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2-HBM Volume 2 For RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS: ETHICAL ISSUES AND POLICY GUIDANCE VOLUME II COMMISSIONED PAPERS Rockville, Maryland January 2000 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 II COMMISSIONED PAPERS Rockville, Maryland January 2000 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 CONTENTS Privacy and the Analysis of Stored Tissues.........................................................A-1 Sheri Alpert An Ethical Framework for Biological Samples Policy .........................................B-1 Allen Buchanan University of Arizona Research on Human Tissue: Religious Perspectives ...........................................C-1 Courtney S. Campbell Oregon State University Stored Tissue Samples: An Inventory of Sources in the United States ..............D-1 Elisa Eiseman RAND Critical Technologies Institute Contribution of the Human Tissue Archive to the Advancement of Medical Knowledge and the Public Health......................................................E-1 David Korn Stanford University School of Medicine The Ongoing Debate About Stored Tissue Samples ............................................F-1 Robert F. Weir University of Iowa Mini-Hearings on Tissue Samples and Informed Consent..................................G-1 James A. Wells and Dana Karr Center for Health Policy Studies Bartha Knoppers, CRDP (Public Law Research Centre), Faculty of Law, Université de Montréal, Québec, Canada, prepared a paper for NBAC on the topic of control of DNA samples and information. That paper was published in 1998 in the journal Genomics. The reader can find the article at the following citation: Knoppers, B.M., M. Hirtle, S. Lormeau, C.M. Laberge, and M. Laflamme. 1998. “Control of DNA Samples and Information” Genomics 50(3):385–401. v PRIVACY AND THE ANALYSIS OF STORED TISSUES Commissioned Paper Sheri Alpert 1 A-1 Preface his paper resulted from a request by the National Bioethics Advisory Commission Genetics Subcommittee Tfor an analysis of the privacy issues inherent in using tissue samples in genetic research. While this paper focuses mostly on genetic research, it does so with a broad view. The paper bases the definition of genetic research on the definition of genetic testing used by the National Institutes of Health/Department of Energy Task Force on Genetic Testing: Genetic research includes analysis of human DNA, RNA, chromosomes, proteins, and certain metabolites, in order to detect heritable genotypes, mutations, phenotypes, or karyotypes. The purpose of this research includes assessing the prevalence, penetrance, and expressivity of these heritable traits within the overall population, a particular subpopulation, or an individual. It must also be pointed out that most of the observations and much of the analysis presented in this paper may be equally applicable to other research using human tissue samples and/or medical records. Introduction One of the biggest challenges in addressing the issues surrounding the collection, use, and genetic analysis of tissue samples is making the issues accessible to the public—the same public which, as individual members, has been and will continue to be asked to surrender their tissues for medical care or for medical research. Why, after all, should the public care about issues that may seem so remote to their lives? The increasing use of genetic analysis on these tissues provides a large part of the answer. It is important, therefore, to keep in mind the very fundamental kinds of questions that might be of most concern to most people outside the scientific, research, and medical establishments. Below are scenarios containing the types of questions and issues that may be most relevant to the public: 1. A consent form was among all the papers I received when I checked into the hospital. What does it mean when the form asks if I will let my tissues be used for research? What kind of research? Is it research that will help me with my medical condition? What happens to my tissues when they’re done with the research? Will I find out what they learn from my tissues? Who else may find out what they learn from my tissues? 2. I recently had the occasion to look at my medical record from when I had surgery about eight years ago. I saw that the consent form I signed for the surgery had a clause in it that said that I authorized the hospital to “dispose” of my excess tissue. I thought that meant they’d throw it out after I was diagnosed. I have since found out that it may have meant they could do practically any kind of research on my tissues that they wanted. With all this news about genetics, I am uncomfortable with the thought that strangers know more about me than I know about myself. What can I do to make sure they don’t do anything with my tissues that I don’t want them to do? How can I find out what they’ve done with them so far? What else do they know about me? Who can answer these questions? 3. I am an Ashkenazi Jewish woman and have been asked to sign up for a research protocol looking for a genetic mutation for pancreatic cancer in Eastern European Jews. I am concerned because there has been some cancer in my family. I do not want to know how the research results turn out for myself, but I am afraid that just participating in the research will make me vulnerable when I apply for insurance. What do I need to know to decide what’s best for me? I am also concerned, given all the other genetic mutations associated with my group, about contributing to research that will leave others thinking that Ashkenazi Jews are more “genetically damaged” than other people. Can the researchers assure me that this won’t happen if they find the mutation? A-3 These three scenarios are not intended to represent the universe of concerns surrounding the genetic analysis of stored tissues. They focus, however, on the personal kinds of issues that people may confront when they start to understand
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