The reviewed document presents preliminary findings from COGR and APLU regarding comments submitted by professional societies and associations on the Notice of Proposed Rulemaking (NPRM) to revise the Common Rule governing human subjects research. The analysis covers responses from 86 organizations representing a broad range of scientific, medical, and academic disciplines. The primary focus of the comments centered on proposed regulations affecting biospecimens, single Institutional Review Boards (IRBs) for multisite studies, the extension of the Common Rule to all clinical trials at federally-funded institutions, security requirements, and transparency regarding consent forms.
A significant majority of professional society comments opposed key NPRM proposals related to biospecimens, including expanding the definition of “human subject” to encompass non-identified biospecimens, mandating broad consent for secondary research use, and restricting IRB waivers of consent, largely arguing that these measures would hinder scientific discovery, disproportionately burden institutions, and potentially exclude underserved populations from research benefits. Conversely, there was strong support for the mandate to use a single IRB for multisite studies, citing improvements in efficiency and regulatory harmonization. While a smaller proportion addressed proposals on security safeguards and extending Common Rule coverage, those commenting were generally supportive. Notably, a minority of societies suggested the NPRM should not move forward without significant revision, voicing overarching concerns about administrative burden, research accessibility, and the balance of ethical principles underpinning human subjects protections. The findings reflect considerable divergence of opinion within the research community but highlight a consensus on the importance of minimizing barriers to valuable research while maintaining ethical standards.
