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?
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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Admninistrative Issues: If my institution has already joined SMART IRB Agreement v1.0, can my institution continue to use that Version 1.0?

Liz Witte

November 19, 2020 19:06
Updated

Yes. However, note that an institution that serves as a Reviewing IRB for the NIH Intramural Research Program will need to sign Version 2.0, as will any Relying Institution for which the NIH Intramural Research Program IRB serves as the Reviewing IRB. Once Version 2.0 is finalized, any new institution that wishes to join SMART IRB and has not yet completed a Joinder will only have the option to sign SMART IRB Agreement v2.0.

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