#  Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) 

 



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**Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential**

The federal government regulates research involving biological agents and toxins that pose risks to public health, agriculture, food security, economic security, or national security, including dual use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPP).

The United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (“the Policy”) —effective May 6, 2025—outlines these requirements. The Implementation Guidance to these new policies (“Implementation Guidance”) was released in conjunction with the Policy to aid and assist in consistent implementation.

Research under the Policy is grouped into Category 1 (DURC) or Category 2 (PEPP) based on the characteristics of the agents used and the potential research outcomes. Each experimental category has specific review and mitigation processes.

**IMPORTANT NOTE:** **Policies, actions, and definitions in this** [**Executive Order** ](https://www.whitehouse.gov/presidential-actions/2025/05/improving-the-safety-and-security-of-biological-research/)**supersede implementation of the DURC/PEPP Policy, which will be replaced or revised by September 2025. Research meeting the definition of “dangerous gain-of-function research” is paused. Updates will be made upon publication of the new policy.**

- [Implementation Update: Improving the Safety and Security of Biological Research Notice Number: NOT-OD-25-112](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-112.html)



 

 Institutional Review Entity (IRE) DURC/PEPP Research Review Process PI Determination Checklist References 

## Institutional Review Entity (IRE)

The COMS Office also administers the Institutional Review Entity (IRE) for all DURC and PEPP projects at Harvard University, including both sponsored and non-sponsored research. While related to its Institutional Biosafety Committee (IBC) function, IRE meetings are held separately and as needed. Applications for review are submitted by the principal investigator (PI) in eCOMS, with specific questions to identify the Policy applicability, assess benefits and risks, and propose a risk mitigation plan. The IRE works in conjunction with the Grants Offices, Material Transfer Agreement Offices, Institutional Biosafety Officers and PIs to identify and assess related projects.

PIs are responsible for:

- Identifying research subject to the Policy
- Registering their research with the IRE
- Following all risk mitigation measures prescribed by the IRE and funding agency (as applicable)

If research is determined to fall initially outside the scope of the Policy, but through experimentation it is later determined that the work may fall into a regulated category, PIs must:

- Immediately stop all related research
- Secure the relevant infectious or toxic agents
- Report observations to the IRE for further review and evaluation

The IRE must then reapprove the research before it can continue.

 

 

 

## DURC/PEPP Research Review Process

Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential [Review Process](/sites/g/files/omnuum5351/files/2025-05/Research%20Review%20Flowchart-DURC-PEPP.pdf "Research Review Process")

 

 

 

## PI Determination Checklist

This[ PI Determination Checklist](/sites/g/files/omnuum5351/files/2025-05/PI%20Determination%20Checklist-Updated-5142025.pdf "PI Determination Check List Updated") is provided as a tool to assist Principal Investigators in identifying when proposed or ongoing research may be subject to the DURC and PEPP policy.

 

 

 

## References

1. [United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential](/sites/g/files/omnuum5351/files/2025-04/USG-Policy-for-Oversight-of-DURC-and-PEPP-May2024.pdf "United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential")
2. [Implementation Guidance for the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential](https://bidenwhitehouse.archives.gov/wp-content/uploads/2024/05/USG-DURC-PEPP-Implementation-Guidance.pdf)
3. [NIH Implementation of the U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) Notice](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-061.html)