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March 2016
POLICY AND ADVOCACY
IDSA Comments on NSABB Draft Recommendations on Gain-of-Function Research
IDSA recently submitted comments on draft recommendations from the federal agency that is charged with developing a flexible, transparent regulatory framework to oversee so-called “gain-of-function” (GOF) research of concern on pathogens with pandemic potential. 
 
In late 2014, the White House Office of Science and Technology Policy issued a “pause” for all gain-of-function research, defined as “that which aims to increase the transmissibility, host-range, and/or pathogenicity of a pathogen,” so that the risks and benefits associated with such research can be more effectively assessed. The White House directed the National Science Advisory Board for Biosecurity (NSABB) to establish a framework by which this risk/benefit assessment can be undertaken. The NSABB undertook a risk benefit assessment of the paused research in the summer of 2015 to inform the development of its recommendations.  
 
At the time, IDSA submitted recommendations to the NSABB and followed up with a Journal of Infectious Diseases editorial.  
 
In its new comment letter, IDSA applauded the NSABB’s efforts to address IDSA’s earlier recommendations, including NSABB’s focus back to only the research of highest concern and its exclusion of seasonal influenza vaccine manufacturing and development. On the other hand, IDSA expressed concern that the NSABB’s latest recommendations will not provide the appropriate guidance needed to develop a streamlined mechanism that provides appropriate oversight of the risk and benefits of GOF research of concern.
 
Final recommendations are expected to be released by NSABB in May.
 


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