Background on SMART IRB Agreement V3.0
Background: Why are the revisions to the SMART IRB Agreement reflected in SMART IRB Agreement V3.0 necessary?
Background: How will SMART IRB Agreement v2.0 allow NIH to collaborate with extramural organizations?
If my institution has already joined SMART IRB Agreement V1.0 or V2.0, can my institution continue to use that Version of the Agreement?
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?

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Non-Interference with Requirements of Law: What change is effected through the new Section 8.10, No Violation of Law?

Liz Witte

November 19, 2020 19:06
Updated

The new Section 8.10 in SMART IRB Agreement v2.0 states that the Agreement does not require Participating Institutions to take any actions that would be in violation of applicable law, regulation, or other federal or state requirements. We are not aware of any current conflict between the Agreement’s terms and any of these other sources of requirements; however, NIH requires the Agreement to address the possibility that such a conflict could arise.

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