NEW!
*Updates to Federal Policy*
USG Policy for Oversight of Dual Use Research of Concern (DURC) & Pathogens with Enhanced Pandemic Potential (PEPP)
Effective May 6, 2025, the Policy for Oversight of DURC & PEPP (herein referred to as DURC & PEPP Policy) will supersede previous DURC and P3CO Life Science Policies.
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.
- UConn and other research institutions have been awaiting additional guidance regarding how Federal Funding Agencies plan to implement the DURC & PEPP Policy.
- In the meantime, the UConn IRE is working to develop procedures to best assist PIs with the new requirements.
- Proposals - New and Ongoing: PIs may be asked to complete an Initial Assessment.
- Questions in assessment help to determine if research is subject DURC & PEPP Policy.
- IRE created forms to help PIs.
- IRE will be in touch with labs that may be impacted.
- The IRE is here to help! See contact information below, and reach out with any questions.
The Implementation Guidance document contains agent specific details, examples of research within the scope of the policy, and tools to aid in compliance for all involved in life sciences research - PIs, research institutions, institutional review entities (IREs) and federal funding agencies.
Framework for Nucleic Acid Synthesis Screening
Policy effects the purchase of oligonucleotides and benchtop synthesis equipment. Federally funded PIs must purchase applicable materials from suppliers who screen orders for sequences of concern (SOCs). SOCs are unique to specific pathogens. Applicable materials must be purchased from Providers or Manufacturers that publicly state adherence to the Policy (on website or provide documentation). Labs may be contacted more frequently from vendors in the process of verifying legitimacy; additional documentation may be requested. How granting agencies will monitor adherence to this policy is unclear.
Institutional Review Entity (IRE)
- IRE is an entity established by the research institution to execute institutional oversight responsibilities described in Section 5.2, with the attributes described in Section 5.2.B of the USG Policy on Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP).
- UConn's IRE was established as a subcommittee of the IBC in 2014. The IRE authority and responsibilities were implemented in accordance with provisions outlined in the 2014 USG Policy on DURC.
- With the expansion in scope of research subject to the DURC & PEPP Policy, the IRE will begin holding regular meetings to review potential Category 1 and Category 2 experiments.
More details to come!
For additional information or assistance with compliance with the new policy, contact:
| Name | Title | Phone | |
|---|---|---|---|
| Danielle Delage, CPBCA | IBC Program Director | 860.486.1838 | danielle.delage@uconn.edu |
| David Cavallaro, MS, RBP, CBSP | Biosafety Officer | 860.486.3180 | david.cavallaro@uconn.edu |
Links below contain additional resources such as fact sheets, templates, and FAQs.
Resources
Additional resources and summaries on the new policy can be found below.
Fact Sheet - DURC & PEPP Policy
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Open in new tab Agents & Toxins
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Institutional Workflow - DRAFT
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PI Initial Assessment Tool
UConn Policy on DURC & PEPP
Risk-Benefit Assessment Template
Risk Mitigation Plan Template
FAQs
Frequently Asked Questions (FAQs)
My lab does not receive federal funding, but RG2 pathogens are modified to enhance virulence and transmissibility. Do I need to comply with this policy?
- DURC & PEPP Policy is applicable to non-federally funded research at institutions that receive federal funding, via term and condition awards. Since UConn is sponsored by federal funding agencies, your work should be assessed by the IRE.
Who is responsible to determine if research is subject to the DURC & PEPP Policy?
- PIs assess research initially, to identify covered research. PI assessments are reported to the sponsor and if the PI believes the project meets Category 1 or Category 2, the IRE must be notified as well.
- UConn IRE will provide a Self Assessment Tool to aid PIs in conducting this assessment.
I assessed my proposed research and my determination was that our new project may be subject to Category 2 oversight. What do I do now?
- Contact the IRE and your sponsor. Do not begin work on any new experiments. The IRE must conduct an assessment of the PI's determination, which will result in one of the following workflows.
- IRE Determination = Not Subject to Policy: The institution will notify the sponsor and the PI. Work can be initiated according to DURC & PEPP; however, other regulations may apply (e.g. NIH Guidelines). Contact the IBC to ensure the lab has all approvals necessary.
- IRE Determination is Category 1 or 2 = Subject to Policy: Ensure sponsor is notified, and work with IRE to draft risk benefit analysis, and risk mitigation plans. Sponsor must conduct thorough review.
Additional FAQs - S3: Science Safety Security, ASPR
Current Life Science Policies – DURC and P3CO, expiring May 6, 2025
Current Federal Policies on Life Sciences Research - Expiring May 6, 2025
USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC)
Life sciences research is essential to the scientific advances that underpin improvements in public health and safety, agriculture (including crops and other plants and animals) the environment, materiel, and national security. Despite its value and benefits, certain types of research conducted for legitimate purposes can be utilized for both benevolent and harmful purposes. Such research is called “dual use research". The current policy defines DURC as a subset of dual use research defined as life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
The 2014 DURC Policy will expire effective May 6, 2025; and will be replaced with the USG Policy on Oversight of DURC and PEPP described at the top of this page.
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: