If study team members from a non-federal Relying Institution identify potential financial conflicts of interest after the study has received IRB approval, must they disclose this information to the Reviewing IRB?

Yes. If the SMART IRB Standard Operating Procedures are being followed for a study, the study team must first disclose this potential financial conflict of interest (COI), as well as any applicable management plans, to their institution’s Point of Contact (POC), who will then assess whether the COI impacts their decision to cede IRB review. If the POC determines that the study can continue to be ceded to the Reviewing IRB, the study team from the non-federal Relying Institution is responsible for disclosing the COI and any applicable management plans to the Lead Study Team (LST), or designee. The LST (or designee) will then inform the Reviewing IRB so that the IRB can determine how to address the potential conflict in regard to the study under its purview.

Note: This article is applicable to non-federal Relying Institutions only. In the case of federal agency study teams, research personnel may be asked to provide an assurance that the agency has completed COI analyses and that the participation of agency research personnel is permissible and consistent with federal law. See the SMART IRB Agreement v2.0 FAQS as well as NIH's Guidance on the Conflict of Interest Policies of the NIH Intramural Research Program for more information.