The Council on Governmental Relations provided a detailed overview of the final revisions to the federal Common Rule, which governs the protection of human research subjects, as published in early 2017. The majority of the new regulations take effect on January 19, 2018, with the requirement for single IRB review of multisite cooperative research deferred to January 20, 2020. Significant updates include clarifications to the definitions of “human subject,” “identifiable biospecimen,” and “identifiable private information,” with a process for ongoing review of these definitions as scientific techniques advance. The final rule maintains traditional informed consent standards but introduces “broad consent” as an optional mechanism for storage and secondary research use of identifiable information and biospecimens, accompanied by new, detailed consent elements. The waiver of consent process has been clarified, particularly regarding situations where subjects have expressly refused broad consent. Requirements for consent now place greater emphasis on clarity, brevity, transparency, and the prospective subject’s reasonable expectations.
The rule expands the categories of exempt research and introduces the concept of “limited IRB review” for certain activities involving identifiable information. Notably, continuing review requirements have been significantly reduced, especially for minimal-risk studies and research limited to data analysis. The revised Common Rule mandates the use of a single IRB for most U.S.-based multi-institutional studies, but allows agencies significant flexibility in implementing this policy. Exclusions from coverage are more clearly delineated, especially for journalistic, historical, public health surveillance, and certain criminal justice activities. The rule also streamlines institutional compliance requirements, eliminates the need for IRB review of grant applications for certification, and provides new guidance provisions on privacy and data security, although it stops short of mandating new privacy/security standards. These revisions are projected to result in net regulatory cost savings and efficiencies, particularly by reducing redundant reviews and expanding exemptions. The final rule also reflects efforts to harmonize with other federal regulations, offers flexibility for tribal law, and removes certain populations (e.g., pregnant women) from being automatically classified as vulnerable to coercion. Overall, the revisions aim to modernize and streamline the oversight of research involving human subjects while maintaining essential ethical protections.
