Conflicts of Interest: If a Reviewing IRB concludes that it cannot rely upon the conflict of interest assurances from a Relying Institution that is a federal agency, can the Research be withdrawn from Ceded Review with respect to that agency?

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from agency are not sufficient for it to rely upon may so inform the federal agency, and the Research will be withdrawn from Ceded Review (without an IRB approval or disapproval) with respect to that agency.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).