Automatic termination and the grace period

No Participating Institution can terminate another's participation. Only two things end participation involuntarily:

Loss of Assurance or IRB registration. If an institution's Assurance is suspended, restricted, terminated, or expires, or (for an institution serving as a Reviewing IRB) its IRB registration with HHS lapses, its participation terminates automatically 60 business days after the effective date of that event unless the Assurance or registration is fully reinstated within that period. The affected institutions may agree to extend the period by a further 30 business days. During the grace period the institution may continue existing activities but may not begin any new Covered Activity until reinstated. Version 3.0 introduced this grace period; earlier versions terminated participation immediately. An institution whose participation terminates this way may rejoin once its Assurance or registration is reinstated, provided it meets all other eligibility requirements.

Network or consortium rules. If your institution takes part in a clinical trials network or other arrangement with its own reliance terms, those terms may provide grounds for ending reliance within that network. That does not end your participation in SMART IRB for other studies.

An institution facing loss of its Assurance or registration must notify its reliance partners promptly and in writing (§4.6.1) so oversight of ongoing studies can be transferred.

See also

• Terminating your institution's participation
• What survives termination
• Notifying other institutions of federal for-cause investigations