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS: ETHICAL ISSUES AND POLICY GUIDANCE VOLUME I Report and Recommendations of the National Bioethics Advisory Commission Rockville, Maryland August 1999 Table of Contents Letter of Transmittal to the President Commodification of the Body and Its Parts: National Bioethics Advisory Commission Issues of Justice and Respect for Persons 50 National Bioethics Advisory Commission Staff Summary 51 and Consultants Notes 52 Executive Summary i References 52 Chapter 1: Overview and Introduction 1 Chapter 5: Conclusions and Recommendations 55 The Use of Human Biological Materials in Research 1 Introduction 55 The Research Value of Human Biological Materials 1 Research Governed by the Federal Regulations: Is Genetic Information Different from Other Activities Beyond Clinical Care 56 Medical Information? 3 Interpretation of the Existing Federal Policy for the Increasing Discussion About the Appropriate Research Use Protection of Human Subjects 57 of Human Biological Materials 4 Expedited Review 60 About This Report 9 Special Concerns About the Use of Unlinked Samples 60 Notes 10 Requirements for Investigators Using Coded or References 11 Identified Samples 62 Using Previously Obtained Informed Consent and Reconsent 62 Chapter 2: Collection, Storage, and Use of Human Obtaining New Consent 63 Biological Materials in the United States 13 Criteria for Waiver of Consent 66 Collections of Human Biological Materials 13 Rendering Existing Identifiable Samples Unidentifiable Identifiability of Human Biological Materials 15 to Avoid the Need for Consent 70 The Value of Human Biological Materials to Current Research 19 Reporting Research Results to Subjects 71 Summary 23 Considerations of Potential Harms to Others 72 Notes 24 Publication and Dissemination of Research Results 73 References 24 Professional Education and Responsibilities 74 Use of Medical Records in Research on Chapter 3: Current Guidance on the Use of Human Human Biological Materials 74 Biological Materials in Research 27 Summary 75 Introduction 27 Notes 75 Scope of the Current Federal Regulations 27 References 76 Medical and Scientific Organization Standards and Guidance 32 International Perspectives on the Use of Appendices Human Biological Materials in Research 33 Appendix A: Beliefs About the Research Use of Publication Guidelines 34 Human Biological Materials 77 Medical Record Protection 35 Appendix B: Code of Federal Regulations, Title 45, Part 46 81 Summary 38 Appendix C: Comparison Table of Professional Statements 99 Notes 39 Appendix D: Guidance for Institutional Review Boards References 40 Reviewing Research Using Human Biological Materials 105 Appendix E: Public Comments on NBAC’s Chapter 4: Ethical Perspectives on the Research February 22, 1999, Draft 111 Use of Human Biological Materials 41 Appendix F: Public and Expert Testimony 113 Introduction 41 Appendix G: Commissioned Papers 115 Promoting Benefits and Minimizing Harms and Wrongs 42 Potential Harms from Breaches of Privacy and Confidentiality 43 Group-Related Harms 46 Respecting Persons Who Are Sources of Biological Materials 47 Just Institutions, Policies, and Practices 49 National Bioethics Advisory Commission Harold T. Shapiro, Ph.D., Chair President Princeton University Princeton, New Jersey Patricia Backlar Rhetaugh Graves Dumas, Ph.D., R.N. Research Associate Professor of Bioethics Vice Provost Emerita and Dean Emerita Department of Philosophy The University of Michigan Portland State University Ann Arbor, Michigan Assistant Director Center for Ethics in Health Care Laurie M. Flynn Oregon Health Sciences University Executive Director Portland, Oregon National Alliance for the Mentally Ill Arlington, Virginia Arturo Brito, M.D. Assistant Professor of Clinical Pediatrics Carol W. Greider, Ph.D. University of Miami School of Medicine Professor of Molecular Biology and Genetics Miami, Florida Department of Molecular Biology and Genetics The Johns Hopkins University School of Medicine Alexander Morgan Capron, LL.B. Baltimore, Maryland Henry W. Bruce Professor of Law University Professor of Law and Medicine Steven H. Holtzman Co-Director, Pacific Center for Health Policy and Ethics Chief Business Officer University of Southern California Millennium Pharmaceuticals Inc. Los Angeles, California Cambridge, Massachusetts Eric J. Cassell, M.D., M.A.C.P. Bette O. Kramer Founding President Clinical Professor of Public Health Richmond Bioethics Consortium Cornell University Medical College Richmond, Virginia New York, New York Bernard Lo, M.D. R. Alta Charo, J.D. Director Professor of Law and Medical Ethics Program in Medical Ethics Schools of Law and Medicine The University of California, San Francisco The University of Wisconsin San Francisco, California Madison, Wisconsin Lawrence H. Miike, M.D., J.D. James F. Childress, Ph.D. Kaneohe, Hawaii Kyle Professor of Religious Studies Professor of Medical Education Thomas H. Murray, Ph.D. Co-Director, Virginia Health Policy Center President Department of Religious Studies The Hastings Center The University of Virginia Garrison, New York Charlottesville, Virginia Diane Scott-Jones, Ph.D. David R. Cox, M.D., Ph.D. Professor Professor of Genetics and Pediatrics Department of Psychology Stanford University School of Medicine Temple University Stanford, California Philadelphia, Pennsylvania National Bioethics Advisory Commission Staff and Consultants Executive Director Eric M. Meslin, Ph.D. Research Staff Kathi E. Hanna, M.S., Ph.D., Research Director Emily C. Feinstein, Research Analyst* Melissa Goldstein, J.D., Research Analyst* E. Randolph Hull, Jr., Research Analyst* Stu K. Kim, M.S., J.D., Intern J. Kyle Kinner, J.D., M.P.A., Presidential Management Intern Debra McCurry, M.S., Information Specialist Daniel J. Powell, Intern Andrew Siegel, Ph.D., J.D., Staff Philosopher Sean A. Simon, Research Analyst* Robert Tanner, J.D., Research Analyst Consultants Burness Communications, Communications Consultant Sara Davidson, M.A., Editor Elisa Eiseman, Ph.D., Science Consultant Tamara Lee, Graphic Designer Administrative Staff Jody Crank, Secretary to the Executive Director Evadne Hammett, Administrative Officer Patricia Norris, Public Affairs Officer Lisa Price, Secretary Margaret C. Quinlan, Office Manager Sherrie Senior, Secretary *Until May 1999 Executive Summary Introduction Table 1: Categories of Human Biological iomedical researchers have long studied human bio- Materials Blogical materials—such as cells collected in research projects, biopsy specimens obtained for diagnostic pur- Repository Collections poses, and organs and tissues removed during surgery— Unidentified specimens: For these specimens, identifiable to increase knowledge about human diseases and to personal information was not collected or, if collected, was develop better means of preventing, diagnosing, and treat- not maintained and cannot be retrieved by the repository. ing these diseases. Today, new technologies and advances Identified specimens: These specimens are linked to in biology provide even more effective tools for using such personal information in such a way that the person from whom the material was obtained could be identified by name, resources to improve medicine’s diagnostic and therapeu- patient number, or clear pedigree location (i.e., his or her tic potential. Yet, the very power of these new technologies relationship to a family member whose identity is known). raises a number of important ethical issues. Is it appropriate to use stored biological materials in Research Samples ways that originally were not contemplated either by the Unidentified samples: Sometimes termed “anonymous,” these samples are supplied by repositories to investigators people from whom the materials came or by those who from a collection of unidentified human biological specimens. collected the materials? Does such use harm anyone’s
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