Human Research Review Committee (HRRC-IRB)

Supported by the Human Research Protections Office

Humanitarian Use Research Review

1 copy of each of the following documents should be delivered to our office. You can also view/print this checklist from a word document.

Items Required for EVERY Humanitarian Use Study - All forms are in MS Word except where noted

ü Department Review Form - To be completed by head of department submitting the study

ü The following PDF forms must be filled out by every investigator listed on attachment 1, as well as the Principal Investigator

ü One of the Following:

ü Documentation from the UNM and/or NMVAHCS Creditialing Committee that you are 'credentialed' to use this HUD

ü FDA Humanitarian Device Exemption Letter (or similar documentation)

Items Required if applicable to Study - All forms are in MS Word except where noted

ü Patient labeling information sheet, brochure, and/or consent form

ü Any Applicable Attachments:

	1. Additional Investigators List
	2. Studies Involving Minors
	10. Studies Involving Prisoners