Congruence of Grant Applications/Contract Proposals: Why does SMART IRB Agreement v2.0 retain Section 5.15, Congruence of Grant Applications/Contract Proposals?

This provision is retained and slightly revised in response to public comments noting that such congruence review may still be required by laws/regulations other than the Common Rule (such as state laws) or by the funding agency or sponsor. The comments indicated that to the extent congruence reviews continue to be required, the community wishes to address the issue in the Agreement, rather than leaving it up to Participating Institutions to make arrangements among themselves regarding how such reviews will be performed. By its terms, the provision only applies when congruence review is required by applicable law or regulation or by the funding agency or sponsor. Notwithstanding the retention of the provision, the provision has been further modified to reflect that federal agencies that are serving as Reviewing IRBs will not perform congruence review; in such situations, the Relying Institution will need to perform any required congruence review.