Yes. Some Reviewing IRBs may not be able to rely upon a conflict of interest assurance from a federal agency (for example, if the Reviewing IRB’s policies require the IRB to obtain specific information about investigators’ financial interests or to manage financial interests that are below de minimis thresholds or that do not otherwise constitute conflicts under relevant policies). In response to public comment on this issue, SMART IRB Agreement v2.0 provides that a Reviewing IRB that has agreed to serve as the IRB of record for a federal agency but that subsequently concludes that the conflict of interest assurances from agency are not sufficient for it to rely upon may so inform the federal agency, and the Research will be withdrawn from Ceded Review (without an IRB approval or disapproval) with respect to that agency. Note that the Agreement does not require any IRB to serve as a Reviewing IRB for a federal agency (or any other Participating Institution) in the first instance (e.g., Sections 2.2 and 3.2).
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?