IRB FAQs – Submission Requirements

How do I submit a new study for IRB review and approval?

At ECU we have an electronic IRB submission, review and tracking system, ePirate. It is through the use of this electronic system that you will create and submit new studies, amendments to existing studies, continuing reviews, reportable events and final reports.

What if changes are required after the study is already approved?

Any changes to the protocol, consent form or research process must have UMCIRB approval before they may be implemented. Requests for amendments to approved studies must be promptly submitted via the electronic submission system at any time during the approval period. There are special circumstances in which immediate changes must be made to protect research subjects against immediate risks.