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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Background: Why are the revisions to the SMART IRB Agreement reflected in SMART IRB Agreement V3.0 necessary?

Jeremy Lavigne, MA, CIP

February 17, 2025 15:26
Updated

Over the past several years, SMART IRB leadership worked with the SMART IRB Harmonization Steering Committee, the National Center for Advancing Translational Sciences (NCATS) and other federal agency representatives, and members of the SMART IRB community to discuss changes to Version 2.0 of the SMART IRB Agreement. The SMART IRB Reliance Agreement Version 3.0 changes are intended to:

address feedback from current and potential Participating Institutions
fully reflect changes to IRB review requirements in the 2018 Common Rule; and
allow additional federal agencies to participate in the agreement.

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