The preliminary findings from COGR and APLU provide an overview of 17 responses from state and city health departments, public health labs, CDC staff, and related associations regarding proposed changes to the Common Rule as outlined in the Notice of Proposed Rulemaking (NPRM). The review focused on major issues such as the definition and research use of biospecimens, mandated use of a single institutional review board (IRB) for multisite studies, expansion of the Common Rule to all clinical trials, data security safeguards, and the proposed posting of clinical trial consent forms online. The responses reflected significant concern about the NPRM's treatment of biospecimens, with 79% opposing changes that would redefine “human subjects” to include non-identified biospecimens, and 64% opposing the mandate for broad consent for secondary use of biospecimens. Many respondents warned that these changes could impede public health research reliant on existing sample collections.
Regarding related proposals, opposition was also notable toward the adjusted definition of “human subject” and the broader consent requirements, with some partial or qualified support suggesting alternative definitions or consent mechanisms like notification or opt-out. The responses to other aspects were more evenly divided or limited: half of those who commented on IRB waiver of consent or single IRB use for multisite studies were opposed, with similar proportions supporting or qualifying their support. Fewer respondents addressed the proposals to extend the Common Rule to all clinical trials or to enhance data security, and there was no commentary on the idea of posting consent forms online. Overall, the responses from public health officials and epidemiologists emphasize the critical importance of maintaining biospecimen access for research and express strong reservations about policy changes that could restrict such work or increase administrative burdens.
