The preliminary findings from COGR and APLU summarize responses from approximately 400 academic researchers and practitioners to the Common Rule Notice of Proposed Rulemaking (NPRM), with a predominant focus on proposed changes regarding biospecimens. The vast majority of commenting researchers and practitioners opposed redefining “human subject” to include non-identified biospecimens and the requirement of broad consent for secondary research use, citing significant negative impacts on scientific discovery, public health, research feasibility, and added regulatory burden. There was near-unanimous opposition to restricting IRB waivers of consent, with respondents arguing that such restrictions would impede valuable research without offering meaningful additional protections to participants. While a minority of respondents supported stricter consent requirements, often emphasizing ethical considerations and patient rights inspired by historical cases, the prevailing sentiment viewed the proposed biospecimen regulations as unnecessary and potentially detrimental to medical progress, especially in the use of de-identified samples.
Other key proposals received more mixed or limited attention: the mandate for a single IRB in multisite studies was strongly supported (86%), as were enhanced data security safeguards (100% support among those commenting). Extending the Common Rule to all clinical trials and public posting of consent forms yielded evenly divided feedback, though these topics garnered less overall engagement. Overarching concerns noted that the NPRM, in its current form, failed to balance research facilitation with participant protection and lacked sufficient justification. Additional unsolicited comments reflected strong opposition to removing certain research categories from exemption and strong support for continuing to exclude historical and journalistic scholarship from the Common Rule. Overall, respondents urged a more nuanced approach, emphasizing the need for research community input and the consideration of both practical and ethical implications before finalizing new regulations.
