For multi-year projects reviewed by the convened IRB, continuing IRB review and approval is required. Additionally, the IRB may require continuing review when other regulations apply (e.g. FDA, International Regulatory Agencies), or in instances of continued non-compliance. The Investigator's Progress Report is the application form for continuing review.
Applications approved as Expedited (after 1/21/19 or as transitioned) will not require continuing IRB review but will require an Expedited Status Update (ESU) at least every 3 years and submission of any changes, additions, and/or deletions in those studies should still be submitted to the IRB for review via Project Revision/Amendment Form (PRAF) prior to implementation.
Projects reviewed under Exempt guidelines or given a designation of Not Human Subjects Research (NHSR) do not require any annual continuing IRB review. However, any changes, additions, and/or deletions in those studies should still be submitted to the IRB for review via Project Revision/Amendment Form (PRAF) prior to implementation.
See the IRB Meeting Schedule for submission deadlines of materials for continuing review.
Convened Reviews
Protocols are subject to continuing review if subjects are still being enrolled, being followed, in long-term follow-up, or if the study is in data analysis. In some cases, protocols initially approved through convened review become eligible for expedited continuing 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.
Open for Enrollment
If the protocol is still open for enrollment, plans for future enrollment must be described. If informed consent is documented, the application must include
- one copy of the consent with tracked changes, if applicable, and
- one "clean" copy of the consent with changes accepted. Leave ample space in the upper left-hand corner of the consent for the IRB approval stamp.
Note, if no changes are being made to a consent form, only a clean consent form should be submitted. Do not change the version date of that consent unless changes are being made.
Closed to Enrollment
If the protocol is closed to enrollment, do not include a copy of the informed consent document unless participants are being "re-consented" or provided with additional information.
Expedited Reviews
Most Expedited protocols will not be subject to continuing review; however, the UAB IRB will require an Expedited Status Update (ESU) at least every 3 years. The IRB or Expedited reviewer will determine and document the need for ongoing continuing review.
Expedited protocols that are subject to continuing review should follow the Application Process for Convened projects.
Any changes, additions, and/or deletions in Expedited projects must still be submitted to the IRB for review via Protocol Revision Amendment Form (PRAF) prior to implementation. Reportable events must be submitted via the Problem Report.
Expedited Status Update (ESU)
The IRB will require a status update of your Expedited project at least every 3 years. The Expedited Status Update (ESU) serves to keep the IRB aware of the project status.
Each time you submit a qualifying submission (i.e., PRAF or a Problem Report) to the IRB, you will be asked to provide the current status of the project (e.g., study has not yet begun, open to accrual) and the number of participants (or data/specimens) that have been enrolled up to that point, if any. This will serve as your ESU, and each time one of these documents is received, the timeline for the required 3-year ESU is reset.
If there is no submission that qualifies as an ESU, the following email schedule will ensue:
At years 1 and 2 after initial qualifying submission - The Investigator and their delegate will receive an email from IRAP approximately 14 days prior to the first year after an ESU. The email will cite the currently known protocol status and state the approved participant enrollment. The Investigator will be advised as to how to respond if any of the IRB information is incorrect. The email will also provide a reminder of Investigator’s responsibilities for keeping the IRB abreast of any changes with the protocol, consent, or staffing. If the information in the email is correct, and no updates are needed, then no action is required by the PI.
At year 3 - The Investigator and their delegate will receive an email from IRAP approximately 30 days prior to the 3rd anniversary after an ESU and again at 14 days prior to the 3rd year anniversary. The email will request current status, current enrollment/current maximum enrollment and reminder of PI’s responsibilities for keeping the IRB abreast of any changes with the protocol, consent or staffing.
The Investigator must submit an ESU at this time, even if no changes have occurred. If you have no changes to make or problems to report, just submit a PRAF and check the ESU only box. If no response, the IRB office will assume the study is over and change the status to complete. Any work on the protocol after the study status is changed to complete is considered non-compliance.
Application Process
Investigators must submit applications for continuing review in a timeframe that allows the IRB to approve the protocol before the current approval period ends. The IRB recommends submitting the application materials 4 weeks to 6 weeks before the end of the approval period. (See "Approval Period" in General Information.) The following application materials are required to be submitted via IRAP:
- The Investigator’s Progress Report
- If the protocol is open to enrollment of new participants or participants are being "re-consented" with an addendum form, submit:
- A copy of the revised consent document with tracked changes (document name: consent.tracked.yymmdd) and
- A "clean" copy for the IRB approval stamp (document name: consent.clean.yymmdd).
- The Problem Summary Sheet, if applicable.
- Any reports not previously submitted for IRB review, if applicable.
Final Report for Convened Reviews
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.
ss Report follows the reporting requirements of the NIH. The following is their description of how the ethnic and racial categories are defined: