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


Use the following resources to prepare an emergency use report:

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