HHS has also released additional guidance on a particular subset of potential Dual Use Research of Concern (DURC). For over a decade, highly pathogenic avian influenza (HPAI) H5N1 virus has been recognized as a threat to agriculture and human health. Research on this virus is important for understanding if the virus could evolve to become more readily transmissible among mammals, including humans, and for the development of countermeasures to prepare for this possibility. In February 2013, HHS developed a Framework for Guiding Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets to guide funding decisions on proposals for research anticipated to generate HPAI H5N1 viruses
The new Framework 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. Development of the Framework was important because of the safety and security concerns raised by experiments that aim to generate mammalian-transmissible HPAI H5N1 strains. The Framework will allow for the most informed decisions possible about whether and how to support and conduct this research. In August 2013, the Framework was expanded to cover certain types of gain-of-function experiments involving H7N9 influenza virus, as described in the August 16, 2013 edition of Science magazine. Research investigators with questions about how the Framework may apply to their research are encouraged to contact the program officer at their funding agency.