Gain-of-function studies, or research that improves the ability of a pathogen to cause disease, help define the fundamental nature of human-pathogen interactions, thereby enabling assessment of the pandemic potential of emerging infectious agents, informing public health and preparedness efforts, and furthering medical countermeasure development. Gain-of-function studies may entail biosafety and biosecurity risks; therefore, the risks and benefits of gain-of-function research must be evaluated, both in the context of recent U.S. biosafety incidents and to keep pace with new technological developments, in order to determine which types of studies should go forward and under what conditions. In light of recent concerns regarding biosafety and biosecurity, effective immediately, the US.Government (USG) will pause new USG funding for gain-of-function research on influenza, MERS or SARS viruses, as defined below. This research funding pause will be effective until a robust and broad deliberative process is completed that results in the adoption of a new USG gain-of-function research policy.
The statement calls on the National Science Advisory Board for Biosecurity (NSABB) and the National Research Council to undertake more formal evaluative reviews of the pros and cons of these experiments. The NSABB held a public meeting last week to begin that work. This announcement did not occur in a vacuum: in the wake of the Ebola virus disease outbreaks and the recent reports of widespread biosafety lapses at high-profile federal laboratories, attention has focused on the status of research into pathogens that cause infectious diseases and into vaccines and drugs for prevention and treatment. The scientific community has been divided over the specific issue of GOF research; both sides have gone public with the formation of professional advocacy groups that support or oppose such research. The control of federal funding for research can be subject to executive branch discretion. An earlier high-profile example of an executive branch dictate is the Bush-era policy of refusing to fund the establishment of new embryonic stem cell lines. This announcement is directed to a pause in funding and the encouragement of what appears to have been missing for the past several years: official acknowledgement that the funding of such controversial research required a formal deliberative process that should precede, not follow, official decisions to allow the work. The statement also calls on those providing private funds for such research to implement a voluntary pause, pending the upcoming reviews.