The Department of Health and Human Services and multiple partner agencies on July 28 released a new government-wide policy prohibiting certain categories of high-risk life sciences research, including gain-of-function experiments that enhance a pathogen’s transmissibility or virulence.
The policy applies across all federal departments and agencies that fund or conduct relevant research, making it the most sweeping biosecurity research restriction in decades. The action targets experiments that could make pathogens more dangerous to humans.
Gain-of-function research has been the subject of intense scientific and political debate since the COVID-19 pandemic, with critics arguing that laboratory manipulation of pathogens poses unacceptable biosecurity risks. Supporters contend that such research is essential for pandemic preparedness.
The cross-agency nature of the policy means it extends beyond HHS and the National Institutes of Health to include the Department of Defense, the Department of Agriculture and other agencies that fund biological research.
Implementation details and enforcement mechanisms are included in the official policy release. Researchers conducting affected experiments will need to either modify their protocols or cease the work entirely.
The policy reflects a bipartisan concern about biosafety that has intensified since 2020. Congressional hearings on gain-of-function research have drawn witnesses from both parties who questioned the adequacy of prior oversight frameworks.
The previous framework governing enhanced pathogen research was a 2017 policy that imposed a case-by-case review process. Critics argued that policy was insufficiently restrictive and inconsistently applied.