A new report from the US Government Accountability Office (GAO) says the Department of Health and Human Services (HHS) should make more information public about how it evaluates and mitigates risks associated with high-risk pathogen research.
For the report, GAO reviewed scientific literature, biosecurity reports, and federal oversight processes from 2019 to 2024 related to research that modifies pathogens in ways that can increase their ability to spread or their virulence—the ability to cause disease or bodily harm. Such experiments are conducted to better understand how microbes spread and cause disease, but they have been the subject of debate because of potential biosafety risks.
Experts divided on practical benefits
GAO found that this type of research has advanced scientific understanding of pathogens and how they infect humans and other animals. Studies involving avian influenza and bat coronaviruses, for example, have helped clarify how viruses evolve and spread.
High-risk pathogen research has advanced scientific understanding of pathogens and how they infect humans and other animals.
At the same time, the report found disagreement about whether research on pathogens that have the potential to cause a pandemic, sometimes referred to as “gain-of-function research of concern,” has directly contributed to the development of vaccines or other therapeutics. Some sources said the experiments have informed pandemic preparedness and drug development, while others argued that the work has limited to no ability to inform vaccine development or predict outbreaks.
Despite these differing views on benefits, the report found broad consensus that the research carries inherent 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,” notes the report.
Calls for increased transparency
GAO also examined how HHS agencies review and oversee the pathogen research they fund or conduct. It found that while HHS shares some information about high-risk research with federal stakeholders, key details about risk and mitigation measures are not routinely shared with the public.
Increasing transparency, the report said, could strengthen public trust and provide greater assurance to the public, the scientific community, and Congress that safeguards are in place to manage the risks associated with dangerous pathogens.
GAO recommended that HHS ensure that key information about its risk-review processes, including steps taken to mitigate risks, is publicly shared as appropriate. HHS neither agreed nor disagreed with the recommendation but said it would work to improve transparency about the scope of research involving higher-risk pathogens and the safeguards put in place around it.
“Such information should be regularly updated and include the outcomes of risk reviews, steps HHS funding agencies and researchers took to mitigate risk, and the total number of research projects involving higher-risk pathogen research that agencies support,” the report concludes.
