Amendments
There are no set deadlines for amendment submissions. Amendments may be submitted at any time and are processed weekly by the IRB office. Amendments requiring full review will be placed on the next available meeting agenda. Amendments that are able to be expedited are sent to the reviewers weekly. Amendments must be complete, requiring no administrative revisions, by 11 business days prior to a meeting to be guaranteed review at the meeting. Similarly, amendments must be complete to be sent to the IRB reviewer for expedited review. If administrative or other revisions are needed, amendment review will be postponed until the following meeting (or until all concerns are adequately addressed).
Based on the specific type of change proposed, certain documentation is needed for a complete submission, as detailed in the guidance below. Please use this guide when determining what to submit with an amendment:
Amendment Guidance
After submission of an amendment, the administrative staff will perform a "pre-review" to identify any potential issues prior to IRB review. The IRB staff utilize a standard format to complete a pre-review. The amendment pre-review form is provided below for reference:
IRB Administrative Pre-Review for Amendments