The National Jewish Health IRB utilizes a primary reviewer system for continuing review. The review encompasses the entire study and evaluates whether the anticipated risks and benefits are reflected in the actual experience of research subjects. However, the main focus is on the progress of the study since the last renewal. The periodic review also assesses whether the safeguards in place at initial approval remain adequate to ensure the safety of the current participants and whether information about any study should be communicated to those no longer in the study.
The National Jewish Health IRB determines the continuing review interval for all IRB approved studies. Exempt protocols do not require continuing review, but may be subject to periodic status inquiries.
Continuing Review by Expedited Process
A study is eligible for continuing review by expedited process if the IRB finds that the study meets the criteria outlined in the regulations or under any of the following three conditions:
- The research is permanently closed to the enrollment of new subjects, all research related interventions have been completed and the research remains active only for long term follow up;
- No subjects have been enrolled and no additional risks have been identified; or
- The remaining research activities are limited to data analysis.
For multi-centered trials, the condition will be applied to the National Jewish Health site only.
Continuing Review Notices and Submissions
A continuing review notice is provided as a courtesy. The Principal Investigator is responsible for ensuring timely submission of renewal documents. The Principal Investigator and the IRB Contact will receive a single notice from the IRB office approximately 6 weeks prior to the expiration date of the protocol. No additional notices will be sent.
It is responsibility of the PI to ensure that a complete continuing review packet is submitted by no later than the date indicated in the continuing review notice.
Missing the Continuing Review Deadline
Once the study approval expiration date passes, the study approval is considered expired. In such a case, if the continuing review report has been submitted and the review is in progress, the study subject enrollment must cease until the renewal is approved by the IRB. Permission must be obtained from the IRB Chairperson in order to continue treatment of currently-enrolled subjects.
If the continuing review report is not submitted to the IRB by the study expiration date, the protocol will be administratively closed.
Response to Stipulations
After the review has been completed the IRB may require that the principal investigator provide responses to stipulations--sometimes including clarification or verifications of information presented in the report or the submission of documentation not included with the submission.
The PI must respond to each stipulation, in writing, including "tracked-changes" and clean versions of any document requiring changes.
If changes to the informed consent documents are stipulated, the changes must be made to the most recently approved version of the document. Once all stipulated changes have been made to the informed consent document, the version date should be updated in the document footer.
According to federal regulations, if final renewal approval is not issued by the study's expiration date, the IRB must suspend or terminate the study and all study-related activities must stop.
Number of Copies
If the study qualifies for expedited review, submit the signed original and one (1) copy of all materials. If unsure, please contact the IRB office.
If the study does not qualify for expedited review, submit the signed original and two (2) copies. All packets must be collated.