NIH Terminating or Suspending Dangerous Gain-of-Function Research

Notice Number: NOT-OD-25-127

Release Date: June 18, 2025

Related Announcements: May 7, 2025 - Implementation Update: Improving the Safety and Security of Biological Research.  See Notice NOT-OD-25-112

Issued by: National Institutes of Health (NIH)

Purpose

The purpose of this notice is to inform the biomedical research community of the following actions NIH is taking and requiring in response to guidance received from the White House Office of Science and Technology Policy pursuant to the May 5, 2025 Executive Order on Improving the Safety and Security of Biological Research (Executive Order). Consistent with the definitions provided in the Executive Order, 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.

NIH will initiate these actions in a manner consistent with any relevant terms and conditions of the funding and will notify affected investigators and institutions of actions being taken. NIH will not be accepting requests for exceptions to terminations or suspensions if deemed to meet the Executive Order’s definition of dangerous gain-of-function research.

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.

As a reminder, per NOT-OD-25-112, NIH is not accepting competitive applications for grants and cooperative agreements submitted for due dates after May 7, 2025 and/or R&D contract proposals submitted to solicitations issued after May 7, 2025 for dangerous gain-of-function research, as defined in Section 8 of the Executive Order.

Background

For the purposes of this Notice and, as defined in the Executive Order, 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.  Covered research activities are those that could result in significant societal consequences and that seek or achieve one or more of the following outcomes:

  • enhancing the harmful consequences of the agent or toxin;
  • disrupting beneficial immunological response or the effectiveness of an immunization against the agent or toxin;
  • conferring to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitating their ability to evade detection methodologies;
  • increasing the stability, transmissibility, or the ability to disseminate the agent or toxin;
  • altering the host range or tropism of the agent or toxin;
  • enhancing the susceptibility of a human host population to the agent or toxin; or
  • generating or reconstituting an eradicated or extinct agent or toxin.

NIH is actively engaging with its federal agency and White House partners to implement the Executive Order and develop an improved policy for oversight of this research. NIH is implementing this directive for all funded and conducted research, including within its Intramural Research Program. NIH will continue to provide updates as needed regarding implementation of this Executive Order in alignment with the Administration’s guidance.