Emergency Use Drug/Biologic
Notification of Emergency Use
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. Subsequent use of the investigational product requires IRB review and approval. 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, hand or foot, loss of hearing, paralysis or stroke.
The emergency use of an unapproved investigational drug or biologic requires an IND. If the intended subject does not meet the criteria of an existing study protocol, or if an approved study protocol does not exist, the investigator should contact the manufacturer and determine if the drug or biologic can be made available for the emergency use under the company’s IND. If not available through the manufacturer, the investigator should contact the FDA in order to obtain an Emergency IND.
For an emergency use, the investigator is required to obtain informed consent of the subject or the subject’s legally authorized representative. If the manufacturer has an existing consent form, that form may be used. If there is no existing consent form available from the manufacturer, a clinical consent form should be used. An exception from the informed consent requirement may be obtained if the following is certified in writing:
- The subject is confronted by a life-threatening situation necessitating the use of the test article.
- Informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from the subject.
- Time is not sufficient to obtain consent from the subject's legal representative.
- No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the subject's life.
The investigator shall notify the IRB of the intended emergency use via phone at 513-558-5259 or email (firstname.lastname@example.org) within 5 days after the use of the test article. The IRB Chair or designee is responsible for concurring with the intended emergency use or determining that the proposed use does not meet the criteria for an emergency exemption from IRB approval. The investigator must submit an Emergency Use submission in ePAS within 5 days after the notification.
Note: All investigators will need to gain access to ePAS in order to submit through the electronic system. (Click here for ePAS instructions).
Emergency Use Review Process