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IRE – DURC & PEPP

Dual Use Research of Concern (DURC) &
Potential Pandemic Pathogen Care and Oversight (P3CO)

 

Research involving biological agents and toxins is essential to the scientific advances that improve national and global health and safety. Such research does not come without potential biosafety and biosecurity risks. Work with pathogens and toxins must be carefully considered. Appropriate risk mitigation strategies must be implemented to protect personnel and public health and safety.

Current regulations, policies, and guidelines regarding oversight for such work are as follows:

  1. 2012 Federal DURC Policy.pdf
  2. 2014 Institutional DURC Policy.pdf
  3. 2017 OSTP Potential Pandemic Pathogen Care and Oversight (P3CO)
  4. 2017 HHS P3CO Framework.pdf

 

Institutional Review Entity (IRE)

Institutional Review Entity (IRE) is a committee established by the institution as described in the USG Section 7.2.E and empowered to execute the requirements in Section 7.2.B.i- iii, v, and viii. The IBC will serve as the IRE.

PIs are responsible to notify all applicable parties in the event they believe their work to meet the criteria of DURC or P3CO policies. Such activities must undergo IRE review. The IRE is activated in the event projects are believed to, or could be perceived to involve DURC or P3CO. The IRE reviews the project, and makes a final determination.

Institutional Contact for Dual Use Research (ICDUR) is an individual designated by the institution to serve as an institutional point of contact for questions regarding compliance with and implementation of the requirements for the oversight of DURC as well as the liaison (as necessary) between the institution and the relevant USG funding agency. A representative from the OVPR will serve as the ICDUR.

 

*Pending Updates to Federal Policy*

 

USG Policy for Oversight of DURC &
Pathogens with Enhanced Pandemic Potential (PEPP)

 

In May of 2024, the United State Government issued the Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.pdf (herein referred to as the DURC/PEPP Policy). DURC/PEPP Policy will supersede previous DURC and P3CO Framework Policies. The policy includes new oversight roles for researchers, applicants, recipients, and federal funding agencies. The DURC/PEPP Policy addresses the identification and mitigation of biosafety, biosecurity, and information risks associated with manipulation of certain pathogens that could cause significant harm to society, be it accidental or intentional. Updates reflect the evolving nature of scientific and technological risks.

Implementation Guidance.pdf was released alongside the Policy, which comprises a set of explanatory materials and tools designed to aid PIs, research institutions, institutional review entities (IREs), and federal funding agencies with implementation.

NIH issued a notice on January 10, 2025. NIH intends to implement the DURC/PEPP Policy effective May 6, 2025. NIH will provide additional details and requirements, including applicable grant and cooperative agreement activity codes, specific implementation timelines, and information regarding implementation for other NIH funding mechanisms, in future Guide Notices.

 

Overview of Changes

  1. Applicable to federal funding agencies that sponsor covered research, and non-federally funded research at institutions that receive federal funding, via term and condition awards.
  2. Responsibilities:
    • Principal Investigators (PIs) – Assess research to identify covered research, and report to sponsor and IRE. Work with IRE to draft risk benefit analysis, and risk mitigation plans.
    • Research Institutions – Established and implement policies to fulfill role of IRE.
  3. Expands scope of covered research – two categories:
    • Category 1 = DURC
    • Category 2 = PEPP
      • Any pathogen modified in such a way that is reasonably anticipated to result in a PEPP. Includes the development of new PPPs from non-PPPs, enhancement of existing PPPs, as well as work with eradicated or extinct PPPs.
      • Covers 4 experimental outcomes.