Any changes to an approved project require COMIRB review and approval prior to their implementation, except when necessary to eliminate apparent immediate hazards to the subject. Any changes directed by COMIRB do not need to include a Change Form.
Changes to the research may not be implemented until the investigator has received documentation of COMIRB approval, except when necessary to eliminate apparent immediate hazards to the subject. In this case, the deviation must be reported to COMIRB within 5 days using the Unanticipated Problem form. For VA research, the VA R&D committee reviews amendments after COMIRB approval, but R&D approval is not required prior to implementation. There is currently no fee for review of amendments. Click here for further guidance on Amendments.
Click here for an Amendment Submission Checklist and Submission Instructions.