Emergency Use

Emergency use of an unapproved or investigational drug, device or biologic may occur only in those circumstances where it is not feasible to secure prospective FDA and IRB approval.
Unless you complete the Emergency Use Process, you may not use an unapproved or investigational drug, device or biologic without prior IRB, sponsor and FDA approval.

Emergency use is permitted only if all of the following criteria are met:

• The patient faces a life-threatening condition (e.g., a serious disease or condition such as a sight-threatening or limb-threatening condition, as well as other situations involving risk of irreversible morbidity) that requires immediate treatment.
• The patient is likely to benefit from treatment with the unapproved drug, biological, or device.
• No generally acceptable alternative for treating the patient is available.
• There is no time to use existing procedures to secure prospective FDA and IRB approval and/or informed consent.
• The drug, device or biologic has not previously been used in the past for emergency use for another patient at the site

Call and email the IRB Office as soon as the decision to use an unapproved or investigational drug, device or biologic is made. This should be done prior to the treatment or procedure if at all possible.

IRB Office Phone: 414-465-3134 or 414-465-3059

IRB Office Email: IRB@Ascension.org and/or current staff

If the use happens after office hours, the voicemail at the numbers above will direct you where to call.

The treating physicians must file a formal report of the emergency use with the IRB within within 5 calendar days of the use. An additional  follow up report is required to provide the IRB an update on the patient's outcome post-treatment.

The initial and follow up reports to the IRB can be made using ONE of the following:

-   IRB Form: Emergency Use of Investigational Drug, Device, or Biologic

-   IRB Report Form for Emergency Use of HUD

Even in an emergency where it is impossible to secure an IND or IDE in advance, FDA must be consulted prior to use.
Contact information (24/7) for drugs/biologics and for devices is available on FDA’s website.

• For Drugs & Biologics: Physician Request for Individual Patient IND
• For Devices: Physician Request for Individual Patient for use of an Unapproved Medical Device

Promptly following an emergency use (within 5 calendar days):

• Obtain an independent physician assessment if time did not permit prior to the treatment or procedure.
• Write or dictate a note or report including a statement of who administered the drug or placed the device and why it was used.
• Submit a report to the IRB (See Reporting to the IRB section above).
• Submit a report to the sponsor (IND/IDE holder).
• If you are the sponsor, notify the FDA of the emergency use and provide FDA with a written summary of the conditions constituting the emergency, subject protection measures, and results.
• Evaluate the likelihood of a similar need for the drug/device occurring again. Refrain from further emergency use until any necessary approvals have been secured (e.g., opening of a new “high risk” arm on the trial), even if the conditions for an emergency use otherwise exist.
• Other than mandatory reports to FDA or the sponsor, do not use data related to the emergency use in any publication or report on a related research project.