On May 5, 2025, President Trump issued an Executive Order 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. This new policy is intended to replace the 2024 USG Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC-PEPP Policy) and supersedes its implementation at NIH previously set to take effect on May 6, 2025.
On May 7, 2025, the 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. All NIH awardees should review ongoing research activities to proactively identify potential dangerous gain-of-function research and identify safe actions to halt such research and to effectively comply with guidance once established. 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.
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;
- generating or reconstituting an eradicated or extinct agent or toxin.