The new Section 8.10 addresses potential conflicts between the terms of the Agreement and the requirements of applicable law, regulation, or other federal or state requirements. “Other federal or state requirements” is intended to include federal/state agency funding terms and policies. Conflicts with a Participating Institution’s contractual obligations under other private contracts are not included; Participating Institutions are expected to manage any conflicts (or assure that there are no conflicts) with the terms of their other private contracts on their own. Only when complying with the terms of the Agreement would cause a Participating Institution to violate an applicable law, regulation, or other governmental requirement is a Participating Institution eligible for consideration of an alternate approach.
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- 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?
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