Emergency use is defined as the use of an investigational drug, biologic or device with 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.  The emergency use provision in the FDA regulations (21 CFR 56.104c) is an exemption from prior review and approval by the IRB.   The exemption allows for one emergency use of a test article without prospective IRB approval.  The term “compassionate use” is no longer applicable.

An investigator who intends to utilize an investigational drug or biologic for emergency use must notify the IRB Chairman or Vice Chairman prior to use of the test article, if possible.  The investigator must then file a report within five (5) business days of use of

the investigational product.  If neither the Chairman or Vice Chairman is available, emergency use can be initiated and the IRB must still be notified within 5 business days.  Any subsequent use of the investigational drug or biologic must have prospective IRB review and approval.