To better understand what causes a pandemic, pathogens may be altered during research in ways that affect how they spread and cause disease. However, these alterations could make them more transmissible or more deadly and lead to a pandemic.
Department of Health and Human Services policy calls for additional reviews of and extra safeguards for proposed research involving altered pathogens with pandemic potential. But, the policy is unclear about how HHS actually reviews and approves such proposals. The Government Accountability Office also found other policy gaps that may allow this research to occur without appropriate oversight.
HHS oversees high-risk research involving potential pandemic pathogens, which are defined as likely highly transmissible and virulent, and capable of causing significant morbidity or mortality. SARS-CoV-2, which causes COVID-19 disease, is an example of a pandemic pathogen. In 2017, HHS developed an oversight policy (the Framework) that requires funding agencies to refer proposed research that is “reasonably anticipated to create, transfer, or use enhanced potential pandemic pathogens” to the Department for an additional review of associated risks and benefits, among other things.
GAO found that HHS’s Framework does not fully meet the key elements of effective oversight identified in past work. For example, the Framework does not provide a standard to help funding agencies interpret what “reasonably anticipated” means. Until HHS develops and documents such a standard, the Framework allows for subjective and potentially inconsistent interpretations of the requirement—leaving HHS without assurance the department is reviewing all necessary research proposals.
HHS also oversees research involving certain pandemic pathogens through its Federal Select Agent Program—a list-based program regulating the possession, use, and transfer of certain pathogens. However, HHS faces trade-offs in adding newly emerged pathogens, like SARS-CoV-2, to the list because, as officials told GAO, doing so would impede the public health response by burdening diagnostic and treatment facilities with additional reporting and inspection requirements. The statute authorizing the Federal Select Agent Program limits HHS’s ability to waive or postpone these requirements during public health emergencies for a maximum of 60 days. HHS has not assessed the risk this limitation poses to its oversight of known pandemic pathogens. Until the risk of this statutory limitation is assessed and action taken to mitigate any risks, HHS will continue to face tradeoffs between impeding public health response efforts and allowing high-risk research involving known pandemic pathogens to be conducted without appropriate HHS oversight.
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 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.