How are conflicts of interest of Research Personnel from non-federal Relying Institutions addressed under the SMART IRB Agreement?

Unless the involved Participating Institutions agree on a different plan in advance for a given research study, a non-federal Relying Institution will analyze potential conflicts of interest of Research Personnel under its own conflict of interest policies. The non-federal Relying Institution will provide the Reviewing IRB with the results of its analysis, including any conflict of interest determinations, institutionally required prohibitions, and institutionally required management plans. The Reviewing IRB must consider this information in reviewing the research study on behalf of the applicable non-federal Relying Institution. The Reviewing IRB must incorporate and implement any prohibitions or management plans (such as institutionally required disclosures in consent forms) without changes, unless such changes are discussed with and accepted by the non-federal Relying Institution. The Reviewing IRB may impose additional requirements (such as further disclosures) if necessary to approve the study.

In the rare situation when the Reviewing IRB determines that implementation of a particular plan would render the study not approvable by the Reviewing IRB (for example, the Reviewing IRB determines that a disclosure statement required by a non-federal Relying Institution in a consent is misleading), and the non-federal Relying Institution does not agree to the Reviewing IRB’s proposed changes (if any), the Reviewing IRB must inform the affected non-federal Relying Institution, and the study will be withdrawn from ceded review with respect to that non-federal Relying Institution (without an IRB approval/disapproval determination).

Note that institutional conflicts of interest (conflicts of a non-federal Relying Institution itself) are not addressed in the Agreement; it is expected that the non-federal Relying Institution would address such conflicts locally, prior to its consideration of any ceded review.