Emergency Use
Investigators are required to report any emergency use of an investigational drug, biologic, or medical device with a human research participant.
Emergency use may be warranted under the following circumstances:
- Life-threatening situation or severely debilitating (diseases or conditions that cause major irreversible morbidity)
- No standard acceptable treatment is acceptable
- Necessitates the use of the investigational drug or biologic or device
- Not sufficient time to obtain IRB approval
Resources
Use the following resources to prepare an emergency use report:
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FDA Guidance
Guidance for IRB members and investigators
We also recommend reviewing the following documents from the HRPP Toolkit Library:
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Emergency and Device Compassionate Use Review (HRP-023, Standard Operating Procedure)
Used to review notifications of emergency use of a drug, biologic, or device in a life-threatening situation.
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Emergency and Device Compassionate Use Post-Review (HRP-027, Standard Operating Procedure)
Used to communicate the review of emergency use of a drug, biologic, or device in a life-threatening situation.
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Emergency Use (HRP-322, Worksheet)
Used by IRB members who are reviewing emergency use of a drug, biologic, or device in a life-threatening situation.