Emergency Use

Overview

Emergency Use With or Without Informed Consent

Emergency use of a product that is not FDA approved will generally include informed consent. It is possible that in certain emergency situations, a physician may treat a patient with an investigational agent without obtaining informed consent (21 CFR 50.23). 
 

More details about emergency use can be found in the IRB SOPs: https://research.columbia.edu/sites/default/files/content/HRPO/IRB_SOP_v5.2_2.12.19_TOC_CUIMC.176a.9.12.19.pdf

Single Emergency Use

FDA regulations (21 CFR 56.104(c)) permit one emergency use of an investigational medical product per institution. 

Any subsequent use of the investigational product at the institution is subject to prospective IRB review and approval. However, when prior IRB review and approval is not feasible, the FDA will not deny the subsequent request for emergency use based on lack of time to obtain prospective IRB review, as long as that use will be reported to the IRB within five working days of initiation of treatment (21 CFR 56.104(c)). 

HRPO Notification

When possible, the HRPO should be notified by email in advance of the proposed emergency use of an investigational medical product. For some emergency use situations, notification to the HRPO may be necessary because the manufacturer of the product requires a letter from the IRB stating that the IRB is aware of the impending use of the investigational product, and will not ship the product until the letter is received. 

Notification to the HRPO is also required when concurrence of the IRB Chair will be one of the subject protection measures to be used. If the proposed emergency use is associated with an existing IRB protocol, the HRPO will request that the Chair or Vice Chair of the reviewing IRB provide concurrence that the emergency use meets the emergency use criteria. If that Chair or Vice Chair is not available, or the proposed emergency use is not associated with an existing IRB protocol, the HRPO will request that one of the other IRB Chairs or Vice Chairs, or a qualified IRB member, conduct the review. 

Investigational Drugs and Biologics

According to the FDA, emergency use means "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."

The FDA must determine that the criteria have been met for emergency use of a drug or biologic. 

In addition, according to 21 CFR 312.310(a), the following must be determined: 

  • The physician must determine that the probable risk to the person from the investigational drug is not greater than the probable risk from the disease or condition; and
  • The FDA must determine that the patient cannot obtain the drug under another IND or protocol. 

In an emergency situation, use of the drug may begin upon authorization (usually provided by telephone or other rapid means of communication) by the reviewing FDA official (21 CFR 312.305(d)(2)(i)), with a requirement for submission of an expanded access request to the FDA within 15 working days of the initial authorization (21 CFR 312.310(d)(2)). Prior IRB approval is not required, but the emergency use must be reported to the IRB within 5 working days of the use, as required under 21 CFR 56.104(c). 

Investigational Medical Devices

Emergency use of a medical device provides patients and physicians with access to devices intended to treat life-threatening or serious diseases or conditions when there is no available alternative and no time to obtain FDA approval. Emergency use of an investigational device may occur before an IDE is approved and when a device is not being studied under an IDE. 

The following criteria must be met for emergency use of a device:

  • The patient has a life-threatening or serious disease or condition that needs immediate treatment;
  • No generally acceptable alternative treatment for the condition exists; and
  • Because of the immediate need to use the device, there is no time to use existing procedures to obtain FDA approval for the use. 

If all of the above criteria are met, an unapproved device may be used in an emergency situation without prior approval by the FDA. Likewise, emergency use of an unapproved medical device does not require prior IRB approval. 

The FDA expects the physician to make the determination that the patient's circumstances meet the above criteria. In the event that a device is used in circumstances meeting the criteria listed above, the physician should follow as many patient protection procedures as possible. Such patient protection procedures include obtaining: 

  • Informed consent from the patient or a legal representative;
  • Clearance from the institution as specified by its policies;
  • Concurrence of an IRB Chair;
  • An independent assessment from an uninvolved physician; and
  • Authorization from the device manufacturer. 

Under 21 CFR 812.35(a)(2) and 812.150(a)(4), emergency use must be reported to the FDA by the IDE sponsor within five working days from the time the sponsor learns of the use. The report should contain a summary of the conditions constituting the emergency, patient outcome information, and the patient protection measures that were followed. If no IDE exists, the physician should follow the above procedures and report the emergency use to the Center for Devices and Radiological Health (CDRH). 

Updated November 2023