NIH commitment to transparency on research involving potential pandemic pathogens

Seasonal influenza annually results in more than half a million deaths worldwide, and the possibility of an even more dangerous pandemic is a real and ongoing threat. Experiments aimed at understanding how the flu evolves from an infection in birds, pigs, or other mammals to a pathogen capable of causing a pandemic in humans are crucial to staying ahead of the naturally evolving virus. Controlled experiments that may enhance pathogens, including the flu virus and others, are critical in helping us identify, understand, and develop strategies or medical countermeasures to preserve public health in the face of evolving threats. But obviously those experiments need to be conducted with extreme care.

After public concerns were raised about the safety and security of this research, the U.S. government paused experiments of this type of research in 2014 and undertook a three-year deliberative process of public consultation and assessment of benefits and risks. In the spirit of full transparency, every step of the deliberative process was open to the public and incorporated public comments.  In December 2017, the Department of Health and Human Services (HHS) announced its Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens to provide an additional level of review and oversight to help ensure such research is conducted with the utmost regard to safety and security. The HHS Framework formalizes robust oversight for federally funded research with enhanced pathogens of pandemic potential. 

With a rigorous oversight process in place, NIH announced in a statement and notice to the research community that it was lifting the funding pause on such research. In keeping with these announcements, two proposals involving research subject to the scope of the HHS Framework have been reviewed by the group established by this policy. Consistent with the HHS Framework, these proposals were deemed to be scientifically sound and were being considered for funding by NIH before they were sent to the HHS review group. The research was determined to be acceptable for NIH funding, and suggestions from the HHS review group were incorporated into the awards to increase the potential benefits to the public while decreasing risks before allowing this important research to proceed.

Although the HHS pre-funding review of specific proposals is not public (to preserve confidentiality and to allow for candid critique and discussion of individual proposals), information about all NIH-supported research projects, once awarded, is publicly available on NIH Reporter. HHS also intends to link to information about projects that are ultimately funded after review under the HHS Framework on their Science, Safety, Security website to further demonstrate our commitment to transparency.

NIH takes the need to ensure the safety of the public very seriously. We believe the HHS Framework process strikes the right balance of rigorous oversight with the advancement of the important science necessary to prevent and treat infectious diseases.

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