The document presents a detailed analysis and response by the Council on Governmental Relations (COGR) to Part 2 of the National Academies Committee’s report, "Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century." The report addresses significant federal regulatory issues impacting academic research, focusing on human subjects research regulations (the “Common Rule”), export controls, select agents and toxins, intellectual property (IP) reporting, and the proposed operationalization of a Research Policy Board (RPB). Central to the discussion on human subjects research is a call for the establishment of an independent national commission—authorized by Congress—to reassess and update the ethical, legal, and institutional frameworks guiding research involving humans, especially in light of evolving contexts such as de-identified biospecimens and large data sets. The Committee critiques recent proposed revisions to the Common Rule, particularly concerning the expansion of definitions and consent requirements, arguing these could impede scientific progress and fail to address fundamental questions; it recommends halting regulatory changes until the proposed commission can weigh in and stakeholder concerns are further considered.
Additionally, the report evaluates the current state of intellectual property and technology transfer, recommending modernization and streamlining of the iEdison reporting system, while recognizing the need for agency uniformity and increased resources rather than mere administrative relocation. Concerning select agents and toxins, the Committee suggests centralizing regulatory authority and improving access for legitimate research, especially during public health emergencies. In the sphere of export controls, it advocates for ongoing reforms that maintain the principle of unrestricted fundamental research while addressing stakeholder concerns about overly restrictive interpretations. Lastly, the proposed Research Policy Board is highlighted as a critical mechanism for streamlined stakeholder engagement, regulatory harmonization, and policy guidance. COGR expresses overall support for the Committee’s recommendations and pending legislative efforts to implement them, emphasizing the need to reduce unnecessary regulatory burdens and ensure a collaborative, adaptive, and efficient research enterprise.
