On July 28, 2026, the U.S. Department of Health and Human Services (HHS) announced a new government-wide policy prohibiting federally funded or supported gain-of-function research. The policy applies broadly to research conducted both within the United States and abroad, marking a significant shift in the federal approach to high-consequence life sciences research. Universities, academic medical centers, independent research institutions, and biotech companies that rely on federal funding should take immediate steps to evaluate the policy's implications for their current and pending work.
Under the new framework, federal agencies are prohibited from providing funding or other support for gain-of-function research, regardless of where the work is performed. The policy also restricts federal funding to countries or institutions that fail to meet specified biosafety requirements. As a result, recipients of federal research support face heightened compliance obligations tied to both the nature of their research activities and the biosafety standards maintained at the facilities where the work is conducted. Domestic institutions collaborating with foreign partners should pay particular attention to how these restrictions apply across international research relationships.
The practical impact will vary depending on an institution's research portfolio, funding structure, and existing biosafety infrastructure. Clients should undertake a careful review of active and pending federal grants, cooperative agreements, and subawards to identify any work that may fall within, or near, the scope of the new prohibition. This review should extend to subrecipients and foreign collaborators, since federal funding restrictions can flow down through contractual relationships. Institutions should also evaluate whether current biosafety protocols, institutional biosafety committee procedures, and oversight documentation align with the requirements referenced in the new policy.
Beyond immediate compliance steps, affected clients should consider how the policy may influence longer-term strategy, including grant applications, research collaborations, publication practices, and reporting obligations. Early engagement with counsel, sponsored programs offices, and biosafety personnel can help institutions position themselves to respond to agency guidance as it develops and to mitigate the risk of funding disruptions or eligibility challenges.
This update is provided for general informational purposes only and does not constitute legal advice. Clients should seek tailored guidance from qualified counsel regarding the application of the new HHS policy to their specific circumstances.