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
Device Compassionate Use may be warranted under the following circumstances:
- The patient has a life-threatening or serious disease or condition;
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; and
- Potential patient benefit justifies the potential risks of the investigational device.
Prior FDA approval is needed before compassionate use occurs.
Emergency Use and Compassionate Use requests involving a single patient should be submitted for review via the Expanded Access Survey.
Provide the IRB with a follow-up report within 5 business days of the use by following the instructions in the Expanded Access IRB Application Quick Reference Guide, found in the Investigator Manual under “What if I need expanded access to investigational drugs, biologics, and devices?”
Use the following resources to prepare an emergency use report:
- HRP-023: Emergency and Device Compassionate Use Review
Used to review notifications of emergency use of a drug, biologic, or device in a life-threatening situation.
- HRP-027: Emergency and Device Compassionate Use Post-Review
Used to communicate the review of emergency use of a drug, biologic, or device in a life-threatening situation.