The review of responses from advisory and related organizations to the Common Rule Notice of Proposed Rulemaking (NPRM) reveals widespread opposition to several proposed regulatory changes concerning human subjects research protections. Six key organizations, including respected federal advisory bodies and research oversight associations, expressed unanimous or near-unanimous opposition to proposals that would expand the definition of “human subject” to include non-identified biospecimens, require broad consent for secondary biospecimen use, and restrict the waiver of consent by Institutional Review Boards (IRBs). Critics argue these changes could hinder valuable research and medical innovation, impose significant administrative and financial burdens—particularly on smaller institutions—and lack clear ethical or empirical justification. Respondents suggested that respect for autonomy is diminished where biospecimens cannot be linked to the donor, and several proposed more nuanced alternatives, such as notice and opt-out mechanisms, rather than broad mandates.
Other proposed changes, such as requiring a single IRB for multisite studies and mandating public posting of consent forms, met with substantial reservations. Concerns centered on the potential for increased complexity, loss of local context, and administrative difficulties, although some support for the efficiency gained by single IRB review was noted if implemented with flexibility and guidance. Calls for a case-by-case approach and the provision of detailed guidance were recurrent. Additional issues, such as extending the Common Rule to all clinical trials and augmenting data security measures, received minimal or critical feedback, primarily worrying about burdens not aligned with risk levels. Broadly, half of the respondents advocated for the NPRM to be substantially revised, simplified, and republished for further comment, arguing that the current proposals were insufficiently coherent or responsive to stakeholder needs and risk impeding both research and participant protections.
