The University of Arizona

Emergency Use

Report Misconduct

Ethics Hotline

HSPP Contacts

VPR-IRB@email.arizona.edu

Mariette Marsh, Director
(520) 626-7575

Andi Encinas, IRB Manager
(520) 626-8630

Liz Baldry, IRB Associate
(520) 626-0256

Mason Burchfield, IRB Associate
(520) 626-0433

Gina Fimbres, IRB Associate
(520) 626-0026

Christine Melton-Lopez, IRB Coordinator
(520) 626-5859

Courtney Olson, IRB Associate
(520) 626-1744

Darlene Villicana, IRB Associate
(520) 626-6282

Street Address
1618 E. Helen Street
Tucson, AZ 85721

Mailing Address
POB 210409
Tucson, AZ 85721


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Overview

The Food and Drug Administration (FDA) defines "emergency use" as the use of a test article (drug, device, or biological product) on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21CFR 56.102 (d)]. The FDA regulates use of all investigational drugs and devices, including emergency use. The IRB must be notified of all emergency use, even though it is not considered research.

Only one emergency use of the test article is permitted at a given institution and any subsequent use must have an IRB approved protocol in place for the use. However, the FDA acknowledges that it would be inappropriate to deny emergency treatment to a second individual if the only obstacle is that the IRB has not had sufficient time to convene a meeting to review the issue.

Submission Requirements

Effective July 2016, any request for use of an unapproved test article for the treatment and care of a patient in a life-threatening situation at Banner-University Medicine requires IRB oversight from Banner Health IRB.

Banner- University Medical Center Tucson: Please contact Derek Shemley (derek.shemley@bannerhealth.com or 520-694-5552) for for questions about IRB approval for Emergency Use at the Tucson Site.

Banner- University Medical Center Phoenix: Please contact the appropriate person below for questions about IRB approval for Emergency Use at the Phoenix site.

Cardiology: Ann Coombs - ann.coombs@bannerhealth.com or 970-810-2012

Neurology: Robert Flynn - robert.flynn@bannerhealth.com or 602-839-6846

Other: Mandy Childs - mandy.childs@bannerhealth.com or 602-839-3207

Please see Banner Health’s policy regarding use of Emergency Use here.

For GENERAL instruction on FDA requirements for emergency use of a test article in a life-threatening situation see guidance here.  NOTE: This guidance is not intended for Exception from Informed Consent (EFIC) research, which is a separate category in the FDA rules for research with test articles. Please see our EFIC guidance here.