The Government Accountability Office is calling on HHS to increase transparency in how it assesses and mitigates risk related to high-risk pathogen research.
In a report released Feb. 19, the GAO said HHS does not consistently disclose key details about how it weighs the risks and benefits of research involving pathogens with pandemic potential, or how many federally supported projects involve such pathogens.
The report is based on the GAO’s review of scientific literature and reports published from 2019 to 2024, federal policies governing higher-risk pathogen research and interviews with HHS officials and biosafety experts. Lawmakers requested the review amid ongoing policy debates and recent legislative efforts aimed at restricting or banning certain types of gain-of-function research.
Four notes:
1. The GAO found that gain-of-function research of concern has helped advance scientific understanding of how pathogens infect humans, spread and cause disease. However, the literature review found no broad agreement on the extent to which such research has directly led to the development of vaccines or therapeutics, including those used during the COVID-19 pandemic.
2. At the same time, there was broad consensus among experts that this type of research carries biosafety and biosecurity risks.
“This is because this research can involve enhancing the transmissibility or virulence of pathogens that have the potential to cause widespread and uncontrollable disease, resulting in significant morbidity and mortality if they were to be accidentally or deliberately released from a lab,” the GAO said in its report.
3. The GAO recommended that HHS ensure key information about its risk reviews for federally funded and internally conducted pathogen research is publicly shared with researchers, Congress and the public. This includes outcomes of risk reviews, mitigation steps taken and the total number of higher-risk pathogen projects supported by the agency. HHS neither agreed nor disagreed with the recommendation, though said it plans to work toward improving transparency around the scope of such research and steps taken to mitigate risks.
4. Research that modifies pathogens to study how diseases spread — often referred to as gain-of-function research of concern — has faced heightened scrutiny in recent years. The debate intensified during the COVID pandemic, as policymakers and scientists examined competing theories about the virus’s origins and called for stronger oversight of experiments involving potentially dangerous pathogens.
A Republican-led House subcommittee concluded in a 2024 report that a lab leak was the most likely origin of SARS-CoV-2, while Democrats on the panel and many scientists disputed that conclusion, underscoring the ongoing debate around oversight of high-risk pathogen research.
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