News from the NIH Office of Science Policy:

Executive Order on Improving the Safety and Security of Biological Research

Questions can be sent to: SciencePolicy@od.nih.gov

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USG Policy for Oversight of Dual Use Research of Concern (DURC) & Pathogens with Enhanced Pandemic Potential (PEPP)

Previous implementation date was set to take 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.

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, institutions, IREs and federal funding agencies.

NIH issued a notice on January 10, 2025, announcing intentions to implement the DURC & PEPP Policy effective May 6, 2025. NIH stated that they would 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. As of May 5, 2025 no additional guidance has been provided.

In the meantime, the UConn IRE is working to develop procedures to best assist PIs with the new requirements.

PI Responsibilities Applicability: New Proposed & Ongoing Research
Complete Initial Assessment	Assess based on agents and experiments within the scope of the policy. Must complete by proposal stage for new awards, and as requested for ongoing projects Complete using Kuali Form:  PI Self-Assessment Tool  Forms automatically forwarded to PI and the IRE. If assessed as Category 1 or Category 2, notify FFA of potential DURC or PEPP at time of proposal!
Assessment Results NOT DURC or PEPP	Continuously monitor research for changes that could affect assessment. If changes occur where research becomes DURC or PEPP, STOP WORK IMMEDIATELY! Notify FFA and IRE as soon as possible. Work with IRE and FFA to complete applicable documentation (risk-benefit analysis and risk mitigation plan).
Assessment Results may be DURC or PEPP	Notify Sponsor that research may meet DURC or PEPP at time of proposal Notify IRE of Initial Assessment Collaborate with IRE on Risk-Benefit Assessment and Risk Mitigation Plan Submit required DURC or PEPP documents to Federal Funding Agency (FFA) FFA reviews and approves Risk Mitigation Plan prior to awarding ALL approvals must be in place PRIOR to initiation of research!

Institutional Review Entity (IRE)

• IRE is an entity established by the institution to execute oversight responsibilities described in Section 5.2 of the Policy.
• UConn's IRE was established as a subcommittee of the IBC in 2014, and granted authority to fulfill the responsibilities outlined in the current DURC Policy.
• 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.

IRE will be in touch with labs that may be impacted.

We are here to help! See contact information below, and reach out with any questions.

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.

Links below contain additional resources such as fact sheets, templates, and FAQs.