How do study team members from a non-federal Relying Institution communicate potential conflicts of interest and applicable management plans to the Reviewing IRB?

Under the SMART IRB Standard Operating Procedures, if any study team members from a non-federal Relying Institution have a potential conflict of interest (based on their institution’s policies) that is relevant to the study, this potential conflict and any related management plans must be reported to their institution’s Point of Contact (POC) and to the Lead Study Team (LST), or LST designee. The LST is responsible for informing the Reviewing IRB of this information, so that the IRB can determine how to address the conflict. The Reviewing IRB will ensure the non-federal Relying Institution’s management plans are applied and can impose additional requirements above and beyond those of the non-federal Relying Institution’s.

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.