DUAL USE RESEARCH
IN THE LIFE SCIENCES
Current Issues and Controversies
Committee on Dual Use Research of Concern:
Options for Future Management
Committee on Science, Technology, and Law
Policy and Global Affairs
A Consensus Study Report of
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This activity was supported with grants to the National Academy of Sciences from the Burroughs Wellcome Fund, the Gordon and Betty Moore Foundation, and the Alfred P. Sloan Foundation (#G-2014-13656) and by a contract between the National Academy of Sciences and the Federal Bureau of Investigation of the U.S. Department of Justice (#DJF-15-2300-P-0006686). 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: 978-0-309-45888-7
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Digital Object Identifier: https://doi.org/10.17226/24761
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24761.
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COMMITTEE ON DUAL USE RESEARCH OF CONCERN: OPTIONS FOR FUTURE MANAGEMENT
RICHARD A. MESERVE (NAE), Senior Of Counsel, Covington & Burling LLP
HAROLD E. VARMUS (NAS/NAM), Lewis Thomas University Professor, Weill Cornell Medicine
ARTURO CASADEVALL (NAM), Professor and Chair, W. Harry Feinstone Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health
DENISE CHRYSLER, Director, The Network for Public Health Law–Mid-States Region, University of Michigan School of Public Health
ANUJ C. DESAI, William Voss-Bascom Professor of Law, University of Wisconsin
MICHAEL ETTENBERG (NAE), Managing Partner, Dolce Technologies
DAVID FIDLER, James Louis Calamaras Professor of Law, Indiana University Maurer School of Law
CLAIRE FRASER (NAM), Director of the Institute for Genome Sciences and Professor of Medicine, University of Maryland School of Medicine
MICHAEL HOPMEIER, President, Unconventional Concepts, Inc.
JAMES LE DUC, Professor, Department of Microbiology and Immunology and Director, Galveston National Laboratory, University of Texas Medical Branch, Galveston
W. IAN LIPKIN, John Snow Professor of Epidemiology, Professor of Neurology and Pathology, and Director of the Center for Infection and Immunity, Columbia University Mailman School of Public Health
STEPHEN S. MORSE, Professor of Epidemiology and Director, Infectious Disease Epidemiology Certificate Program, Columbia University Mailman School of Public Health
ANNE-MARIE MAZZA, Study Director and Senior Director, Committee on Science, Technology, and Law
JO L. HUSBANDS, Scholar/Senior Project Director, Board on Life Sciences
STEVEN KENDALL, Program Officer, Committee on Science, Technology, and Law
KAROLINA KONARZEWSKA, Program Coordinator, Committee on Science, Technology, and Law
KARIN MATCHETT, Consultant Writer
D. ALLEN AMMERMAN, Financial Officer, Committee on Science, Technology, and Law (until June 2017)
EILEEN N. ONI, Christine Mirzayan Science and Technology Fellow
COMMITTEE ON SCIENCE, TECHNOLOGY, AND LAW
DAVID BALTIMORE (NAS/NAM), 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
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 (NAM), Vice Provost and Dean of Research, Lucile Salter Packard Professor of Pediatrics, and Professor of Microbiology and Immunology, Stanford University
CLAUDE R. CANIZARES (NAS), Bruno Rossi Professor of Physics, Massachusetts Institute of Technology
JOE S. CECIL, Project Director, Program on Scientific and Technical Evidence, Division of Research, Federal Judicial Center
R. ALTA CHARO (NAM), 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
CHARLES ELACHI (NAE), Professor of Electrical Engineering and Planetary Science, Emeritus, California Institute of Technology
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 IMPERIALE, Arthur F. Thurnau Professor of Microbiology and Immunology, University of Michigan
ROBERT S. LANGER (NAS/NAE/NAM), David H. Koch Institute Professor, Massachusetts Institute of Technology
GOODWIN LIU, Associate Justice, California Supreme Court
JUDITH MILLER, Independent Consultant
JENNIFER MNOOKIN, Dean and David G. Price and Dallas P. Price Professor of Law, University of California, Los Angeles School of Law
DAVID A. RELMAN (NAM), 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
MARTINE A. ROTHBLATT, Chairman and Chief Executive Officer, United Therapeutics
JOSHUA R. SANES (NAS), Professor of Molecular and Cellular Biology and Paul J. Finnegan Family Director, Center for Brain Science, Harvard University
WILLIAM B. SCHULTZ, Partner, Zuckerman Spaeder LLP
SUSAN S. SILBEY, Leon and Anne Goldberg Professor of Humanities, Professor of Sociology and Anthropology, and Professor of Behavioral and Policy Sciences, Massachusetts Institute of Technology
DAVID VLADECK, Professor and Co-Director, Institute for Public Representation, Georgetown Law School
SUSAN WESSLER (NAS), University of California President’s Chair and Distinguished Professor of Genetics, University of California, Riverside
MICHELLE A. WILLIAMS (NAM), Dean of the Faculty, Harvard T.H. Chan School of Public Health
ANNE-MARIE MAZZA, Senior Director
STEVEN KENDALL, Program Officer
KAROLINA KONARZEWSKA, Program Coordinator
D. ALLEN AMMERMAN, Financial Officer, Committee on Science, Technology, and Law (until June 2017)
In the 16 years since the 2001 anthrax letters mailings, the federal government, scientists, research institutions, and the international community have wrestled with the potential uses of peaceful biological research to do harm. Since 2001, there have been no public reports of serious biosecurity incidents in the United States. Nonetheless, concerns persist that a serious biosecurity event could occur, and there is a consistent desire to limit this possibility.1 While numerous discussions2 have taken place to consider approaches, policies, and mechanisms that would support an environment that optimizes the benefits of life sciences research while minimizing the possibility of the use of such research to do harm, consensus has not been reached domestically or internationally. Therefore, the following report examines the nation’s policies on managing the dissemination of biological research of concern from conception to formal publication and offers findings that the committee hopes will inform future discussions and policies to manage such research.
1 See, e.g., the reports and scorecards of the Blue Ribbon Study Panel on Biodefense. The study panel’s website is http://www.biodefensestudy.org/index.htm.
2 See, e.g., National Research Council, Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities (Washington, DC: The National Academies Press, 2007), doi:https://doi.org/10.17226/12013; The Johns Hopkins Center for Health Security Conference, Preserving National Security: The Growing Role of the Life Sciences, March 3, 2011; Institute of Medicine and National Research Council, Perspectives on Research with H5N1 Avian Influenza: Scientific Inquiry, Communication, Controversy: Summary of a Workshop (Washington, DC: The National Academies Press, 2013), doi:https://doi.org/10.17226/18255; University of Maryland Center for Health and Homeland Security (CHHS) / Middle Atlantic Regional Center of Excellence for Biodefense and Emerging Infectious Diseases (MARCE) Conference, Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern, February 10, 2014; Institute of Medicine and National Research Council, Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop (Washington, DC: The National Academies Press, 2015), doi:https://doi.org/10.17226/21666; National Academies of Sciences, Engineering, and Medicine, Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016 (Washington, DC: The National Academies Press, 2016), doi:https://doi.org/10.17226/23484.
We are indebted to the members of the committee who shared their experiences and knowledge with us, the experts who spoke to the committee, and the authors of papers commissioned to inform our deliberations. We also thank the staff at the National Academies of Sciences, Engineering, and Medicine—Anne-Marie Mazza, Jo Husbands, Steven Kendall, and Karolina Konarzewska—for their support in this project, and we express our thanks to consultant writer Karin Matchett.
Harold E. Varmus and Richard A. Meserve
ACKNOWLEDGMENT OF PRESENTERS
The committee gratefully acknowledges the thoughtful contributions of the following individuals who made presentations before the committee at its July 2016 meeting:
Philip Campbell, Nature; Gerald L. Epstein, White House Office of Science and Technology Policy; Elisa D. Harris, University of Maryland; Teresa Hauguel, National Institute of Allergy and Infectious Diseases; Michael Imperiale, University of Michigan; Alan B. Morrison, The George Washington University; David A. Relman, Stanford University and VA Palo Alto Healthcare System; Randy Schekman, eLife; Ara Tahmassian, Harvard University; Inder Verma, Proceedings of the National Academy of Sciences of the United States of America; Carrie Wolinetz, National Institutes of Health; and David L. Wynes, Emory University.
The committee also would like to thank the authors of the commissioned papers who presented their work at the committee’s January 2017 workshop. Their papers are available at https://www.nap.edu/catalog/24761 under the Resources tab. Those authors and the titles of their papers are:
Sam Weiss Evans, Harvard University—The Construction of New Security Concerns in the Life Sciences.
Michael Imperiale, University of Michigan and David A. Relman, Stanford University and VA Palo Alto Healthcare System—Options for Management of Potentially Dangerous Information Generated by Life Science Research.
Joseph Kanabrocki, The University of Chicago—Biosafety, Biosecurity and Dual-Use Research of Concern.
Duane Lindner and Winalee Carter,1 Sandia National Laboratories—Control of Sensitive Information: Policy, Procedure, and Practice in a National Security Context.
Piers D. Millett, Biosecure Ltd.—Gaps in the International Governance of Dual-Use Research of Concern.
Tim Stearns, Stanford University—Moving Beyond Dual Use Research of Concern Regulation to an Integrated Responsible Research Environment.
Kimberly Strosnider, Doron Hindin, and Peter D. Trooboff,2 Covington & Burling LLP—The Role of Export Controls in Regulating Dual Use Research of Concern: Striking a Balance Between Freedom of Fundamental Research and National Security.
Finally, the committee would like to thank the moderators of January 2017 workshop sessions:
Nancy Connell, Rutgers, The State University of New Jersey; Gigi Kwik Gronvall, The Johns Hopkins Bloomberg School of Public Health; and Margaret E. Kosal, Georgia Institute of Technology.
The commissioned papers and the presentations from both committee meetings are cited throughout this report.
ACKNOWLEDGMENT OF REVIEWERS
This Consensus Study Report was 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 National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, 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 thank the following individuals for their review of this report: Philip Campbell, Nature; Susan Coller-Monarez, U.S. Department of Homeland Security; Diane Griffin, The Johns Hopkins Bloomberg School of Public Health; Gigi Kwik Gronvall, The Johns Hopkins Bloomberg School of Public Health; Gregory Koblentz, George Mason University; David Korn,
1 Ms. Carter did not attend the January workshop. Dr. Lindner presented and discussed the paper with the committee at that event.
2 Mr. Trooboff did not attend the January workshop. Ms. Strosnider and Mr. Hindin presented and discussed the paper with the committee at that event.
Harvard University; Marc Lipsitch, Harvard University; Peter Palese, Icahn School of Medicine at Mount Sinai; and Ara Tahmassian, Harvard University.
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by Ann Arvin, Stanford University and Martin Philbert, University of Michigan. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.
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Boxes, Figure, and Tables
2-1 Size of the Life Sciences Enterprise
2-2 U.S. Government Policies Relevant to the Dissemination of Dual Use Research of Concern
2-1 Comparison of the Scope of Different Policies for the Oversight of Life Sciences Research Involving Pathogens
1-1 Manuscripts Reviewed by the National Science Advisory Board for Biosecurity (NSABB)
2-1 The Initial and Current Charge of the National Science Advisory Board for Biosecurity (NSABB)
3-1 Principles for the Dissemination of Life Sciences Research of Concern