Dual Use Research of Concern

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About

On May 6, 2024, the US Government released a new Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (USG DURC-PEPP Policy). This policy which supersedes previous DURC policies, goes into effect on May 6, 2025. Guidance on implementation of this policy can be found in the USG Implementation Guidance (USG Guidance). OSU’s ICDUR and IRE are working on updating OSU’s DURC Policy and procedures to align with the new USG policy requirements. More information will be posted as it becomes available.

 

Scope

All research directly involving the biological agents and toxins listed below is subject to additional review and oversight.  Principal investigators (PI) are ultimately responsible for ensuring that all research involving these agents is submitted to the Institutional Biosafety Committee (IBC) for review.

 

Research Requiring Review and Oversight

Per the United States Government Policy for Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential, two research categories are used to further define DURC/PEPP and identify the research subject to this policy:

 

Category 1: research categorized as DURC

Category 2: research categorized as PEPP

 

Process for Review of Life Sciences Research with DURC Potential

DURC Review Process

 

Risk Mitigation Plan

If the IRE finds that the proposed research meets the definition of DURC, the committee will work with the PI to develop a draft risk mitigation plan based on an assessment of the risks and benefits associated with the research.  The plan will be specifically tailored to the research in question and will outline the strategies that will be used to mitigate all identified risks.  Possible risk mitigation measures may include the application of additional biosafety or biosecurity measures, modification of the experimental design or methodology, and/or the application of medical countermeasures.  Additionally, the plan may include information regarding the responsible communication of DURC-PEPP findings.

 

This draft plan will be submitted to the federal funding agency within 90 days of the IRE’s determination that the research in question is DURC-PEPP.  To the extent practicable, the agency review entities should complete the review process within 90 calendar days of receiving the risk-benefit assessments and draft risk mitigation plan for Category 1 or Category 2 research from the research institution. The project may not be initiated until an approved risk mitigation plan is received from the federal funding agency.