Continuation of an Approved Project
As per the requirements of the Federal Regulations under 45 CFR 46.109(e); the IRB is required to complete a continuing review of research not less than once per year. When your project is approved, the project is given an approval date and expiration date. The project MUST be re-reviewed and approved by the IRB before your project’s expiration date is reached.
Please submit your continuation to the IRB office at least 2 months prior to your expiration date. This will allow for any revisions or additional information that may be needed to complete the review. Please note: the IRB does not meet in the month of December. The project must be reviewed in October or November to remain in compliance.
What does the IRB need to review for Continuation?
The IRB is required to complete what is called a substantive review. This means that a re-review of the project needs to be completed to ensure nothing has changed to the original approval that may increase the risk to subjects. The members review the project in its entirety as if the project was being submitted for the first time with additional information provided that tells the IRB what the current progress of the project has been.
At what point do I NOT need to request for a Continuing Review by the IRB?
Until your research activities have been completed and your project is closed. Your project is considered closed when your project meets the following criteria: closed to enrollment, your methods/procedures have been completed, no subjects are completing any follow-up procedures AND all analysis on your data specific to the aims/hypotheses of your approved project has been completed. At the end of your research, a final closure report must be submitted to the IRB Administration. Please see the web page titled Final Closures for guidance.
Documents to be submitted:
- Completed Request for Continuing Review Application
- Copy of the CURRENT approved Informed Consent Form Document(s)
- Copy of the CURRENT Assent Form(s) (if applicable, necessary for research with children and other vulnerable subjects)
- Any NEW or REVISED Recruitment Materials: Flyers, poster, Radio/TV ad scripts, other advertisements, Pamphlets, etc.
- Any NEW or REVISED Instruments: Surveys, Questionnaires, Assessments, etc.
- Any AMENDMENTS NOT previously reviewed and approved by the IRB
- Any REVISED information not reviewed by the IRB such as: Methods and Procedures, Application, etc.