The preliminary review by COGR and APLU of the Disease Registries’ responses to the Common Rule NPRM highlights significant opposition among disease registry stakeholders to several proposed regulatory changes, particularly those involving biospecimens. The majority of responding registries—large national databases and professional organizations—expressed concern about expanding the definition of “human subject” to include deidentified biospecimens, with 100% opposition among those commenting due to anticipated negative impacts on scientific progress, research costs, and the potential to impede initiatives in precision medicine. Similarly, there was unanimous opposition by those commenting on mandating broad consent for secondary use of biospecimens, citing impracticality for smaller institutions and the risk of introducing research bias if certain populations were inadequately represented. Restrictions on IRB waiver of consent also faced substantial resistance (75% opposed), especially regarding archived tissues essential for long-term population-based research.
Conversely, there was considerable support (75%) for mandating a single institutional review board (IRB) for multisite studies, with proponents emphasizing reduced administrative burden and faster research startup times. However, concerns were noted about the necessary infrastructure to implement a central IRB. Additional topics, such as extending the Common Rule to all clinical trials irrespective of funding and the public posting of consent forms, gathered limited but notable opposition. Disease registries did not provide feedback on proposed data security provisions. Overall, the registries’ responses reflect a preference for maintaining current regulatory flexibilities in biospecimen research and highlight practical considerations related to efficient management of multisite studies.
