RESEARCH PROTOCOL AMENDMENT FORM

Federal regulation requires that changes to approved protocols be submitted to the IRB for review and approval prior to the implementation of these changes

INSTRUCTIONS

SUBMIT COMPLETED APPLICATION AND ALL SUPPORTING DOCUMENTS TO:

The signature page must be signed by all applicable investigators and must be submitted to the IRB office via:

Email – nobles.penny@navicenthealth.org (as scanned .pdf file)

Mail – Medical Center of Central Georgia, Institutional Review Board, 777 Hemlock Street, MSC 113, Macon, Ga 31201

Study Title:

IRB Protocol #:

AMENDMENT INFORMATION

Please select the type of amendment you are requesting (select all that apply)

☐ Change in protocol (design, methods, procedures, etc)*

☐ Change to number of participants and/or selection criteria

☐ Change in recruitment materials (flyers, emails, compensation, etc)*

☐ Change in study materials (surveys, questionaires, etc.)*

☐ Change in consent form*

☐ Change in research personnel

☐ Other Changes

*Attach all revised/new documents with the changes highlighted

For each item selected above, describe the changes being made and rationale for the proposed changes.

Do the requested changes increase the risks to participants? ☐ Yes ☐ No If yes, explain:
Are any of the changes the result of an unexpected or adverse event? ☐ Yes ☐ No If yes, explain:
If yes, did you promptly report these events to the IRB? ☐ Yes ☐ No If no, you must submit an Adverse Event Report Form the the IRB along with the IRB Amendment Form.
Are the changes expected to affect participants’ willingness to participate in the research? ☐ Yes ☐ No If yes, explain:

CERTIFICATION BY PRINCIPLE INVESTIGATOR

I certify that the information provided entirely and accurately describes the proposed changes to the research protocol. I agree not to make any changes to the project during the approval period until IRB approval for these changes has been obtained, except in the case of immediate harm to participants.

Name:

Department:	Phone:

Email:

Signature: