DUAL USE RESEARCH
OF CONCERN
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.

COMMITTEE ON DUAL USE RESEARCH OF CONCERN: OPTIONS FOR FUTURE MANAGEMENT

Co-Chairs

RICHARD A. MESERVE (NAE), Senior Of Counsel, Covington & Burling LLP

HAROLD E. VARMUS (NAS/NAM), Lewis Thomas University Professor, Weill Cornell Medicine

Members

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

Staff

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

Co-Chairs

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

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 (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

Staff

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)

Preface

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.

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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
Committee Co-Chairs

Acknowledgments

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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Contents

Summary

1 Introduction

2 The Current Policy Environment

3 Managing Dual Use Research of Concern

4 Committee Findings

Appendixes

A Biographical Information of Committee and Staff

B Committee Meeting Agendas

C Acronyms and Abbreviations

Boxes, Figure, and Tables

BOXES

2-1 Size of the Life Sciences Enterprise

2-2 U.S. Government Policies Relevant to the Dissemination of Dual Use Research of Concern

FIGURE

2-1 Comparison of the Scope of Different Policies for the Oversight of Life Sciences Research Involving Pathogens

TABLES

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