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.
Articles in this section
- Background on SMART IRB Agreement v2.0
- Background: Why are the revisions to the SMART IRB Agreement reflected in SMART IRB Agreement v2.0 necessary?
- Background: How will SMART IRB Agreement v2.0 allow NIH to collaborate with extramural organizations?
- Admninistrative Issues: If my institution has already joined SMART IRB Agreement v1.0, can my institution continue to use that Version 1.0?
- Administrative Issues: My institution is not serving as a Reviewing IRB for the NIH nor is it ceding IRB review to the NIH Intramural Research Program IRB. Does my institution need to sign SMART IRB Agreement v2.0?
- Administrative Issues: If my institution serves as a Reviewing IRB for the NIH engaged and for other institutions engaged in the Research, would all of the institutions engaged in that Research need to sign SMART IRB Agreement v2.0?
- Administrative Issues: Does my institution need to re-execute a Joinder Agreement to sign Version 2.0 of the SMART IRB Agreement?
- Administrative Issues: Re-execution of a Joinder Agreement to sign Agreement v2.0 & satisfaction of Section 1.2, HRPP Quality
- Administrative Issues: Does my institution need to document which version of the SMART IRB Agreement covers each of our reliance arrangements in effect?
- Reporting: How will reporting of noncompliance and unanticipated problems be handled by NIH?