Describe the requested modification(s) to the approved research protocol.
Explain the rationale for the requested modification(s).
How will the requested modification(s) affect the overall risks to participants in the study?
If the requested modification(s) necessitate changes to the informed consent form, describe the change.
If enrolled subjects will be informed of the modification(s), explain how they will be informed.
List all documents (such as informed consent form, recruiting materials, or research instrument) that have been modified as part of this request. These documents must be emailed to email@example.com before your request can be approved.