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.

Robert Flynn - robert.flynn@bannerhealth.com or 480-412-6859 (for questions about operational considerations)

Jenny Maxon -  jenny.maxon@bannerhealth.com or 602-839-5777 (for questions about IRB submission)

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.