The document outlines a Principal Investigator (PI) Self-Assessment Tool designed to evaluate whether a research project falls within Category 1 (Pandemic Potential Pathogens, PPP) or Category 2 (Potential Enhanced Pandemic Pathogens, PEPP). Through a series of structured questions, the tool guides researchers in identifying if their work involves high-risk agents or experimental modifications—such as increased transmissibility, virulence, resistance, or immune evasion—that could significantly impact human, animal, or environmental health. Researchers answering affirmatively to any screening questions are instructed to report their work to their Institutional Review Entity (DURC-IRE) for a more comprehensive risk assessment before proceeding. The assessment process includes a detailed risk evaluation and emphasizes compliance with oversight and reporting requirements to prevent misuse or unintended consequences.
Additionally, the document provides an extensive list of specific biological agents and toxins subject to Dual Use Research of Concern (DURC) policies. These include various viruses, bacteria, and toxins known for their potential to cause widespread harm or pandemics. The document reinforces that the self-assessment is an initial screening mechanism and affirms that final categorization and authorization rest with the DURC-IRE and relevant funding agencies. Researchers are reminded to remain vigilant and continually reassess their projects for any changes that might alter their risk profile, ensuring that institutional controls and federal guidelines are strictly adhered to throughout the research process.
