Single IRB Boilerplate Language: For studies that are reviewed through a reliance, certain language is required to be included in the informed consent document that is approved by the Reviewing IRB. Sections have been highlighted to assist with the process. In some cases, specific language may already be included in the reviewing IRB consent document, and if so, only the missing information that is relevant to our institution should be included.  For research taking place at UMC, please include the subject research ID# at the top of the first page of the consent form and signature page of the HIPAA authorization. 
Subject Research ID#: _________

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 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 (Choose one of the following: at any time OR during normal business hours) if you have any concerns or 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 questionnaires and have one blood draw, 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. For a complete description of the benefits, refer to the ‘Detailed Information’ section of the consent form (this sentence should be deleted if there are no other benefits).

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 a complete description of the risks, refer to the ‘Detailed Information’ section of the consent form (this sentence should be deleted if there are no other benefits).

There may be some risks that the study doctors do not yet know about.

If alternative treatments/procedures are key to the participant’s choice, discuss those that might be advantageous to the subject or indicate if no known alternative exists. For a complete description of the alternative treatment/procedures, refer to the ‘Detailed Information’ section of the consent form (this sentence should be deleted if there are no other benefits).

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

In the event you believe an emergency may affect your participation in this study, contact the investigator.

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?
Provide a specific description of why the study is being done. 

Insert the names and types of any investigational drugs/agents/interventions/biomarkers, where indicated.

Insert the number of study participants taking part in the study at this site and, if this is a multi-site study, total number of subjects 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.	What will be done that is different from my usual care? (If all procedures are only for research purposes, please state this.) [Identify exams, tests, treatment, and/or procedures that need to be done as part of this study, but may not be included in the usual care].

10.	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 in the key section, otherwise, it should be deleted)

11.	What are the risks and/or discomforts to me if I join this study? (This question is only necessary if additional risks may be anticipated beyond what was listed in the key section, otherwise, it should be deleted.)

12.	Will there be any added risks to me from this study if I am a female/male? (If there are added risks, describe them.  If there are added risks because a subject is a male, answer that too [or instead]).

13.	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.] 

14.	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 EP) representatives, representatives from any hospital or site where the research takes place, and the TTUHSC EP Institutional Review Board (a committee that reviews and approves research).  These people may review and copy records involving your participation in this research.  A copy of this document may be placed in your medical record. 
	
Study results that are used in publications or presentations will not use your name.  

[If the research has an external sponsor, include this last paragraph and state the name of the sponsor where indicated. If there is no external sponsor, delete this paragraph.]
The sponsor of the study, NAME, can also review the study records, but the sponsor is not allowed to remove or copy information that identifies you by name, with one exception.   If you receive Medicare benefits, the Sponsor, NAME is required by law to report payments made to you for treatment, complications, and injuries that arise from this Study. Information that you are taking part in the Study, medical treatments received, Medicare claims, and other personal information about you such as your name, social security number, and date of birth, will be provided to the Centers of Medicare and Medicaid Services and its agents and/or contractors for this purpose.
	
15.	Who is funding this study?
(Choose the correct response below; delete the other response)

	(For investigator-initiated studies with no external sponsor) NAME OF DEPARTMENT is providing the space and supplies for this study.  No one on the research staff will receive anything of value from other agencies, organizations, or companies to carry out this research. 

	OR

	(For externally sponsored studies) NAME OF AGENCY/ORG/CO is funding this research study. This means that TTUHSC El Paso (or affiliate) is being paid by NAME OF SPONSOR to support the activities that are required to carry out the study.  No one on the research staff will receive anything of value from NAME OF SPONSOR for carrying out this study.   (If someone IS receiving something of value from the sponsor for carrying out the study, it should be disclosed here).   

16.	Will it cost me anything to take part in this research study?  
[If the research includes chargeable exams, tests and procedures, then the following four paragraphs should be included. If the research does not involve chargeable exams, tests and procedures, delete the following four paragraphs and use only the last statement in this section.]
You and/or your insurance provider will not have to pay for exams, tests, and procedures done for research purposes only or that are covered by the study.  These include:  xx (List procedures covered by the study.)  

Any procedures that are considered standard of care are your or your insurance provider’s responsibility.

Talk to your insurance provider and the study staff to make sure that you understand what your insurance pays for and what it does not pay for if you take part in this study.  Also, find out if you need approval from your plan before you can take part in the study. 

Ask your researcher/doctor or nurse for help finding the right person to talk to if you are unsure which costs will be billed to you or your insurance provider. 

[If the research does not involve chargeable exams, tests and procedures, use the following statement:]
There are no costs to you for participating in this study.

17.	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].

18.	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
Yes, [NAME OF RESEARCHER/INVESTIGATOR/ STAFF] has [describe the 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. 
	
19.	What if I am hurt by participating in this study?
	(Do not delete-This must remain as the first paragraph.)
Texas Tech University Health Sciences Center El Paso (and UMC EP or EPCH if the research is being conducted at an affiliated hospital) 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 unless specifically stated.	
(Choose the correct response below; delete the other response)
		
The following two paragraphs are required for greater than minimal risk, industry-sponsored clinical trials:
	
If you have a research related illness or injury, [THE STUDY SPONSOR] will provide payment for extra unanticipated tests, treatments, and hospitalizations unless such expenses were due to: (i) TTUHSC El Paso’s and Principal Investigator’s failure to strictly adhere to the terms of the Protocol; (ii) the negligence or misconduct of TTUHSC El Paso or its employees or agents; or (iii) a pre-existing medical condition or your underlying disease. You or your medical or hospital insurance company is not responsible for any costs of extra treatment.
	
If you think you have a research-related illness or injury, you should notify the study doctor and seek care as you normally would.  If you or your insurance company is billed for treatment for an illness or injury that is determined to be related to this research study, TTUHSC El Paso and your study doctor will work with [THE STUDY SPONSOR] to reimburse you or the insurance company for the cost of that care.

OR

This paragraph may be used for investigator-initiated or minimal risk studies along with the first paragraph of this section:  
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. 

20.	Can I stop being in the study?
Yes, your participation is voluntary.  You may decide to stop taking part in the study at any time. If you leave the study, we cannot remove any information we have collected to that point. 

If you decide to stop, let your researcher/study doctor know as soon as possible so we can assure your needs related to this research are met.  It is important that you stop safely.  (*Adapt and insert as applicable:  This may mean slowly stopping the study drugs so that there is not a sudden unsafe change, risk to your health, etc.*).  If you decide to stop the study intervention(s), you can decide if you want to keep letting the researcher know how you are doing or if you want to completely withdraw from participation.

Your researcher/study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.

21.	Can someone else end my participation in the study?
Under certain circumstances, the investigators, TTUHSC El Paso, or the study sponsor may decide to end your participation in this research study earlier than planned.  This might happen because:
•	Your health changes and the study is no longer in your best interest.
•	New information becomes available and the study is no longer in your best interest.
•	You do not follow the study rules.
•	The study is stopped by the Institutional Review Board (a committee that reviews and approves research), the Food and Drug Administration or study sponsor, [name of sponsor]. 

22.	What will happen to my [name specific biospecimens here – blood, tissue, sample, etc./medical record information] when the research study is over? 
[(This question may be deleted if it does not apply). If biospecimens or medical record information is to be collected, be sure to identify what you are collecting and incorporate the following as needed:]
In this study, we will be collecting some of your [describe the biospecimens to be collected and/or recorded medical information.] When the study is done, we will make sure that this [biospecimen/recorded medical information] cannot be identified as belonging to you.  

(Choose one response from below):  
We will properly dispose of your [biospecimen/recorded medical information] and [it/they] will not be used in future studies. 

OR 
We will keep your [choose the correct language] identifiable [or] unidentifiable biospecimen/recorded medical information to use in our future research, or in research done by our colleagues. If your identifiable [or] unidentifiable [choose the correct language] biospecimen/recorded medical information is used in future studies, we will not ask for your consent again before using it/them. You will not know when or if those samples are used for research, and no one will be able to tell you any results of research that used your samples.   

The following statements must also be included if appropriate. You may delete either or both:  
(1) It is possible that these samples will be used in research that could profit the investigator or others. If the sample is used in that way, you will not share in any of the potential profit. 
(2) The future research might include whole genome sequencing. Sequencing allows researchers to identify your genetic code. Changes in your genetic code may be passed down through your family.  For example, these genetic changes may be passed down to your children in the same way that eye and hair color are passed down. These are called germline changes.

(The following language is required if you are conducting a clinical trial of a drug or device that is regulated by the FDA.  If this is not an applicable clinical trial, you may delete the following paragraph.)

A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not include information that can identify you.  At most the Web site will include a summary of the results.  You can search this Web site at any time.

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 accept your responsibility to follow the instructions given to you by the research team regarding study participation and, if applicable, research medication;
•	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 that will need to be included.) 

Make a page break here – this ends the consent document.  The HIPAA form is the next document.

INVESTIGATORS:   THIS IS THE TTUHSC EP HIPAA AUTHORIZATION FORM.   If your study is not using Protected Health Information and does not need HIPAA Authorization, you can delete these pages.

Also, note that TTUHSC EP HIPAA policies prohibit investigators from making ANY CHANGES to this document without prior written approval from the HIPAA Privacy Officer. Approval will need to be attached to the submission.
Subject Research ID#: _________
TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER EL PASO
AUTHORIZATION TO USE AND/OR DISCLOSE YOUR PROTECTED HEALTH INFORMATION for a RESEARCH STUDY

STUDY TITLE: (Same as on page 1)

This form is intended to tell you about the use and/or disclosure (sharing) of your personal Protected Health Information (PHI) if you decide to participate in the research study described on the previous pages. The health information about you that may be used or disclosed is described below. This information is usually found in your medical records.  Only the health information about you that is needed for this research study will be used or disclosed.  When you consider taking part in this research study, you are also being asked to give your permission for your Protected Health Information to be released from your doctors, clinics, and hospitals to the research personnel approved for this research study.  This Authorization specifically relates to the research study described in the attached Informed Consent document.

1.	This Authorization is valid indefinitely or until such time as legal requirements will allow this Authorization to be destroyed.

2.	If you choose to cancel this Authorization, please give notice in writing to:

TTUHSC-El Paso Privacy Officer 
Office of Institutional Compliance 
5001 El Paso Drive
El Paso, TX 79905

If you sign this Authorization, the following persons, groups or organizations may rely on this Authorization to disclose your Protected Health Information to the Principal Investigator and other research personnel who are conducting this Study: 

•	your treating physicians and healthcare providers and their staff,
•	associated healthcare institutions and hospitals where you have or may receive care.

While this research study is in progress, the Principal Investigator or research personnel working on this study will inform you whether or not you will be allowed to see the research related health information that is created about you or collected by the research personnel prior to the end of the study.  After the study is finished you may request this information as allowed by the TTUHSC EP Notice of Privacy Practices.
The Protected Health Information that you authorize to be used or disclosed for research purposes may include your current or future health information from some or all of your health records, including: 

•	hospital records and reports
•	admission history, and physical examination
•	X-ray films and reports; operative reports
•	laboratory reports, treatment and test results (including sexually transmitted diseases, HIV or AIDS)
•	any other Protected Health Information needed by the research personnel listed above.

(* use separate form for disclosure of psychotherapy notes)	•	immunizations
•	allergy reports
•	prescriptions
•	consultations
•	clinic notes
•	mental health records
•	alcohol / substance abuse records

For the purposes of this study, your Protected Health Information may need to be reviewed or disclosed to individuals or organizations within and/or outside of TTUHSC EP who sponsor, approve, assist with, monitor or oversee the conduct of research studies.  This includes, but is not limited to, the TTUHSC EP Institutional Review Board, TTUHSC EP compliance reviews, the US Food and Drug Administration (FDA) or governmental agencies in other countries. Some of these individuals or organizations may share your health information further, and your health information may not be protected by the same privacy standards that TTUHSC EP is required to meet.

If you choose to sign this Authorization form, you can change your mind about this later.  If you change your mind, send a letter to the person identified above telling us to stop collecting and sharing your Protected Health Information.  When we receive your request, you may be asked to leave the research study if all the necessary information has not been collected.  We may still use the information about you that we have already collected.  We need to know what happens to everyone who starts a research study, not just those people who stay in it.

You have the right to refuse to sign this form.  If you choose not to sign this form, your regular health care will not be affected.  However, not signing this form will prevent you from participating in this research study and prevent you from receiving research related health care services provided under this study.

I have had the opportunity to review and ask questions regarding this Authorization to use or disclose my personal health information, and I will receive a copy of this form.  By signing this Authorization, I am confirming that it reflects my wishes.

Printed Name of Subject

Signature of Subject or Authorized Representative				Date

If applicable, Relationship of Authorized Representative				Date
or Authority to Sign