Consent to Undergo [Insert “Emergency” if this is Emergency Use] Treatment with

Investigational Drug/Biologic/Device

At:

The University of Texas Southwestern Medical Center

Parkland Health & Hospital System

Children’s Health

Retina Foundation of the Southwest

Texas Scottish Rite Hospital for Children

Texas Health Resources

Name of Device/Drug/Biologic:
Manufacturer:
Physician Name:	Telephone No. (regular office hours)	Telephone No. (other times)

Treatment of your disease or condition by standard, conventional methods is not/no longer effective. By signing this form, you consent to receive an investigational treatment that is not approved by the Food and Drug Administration (FDA). Although your physician believes this is the best option for you, no guarantees can be made when using investigational treatments.

Although this treatment is experimental, you are not a subject in a research study. Your doctor will release safety information about this investigational treatment to the manufacturer/supplier of the investigational test article and to the FDA.

DESCRIPTION: [insert the name of the investigational agent and describe its uses. Provide information on why the patient is a candidate for the use of the investigational agent].

POSSIBLE RISKS: [provide information describing the possible risks, side effects and/or adverse events associated with the investigational agent and its proposed use].

When using investigational treatments, it is not possible to know all potential risks and side effects. This treatment may involve risks or side effects other than those listed above.

POSSIBLE BENEFITS: We cannot promise that this treatment will benefit you. The goal of this treatment is to: __________________. [Describe the potential benefits of the treatment]

ALTERNATIVE TREATMENTS: You may refuse to receive this investigational treatment or may have it stopped at any time. The doctor may also stop its use if they feel it is in your best interest to do so. If you do not agree to this treatment or if the treatment is stopped early, the following alternatives are available: [describe alternative treatments that may be available to patients].

ESTIMATED COSTS: [provide the estimated costs to the patient for the investigational treatment].

What else do I need to know?

Efforts will be made to limit your personal information, including medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the Institutional Review Board (IRB), representatives of this organization, and the Food and Drug Administration. [NOTE: HIPAA Authorization is not required because this does not meet the HIPAA definition of research.]

If you are injured or made sick from taking part in this treatment, medical care will be provided. Generally, this care will be billed to you or your insurance. Depending on the circumstances, this care may be provided at no cost to you. Contact the investigator for more information.

Who can I talk to?

If you have questions, concerns, or complaints, or think the treatment has hurt you, call your doctor at the phone number listed on the top of this form.

This treatment is subject to oversight by an Institutional Review Board. If you have questions about your rights or any unresolved question, concern, or complaint, talk to them at (214) 648-3060.

YOU WILL HAVE A COPY OF THIS CONSENT FORM TO KEEP.

Your signature below certifies the following:

•	You have read (or been read) the information provided above.
•	You have received answers to all of your questions.
•	You have received and read the manufacturer’s information about this treatment.
•	You have freely decided to allow your doctor to use this investigational treatment in your care.
•	You understand that you are not giving up any of your legal rights.

__________________________________________________ Patient’s Name (printed)
__________________________________________________ Patient’s Signature	_______________ Date / Time: AM-PM
__________________________________________________ Legally authorized representative’s name (printed)
__________________________________________________ Legally authorized representative’s Signature	________________ Date / Time: AM-PM
__________________________________________________ Name (printed) of person obtaining Consent
__________________________________________________ Signature of person obtaining consent	________________ Date / Time: AM-PM