IBC Insights
We are thrilled to launch our very first IBC Insights, your quarterly guide through the world of biosafety and compliance. Our Mission? To empower your research with the knowledge and tools you need to excel safely and responsibly.
UCLA to Implement Updated Federal Policy on High-Risk Biological Research
Effective May 6, 2025, UCLA must be compliant with the updated U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) (USG Policy). This policy addresses the evolving landscape of biological research, ensuring that scientific advancements do not inadvertently contribute to threats against public health, agriculture, national security, or the environment.
The policy supersedes the 2012 Federal DURC Policy, the 2014 Institutional DURC Policy, and the 2017 P3CO Framework to provide a unified oversight framework for biosafety and biosecurity.
Updated SafetyNet DURC/PEPP Page Launching March 6!
On Thursday, March 6, UCLA is launching an updated DURC/PEPP page in our IBC SafetyNet system. This update will streamline assessment, monitoring, and reporting in alignment with the latest policy. Moving forward, the new DURC/PEPP page will be required for all new Biological Use Authorizations (BUAs) and amendments. Investigators must complete this section as part of the submission process.
Education & Training Coming Soon! We are developing training to support PIs and research teams in navigating compliance requirements. Stay tuned for more details!
What Researchers Need to Know!
Categories of Research
The new policy divides research into two categories:
● Category 1: Involves a specific list of biological agents or toxins and is reasonably anticipated to result in certain high-risk outcomes, such as increased transmissibility, virulence, and resistance to medical countermeasures. Examples include Botulinum Neurotoxins, Chikungunya virus, and Francisella tularensis.
● Category 2: Involves, or is reasonably anticipated to result in, a Potential Pandemic Pathogen (PPP), the development, use, or transfer of a Pathogen of Enhanced Pandemic Potential (PEPP), or an eradicated or extinct PPP that may pose a significant public health threat.
Who Should Pay Attention to This Policy?
Key Stakeholders:
● Principal Investigators (PIs): Must comply with the new policy for research involving Category 1 or 2 agents and experimental outcomes.
● Institutional Bodies (e.g., IBCs, IREs, EH&S): Responsible for evaluating research, assessing risks and ensuring institutional compliance through oversight and review processes.
● Research Team Members and Collaborators: Required to complete relevant education and training on DURC/PEPP policies and adhere to all oversight and safety requirements.
Researchers not directly working with DURC/PEPP agents should stay informed, as updated institutional policies and federal regulations may impact broader research practices and compliance requirements.
Next Steps for PIs Ahead of the May 6th Policy Implementation
To prepare for implementation of the new USG Policy, PIs should take the following actions:
1. Self-Assess: Complete the ‘PI Self-Assessment’ form available on the UCLA Institutional Review Entity (IRE) Website to determine if your research involves Category 1 or 2 agents or outcomes. This must be done before submitting proposals to federal funding agencies (FFA).
2. Review Current Research: Evaluate ongoing projects for high-risk agents or experimental outcomes and consult the IRE for guidance if needed.
3. Submit Amendments: Use SafetyNet to update your Biological Use Authorization (BUA) if your research scope changes or new high-risk agents are added.
4. Education and Training: Training requirements at UCLA include taking CITI Dual Use Research of Concern (DURC) training. This training is required for PIs and research staff working with a listed Category 1 agent, regardless of whether the research falls under the USG policy, as well as for anyone conducting research that is subject to the policy. Reach out to the ICDUR or IBC Mailbox for additional information and personalized education tailored to your research needs.
References
USG Policy
USG Implementation Guide
UCLA IRE Website
UCLA
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