The reviewed document summarizes preliminary findings from COGR and APLU regarding feedback from research universities, medical centers, and related stakeholders on proposed revisions to the Common Rule, as outlined in the Notice of Proposed Rulemaking (NPRM). Overall, there was considerable concern and widespread opposition among respondents, particularly surrounding the proposed changes to the regulation of biospecimens. The vast majority opposed expanding the definition of “human subject” to include non-identified biospecimens, the requirement for broad consent for biospecimen research, and restrictions on IRB waivers of consent. Respondents cited potential negative impacts on scientific progress, increased cost and impracticability, diminished research resources, and questioned whether such changes would meaningfully enhance participant protections. Alternative approaches, such as selective inclusion based on whole genome sequencing, were preferred by some, though many advocated maintaining current definitions and processes.
Opposition also predominated with respect to other significant NPRM proposals, notably the mandated use of a single IRB for multisite studies, extending the Common Rule to all clinical trials, implementing federally mandated security safeguards, and the proposed posting of clinical trial consent forms on a federal website. Respondents contended that these changes would introduce unnecessary costs, administrative burdens, and possible regulatory conflicts without commensurate benefits to research participant protection or research efficiency. Underlying these detailed critiques was a broader concern that the NPRM was hastily developed, insufficiently detailed, and failed to address practical implications for research institutions, especially those conducting significant NIH-funded research. The document highlights that the most research-intensive institutions, responsible for the majority of NIH-supported biomedical research, demonstrated near-universal opposition to the NPRM’s central provisions, reflecting serious apprehension regarding the potential impacts on national biomedical research capacity and innovation.
