DURC/PEPP Policy

Quick Links

• Duke DURC/PEPP Policy
• PI Self-Assessment form
• Duke DURC/PEPP Training
• Risk Benefit Assessment template
• Risk Mitigation Plan template

Life sciences research plays a critical role in advancing public health, as well as protecting agricultural crops, animals, plants, and the environment. While most research yields significant benefits to society, certain studies carry the risk of potential misuse. These studies require additional risk assessments and the implementation of biosafety and biosecurity measures to mitigate such risks.

To prevent intentional or unintentional misuse, Duke University adheres to the May 2024 U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)  (2024 USG Policy). This policy promotes responsible oversight of research that may impact public health, agriculture, the environment, or national security. Duke University has developed a DURC/PEPP Policy  that describes the mechanisms through which the institution will enable individuals and the University to comply with federal requirements. 

Individuals should note that the Duke DURC/PEPP policy applies to all research at Duke University that meets the criteria set forth in the 2024 USG policy regardless of the funding source. Compliance with both policies is a shared responsibility between the Principal Investigator and institutional offices, which are outlined below.

Principal Investigators’ Responsibilities

• Become familiar and comply with the requirements of the 2024 USG and Duke DURC/PEPP Policies
• Ensure that all laboratory personnel conducting life sciences research that falls under the scope of the Duke DURC/PEPP Policy—including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists under the supervision of laboratory leadership—receive and maintain training on all relevant research oversight policies and procedures and demonstrate continued competency
• Assess research for potential DURC/PEPP at the proposal stage and throughout the lifecycle of the research project by completing a “PI Self-Assessment” (triggered via Intent to Submit or SPS). If at any point—before or during a project—potential DURC or PEPP risks (including research that may evolve into DURC/PEPP) are identified, the ICDUR must be notified immediately at biosafety@duke.edu
• If the research is determined to be DURC/PEPP by the IRE (the Duke Institutional Biosafety Review Committee [IBRC] will serve as the Institutional Review Entity [IRE]):
  • Work with the ICDUR and the IBRC to develop a Risk Benefit Assessment and a Risk Mitigation Plan (RMP)
  • Conduct research according to the RMP after approval from the funding agency
  • Provide annual (DURC) and semi-annual (PEPP), or as requested, progress reports to the funding agency as per their requirements
  • Work with the respective grants and contracting offices and adhere to all reporting requirements in a timely manner
• If the IRE determines the research is not DURC/PEPP, continue on-going assessment of research for DURC/PEPP risk; immediately notify ICDUR and the IBRC of any potential DURC/PEPP issues.

Contact Information

If there are any questions or if assistance is needed, please contact Dr. Antony Schwartz, the Institutional Contact for Dual Use Research (ICDUR), at biosafety@duke.edu or 919-684-8822.