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Issues in Returning Individual Results from Genome Research Using Population-Based Banked Specimens, with a Focus on the National Health and Nutrition Examination Survey WORKSHOP SUMMARY Kevin Kinsella, Rapporteur Steering Committee for the Workshop on Guidelines for Returning Individual Results from Genome Research Using Population-Based Banked Specimens Committee on National Statistics Division of Behavioral and Social Sciences and Education

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THE NATIONAL ACADEMIES PRESS  500 Fifth Street, NW  Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Gov- erning Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engi- neering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by a transfer from the National Center for Health Sta- tistics to Grant No. SES-1024012 between the National Academy of Sciences and the National Science Foundation, which provides funding for the Committee on National Statistics from a consortium of federal agencies. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number-13:  978-0-309-30704-8 International Standard Book Number-10:  0-309-30704-X Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2014 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Research Council. (2014). Issues in Returning Indi- vidual Results from Genome Research Using Population-Based Banked Specimens, with a Focus on the National Health and Nutrition Examination Survey: A Workshop Summary. K. Kinsella, Rapporteur. Steering Committee for the Workshop on Guidelines for Returning Individual Results from Genome Research Using Population-Based Banked Specimens, Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press.

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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 govern- ment on scientific and technical matters. Dr. Ralph J. Cicerone 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 mem- bers, sharing with the National Academy of Sciences the responsibility for advis- ing 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. C. D. Mote, Jr., 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. Victor J. Dzau 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 pro- viding 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. Ralph J. Cicerone and Dr. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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STEERING COMMITTEE FOR THE WORKSHOP ON GUIDELINES FOR RETURNING INDIVIDUAL RESULTS FROM GENOME RESEARCH USING POPULATION-BASED BANKED SPECIMENS WYLIE BURKE (Chair), Department of Bioethics and Humanities, University of Washington LESLIE G. BIESECKER, Genetic Disease Research Branch, National Human Genome Research Institute JEFFREY BOTKIN, Division of Medical Ethics and Humanities, University of Utah MILDRED K. CHO, Center for Biomedical Ethics, Stanford University School of Medicine ELLEN WRIGHT CLAYTON, Center for Biomedical Ethics and Society, Vanderbilt University EILEEN M. CRIMMINS, Davis School of Gerontology, University of Southern California KEVIN KINSELLA, Study Director JACQUELINE R. SOVDE, Program Associate v

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COMMITTEE ON NATIONAL STATISTICS 2013-2014 LAWRENCE D. BROWN (Chair), Department of Statistics, The Wharton School, University of Pennsylvania JOHN M. ABOWD, School of Industrial and Labor Relations, Cornell University MARY ELLEN BOCK, Department of Statistics, Purdue University DAVID CARD, Department of Economics, University of California, Berkeley ALICIA CARRIQUIRY, Department of Statistics, Iowa State University MICHAEL E. CHERNEW, Department of Health Care Policy, Harvard Medical School CONSTANTINE GATSONIS, Center for Statistical Sciences, Brown University JAMES S. HOUSE, Survey Research Center, Institute for Social Research, University of Michigan MICHAEL HOUT, Department of Sociology, New York University SALLIE KELLER, Virginia Bioinformatics Institute at Virginia Tech, Arlington, VA LISA LYNCH, The Heller School for Social Policy and Management, Brandeis University COLM O’MUIRCHEARTAIGH, Harris School of Public Policy Studies, University of Chicago RUTH PETERSON, Criminal Justice Research Center, Ohio State University EDWARD H. SHORTLIFFE, Departments of Biomedical Informatics, Columbia University and Arizona State University HAL STERN, Donald Bren School of Information and Computer Sciences, University of California, Irvine CONSTANCE F. CITRO, Director vi

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Acknowledgments T his report summarizes the proceedings of a workshop convened in February 2014 to consider guidelines for returning individual results from genomic research using population-based banked spec- imens. The workshop was sponsored by the National Center for Health Statistics (NCHS) and convened by the Committee on National Statistics (CNSTAT) in the Division of Behavioral and Social Sciences and Educa- tion (DBASSE) of the National Research Council (NRC). The workshop was organized by a six-member steering committee composed of experts in the fields of bioethics, law and genetics, biomedi- cal genetics, and demography. The committee was chaired by Wylie Burke, University of Washington, and included Leslie G. Biesecker, National Human Genome Research Institute; Jeffrey Botkin, University of Utah; Mildred K. Cho, Stanford University; Ellen Wright Clayton, Vanderbilt University; and Eileen M. Crimmins, University of Southern California. The committee provided indispensable guidance in developing the work- shop agenda, securing expert presentations, and facilitating the conduct of the workshop. Although the steering committee members played a central role throughout, they did not actively participate in writing this summary. The committee would like to thank NCHS staff members Virginia Cain, Jennifer Madans, Geraldine McQuillan, and Kathryn Porter for their planning-meeting input prior to the workshop. The presentations during the workshop provided the basis for lively and informative dis- cussions. We greatly appreciate the contributions of Benjamin Berkman, vii

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viii ACKNOWLEDGMENTS Laura Beskow, Barbara Biesecker, Jeffrey Botkin, Kelly Edwards, Carolyn Tucker Halpern, Tina Hambuch, Robert M. Hauser, Gail Jarvik, Steven Joffe, Sharon Kardia, Muin Khoury, Jennifer H. Madans, Martha McClintock, John Moye, Kathryn Porter, Henry S. Richardson, David Weir, Marc Williams, and Susan M. Wolf. The steering committee acknowledges the work of the staff of the NRC in organizing the workshop and this report. Constance F. Citro, director of CNSTAT, provided overall direction and guidance for the project. Adam C. Berger of the Institute of Medicine offered valuable sug- gestions regarding steering committee membership and chaired a work- shop session. Kevin Kinsella of the DBASSE Committee on Population assisted with organizing the steering committee and setting the agenda for the study, and served as rapporteur for the workshop. Jacqui Sovde of CNSTAT provided invaluable assistance with all aspects of the project, including myriad logistical details as well as report preparation. Paula Whitacre edited the report, and Kirsten Sampson Snyder orchestrated the review process. This workshop summary was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accor- dance with procedures approved by the Report Review Committee of the NRC. The purpose of this independent review is to provide candid and critical comments that assist the institution in making its report as sound as possible, and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integ- rity of the deliberative process. The panel thanks the following individuals for their review of this report: Eileen M. Crimmins, Andrus Gerontology Center, University of Southern California; Alan R. Fleischman, Clinical Pediatrics and Clinical Epidemiology and Population Health, Albert Einstein College of Medi- cine; Norman Fost, Pediatrics and Bioethics, University of Wisconsin School of Medicine and Public Health; and Jennifer R. Harris, Division of Epidemiology, The Norwegian Institute of Public Health, Oslo, Norway. Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the report nor did they see the final draft of the report before its release. The review of this report was overseen by Robert M. Groves, Provost and Department of Mathematics and Statistics, and Department of Sociology, Georgetown University. Appointed by the NRC, he was responsible for

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ACKNOWLEDGMENTS ix making certain that the independent examination of this report was car- ried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report rests entirely with the rapporteur and the NRC. Wylie Burke, Chair Steering Committee for the Workshop on Guidelines for Returning Individual Results from Genomic Research Using Population-Based Banked Specimens

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Contents 1 INTRODUCTION 1 2 GENOMICS IN POPULATION-BASED DATA COLLECTION: THE EXAMPLE OF THE NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY 5 3 PERSPECTIVES ON RETURNING GENOME-BASED RESEARCH RESULTS 9 Role-Based Obligations, 9 The Case for a Cautious Approach to Returning Results, 10 The Case for Broader Return of Results, 12 4 FRAMING THE DISCUSSION 17 The Evolution of Genomic Technology and Clinical Utility, 17 Ethical Frameworks, 20 5 HOW IS NHANES SIMILAR TO/DIFFERENT FROM OTHER POPULATION-BASED STUDIES? 25 The National Longitudinal Study of Adolescent Health, 25 The Health and Retirement Study, 26 The National Social Life, Health, and Aging Project, 28 The Wisconsin Longitudinal Study, 29 The National Children’s Study, 30 Illumina, 31 xi

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xii CONTENTS 6 ISSUES FOR NHANES 35 The Scientific Value of Incorporating Genomic Data Collection into NHANES, 35 Determining What Data Are Returnable, 36 Survey Participant Attitudes and Preferences, 41 7 THE LOGISTICS OF RETURNING GENOMIC RESULTS FROM NHANES 45 The NHANES View, 45 Retrospective Versus Prospective Samples, 47 Practical Aspects of Returning Results, 49 8 SPECIAL CONSIDERATIONS FOR REPORTING OF RESULTS IN NHANES 53 Statistical Agency Considerations in Releasing DNA Results, 53 The Notion of Genetic Exceptionalism, 55 9 SUMMARY OF PRESENTATIONS AND DISCUSSION 59 Genetics and the NHANES Mission, 59 Usefulness for Genetic Research, 60 Should Genetic Results Be Returned to Participants?, 61 Adaptive Governance and Communication with Participants, 62 Participant Consent or Re-Consent Regarding Genetic Data, 64 Participant Understanding of Trade-Offs, 64 Should Population-Based Biobank Research Live by Different Rules?, 64 Further Clarifications for NCHS, 66 REFERENCES 69 ACRONYMS 73 APPENDIXES A Workshop Agenda 75 B List of Registrants 79 C Biographical Sketches of Steering Committee Members and Presenters 87