Submission of previously approved applications
- If my application was already approved, why do I have to submit an application for continuing review?
- What happens if I don't submit my application for continuing review before the previous approval lapses?
- How long does the process take?
- When can I begin my research project?
- For how long is my approval valid?
- What do I need to do if I need to make changes to my project?
- What happens if I am finished with the project?
- What if I never started the project for which I received approval?
If my application was already approved, why do I have to submit an application for continuing review?
A Continuing Review is a reevaluation of an approved project conducted at least once a year as mandated by federal regulations. This review allows the IRB to monitor the progress of the project. If you plan to continue conducting research beyond your current expiration date, you must complete a continuing review application.
What happens if I don't submit my application for continuing review before the previous approval lapses?
The IRB cannot accept a continuing review application for an expired protocol. You must submit a new inital application form. No data collected during the the expired period can be used.
The IRB has set goals for turnaround time from the time of receipt of the application to the time of approval. The time it takes for a complete review of the continuing review application, regardless of type of review, depends in part on completeness of the application, the time spent by the investigator in responding to the concerns of the IRB, and the need for additional review.
- Expedited - Goal: Four to Six weeks
- Full - Goal: Six to Eight weeks
You can begin your study only after you have received your signed approval letter and your stamped documents that you will use in the course of your study.
Approval is generally valid for one year; however, this is not a guarantee. The length of approval is determined by the IRB and depends in part of the amount of risk perceived to be in the study. Length of approval can be time-limited, or it may be limited to a prescribed number of procedures. The letter of approval will indicate the length of the approval period.
An investigator must complete an amendment application and submit it to the IRB. No changes to your project can be implemented until the amendment is approved.
When your project is completed in its entirety, the investigator(s) completes and files a project completion form.
If your project was approved but never started, then you still must submit a project completion form.