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 If a mutually agreeable approach cannot be identified, Section 8.10 requires that the Research be withdrawn from Ceded Review with respect to the affected Participating Institutions.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 on SMART IRB Agreement v2.0
- Background: Why are the revisions to the SMART IRB Agreement reflected in SMART IRB Agreement v2.0 necessary?
- Background: How will SMART IRB Agreement v2.0 allow NIH to collaborate with extramural organizations?
- Admninistrative Issues: If my institution has already joined SMART IRB Agreement v1.0, can my institution continue to use that Version 1.0?
- 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?