Assessment of Research That Requires Institutional Review

This document outlines the requirements for principal investigators (PIs) to assess and report whether their proposed research falls within two federally defined categories related to dual use research of concern and pathogens with enhanced pandemic potential, as part of a federal grant application. It provides detailed criteria and checklists for identifying research involving specific high-risk biological agents, toxins, or experimental outcomes that could significantly enhance transmissibility, virulence, immune evasion, or resistance of pathogens, among others. The self-assessment is mandatory for compliance, subject to review by the institutional review entity, and includes comprehensive agent lists and definitions to guide researchers in determining the regulatory scope of their projects.