Continuing Review of a Research Project
ALL research projects involving human subjects require a review by the North Texas Regional Institutional Review Board (IRB). Note that this review process may involve several stages or levels of review, depending on the various features of the research project and the potential risk to the subjects.
What is Continuing Review of a Research Protocol (Progress Report)?
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 North Texas Regional 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 Final Reports, see the section below on “How do I submit a Final Report?”
EXEMPT category projects do not need continuing IRB review or any annual reporting. Additionally, no formal close out for Exempts are required. back to top
How do I submit a Protocol for Continuing Review?
Please submit all documents to the North Texas Regional IRB via IRBNet. Instructions for submitting continuing review materials in IRBNet can be found in the North Texas Regional IRB Continuing Review Form.
NOTE: Protocols in which the Principal Investigator (PI) and research members are considered John Peter Smith Health Network (JPS) personnel MUST be initially submitted to the Office of Clinical Research (OCR) located at 1500 S. Main Street, Fort Worth. For additional assistance, please contact the JPS Office of Clinical Research at 817-702-3655.
How do I submit a Final Report?
Please refer to the North Texas Regional IRB Forms page for the appropriate Final Report/Close Out Form (Sponsored-Initiated Close Out Form or Investigator-Initiated Close Out Form). Instructions for submitting the Final Report Form are included in the form.
How (and When) will I know that Continuing Review of a Protocol has been Approved?
Once a protocol has been reviewed and approved, a formal written notice of approval will be sent to the Principal Investigator.
Similar to initial reviews, review and approval of Progress Reports (continuing reviews) are managed by Board Action Notices signed by the IRB Chair, specifying the current terms and conditions for the continuation of the research protocol. These notices are sent to the Principal Investigator for both Expedited and Full Board protocols, and are usually dispatched within 48 hrs of approval (whether approved by the IRB Chair alone, or by a convened Board).
Recall that Exempt category projects do not submit Continuing Reviews (Progress Reports) back to top
Who receives these IRB Board Action Notices / Letters of Approval?
The Principal Investigator of record is responsible for all aspects of a research protocol involving human subjects, and is the person who will receive formal correspondence from the North Texas Regional IRB.
The principal investigator may designate, in writing, other project personnel to receive copies of such notices or correspondence, and such designation should be sent directly to the IRB for inclusion in the protocol folder. However, the principal investigator is still fully responsible for acting on such correspondence from the North Texas Regional IRB. back to top>