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
THE NATIONAL ACADEMIES PRESS
Washington, DC
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 Institutes 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 National Academy of Sciences Biology and Biotechnology 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: 978-0-309-43787-5
International Standard Book Number-10: 0-309-43787-3
Library of Congress Control Number: 2016946673
Digital Object Identifier: 10.17226/23405
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Copyright 2016 by the National Academies of Sciences. All rights reserved.
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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.
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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.
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
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 organisms 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 research 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 expectations 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, 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
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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, 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 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, 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 authoring committee and the institution.
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Contents
What Are Gene Drives? And, How Could They Be Used?
Selfish Genetic Elements and Their Drive Mechanisms
Population Ecology and Ecosystem Considerations
3 CASE STUDIES TO EXAMINE QUESTIONS ABOUT GENE-DRIVE MODIFIED ORGANISMS
Basic Criteria for the Development of Gene-Drive Modified Organisms
Case Study 1: Using Aedes Aegypti and Aedes Albopictus Mosquitoes to Manage Dengue
Case Study 2: Using Anopheles Gambiae Mosquitoes to Combat Human Malaria
Case Study 3: Using Culex Quinquefasciatus Mosquitoes to Combat Avian Malaria in Hawaii
Case Study 6: Controlling Palmer Amaranth to Increase Agriculture Productivity
Case Study 7: Developing a Vertebrate Model for Gene Drive Research Using Zebrafish
Central Value Considerations in Debates About Genetic Engineering
Potential Human Benefits of Gene Drives
Potential Human Harms of Gene Drives
Values Relevant to Potential Environmental Effects
5 PHASED TESTING AND SCIENTIFIC APPROACHES TO REDUCING POTENTIAL HARMS OF GENE DRIVES
Learning from Field Research and Biocontrol Efforts with Other Types of Modified Organisms
Conclusions and Recommendations
6 ASSESSING RISKS OF GENE-DRIVE MODIFIED ORGANISMS
Assessing Environmental Impacts Versus Assessing Risks
Key Considerations for Ecological Risk Assessments of Gene-Drive Modified Organisms
A Conceptual Cause-Effect Model
Illustrating a Conceptual Cause-Effect Model Using Two Case Studies
Conclusions and Recommendations
7 ENGAGING COMMUNITIES, STAKEHOLDERS, AND PUBLICS
Communities, Stakeholders, and Publics
Frameworks to Guide Engagement
Conclusions and Recommendations
8 GOVERNING GENE DRIVE RESEARCH AND APPLICATIONS
Key Considerations for Governing Gene Drives
Relevant Governance Frameworks for Gene Drive Research and Applications in the United States
Governance of Gene Drives in Global Contexts
Conclusions and Recommendations
9 GENE DRIVES ON THE HORIZON: OVERARCHING CONSIDERATIONS