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