Privacy Issues in Biomedical and Clinical Research

Privacy Issues in Biomedical and Clinical Research Proceedings of Forum on November 1, 1997 National Academy of Sciences Washington, D.C.

Board on Biology

National Research Council

Washington, D.C.

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--> Privacy Issues in Biomedical and Clinical Research Privacy Issues in Biomedical and Clinical Research Proceedings of Forum on November 1, 1997 National Academy of Sciences Washington, D.C. Board on Biology National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 1998

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--> NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance. This report has been prepared with funds provided by the Department of Energy, Grant No. DE-FG02-94ER61939 and the National Cancer Institute, Contract No. N01-OD-4-2139 (Task Order 33). International Standard Book Number 0-309-06328-0 Additional copies of this report are available from: National Academy Press 2101 Constitution Ave., NW Box 285 Washington, DC 20055 800-624-6242 202-334-3313 (in the Washington metropolitan area) Copyright 1998 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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--> Steering Committee RAY WHITE, Chair, University of Utah, Salt Lake City MICHAEL CLEGG, University of California, Riverside THOMAS D. POLLARD, The Salk Institute for Biological Studies, La Jolla, California Science Writer ROBERT POOL, Arlington, Virginia Staff PAUL GILMAN, Acting Director, Board on Biology REGIS KRAH, Program Officer Board on Biology MICHAEL T. CLEGG, Chair, University of California, Riverside JOHN C. AVISE, University of Georgia, Athens DAVID ELSENBERG, University of California, Los Angeles GERALD D. FISCHBACH, Harvard Medical School DAVID J. GALAS, Darwin Technologies, Seattle, Washington DAVID V. GOEDDEL, Tularik, Inc., San Francisco, California ARTURO GOMEZ-POMPA, University of California, Riverside COREY S. GOODMAN, University of California, Berkeley BRUCE R. LEVIN, Emory University, Atlanta, Georgia OLGA F. LINARES, Smithsonian Tropical Research Institute, Balboa, Panama ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena ROBERT T. PAINE, University of Washington, Seattle RONALD R. SEDEROFF, North Carolina State University DANIEL S. SIMBERLOFF, Florida State University ROBERT R. SOKAL, State University of New York, Stony Brook SHIRLEY M. TILGHMAN, Princeton University RAYMOND L. WHITE, University of Utah, Salt Lake City Staff KATHLEEN BEIL, Project Assistant

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--> Commission on Life Sciences THOMAS D. POLLARD, Chair, The Salk Institute for Biological Studies, La Jolla, California FREDERICK R. ANDERSON, Cadwalader, Wickersham and Taft, Washington, D.C. JOHN C. BAILAR, III, University of Chicago PAUL BERG, Stanford University JOANNA BURGER, Rutgers University SHARON L. DUNWOODY, University of Wisconsin, Madison JOHN L. EMMERSON, Portland, Oregon NEAL L. FIRST, University of Wisconsin URSULA W. GOODENOUGH, Washington University, St. Louis, Missouri HENRY W. HEIKKIEN, University of Northern Colorado, Greeley, Colorado HANS J. KENDE, Michigan State University, Lansing, Michigan CYNTHIA J. KENYON, University of California at San Francisco DAVID M. LIVINGSTON, Dana-Farber Cancer Institute THOMAS E. LOVEJOY, Smithsonian Institution, Washington, D.C. DONALD R. MATTISON, University of Pittsburgh JOSEPH E. MURRAY, Wellesley Hills, Massachusetts EDWARD E. PENHOET, Chiron Corporation, Emeryville, California MALCOLM C. PIKE, Norris/University of Southern California Comprehensive Cancer Center, Los Angeles, California JOHNATHAN M. SAMET, John Hopkins University, Baltimore, Maryland CHARLES F. STEVENS, The Salk Institute for Biological Studies, La Jolla, California JOHN L. VANDEBERG, Southwest Foundation for Biomedical Research, San Antonio, Texas Staff PAUL GILMAN, Executive Director

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--> Preface In 1993 the National Research Council's Board on Biology established a series of forums on biotechnology. The purpose of the discussions is to foster open communication among scientists, administrators, policy-makers, and others engaged in biotechnology research, development, and commercialization. The neutral setting offered by the National Research Council is intended to promote mutual understanding among government, industry, and academe and to help develop imaginative approaches to problem solving. The objective, however, is to illuminate issues, not to resolve them. Unlike study committees of the National Research Council, forums cannot provide advice or recommendations to any government agency or other organization. Similarly, summaries of forums are precluded from reaching conclusions or recommendations, but instead, are intended to reflect the variety of opinions expressed by the participants. The comments in this report reflect the views of the forum's participants as indicated in the text. For the first forum, held on November 5, 1996, the Board on Biology collaborated with the Board on Agriculture to focus on intellectual property rights issues surrounding plant biotechnology. The second forum, held on April 26, 1997, also conducted in collaboration with the Board on Agriculture, was focused on issues and obstacles to a broad genome project with numerous plant and animal species as its subjects. After discussions with the National Cancer Institute and the Department of Energy the Board on Biology of the National Research Council agreed to run a workshop under the auspices of its Forum on Biotechnology entitled "Privacy Issues in Biomedical and Clinical Research" on November 1, 1997. Participation by representatives of the U.S. Department of Energy, U.S. Department of Agriculture, National Institutes of Health, and Congressional staff suggests that this

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--> issue is important to many federal bodies. Scientists from industry, academe, and federal agencies shared their experiences in human genetic research. The organizers want to stress the forum was not intended to cover the full gauntlet of issues concerning Genomics and the Privacy of Medical Records. The emphasis of this forum was to look at pending legislation in Congress (Fall, 1997) and consider, if enacted as written, how this would affect genetic research. The broad language of this legislation written to protect the individual could inadvertently restrict research intended to help these same individuals. Scientific progress requires the sharing of information for the validation of results and the dissemination of gained knowledge to be effective. Other issues which were touched upon in this forum but not fully explored include; the trust of individuals involved in genetic studies in the manner their genetic information could be used, the practice of the generalized "linking" of particular ethnic groups with specific genetic traits, and the potential for positive and negative impact on the quality of life by having knowledge of one's genetic potential. These and other issues which have come upon us in the age of genomics require separate, focused efforts to explore their potential effect on society. At the conclusion of the Forum on "Privacy Issues in Biomedical and Clinical Research" we invited participants to write their thoughts about the issue to be included in the appendix. One person, Mr. Frederick Anderson, responded and his comments can be read on pp. 35-39. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise in accordance with procedures for reviewing NRC and IOM report approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the NRC in making the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The content of the final report is the responsibility of the NRC and the study committee, and not the responsibility of the reviewers. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals, who are neither officials nor employees of the NRC, for their participation in the review of this report: Edward Furtek, Ph.D., Office of Science and Technology Policy and Projects, University of California, San Diego Rev. William E. Nebo, Livermore, California Mary Kay Pelius, Ph.D., Department of Biometry and Genetics, Louisana State University Medical Center Barbara K. Rimer, Dr. PH, Division of Cancer Control and Population, National Cancer Institute Karen H. Rothenberg, J.D., M.P.A., School of Law, University of Maryland

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--> While the individuals listed above have provided many constructive comments and suggestions, it must be emphasized that responsibility for the final content of this report rests entirely with the authoring committee and the NRC. MICHAEL T. CLEGG Chair Board on Biology RAYMOND L. WHITE Board on Biology

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--> The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice-chairman, respectively, of the National Research Council.

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--> Contents     Introduction: Privacy Issues in Research   1     The Potential—and the Threat—of Genetic Information   3     Can We—and Should We—Ensure Genetic Privacy?   7     Handling Genetic Data in the Laboratory   11     Institutional Safeguards   18     What, If Anything, Should the Federal Government Do?   22     APPENDIXES         A Program and Discussion Questions   31     B Agenda   33     C A Comment by Frederick R. Anderson   35     D Participant Biographies   40

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