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									Emergency Use of an Investigational Drug, Agent, or Biologic
Content Applies To
Office of Human Research Subjects Protection Institutional Review Board (IRB) Mayo
Clinic Rochester, Florida and Arizona

Purpose
This document describes the process for the emergency use of an investigational drug,
agent, or biologic.

Scope
This procedure applies to clinicians who may request an emergency use of an
investigational drug, agent, or biologic and to the Mayo Clinic Institutional Review Board
(IRB) who conducts the review and acknowledgement of emergency use requests
submitted by the clinician.

Background
An emergency use of an investigational drug, agent, or biologic by a clinician without
prior IRB review and approval is permitted under 21 CFR 56.104(c). The one-time
emergency use of an investigational drug, agent, or biologic is not consider research by
the FDA but must be reported to the IRB.

Key Terms
Emergency Use: The use of an investigational drug, agent, biologic, or device with a
patient in an immediate serious life-threatening situation in which no standard
acceptable treatment is available, and in which there is not sufficient time to obtain
approval by a fully convened IRB.
Investigational New Drug (IND): FDA granting of permission that a new drug, agent or
biologic may be used in humans prior to FDA review of clinical data that has determined
that a particular new drug, agent, or biologic is safe and effective for a specific use. This
FDA permission is evidenced by the assignment of an IND number by the FDA or the
granting of an IND exemption.

Clinician Responsibilities
The clinician is responsible for:
      Contacting the manufacturer or sponsor to determine if the drug, agent, or
       biologic can be made available for the emergency use under the company’s IND.
      Obtaining Emergency Investigational New Drug Application (IND) from the FDA if
       the manufacturer does not permit use of the agent under the company's IND.
      Notifying an IRB on-call Chair or Vice-Chair to confirm that the proposed
       emergency use complies with the FDA regulations.
      Arranging for a physician not involved in the planned emergency intervention to
       assess and document in the medical record that the proposed emergency use is
       appropriate and to provide documentation for allowing use of the unapproved
       investigational drug, agent, or biologic when informed consent cannot be
       obtained from the patient or patient's legally authorized representative.
      Obtaining informed consent of the patient or the patient’s legally authorized
       representative when possible.
      Reporting to the FDA and the IRB any adverse event or unanticipated problems
       with the emergency use of the investigational drug, agent, or biologic.
      Completing the IRB Emergency Use Follow-up Form and submitting to the IRB
       electronically, via IRBe, within 5 working days of the emergency use of the
       investigational drug, agent, or biologic.

IRB Responsibilities
The IRB is responsible for:
      Evaluating the clinician’s request for an emergency use of an investigational
       drug, agent, or biologic and confirming that the emergency use request meets or
       does not meet the regulatory criteria for emergency use.
      Reviewing and acknowledging the Emergency Use Follow-Up submission and
       associated documentation at a fully convened IRB meeting.
      Notifying the clinician, via IRBe system, of the IRB’s review and
       acknowledgment.

Procedure for the Clinician
Obtaining an            The emergency use of an unapproved investigational drug,
Emergency IND           agent, or biologic requires an IND. The clinician is responsible to
                        obtain the emergency use IND by one of the following methods:
                              1. Contact the manufacture or sponsor of the investigational
                                 drug, agent, or biologic to determine if the investigational
                                 drug, agent, or biologic can be made available for the
                                 emergency use under the manufacturer’s or sponsor’s
                                 IND.
                              2. If the manufacture or sponsor does not have an active
                                 IND or if the manufacturer or sponsor will not permit the
                                 emergency use of the IND, then contact the appropriate
                                 department at the FDA to obtain an emergency IND.
                                     o For investigational drugs, call 301-796-3400
                                     o For biological products, call 301-827-1800
                                     o After working hours (EST), call FDA’s Office of
                                       Emergency Operations, at 301-443-1240
                              3. Contact the Office of Research Regulatory Support
                                 (ORRS) at 507-266-0022, (77)6-0022, or
                                 ORRS@mayo.edu for assistance with the Emergency
                                 IND submission to the FDA.
                        Note: The following conditions must exist for a situation to be
                        considered an emergency use of an investigational drug, agent,
                        or biologic:
                                 The patient is in an immediate serious or life-threatening
                                  condition that needs immediate treatment,
                               No generally acceptable alternative for treating the
                                patient is available, and
                               Because of the immediate need to use the drug, agent, or
                                biologic, there is insufficient time to obtain the prior
                                approval of the convened IRB.
                        Note: The clinician must determine whether these criteria have
                        been met, to assess the potential for benefits from the
                        unapproved use of the device, and to have substantial reason to
                        believe that benefits will exist.
Notifying the on-call   The clinician must notify the IRB on-call chairperson to inform
IRB chairperson         him/her of the emergency use situation and if applicable, the
                        need for a manufacturer release letter to be drafted.
                           1. To notify the on-call IRB chairperson, call the Mayo Clinic
                              (Rochester) Operator at 507-284-2511 or (77) 4-2511
                              and ask for the IRB chairperson on-call.
                           2. As may be required by the manufacturer, request a letter
                              of IRB concurrence for the manufacturer to release the
                              investigational drug, agent, or biologic.
Independent             Prior to the use of the investigational drug, agent, or biologic,
physician’s             the clinician is responsible to obtain a written assessment from a
assessment              physician not involved in the emergency use with documentation
documentation           that the proposed emergency use is appropriate (i.e. the
                        conditions for emergency use are met) and, if applicable,
                        justification for not obtaining informed consent from the patient
                        or legally authorized representative.
                        Note:
                        The physician’s independent assessment must be submitted to
                        the IRB via the IRBe system (by accessing the Emergency Use
                        Follow-up Form) within 5 working days of the emergency use of
                        the drug, agent, or biologic.
Emergency Use           The clinician is responsible to obtain informed consent from the
Authorization Form      patient or the patient’s legally authorized representative prior to
                        the emergency use of the drug, agent, or biologic when
                        possible.
                           1. Complete the Emergency Use Authorization Form,
                           2. Provide a copy to the patient or the patient’s legal
                              representative, and
                           3. Send a photocopy of the Emergency Use Authorization
                              document to the Mayo Clinic Health Information
                              Management Services (HIMS) scanning department for
                              scanning into the patient’s electronic medical record.
Emergency Use           The clinician is responsible to notify the IRB within 5 working
Follow-up               days of the emergency use of the investigational drug, agent, or
Submission to the       biologic by:
IRB via the IRBe
System                    1. Logging into the IRBe system and completing the IRBe
                             Emergency Use Follow-up Form,
                          2. Attaching the independent physician’s assessment,
                          3. Attaching the Emergency Use Authorization document
                             provided to the patient or the patient’s legal
                             representative, and
                          4. Submitting the application and associated documentation
                             electronically to the IRB via the IRBe system.

Procedure for the IRB
Documentation of       When required by the manufacturer, IRB staff is responsible for
concurrence with       producing a written letter of IRB concurrence for the
conditions for         manufacturer to release of an investigational drug, agent, or
emergency use and      biologic.
follow-up monitoring      1. Refer to template entitled: Letter to Manufacturer for
                             Release of an Investigational Drug, Agent, Biologic or
                             Device for Emergency Use. An IRB senior specialist,
                             operations coordinator or manager, or administrator may
                             provide signature for the letter.
                          2. Scan and email the signed letter to the requesting
                             clinician, with a copy to the Mayo Clinic Office of
                             Research Regulatory Support (ORRS) at
                             ORRS@mayo.edu. Include reminder instructions to
                             complete the IRBe Emergency Use Follow-up Form via
                             IRBe within 5 working days following the-emergency use.
                          3. Monitor and facilitate clinician completion of the IRBe
                             Emergency Use Follow-up Form, interacting with the
                             clinician as necessary.
                          4. Verify that an electronic copy of the IRB concurrence
                             letter is submitted in the clinician's IRBe Emergency Use
                             Follow-up Form or uploaded in an IRBe logged comment.
Evaluation of the         1. The emergency use follow-up application and associated
emergency use                documentation submitted by the clinician via the IRBe
request and IRB              system, is assigned to a fully convened IRB Committee
Committee                    meeting for review and acknowledgement.
acknowledgement
                          2. The convened IRB reviews and evaluates the clinician’s
                             emergency use of the investigational drug, agent, or
                             biologic. The review consists of verifying the following:
                                 o The sponsor’s or manufacturer’s authorization that
                                   allows for the use of the investigational drug,
                                   agent, or biologic.
                                 o The approved IND, or if applicable, a letter
                                   explaining the IND exemption from the FDA.
                                 o The clinician's description of the circumstances
                                   under which the emergency use occurred, and the
                                       independent physician's assessment certifying the
                                       conditions for emergency use, and
                                   o The informed consent (i.e. Emergency Use
                                     Authorization) or, if applicable, the independent
                                     physician’s assessment for the exception from
                                     obtaining informed consent.
                            3. The clinician is notified, via the IRBe system, of the IRB’s
                               review

Procedural Notes
The data obtained from the emergency use of the investigational drug, agent, or biologic
may not be used as part of a prospective research study conducted by the clinician or
the sponsor of the drug, agent, or biologic.


The Emergency Use Follow-up Form requests the following information from the
clinician:
      Name of the investigational test article (i.e. drug, agent, biologic, device)
      Name and date of the IRB chairperson consulted prior to the emergency use
      Date and time the investigational test article was administered or used with the
       patient
      Conditions under which the investigational test article was administered or used
      Copies of the independent physician’s assessment and the Emergency Use
       Authorization (consent document)
      Protective measures taken prior to the emergency use
      Adverse events or unanticipated problems to the recipient or others
      Outcomes, if known
The expectation of the FDA in granting an Emergency Use IND in the event that the
manufacturer does not agree to the use of the product is that the clinician, now the
sponsor of the IND, promptly submits the appropriate documentation to the FDA to
support the IND. If the FDA does not receive the application within 30 days of the date
on the Emergency Investigational New Drug Application letter, the FDA will deem the
IND to be canceled prior to use of the Investigational product. Any use of the product
will not have been in compliance with the Federal Food, Drug, and Cosmetic Act or with
the licensing provisions of the Public Health Service Act.

Related Documents
Investigational Drugs, Agents, and Biologics Policy 15033
Emergency Use Authorization Form IRB 10346
Letter to Manufacturer for Release of an Investigational Drug, Agent, Biologic, or Device
Form IRB 10048
Emergency Use Follow-Up - IRBe System Application IRB 10265
Emergency Use of an Investigational Drug, Agent, Biologic, or Device Process Flow IRB
10365

References
21 CFR 312

								
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