Investigational Product Use in Treatment Consent Form

INVESTIGATIONAL PRODUCT-- USE IN TREATMENT CONSENT FORM

Physician Name: Dept:

Address:

Phone:

Patient Name:

Patient at the following facility: University of Miami; or Jackson Health System; or Both

Name of Investigational Product (biologic/drug/device):

Your consent is requested to use the above named product in: Your care; The care of your child; The care of someone for whom you are the legally authorized representative.

PURPOSE

You have this condition: . The purpose of this consent form is to advise you that traditional methods of treatment for your condition have failed, and that with your consent, we are providing you with this investigational product to help treat your condition. Left untreated, your condition may lead to serious or life-threatening harm or even death.

PROCEDURES

This investigational product has not been approved by the Food and Drug Administration (FDA) for treatment of your condition, but it may be a possible treatment . If you agree to the use of this investigational product, this is what we will do:

BENEFITS

It is unknown whether treatment of your condition with this product will have any benefits. However, the following is known:

RISKS

The most likely risks of using this investigational product are:

There may be other significant or even life-threatening risks that we do not know about. The safety and efficacy of the investigational product cannot be guaranteed, and there could be side effects that we do not know about. You agree to expressly assume any and all risks that may arise from the use of this product. If injury occurs as a result of this treatment, we will provide medical care, but we will not provide special services, free care or any compensation for injuries resulting from the use of this product.

ALTERNATIVES

If you do not consent to the use of this product, your treatment alternatives other than this product are:

CONFIDENTIALITY

If the medications or devices described in this consent form are regulated by the FDA, the FDA and other regulatory agencies, and authorized University of Miami employees or other agents may inspect records identifying you as a recipient of this investigational product. In addition, the facility in which you are treated may ask you to sign a separate informed consent document for specific procedures or treatment, and that informed consent form may be included in the medical record of that facility. Please be assured that your medical records will be kept confidential to the extent permitted by law. For certain emergency uses of an investigational product in a life-threatening situation, your physician is required to report the one-time use of such product to the University of Miami Institutional Review Board (IRB) within 5 days of administration and provide certain applicable certifications, under FDA regulations. Any subsequent use of the product would be subject to IRB review.

OTHER PERTINENT INFORMATION:

If you consent to this treatment and later believe that you have suffered any injury as a result of this investigational product or if you have any questions about the product or about the rights of those agreeing to have an investigational product used in their medical care, you may contact Dr. at .

I have read the above explanations and have received answers to any questions I have about treatment with this product. I consent voluntarily to the use of this investigational product.

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Signature of Patient or Legal Representative Print Name of Patient or Legal Representative Date

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Signature of Witness Print Name of Witness Date

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Signature of Person Obtaining Consent Print Name Person Obtaining Consent Date

PATIENT IMPRINT

Revised: 2/1/07 Page 2 of 2