As called for under the CARES Act stimulus bill of 2020, the Government Accountability Office (GAO) conducted an investigation of the U.S. Department of Health and Human Services’ (HHS) oversight practices surrounding research into pandemic pathogens and found cause for concern.
While such research is critical to preparation, response, and recovery efforts concerning public health threats – it was a major driver in the rapid development of COVID-19 vaccines and therapeutics, for example – GAO found that numerous incidents and research projects have raised concerns about the department’s safety in that area. GAO found gaps in its wider research management practices and inadequate safeguards during a review of HHS oversight policies, programs, staff, and research grant documentation.
In 2017, HHS created an oversight framework that required funding agencies to refer proposed research reasonably anticipated to create, transfer or use enhanced potential pandemic pathogens to the department for additional layers of review on risks, benefits, and more. Enhanced potential means altered pathogens – the worry there is that alterations for research purposes could also affect how they spread and cause disease, making them potentially more transmissible and deadly than before.
However, GAO determined that the HHS framework failed to provide effective oversight, leaving items critical to the effort – like the definition of reasonably anticipated – vague and, therefore, potentially inconsistent in pursuit.
Further, HHS is limited in waiving or postponing requirements for adding newly emerged pathogens – like SARS-CoV-2 – to its Federal Select Agent Program for regulating the possession, use, and transfer of specific pathogens. This restriction applies for 60 days during public health emergencies, ostensibly to keep HHS from impeding public health responses by putting more reporting and inspection requirements on diagnostic and treatment facilities. GAO argued that risks linked to these limitations should be investigated.
In the end, in addition to the investigation of limitations, GAO recommended that HHS set a clear standard for its use of the terms “reasonably anticipated” in oversight considerations and work with funding agencies to identify and share non-sensitive information with researchers, Congress, and the public about the HHS review process surrounding potential pandemic pathogens.