Today, the National Institutes of Health announced that it is lifting a funding pause dating back to October 2014 on gain-of-function (GOF) experiments involving influenza, SARS, and MERS viruses. GOF research is important in helping us identify, understand, and develop strategies and effective countermeasures against rapidly evolving pathogens that pose a threat to public health. The funding pause was lifted in response to today’s release of the Department of Health and Human Services Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework). The HHS P3CO Framework describes a multi-disciplinary review process, involving the funding agency and a Department-level review group, that considers the scientific merits and potential benefits of the research, as well as the potential to create, transfer, or use an enhanced potential pandemic pathogen. This framework formalizes robust oversight for federally funded research with enhanced pathogens of pandemic potential. It is the product of an extensive deliberative process undertaken by experts throughout the public and private sectors, and is aligned with the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO).

We have a responsibility to ensure that research with infectious agents is conducted responsibly, and that we consider the potential biosafety and biosecurity risks associated with such research. I am confident that the thoughtful review process laid out by the HHS P3CO Framework will help to facilitate the safe, secure, and responsible conduct of this type of research in a manner that maximizes the benefits to public health.

I would especially like to acknowledge the efforts of the National Science Advisory Board for Biosecurity and the National Academies of Sciences, Engineering, and Medicine for their thoughtful deliberations on the issues surrounding this important area of research. The work of these committees was instrumental in guiding the United States Government in its job of creating rigorous policy that allows vital research to move forward.

Francis S. Collins, M.D., Ph.D.

Director, National Institutes of Health