University of Miami

Human Subject Research Office

POST - EMERGENCY USE REPORT

Notification of Use of Drug, Biologic or Device (Subsequent to Administration of the Test Article)

[21 CFR 56.102(d)]

This report must be submitted to the Human Subject Research Office within 5 business days after the use of the test article. If you have any questions on how or when to use this form contact us at the IRB Office 305-243-3195

Definitions

Emergency Use: Emergency use means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)].

Test Article: A test article includes any drug, biological product, or medical device for human use [21 CFR 56.102(l)].

Life-threatening: For an emergency use of a test article, FDA regulations define a “life threatening” situation to include the scope of both life-threatening and severely debilitating, as defined below.

Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.

Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.

1.  Administrative Information

eProst # / Date of Report
Department / Date of Use
Role* / Name / Phone / Fax
Name of Physician Reporting the Use
Contact Person

2.  Investigational Article Information

I am informing the IRB of the use of
List your drug or device and IND/IDE/HUD#
FDA status / IND/IDE sponsor’s name
Name of Investigational Drug or Biologic:
IND #:
Name of Investigational Device:
IDE #:
Restrictions
Has there been a previous Emergency Use of this test article at this site?
(Please note: FDA regulations will only permit one emergency use of a test article at an institution.) / Yes
STOP. Use of this article again will require submission of a new study for full board review. Contact the Human Subject Research Office at (305) 243-3195 to discuss how to most expeditiously get this study reviewed.
No Explain how you have verified this information:
Patient is / Under the age of 18
18 or older
Does the patient belong to any of the vulnerable population groups? / Yes No
Pregnant women, fetuses, or neonates of uncertain viability or nonviable (45 CFR Part 46, Subpart B)
Prisoners 45 CFR Part 46, Subpart C); Mentally disabled; Cognitively Impaired;
Wards of state; Fetal Tissues - Please access the following link for guidance,
http://www.hhs.gov/ohrp/humansubjects/guidance/publiclaw103-43.htm
Other, specify:

3.  Emergency Use Exemption from Prior Board Review

The medical indication is
Emergency use situation: All four of the following conditions must apply for exemption from prior board review: / YES 1. A life-threatening or severely debilitating situation exists necessitating
the use of the investigational drug, biologic or device; AND
YES 2. No standard acceptable treatment is available; AND
YES 3. There is not sufficient time to obtain IRB/FDA approval
Agent(s)
Dose
Duration
Off Label Use / YES No
Frequency
Location of treatment (hospital & service)
Explain condition requiring use
Prior course of treatment (include medication)
Current Patient Status/Result of Use
Description of Life Threatening Condition:
a. Diagnosis:
b.  Why was the condition considered life-threatening?
c. Please justify your opinion that there is no alternative method of approved or generally recognized therapy
available that provides an equal or greater likelihood of saving the subject's life.
d. What made the physician(s) conclude that there was no standard acceptable treatment available, so that an
investigational treatment has to be offered?
If the test article is a drug, what is the drug trial phase status, as assigned by the FDA?
Phase I Phase II Phase III Phase IV Treatment
If the test article is a device, what is the device status, as assigned by the FDA?
This device is: Significant Risk Non-Significant Risk
This device is: Investigational Marketed
What was the source (supplier or manufacturer) of the test article?
How did the physicians gain possession of the test article?
Will the patient or his/her health care provider be required to pay for any related procedures or products?
No
Yes, please explain:
Who is responsible for costs incurred due to adverse events?
Identify the risks (current and potential):
NA / a)  Describe the expected frequency, degree of severity, and potential reversibility.
NA / b)  Describe possible late effects:
NA / c)  Risks from article:
NA / e)  How will the patient be assessed for the occurrence of adverse events described above?
NA / f)  Describe your monitoring plan:
4. Informed Consent/Emergency Waiver
1. What type of informed consent process was implemented prior to administration or application of the test article to
the patient?
Informed consent obtained from the Subject or the subject legally authorized representative:
Yes; attach a copy of the consent form and skip section 5 below
No; provide justification below and complete section 5
If informed consent was not obtained before use please provide justification.
a. Subject had a life-threatening condition necessitating use of test article Explain:
b. Consent could not be obtained because of inability to communicate with, or obtain legally effective consent
From the subject. Explain:
c. Time was insufficient to obtain consent from the subject’s legal representative. Explain:
d. No alternate method of approved or generally recognized therapy is available that provides an equal or
greater likelihood of saving the subjects life. Explain:
If the mental acuity of the patient was in doubt, the person who gave the informed consent was:
Legally Appointed Guardian
Patient advocate named in a Durable Power of Attorney for Health Care
Next-of-Kin:
Spouse
Adult Child
Parent
Adult brother or sister
If the patient was age <18 years, did he or she provide assent? Yes; No.
2. If the interval between the date of initial administration of the test article and the date of submission of this application
is more than five days, what was the reason for the delay in reporting?

5. Independent Physician’s Assessment

Assessment prior to the use of the test article:
By my signature below, I certify that all four of the conditions for the emergency waiver of informed consent were met in this emergency situation: The subject was confronted by a life-threatening situation necessitating the use of the test article; and informed consent could not be obtained because of an inability to communicate with, or obtain legally effective consent from, the subject; and time was not sufficient to obtain consent from the subject's legal representative; and no alternative method of approved or generally recognized therapy was available that provided an equal or greater likelihood of saving the subject's life.
I am not participating in the clinical investigation.
Print Date: Sign Name: Date: Department
Email: Phone: Fax:
Notice
The independent physician’s assessment must be made within 5 business days of the date of the use of the test article. The investigator must notify the IRB of the use within 5 working days after the use of the test article.
The emergency use exemption from prior IRB review is intended to allow a one time use for a course of treatment for a single individual. If the physician determines that a similar future need for the drug or device is likely, the physician should immediately initiate efforts to obtain IRB and FDA approval for the subsequent use of the drug or device.

Documents and Attachments

v  Please attach the informed consent document used. If already executed, please provide a copy of the signed document.

v  Attach a copy of the sponsor protocol, if applicable.

v  Attach any monitoring or debriefing plans not already addressed in the application.

v  Attach any other documentation you feel may be pertinent to the review of this application (drug/device/biologic brochure, etc.).

v  If this use is supported by an external funding agency, please provide Grant Application or Sponsor Protocol.

6. Investigator’s Assurance

Date
Print name
Sign name / In notifying the IRB of the emergency use, I agree to adhere to the treatment protocol as herein described. I agree not to extend the use of this protocol beyond the patient and treatment involved in this request.

7. Department Chair’s Signature

Date
Department
Print name
Sign name

1

Post-Emergency Use Report

Version 8/08