GAO Recommends Research Improvements to HHS, Pandemic Pathogens

Based on the results of an internal study, the United States Government Accountability Office (GOA) has made three recommendations to the HHS for improving research on potential pandemic pathogens. The organization analyzed and assessed the HHS policies, programs, and research grants focused on pandemic pathogens. Additionally, the GOA also interviewed officials from the HHS to gather additional insight on research biosafety and biosecurity.

According to the GAO, the HHS oversight policy — named the Framework — requires that any proposed research that may increase the risk of spreading potential pandemic pathogens be reported for review and a risk–benefit analysis. However, the GAO determined that Framework is inadequate for pandemic pathogen oversight. The organization notes multiple fallacies in the current supervision of pandemic pathogens, including unclear definitions of what kind of research poses a potential risk.

The GAO proposed three primary recommendations to the HHS based on their analysis. The first recommendation is for the HHS secretary to work with the rest of the organization to define a reasonably anticipated risk of spread. The GAO believes that a more adequate or consistent definition can help ensure that all relevant studies are being reviewed.

The next recommendation states that the HHS should share information with researchers, government officials, and the public on how they review research that may involve potential pandemic pathogens. This information, while not revealing any sensitive information from the organization, should explain the evaluation criteria and the credentials of the review board.

The final recommendation states, “As HHS and CDC deliberate any changes to the DSAT program, the Director of the Centers for Disease Control and Prevention should assess and document the risk posed by the limitations of the existing DSAT exemptions for public health emergencies and seek legislative authority as needed.”

The HHS commentary to the GAO implies that they are willing to consider and implement the third recommendation; however, they have yet to make clear commentary on the other two proposals.