On May 5, 2025, the White House issued an Executive Order (EO) on Improving the Safety and Security of Biological Research and an accompanying Factsheet regarding dangerous gain-of-function (GOF) research[1]. The EO struck down the recently implemented 2024 US Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Pandemic Potential (USG Policy). Two days later, NIH released Notice NOT-OD-25-112, directing awardees to pause any NIH-funded research that meets the definition of dangerous GOF until a new updated federal policy is issued (expected within 120 days).
What You Need to Know:
- Dangerous GOF research includes experiments that increase an agent’s transmissibility, resistance, or ability to evade detection. (see footnote for full definition)
- NIH-funded research that meets this definition must be paused immediately.
- Institutions are advised to review all research projects, regardless of funding source, for alignment with this definition.
- If you believe your research meets the definition of dangerous GOF, pause the research immediately and contact the IBC (ibc@research.ucla.edu) and/or Institutional Contact for Dual Use Research (jennifer.klahn@research.ucla.edu).
What UCLA Is Doing:
In March 2025, the IBC launched changes to SafetyNet to implement the 2024 USG Policy. Although the USG Policy has been struck down, the IBC will continue to request completion of the DURC/PEPP page of your BUA according to instructions provided in SafetyNet. Most researchers will answer NO to the first question on the DURC/PEPP page, requiring no further action. Those who answer YES will provide a small amount of additional information. Investigator responses on the DURC/PEPP page will be useful as we anticipate the White House Office of Science and Technology Policy releasing a more stringent federal policy.
We acknowledge the burdens and stressors our research community are faced with right now and thank you for your patience and understanding. We will continue to provide updates as additional federal guidance is issued.
Please reach out to ibc@research.ucla.edu if you have any questions.
[1] “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:
(a) enhancing the harmful consequences of the agent or toxin;
(b) disrupting beneficial immunological response or the effectiveness of an immunization against the agent or toxin;
(c) 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;
(d) increasing the stability, transmissibility, or the ability to disseminate the agent or toxin;
(e) altering the host range or tropism of the agent or toxin;
(f) enhancing the susceptibility of a human host population to the agent or toxin; or
(g) generating or reconstituting an eradicated or extinct agent or toxin.