Background
How did 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?
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 V3.0?
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?
Reporting: How will reporting of noncompliance and unanticipated problems be handled by NIH?
Non-Interference with Requirements of Law: What must a Participating Institution do if it determines that complying with a provision of the Agreement will cause it to be in violation of applicable law, regulation, or other federal or state requirements?
Non-Interference with Requirements of Law: What violations or conflicts are addressed in the new Section 8.10?
Non-Interference with Requirements of Law: What change is effected through the new Section 8.10, No Violation of Law?

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

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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