MAINTAINING IRB APPROVAL


Amendments/Modifications

No changes to research that has been approved by the IRB may be made, including changing study personnel, until the request for the change has been submitted and approved, unless the change is necessary to prevent an apparent immediate hazard to subjects.

For research that has received a determination of exempt or not human subjects research, changes should be submitted only if they are extensive enough to alter the original determination.

Amendments are submitted through the IRBManager electronic system. Instructions for submitting study amendments, including changes in personnel, can be found on the IRBManager Guidance page.

 

Study Re-approval or Closure

Submit appropriate annual form at least 30 days prior to due date.

 

Adverse Event Reporting 

 

Protocol Deviation or Violations