For multi-year projects, continuing IRB review and approval is required. The Investigator's Progress Report is the application form for continuing review. Applications approved as Exempt or given a designation of Not Human Subjects Research do not require continuing IRB review.
Protocols are subject to continuing review if subjects are still being enrolled, being followed, in long-term follow-up, or if the protocol is in data analysis. For example, if a protocol involves long-term follow-up for survival after data analysis is complete, that protocol must still receive continuing approval until no participants remain alive. In some cases, protocols that were initially approved through convened review become eligible for expedited review. The IRB will notify the investigator in such cases.
The IRB expects findings to be included for all studies that have been ongoing for 5 or more years. In addition, if the protocol remains open for enrollment, an updated ("new") HSP must be submitted every 5 years. The determination letter will advise the investigator when the updated HSP must be submitted.
Continuing review and approval is necessary as long as participants fit any one of these categories. Questions about the selection of a category should be directed to the OIRB (934-3789, firstname.lastname@example.org).
If the project is completed (i.e., participants no longer fit any of the categories under "Closed to Enrollment"), the principal investigator is required to submit a Final Report before approval expires. Use the Investigator's Progress Report and check "FINAL report” on the top of the form. Findings from the study must be reported to the IRB at this time if they have not previously been reported.
Page updated: October 15, 2013