COGR Response to Part 2 of the National Academies Report

The document provides a detailed analysis and response from COGR to Part 2 of the National Academies report "Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century." The report examines key federal regulatory challenges affecting academic research, such as human subjects research protections (the Common Rule), export controls, select agents and toxins, intellectual property (IP) and technology transfer, and operationalizing a proposed Research Policy Board (RPB). Regarding human subjects research, the Committee calls for a new independent national commission to reassess ethical and regulatory frameworks, given emerging research types and public concerns over proposed Common Rule revisions—especially those related to biospecimens. Both the Committee and COGR argue for withdrawing the current Notice of Proposed Rulemaking (NPRM) to allow thorough, consensus-driven reform led by such a commission. In the areas of IP and technology transfer, the document highlights inefficiencies in the current iEdison reporting infrastructure and endorses creating uniform, less burdensome reporting standards, though it questions the benefit of shifting system management away from the NIH without more resources. For select agents and toxins, the Committee recommends regulatory consolidation and clearer, risk-based criteria, with COGR supporting changes but noting possible legislative barriers. On export controls, the report and COGR endorse ongoing reform to safeguard fundamental research from unnecessary restrictions, emphasizing stakeholder engagement and harmonization of regulatory definitions. Finally, the formation of a Research Policy Board is advanced as a necessary mechanism for continuous stakeholder input and systematic review of research regulations. COGR supports this concept, noting the need for collaboration with existing university associations and pragmatic legislative approaches, as reflected in recent Congressional proposals. The document concludes by commending efforts to streamline research regulation and foster a more supportive environment for federally funded research.