The document summarizes discussions from a meeting between representatives of higher education institutions and federal agencies regarding the proposed delayed implementation of the revised Common Rule, which governs human subject research protections. Academic institutions strongly advocate for a one-year delay in the Common Rule’s compliance date, rather than both its effective and compliance dates, to allow for partial implementation—especially of provisions that reduce administrative burden—while affording time to develop necessary policies, adapt electronic systems, and provide comprehensive guidance and training. Delegates noted the unusual challenge posed by the simultaneous effective and compliance dates and referenced prior regulations with staggered deadlines as a more workable model. They also expressed concern over the lack of official guidance or educational resources from relevant agencies, warning that moving forward without such direction could lead to inconsistent compliance efforts and costly, potentially redundant system changes.
Further compounding institutional uncertainty is the broader regulatory environment, marked by other concurrent policy changes (such as NIH regulations and FDA guidance) and the as-yet incomplete efforts to harmonize human subject protection requirements between the FDA and HHS. This lack of harmonization could result in conflicting compliance obligations. A one-year postponement, according to the institutions, would provide agencies the opportunity to release critical guidance, promote harmonization, and allow thorough engagement with the research and IRB communities to refine processes and best practices, ultimately reducing confusion, administrative burden, and cost. The document closes by urging that the compliance date be separated and extended, ideally through an expedited administrative process, to ensure a more orderly and effective implementation of the revised Common Rule.
