Complete this form to request IRB approval for a one-time planned, non-emergent exception to the protocol. These types of exceptions must be approved by the IRB in advance of implementation. If requesting a permanent change, do not complete this form and submit a protocol modification for your study.

Examples of one-time exceptions include: exceptions to eligibility criteria, exceptions to the form or manner of obtaining informed consent, use of out-of-window test results, and exceptions to the administration or use of an investigational product.

Complete this form and press “Submit” at the end of the form to generate a PDF of the form. Upload the PDF in the eIRB system as an RNI.

Send an email to to ensure prompt review. Please allow at least one business day for IRB review.

NOTE: If you are unable to complete the form in its entirety, the form can be saved and retrieved later by pressing the “Save and Return” button. A form code will generate and must be saved to access the form later.

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