In this situation, the new Section 8.10 requires the Participating Institution to notify the other affected Participating Institutions and work with them to identify a mutually agreeable alternative approach to address the provision of the Agreement that is at issue. Such an approach might include identification of a different way to satisfy the Agreement provision (when possible) or a decision not to insist on the Participating Institution’s performance of the Agreement provision (if acceptable to the other affected Participating Institutions). (Note that under Section 8.6 of the Agreement, a decision not to insist on performance of an Agreement term does not constitute a waiver of the Agreement by the other affected Participating Institutions). If a mutually agreeable approach cannot be identified, Section 8.10 requires that the Research be withdrawn from Ceded Review with respect to the affected Participating Institutions.
Articles in this section
- 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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