Does the Agreement comply with the revised Common Rule?

Yes. At the time of its drafting, the SMART IRB Agreement was designed with the proposed regulatory requirements in the Common Rule Notice of Proposed Rulemaking (80 Fed. Reg. 53933 (Sept. 8, 2015)) in mind, and the terms of the Agreement comply with the 2018 requirements of the final revised Common Rule, including the cooperative research provision (45 CFR 46.114(b)). The Agreement was drafted to be deliberately flexible with regard to the concepts of limited IRB review and broad consent introduced in the revised Common Rule; the expectation under the Agreement is that institutions will require institutional oversight, which may include limited IRB review in some cases, for the new exempt categories of human subjects research that will require such review, and the Agreement is not explicitly restrictive as to which portions of a consent document may be revised, therefore accommodating customization related to broad consent. Note: select provisions of the Agreement may no longer apply to research subject to the Common Rule (e.g., references to grant congruency review, scope of an institution’s FWA).