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

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

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.

Printed in the United States of America

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.

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.

This page intentionally left blank.

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

This page intentionally left blank.

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:

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

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.

Contents

ACRONYMS AND ABBREVIATIONS

1 INTRODUCTION

Opening Remarks

2 THE DRAFT NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY POLICY FRAMEWORK, THE RISK AND BENEFIT ASSESSMENT, AND INSIGHTS FOR THE POLICY PROCESS

Overview of the National Science Advisory Board for Biosecurity Draft Working Paper

Discussion

Lessons from the Risk and Benefit Assessment

Discussion

The Science of Safety and the Science of Public Consultation

Discussion

3 ISSUES FOR U.S. POLICY

The Policy Landscape in the United States

Discussion

Best Practices to Inform Policy Design and Implementation

Discussion

4 INTERNATIONAL POLICY

International Dimensions of Gain-of-Function Research

Discussion

Opportunities to Harmonize GOF Research Policy and Practice

Discussion

5 SUMMING UP

BIBLIOGRAPHY

APPENDIXES

A Board and Committee Members of Collaborating Units

B Committee Biographies

C Symposium Agenda

D Speaker and Panelist Biographies

E List of Attendees

Acronyms and Abbreviations