Notice: Instructions for filling out the consent form are written in BLUE.  DELETE all of the instructions before submitting your informed consent. Delete this notice.  Do not delete the IRB stamp statement. 

This consent form is not valid without a TTUHSC El Paso IRB stamp in the lower left corner of each page.  
   
CONSENT TO TAKE PART IN A SOCIO-BEHAVIORAL RESEARCH STUDY

This is a research study for people who voluntarily choose to take part.  Please take your time to make a decision, and discuss the study with anyone you think could help you with your decision.

STUDY TITLE:  (This title must match in all study documents)

INVESTIGATOR(s):  

CONTACT TELEPHONE NUMBERS:  
(You may contact the investigator(s) at the number(s) listed above (Investigator choose one of the following: at any time OR during normal business hours) if you have any unexpected complications.

INSTITUTION: Texas Tech University Health Sciences Center El Paso (you may include other approved sites that will be involved in the study)

KEY INFORMATION

1.	What am I being asked to do?
We are asking you to take part in a research study about [insert general description of the study]. 

This key information is being provided to you to help you decide whether or not you should participate. Additional information is provided to you in the ‘Detailed Information’ section of the document.  

2.	Do I have to take part in this study?
You can choose to take part or you can choose not to take part in this study.  You also can change your mind at any time.  Whatever choice you make, you will not lose access to your medical care or give up any legal rights or benefits. (If subject is an employee or student, please include the following statement, and also select on the application):  If you are a student or employee, your participation in this study will have no effect on your grades or employment status.

This document has important information to help you make your choice. Take time to read it. Talk to your doctor, family, or friends about the risks and benefits of taking part in the study.  It is important that you have as much information as you need and that all your questions are answered.  

3.	What is this study about?  How long will it last?
This study is being done to answer the following question: [provide brief description].

Provide a very BRIEF description of what the study involves (Include length of time, description of intervention). Example: You will come to the clinic 4 times to complete 3 questionnaires over 4 month period.  Each visit will last one hour.  State the overall time commitment for the subject’s participation in the research. This will end your study involvement. If multiple procedures, please separate with bullets or letters.

4.	What are the key reasons I might choose to take part in this study?
Briefly state the most important reason(s) [potential benefit(s)] a person may want to volunteer to be in this study.  If there is no direct benefit, state that. Payment is not a benefit. If there are additional benefits, indicate: For a complete description of the benefits, refer to the ‘Detailed Information’ section of the consent form.

5.	What are the key reasons I might choose not to take part in this study?
Briefly state the most important reason(s) [risk(s)] why a person may not want to volunteer for this study.  For socio-behavioral studies, possible loss of confidentiality is a common risk. If you list this risk, also include your plan to minimize the possibility. If there are additional risks, indicate: For a complete list of the risks, refer to the ‘Detailed Information’ section of the consent form.

There may be some risks that we do not yet know about.

6.	What if I have questions?
For questions about this study, contact the Investigator, NAME, at xxx-xxx-xxxx.  

If you would like to speak to someone who is not involved in the study about your rights as a participant, research-related injuries, or any other matter related to the study, you can call the TTUHSC EthicsPoint Hotline:  1-866-294-9352. Or, you can file an EthicsPoint report online: https://secure.ethicspoint.com/domain/media/en/gui/44534/index.html.  Please choose the “Regulatory Compliance” option when making an online report.  

It is important that you understand the information in the informed consent before making your decision. Please read, or have someone read to you, the rest of this document. If there is anything you do not understand, be sure to ask your study doctor or nurse.

Make a page break here – this ends the key information

DETAILED INFORMATION

7.	What is the purpose of this study?
This study is being done because we are interested in (General topic of study).  We hope that the results of this study will help us to learn whether (Specific research questions).  
Insert the number of study participants taking part in the study at this site and at all sites.

8.	What will happen during this study? (The research procedures listed should match the research procedures section of the application. These should be listed with the timing when they occur in the study). [This should include a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects and if so, under what conditions. If the subject is to be directed to other healthcare services as a result of the findings, this should clearly be stated.]. If multiple procedures, please separate with bullets or letters.

9.	Are there any benefits to me if I take part in this study?  (This question is only necessary if additional benefits may be anticipated beyond what was listed earlier in #4.)

10.	What are the risks or discomforts to me if I join this study? (This question is only necessary if additional risks may be anticipated beyond what was listed earlier in #5.)
	
11.	What other choices do I have if I do not take part in the research study?
[Describe what the usual care for the disease/circumstance/testing would be done if the person was not participating in the study. If there is no usual care for this disease/circumstance/testing then state that as well as ‘You do not have to take part in this study’.]
	
12.	What about confidentiality and the privacy of my records?
We will keep your involvement in this research study confidential to the extent permitted by law.  In addition to the staff carrying out this study, others may learn that you are in the study.  This might include 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 El Paso) representatives, representatives from any hospital or site where the research takes place, and the TTUHSC El Paso Institutional Review Board (a committee that reviews and approves research).  These people may review and copy records involving your participation in this research.  

Study results that are used in publications or presentations will not use your name.

13.	Will I receive anything for taking part in this research study? [If the research provides financial compensation (more than $25) to the subject for their participation, the following two paragraphs MUST be included. If the research does not provide financial compensation to the subject, delete the following two paragraphs and use the last statement only in this section.] 

Payment for participation in this research is considered taxable income. In order for you to receive payment for this research, we will need to collect your name, address, and social security number.   If you are not able to provide this information, 30% of the amount being paid for this research study will be automatically deducted and sent to the Internal Revenue Service (IRS). 

If you receive payments that total more than $600 in one calendar year, Texas Tech University Health Sciences Center El Paso is required to report this information to the IRS.  A Miscellaneous Income form (1099-MISC) will be sent to you and to the IRS. 

(If payment is $25 or less and there is a possibility of enrolling non-resident aliens, please only include the following paragraph-delete previous two paragraphs): 

If you are a non-resident alien, payment for participation in this research is considered taxable income and 30% of the amount being paid for this research study will be automatically deducted and sent to the Internal Revenue Service (IRS). In order for you to receive payment for this research, we will need to collect your name and address. 

[Include if no compensation]
You will not be paid for participating in this study. [If some gratuitous gift is provided, that should also be stated here].

14.	Does anyone on the research staff have a personal financial interest in this study?
(Choose the correct response; delete the other one).
No one on the research staff has a financial interest in this study.

OR
NAME OF INVESTIGATOR/ STAFF has NATURE OF FINANCIAL INTEREST [e.g., paid consultant, owns stock in, etc.] in NAME OF COMPANY.  PERSON’s financial interest in this company has been reviewed by the TTUHSC El Paso Conflict of Interest in Research Committee and an approved management plan is in place to make sure that the research will be conducted objectively.

15.	What if I am hurt by participating in this study?
It is very unlikely that you will be hurt by participating in this study, but if so, Texas Tech University Health Sciences Center El Paso (and UMC or EPCH) does not offer to pay for or cover the cost of medical treatment for research related illness or injury.  No funds have been set aside to pay or reimburse you in the event of such injury or illness.

If you have a research related illness or injury, 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. Before entering this study, you should check whether your insurance company might limit your insurance coverage if you take part in a research study.

Contact for Future Research (THIS IS OPTIONAL AND THE QUESTION MAY BE DELETED IF YOU DO NOT PLAN ON DOING THIS-If it being done, the plan for doing so must be indicated in the protocol and application)
I agree that my study doctor, or someone on the study team, may contact me to see if I wish to participate in other research in the future.

 YES	 NO
Initial in the box above

Your signature indicates that:
•	this research study has been explained to you, 
•	you have been given the opportunity to ask questions and have received answers; 
•	you agree to take part in this study.  

You will be given a signed and dated copy of this form.  

	
Printed Name of Subject

			
Signature of Subject				Date	

			
Signature of Authorized Representative				Date

[Delete the above signature line if the research does not involve a population that may require guardian/authorized representative signature.]

I have discussed this research study with the subject [and his or her authorized representative] using language that is understandable and appropriate.  I believe I have fully informed the subject of the possible risks and benefits, and I believe the subject understands this explanation.  I have given a copy of this form to the subject.  

		
Printed name of authorized research personnel who
conducted the informed consent discussion

			
Signature of authorized research personnel who				Date
conducted the informed consent discussion

(Investigator:  If population includes subjects who are unable to read the written consent form [English/Spanish] and lack an authorized representative, contact your IRB administrator for additional instructions and language.)