Protocol Violations

Incidents of noncompliance that have a basis in fact must be reported to the ORA by submission of a Noncompliance Report.  The PI is responsible for ensuring that the required reports are submitted within five (5) business days following discovery of the incident. 

Once the form is received, it will be reviewed and processed by the IRB Compliance Coordinator who will, in consultation with the IRB Executive Chair if necessary, review the noncompliance. Noncompliance that is considered more than minor must go to the Full Board for review.  When the corrective action plan has been approved, the letter will be attached to the electronic IRB application. 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 Noncompliance Report 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 Noncompliance Report 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".

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