Modification of Previously Approved Study
To modify a protocol that was first approved prior to April 1, 2021, please submit:
1. A memo outlining the modifications requested and any effects of the proposed modifications on benefits, risks to human subjects, risk management, and consent processes;
2. A revised protocol with all proposed modifications and effects on benefits, risks, risk management, and consent processes highlighted;
3. A revised consent form, if applicable;
4. When new study personnel will execute the protocol, a description of their background appropriate to the work of the project. Include current CITI certificates;
5. When new agencies will participate in the study, agency approvals.
To modify a protocol that was approved through the Kuali IRB system (after April 1, 2021), you can modify the protocol directly through Kuali. Please submit a protocol amendment as described on page 9 of the Kuali User Guide.