Printer-friendly version
Emergency use is defined as the use of an investigational drug or biological product with a human subject in a life-threatening or severely debilitating situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)]. The emergency use provision in the FDA regulations [21 CFR 56.104(c)] is an exemption from prior review and approval by the IRB.
The exemption, which may not be used unless the subject is in a life-threatening or severely debilitating situation in which no standard acceptable treatment is available, allows for one emergency use of a test article without prospective IRB review. Life threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life threatening do not require the condition to be immediately life threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible. Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.
Not all emergency use requires an exemption from prospective IRB review. When there is time for prospective IRB approval, the University of Iowa IRB expects the investigator to complete a New Project application describing the emergency use. The application will be scheduled for review at the next IRB meeting. The FDA regulations require that any subsequent use of the investigational product at the institution have prospective IRB review and approval. [21 CFR 56.104(c)] Therefore, if the first use does not have prospective review, the IRB notifies the investigator that if it is possible subsequent use of the agent will occur, a New Project application should be submitted for IRB review immediately following the first emergency use. The FDA defines emergency use as the use of a test article 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 (21 CFR 56.102(d)). However, 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.
The investigator should notify the IRB Chair prior to the emergency use. However, this notification should not be construed as IRB approval. The investigator is required to file a written report within five working days, and notifying the chair is used to initiate tracking to ensure that the investigator files this report as required by 21 CFR 56.104(c). The FDA regulations do not provide for expedited IRB approval in emergency situations. An IRB must convene and give "full board" approval of the emergency use or, if the conditions of 21 CFR 56.102(d) are met and it is not possible to convene a quorum within the time available, the use may proceed without any IRB approval.
Some manufacturers will agree to allow the use of the test article, but their policy requires "an IRB approval letter" before the test article will be shipped. If it is not possible to convene a quorum of the IRB within the time available, the IRB Chair will send the sponsor a written statement that the IRB is aware of the proposed use and considers the use to meet the requirements of 21 CFR 56.104(c).