HUMANITARIAN USE DEVICE INFORMED CONSENT
[Insert name of HUD]

The Food and Drug Administration (FDA) has approved [insert name of HUD] as a Humanitarian Use Device (HUD) to provide treatment for patients who have [insert name of disease or condition].   

A HUD is a medical device that may benefit patients by treating or diagnosing a condition or disease that affects fewer than 4,000 people in the United States per year and where there is no comparable device available for treatment.  

Please read this form and ask any questions you may have before agreeing to use/receive [insert name of HUD].

[Insert principal investigator, degree] will use the device provided by [insert name of sponsor if sponsored] during procedures that will take place at [insert name of site].

Purpose and background: 
Describe background information in lay language that informs and justifies why the HUD treatment is being performed, so the participant can understand clearly, why the HUD is important given their current condition.  

Procedures:
If you agree to the use of [insert name of HUD], you will [describe the procedure chronologically using lay language].

Risks:  
You may experience the following risks [describe (in lay language) the risks, that are inherent to the device in order of severity and likelihood, as applicable; when possible please quantify in percentage of occurrence]. 

There may be adverse events or side effects that are currently unknown and it is possible that certain of these unknown risks could be permanent, serious or life threatening. 

There is no guarantee about the effectiveness of this device, as this has not been proven for this use.

Benefits: 
You may not benefit from this treatment.  Your condition may get better, stay the same, or get worse. The possible benefits to you associated with the use of this device are [list all benefits of the device].

Alternatives:
You may choose not to be treated with the [insert name of HUD]. [Describe any alternatives that may be appropriate for the participant.  If there are no alternatives, state that an alternative is to not allow use of the HUD].

Confidentiality:
The treating physician and his/her collaborators and staff will consider your records confidential to the extent permitted by law. Others may be able to review and inspect your records.  This might include the manufacturer of the HUD [insert name of HUD], federal regulatory agencies such as the Food and Drug Administration (FDA) and the Office for Human Research Protection (OHRP), Texas Tech University Health Sciences Center El Paso (TTUHSC EP) representatives, representatives from University Medical Center of El Paso, and the TTUHSC EP Institutional Review Board (a committee that reviews and approves research).  A copy of this document will be placed in your medical record. 

Costs:
You or your insurance provider will be responsible for any costs or charges associated with the use of [insert name of HUD] and any procedures needed to use or insert the device as these are considered part of standard of care.  

Treatment Related Injury:
If you have are injured as a result of the use of [insert name of HUD], care will be available to you as usual, but you and/or your medical or hospital insurance company will be responsible for the cost of treatment. Texas Tech University Health Sciences Center El Paso and University Medical Center of El Paso do not offer to pay for or cover the cost of medical treatment related to illness or injury.  No funds have been set aside to pay or reimburse you in the event of such injury or illness.

If you think that you have suffered an injury from using the device, please contact [insert name of principal investigator] or one of [his/her] staff members at the following phone number [insert telephone number]. 

Voluntary Use of HUD/Withdrawal:
Your choice to use the device is voluntary.  You do not have to agree to use this device.  If you do receive the device and later change your mind, you may stop using the device [Explain what must take place if participants choose to stop using the device].  

If you choose not to have the device used, or want to stop using it, you will not be penalized or lose any benefits to which you are otherwise entitled. Your decision will not change any present or future relationships with Texas Tech University Health Sciences Center El Paso or University Medical Center of El Paso.

Questions:
If you have any questions now or in the future, please contact [insert name of principal investigator] or one of [his/her] staff members at the following phone number [insert telephone number].  

If you would like to speak to someone about your rights as a recipient of this device or any other matter, you can call the TTUHSC EthicsPoint Hotline:  1-866-294-9352.

Consent to use of a Humanitarian Use Device (HUD):
I have read this consent document and have been able to ask questions and express concerns to which the doctors have responded.  I believe I understand the purpose and procedures involved with the HUD treatment, as well as the potential benefits and risks that are involved.  

By signing this consent form you are not giving up any legal rights. Your signature means that you understand the information given to you about the HUD in this form and wish to use the device as described.  If you agree to the use of the HUD, you will be given a copy of this consent form. 

	
Printed Name of Participant

			
Signature of Participant	Date				

	
If applicable, Printed Name of Legally
Authorized Representative

			
If applicable, Signature of Legally 	Date				
Authorized Representative

I certify that I have explained to the above individual the possible benefit and risks associated with treatment.   I have answered any questions that have been raised and the patient has received a copy of this signed consent document.

		
Printed name of person who conducted the 
informed consent discussion

			
Signature of person who conducted the 	Date 
informed consent discussion