Biosafety: New NIH “Dangerous Gain-of-Function” Research Requirements for Notification, Suspension, or Termination – June 2025
On June 18, 2025, the National Institutes of Health (NIH) issued notice NIH NOT-OD-25-127 Implementation Update: Terminating or Suspending Dangerous Gain-of-Function Research in Accordance with the Executive Order on Improving the Safety and Security of Biological Research (external link).
Within this notice, NIH provided the following definition of “dangerous gain-of-function research”:
“Dangerous gain-of-function research means scientific research on an infectious agent or toxin with the potential to cause disease by enhancing its pathogenicity or increasing its transmissibility.”
According to the notice, which is effective immediately, NIH will:
“Terminate funding and other support for projects, including unfunded collaborations/projects, meeting the definition of dangerous gain-of-function research conducted by foreign entities in countries of concern or foreign countries where there is not adequate oversight; and
Suspend all other funding and other support for projects, including unfunded collaborations/projects, meeting the definition of dangerous gain-of-function research at least until implementation of the new policy described in Section 4(a) of the Executive Order.”
Additionally:
“NIH is also requiring all awardees to review ongoing research activities to identify NIH funding and other support for projects, including unfunded collaborations/projects, meeting the definition of dangerous gain-of-function research that has not been identified as such by NIH and immediately notify the funding NIH Institute, Center, or Office. Review must be complete by June 30, 2025.”
This notice is in response to the May 5, 2025 Executive Order: Improving the Safety and Security of Biological Research (external link), which was followed by NIH’s first notice on this topic on May 7, 2025, NOT-OD-25-112: Implementation Update: Improving the Safety and Security of Biological Research (external link).
Additionally, on June 20, 2025, the USDA issued a notice to the agricultural research community about Gain of Function Research Reporting (external link) with similar requirements to identify USDA-funded projects, inclusive of all source(s) or type(s) of funding, including in-kind support, that is believed to meet or has the potential to meet the dangerous gain-of-function definition. Other funders may release similar requirements in the coming days, please be sure to monitor your sponsor’s requirements and keep the IBC updated about your research activity and plans.
The Office of Research Compliance will continue to monitor for future updates and work to implement them as they are released. Further information will be shared as it is made available. In the meantime, please contact us with any questions regarding these updates, biosafety, or the IBC.