In May, the National Science Advisory Board for Biosecurity (NSABB) approved recommendations for the evaluation and oversight of proposed Gain of Function Research of Concern (GOFROC), following a process involving a risk/benefit and ethical analysis and several public meetings. The recommendations focus on a small subset of Gain of Function (GOF) research proposals, or research generating a pathogen with pandemic potential that entails risks that warrant additional oversight beyond the current oversight. Decisions about whether to fund GOFROC would be based on a set of principles, including merit, a risk/benefit analysis, consideration of alternative methods, history of the investigator and the institution, ability to respond to lab accidents, and whether an organism contains a virulence gene from another organism with which it could not recombine in nature. Oversight of GOFROC would apply to all microorganisms meeting these criteria, not just GOF research with influenza, MERS and SARS virus, which are currently subject to a pause of research funding. The new evaluations would occur pre-funding to determine whether or not a GOFROC study should be undertaken.
The NSABB report is available here. The next step is approval by the NIH director, HHS Secretary and other department heads. The Office of Science and Technology Policy (OSTP) will then develop new guidance for funding and oversight of GOF research. OSTP hopes to complete an overarching structure for GOF research and then to lift the year and a half funding pause on certain projects involving influenza, SARS and MERS, which is viewed as discouraging to the field of infectious diseases. The NSABB expressed satisfaction with the recommendations, as an affirmation that GOF research has public benefit and that the new guidance will provide assurance to the public that this research will receive greater scrutiny and oversight, although a regulatory approach and new statutes are not desirable.