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.

Resources

Responding to IRB request for revisions or additional information:

• Working with Reviewer Comments

We also recommend reviewing the following resources:

• Investigator Manual (HRP-103)
  Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Wisconsin-Madison.

• Criteria for Approval (HRP-314, Worksheet)
  Used by IRB members who are reviewing research protocols that have been submitted.