PI Responsibilities for DURC & PEPP

• Self-Assessment: The PI is responsible for assessing their proposed or ongoing research at the proposal stage and continuously throughout its lifecycle to identify if it could be classified as Category 1 (DURC) or Category 2 (PEPP) research. This involves checking if the research uses specific biological agents/toxins and is reasonably anticipated to result in certain experimental outcomes (e.g., enhanced virulence, transmissibility, or immune evasion of a pathogen). 
• Notification: If the PI's self-assessment suggests the research may be within the scope of the policy, they must immediately notify their federal funding agency and the university's the DURC & PEPP committee  
• Halting Work: If potential DURC/PEPP is identified during the course of experimentation, the PI must immediately halt all related work, secure the materials, and report their observations to the IRE for further review. 
• Collaboration on Risk Mitigation: The PI must work collaboratively with the IRE to conduct a risk-benefit assessment and draft a risk mitigation plan. This plan outlines measures to minimize the risks associated with the research's conduct and communication. 
• Compliance and Adherence: Research cannot begin or continue until the risk mitigation plan has been reviewed and approved by the federal funding agency. The PI is responsible for ensuring all research activities are conducted in strict accordance with the approved plan. 
• Reporting: PIs must submit annual progress reports for Category 1 research and semi-annual reports for Category 2 research to the IRE and funding agency, or as requested. 
• Training and Education: The PI must ensure that all laboratory personnel under their supervision receive appropriate education and training on DURC/PEPP policies and demonstrate competency. 
• Responsible Communication: PIs must communicate their research findings in a responsible manner, adhering to any restrictions or guidelines specified in the approved risk mitigation plan.   

In essence, the PI acts as the primary point of contact and compliance, working within the university's established framework (DURC&PEPP/IBC) to ensure that potentially harmful research is identified, assessed, and managed safely and securely in accordance with US Government policies.