Who performs any required reporting of unanticipated problems, serious/continuing noncompliance, and suspension/termination of IRB approval to sponsors and oversight agencies, and how are such requirements determined?
The Reviewing IRB will determine whether an event falls within one of these reportable categories and whether a report is required to a regulatory agency, sponsor, funding agency, or other oversight authority. Federal agency IRBs may decline to make reports to study sponsors and should communicate this limitation on their reporting to Relying Institutions at the time the reliance arrangement is put in place. In making the determination, the Reviewing IRB will consider any regulatory requirements applicable to it or to the Relying Institution (including applicable FDA requirements), as well as the terms of the Relying Institution’s FWA. Prior to participating in a determination whether to cede review of a particular research study under the Agreement, the Participating Institutions involved in the study must inform one another of whether their FWAs apply to the specific study.
Unless the involved Participating Institutions agree on an alternate reporting arrangement, the Reviewing IRB, with support of its institution as applicable, will draft and make the report and will provide the Relying Institution with an opportunity to review and comment on the report prior to its submission to the external authority. Nothing in the Agreement prohibits the Relying Institution from making its own additional report; in such case, the Relying Institution will provide a copy of that report to the Reviewing IRB. The involved Participating Institutions may agree on an alternate arrangement whereby the Relying Institution drafts and makes the report or the Reviewing IRB and Relying Institution jointly make the report.