Modification Request Form
Kentucky State University • Institutional Review Board (IRB)
PI Name:
Principal Investigator name
IRB #:
IRB #:
Instructions
Use this form to request IRB approval of the following:
Proposed changes to your current IRB-approved protocol.
A proposed change which impacts an individual subject but does not change the overall protocol (i.e., exception and deviation).
Do NOT use this form:
To report a change to the currently approved protocol which has already been implemented without prior IRB approval.
In emergency situations involving unanticipated problems involving risk to human subjects or others (contact ORI staff immediately at 502-597-6530).
To close a study or to report that a study has been completed (contact ORI).
Please be sure to...
- Revise consent and assent forms, as needed, based on the proposed changes.
- Complete and attach appropriate forms.
- If you are adding new study personnel, confirm that all new members have completed the mandatory human-subject-protections CITI training BEFORE you submit your modification request.
- Have the PI sign on the line provided at the top of the form (next page).
- Attach two copies – one marked and one clean – of all documents affected by the modification (i.e., consent form). On the track-changes copy, underline or highlight each change being made.
- Allow ample time for processing this modification request. NOTE: changes may not be implemented prior to receiving IRB approval.