Emergency Waivers for Unapproved Drugs or Devices

Emergency waivers of IRB approval for the use of an unapproved drug or device are granted in "emergency use" situations that meet federal regulation criteria. The IRB will work with physicians and investigators to make sure patients in critical or novel situations are cared for as soon as possible and in accordance with federal regulations.

Experiencing a situation that meets these criteria? See how to obtain an Emergency Waiver below and be aware of the other responsibilities that come with this waiver.

Obtaining an Emergency Waiver from the IRB

A physician who wants approval for emergency use of a test article must contact the manufacturer to determine if the product can be made available for use (in one, specific patient) under the company's IND or IDE. If the company declines or cannot be reached, the physician can contact the FDA for approval.

To be granted an emergency waiver to use an unapproved drug or device from the IRB, make a request to the IRB:

Instructions for Requesting an Emergency Waiver from the IRB

• During business hours (M-F, 8-4:30 CST)
• Outside of business hours

Reporting Responsibilities when using an Emergency Waiver

Five working days after the use of an unapproved drug or device that is granted an Emergency Waiver from IRB review, a written report must be submitted to the IRB including written documentation of the oral approval and a copy of the unsigned consent form used to document informed consent of the subject.

• Making an "Emergency Use" Report

Many drug companies require IRB certification of approval to release drugs or biologics. The paperwork and report filing required by sponsors, drug companies, and the FDA are the responsibility of the physician requesting the emergency waiver of approval.

Informed Consent Responsibilities

Obtaining informed consent of the subject (or the subject's legal representative) is still required unless both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following [21 CFR 50.23(a)]:

1. The subject is confronted by a life-threatening situation necessitating the use of the test article.
2. Informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the subject.
3. Time is not sufficient to obtain consent from the subject's legal representative.
4. No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the subject's life.

Responsibilities with Data Resulting from "Emergency Use"

Data gathered as a result of an "Emergency Use" cannot be considered research data in a prospective research project. However, it may be acceptable in case report research.