On May 6, 2025, a significant shift will take place in the regulatory environment with the implementation of the new United States Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP). Dual use research refers to studies that, although intended for beneficial purposes, may also pose risks if misused or if the knowledge gained could be exploited for harmful purposes. Enhanced pandemic potential refers to research involving pathogens that could potentially lead to widespread outbreaks.
This enhanced DURC/PEPP Policy expands the scope of research previously overseen by the 2012 Federal DURC, the 2014 Institutional DURC, and the 2017 P3CO Framework policies and organizes research into Category 1: involving dual use research of concern (DURC), and Category 2: involving pathogens with enhanced pandemic potential (PEPP).
This policy comes in the wake of heightened global concerns about biosecurity and the potential misuse of research, particularly in light of recent events that have underscored the need for stringent safety and oversight measures. It aims to ensure that sensitive research does not pose risks to public health and national security while fostering responsible scientific innovation.
All research institutions that receive funding from federal agencies are obligated to fully follow this Policy as a condition of their funding. According to section 5.6 of the Policy, “failure to follow the research oversight framework under this Policy may result in suspension, limitation, or termination of federal funding and loss of future federal funding opportunities for the research proposal and for other life sciences research at the research institution, as imposed by the federal funding agency.”
Breaking Down the New Policy Requirements
Under the new policy, research entities involved in DURC or PEPP must adhere to several key requirements:
- Risk Assessment: Institutions must conduct thorough risk assessments for proposed research to identify any potential dual-use implications. This will involve evaluating how results can be used or misused and detailing necessary mitigation strategies.
- Review Processes: The research institution, through an IRE (sometimes as a component of an IBC), reviews the PI’s initial assessment and confirms whether proposed or ongoing research is within the scope of Category 1 or Category 2 research
- Training and Compliance: Institutions must ensure that all personnel involved in relevant research are adequately trained on the ethical, legal, and safety concerns associated with DURC and PEPP. A risk mitigation plan must be drafted if research falls under Category 1 or Category 2.
- Transparency and Reporting: Research entities will be required to maintain transparent records and report any incidents or concerns related to misuse or safety violations promptly to relevant oversight bodies.
Concerns for Research Entities
This new oversight policy is understandably causing concerns among research entities due to fear of increased administrative burdens for researchers and reviewers, as well as potential for delays as institutions implement the new policy. The NIH has released a Notice for their implementation of the Policy for all NIH-funded research, including grants and cooperative agreements; with other funding agency implementation plans yet to be published.
How SciShield Can Help
The responsibility of assessing whether or not research falls under the scope of Category 1 and Category 2 research, as defined in the new USG Policy, falls on Principal Investigators and Researchers named in the application for which federal funding is received or proposed, at the proposal stage and continuously throughout the research lifecycle.
While the onus is on the PI to make these assessments, the DURC/PEPP Policy posits that the research institution is responsible for “ensuring that PIs are aware of and executing this responsibility appropriately.” One key approach to achieving this is by arming researchers with the tools to make compliance faster and easier.
With SciShield’s new DURC/PEPP Assessment in the Biosafety Management Module, researchers may easily self-assess whether research falls under Category 1 and/or Category 2 research. This speeds up the assessment cycle for Institutional Review Entity (IRE) and Institutional Contact for Dual Use Research (ICDUR).
Learn More
Interested in learning more about SciShield’s Biosafety Management Module or getting a DURC/PEPP Assessment? Schedule a personal consultation with one of our experts!
