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?

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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?

Liz Witte

November 19, 2020 19:06
Updated

No. However, note that if an institution wishes to serve as a Reviewing IRB for the NIH Intramural Research Program, it will need to sign SMART IRB Agreement v2.0, as will any Relying Institution for which the NIH Intramural Research Program IRB serves as the Reviewing IRB.

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