Overview
On May 5, 2025, President Trump issued an Executive Order (EO) on Improving the Safety and Security of Biological Research, which pauses dangerous research that could or will make a naturally occurring pathogen or toxin more dangerous to American citizens, and directs the Director of the Office of Science and Technology Policy (OSTP) and the National Security Advisor to work with funding agencies to develop such a policy within 120 days. It is expected that the 2024 DURC-PEPP policy will be either revised or replaced.
On May 7, 2025, the National Institutes of Health (NIH) released a notice (NOT-OD-25-112) to specify that it intends to suspend ongoing funding in accordance with guidance developed under Section 3(b) of the Executive Order (EO). Also, the NIH will not accept competitive applications for grants and cooperative agreements submitted for due dates after 5/7/25 and/or R&D contract proposals submitted to solicitations issued after 5/7/25 for dangerous gain-of-function research.
On June 18, 2025, the NIH released a notice (NOT-OD-25-127) requiring all NIH awardees to complete a review of their research portfolios to identify NIH funding and other support for projects (including unfunded collaborations/projects) meeting the definition of dangerous gain-of-function research (dGOF).
Defining dGOF
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.
Demonstrating Compliance
The Executive Order is fairly broad in its wording, and currently there is no clear guidance available for PIs to demonstrate compliance if, after review, they determine that their funded activities do not fit the dGOF research definition. If in doubt, we recommend that investigators proactively reach out to their program officers for guidance. If a program officer recommends sending an official response to the funding agency that details why funded activities do not fit the EO dGOF definition, we recommend drafting a justification and sending it to a University SPA Grants and Contracts Officer for review, endorsement, and submission to the funding agency.
For those federal grant awardees that review their ongoing research activities, find that those activities meet the dGOF definition, and have not yet been identified as such by a funding agency, we recommend they immediately pause their research and notify their funding agency program officer (or relevant staff). They should also prepare to provide written confirmation that they have ceased using sponsored funds for all research meeting the definition of dGOF research.
Funding Agency Notifications
If you have received communication from a funding agency on an award termination, please contact your SPA Grants and Contracts Officer. You may also reach out to Amy Rollinger, SPA Associate Director at [email protected] or Nicolas Allyn, SPA Assistant Director at [email protected].
Please also refer to SPA’s Federal Executive Orders (EOs) & Other Policy Directives page for information on federal policy changes.
Resources
We expect to update this website as information is released.
Questions may be sent to [email protected] regarding the NIH notices.