A May 2025 Executive Order has directed government agencies to revise or replace the 2024 “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential” with legislation and oversight focused on preventing dangerous gain-of-function research. While we await further regulation, the following applies:
Within the 2025 Order, “dangerous gain-of-function research” is defined as scientific research on an infectious agent or toxin with the potential to cause disease by enhancing its pathogenicity or increasing its transmissibility.
The 2025 Order defines covered research activities as those that could result in significant societal consequences and that seek or achieve one or more of the following outcomes:
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- 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.
If you think your work qualifies as dangerous gain-of-function research, or if you receive any request for information regarding your research and dangerous gain-of-function oversight, contact the Stanford Biosafety Officer (biosafety-officer@lists.stanford.edu).
