Guidance

Emergency Use of a Test Article in Life-Threatening Circumstances

IRBMED
Dec 13, 2016 2:00 pm

This guidance describes the circumstances regarding Expanded Access Emergency Use (Emergency Use) of an investigational product (drug, biologic, or device) and the procedures to be followed before or immediately following the emergency use of an investigational product.

Emergency Use is part of the FDA Expanded Access program. See also the IRBMED Expanded Access guidance page. Ordinarily, FDA regulations require prior approval by the FDA and an IRB, and informed consent, for the administration of an investigational drug, biologic, or device.  Exceptions to this rule apply in very limited cases, including serious or immediately life-threatening emergencies: in an Emergency Use, some of these requirements may be met after the fact.

  • When is an Emergency Use appropriate?

    Emergency Use of an FDA-regulated investigational product may occur in circumstances where it is not feasible to secure IRB approval and/or informed consent of an individual participant.  Emergency Use is permitted only if all of the following criteria are met:

    • The patient faces a serious or life-threatening or severely debilitating condition (e.g., a serious disease, or 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, biologic, or device.
    • No generally acceptable alternative for treating the patient is available.
    • There is no time to use existing procedures to secure prospective IRB approval or, for a device, FDA approval for the use.
  • What is the procedure for reporting an Emergency Use to IRBMED?

    Notify the IRBMED Chair-on-Call to inform him/her of the Emergency Use necessity by contacting the UMHS operator to page the IRBMED Chair-on-Call at (734) 936-4000.  The IRBMED Chair-on-Call can provide guidance on securing FDA approval prior to the administration of the investigational product as necessary.  Additionally, the IRBMED Chair‑on‑Call will ask what measures have been taken to contact the sponsor of the investigational product.

    Contact the Michigan Institute for Clinical and Health Research IND/IDE Investigator Assistance Program (MICHR/MIAP) at UM-Expanded-Access-Request@med.umich.edu, prior to the administration of the investigational product if at all possible. This email contacts (MICHR/MIAP) directly, and also notifies the Research Pharmacy (also known as IDS) of the impending emergency use necessity. There is no charge for MICHR/MIAP assistance when utilizing an Expanded Access investigational product, including Emergency Use.

    With MICHR/MIAP assistance, submit an application for IRB approval of the emergency use in the eResearch system within 5 calendar days of the administration of the product.  MICHR/MIAP provides guidance on, and facilitates fulfilling, additional reporting requirements to FDA and to IRBMED.

  • When must FDA be notified of an Emergency Use of an investigational product?

    The FDA must be contacted prior to the Emergency Use of an investigational drug or biologic product.  FDA contacts for obtaining an Emergency IND for the use of an investigational drug or biologic are available at the Emergency IND Information Sheet.

    For Emergency Use of a medical device, prior FDA approval is not necessary.  However, if the physician wants an opinion from FDA regarding whether or not the case meets criteria or emergency use, contact Office for Device Evaluation IDE Staff at 301-796-5640.  Also, see this FDA website link:  Expanded Access for Use of an Investigational Medical Device.

  • What other procedures are indicated BEFORE the Emergency Use?

    If time permits, prior to Emergency Use treatment with an investigational product, the principal investigator/clinician should (Contact MICHR/MIAP at UM-Expanded-Access-Request@med.umich.edu for assistance):

    • Obtain informed consent from the recipient or recipient’s legally authorized representative, using the IRBMED Specialty Consent Template for FDA Expanded Access (or consent template provided by investigational product sponsor/manufacturer)
    • Secure concurrence from an IRBMED Chair-on-Call of the Emergency Use treatment necessity.
    • For a device, obtain an independent assessment from an uninvolved physician that the case meets criteria for emergency use.
    • Obtain permission from the investigational product sponsor/manufacturer for the emergency use of the investigational product.
    • Some manufacturers may request “IRB approval” before providing the product; MICHR/MIAP and IRBMED can help facilitate this request even if there is not time to submit and review an application beforehand.

    Any of these procedures not completed before Emergency Use treatment should still be completed afterward.

  • What Other Procedures are Indicated AFTER the Emergency Use?

    Promptly, contact MICHR/MIAP at UM-Expanded-Access-Request@med.umich.edu for assistance.  Within 5 calendar days, the principal investigator/clinician must:

    • If obtaining informed consent prior to use was NOT possible, secure an uninvolved, independent physician’s certification that:
    1. It was not feasible to secure the recipient’s legally effective consent (for example because the recipient was unconscious or sedated or legally incompetent
    2. Time was insufficient to secure consent from the recipient’s legally authorized representative
    3. The patient was confronted by a life-threatening situation (including one involving risk of serious, irreversible morbidity), necessitating use of the product.
    4. At the time of the procedure, there was no available alternative method of approved or generally recognized therapy that would have provided equal or greater likelihood of saving the subject’s life or avoiding serious, irreversible morbidity.
    • 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 an application for IRB approval of the emergency use in the eResearch system, utilizing MICHR/MIAP assistance.
    • Submit a report to the sponsor (IND/IDE holder), utilizing MICHR/MIAP assistance.
    • If you are the sponsor for the investigational product, 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 of the investigational product 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.  MICHR/MIAP can assist you in understanding how to proceed if the situation warrants continued usage of the Emergency Use investigational product.

    Note: subject to VERY limited exceptions, FDA prohibits additional emergency uses that depart from approved investigational plans and IRB protocols.

  • Additional Resources

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: bpsea@umich.edu
Last Updated: June 1, 2018 9:00 AM