The document, authored by Kelly Cole and Allen DiPalma, outlines the regulatory framework and institutional responsibilities for the oversight of Dual Use Research of Concern (DURC) at the University of Pittsburgh, in accordance with federal policies. It defines DURC as life sciences research that could be intentionally misapplied to pose significant threats to public health, agriculture, the environment, or national security, with a primary focus on work involving 15 high-risk biological agents categorized as Tier 1 Select Agents. The presentation reviews key U.S. Government policies implemented since 2012, which require regular review, risk assessment, and management of federally funded research involving specified pathogens and experimental outcomes, such as increased virulence, resistance, or dissemination potential.
Institutionally, the document describes an integrated framework involving the Principal Investigator, a DURC Committee, and designated institutional officials, as well as dedicated units focusing on research compliance and biosafety. The process includes mandatory notification and documentation, periodic reassessment, and the development of Risk Mitigation Plans in coordination with oversight bodies. The committee structure ensures ongoing compliance, training, and responsible communication of research, while reporting obligations to federal agencies are clearly delineated. Additionally, the document prompts consideration of broader challenges, including the rising costs of high-containment research, the potential restrictive impact of regulations on scientific inquiry, and the necessity of balancing safety concerns with public understanding. The overarching goal emphasized is to maximize scientific freedom while minimizing potential risks associated with sensitive research.
