Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)
Definition
According to the University of Maine Policies and Procedures for Research Involving Recombinant or Synthetic Nucleic Acid Molecules or Infectious Agents (Word):
“Dual use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPP) are types of life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops, and other plants, animals, the environment, material, or national security.”
How is DURC & PEPP research regulated?
At the federal level, DURC and PEPP research is regulated by the United States Government (USG) Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) – also known as the DURC/PEPP Policy (PDF) (external link) – released May 6, 2024, effective as of May 6, 2025.
The National Institutes of Health (NIH) has issued its own implementation guidance for the USG DURC/PEPP Policy as of January 10, 2025, applicable to all NIH-funded research, etc.: NOT-OD-25-061 (external link).
At the University of Maine, all researchers are required to comply with the Policies and Procedures for Research Involving Recombinant or Synthetic Nucleic Acid Molecules or Infectious Agents (Word). Section X of this policy specifically addresses research involving DURC and PEPP.
Countries of Concern
U.S. Government (USG) agencies (including the National Institutes of Health [NIH]) will not fund Category 1 or Category 2 research (as described in the USG DURC/PEPP Policy) in select “countries of concern,” as identified by the USG.
This list of countries is subject to change at the discretion of the USG, so researchers should always consult agency websites and policies to confirm the current list. However, as of the USG DURC/PEPP Policy release date, according to the Implementation Guidance for the USG DURC/PEPP Policy (PDF) (external link), the identified countries of concern are:
- North Korea
- Iran
- Russia
- China (including the Special Administrative Regions of Hong Kong and Macau)
- Cuba
- Syria
- Venezuela
Furthermore, regardless of funding source and country, all researchers at the University of Maine must consult with the Office of Research Compliance before initiating any international research.
Training
Online training on DURC is available through the university’s Collaborative Institutional Training Initiative (CITI) subscription as an optional module within the Biosafety/Biosecurity course. Please see Training for Biosafety for instructions to enroll in CITI courses.
Institutional Contact for Dual Use Research (ICDUR)
Andrew Holmes, Ph.D.
Institutional Biosafety Officer
andrew.p.holmes@maine.edu
207.581.3827