Policy Update: Manuscripts on Transmissibility of A/H5N1 Influenza Virus

NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY

March 29‐30, 2012 Meeting of the National Science Advisory Board for Biosecurity to Review Revised Manuscripts on Transmissibility of A/H5N1 Influenza Virus

STATEMENT OF THE NSABB [full text]

The United States Department of Health and Human Services convened the National Science Advisory Board for Biosecurity (NSABB) on March 29‐30, 2012, to examine two revised manuscripts regarding the transmissibility of A/H5N1 influenza virus (avian flu) in ferrets. Earlier versions of these manuscripts had been submitted for publication in Science and Nature and were reviewed by the Board.

The NSABB is an independent federal advisory committee chartered to provide advice and guidance on the biosecurity oversight of dual use research to the Secretary of the Department of Health and Human Services, the Director of the National Institutes of Health, and all federal entities that conduct, support or have an interest in life sciences research. Dual use research is defined as biological research with legitimate scientific purpose that may be misused to pose a threat to public health and/or national security.

The Board was asked to consider the revised manuscripts from Dr. Ron Fouchier of Erasmus Medical Center and Dr. Yoshihiro Kawaoka of the University of Wisconsin and to recommend whether the information they contain should be communicated and, if so, to what extent. In their evaluation, the Board used analytical tools that it previously developed for considering the risks and benefits associated with the communication of dual use research of concern (available at http://www.biosecurityboard.gov). After careful deliberation, the NSABB unanimously recommended that this revised Kawaoka manuscript should be communicated in full. The NSABB also recommended, in a 12 to 6 decision, the communication of the data, methods, and conclusions presented in this revised Fouchier manuscript.

As a general principle, the NSABB strongly supports the unrestricted communication of research information unless that information could be directly misused to pose a significant and immediate risk to public health and safety. While the communication of the information in these revised manuscripts still presents dual use concerns, the additional information changed the Board’s risk/benefit calculation.

– The data described in the revised manuscripts do not appear to provide information that would immediately enable misuse of the research in ways that would endanger public health or national security.

– New evidence has emerged that underscores the fact that understanding specific mutations may improve international surveillance and public health and safety. Global cooperation, critical for pandemic influenza preparedness efforts, is predicated upon the free sharing of information and was a fundamental principle in evaluating these manuscripts.

The Board’s recommendations were informed by the newly released United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern. This policy applies to federally funded life sciences research and will ensure that dual use concerns are addressed during evaluation of ongoing and future research on A/H5N1 influenza virus.

As a part of these deliberations, the Board emphasized the urgent need for the further development of processes for the responsible communication of dual use research of concern. It noted that improving public health and safety will require a sustained global approach to addressing dual use concerns presented by life sciences research while encouraging a robust research enterprise.

The NSABB recommendations from this meeting will be forwarded to the U.S. Government for review and consideration.

http://oba.od.nih.gov/oba/biosecurity/PDF/NSABB_Statement_March_2012_Meeting.pdf

New Policy: US Government Issues Policy on Oversight of Life Science Dual Use Research of Concern:

The purpose of this Policy is to establish regular review of United States Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern (DURC) in order to: (a) mitigate risks where appropriate; and (b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research. (March 29, 2012)