A Single Subject Protocol deviation is a change in an IRB-approved protocol which is permitted for an individual subject when it is in the best interest of that subject and/or is necessary for research purposes (e.g., data completion). Protocol deviations are classified as either “minor” or “more than minor”. Once the form is received, the deviation will be reviewed and processed for further review if necessary by the IRB Compliance Coordinator. Deviations may be approved in one of two ways:
- Deviations that are minor are eligible for expedited review under the provisions of HHS regulations at 45 CFR 46.110(b)(2) and FDA regulations at 21 CFR 56.110(b)(2), as applicable.
- Deviations that are more than minor do not qualify for expedited review and therefore must be reviewed by the full IRB.
Once the deviation is approved, an approval letter for the Single Subject Protocol Deviation will attached to the electronic IRB application. The PI and Lead Coordinator will be notified via email when the letter has been attached.
To obtain Single Subject Protocol Deviation approval, a Single Subject Protocol Deviation Request must be submitted PRIOR to the implementation of the deviation. The instructions for submission are below:
Studies which are not in the electronic submission system:
If you have not created an "Existing Paper Format" application for your study, you will need to do so since all submissions are now done through the electronic IRB system. You will only need to create an "Existing Paper Format" application one time per study. First, a new online application (#13 - Existing Paper Format) must be started. This is NOT a full application. It requires only the IRB# and title. If the current approved IRB application, consent form(s) and/or information sheet(s) are not attached, these documents must be attached in the "ADD DOCUMENTS" section of the online application.
The Single Subject Deviation form can be created by opening the "VIEW/EDIT" and clicking the "NOTEPAD" icon on the Application List page, which is in the far right column. Once the form has been completed and the PI has electronically signed, click "SUBMIT". If you have any questions regarding this submission process, please contact the IRB Office at (402) 559-6463.
Studies submitted through the electronic system
The Single Subject Deviation form can be created by clicking the "NOTEPAD" icon on the Application List page, which is in the far right column. Once the form has been completed and the PI has electronically signed, click "SUBMIT".