Applies to: Agreement V3.0
The 2018 Common Rule eliminated the federal requirement that an IRB compare a grant application with the protocol. The Agreement keeps a congruence provision (§5.15) anyway, because congruence review may still be required by other laws, by a funding agency, or by a sponsor — and when it is, the community asked that the Agreement assign the task rather than leave it to ad hoc arrangements.
When it applies. Only when congruence review is required by law, regulation, a funding agency, or a sponsor. Otherwise §5.15 is dormant.
Who does it. When required, and unless other arrangements are made in advance, the Reviewing IRB compares the grant application or contract proposal with the protocol and addresses inconsistencies (often through an amendment). Exception: a federal agency serving as Reviewing IRB does not perform congruence review; the responsibility stays with the Relying Institution.
Who certifies. The awardee institution — the one holding the grant — remains responsible for any certification to the funding agency that the review was done (SOP section 15).
See also
- Selecting the Reviewing IRB
- What's new in Version 3.0
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