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handle is hein.crs/govesrq0001 and id is 1 raw text is: Cogesoa Resarc Serv 0 Updated March 10, 2025 Global Pandemics: Gain-of-Function Research of Concern Gain-of-function (GOF) research is a broad area of scientific inquiry that examines how and why an organism gains a new property or an existing property is altered. The terms gain offunction and loss offunction refer to any genetic mutation in an organism that, respectively, confers a new or enhanced ability or causes the loss of an ability. Such changes often occur naturally. Additionally, scientists can induce some changes to organisms through experimentation. A key area of GOF research is the study of both naturally occurring and experimentally induced changes in organisms to better understand the transmission, infectious properties, and pathogenesis of viruses. Some argue that GOF research may improve understanding of human-pathogen interactions, aid in assessments of potential pandemic pathogens, and further public health preparedness. Others have raised concerns that studies designed to understand how viruses might evolve may generate pathogens that affect humans and have the potential to cause a pandemic. To focus attention on this small subset of studies that involve GOF-type research, the scientific and policy communities use terms such as GOF research of concern (GOFROC); enhanced potential pandemic pathogens; and most recently, pathogens with enhanced pandemic potential (PEPPs). However, these terms have, and can be, used interchangeably in some public discussions and media. Risks and Benefits Scientists and the public have debated the risks and benefits of GOF research, which also has been of interest to Congress. Some in the scientific community argue that this research is needed to better understand how viruses evolve and to develop better medical countermeasures and surveillance regimes for emerging pathogens. Further, they assert that this research can be conducted responsibly with proper biosafety and security protocols. Others argue that the risks outweigh any potential benefits and that alternative experiments should be considered. Multiple federal policies and guidelines govern the funding and oversight of life sciences research broadly, which includes GOF research (see Table 1). These require certain biosafety and biosecurity protocols to be implemented at the institutions where the research is to be conducted. These policies and guidelines do not currently apply to GOF research. History of Oversght Mechanisms Concerns over GOF research emerged in 2011-2012 around a set of studies funded by the National Institutes of Health (NIH) on respiratory transmission of the highly pathogenic avian influenza virus H5N1. At that time, the debate centered on the security risks of publishing the results of these studies and whether the research should have been allowed to proceed, considering the risk of accidental release. These debates, along with a series of government laboratory biosafety incidents not associated with the H5N1 studies, led the White House Office of Science and Technology Policy (OSTP) to issue U.S. Government Gain- of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses in October 2014. This initial pause affected 18 federally funded research projects and contracts; 7 of them subsequently received exemptions from the pause. As part of the 2014 pause, OSTP initiated a deliberative process to evaluate the potential risks and benefits of GOF research with potential pandemic pathogens. In January 2017, OSTP released Recommended Policy Guidancefor Departmental Development ofReview Mechanismsfor Potential Pandemic Pathogen Care and Oversight (P3CO), which described attributes of federal agency review and reporting processes for the additional oversight of federally funded research that would be anticipated to create, transfer, or use enhanced pathogens with pandemic potential. Agency implementation of a review and reporting process with the described attributes would allow an agency to support certain types of GOF research. Following the OSTP guidance, the Department of Health and Human Services (HHS) released Frameworkfor Guiding Funding Decisions About Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework) in December 2017. Consequently, the issuance of the HHS P3CO Framework excused HHS from the 2014 GOF research pause. HHS was the only agency that developed a GOF review process in response to the 2017 OSTP GOF guidance and the only federal agency that has reported GOF research funding. COVID-19 and GOF The emergence of COVID-19 and debates on its origin have refocused attention on GOF and particularly the NIH funding of the EcoHealth Alliance study Understanding the Risk of Bat Coronavirus Emergence, in which scientists from the United States and the Wuhan Institute of Virology collaborated. Some have argued that this project should have been captured by the 2014 pause on GOF research and reviewed under the HHS P3CO guidance. In testimony to the House Select Committee on the Coronavirus Pandemic, NIH reportedly concluded that the research project did not meet the criteria of the 2014 pause on GOF research or the 2017 HHS P3CO guidance. https://crsreport