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Human Subjects Division (HSD)

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Single Patient Emergency Use

These documents provide instructions for UW physicians who wish to use an investigational drug, device or biologic for clinical treatment of a single patient.

Specific Requirements

  • All requirements are described in the INSTRUCTIONS documents.
  • It is no longer necessary to obtain the concurrence of an IRB chair or to inform the Human Subjects Division (HSD) before the emergency or compassionate use.
  • The special Consent template listed above must be used to ensure compliance with FDA regulations.

What is the difference between emergency use and compassionate use?

Both types of use are generally intended for the clinical treatment of a single patient.

Drugs: Emergency use means that there is not sufficient time to obtain standard IRB review and approval before the drug must be used. At the UW, this is defined as less than seven business days. The drug division of the FDA does not recognize the concept of compassionate use. If the use is not an emergency, then the treating physician is required to obtain standard IRB review and approval (like a research study) before using the drug. Prior FDA approval and Investigational Drug Exemption (IND) are required in emergency and non-emergency situations.

Devices: Emergency use means that there is not sufficient time to use existing procedures to obtain FDA approval (Investigational Device Exemption, or IDE) before the device must be used. Compassionate use means that the use does not meet the criteria for emergency use, and therefore prior FDA approval (IDE) is required before the device can be used. Standard IRB review and approval (like a research study) is required for neither emergency nor compassionate use.

Are these also the procedures for using a Humanitarian Use Device (HUD)?

A HUD is a device that has been approved by the FDA for treatment or diagnosis of a disease or condition that affects fewer than 4,000 individuals per year in the United States. The procedures for using a HUD depend upon the purpose and circumstances:

 

Change Notes

  • Noted 05/23/2013 @ 08:57am
    Keyword newly added.
    - sherrye