Summary of the Second Symposium
March 10–11, 2016
Piers Millett, Jo Husbands, Frances Sharples, and Audrey Thevenon,
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
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.
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PLANNING COMMITTEE ON GAIN-OF-FUNCTION RESEARCH: THE SECOND SYMPOSIUM
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
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
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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
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.
|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|
|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|
|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|
|R-BAT||Risk–Benefit Assessment Team|
|RAC||Recombinant DNA Advisory Committee|
|SARS-CoV||severe acute respiratory syndrome coronavirus|
|UPMC||University of Pittsburgh Medical Center|
|WHO||World Health Organization|