The University of Texas Southwestern Medical Center

Parkland Health & Hospital System

Children’s Medical Center

Retina Foundation of the Southwest

Texas Scottish Rite Hospital for Children

Texas Health Presbyterian Hospital Dallas

CONSENT TO PARTICIPATE IN RESEARCH

Title of Research:	[insert title]

Funding Agency/Sponsor:	[if no external funds, state UT Southwestern Medical Center]

Please insert the names of the investigators and those individuals who will obtain consent.

Study Doctors:	[insert investigators names]

Research Personnel:	[insert research personnel names]

You may call these study doctors or research personnel during regular office hours at [insert phone number]. At other times, you may call them at [insert after hours phone number].

[Remove if not applicable]

Note: If you are a parent or guardian of a minor and have been asked to read and sign this form, the “you” in this document refers to the minor.

Instructions:

Please read this consent form carefully and take your time making a decision about whether to participate. As the researchers discuss this consent form with you, please ask him/her to explain any words or information that you do not clearly understand. The purpose of the study, risks, inconveniences, discomforts, and other important information about the study are listed below. If you decide to participate, you will be given a copy of this form to keep.

Why is this study being done?

This study is being done to [please complete].

Why am I being asked to take part in this research study?

You are being asked to take part in this study because [name reason/condition here].

(Sample Language:)

You are being asked to take part in this study because you have high blood pressure.

How many people will take part in this study?

About [insert number] people will take part in this study at UT Southwestern or [insert Children’s Medical Center, Parkland Health & Hospital System, Texas Scottish Rite Hospital for Children]. [If a multi-center trial, please also insert: “This study also is taking place at a number of other medical facilities around the country. There will be a total of [insert number] people participating in this research study throughout the United States and/or other countries.”]

What is involved in the study?

If you agree to be in this study, you will be asked to sign this consent form and will have the following tests and procedures. [Describe procedures in detail identifying any procedures that are experimental (if applicable). Include an estimate of expected duration of participation. For example, provide the length of time to complete a questionnaire, etc.]

Procedures and Evaluations during the Research:

[Explain the procedures and evaluations (as outlined in the protocol).]

[Clearly identify any inconvenient or experimental or painful procedures (such as long clinic visits, keeping a detailed diary between clinic visits, collection of multiple blood samples, etc.)]

[Specify the amount of blood that will be drawn at any one time in teaspoons, tablespoons or cups.]

[Specify the number of study visits and the approximately length of time it will take to complete each study visit.

[When describing what is involved in the study, please consider using a detailed timeline.]

For example:

You will have the following tests and/or evaluations:

Visit 1:

complete two short questionnaires about your pelvic discomfort

two tablespoons of blood will be drawn from your arm by needle stick for blood tests.

a brief pelvic exam will be completed to measure pelvic organ prolapse

Visit 2 :

you will complete two questionnaires

a brief pelvic exam will be completed to measure pelvic organ prolapse

Or insert a simple table

The [insert research related test(s)] in this study are designed for research, not for medical purposes. They are not useful for finding problems or diseases. Even though the researchers are not looking at your [insert research related test(s)] to find or treat a medical problem, you will be told if they notice something unusual. You and your regular doctor can decide together whether to follow up with more tests or treatment. Because the [insert research related test(s)] done in this study are not for medical purposes, the research results will not be sent to you or to your regular doctor.

Procedures for storing of extra or left over samples [Please note if DNA testing will be completed on the samples, a separate DNA Consent Form must be completed]:

[Explain the procedures for the storing of the extra or left over samples and the purpose of storing the samples. This information should include:

how the samples will be labeled

whether or not identifiers will be kept

location of where the samples will be kept and

who will have access to the samples

[Insert the following, if the study will collect and use the subject’s social security number as part of the research. NOTE: Do not include this paragraph if the social security number will only be used for processing study payments].

The researchers will record and use your social security number (SSN) in order to [state intended use]. You do not have to give this information to the researchers; however it may result in [state what may happen if the subject fails to provide SSN]. This information will remain confidential unless you give your permission to share it with others, or if we are required by law to release it.

How long can I expect to be in this study?

[Please describe here how long the study will be (in weeks, days or months). Describe also (if applicable) whether you intend to collect follow-up information and how much time that collection will require. For example, until six months after your last study visit.

You can choose to stop participating for any reason at any time. However, if you decide to stop participating in the study, we encourage you to tell the researchers. You may be asked if you are willing to complete some study termination tests.

What are the risks of the study?

[Please note: The risk section should only contain the risks associated with study procedures. Risks of standard medical care procedures that are not required for the research should not be included in the consent form.

Additional template language regarding MRI risks can be found on Forms page of the IRB website located at www.utsouthwestern.net/irb under the document titled “Additional Template Language for Studies Involving MRI Procedures”.

Study Intervention

Because of your participation in this study, you are at risk for the following side effects.

[Please describe any risks and side effects related to the investigational aspects of the study.

Psychological Stress

[If the study involves psychological stress, please state.] Some of the questions we will ask you as part of this study may make you feel uncomfortable. You may refuse to answer any of the questions, take a break or stop your participation in this study at any time.

Loss of Confidentiality

Any time information is collected; there is a potential risk of loss of confidentiality. Every effort will be made to keep your information confidential; however, this cannot be guaranteed.

If applicable:

Risks to an Embryo, Fetus or Breast-fed Infant [insert this risk section if applicable to your study]

Females: If you are part of this study while pregnant or breast-feeding an infant, it is possible that you may expose the unborn child or infant to risks. For that reason, pregnant and breast-feeding females can not participate in the study. If you can become pregnant, a pregnancy test will be done (using 1 teaspoon of blood drawn from a vein by needle-stick or a urine sample), and it must be negative before you be a part of this study.

If you do become pregnant during this study, you must tell the researchers immediately.

If your parents or guardian asks, we will tell them the results of your pregnancy test or that you are using birth control.

Risks of Blood Drawing [insert the risk statement if applicable to your study]

Risks associated with drawing blood from your arm include minimal discomfort and/or bruising. Infection, excess bleeding, clotting, and/or fainting also are possible, although unlikely.

[If blood samples are collected as part of the participants’ standard medical care, please include the following sentence.] You will have the same amount of blood collected whether you receive standard medical care for your health problem or take part in this research.

[If blood samples are collected solely for the purpose of research, please include the following sentence.] You will have [insert amount in lay terms] of blood collected because you are in this research study.

Other Risks

There may possibly be other side effects that are unknown at this time. If you are concerned about other, unknown side effects, please discuss this with the researchers.

What are the possible benefits of this study?

[Please note: The description of benefits to the participant should be clear and not overstated. If no direct benefit is anticipated, then that should be stated. If these benefits may be materially relevant to a participant’s decision to participate, the benefits should be disclosed in the informed consent document.]

If you agree to take part in this study, there [may or may not] be direct benefits to you. The researchers cannot guarantee that you will benefit from participation in this research.

We hope the information learned from this study will benefit others with [insert condition] in the future. Information gained from this research could lead to better [insert appropriate care/prevention/treatment].

What options are available if I decide not to take part in this research study?

If a treatment study, insert: You do not have to participate in this research to receive care for your medical problem. Instead of being in this study, you have the following options:

[please insert all alternative treatment options available to the participant] Please note: When applicable, this should include receiving the study drug or treatment off study or the possibility of no treatment at all.

Please talk to the researchers or your personal doctor about these options.

[If not a treatment study, insert: This is not a treatment study. You do not, have to be part of it to get treatment for your condition.

Will I be paid if I take part in this research study?

Yes. [Please explain what the participant will receive]

Sample Language 1:

You will be paid $100.00 at the end of the study. If you stop taking part in this study or are withdrawn by the research team, you will receive payment for only the visits you have completed. For example, if you complete 4 study visits you will be paid $40.00.

Sample Language 2:

You will be given a $50.00 gift card to Toys R US, at the end of the study if you take part in this research.

Sample Language 3:

You will be given the following, if you take part in this research:

XYZ Tote Bag

XYZ T-Shirt; and

XYZ Notepads.

If applicable:

There are no funds available to pay for parking expenses, transportation to and from the research center, lost time away from work and other activities, lost wages, or child care expenses.

How will I be paid?

You will be issued a UT Southwestern Greenphire ClinCard, which can be used as a credit or debit card. You will also receive instructions on how to use the card. In order to receive study payments, your name, address, date of birth and Social Security Number (SSN) will be collected from you by the research staff. All information will be stored in a secure fashion and will be deleted from the UT Southwestern Greenphire ClinCard system once the study has been completed.

Important Information about Study Payments

1.	Your SSN is needed in order to process your payments. Should you decide not to provide your SSN, your study participation payment will be decreased at the current IRS tax rate. Study payments are considered taxable income and are reportable to the IRS.

2.	An IRS Form 1099 will be sent to you if your total payments are $600 or more in a calendar year.

3.	Your ClinCard payment information will not be shared with any third parties and will be kept completely confidential

This information will remain confidential unless you give your permission to share it with others, or if we are required by law to release it.

UT Southwestern, as a State agency, will not be able to make any payments to you for your participation in this research if the State Comptroller has issued a “hold” on all State payments to you. Such a “hold” could result from your failure to make child support payments or pay student loans, etc. If this happens, UT Southwestern will be able to pay you for your taking part in this research 1) after you have made the outstanding payments and 2) the State Comptroller has issued a release of the “hold.”

Insert the following, if participants will receive reimbursement for travel expenses, parking, etc.

You will be reimbursed for your parking expenses, transportation to and from the research center (for example cab or bus fare), or child care expenses. In order to receive reimbursement, you will need to turn in all your receipts to the research coordinator.

Will my insurance provider or I be charged for the costs of any part of this research study?

No. Neither you, nor your insurance provider, will be charged for anything done only for this research study (i.e., the Screening Procedures, Experimental Procedures, or Monitoring/Follow-up Procedures described above).

If applicable:

However, the standard medical care for your condition (care you would have received whether or not you were in this study) is your responsibility (or the responsibility of your insurance provider or governmental program). You will be charged, in the standard manner, for any procedures performed for your standard medical care.

[Please note: If the participant’s insurance company will be responsible for any research- related costs, please use the following language.]

Yes. The costs of [insert items] will be billed to you or your insurance provider. We expect the costs of [insert items] to be [insert amount].

What will happen if I am harmed as a result of taking part in this study?

It is important that you report any illness or injury to the research team listed at the top of this form immediately.

Compensation for an injury resulting from your participation in this research is not available from the University of Texas Southwestern Medical Center at Dallas or [insert only Children’s Medical Center, Parkland Health & Hospital System, Presbyterian Hospital of Dallas, Retina Foundation of the Southwest, and/or Texas Scottish Rite Hospital for Children].

[If applicable] The sponsor has expressed a willingness to help pay the medical expenses necessary to treat such injury.

You retain your legal rights during your participation in this research

Can I stop taking part in this research study?

Yes. If you decide to participate and later change your mind, you are free to stop taking part in the research study at any time.

If you decide to stop taking part in this research study, it will not affect your relationship with the UT Southwestern staff or doctors. Whether you participate or not will have no effect on your legal rights or the quality of your health care.

If you are a medical student, fellow, faculty, or staff at the Medical Center, your status will not be affected in any way.

[Include if recruiting from investigator’s own patients: Your doctor is a research investigator in this study. S/he is interested in both your medical care and the conduct of this research study. At any time, you may discuss your care with another doctor who is not part of this research study. You do not have to take part in any research study offered by your doctor.

Will my information be kept confidential?

If applicable (for example, any tests or procedures ordered and resulted in the EPIC system): Medical information collected during this study and the results of any test or procedure that may affect your medical care may be included in your medical record. The information included in your medical record will be available to health care providers and authorized persons including your insurance company.

You should know that certain organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:

•	[Insert Sponsor’s name]

•	Representatives of government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for people, and

•	The UT Southwestern Institutional Review Board.

Insert next paragraph for studies required to be registered on ClinicalTrials.gov.

A description of this clinical trial will be available on http://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.

In addition to this consent form, you will be asked to sign an "Authorization for Use and Disclosure of Protected Health Information." This authorization will give more details about how your information will be used for this research study, and who may see and/or get copies of your information.

Insert this section for studies with a Certificate of Confidentiality:

If applicable (for example, any tests or procedures ordered and resulted in the EPIC system): Medical information collected during this study and the results of any test or procedure that may affect your medical care may be included in your medical record. The information included in your medical record will be available to health care providers and authorized persons including your insurance company.

You should know that certain organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:

•	[Insert Sponsor’s name];

•	Representatives of government agencies, like the U.S. Food and Drug Administration (FDA), involved in keeping research safe for people; and

•	The UT Southwestern Institutional Review Board.

Insert the next paragraph for studies required to be registered on ClinicalTrials.gov.

A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by the 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.

In addition to this consent form, you will be asked to sign an "Authorization for Use and Disclosure of Protected Health Information." This authorization will give more details about how your information will be used for this research study, and who may see and/or get copies of your information.

To help us further protect the information, the investigators will obtain a Certificate of Confidentiality from the U.S. Department of Health and Human Services (DHHS). This Certificate adds special protections for research information that identifies you and will help researchers protect your privacy.

With this Certificate of Confidentiality, the researchers cannot be forced to disclose information that may identify you in any judicial, administrative, legislative, or other proceeding, whether at the federal, state, or local level. There are situations, however, where we will voluntarily disclose information consistent with state or other laws, such as:

to DHHS for audit or program evaluation purposes;

information regarding test results for certain communicable diseases to the Texas Department of State Health Services, including, but not limited to HIV, Hepatitis, Anthrax, and Smallpox;

if you pose imminent physical harm to yourself or others;

if you pose immediate mental or emotional injury to yourself;

if the researchers learn that a child has been, or may be, abused or neglected; or

if the researchers learn that an elderly or disabled person has been, or is being, abused, neglected or exploited.

The researchers will not, in any case, disclose information about you or your participation in this study unless it is included in the Authorization for Use and Disclosure of Protected Health Information for Research Purposes as stated above.

The Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about your involvement in this research study. In addition, the researchers may not use the Certificate to withhold information about your participation in this research study if you have provided written consent to anyone allowing the researchers to release such information (including your employer or an insurance company). This means that you or your family must also actively protect your privacy.

A Certificate of Confidentiality does not represent an endorsement of this research project by the Department of Health & Human Services or any other Federal government agency.

[If applicable, please include: Is there anything else I should to know before I decide?

[Insert name(s)] has/have financial interests in the company sponsoring this study. You should feel free to ask questions about this.

Whom do I call if I have questions or problems?

For questions about the study, contact [insert PI’s name here] at [insert PI’s number here with area code] during regular business hours and at [insert PI’s 24-hour number here with area code] after hours and on weekends and holidays.

For questions about your rights as a research participant, contact the UT Southwestern Institutional Review Board (IRB) Office at 214-648-3060.

Signatures:

YOU WILL BE GIVEN 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 and have been told who to call if you have any more questions.

You have freely decided to participate in this research.

You understand that you are not giving up any of your legal rights.

If applicable: You understand that a copy of this signed consent document, information about this study, and the results of any test or procedure that may affect your medical care, may be included in your medical record. The information included in your medical record will be available to your health care providers and other authorized persons including your insurance company.

____________________________________________
Name of Participant (Printed)
____________________________________________	________	_______ AM / PM
Signature of Participant	Date	Time

____________________________________________
Legally Authorized Representative’s Name (Printed)
____________________________________________	________	_______ AM / PM
Legally Authorized Representative’s Signature	Date	Time

____________________________________________
Name of Person Obtaining Consent (Printed)
____________________________________________	________	_______ AM / PM
Signature of Person Obtaining Consent	Date	Time

[If applicable:]

ASSENT OF A MINOR:

I have discussed this research study with my parent or legal guardian and the researchers, and I agree to participate.

____________________________________________	________	_______ AM / PM
Participant’s Signature (age 10 through 17)	Date	Time

[Insert if non-English short form is used:]

Witness

I attest that the information in the consent form was accurately explained to, and apparently understood by the subject or the subject's legal authorized representative, and that informed consent was freely given by the subject or the subject’s legal authorized representative.

____________________________	________ _______AM / PM

Name of Witness (Printed)	Date	Time

__________________________ ________ _______AM / PM

Signature of Witness Date Time