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:

• FDA Guidance
  Guidance for IRB members and investigators

We also recommend reviewing the following documents from the HRPP Toolkit Library:

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