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THE NATIONAL ACADEMIES PRESS This PDF is available at http://www.nap.edu/24623 SHARE Human Genome Editing: Science, Ethics, and Governance DETAILS 300 pages | 6 x 9 | PAPERBACK ISBN 978-0-309-45288-5 | DOI: 10.17226/24623 CONTRIBUTORS GET THIS BOOK Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations; National Academy of Sciences; National Academy of Medicine; National Academies of Sciences, Engineering, and FIND RELATED TITLES Medicine Visit the National Academies Press at NAP.edu and login or register to get: – Access to free PDF downloads of thousands of scientific reports – 10% off the price of print titles – Email or social media notifications of new titles related to your interests – Special offers and discounts Distribution, posting, or copying of this PDF is strictly prohibited without written permission of the National Academies Press. (Request Permission) Unless otherwise indicated, all materials in this PDF are copyrighted by the National Academy of Sciences. Copyright © National Academy of Sciences. All rights reserved. Human Genome Editing: Science, Ethics, and Governance Prepublication Copy Subject to Further Editorial Revisions HUMAN GENOME EDITING Science, Ethics, and Governance Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations A Report of PREPUBLICATION COPY—SUBJECT TO FURTHER EDITORIAL REVISION Copyright © National Academy of Sciences. All rights reserved. Human Genome Editing: Science, Ethics, and Governance THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by Contract No. HHSP233201400020B/HHSP23337045 with the Defense Advanced Research Projects Agency, the Greenwall Foundation, Grant No. 15-108819- 000-DIS with the John D. and Catherine T. MacArthur Foundation, Contract No. HHSP233201400020B/HHSP23337035 with the U.S. Department of Health and Human Services, U.S. Food and Drug Administration, and The Wellcome Trust, with additional support from the National Academies’ Presidents’ Circle Fund and the National Academy of Sciences W.K. Kellogg Foundation Fund. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: 10.17226/24623 Library of Congress Control Number: Additional copies of this publication are available for sale 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 2017 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623. PREPUBLICATION COPY—SUBJECT TO FURTHER EDITORIAL REVISION Copyright © National Academy of Sciences. All rights reserved. Human Genome Editing: Science, Ethics, and Governance The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia K. McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.national-academies.org. PREPUBLICATION COPY—SUBJECT TO FURTHER EDITORIAL REVISION Copyright © National Academy of Sciences. All rights reserved. Human Genome Editing: Science, Ethics, and Governance Reports document the evidence-based consensus of an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and committee deliberations. Reports are peer reviewed and are approved by the National Academies of Sciences, Engineering, and Medicine. Proceedings chronicle the presentations and discussions at a workshop, symposium, or other convening event. The statements and opinions contained in proceedings are those of the participants and have not been endorsed by other participants, the planning committee, or the National Academies of Sciences, Engineering, and Medicine. For information about other products and activities of the National Academies, please visit nationalacademies.org/whatwedo. PREPUBLICATION COPY—SUBJECT TO FURTHER EDITORIAL REVISION Copyright © National Academy of Sciences. All rights reserved. Human Genome Editing: Science, Ethics, and Governance COMMITTEE ON HUMAN GENE EDITING: SCIENTIFIC, MEDICAL, AND ETHICAL CONSIDERATIONS R. ALTA CHARO (Co-Chair), Sheldon B. Lubar Distinguished Chair and Warren P. Knowles Professor of Law & Bioethics, University of Wisconsin–Madison RICHARD O. HYNES (Co-Chair), Investigator, Howard Hughes Medical Institute, Daniel K. Ludwig Professor for Cancer Research, Massachusetts Institute of Technology DAVID W. BEIER, Managing Director, Bay City Capital ELLEN WRIGHT CLAYTON, Craig Weaver Professor of Pediatrics, Professor of Law, Vanderbilt University BARRY S. COLLER, David Rockefeller Professor of Medicine, Physician in Chief, and Head, Allen and Frances Adler Laboratory of Blood and Vascular Biology, Rockefeller University JOHN H. EVANS, Professor, University of California, San Diego JUAN CARLOS IZPISUA BELMONTE, Professor, Gene Expression Laboratory, Salk Institute for Biological Studies RUDOLF JAENISCH, Professor of Biology, Massachusetts Institute of Technology JEFFREY KAHN, Andreas C. Dracopoulos Director, Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University EPHRAT LEVY-LAHAD, Director, Fuld Family Department of Medical Genetics, Shaare Zedek Medical Center; Faculty of Medicine, Hebrew University of Jerusalem ROBIN LOVELL-BADGE, Senior Group Leader, Laboratory of Stem Cell Biology and Developmental Genetics, The Francis Crick Institute GARY MARCHANT, Regents’ Professor of Law, Arizona State University JENNIFER MERCHANT, University Professor, Université de Paris II (Panthéon-Assas) LUIGI NALDINI, Professor of Cell and Tissue Biology and of Gene and Cell Therapy, San Raffaele University, and Director of the San Raffaele Telethon Institute for Gene Therapy DUANQING PEI, Professor and Director General of Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences MATTHEW PORTEUS, Associate Professor of Pediatrics, Stanford School of Medicine JANET ROSSANT, Senior Scientist and Chief of Research Emeritus, Hospital for Sick Children, University of Toronto DIETRAM A. SCHEUFELE, John E. Ross Professor in Science Communication and Vilas Distinguished Achievement Professor, University of Wisconsin–Madison ISMAIL SERAGELDIN, Founding Director, Bibliotheca Alexandrina SHARON TERRY, President & CEO, Genetic Alliance JONATHAN WEISSMAN, Professor, Department of Cellular and Molecular Pharmacology, University of California, San Francisco KEITH R. YAMAMOTO, Vice Chancellor for Science Policy and Strategy, University of California, San Francisco Study Staff KATHERINE W. BOWMAN, Study Director MONICA L. GONZALEZ, Associate Program Officer JOANNA R. ROBERTS, Senior Program Assistant ANDREW M. POPE, Director, Board on Health Sciences Policy FRANCES E. SHARPLES, Director, Board on Life Sciences Consultants RONA BRIERE, Editor HELAINE RESNICK, Editor PREPUBLICATION COPY—SUBJECT TO FURTHER EDITORIAL REVISION Copyright © National Academy of Sciences. All rights reserved. Human Genome Editing: Science, Ethics, and Governance DEDICATION Dr. Ralph Cicerone (1943-2016) was President of the National Academy of Sciences in 2015 when, in partnership with the President of the National Academy of Medicine, he announced a human genome editing initiative that would encompass science, ethics and regulation. He noted that the National Academies of Sciences, Engineering, and Medicine have led the effort to develop responsible, comprehensive policies for many emerging and controversial areas of genetics and cell biology, such as human embryonic stem cell research, human cloning, and “gain-of-function” research. Most notable was its involvement in key events leading up to the 1975 Asilomar conference. But there are important differences between the Asilomar era and today, Dr. Cicerone said
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