Gene Drives on the Horizon

215 Pages·2016·7.97 MB·English

THE NATIONAL ACADEMIES PRESS
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Gene Drives on the Horizon: Advancing Science, Navigating
Uncertainty, and Aligning Research with Public Values
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214 pages | 7 x 10 | PAPERBACK
ISBN 978-0-309-43787-5 | DOI: 10.17226/23405
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BUY 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,
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Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values
PREPUBLICATION COPY

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

Board on Life Sciences

Division on Earth and Life Studies

Copyright © National Academy of Sciences. All rights reserved.
Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by Contract No. 10002551/10002584 with the U.S. Department of Health and
Human Services/NIH, Contract No. 040815 with the Foundation for the National Institutes of Health, Inc.
(FNIH). The Defense Advanced Research Projects Agency and the Bill & Melinda Gates Foundation provided
funding to NIH and FNIH, respectively, in support of this study. Any opinions, findings, conclusions, or rec-
ommendations expressed in this publication do not necessarily reflect the views of any organization or agency
that provided support for the project. The activities received additional support from the National Academy of
Sciences Biology Fund.

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; [phone] or [phone]; 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.

Copyright © National Academy of Sciences. All rights reserved.
Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values

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 tech-
nology. Members are elected by their peers for outstanding contributions to research. Dr. Ralph J. Cicerone
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 Academies also encourage education and re-
search, 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.

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
1
VICKI CHANDLER, NAS, Minerva Schools at Keck Graduate Institute
JASON A. DELBORNE, North Carolina State University
BRANDON S. GAUT, Professor, 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
1
LYNN RIDDIFORD, NAS, 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, Organization for Economic
Cooperation and Development, Paris

Project Staff

KEEGAN SAWYER, Project Director
AUDREY THÉVENON, Associate Program Officer
ROBIN MILLER, Christine Mirzayan Science and Technology Policy Graduate Fellow
(until April 2016)
FRANCES SHARPLES, Director, Board on Life Sciences
ANGELA KOLESNIKOVA, Administrative Assistant
ANNE FRANCES JOHNSON, Editor

1
National Academy of Sciences.
Prepublication Copy 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 Prepublication Copy
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, observation, and
technology change our understanding of the natural world and the ways in which we interact with the organ-
isms around us. Occasionally, the pace of discovery in a particular research 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 re-
search is breathtaking. Not surprisingly, the depth, breadth, and practical implications of scientific advances
in gene drive research are simultaneously 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 Medicine 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 science and ex-
pectations for responsible research. The committee’s analyses are based on reviews of the multidisciplinary
literature, interviews of experts, and presentations from natural and social 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 committee often had to re-examine fundamental aspects of genetics, popu-
lation biology, probability, public policy, and the law in order to understand the full scope of gene drive re-
search 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. An-
gela 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 discover-
ies 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

Prepublication Copy 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 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 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, U.S. Centers for Disease Control and Prevention
Sarah P. Otto, University of British Columbia
Kenneth Oye, Massachusettes Institute of Technology
Ronald Sandler, Northeastern University

Although the reviewers listed above have provided many constructive comments and suggestions,
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, Uni-
versity 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 institu-
tional 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.

Prepublication Copy ix
Copyright © National Academy of Sciences. All rights reserved.