This process should be used only to renew protocols that were previously approved and have not expired.
To renew a protocol, please submit a cover letter outlining the need for the renewal, and include the following:
- The number of subjects accrued since the last IRB review of the protocol and (for ongoing studies) the total number accrued for the study;
- A summary of adverse events and any unanticipated problems involving risks to subjects or others and any withdrawal of subjects from the research or complaints about the research since last IRB review;
- A summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review;
- Any relevant multi-center trial reports;
- Any other relevant information (especially information about risks associated with the research);
- A copy of the current informed consent document (without the approval stamp) and any newly proposed consent documents; and
- New Protocol Approval Form with items #5 and #7 updated to reflect renewal;
- Most recent version of the Project Information Form and all additional related documents.