Overview
On May 5, 2025, the NIH took a pivotal step toward enhancing the safety and security of biological research in the United States. In response to the newly issued Executive Order on Improving the Safety and Security of Biological Research, the National Institutes of Health (NIH) released Notice Number: NOT-OD-25-112, outlining immediate actions the biomedical research community must heed. Below, we break down the key takeaways from the notice, its implications for current and future research, and the types of training that may be essential moving forward.
Key Highlights of the NIH Notice
1. Immediate Policy Changes
The NIH has made significant shifts to align with the Executive Order, including:
- Superseding the DURC/PEPP Policy: The Executive Order overrides NIH’s previous implementation of the May 2024 U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP).
- Rescission of Prior Guidance: Specifically, the NIH officially rescinded NOT-OD-25-061.
- New Funding Restrictions: NIH will not accept new grant or cooperative agreement applications or R&D contract proposals involving dangerous gain-of-function research after May 5, 2025.
2. Pause and Suspension of Ongoing Research
- NIH plans to suspend funding for existing research that meets the criteria for dangerous gain-of-function activities.
- NIH urges awardees to immediately review their current research to identify projects that might fall under the new definitions and prepare to halt or adjust such activities accordingly.
3. Revised Definitions and Scope
As defined by the Executive Order, dangerous gain-of-function research refers to studies involving pathogens or toxins that:
- Increase pathogenicity or transmissibility,
- Evade immune responses or therapeutics,
- Alter host specificity,
- Or recreate eradicated/extinct biological agents.
This sweeping definition covers activities with potentially severe societal consequences.
Context: Why This Matters
The Executive Order and subsequent NIH actions stem from a growing need to balance innovation with responsibility. As biomedical and life sciences research becomes more sophisticated, so does the risk of unintentional misuse or accidental release of engineered pathogens.
The NIH shifted policy to prevent future pandemics and ensure that the scientific community operates within a secure, ethical, and transparent framework. By halting dangerous gain-of-function work until robust oversight is in place, the NIH and the federal government aim to protect both public health and scientific integrity.
Recommended Training for Compliance and Preparedness
To support researchers and institutions navigating these new mandates, several types of training are especially relevant:
2. Responsible Conduct of Research (RCR)
3. Dual Use Research of Concern (DURC)
Looking Ahead
This NIH regulatory update is a call to action for every stakeholder in the biomedical research ecosystem. Proactive compliance and training will be vital in adapting to this new era of enhanced oversight.
Researchers should remain vigilant, follow future updates from NIH, and seek guidance and training to safeguard their work and public trust.
