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?
Once a 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, such as 6 or 9 months, depending upon risks or procedures associated with the study. The intent of the continuing review is to ensure that the protocol continues to meet the necessary regulatory criteria for approval and assess new study information, if any is available. The review must occur prior to the approval period lapsing.
For projects deemed Expedited category of review, no continuing review is required under the Revised Common Rule (i.e. no expiration date associated with the approval) unless the IRB finds it appropriate/necessary to conduct one based on specific criteria (e.g., sensitive topic matter, vulnerable population, etc.).
For projects deemed EXEMPT category of review (similarly to Expedited projects), there is no continuing review or any annual reporting required.
It should be noted that 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 (through its electronic system, IRBNet) sends out courtesy reminder notifications several weeks in advance of the expiration date, it is the investigator’s responsibility to file a Continuing Review Report for continuing review of the project in a timely manner (click here for the appropriate form and instructions).
If a Continuing Review Report is not filed (or filed with sufficient time) with the 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. Full Board protocols require continuing review at the convened Board, or Full Board level; Expedited protocols have their continuing review conducted on an Expedited basis by the IRB Chair (or designated IRB reviewer). As with the initial review, allow plenty of time to prepare a Continuing Review Report for an effective review before the protocol approval period expires.
If the project is essentially complete (all subject interactions, including recruitment, intervention and follow-ups are done) during the approval period, then the Continuing Review Report becomes a “Final Report” and researchers may close the study. Note that all data must be de-identified in order to close a study with the IRB. Researchers may continue with data analyses even after a study is closed.
For more details and instructions on Final Reports, see the section below on “How do I submit a Final Report?”
How do I submit a Protocol for Continuing Review?
Please submit all required 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: The NTR IRB encourages Principal Investigators and research members who are considered John Peter Smith Health Network (JPS) personnel to consult with the Office of Clinical Research (OCR) at 817-702-3655 prior to submitting.
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. As previously noted, all subject interaction must be completed, and all data must be de-identified (i.e. all identifiers removed from research data) prior to requesting the closure of a study.
Researchers must submit a Final Report for all Full Board and Expedited category of review projects (including Expedited projects that do not require an annual review) for IRB review and acknowledgement. However, investigators do not need to notify the IRB regarding the closure, or completion of an Exempt category projects unless they would like it noted as such within the NTR IRB records. To do this, please contact the NTR IRB Office for additional guidance.
How (and When) will I know that Continuing Review of a Protocol has been Approved?
Once a protocol has received continuing review and approval, a formal notice of approval will be sent to the Principal Investigator/Research team through our electronic system (IRBNet).
Similar to initial reviews, review and approval of Continuing Reviews are managed by Board Action/Approval Notices, specifying the current terms and conditions for the continuation of the research protocol.
Who receives these IRB Board Action Notices / Letters of Approval?
The Principal Investigator (PI) 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 along with those the PI has given full study access within IRBNet.
The Principal Investigator may designate within IRBNet other project personnel to receive notifications from the IRB . However, please note that the Principal Investigator is still fully responsible for acting on such correspondence from the North Texas Regional IRB and must have full access to the study account.
This page was last modified on May 25, 2023