PURPOSE

The emergency use of a test article at the University of Utah must be reported to the University of Utah Institutional Review Board (IRB).

SCOPE

This policy applies to the emergency use of a test article at the University of Utah. This policy does not cover the planned research in emergency settings, which is addressed in IRB SOP 508: Exception from Informed Consent for Planned Research in Emergency Settings.

DEFINITIONS

1. Emergency use is defined as the use of a test article (unapproved drug, biologic, or device) on a human participant 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)].
2. Test Article is a term used in the FDA regulations meaning drugs, biologics, and devices intended for human use. The FDA has authorization to regulate the development, approval, and marketing of these products.

POLICY

FDA regulations [21 CFR 56.104(c)] permit the emergency use of a test article without prospective IRB review, as described in this policy. FDA regulations require that any subsequent use of the test article at the institution have prospective IRB review and approval. Data from an emergency use may not be reported in a way that implies that the activity was a prospectively planned systematic investigation designed to develop or contribute to generalizable knowledge. Emergency use is specifically emergency clinical care and is not considered research.

Physicians notifying the University of Utah IRB of an emergency use of a test article or reporting the emergency use of a test article must use the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA).

Physicians must obtain informed consent of the subject or the subject’s legally authorized representative for emergency use of a test article. The informed consent document must be submitted to the IRB. If the informed consent document is signed by the patient, all identifiers must be redacted prior to submission. The FDA provides an exception from the requirements of informed consent [21 CFR 50.23]. If the exception from informed consent for emergency use is applied, the physician must submit the required certification to the IRB as outlined in this policy.

PROCEDURES

1. Procedures for Exemption from IRB Review Requirements for Emergency Use of a Test Articl
   1. Physicians must notify the IRB before the test article is administered. Physicians submit an Emergency Use of a Test Article application in ERICA. The IRB Chair or designee reviews the notification using the Emergency Use Checklist to confirm whether the FDA requirements for emergency use of a test article are met.
      1. If the IRB Chair or designee agrees that it meets the FDA requirements for emergency use of a test article in a life-threatening situation, a letter is sent to the physician by ERICA. This letter should not be interpreted as IRB approval for emergency use.
      2. If the IRB chair or designee finds that it does not meet the FDA requirements for emergency use of a test article in a life-threatening situation, the application will be referred to a convened IRB meeting.
   2. If immediate use of the test article is required to save the life of the participant and there is not sufficient time to contact the IRB, the physician may proceed with the emergency use. In this case, the physician must submit the Emergency Use of a Test Article application in ERICA within 5 working days of the emergency use of a test article. The IRB Chair or designee reviews the reported emergency use using the Emergency Use Checklist to confirm whether the FDA requirements for emergency use of a test article are met.
      1. If the IRB Chair or designee agrees that the reported activity meets the FDA requirements for emergency use of a test article, a letter is sent to the physician by ERICA. This letter should not be interpreted as IRB approval for emergency use.
      2. If the IRB Chair or designee finds that the physician failed to comply with the regulatory requirements for emergency use of a test article, appropriate corrective action will be taken according to IRB SOP 903: HRPP and Non-Compliance.
2. Procedures for Exception from Informed Consent Requirements
   1. The physician must submit the Certification for Emergency Use of a Test Article without Informed Consent to the IRB for review within 5 working days after use of the test article using the Report of Emergency Use of a Test Article in ERICA.
   2. The IRB Chair or designee will review the certification using the Emergency Use Checklist (Exception from Informed Consent portion).
      1. If the IRB Chair or designee determines that the certification meets the FDA requirements for exception from informed consent before the use of a test article, a letter is sent to the physician by ERICA.
      2. If the IRB Chair or designee determines that the physician failed to comply with the regulatory requirements for exception from informed consent before the use of a test article, appropriate corrective action will be taken according to IRB SOP 903: HRPP Requirements and Non-Compliance.