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Suggested Citation:"Front Matter." 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.
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Human
Genome
Editing

SCIENCE, ETHICS, AND GOVERNANCE

Committee on Human Gene Editing:
Scientific, Medical, and Ethical Considerations

A Report of

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." 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.
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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. Food and Drug Administration of the U.S. Department of Health and Human Services, and the Wellcome Trust, with additional support from the National Academies of Sciences, Engineering, and Medicine’s 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: 978-0-309-45288-5
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24623.

Suggested Citation:"Front Matter." 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.
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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 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.

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Learn more about the National Academies of Sciences, Engineering, and Medicine at www.national-academies.org.

Suggested Citation:"Front Matter." 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.
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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.

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Suggested Citation:"Front Matter." 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.
×

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 and 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, The 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, Lincoln Professor of Emerging Technologies, Arizona State University

JENNIFER MERCHANT, 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 Scientific 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 University School of Medicine

JANET ROSSANT, Senior Scientist and Chief of Research Emeritus, Hospital for Sick Children, University of Toronto

Suggested Citation:"Front Matter." 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.
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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 and CEO, Genetic Alliance

JONATHAN WEISSMAN, Professor, Department of Cellular and Molecular Pharmacology, University of California, San Francisco; Investigator, Howard Hughes Medical Institute

KEITH R. YAMAMOTO, Vice Chancellor for Science Policy and Strategy, Vice Dean for Research for the School of Medicine, Professor, 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

Suggested Citation:"Front Matter." 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.
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Dedication

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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 in an interview with Nature, because few researchers were pursuing recombinant DNA research in 1975. Modern genome-editing techniques are easy to use and widely accessible, leading him to conclude that the situation requires an approach that is “really more international than Asilomar ever had to be.”

Dr. Cicerone was as good as his word. In collaboration with science and medicine academies from China and the United Kingdom, an initiative was launched with an international summit. From this came a commitment to future summits and the formation of a study committee, with members hailing from or working in Canada, China, Egypt, France, Germany, Israel, Italy, Spain, the United Kingdom, and the United States. This report is the culmination of the work by that committee and is dedicated to this great leader of the National Academy of Sciences.

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Suggested Citation:"Front Matter." 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.
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Reviewers

This report was reviewed in draft form by individuals chosen for their diverse perspectives 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 confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:

Eli Adashi, Brown University

George Annas, Boston University

Dana Carroll, University of Utah

Michael Dahlstrom, Iowa State University

Hank Greely, Stanford University

J. Benjamin Hurlbut, Arizona State University

Maria Jasin, Memorial Sloan Kettering Cancer Center

James Lawford-Davies, Hempsons Law Firm, United Kingdom

Andrew Maynard, Arizona State University

Krishanu Saha, University of Wisconsin–Madison

Fyodor Urnov, Altius Institute

Keith Wailoo, Princeton University

Suggested Citation:"Front Matter." 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.
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Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Harvey Fineberg (Moore Foundation) and Jonathan Moreno (University of Pennsylvania). 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 authoring committee and the institution.

Suggested Citation:"Front Matter." 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.
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Preface

Genome editing—a suite of methods for creating changes in DNA more accurately and flexibly than previous approaches—was hailed as the 2011 Method of the Year by Nature Methods, and the CRISPR/Cas9 system of genome editing was named the 2015 Breakthrough of the Year by Science. The technology has excited interest across the globe because of the insights it may offer into fundamental biological processes and the advances it may bring to human health. But with these advances come many questions, about the technical aspects of achieving desired results while avoiding unwanted effects, and about a range of uses that may include not only healing the sick, but also preventing disease in this and future generations, or even altering traits unrelated to health needs. Now is the time to consider these questions. Clinical trials using edited human somatic cells are already underway, and more are anticipated. To help direct the use of genome editing toward broadly promoting human well being, it is important to examine the scientific, ethical, and social issues it raises, and assess the capacity of governance systems to ensure the technologies’ responsible development and use. Doing so also entails articulating the larger principles that should underlie such systems.

These were not easy tasks, but we are profoundly grateful to the committee members who joined us in tackling our charge. They willingly and thoughtfully brought their diverse perspectives to bear on our discussions, and we thank them for their commitment to this study and for devoting so much of their time and energy over the past year. It has been a pleasure and a privilege to work with them. The report was also informed by many presentations and discussions with speakers whose contributions provided a

Suggested Citation:"Front Matter." 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.
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wealth of information and insight. We thank them for sharing their research and viewpoints with us. Finally, on behalf of the committee, we would like to thank the staff of the National Academies of Sciences, Engineering, and Medicine for working alongside us throughout the study—their ideas and support were crucial to bringing the project to fruition—and thank the sponsors of the study, who had an expansive vision for its potential.

R. Alta Charo and Richard O. Hynes, Co-Chairs
Committee on Human Gene Editing: Scientific,
Medical, and Ethical Considerations

Suggested Citation:"Front Matter." 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.
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Suggested Citation:"Front Matter." 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.
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Genome editing is a powerful new tool for making precise alterations to an organism’s genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions.

Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.

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