Normally, within 2-3 days after review of an application by the convened IRB, the OIRB sends the investigator a determination letter (and a copy by fax if a fax number was provided) that indicates the outcome. IRB review has five possible outcomes:
For protocols reviewed through expedited or convened procedures, the IRB approval period begins on the approval date, regardless of whether additional modifications were required for formal approval. The approval period ends on the expiration date. On the expiration date, IRB approval is no longer valid; therefore, research activities must not take place on the expiration date unless continuing IRB approval is received before that date.
For convened review, the "approval date" is the date on which the IRB met and approved the protocol. For expedited review, the "approval date" is the date on which the designated reviewer approved the protocol. In either case, the protocol is no longer approved on the "expiration date."
Most protocols are approved for a period of 1 year, but the IRB may specify a shorter period. In all cases, the IRB Approval Form indicates the approval date and the timing of continuing review (e.g., annual, quarterly).
If informed consent is to be documented, then the investigator will receive, along with the approval letter, one copy of the consent form for the study that will have been stamped with the IRB approval date and expiration date. The investigator makes copies of the informed consent document that bears the IRB-approval stamp and uses those copies for consenting study participants.
Page updated: May 8, 2013