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

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.

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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

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.

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