The investigator must submit proposed research project changes in the study protocol or consent form for review and approval by the MHIRB before the change is initiated. A copy of the protocol amendment or changes and the modified consent form (modified areas are to be highlighted) along with a completed Revision/Amendment for Research form, must be submitted to the MHIRB.

In cases in which the change will eliminate or reduce immediate hazards to the subject, the change may be initiated before IRB approval is granted. However, the change must be reported to the MHIRB within five working days. The MHIRB may, following review, vote to approve or deny approval of the change. Change must be submitted using the Revision/Amendment for Research Project form.