If a continuing review of an active study is not approved prior to the end of the previously approved duration of the study, the IRB approval shall automatically expire and the study shall be suspended in accordance with federal regulations. The HSRO may provide warning notices of study expiration to Principal Investigators prior to the study expiration date, but investigators should understand that these are a courtesy and are not required. It is the responsibility of the Principal Investigator to monitor approval periods and to ensure that continuing reports are filed in ample time to allow for IRB review.
Letters informing the Principal Investigator of a suspension for lapse in IRB approval may be sent by the HSRO but these letters are also a courtesy to Principal Investigators who are responsible for suspending study-related activity, including subject accrual and other changes, pursuant to regulations whenever IRB approval has lapsed.
Expiration of IRB approval will not be reported to OHRP. This is in contrast to the reporting that must occur pursuant to HHS regulations and OHRP guidance if a study is suspended or terminated for cause.
If a study has lapsed in IRB approval and the Principal Investigator wishes to continue the research, continuing reports should be submitted immediately but in no case should a continuing report be submitted to the HSRO later than 45 days after the lapse in IRB approval. During the suspension for lapse in IRB approval, initial (i.e. new) studies from the Principal Investigator may be submitted and the IRB may review and approve such studies, but the IRB has the authority to make implementation of the new study contingent upon approval of either a continuing report or a final report (or administrative closure) for the suspended study.
If a study suspension for lapse in IRB approval extends beyond 90 days, the study shall be administratively closed unless this closure is waived by the Associate Vice Provost for Human Subject Research. This administrative closure shall be reported to the IRB and the Chair of the Principal Investigator's academic department. If two studies from a Principal Investigator are administratively closed within a 3-year period, the IRB shall review the circumstances and make recommendations regarding corrective action.