HHS does not have a strong framework in place to adequately monitor research involving potential pandemic pathogens, the U.S. Government Accountability Office said in a Jan. 18 report.
HHS' oversight policy, developed in 2017, requires funding agencies to refer proposed research "reasonably anticipated" to create or involve high-risk pathogens to the department for an additional analysis of risks and benefits. However, the GAO found the framework for such reviews "allows for subjective and potentially inconsistent interpretations," which leaves HHS "without assurance the department is reviewing all necessary research proposals."
The office recommended HHS develop a clear standard of what "reasonably anticipated" means to ensure consistency in reviewing high-risk research, among other recommendations.
View the full report here.