Oversight of Gain of Function Research with Pathogens: Issues for Congress [May 26, 2022] [open pdf - 1MB]
From the Summary: "The term 'gain of function' refers to any genetic mutation in an organism that confers a new or enhanced ability. Such changes often occur naturally. Additionally, scientists can induce such changes to organisms through experimentation. Gain of function (GOF) research is a broad area of scientific inquiry involving organisms that gain a new property or have an existing property altered. A key area of GOF research is the study of both naturally occurring and experimentally induced changes in viruses to better understand transmission, infection, and pathogenesis. Current U.S. policy focuses on GOF research involving enhanced potential pandemic pathogens. Some in the scientific community argue that this research is needed to better understand how viruses evolve in order to develop better medical countermeasures and surveillance regimes for emerging pathogens. However, an accident, or deliberate misuse of this research, has the potential to impact the larger public, potentially globally. This concern leads some observers to argue that the risks of such research outweigh any potential benefits. An overlapping set of policies and guidance address aspects of biosafety and biosecurity associated with GOF research with pathogens in the United States--some impose requirements, some provide guidance, some apply only to research with select biological agents, and some policies only apply to federally funded research. These policies and guidance include federal regulation of research with select biological agents and toxins, best practice guidance for microbiological and biomedical laboratories, agency guidance on funding research with potential pandemic pathogens, and the institutions and researchers conducting it."
CRS Report for Congress, R47114
Congressional Research Service: https://crsreports.congress.gov/