The Association of American Universities (AAU), the Association of Public and Land-grant Universities (APLU), and the Council on Governmental Relations (COGR) jointly issued a statement in response to Part II of the National Academies of Sciences, Engineering, and Medicine's report, "Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century." The organizations expressed support for the committee’s engagement with key regulatory areas, including export controls, select agents and dual-use research, and intellectual property and technology transfer reporting. They highlighted their concerns regarding the recently proposed Common Rule Notice of Proposed Rulemaking (NPRM) on human subjects in research, noting potential negative impacts on research and medicine, significant implementation costs, and inadequately developed elements such as informed consent templates and privacy safeguards.
Additionally, AAU, APLU, and COGR referenced their previous submission of comments on the NPRM, as well as comprehensive analyses conducted in collaboration with other institutions and advisory panels that echoed their reservations. They emphasized a lack of urgency in finalizing new regulations, advocating for a more deliberate approach that considers the complexity of the issues and the need for input from a broad spectrum of stakeholders. The organizations concurred with the National Academies committee’s assessment that the NPRM fails to comprehensively address critical questions, underscoring the importance of thoughtful and inclusive deliberation in shaping future research regulations.
