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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

GAIN-OF-FUNCTION RESEARCH

Summary of the Second Symposium
March 10–11, 2016

Piers Millett, Jo Husbands, Frances Sharples, and Audrey Thevenon,
Rapporteurs

Board on Life Sciences
Division on Earth and Life Studies

Board on Health Sciences Policy
Health and Medicine Division

Committee on Science, Technology, and Law
Policy and Global Affairs Division

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by Contract No. HHSN263201200074 between the National Academy of Sciences and the National Institutes of Health, by the John D. and Catherine T. MacArthur Foundation, and by the Wellcome Trust. 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: 978-0-309-44077-6
International Standard Book Number-10: 0-309-44077-7
Digital Object Identifier: 10.17226/23484

Additional copies of this workshop summary 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 Academy of Sciences. All rights reserved.

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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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. 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 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.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

PLANNING COMMITTEE ON GAIN-OF-FUNCTION RESEARCH: THE SECOND SYMPOSIUM

Members

HARVEY V. FINEBERG (Chair), President, Gordon and Betty Moore Foundation, San Francisco, California

RONALD M. ATLAS, Professor, University of Louisville, Kentucky

RUTH L. BERKELMAN, Rollins Professor and Director, Center for Public Health Preparedness and Research, Emory University, Atlanta, Georgia

BARRY R. BLOOM, Harvard University Distinguished Service Professor and Joan L. and Julius H. Jacobson Professor of Public Health, Harvard University, Cambridge, Massachusetts

DONALD S. BURKE, Dean, Graduate School of Public Health, and Director, Center for Vaccine Research, University of Pittsburgh, Pennsylvania

PHILIP DORMITZER, Vice President and Chief Scientific Officer: Viral Vaccines, Pfizer Vaccine Research and Development, Pearl River, New York

BARUCH FISCHHOFF, Howard Heinz University Professor, Carnegie Mellon University, Pittsburgh, Pennsylvania

CHARLES N. HAAS, Betz Professor of Environmental Engineering, Drexel University, Philadelphia, Pennsylvania

MICHELLE M. MELLO, Professor of Law, Stanford Law School, and Professor of Health Research and Policy, Stanford University School of Medicine, Stanford, California

SIR JOHN SKEHEL, Emeritus Research Fellow, National Institute for Medical Research, London, United Kingdom

Staff

FRANCES E. SHARPLES, Director, Board on Life Sciences

JO L. HUSBANDS, Scholar/Senior Project Director, Board on Life Sciences

AUDREY THEVENON, Associate Program Officer, Board on Life Sciences

AANIKA SENN, Senior Project Assistant, Board on Life Sciences

JENNA OGILVIE, Research Associate, Board on Life Sciences

BRENDAN McGOVERN, Senior Project Assistant, Water Science and Technology Board

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

Acknowledgments

This workshop summary 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 workshop summary as sound as possible and to ensure that the summary 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 summary:

Thomas W. Armstrong, TWA8HR Occupational Hygiene Consulting, LLC

Harvey Fineberg, Gordon and Betty Moore Foundation

Matthew Frieman, University of Maryland

Diane E. Griffin, Johns Hopkins Bloomberg School of Public Health

Charles Haas, Drexel University

Gregory Koblentz, George Mason University

Peter Palese, Icahn School of Medicine at Mount Sinai

David Relman, Stanford University

Robert Webster, St. Jude Children’s Research Hospital

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before public release. The review of this summary

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

was overseen by Ellen Wright Clayton, Vanderbilt University, and Michael J. Imperiale, University of Michigan. They were responsible for making certain that an independent examination of this summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this summary rests entirely with the rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

Acronyms and Abbreviations

APLU Association of Public and Land-grant Universities
ASPR Office of the Assistant Secretary for Preparedness and Response
BMBL Biosafety in Microbiological and Biomedical Laboratories (CDC and NIH manual)
BWC Biological Weapons Convention
DURC dual use research of concern
EASAC European Academies Science Advisory Council
EHS environmental, health, and safety
EU European Union
FACA Federal Advisory Committee Act
FDA Food and Drug Administration
GAO Government Accountability Office
GEC German Ethics Council
GOF gain of function/gain-of-function
GOFRC GOF research of concern
HHS Department of Health and Human Services
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
IBC Institutional Biosafety Committee
IDA Institute for Defense Analyses
IRB Institutional Review Board
IRE Institutional Review Entity
MENA Middle East and North Africa
MERS-CoV Middle East respiratory syndrome coronavirus
NAS National Academy of Sciences
NBACC National Biodefense Analysis and Countermeasures Center
NIAID National Institute of Allergy and Infectious Diseases
NIH National Institutes of Health
NRC National Research Council
NSABB National Science Advisory Board for Biosecurity
NSABB WG National Science Advisory Board for Biosecurity Working Group
OCS Office of the Chief Scientist, Food and Drug Administration
OSP Office of Science Policy, National Institutes of Health
OSTP Office of Science and Technology Policy
PAPR powered air purifying respirator
PI principal investigator
R-BAT Risk–Benefit Assessment Team
RAC Recombinant DNA Advisory Committee
RBA risk–benefit assessment
SARS-CoV severe acute respiratory syndrome coronavirus
UPMC University of Pittsburgh Medical Center
WHO World Health Organization
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page R10
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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On March 10-11, 2016, the National Academies of Sciences, Engineering, and Medicine held a public symposium on potential U.S. government policies for the oversight of gain-of- function (GOF) research. This was the Academies’ second meeting held at the request of the U.S. government to provide a mechanism to engage the life sciences community and the broader public and solicit feedback on optimal approaches to ensure effective federal oversight of GOF research as part of a broader U.S. government deliberative process.

The first symposium, held in December 2014, examined the underlying scientific and technical questions surrounding the potential risks and benefits of GOF research involving pathogens with pandemic potential. The second symposium focused on discussion of the draft recommendations regarding GOF research of a Working Group of the National Science Advisory Board for Biosecurity. This report summarizes the key issues and ideas identified during the second symposium.

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