Workshop Report/Summary

Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016 (2016)

The second National Academies of Sciences, Engineering, and Medicine symposium on gain-of-function research gathered feedback from the life sciences community on draft policies developed by the National Science Advisory Board on Biosecurity (NSABB) for federal oversight of this emerging research area as part of a broader U.S. government deliberative process.

"Gain-of-function" research refers to studies that enhance the ability of pathogens to cause disease. Together with "loss-of-function" studies, they are common tools in molecular and microbiology which allow investigators to understand pathogen effects and the host-pathogen interactions that underlie transmission, infection, and drug resistance, and can help determine the biological function of genes and proteins. However, there are biosafety and biosecurity concerns that some gain-of-function research could result in engineered pathogens capable of causing a pandemic if accidentally or deliberately released.

The first symposium in this series examined the underlying scientific and technical questions surrounding the potential risks and benefits of gain-of-function research involving pathogens with pandemic potential. This second symposium focused on discussions on the draft recommendations of the NSABB regarding gain-of-function research, and of a formal Risk-Benefit Assessment commissioned to inform the NSABB's work. Sessions were also devoted to current U.S. policy and the international developments that provide essential context for U.S. decisions. This report has been prepared by the workshop rapporteurs as a factual summary of the key issues and ideas identified during the symposium.