The preliminary findings from COGR and APLU's review of responses to the Common Rule NPRM reveal a range of perspectives from twelve submissions, including those from independent institutional review boards (IRBs). The areas evaluated primarily concern biospecimens, the use of a single IRB for multisite studies, broader application of the Common Rule, data security, and the public posting of clinical trial consent forms. Feedback on biospecimen-related proposals was mixed: opposition was evident toward expanding the definition of "human subject" to non-identified biospecimens and toward mandating broad consent for secondary use, while there was unified resistance to restricting IRB waivers of consent.
Strong support emerged for the single IRB mandate among independent IRBs, with the majority favoring its implementation. Opinions were more divided on other areas; a minor proportion endorsed extending the Common Rule to all clinical trials and strengthening data security measures. The proposal to require posting of consent forms to a federal website also faced divided responses, with slightly more opposition than support. Overall, while consensus exists on certain regulatory changes, the preliminary review underscores ongoing debate and nuanced positions within the research oversight community.
