EMERGENCY USE – EXCEPTION FROM INFORMED CONSENT

(Other documentation may be accepted as long as all the information requested below is provided.)

Note: Use this form in “emergency use” situations where informed consent cannot be obtained. See policy on emergency use for requirements for informed consent. This form must be attached to the Emergency Use Report and submitted to the Office of Research Integrity & Protections – 1R4 within 5 working days of use of the test article.

In order for an exception to be allowed from the requirement to obtain informed consent, both the investigator and a physician who is not otherwise participating in the clinical investigation* must certify the following:

1. The subject is confronted by a “life-threatening” or “severely debilitating” (see definitions on p. 2) situation necessitating the use of the test article.

2. Informed consent cannot be obtained because of an inability to communicate with or obtain legally effective consent from the subject.

3. Time is not sufficient to obtain consent from the subject’s legal representative.

4. No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the subject’s life.

*If, in the investigator’s opinion, immediate use of the test article is required to preserve the subject’s life, and if time is not sufficient to obtain an independent physician’s determination, the clinical investigator should make the determination. The determination should then be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.

Date:

Physician Responsible for the Administration of the Test Article:

Routing Location:	Phone:

Date of Emergency Use of the Test Article:

Patient Initials:

STATEMENT

I certify that informed consent was not obtained for the emergency use noted on the attached Emergency Use Report but that conditions 1 through 4 noted above, were met.

______________________________________________

Signature of Physician Administering Test Article	Date

______________________________________________

Signature of Independent Physician	Date

Printed Name of Independent Physician	Routing Location

Definitions

Emergency Use – The use of a test article with a human subject in a “life-threatening” or “severely debilitating” situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval.

Life-threatening – 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 trail 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 – 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.

Test article – any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq. as amended (21 U.S.C. 321-392) or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n).

Revised: 4/1/2009

Consent from the subject is REQUIRED unless both the investigator and a physician who is not otherwise participating in the cl

MMRF

2009-03-20

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Marshfield Clinic