The preliminary findings from COGR and APLU’s review of industry, pharmaceutical, and trade group responses to the Common Rule NPRM reveal significant opposition to several key proposed regulatory changes, particularly those affecting biospecimens and informed consent procedures. All respondents who addressed the proposal to expand the definition of "human subject" to include non-identified biospecimens opposed it, citing concerns about negative impacts on scientific advancement and the need to balance privacy with research facilitation. While a slim majority expressed qualified support for the concept of broad consent for future research use of biospecimens, nearly half opposed this approach, and many highlighted implementation challenges and potential negative effects on research material availability.
Regarding the mandate for a single institutional review board (IRB) for multi-site research, there was strong support (67%), with additional stakeholders offering qualified support, primarily emphasizing the need for institutional flexibility rather than a rigid mandate. Proposals to require public posting of consent forms met with overwhelming opposition, with stakeholders arguing that such measures do little to improve transparency or patient comprehension and could inadvertently compromise proprietary information, legal confidentiality, or research competitiveness. Concerns were also raised about the negative consequences of extending standardized data protections and Common Rule applicability, with some fearing that overly broad requirements could push industry-sponsored research outside the United States. A minority called for the Notice of Proposed Rulemaking (NPRM) itself to be revised and simplified before any final regulatory changes are adopted. Overall, the responses underscore a preference for regulatory changes that safeguard participant rights without unduly hindering research innovation or operational efficiency.
