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.

In response to a request from Dr. Paul Joskow, the President of the Alfred P. Sloan Foundation, for a discussion and debate involving more than influenza researchers and members of the scientific community, an ad hoc committee will organize a one-day public workshop for the purposes of 1) discussing the H5N1 controversy; 2) considering 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) providing 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.

Since the December 2011 announcements, numerous high-profile events have been held and others planned for the purpose of discussing the H5N1 controversy. These include events organized by the New York Academy of Sciences, the World Health Organization, the UK Royal Society, and the American Society of Microbiology. In light of these proceedings, and recognizing that the H5N1 research is only the most recent scientific activity subject to widespread attention due to safety and security concerns, the National Academies workshop will broaden the dialogue by considering lessons applicable to other areas of research. The workshop may examine possible points of intervention from research conceptualization through publication. Additionally, the workshop will discuss the current regulation and oversight of research whose results may raise bio-security concerns in the US and abroad and will consider alternative mechanisms for the oversight and governance of such research.

Specifically, the workshop may:

1. Review the current H5N1 research controversy;

2. Consider whether more general lessons, applicable to other areas of research, can be learned from the H5N1 research of interest;

3. Discuss existing U.S. regulations, oversight, guidance, and governance of such research;

4. Discuss existing international regulations, guidelines, and governance of such research, including the role of the WHO and other international bodies, as well as other approaches for mitigating the risks posed by dual use research of concern;

5. Discuss the social contract between scientists and society, and ethical principles in the conduct of science, including the responsibilities of scientists;

6. Identify possible points of intervention (and actors and their roles) along the research continuum starting with the conceptualization of the research and covering funding of the research, conduct of the research, review of the research proposal and the manuscript, dissemination of research findings, methods, and materials, and publication;

7. Discuss gaps and needs related to research governance, including alternative mechanisms for assessing the benefits and risks of research, its design, and communication. These may include such elements as self-governance by the scientific community, voluntary adoption of guiding principles, codes of conduct and institutional, national, and international guidelines, and various regulatory regimes; and

8. Discuss options for moving forward.

In the discussion of these topics the workshop will seek to distill key themes that should be explored in greater depth with various constituencies through further discussion and other activities. The aims are to allow science to fulfill its promise of great societal benefit while simultaneously ensuring appropriate attention to matters of safety and security and fostering greater public understanding and trust in the scientific enterprise.

The ad hoc committee will develop the agenda for the workshop, select and invite speakers and discussants, and moderate the discussions. A rapporteur will write a summary of the workshop. While options for future work relevant to various actors may be articulated and examined in the course of the workshop, no recommendations will be made. The summary will be subject to appropriate institutional review procedures prior to release.