Emergency Use of a Test Article Report
Institutional Review Board (IRB)
EMERGENCY USE OF A TEST ARTICLE REPORT
Submission Information: Emergency use of an investigational (non-FDA approved) drug, biologic or device (a test article) is permitted by the FDA under the following circumstances:
1) the patient must be suffering from a serious, life-threatening, or 2) severely debilitating illness for which there is no satisfactory treatment alternative(s) and there is not sufficient time to obtain full IRB review and approval.
Submission Deadline: The Emergency Use of a Test Article Report must be submitted to the IRB within five (5) business days following initiation of treatment.
Submission Documents: Submit one (1) original and one (1) copy of the Emergency Use of a Test Article Report. This report can be obtained from the IRB home page (
1.Identifying Information
A.Physician(s):
B.Department:
C.Campus Zip:
D.Phone:
E.Patient Medical Record Number:
F.Date of Verbal IRB Chair/Designee Notification:
G.Name of IRB Chair/Designee who concurred that FDA requirements were met:
H.Date the test article was used:
2.Certification of Physician:
My signature certifies that I have met all the requirements of the FDA regulations [21CFR56.102(d); 21CFR56.104(c)] and UNMC HRPP policy #6.4governing the emergency use of FDA regulated products. I understand that any subsequent use of the test article on the same patient in a separate course of therapy or for the first time on a second patient requires full IRB review and approval of a protocol unless there are compelling medical circumstances and the IRB has not had sufficient time to convene a meeting.
______
Printed Name of PhysicianSignature of PhysicianDate
Instructions: Each required subpart must be titled using boldface subheadings as described below and addressed independently in the listed sequence without reliance on information covered under other subparts. Please include sufficient information to facilitate an effective review by the IRB. All abbreviations and terms not part of common usage should be defined and simplified language should be used as much as possible. Pages should be numbered.
1.Test Article
Specify the FDA-unapproved article used.
2.Justification
Describe the clinical situation and provide complete justification for the emergency use of a test article. Note: The patient must be suffering from a life-threatening or severely debilitating condition where no standard medically acceptable treatment is available, and there is not sufficient time to obtain IRB approval.
A life threatening and/or severely debilitating condition does not necessarily mean that the condition is immediately life-threatening or may imminently result in death or irreversible morbidity. Rather, the patient must be in a situation requiring prompt administration of the test article before review at a convened meeting of the IRB is feasible and any treatment delay will have a significant deleterious effect on the patient. Consequently, premature death and/or persistent morbidity is likely.
3.Patient Response to Treatment
Provide a description of the patient’s response to the treatment. Note: A reasonably detailed description of the patient’s initial response to the treatment should be provided. Follow-up reports should be filed as necessary.
4.Obtainment of Informed Consent
Describe how informed consent was obtained and attach a copy of the signed consent form. Note: The consent form must comply with the requirements of 21CFR50.25 and include all the basic elements of informed consent as well as appropriate additional elements of consent. The consent form must clearly acknowledgethe FDA status of the test article and the test article is being used under emergency circumstances where the patient has a life-threatening or severely debilitating conditionand there is no standard medically acceptable treatment available.
5.Inability to Obtain Consent
If obtainment of informed consent from the patient (or their legally authorized representative) was not feasible before the treatment was initiated, state the reason(s) and have an independent physician who is not otherwise participating in any clinical investigation of the test article and who has the appropriate medical expertise certify in writing all of the following:
A.The patient was confronted by a life threatening situation necessitating use of the treatment.
B.Informed consent could not be obtained from the patient because of an inability to communicate with, or obtain legally effective consent from the patient.
C.Time was not sufficient to obtain consent from the patient’s legally authorized representative.
D.There was no alternative method of approved or generally recognized therapy available that could provide an equal or greater prospect of health benefit for the patient.
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