Why does the SMART IRB Agreement v1.0 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? Is this provision now out of date given that the revised (2018) Common Rule eliminated the requirement for congruency review?
The intent of the congruence provision in v1.0 of the Agreement was to make sure that the responsibility for IRB review of the grant application/proposal under the pre-2018 Common Rule or any other federal human subjects research regulations was specifically assigned amongst institutions participating in a ceded review, and not missed. Where congruence review is required, the Reviewing IRB is often 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 be responsible for making the certification to the applicable federal department/agency that the review has been performed. Although the revised (2018) Common Rule eliminated the requirement for congruency review for research subject to that Rule, the congruence provision remains in v1.0 in case such review may be required by any other applicable federal human subjects research regulations or oversight agencies; by its terms, the provision is only triggered if such regulations or agencies require congruence review.