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POTENTIAL RISKS AND BENEFITS Summary of a Workshop |
Frances Sharples, Jo Husbands, Anne-Marie Mazza,
Audrey Thevenon, and India Hook-Barnard, Rapporteurs
Board on Life Sciences
Division on Earth and Life Studies
Committee on Science, Technology, and Law
Policy and Global Affairs Division
Board on Health Sciences Policy
Institute of Medicine
NATIONAL RESEARCH COUNCIL AND
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
This study was supported by Contract No. 10002374 between the National Academy of Sciences and the National Institutes of Health, by the John D. and Catherine T. MacArthur Foundation, the Alfred P. Sloan Foundation, the Wellcome Trust, and by internal support from the National Academies. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project.
International Standard Book Number-13: 978-0-309-36783-7
International Standard Book Number-10: 0-309-36783-2
Additional copies of this report 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 2015 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.
The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. C. D. Mote, Jr., is president of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Victor J. Dzau is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council.
COMMITTEE ON GAIN-OF-FUNCTION RESEARCH WITH H5N1/H7N9 AVIAN INFLUENZA: A SYMPOSIUM
Members
HARVEY V. FINEBERG (Chair), President, Gordon and Betty Moore Foundation, San Francisco, California
RONALD M. ATLAS, Professor, University of Louisville, Kentucky
RALPH BARIC, Professor, University of North Carolina
RUTH L. BERKELMAN, Rollins Professor and Director, Center for Public Health Preparedness and Research, Emory University, Georgia
DONALD S. BURKE, Dean, Graduate School of Public Health and Director, Center for Vaccine Research, University of Pittsburgh, Pennsylvania*
R. ALTA CHARO, Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin-Madison
PHILIP DORMITZER, Head of U.S. Research and Global Head of Virology, Novartis Vaccines, Cambridge, Massachusetts
BARUCH FISCHHOFF, Howard Heinz University Professor, Carnegie Mellon University, Pittsburgh, Pennsylvania
CHARLES N. HAAS, Betz Professor of Environmental Engineering, Drexel University, Philadelphia, Pennsylvania
STEPHEN C. HARRISON, Investigator, Howard Hughes Medical Institute and Giovanni Armenise-Harvard Professor in Basic Biomedical Sciences, Harvard Medical School, Boston, Massachusetts
SIR JOHN SKEHEL, Emeritus Research Fellow, National Institute for Medical Research, London, United Kingdom
ROBERT G. WEBSTER, Professor and Rose Marie Thomas Chair, St. Jude Children’s Research Hospital, Memphis, Tennessee
Staff
FRANCES E. SHARPLES, Study Director and Director, Board on Life Sciences
JO L. HUSBANDS, Scholar/Senior Project Director, Board on Life Sciences
ANNE-MARIE MAZZA, Director, Committee on Science, Technology, and Law
_______________
*Resigned as of 12/1/2014.
INDIA HOOK-BARNARD, Senior Program Officer, Board on Health Sciences Policy
AUDREY THEVENON, Associate Program Officer, Board on Life Sciences
STEVEN KENDALL, Program Officer, Committee on Science, Technology, and Law
JENNA OGILVIE, Senior Program Assistant, Board on Life Sciences
LAUREN SONI, Senior Program Assistant, Board on Life Sciences
ANGELA KOLESNIKOVA, Administrative Assistant, Board on Life Sciences
KAROLINA KONARZEWSKA, Program Assistant, Committee on Science, Technology, and Law
ANNALYN WELP, Senior Program Assistant, Board on Health Sciences Policy
BOARD ON LIFE SCIENCES
Members
JAMES P. COLLINS (Chair), Arizona State University, Tempe
ENRIQUETA C. BOND, Burroughs Wellcome Fund (retired), Marshall, Virginia
ROGER D. CONE, Vanderbilt University Medical Center, Nashville, Tennessee
JOSEPH R. ECKER, Salk Institute for Biological Studies, La Jolla, California
SEAN EDDY, HHMI Janelia Farm Research Campus, Ashburn, Virginia
SARAH C. R. ELGIN, Washington University, St. Louis, Missouri
DAVID R. FRANZ, Former Cdr USAMRIID; Consultant, Frederick, Maryland
STEPHEN FRIEND, Sage Bionetworks, Seattle, Washington
ELIZABETH HEITMAN, Vanderbilt University Medical Center, Nashville, Tennessee
JOHN G. HILDEBRAND, University of Arizona, Tucson
RICHARD A. JOHNSON, Arnold & Porter, LLC, Washington, DC
JUDITH KIMBLE, University of Wisconsin, Madison
MARY E. MAXON, Science Philanthropy Alliance, Palo Alto, California
KAREN E. NELSON, J. Craig Venter Institute, Rockville, Maryland
ROBERT M. NEREM, Georgia Institute of Technology, Atlanta
MARY E. POWER, University of California, Berkeley
MARGARET RILEY, University of Massachusetts, Amherst
LANA SKIRBOLL, Sanofi, Baltimore, Maryland
JANIS C. WEEKS, University of Oregon, Eugene
MARY WOOLLEY, Research!America, Alexandria, Virginia
Staff
FRANCES E. SHARPLES, Director
JO L. HUSBANDS, Scholar/Senior Project Director
JAY B. LABOV, Senior Scientist/Program Director for Biology Education
KATHERINE W. BOWMAN, Senior Program Officer
MARILEE K. SHELTON-DAVENPORT, Senior Program Officer
KEEGAN SAWYER, Program Officer
AUDREY THEVENON, Associate Program Officer
BETHELHEM MEKASHA, Financial Associate
ANGELA KOLESNIKOVA, Administrative Assistant
JENNA OGILVIE, Senior Project Assistant
LAUREN SONI, Senior Project Assistant
COMMITTEE ON SCIENCE, TECHNOLOGY, AND LAW
Co-Chairs
DAVID BALTIMORE (NAS/IOM), President Emeritus and Robert Andrews Millikan Professor of Biology, California Institute of Technology
DAVID S. TATEL, Judge, U.S. Court of Appeals for the District of Columbia Circuit
Members
THOMAS D. ALBRIGHT (NAS), Professor and Director, Vision Center Laboratory and Conrad T. Prebys Chair in Vision Research, Salk Institute for Biological Studies
ANN ARVIN, Lucile Packard Professor of Pediatrics and Microbiology and Immunology; Vice Provost and Dean of Research, Stanford University
BARBARA E. BIERER, Professor of Medicine, Harvard Medical School
CLAUDE CANIZARES, Vice President and the Bruno Rossi Professor of Physics, Massachusetts Institute of Technology
ARTURO CASADEVALL, Leo and Julia Forchheimer Professor of Microbiology and Immunology; Chair, Department of Biology and Immunology; and Professor of Medicine, Albert Einstein College of Medicine
JOE S. CECIL, Project Director, Program on Scientific and Technical Evidence, Division of Research, Federal Judicial Center
R. ALTA CHARO, Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin at Madison
HARRY T. EDWARDS, Judge, U.S. Court of Appeals for the District of Columbia Circuit
DREW ENDY, Associate Professor, Bioengineering, Stanford University and President, The BioBricks Foundation
MARCUS FELDMAN, Burnet C. and Mildred Wohlford Professor of Biological Sciences, Stanford University
JEREMY FOGEL, Director, The Federal Judicial Center
HENRY T. GREELY, Deane F. and Kate Edelman Johnson Professor of Law and Professor, by courtesy, of Genetics, Stanford University
MICHAEL GREENBERGER, Law School Professor and Director, Center for Health and Homeland Security, University of Maryland
BENJAMIN W. HEINEMAN, JR., Senior Fellow, Harvard Law School and Harvard Kennedy School of Government
MICHAEL IMPERIALE, Arthur F. Thurnau Professor of Microbiology and Immunology, University of Michigan
GREG KISOR, Chief Technologist of Global Licensing, Intellectual Ventures
GOODWIN LIU, Associate Justice, California Supreme Court
JENNIFER MNOOKIN, David G. Price and Dallas P. Price Professor of Law, University of California, Los Angeles School of Law
R. GREGORY MORGAN, Vice President and General Counsel, Massachusetts Institute of Technology
ALAN B. MORRISON, Lerner Family Associate Dean for Public Interest and Public Service Law, George Washington University Law School
CHERRY MURRAY, Dean, School of Engineering and Applied Sciences, Harvard University
ROBERTA NESS, Dean and M. David Low Chair in Public Health, University of Texas School of Public Health
HARRIET RABB, Vice President and General Counsel, The Rockefeller University
DAVID RELMAN, Thomas C. and Joan M. Merigan Professor, Departments of Medicine and of Microbiology and Immunology, Stanford University and Chief, Infectious Disease Section, VA Palo Alto Health Care System
RICHARD REVESZ, Lawrence King Professor of Law; Dean Emeritus; and Director, Institute for Policy Integrity, New York University School of Law
MARTINE A. ROTHBLATT, Chairman and Chief Executive Officer, United Therapeutics
DAVID VLADECK, Professor and Co-Director, Institute for Public Representation, Georgetown Law School
Staff
ANNE-MARIE MAZZA, Director
STEVEN KENDALL, Program Officer
KAROLINA KONARZEWSKA, Program Assistant
BOARD ON HEALTH SCIENCES POLICY
Members
JEFFREY KAHN (Chair), Johns Hopkins University, Baltimore, Maryland
ELI Y. ADASHI, Brown University, Providence, Rhode Island
HUDA AKIL, University of Michigan, Ann Arbor, Michigan
WYLIE BURKE, University of Washington, Seattle
ROBERT M. CALIFF, Duke University Medical Center, Durham, North Carolina
R. ALTA CHARO, University of Wisconsin-Madison
KATHLEEN A. DRACUP, University of California, San Francisco
MICHAEL EHLERS, Pfizer Inc., Cambridge, Massachusetts
NAOMI L. GERBER, George Mason University, Fairfax, Virginia
LEWIS R. GOLDFRANK, New York University School of Medicine, New York City
STEVEN E. HYMAN, The Broad Institute, Cambridge, Massachusetts
PATRICIA A. KING, Georgetown University Law Center, Washington, DC
HARRY T. ORR, University of Minnesota, Minneapolis
SHARON TERRY, Genetic Alliance, Washington, DC
REED V. TUCKSON, Tuckson Health Connections, LLC, Edina, Minnesota
CLYDE YANCY, Northwestern University, Chicago, Illinois
Anniversary Fellow
SCOTT HALPERN, University of Pennsylvania, Philadelphia
Staff
ANDREW M. POPE, Senior Board Director
INDIA HOOK-BARNARD, Senior Program Officer
ANNALYN WELP, Senior Program Assistant
Acknowledgments
This workshop summary has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published 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 deliberative process.
We wish to thank the following individuals for their review of this workshop summary:
Arturo Casadevall, Johns Hopkins University
Harvey Fineberg, Gordon and Betty Moore Foundation
Matthew Frieman, University of Maryland
M. Granger Morgan, Carnegie Mellon University
Johannes Rath, University of Vienna
Erin Sorrell, George Washington University
Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this summary was overseen by Stephen Fienberg, Carnegie Mellon University. Appointed by
the National Research Council, he was 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 authors and the institution.
