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

 

*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 (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 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
     • Current DURC covers 15 agents. New policy includes all BSAT, RG4 pathogens, and subset of RG3 pathogens listed in NIH Guidelines.
     • Current DURC covers 7 experimental outcomes. New policy increased to 9 experimental outcomes.
   • 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.