Revisions to a Protocol

All revisions/changes in a project previously approved by the UMass Amherst Human Subjects Institutional Review Board (IRB) must be received and approved by the IRB before they are initiated except where necessary to eliminate apparent immediate hazard to the subject. Requests for approval of revisions/changes may be submitted at any time by an investigator.

"Major" revision requests for protocols that were approved by full IRB review must be reviewed through the full committee review process. Major revisions to protocols initially reviewed by the expedited review process may receive expedited review. However, depending on the nature of the revisions the reviewer may recommend review by the full committee. Examples of revisions considered to be major include, but are not limited to, the introduction of additional risk; the addition of a new invasive procedure change in population group. Major revisions may impact on the risk/benefit ratio in the study. It is the investigator's responsibility to assess the degree of change in the risk/benefit ratio.

"Minor" revision requests are reviewed administratively. If during this review it is determined that the revision is not minor the investigator will be contacted with instructions on how to proceed. A revision is approved only to the expiration date that was received at the protocol's most recent review.