Dual Use Research of Concern (DURC) & Pathogens with Enhanced Pandemic Potential (PEPP)
Important Information
**Upcoming Changes to Federal Policy**USG Policy for Oversight of DURC & Pathogens with Enhanced Pandemic Potential (PEPP)On May 6, 2025, a new federal policy for oversight of Dual Use Research of Concern (DURC) and certain other research with pathogens will go into effect and will apply to both funded and non-funded research. The United States Government Policy for Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (“USG DURC-PEPP Policy”) supersedes previous DURC policies and the 2017 Enhanced Potential Pandemic Pathogens Framework (P3CO). The USG DURC-PEPP Policy does not supersede, but complements other existing federal regulations, including the Select Agent Regulations. |
What Is DURC & PEPP?
At FIU, the USG DURC-PEPP Policy applies to all research, regardless of funding source, that meets the criteria for DURC-PEPP research. Federal sponsors may delay release of funds if a project identified as DURC-PEPP research does not fulfill all requirements for compliance with the USG DURC-PEPP Policy – this includes research that is funded or sponsored by federal grants, contracts, cooperative agreements, and other agreements.
All FIU Principal Investigators (PIs) proposing or conducting research involving biological agents and toxins must assess whether or not their research potentially falls under the USG DURC-PEPP Policy. Specifically, PIs proposing to work with or generate any replication-competent infectious agent or proposing to work with a toxin of any amount from the Federal Select Agents and Toxins list must make a Self-Assessment of whether the research is reasonably anticipated work with the FIU Institutional Review Entity (IRE) to develop a risk-benefit assessment and risk mitigation plan that must be approved by the funding agency before the work can begin.
Click here for the list of Select Agents & Toxins. Please visit our IRE tools and resources page for additional information.
The FIU Institutional Review Entity (IRE)
The intent of the USG DURC-PEPP Policy is to strengthen oversight of life sciences research with biological agents and toxins throughout the research lifecycle by:
- Defining an expanded scope of biological agent and toxin research subject to additional oversight by the U.S. government;
- Providing a unified framework to support the consistent identification and oversight of research proposals subject to this policy that accounts for safety, security, and ethical considerations; and
- Delineating the roles and responsibilities of principal investigators, research institutions, and federal departments and agencies that conduct, fund, or oversee research within the scope of this policy, with an emphasis on institutional oversight and management of this research.
It is the policy of the U.S. Government that federally funded intramural or extramural research that meets the scope of Category 1 or Category 2 research within this policy is subject to federal and institutional oversight. The purpose of this oversight is to preserve the benefits of such research while minimizing the biosafety and biosecurity risks, including risks that the knowledge, information, products, or technologies generated by the research could be used in a manner that results in harm to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security.
Need Assistance?
The Office of Research Integrity (ORI) is responsible for the ethical and regulatory oversight of research at Florida International University that involves Dual Use of Research Concern and Pathogens with Enhanced Pandemic Potential (PEPP). ORI supports and oversees the work of the Institutional Review Entity (IRE).
If you have any questions regarding the IRE, please contact the IRE Coordinator, Angel Rayo or Barbara Llaneras Rodriguez, in the Office of Research Integrity located in MARC 430. They also be reached at: (305) 348-2407 or (305) 348-8316.
