Help
Understanding the difference between “minor” and “major” changes
IRB Committee Member Help: Understanding the difference between “minor” and “major” changes. When reviewing a study at a convened meeting of the full committee, the IRB can approve research, with “minor” changes to be verified by the Chair. When the IRB requires the researcher make changes and asks the IRB Chair to verify the changes, this review by the Chair of minor changes represents expedited review. Review of modifications by the chair has to follow regulations governing expedited review. If the Chair is asked to evaluate, or make a judgment about, or assess, or otherwise make a substantive determination on behalf of the full board, then the change cannot be approved by the Chair, because the Chair is doing more than verifiying.
The table below summarizes the differences between “minor” changes that may be verified by the Chair, and “major changes” that require deferral of approval and review by the convened IRB.