The document summarizes public feedback on the Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule, as reviewed in May 2016. Over 2,100 comments were received, a significant increase from earlier rounds, with the majority submitted by individuals without clear affiliations. Institutions, particularly medical and academic entities, also participated. Commenters raised concerns about the complexity and length of the NPRM, internal inconsistencies, the unavailability of key tools (such as consent form templates and privacy safeguard guidelines), and the perceived rush to finalize the rule. Critiques emphasized the challenge of providing meaningful feedback without access to these essential materials.
Several NPRM proposals drew particular attention. The expansion of the definition of human subjects to include non-identified biospecimens, stricter waiver criteria, and broad consent requirements were opposed by a broad coalition of patients, the general public, and research professionals, primarily due to concerns about restricting research and inadequate consent processes. The single IRB review mandate saw divided opinion: institutions generally opposed it due to increased administrative burdens and the perceived value of local review, while individuals tended to be more supportive. Tools for exemption determinations and improvements to informed consent processes also elicited mixed responses, complicated by the lack of details on deliverables. Support was strong for eliminating certain continuing reviews and for new privacy safeguards, although skepticism remained about their applicability, especially in social and behavioral research. Overall, commenters advocated for greater clarity, simplicity, and access to proposed guidance before regulatory changes are finalized.
