Statement on the HHS framework to guide funding for avian (HPAI) H5N1 influenza research

In late January, after a year-long moratorium, the H5N1 influenza research community announced its intention to resume highly pathogenic avian (HPAI) H5N1 influenza research in countries that established final guidelines for funding, conducting, and communicating about this research. I am pleased to say that today the U.S. Department of Health and Human Services has published its framework to guide U.S. funding decisions on proposals for research anticipated to generate HPAI H5N1 viruses that are transmissible among mammals by respiratory droplets. Research on HPAI H5N1 is vitally important for understanding whether the virus could evolve to become more readily transmissible among mammals, including humans, and for the development of countermeasures to prepare for this possibility. The new framework, developed with extensive international and public consultation, outlines a robust review process that takes into account the scientific and public health benefits, the biosafety and biosecurity risks, and the appropriate risk mitigation measures pertinent to the proposed research. The framework (outlined in the Science Policy Forum in the sidebar) will allow for the most informed decisions possible about whether and how to support and conduct research that aims to generate mammalian-transmissible HPAI H5N1 strains.

One concern addressed by the framework is the potential of this research to be misused by those who might aim to harm public health or national security. Such “dual use research of concern” (DURC) is also subject to an overarching Federal policy issued in March 2012 that requires Federal research agencies to review their research portfolios periodically to identify DURC and to develop strategies to manage the risks of this type of research. The policy aims to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by the research. Addressing DURC effectively will also require sustained attention to the issue on the part of the research community. Toward that end, the White House Office of Science and Technology Policy today issued for public comment a proposed policy to formalize the roles and responsibilities of federally funded institutions and researchers in addressing DURC. These policies combined with existing requirements for biosafety and biosecurity will ensure comprehensive management of the risks of research while permitting continued progress in science.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health