The IRB may request clarifications to a study at any stage during the review process. Also, the official IRB determination may be that the study requires changes before research can begin. Both situations require the PI or study staff to respond to the IRB.
Responding to IRB request for revisions or additional information:
- Responding to the IRB: Quick Guide
- Respond to IRB Request for Changes as part of Continuing Review: Quick Guide
- Guide to submit a response to the IRB: Updating Study Documents
We also recommend reviewing the following resources:
- Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Minnesota: Investigator Manual (download)
- Explanation of criteria, frequently used by IRB members who are reviewing research protocols that have been submitted: Criteria for Approval (download)
- What to Expect after Submitting to the IRB: Quick Guide
- Explanation of the IRB process once a submission is received by the IRB.