On May 6, 2025, the United States Government will implement a new policy addressing Dual Use Research of Concern (DURC) and Pathogens of Enhanced Pandemic Potential (PEPP). This policy supersedes the 2012 DURC policy and the 2017 Policy Guidance for Potential Pandemic Pathogen Care and Oversight (P3CO Framework), reflecting a proactive approach to addressing the evolving landscape of biological research and its potential implications for global health and security.
There are two categories of research that will be subject to the policy.
| Category 1 | Category 2 |
|---|---|
| Involves one or more biological agents and toxins: select agents and toxins, risk group 4 pathogens and a subset of risk group 3 pathogens | Involves, or is reasonably anticipated to result in, a Pathogen of Pandemic Potential (PPP) |
| Nine experimental outcomes | Four experimental outcomes |
PI Responsibilities
- Principal Investigator (PI) assessment of the research: At the time of submission of a research proposal to a federal funding agency, PIs will need to identify research that may fall within the scope of Category 1 or Category 2 research.
- PIs are expected to continuously monitor research for the potential to fall within the scope of the policy.
The PI self-assessment form will assist in the evaluation of the research. If the research may fall into Category 1 or Category 2 research, the PI should send the self-assessment form to biosafety@case.edu.
See the PI DURC/PEPP Self-Assessment Form
See a List of Category 1 Agents and Toxins
Institutional Responsibilities
The ÐÇ¿Õ´«Ã½ Institutional Review Entity (IRE) Committee provides oversight for DURC and PEPP.
- The IRE will review research that may be within the scope of Category 1 and Category 2 research if the work is considered for federal funding.
- The IRE review will include a risk benefit assessment and a draft mitigation plan if it is determined that the research meets the criteria for Category 1 or Category 2 research.