Once an Expedited or Full Board protocol is approved, the approval period extends for not more than one year (as specified by federal regulations). Some projects may be approved for a shorter time period, perhaps 6 or 9 months, depending upon risks or procedures associated with the study. In any case, the approval period will be stated on the initial approval letter and investigators are encouraged to mark this date. Although the North Texas Regional IRB will send out courtesy reminder letters several weeks in advance of the expiration date, it is the investigator’s responsibility to file a Progress Report for continuing review of the project in a timely manner (click here for the appropriate form and instructions).
If a Progress Report is not filed with the IRB for continuing review, the approval period will expire, the protocol will be suspended, and the lapse in approval caused by the investigator’s non-compliance will need to be reported to the sponsor/funding agency as well as appropriate federal authorities.
The continuing review process follows a format similar to initial review. Expedited Review have their continuing review conducted on an Expedited basis; Full Board protocols needs to have continuing review conducted by the Full Board. As with initial review, allow plenty of time to prepare a Progress Report for an effective review before the protocol approval period expires.
If the project is essentially complete, and all subject interactions and follow-ups are done during the approval period, then the Progress Report becomes a “Final Report”. Using the same form (check the box for Final Report), investigators submit the same information as for a continuing review, with some minor exceptions.
For more details and instructions on Progress reports / Final reports, see the guidance section on “Continuing Review“.
EXEMPT category projects do not need continuing IRB review and do not need any annual reporting.
This page was last modified on December 21, 2017