New Federal Biosafety Policy for High-Risk Life Sciences Research: Information and Resources Available
Dear Researchers,
A new federal policy governing certain high-risk life sciences research activities will soon introduce additional oversight, review, and disclosure requirements for some research involving biological agents. Drexel University is actively preparing for implementation and has launched a dedicated website to help researchers understand these upcoming requirements and stay informed as additional federal guidance becomes available.
The United States Government Policy for Stopping High-Risk Life Sciences Research [PDF], issued on July 20, 2026, establishes a new framework for identifying, reviewing, and overseeing:
- Dangerous Gain-of-Function (DGOF) Research
- Potential DGOF Research
- International Research of Concern (IROC)
The new framework replaces previous federal oversight requirements related to Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP).
Key Implementation Dates
July 20, 2026
- Federal policy issued.
October 2026
- Federal agencies establish the Independent Third-Party Review Body (ITPRB).
November 2026
- Federal agencies issue implementation guidance to institutions and identify entities of concern.
- The Drexel University Biosafety Office will host a webinar to discuss implementation strategies, review key requirements, and introduce resources available to support investigators.
January 2027
Institutions receiving federal life sciences funding must:
- Designate an ICDGOF
- Establish an IRE
- Implement institutional procedures
- Develop researcher training
- Create DGOF review processes
Does this affect your research?
Your current and planned projects may be subject to additional review if they involve biological agents and have the potential to alter pathogenicity, transmissibility, host range, immune evasion, resistance to medical countermeasures, or other characteristics identified under the new policy. Research involving international collaborators, foreign institutions, foreign research locations, or international funding arrangements may also require additional review.
What should researchers do now?
We encourage investigators to:
- Review current and planned research activities for potential applicability under the new policy.
- Evaluate international collaborations, research locations, and sources of support.
- Maintain accurate records regarding personnel, collaborators, institutional affiliations, and research activities.
- Become familiar with the new oversight framework and proposed institutional requirements.
- Watch for news and information on policy changes from our Office of Research and Innovation (ORI).
Visit the New Drexel DGOF Information Website
Dangerous Gain of Function
The new website provides:
- An overview of the federal policy and proposed implementation guidance
- Key definitions and terminology
- Information on investigator responsibilities
- Expected review and oversight processes
- Implementation updates and timelines
- Frequently asked questions
- University contacts and resources
The site will be updated regularly as federal agencies release additional guidance, and Drexel finalizes institutional procedures.
Stay Informed
Federal implementation guidance is expected over the coming months, and additional institutional processes, training requirements, and submission procedures will be communicated as they become available. Researchers are encouraged to bookmark the webpage and check back periodically for updates.
Following the release of implementation guidance, Drexel University’s Biosafety Office will host a webinar to discuss implementation strategies, review key requirements, and introduce resources available to support investigators.
If you have questions about ongoing or proposed research activities, please contact the Institutional Biosafety Committee Office at biosafety@drexel.edu.
Thank you for your partnership as we prepare for implementation of these important new federal requirements.