Gain of Function Research
Certain gain-of-function studies with the potential to enhance the pathogenicity or transmissibility of potential pandemic pathogens (PPPs) have raised biosafety and biosecurity concerns, including the potential dual use risks associated with the misuse of the information or products resulting from such research.
On October 16, 2014, the White House Office of Science and Technology Policy announced the launch of the U.S. Government (USG) gain-of-function (GOF) deliberative process to re-evaluate the potential risks and benefits associated with certain GOF experiments. During this process the USG paused the release of federal funding for GOF studies anticipated to enhance the pathogenicity or transmissibility among mammals by respiratory droplets of influenza, MERS, or SARS viruses.
The NSABB served as the official federal advisory body on the GOF issue and was tasked with providing recommendations to the USG on a conceptual approach for evaluating proposed GOF research. The NSABB finalized its recommendations on May 24, 2016. The U.S. Government considered the NSABB’s findings and recommendations during the development of policy on gain-of-function research. In January 2017, the U.S. Government released policy guidance for the review and oversight of research anticipated to create, transfer, or use enhanced PPPs.
Department of Health and Human Services P3CO Framework
U.S. Government Policy on Enhanced PPP Research
U.S. Government Gain-of-function Deliberative Process
Symposia Summaries and Commissioned Reports
Risk and Benefit Analysis of Gain of Function Research – Final Report (Gryphon Scientific)
Gain-of-Function Research: Ethical Analysis (Professor Michael J. Selgelid)