The deliberative process will offer recommendations for risk mitigation, potential courses of action in light of this assessment, and propose methodologies for the objective and rigorous assessment of risks and potential benefits that might be applied to the approval and conduct of individual experiments or classes of experiment.The OSTP called for a two-track process:
The deliberative process is envisioned to be time-limited, to involve two distinct, but collaborating, entities, and to be structured to enable robust engagement with the life sciences community. As a first step, the National Science Advisory Board for Biosecurity (NSABB) will be asked to conduct the deliberative process described above and to draft a set of resulting recommendations for gain-of-function research that will be reviewed by the broader life sciences community. The NSABB will serve as the official federal advisory body for providing advice on oversight of this area of dual use research, in keeping with federal rules and regulations. As a second step, coincident with NSABB recommendations, the National Research Council (NRC)of the National Academies then will be asked to convene a scientific conference focused on the issues associated with gain-of-function research and will include the review and discussion of the NSABB draft recommendations. This NRC conference will provide a mechanism both to engage the life sciences community as well as solicit feedback on optimal approaches to ensure effective federal oversight of gain-of-function research. The life sciences community will be encouraged to provide input through both the NRC and NSABB deliberative process.Although the federal decision to halt research funding has been interpreted as a reaction to the spate of biosecurity incidents last year at government laboratories, the general topic of GOF research has required more attention from deliberative bodies since the controversies of 2011-2012, and the NSABB thus began to pick up that project last fall. In parallel, a meeting was organized by the National Research Council in December, 2014. Now, a working group of the NSABB has issued a preliminary draft for the May meeting, the Framework For Conducting Risk And Benefit Assessments Of Gain of Function Research. This draft outlines the deliberative schedule already underway as the NSABB is charged with identifying the parameters that would shape decision-making on the merits of the research going forward. It identifies specific categories and exemplars of risks and benefits, all of which will guide the third-party contractor hired to perform and analyze the risk/benefit ratio for this research and provide these inputs to the NSABB and NRC. This draft framework will be discussed at the May 5 meeting; public comments to the NSABB can be provided until April 28, 2015.