Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research PDF
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THE NATIONAL ACADEMIES PRESS This PDF is available at http://nap.edu/23405 SHARE Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values DETAILS 230 pages | 7 x 10 | PAPERBACK ISBN 978-0-309-43787-5 | DOI 10.17226/23405 CONTRIBUTORS GET THIS BOOK Committee on Gene Drive Research in Non-Human Organisms: Recommendations for Responsible Conduct; Board on Life Sciences; Division on Earth and Life Studies; National Academies of Sciences, Engineering, and Medicine FIND RELATED TITLES 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. Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values Gene Drrives on the Horrizon Advanccing Science, NNavigatting Unccertaintty, and AAligningg Research withh Publicc Valuess Commmittee on Geene Drive Reesearch in Non-Human OOrganisms: Recommmendations ffor Responsible Conducct Board onn Life Sciencces Divvision on Eaarth and Lifee Studies Copyright National Academy of Sciences. All rights reserved. G e n e D r i v e s o n t h e H o r i z o n A d v a n c i n g S c i e n c e , N a v i g a t i n g U n c e r t a i n t y , a n d A l i g n i n g R e s e a r c h w i t h P u b l i c V a l u e s THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by Contract No. 040815 with the Foundation for the National Insti- tutes of Health, Contract No. 10002551/10002584 with the US Department of Health and Human Services/National Institutes of Health. The activities received additional support from the Na- tional Academy of Sciences Biology and Biotechnology Fund. Any opinions, findings, conclu- sions, 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: 978-0-309-43787-5 International Standard Book Number-10: 0-309-43787-3 Library of Congress Control Number: 2016946673 Digital Object Identifier: 10.17226/23405 Additional copies of this report 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 2016 by the National Academies of Sciences. All rights reserved. Printed in the United States of America Cover design by Claire Ballweg. Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2016. Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values. Washington, DC: The National Academies Press. doi: 10.17226/23405. C o p y r i g h t N a t i o n a l A c a d e m y o f S c i e n c e s . A l l r i g h t s r e s e r v e d . Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values Thhe National Accademy of Sciiences was estaablished in 1863 by an Act of Congress, ssigned by Preesident Lincolnn, as a private, nnongovernmenntal institution to advise the naation on issues related to sciience and technnology. Membbers are electedd by their peerrs for outstanddiing contributioons to re- seaarch. Dr. Ralphh J. Cicerone is president. Thhe National Accademy of Enggineering was established in 1964 under thee charter of thee National Accademy of Scieences to bring the practices oof engineering to advising thhe nation. Memmbers are eleected by their ppeers for extraoordinary contribbutions to engiineering. Dr. CC. D. Mote, Jr.,, is presi- dennt. Thhe National Accademy of Meddicine (formerlly the Institute of Medicine) wwas establishedd in 1970 undder the charter of the Nationaal Academy off Sciences to addvise the nationn on medical aand health issuues. Members are elected by their peers forr distinguished contributions to medicine annd health. Drr. Victor J. Dzauu is president. Thhe three Academmies work toggether as the NNational Acadeemies of Sciennces, Engineerring, and Meedicine to provvide independeent, objective aanalysis and addvice to the naation and condduct other acttivities to solvee complex probblems and infoorm public policy decisions. TThe Academiess also en- couurage education and researchh, recognize ouutstanding conttributions to knnowledge, andd increase pubblic understandding in matters of science, enggineering, and mmedicine. Leearn more about the Natioonal Academiies of Sciencces, Engineeriing, and Meddicine at wwww.national-academies.org.. Copyright National Academy of Sciences. All rights reserved. Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values Copyright National Academy of Sciences. All rights reserved. Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values COMMITTEE ON GENE DRIVE RESEARCH IN NON-HUMAN ORGANISMS: RECOMMENDATIONS FOR RESPONSIBLE CONDUCT Co-Chairs JAMES P. COLLINS, Arizona State University ELIZABETH HEITMAN, Vanderbilt University Medical Center Members NICOLE L. ACHEE, University of Notre Dame VICKI CHANDLER, NAS,1 Minerva Schools at Keck Graduate Institute JASON A. DELBORNE, North Carolina State University BRANDON S. GAUT, University of California, Irvine STEPHEN HIGGS, Kansas State University GREGORY E. KAEBNICK, The Hastings Center ANN KINGIRI, African Centre for Technology Studies WAYNE LANDIS, Western Washington University LYNN RIDDIFORD, NAS,1 Howard Hughes Medical Institute JOYCE TAIT, University of Edinburgh LISA A. TANEYHILL, University of Maryland JOSEPH TRAVIS, Florida State University PAUL E. TURNER, Yale University DAVID E. WINICKOFF, University of California, Berkeley; Organisation for Economic Co-operation and Development, Paris Project Staff KEEGAN SAWYER, Project Director AUDREY THÉVENON, Associate Program Officer ROBIN MILLER, Christine Mirzayan Science and Technology Policy Graduate Fellow FRANCES SHARPLES, Director, Board on Life Sciences ANGELA KOLESNIKOVA, Administrative Assistant ANNE FRANCES JOHNSON, Editor 1National Academy of Sciences. v Copyright National Academy of Sciences. All rights reserved. Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values BOARD ON LIFE SCIENCES Chair JAMES P. COLLINS, Arizona State University Members ENRIQUETA C. BOND, Burroughs Wellcome Fund ROGER D. CONE, Vanderbilt University NANCY D. CONNELL, Rutgers, New Jersey Medical School JOSEPH R. ECKER, Salk Institute for Biological Studies SARAH C.R. ELGIN, Washington University, St. Louis LINDA G. GRIFFITH, Massachusetts Institute of Technology ELIZABETH HEITMAN, Vanderbilt University Medical Center RICHARD A. JOHNSON, Global Helix LLC JUDITH KIMBLE, University of Wisconsin, Madison MARY E. MAXON, Lawrence Berkeley National Laboratory JILL P. MESIROV, University of California, San Diego KAREN E. NELSON, J. Craig Venter Institute CLAIRE POMEROY, Albert and Mary Lasker Foundation MARY E. POWER, University of California, Berkeley MARGARET RILEY, University of Massachusetts, Amherst LANA SKIRBOLL, Sanofi JANIS WEEKS, University of Oregon Staff FRANCES SHARPLES, Director KATIE BOWMAN, Senior Program Officer JO HUSBANDS, Senior Scholar JAY LABOV, Senior Scholar KEEGAN SAWYER, Program Officer MARILEE SHELTON-DAVENPORT, Senior Program Officer AUDREY THÉVENON, Associate Program Officer BETHELHEM MEKASHA, Financial Associate JENNA OGILVIE, Research Associate ANGELA KOLESNIKOVA, Administrative Assistant AANIKA SENN, Senior Program Assistant vi Copyright National Academy of Sciences. All rights reserved. Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values Preface Historians of science and engineering illuminate how discoveries related to theory, obser- vation, and technology change our understanding of the natural world and the ways in which we interact with the organisms around us. Occasionally, the pace of discovery in a particular re- search area is so rapid it is impossible to miss. If the current pace of change in general genetics is thrilling, the pace of change in gene drive research is breathtaking. Not surprisingly, the depth, breadth, and practical implications of scientific advances in gene drive research are simultane- ously raising many challenges at the interface of science and society. The National Institutes of Health and the Foundation for the National Institutes of Health asked the Board on Life Sciences of the National Academies of Sciences, Engineering, and Med- icine to convene a consensus committee to summarize current understanding of the scientific discoveries related to gene drives and their accompanying ethical, legal, and social implications. This report reflects the committee’s consensus conclusions regarding the state of the sci- ence and expectations for responsible research. The committee’s analyses are based on reviews of the multidisciplinary literature, interviews of experts, and presentations from natural and so- cial scientists working at the leading edges of research on gene drives and related technologies. Appropriate for such a task, the committee’s 16 members have diverse interdisciplinary expertise and a range of backgrounds across the natural and social sciences, ethics, and the law. The com- mittee often had to re-examine fundamental aspects of genetics, population biology, probability, public policy, and the law in order to understand the full scope of gene drive research and its effects. To ensure that the audience has a common understanding of the scientific, social, and regulatory knowledge essential to responsible research with gene drives, the report also outlines some of these fundamentals before moving to the complex picture we ultimately describe. This report would not have been possible without the exceptional contributions of the Academies staff members: Keegan Sawyer, Audrey Thévenon, Robin Miller, Nancy Huddleston, and Frances Sharples. Angela Kolesnikova provided the committee with outstanding logistical support. We acknowledge gratefully all of their efforts. A special thanks goes out to our colleagues on the committee for their thoughtful review and analysis of an enormous amount of information some of which changed on a daily or weekly basis as new discoveries were made. It was an honor to work with all of them. James P. Collins, Co-Chair Elizabeth Heitman, Co-Chair Committee on Gene Drive Research in Non-Human Organisms: Recommendations for Responsible Conduct vii Copyright National Academy of Sciences. All rights reserved. Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values Copyright National Academy of Sciences. All rights reserved. Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values Acknowledgment of Reviewers This report has been reviewed in draft form by individuals chosen for their diverse per- spectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its 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 review comments and draft manuscript remain confiden- tial to protect the integrity of the process. We wish to thank the following individuals for their review of this report: Austin Burt, Imperial College R. Alta Charo, University of Wisconsin-Madison Roger D. Cone, Vanderbilt University Rebecca A. Efroymson, Oak Ridge National Laboratory Fred Gould, North Carolina State University Anthony A. James, University of California, Irvine Calestous Juma, Harvard University James Lavery, St. Michael’s Hospital and University of Toronto Morven A. McLean, International Life Sciences Institute Research Foundation Stephen S. Morse, Columbia University Robert D. Newman, US Centers for Disease Control and Prevention Sarah P. Otto, University of British Columbia Kenneth Oye, Massachusetts Institute of Technology Ronald Sandler, Northeastern University Although the reviewers listed above have provided many constructive comments and sug- gestions, they were not asked to endorse the report’s conclusions or recommendations, nor did they see the final draft of the report before the release. The review of this report was overseen by Stephen Barthold, University of California, Davis, and Barbara Hansen, University of South Florida. They were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the au- thoring committee and the institution. ix Copyright National Academy of Sciences. All rights reserved.
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