Issues Raised, Lessons Learned, and Paths Forward for Dual-Use
Research in the Life Sciences: The H5N1 Research Controversy

A Workshop

National Academy of Sciences’ Committee on Science, Technology, and Law
National Academy of Sciences’ Board on Life Sciences
Institute of Medicine’s Forum on Microbial Threats
20 F Street, NW Conference Center
Washington, DC 20001

In December 2011 it was announced that two research groups, one in the US and the other in the Netherlands, both supported by NIH funding, had submitted for publication papers describing research whereby variants of H5N1 influenza viruses produced in the laboratory by well-established techniques had become readily transmitted among ferrets. It also was announced that the U.S. National Science Advisory Board for Biosecurity (NSABB), after consideration of the benefits and risks of publishing these papers, had recommended that details of these studies be redacted from the manuscripts prior to publication, and that the U.S. Government had endorsed this recommendation. These announcements precipitated a vigorous and far-reaching international discussion about the appropriateness and the risk assessment of this work and of dual use research, in general. As a result, the two research groups and other influenza researchers called for a temporary moratorium on research involving H5N1 influenza viruses that might lead to the creation of highly pathogenic, highly transmissible strains.

This workshop was organized to 1) discuss the H5N1 controversy; 2) consider responses by the NIAID, which had funded this research, the WHO, the U.S. National Science Advisory Board for Biosecurity (NSABB), scientific publishers, and members of the international research community; and 3) provide a forum wherein the concerns and interests of the broader community of stakeholders, including policy makers, biosafety and biosecurity experts, non-governmental organizations, international organizations, and the general public may be articulated.

Agenda
Tuesday, May 1, 2012

8:00 Continental Breakfast

8:30 Welcome: Harvey Fineberg, Institute of Medicine

8:35 Opening Remarks: Workshop Planning Committee Co-Chairs

David Relman, Stanford University
David Korn, Harvard University

8:40 Session 1: The Ongoing Revolution in the Life Sciences and Associated Technologies

Moderator: David Baltimore, California Institute of Technology

Speaker: Roger Brent, Fred Hutchinson Cancer Research Center
Background Reading: “In the Valley of the Shadow of Death”

Commentators:
Lawrence D. Kerr, National Counterproliferation Center, Office of the Director
of National Intelligence
Joe Palca, National Public Radio

9:30 Discussion with Participants

10:00 Break

10:15 Session 2: Two Case Studies from Conceptualization to Dissemination of Findings with Consideration of Plausible Points of Intervention and Decision-Making

Moderator: Alice Huang, California Institute of Technology

Speakers: 1918 Spanish Flu Reconstruction: Jeffrey K. Taubenberger, National Institute of Allergy and Infectious Diseases, National Institutes of Health
H5N1 Avian Influenza: Robert G. Webster, St. Jude Children's Research Hospital

11:15 Discussion with Participants

12:00 Lunch

1:15 Session 3: Roundtable Discussion on the Nature of the Social Contract

Moderator: Harold T. Shapiro, Princeton University

Speakers: Ruth L. Berkelman, Emory University
Christopher Chyba, Princeton University
Robert Cook-Deegan, Duke University
Gregory E. Kaebnick, The Hastings Center
Daniel J. Kevles, Yale University
Carl Zimmer, Frequent Contributor, The New York Times

2:15 Discussion with Participants

3:00 Break

3:15 Session 4: Roundtable Discussion on Governance, Oversight, and the Path Forward

Moderator: Lawrence O. Gostin, Georgetown University

Speakers: Ann Arvin, Stanford University
Anthony S. Fauci, National Institute of Allergy and Infectious Diseases,
National Institutes of Health
David Franz, United States Army Medical Research Institute for Infectious
Diseases (retired)
David Heymann, U.K. Health Protection Agency
Piers Millet, United Nations Office for Disarmament Affairs’ Implementation
Support Unit

4:15 Discussion with Participants

5:00 Wrap-Up: Workshop Planning Committee Co-Chairs

David Korn, Harvard University
David Relman, Stanford University

5:15 Adjourn