This section of the Investigator Manual provides information related to emergency uses, including when to contact the manufacturer or PRC, notifying the IRB, and obtaining consent.

Emergency Use: General Information

To qualify as an emergency under FDA regulations, the proposed use must meet the following criteria, which differ for drugs/biologics and devices.

For a drug or biologic:

  • Patient is in a life-threatening or severely debilitating situation
  • No standard acceptable treatment is available; AND
  • There is insufficient time to obtain IRB approval prior to the proposed date of use.

For a device:

  • Patient has a life-threatening condition that needs immediate treatment;
  • No generally acceptable alternative treatment for the condition exists; AND
  • There is insufficient time to obtain IRB approval prior to the proposed date of use.
  • Because of the immediate need to use the device, there is not time to use existing procedures to obtain FDA approval for the use.

The FDA defines life-threatening as diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.

The FDA defines severely debilitating as diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness; loss of arm, leg, hand or foot; loss of hearing; paralysis or stroke.

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E-Use: Who to Contact

Contacting the Manufacturer

For all types of investigational medical products, the FDA requires that the clinician contact the manufacturer to see if they will provide the investigational medical product for expanded access use. The manufacturer may provide the investigational medical product for use under its own IND or IDE.

If no IND for use of a drug or biologic exists, the clinician may need to obtain their own IND; however, the FDA may authorize shipment of a drug or biologic in advance of an IND submission in an emergency.

For devices, the FDA does not require the clinician to obtain an IDE in emergency use situations if one does not already exist. See “E-Use: Initial Notification to the FDA” for contact information for the FDA.

Contacting the Pharmaceutical Research Center (PRC)

For emergency use of a drug or biologic only, the clinician must contact the PRC for assistance (608.263.8902).

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E-Use: Initial Notification to the FDA

  • For drugs or biologics, clinicians MUST contact the FDA prior to use of the drug or biologic. Step-by-step instructions for this process are here: https://www.fda.gov/news-events/expanded-access/expanded-access-how-submit-request-forms#AccessPhysEmerg.
  • For devices, clinicians are NOT required to contact the FDA prior to use of the device IF all the criteria for emergency use of a device are met. The FDA still advises that the clinician follow as many patient protection measures as possible when emergency use of a device occurs. These include obtaining:
    • Informed consent from the patient or a legal representative;
    • Clearance from the institution as specified by their policies;
    • Concurrence of the Institutional Review Board (IRB) chairperson or their designee;
    • An independent assessment from an uninvolved physician; and
    • Authorization from the device manufacturer.

To contact the FDA for approval of or guidance regarding a potential emergency use, please see the contact information found at the bottom of this page: https://www.fda.gov/news-events/public-health-focus/expanded-access.

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E-Use: Notifying the IRB

Initial Notification to the IRB

For use of investigational medical products, clinicians should notify the IRB of the proposed use prior to the actual use or, if not feasible, within five days of the use. Please provide initial notifications to the IRB as follows:

  • During business hours (Monday-Friday, 8AM-5PM), notify the IRB of the proposed emergency use by email (irbdirector@hsirb.wisc.edu and csrogers@wisc.edu) and include the following information:
    • Description of how the use meets the criteria outlined above in the “Criteria for Emergency Use”, including whether any other reasonable alternative treatments are available;
    • Summary of the patient’s diagnosis and treatment history; and
    • Date and/or timing of the proposed use;
    • Description of the informed consent process, including when and from whom consent will be obtained; and
    • Attach the following as appropriate:
      • Draft consent document
      • For drugs or biologics only, documentation of approval of the use from the FDA (or include in the email the date when the request was submitted to the FDA).
      • For devices only, a concurrence letter from an independent physician that states that use of device is warranted and no other reasonable alternative treatments are/were available.
      • See “IRB Chair Concurrence Process” and “Reporting to the IRB” below for next steps in the process.
  • Outside business hours, clinical judgement prevails over the need for administrative procedures. Emergency use of an investigational medical product in one patient outside IRB business hours may proceed as follows:
    • For a drug or biologic, notify the PRC.
    • Notify the IRB of the use by email (IRBdirector@hsirb.wisc.edu).
    • Within 5 business days of the use, submit an Expanded Access application in ARROW (see “Reporting to the IRB”).

IRB Chair (or Designee) Concurrence Process

The IRB Office will notify the chair or their designee of the initial notification that was made to the IRB via email. If the IRB chair or their designee concurs with the request and agrees it meets applicable IRB requirements, the treating physician will receive an acknowledgement via email from the IRB Office after which (and within 5 days of the use) an Expanded Access application in ARROW should be submitted.

If the IRB chair or their designee determines that sufficient time exists for the convened IRB to review the request, the treating physician will be notified by the IRB Office and will need to submit an Expanded Access application in ARROW. Treatment will be allowed to begin following IRB approval of the application.

Reporting to the IRB

If not completed before use, an Expanded Access application must be submitted in ARROW within 5 days of the emergency use. This application will be reviewed for compliance with FDA requirements by the IRB Chairperson or designee.

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