HUMANITARIAN USE DEVICE REVIEW APPLICATION

INSTRUCTIONS

There is no fee required for the review of a Humanitarian Use Device

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

IRB Use Only Protocol #:_______________________

General Information

Humanitarian Use Device Name:

Company:

REQUESTING PHYSICIAN INFORMATION

Name:

Full Title:

Department:	Phone:

Email:

ADDITIONAL PHYSICIANS WHO MAY USE THE DEVICE

Do you have additional research personnel (Sub-investigators, key personnel, research assistant, etc.)?

☐ YES	☐ NO If yes, Please least each person and their title.

Principle Physician Assurance and Acknowledgement

I certify that the information provided in this application is complete and accurate. I will conform to all federal, state, and institutional provisions concerning the use of a Humanitarian Use Device. I will ensure all personnel involved in the use of this HUD will be appropriately trained.

I agree to notify the IRB/Office of Research Compliance of any adverse events that may occur with the use of the requested device.

Principle Investigator Name (printed)	Signature	Date