Difference Between Approved With 'Major' Or 'Minor' Revisions
The letter from the IRB following review of a submitted protocol may have “Approved With Major Revisions” or “Approved With Minor Revisions.”  Major revisions require that the protocol be returned to the full IRB committee for re-evaluation.  Assuming that the PI responds in a timely fashion to address the required revisions, the protocol typically is assigned to the next month’s agenda of the IRB Committee which reviewed the original protocol.  Request for earlier agenda scheduling can be considered following a request to the IRB Chair.  Response to minor revisions DOES NOT require full committee review but can be handled by expedited review of the Chair or designee.  In addressing responses to the IRB for either major or minor revisions, the PI should highlight all changes made to the consent and protocol.  A letter explaining the changes made should also be provided.  For complex revisions, changes can be documented using the “tracking” feature of Microsoft Word.

Jimmie Valentine, Ph.D.
September 2, 2004