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Gain-of-Function Oversight

The National Science Advisory Board for Biosecurity has developed a new policy to guide how gain-of-function studies are overseen, ScienceInsider reports.

The publication of two gain-of-function studies involving H5N1 avian influenza in 2011 and additional papers in 2014, followed by pathogen-handling blunders at federal labs led the White House to announce a 'pause' on funding for gain-of-function studies involving influenza, SARS, and MERS in the US as new policy was developed.

To develop a new protocol for handling such studies, NSABB held six meetings, two National Academy of Sciences workshops, and commissioned a 1,000-page risk assessment, ScienceInsider says.

In the policy, the panel notes that only a small portion of studies raise concerns, namely ones that would yield highly transmissible and highly virulent pathogens.

Under this plan for evaluating potentially concerning studies, the PI or the PI's institution would first determine if the study falls under the 'Gain of Function Research of Concern' category, and if the proposal passes peer review, the funder would then evaluate it using eight criteria, including whether the PI's lab has needed safety measures and whether the benefits of the proposed research outweigh the risks, ScienceInsider says.

In this way, NSABB chair Samuel Stanley from Stony Brook University says that 'Gain of Function Research of Concern' would be identified early on. "We can start to avoid situations where [it] is only first identified at the publication stage," he tells ScienceInsider.

This proposal is now being sent over government officials who say they hope to have a final policy out by the end of the year.