Governing Dual-Use Research of Concern in the Life Sciences: United States and Canada Policy Comparative Analysis and Recommendations.

Introduction: This study examines and compares dual-use research of concern (DURC) policies in the United States and Canada, two countries with advanced biosafety frameworks, to identify strengths, weaknesses, and areas for improvement in DURC governance. Methods: The study conducts a comprehensive review of current DURC policies, regulatory frameworks, and oversight mechanisms in the United States and Canada, analyzing key policy documents, including the 2024 U.S. Government Policy for Oversight of DURC and Canada's Human Pathogens and Toxins Act. Results: Both U.S. and Canadian DURC policies require principal investigators (PIs) to conduct continuous project reviews throughout the research duration and maintain dedicated advisory agencies for biosecurity. Their approaches are notably multi-layered, integrating policymaking with educational initiatives and surveillance systems. However, important differences exist in their governance strategies. The United States has specific DURC policies primarily for federally funded research, while Canadian regulations apply to all facilities handling human pathogens and toxins. Notably, Canada also employs more detailed pathogen classification and quantity specifications than the United States and requires designated biological safety officers for oversight. Conclusion: While both countries maintain robust DURC oversight frameworks, they differ in their approach to governance, scope, and implementation. Based on this analysis, five key recommendations were developed. This includes establishing an international minimum standard for DURC regulation, extending U.S. DURC legislation to non-federally funded research, developing detailed risk-benefit analysis guidelines, and strengthening policies for responsible scientific communication.