Why does the SMART IRB Agreement require the Reviewing IRB to review the congruence of any federal grant application/proposal with the research protocol submitted to the IRB when such review is required by federal regulations or oversight agencies?
At the time of its drafting, the intent of the congruence provision in the Agreement was to make sure that the responsibility for IRB review of the federal grant application/proposal was specifically assigned amongst institutions participating in a ceded review, and not missed. The Reviewing IRB has generally been considered to be in the best position to be able to compare the grant with the study protocol and address any inconsistencies, which might need to be addressed, for example, via a protocol amendment. The awardee institution would still have been responsible for making the certification to the applicable federal department/agency that the review had been performed. The 2018 final revised Common Rule removes the requirement for federal grant congruency review. Because the congruence provision, by its terms, is only applicable when congruence review “is required by federal regulations,” it does not require congruence review for research subject to the final Common Rule. Other agencies, including state regulatory authorities, may still require congruency reviews. If congruency review is required by another authority, the Relying Institution should communicate the requirement with the Reviewing IRB as an explicit expectation of local requirements.