Notifying other institutions of federal for-cause investigations

Applies to: Agreement V3.0

Version 3.0 requires every Participating Institution to notify, promptly and in writing, the institutions with which it is in a reliance relationship when it or its Personnel become subject to a for-cause compliance investigation by OHRP, FDA, NIH, or another federal human subjects regulatory or funding agency, if the investigation relates to research under ceded review or exemption determination, or could affect the conduct or integrity of that research, participants' rights or welfare, or the Reviewing IRB's ability to perform its role (§4.6.1). The same provision covers suspension, restriction, termination, or expiration of your Assurance; loss of IRB registration; and loss or downgrading of HRPP accreditation or assessment status. Separately, a Relying Institution tells the Reviewing IRB of any suspension or restriction of the research or of its Personnel's authority to conduct it (§6.14).

SMART IRB recommends routing the notice through your SMART IRB Point of Contact to the affected institutions' Points of Contact, as for other notifications under the SOPs. Routine (not-for-cause) inspections do not trigger this provision.

See also - Noncompliance, investigations, and audits - Automatic termination and the grace period