Why does SMART IRB Agreement v2.0 include the potential for the Reviewing IRB to review the congruence of a grant application/proposal with a research protocol? Didn’t the revised (2018) Common Rule eliminate this requirement?
SMART IRB Agreement v2.0 retains and slightly revises the congruence provision because congruency review may be required by laws/regulations other than the Common Rule or other federal rules (such as state laws) or by any type of funding agencies or sponsor. By its terms, the provision is still only triggered if such laws or regulations or any funding agencies or sponsors require congruence review. However, at the request of federal agencies, SMART IRB Agreement v2.0 provides that federal agencies, when serving as the Reviewing IRB, are not required to and will not perform a grant congruence review and that in such reliances the responsibility for that review (where it is required) will remain with the Relying Institution. See the SMART IRB Agreement v2.0 FAQS for more information.