The document presents preliminary findings from COGR and APLU’s analysis of advocacy group responses to the Notice of Proposed Rulemaking (NPRM) on changes to the Common Rule for human subjects research. Sixty responses from a broad range of organizations—including disease-specific advocacy groups, patient and privacy advocates—were reviewed, focusing on proposals concerning biospecimens, IRB review processes, the scope of the Common Rule, security safeguards, and transparency requirements for clinical trial consent forms. The findings indicate significant diversity of opinion, often correlating with organizational focus: general citizen, health, and privacy advocacy groups demonstrated greater support for expanded definitions of human subjects (to include non-identified biospecimens), broad consent requirements, and enhanced privacy/security measures, while cancer and rare disease groups expressed stronger opposition, citing concerns about research barriers, burdensome consent processes, and negative impacts on rare biospecimen availability and research advancement.
Opposition or support for specific NPRM provisions varied across topics. For proposals on biospecimens and broad consent, there was a notable split, with a significant portion of respondents either opposing or supporting with qualifications, reflecting ongoing debates over risks, burdens, and participant autonomy. Proposals to limit IRB waivers for consent in secondary research were predominantly opposed, especially by rare disease advocates, who emphasized the critical importance of access to biospecimens for advancing rare condition research. In contrast, the mandate for a single IRB in multisite studies and extension of the Common Rule to all clinical trials found broader support, although calls for cautious implementation and exceptions were noted. Most respondents favored stronger security safeguards and increased posting of consent forms, though there were concerns regarding the feasibility of uniform standards and administrative burdens. Finally, a subset of respondents expressed overarching critiques of the NPRM’s complexity, lack of clarity, and insufficient detail for meaningful public comment, urging its reconsideration or substantial revision before finalization.
