HUMANITARIAN USE DEVICE CONSENT

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:
Manufacturer:
Physician Name:	Telephone No. (regular office hours)	Telephone No. (other times)

A Humanitarian Use Device (HUD) is intended for use in patients with conditions that affect less than 8,000 people in the United States.

Because the number of patients is so small, the Food and Drug Administration (FDA) has approved the use of HUDs for the clinical treatment of patients without the same rigorous testing that other products get. The FDA believes that these devices are likely to be safe and will probably benefit patients.

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

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

POSSIBLE BENEFITS: [provide information regarding the benefits associated with the use of the device].

ALTERNATIVE TREATMENTS: [describe alternative treatments that may be available to patients].

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

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 device.
•	You have freely decided to allow your doctor to use this device 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