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123. IRB Notification and Review of Emergency Use of Test Article

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 all of the conditions described in 21 CFR 56.102(d) exist, allows for one emergency use of a test article without prospective IRB review.
  • FDA regulations require that any subsequent use of the investigational product at the institution have prospective IRB review and approval.
  • FDA acknowledges, however, that 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.

Life-threatening, for the purposes of section 56.102(d), includes the scope of both life-threatening and severely debilitating (see policy definitions web page).

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.

Prior to use of this FDA exemption, the physician should notify the Director, Research Integrity Office or her delegate of intent for emergency use.

  • This notification should not be construed as IRB approval.
  • The IRB will use the notification to initiate tracking to ensure that the investigator files a report within the five days required by 21 CFR 56.104(c).

An IRB must either 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, Director, Research Integrity Office or her delegate 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).
  • Although, this is not an "IRB approval," the acknowledgment letter has been acceptable to manufacturers and has allowed the shipment to proceed.

See IRB policy for FDA exceptions for requirements for informed consent for emergency uses of test articles.

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