The COGR-APLU analysis provided a comprehensive review of public comments submitted to the federal government regarding the Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule, which governs human subjects research. Over 2,100 comments were examined, representing a wide array of stakeholders, including the public, patients, researchers, institutions, industry, advocacy groups, and government bodies. A particularly contentious issue was the proposal concerning non-identified biospecimens, with 76% of respondents addressing this point and a vast majority (74%) expressing opposition, including strong resistance from patients, researchers, universities, and industry. The chief concerns highlighted the potential for a significant reduction in both the availability and diversity of biospecimens, especially from underserved groups, which could negatively impact research into rare diseases and medical advancements.
Debate also centered around the proposal for a single Institutional Review Board (IRB) for multisite studies—an idea nearly evenly split in support and opposition, with advocacy groups tending to support it for perceived efficiency, while universities and tribal governments generally opposed it for concerns over applicability and administrative burden. Other proposals, such as the extension of the Common Rule to all clinical trials and the requirement to post consent forms publicly, also received mixed or predominantly negative feedback, especially from universities, due to perceived increases in administrative workload without commensurate improvements in protections. Notably, a segment of the comments (5%) called for the NPRM to be withdrawn and rewritten, with organizations like SACHRP advocating for a simplified, more targeted approach. Overall, the analysis underscores widespread concern with several of the proposed changes and emphasizes the need for further deliberation and stakeholder engagement in revising human subjects research regulations.
