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”).

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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.

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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.