Emergency Use Report

Note: This form is to be completed for use of an investigational agent for a life-threatening condition in which there is not sufficient time for the IRB to convene a meeting. Please note that whenever emergency care is initiated without prior IRB review and approval, the patient may not be considered a research subject. The data from such care cannot be included in any aspect of a research activity.

All questions/blanks must be completed-Incomplete reports will be returned. Whenever possible, use lay terms. This completed, signed report must be submitted to the Office of Research Integrity & Protections – 1R4. All paperwork submitted must be on 8 ½ x 11 paper and must be single-sided copies. Report must be submitted, along with a copy of the signed consent document no later than 5 working days of the emergency event.

Date:

Physician Responsible for this Emergency Use:

Routing Location:	Phone:

Patient Initials:

Name of investigational agent used:

Date investigational agent was administered:

Duration of Treatment:

Provide a summary of the conditions that constituted the emergency use:

Patient outcome, if available:

Was written informed consent obtained?

Yes - attached signed consent document:

No - attach the signed Emergency Use - Exception to Informed Consent form:

ASSURANCE

I certify that statements herein and attached are true and complete to the best of my knowledge. I certify that use of an investigational agent for my patient met the criteria for “emergency use.” Use of the agent was necessary for a life-threatening condition and there was not sufficient time for the IRB to convene a meeting.

_______________________________________________

Signature of Physician	Date

Consent from the subject is required unless both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:

The subject is confronted by a life-threatening situation necessitating the use of the test article.

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

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

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

STATEMENT

“I certify that emergency treatment with the above investigational agent was administered without the subject’s consent. Immediate use of the test article was required and the above four conditions are applicable for this emergency situation.”

___________________________________

Signature of Principal Investigator	Date

Printed Name of Principal Investigator	Routing Location

___________________________________

Signature of Independent Physician	Date

Printed Name	of Independent Investigator	Routing Location

To access this form in Microsoft Word, click on File/New/MMRF/IRB Emergency Use

Revised: 10/2001; 3/2003; 9/2004

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2016-07-18

Knecht, Justin E

Marshfield Clinic