Emergency Use & Device Compassionate 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

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 HRP-103, Investigator Manual under “What if I need expanded access to investigational drugs, biologics, and devices?”

Resources

Use the following resources to prepare an emergency use report:

• 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.

• 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.

• Emergency Use (download) (HRP-322, Worksheet)
  Used by IRB members who are reviewing emergency use of a drug, biologic, or device in a life-threatening situation.

• Device Compassionate Use (download) (HRP-325, Worksheet)
  Used by IRB members who are reviewing non-emergency compassionate use requests.