This document presents preliminary findings from COGR and APLU based on a review of 906 responses by individual members of the general public to the Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule, which governs human subjects research in the United States. The majority of public comments primarily addressed proposed regulatory changes concerning the use of biospecimens, including expanding the definition of "human subject," mandating broad consent for secondary research, and restricting the Institutional Review Board (IRB) waiver of consent. Opinion pieces in major media, particularly Rebecca Skloot’s New York Times op-ed, significantly influenced the volume and stance of public responses, with a marked increase in support for regulation following its publication.
The findings indicate a nuanced public perspective. Opposition slightly outweighed support across key biospecimen proposals: 55% opposed changes, 45% supported (many citing Skloot’s influence), with earlier comments more likely to oppose changes compared to those submitted post-op-ed. Specifically, 61% opposed expanding the definition of "human subject" to non-identified biospecimens, while 36% supported this measure; 53% opposed mandated broad consent, 32% supported, and 15% gave qualified support, often preferring specific consent mechanisms. Concerns raised by opponents centered on the negative impact on medical research, increased logistical burdens, costs, and potential setbacks to advances in healthcare, particularly regarding underrepresented populations. Supporters of stricter regulations emphasized individual autonomy, ethical concerns, privacy, and compensation in cases of commercial benefit.
Regarding other proposals, comments showed divided opinions: 58% opposed restricting IRB waiver of consent, citing hindrances to retrospective and rare disease research, while 42% supported restrictions, often invoking parental rights over newborn DNA. Mandating single IRB review for multisite studies garnered a split response (52% opposed, 48% supported or conditionally supported), with concerns about administrative burdens and the need for further guidance. Extending the Common Rule to all clinical trials and posting consent forms publicly received limited but generally contentious feedback, reflecting apprehensions about practical utility and privacy. Overarchingly, a notable portion of respondents called for the proposal to be substantially revised, more publicly debated, and incrementally implemented rather than rapidly adopted, highlighting the complexity and divisiveness of the proposed regulatory changes.
