Public health preparedness: HHS could improve oversight of research involving enhanced potential pandemic pathogens : report to congressional committees
Why GAO did this study. Research involving pandemic pathogens is crucial to ensure the nation’s ability to prepare for, respond to, and recover from public health threats. For example, such research resulted in COVID-19 vaccines and therapeutics to prevent severe disease or death. However, a number of incidents and research projects— including research that enhanced the transmissibility of influenza between mammals—have raised questions about the adequacy of HHS oversight of the safety of such research. The CARES Act includes a provision for GAO to report on ongoing federal efforts to prepare for, respond to, and recover from COVID-19. This report examines the extent to which HHS’s oversight Framework for enhanced potential pandemic pathogen research is effective; and gaps that exist in HHS’s broader oversight of such research, among other things. GAO reviewed HHS’s oversight policies and programs as well as documentation for selected research grants. GAO also assessed the Framework against GAO’s elements of effective oversight. GAO interviewed HHS officials and select subject matter experts from the research biosafety and biosecurity community. What GAO Recommends. GAO is making three recommendations to improve HHS’s oversight of research, including developing and documenting a standard for “reasonably anticipated” and assessing the risk of statutory limitations. HHS neither agreed nor disagreed with two of the recommendations and agreed with the third.
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