Who reports to OHRP, FDA, sponsors, and funders

Applies to: Agreement V3.0 · SMART IRB SOPs

Version 3.0 draws a clear line: the Reviewing IRB handles reports to the federal human subjects regulators; the Relying Institution handles everything else.

Step 1 — The Reviewing IRB decides whether an event is reportable. It determines whether an unanticipated problem, serious or continuing noncompliance, or a suspension or termination of approval has occurred, taking into account the regulations that apply to it and to the Relying Institution (including FDA requirements) and the terms of the Relying Institution's Assurance. For this to work, institutions must tell one another whether their Assurances apply to the study before ceding review.

Step 2 — Reports to OHRP and FDA (§5.13). The Reviewing IRB notifies the Relying Institution in advance that a Report is required. Unless the institutions have agreed otherwise (§5.13.2), the Reviewing IRB drafts the Report and gives the Relying Institution at least five business days, whenever possible, to review and comment before sending it, then copies the Relying Institution on the final (§5.13.1). The institutions may instead agree to a joint Report or that the Relying Institution drafts and submits, with the same five-day comment window running the other way. Neither side has to adopt the other's comments, and either may make its own additional Report, copying the other. A Relying Institution that itself concludes a Report is required tells the Reviewing IRB in advance (§6.16).

Step 3 — All other reports are the Relying Institution's responsibility (§5.13.3). Reports or notifications to program officers or other non-human-subjects-protection staff at federal funding agencies, to state funding agencies, to sponsors, to state or local oversight authorities, or to any other federal authority are made by, and are the sole responsibility of, the Relying Institution — regardless of who reported to OHRP or FDA. Reviewing IRBs that are federal agencies (for example, the NIH Intramural Research Program) report only to OHRP and FDA.

Keeping each other informed (§§5.14, 6.17). Each side promptly tells the other about communications it receives from or makes to federal human subjects regulators — and, for the Relying Institution, federal funding agencies — concerning unanticipated problems, noncompliance, suspensions or terminations, or other compliance concerns in the study. Relying Institutions require their investigators to do the same.

Research not subject to federal regulations. The Agreement does not require external reporting for research that is outside the Common Rule, FDA regulations, and other federal human subjects requirements.

See also - Subject complaints and injuries - Noncompliance, investigations, and audits - Reportable events guidance (Harmonization)