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 participant younger than 18 years of age and have been asked to read and sign this form, the “you” in this document refers to the participant.

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].

Sample phrases:

find out more about [insert medical problem]. This research is being done because [insert rationale].

collect information about [insert medical problem] that will be used to better understand how genes may cause diseases and help doctors in their diagnosis and treatment.

create and maintain a tissue databank, which will use tissue, cell and fluid samples for medical research designed to improve the understanding and treatment of [insert medical problem(s)].

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

You are being asked to take part in this study because [insert reason/condition or eligibility criterion].

Sample Language:

You are being asked to take part in this study because you or your relative has a problem with [insert medical problem].

You are being asked to take part in this tissue database because you or your relative has a problem with [insert medical problem].

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 is also 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 test and procedures.

If the study is a tissue repository and will be utilizing medical waste the above paragraph can be deleted and the following paragraph may be inserted.

You will be undergoing a [insert procedure] procedure for [insert medical problem] that your doctor has discussed with you. This procedure has been deemed medically necessary and you have agreed to the procedure. During that procedure certain tissues that are important to our studies will be obtained by your doctor. These tissues (i.e. operative specimens, blood, bodily fluids) are often removed at the time of the procedure and extra pieces of tissue will be obtained for research purposes. Participation in this research will mostly involve using what is called “medical waste.” Medical waste is leftover tissue and fluid that are not needed for diagnosis, and otherwise would be discarded.

Please revise the section below to clearly outline the information and samples being collected:

Questions: [Insert name of investigator] will ask you questions about [describe types of questions that will be asked].

Samples of Blood: Up to [insert number] teaspoons of blood will be drawn from a vein in your arm with a small sterile needle. This is the standard method used to obtain blood for routine hospital tests. We may ask for a second blood sample if the research laboratory cannot process the first sample. Sample language if the study is a tissue databank. We would like to keep any left over blood sample that would otherwise be discarded. If a sample does not exist, we would like to obtain an additional blood sample. The amount collected will be [insert number] teaspoons or less.

Samples of bodily fluids: We would also like to obtain a sample of your [insert sample type]. We will collect [insert a description of what is being collected and the amount.] Sample language if the study is a tissue databank. We would like to keep any left over [insert sample type] that would otherwise be discarded.

Samples of tissue. We would like to obtain a sample of your [insert sample type]. We will collect [insert a description of what is being collected and the amount.] This extra sample is being collected only for research purposes and is not as part of your standard of care.

Cells removed during surgery: If you have surgery for [insert medical condition], we will keep some of the cells already removed during the surgery for research. If a sample already exists which can be used in the study, we will attempt to use it.

Skin Tissue Biopsy: We would like to obtain a small piece of skin (less than 1/8”) to be used for DNA analysis, culture of skin cells, microscopic study of the skin, or other laboratory tests. The skin will be removed using a local anesthetic (numbing medication) and a special instrument called a “punch”.

Medical Record: You are also being asked for permission to obtain from your medical records information about your history and treatment that will make your tissue samples even more useful to the research community.

Please delete the following unless the study is a tissue repository.

By agreeing to participate in this research, you agree to be included in this research database. Investigators may use your health information for future research on various diseases including genetic research. However, your personally identifiable information will never be released to researchers, so they will not know who you are or be able to contact you.

Insert the following, if the study will collect and use the subject’s social security number.

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 will my samples be identified?

Please describe how the samples will be identified:

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 if applicable: To protect your information, personally identifiable information will be kept in a secure facility with limited access and password protection. The computer maintained by UT Southwestern is protected by a firewall which prevents unauthorized access to the information. Any results collected will not be released in a personally identifiable manner, and thus no information will be given to your insurance provider, employer, family, etc. without your permission.

Insert if applicable: Your sample will be marked with a coded identifier and will not be personally identifiable. Neither your name nor any identifying information will be given to the researchers who receive your samples.

What is DNA?

DNA means deoxyribonucleic acid. DNA is the substance in our cells which contains information we inherited from our parents and other family members. Your DNA contains “genes” which predict things like physical characteristics (eye color, hair color, height, etc.) and may also be a factor in whether you develop or are at risk of developing certain illnesses or disorders.

What is genetic testing?

Genetic tests look for naturally occurring differences in a person's genes, or the effects of specific genes. These differences could indicate an increased chance of getting a disease or condition. Genetic testing includes gene tests (DNA testing) and sometimes biochemical tests (protein testing) if it relates to a specific gene.

In gene tests, DNA in cells taken from a person's blood, body fluids or tissues is examined for differences. The differences can be relatively large - a piece of a chromosome, or even an entire chromosome, missing or added. Sometimes the change is very small - as little as one extra, missing or altered chemical within the DNA strand. Genes can be amplified (too many copies), over-expressed (too active), inactivated, or lost altogether. Sometimes pieces of chromosomes become switched, turned over or discovered in an incorrect location.

How long can I expect to be in this study?

In many genetic studies, testing of the DNA may go on for very long periods of time. This is true because we are continually finding new genes that may be involved in [insert medical problem]. Therefore, while your direct participation in this study will be over once you have completed the procedures/visits described above; the DNA isolated from your blood/tissue sample may continue to be studied for many years.

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. You may ask [insert name of investigator] to destroy any record of your participation in this research and to destroy any sample with your name on it. You will not be asked for further information or samples. Your identity will be removed from all research records. However, the resulting data from the research will not be discarded. De-identified copies of DNA and/or growing cells made from your samples will not be destroyed.

Delete if not applicable.

Samples sent to other scientists cannot be identified and destroyed because your name was removed before the samples were shipped to other medical centers.

How is DNA obtained? Cells from blood or other body materials are processed in a laboratory that has special equipment that can extract DNA and identify genes.

What will happen to the samples collected for this research? [Insert name of investigator] will compare information about the health of participants with the results of research tests using their DNA.

Delete if not applicable. Your blood/tissue sample will be used to isolate DNA for genetic analysis. Part of your blood/tissue sample will also be used to grow a long term cell line. This immortalized cell line, called a lymphoblastoid cell line (or fibroblast cell line) will be stored in a Cell Bank and will be available for research, both now and in the future. This also allows us to perform many tests without having to ask you for additional blood/tissue samples.

Insert if data will be shared with the NIH:

De-identified data, including your medical history and results of tests, can be shared by releasing it into scientific databases, including those maintained by the National Institutes of Health (NIH). Sharing this information will help advance medicine and medical research by allowing other researchers to use this information in future research projects. The data will be stored and shared in a manner that would not allow someone to identify you. Please understand that this information cannot be removed once deposited in these databases.

How long will my samples be kept? [Insert name of investigator] will keep your sample in a research laboratory at this medical center until it is all gone, becomes unusable or until [insert he, she, or they] decides to discard the sample.

If your sample remains stored beyond your lifetime, your sample will be used as described in this document.

May other researchers use my sample? When you provide a sample for purposes of this study your sample becomes the property of The University of Texas Southwestern Medical Center and may be used for future studies or provided to other investigators at other medical research facilities without any identifiers.

Who decides which research scientists may receive samples of my DNA?

[Insert name of investigator or group] will decide which researchers at this medical center and at other medical centers may receive samples of your DNA. Your samples may be used in other research only if the other research has been reviewed and approved by an Institutional Review Board (IRB).

Could my sample be used for other purposes? No. Your samples or your DNA will only be used for research.

Research tests using your sample may possibly result in inventions or procedures that have commercial value and are eligible for protection by a patent.

Compensation for any future commercial developments is not available from the University of Texas Southwestern Medical Center at Dallas, its researchers or other facilities or researchers whose research may benefit from the use of your sample.

By agreeing to the use of your sample in research, you are giving your sample without expectation of acknowledgment, compensation, interest in any commercial value or patent, or interest of any other type. However, you retain your legal rights during your participation in this research.

Will the results of research tests be reported to me? Insert one of the following paragraphs. No. [Insert name of investigator] will use samples of your DNA only for research. The samples will not be used to plan your health care.

Note: Results given to a patient for treatment or diagnosis should be verified by a CLIA approved lab. If commercial testing is not available patients should consider the results of the testing investigational as described in the protocol. In addition, quality control measures should be place to avoid false positive or false negative results.

Yes. [Insert name of investigator or group] will try to get in touch with you if any results of DNA tests indicate--with high degree of certainty--that you have a risk of developing [insert name of disorder] or any other medical problem that can be treated. If you prefer that you not be contacted in the future, please make your election below:

No __________initials – I do not want to be contacted in the future.

Insert the next paragraph only if investigators plan to notify subjects about the results of DNA tests.

Is counseling available if I receive the results of DNA tests? Yes. There are specialists at this medical center who can tell you what test results mean. They could make recommendations about your future plans for having children or changing habits that could affect your health.

Is there a charge for counseling?

Yes. You or your insurance provided will be responsible for the cost of the counseling.

Are there any possible benefits from receiving test results?

If you do receive the results of tests using your DNA, you may receive information that reduces the uncertainty about the likelihood of developing [insert medical problem] and/or passing it to your children.

Obtaining the results of DNA tests may help you and other members of your family plan for the future. In some cases, early treatment of a disorder that runs in the family may improve the chances of a good outcome.

What are the risks of the study?

Insert the risk statements that are applicable to your study

Questions

We will ask you questions about your health. However, you can skip any question that makes your uncomfortable.

Risks of Blood Drawing

Risks associated with drawing blood from your arm include minimal discomfort and/or bruising. Infection, excess bleeding, clotting, and/or fainting are also possible, although unlikely. If you have unusual symptoms, pain, or any other problems while you are in the study, you should report them to the researcher staff right away. Telephone numbers where they can be reached are listed on the first page of this consent form.

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.

Sample language for a tissue repository using medical waste.

Collection of the Tissue Samples

Because all specimens obtained for research will come from your routinely scheduled procedures, there will be no additional risk or discomfort related to participating in this research. The only potential risk to you is accidental release of your medical information.

Stress

You could experience stress from participating in this kind of research. Knowing that researchers have personal information about you may trouble you.

Insert the next five paragraphs only if subjects receive the results of DNA tests.

If the results of DNA tests show that you or anybody else in your family may develop [insert name of disorder] or a life-threatening disease, you and other family members could experience serious stress after receiving such information.

If you experience stress because you participate in this research, [insert name of investigator or group] can help you obtain medical care to help you manage stress.

You could learn that you will not have a serious medical problem, but your children (or someone else) will.

Omit the next sub-section if there is a Certificate of Confidentiality for the research project.

Problems obtaining insurance or employment

A new Federal Law called the Genetic Information Nondiscrimination Act of 2008 (GINA), generally makes it illegal for group and individual health insurers from using your genetic information to set insurance eligibility, premiums, or contribution amounts. They cannot request or require that you take a genetic test. In addition, employers with 15 or more employees may not use your genetic information to make decisions regarding hiring, firing, job assignments, or promotions, nor can they request, require, or purchase your genetic information. GINA does not protect you against genetic discrimination by companies that sell life, disability, or long-term care insurance.

Personal, sensitive information

If you are not the parent of a child in your family, or if you are the parent of a child in another family, that information could be learned from DNA tests. This kind of information will not be reported to you or other family members.

Unforeseen Risks and New Information

There may possibly be risks to your participation in this research which [Insert name of investigator] does not know about now. You will be told if any new information becomes available during the study that could cause you to change your mind about continuing to participate or that is important to your health or safety

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. For more information, please see the section called “Will my information be kept confidential?”

Will I be contacted in the future?

You have the option to elect to be contacted in the future in order to obtain follow-up information or to ask you to take part in more research. (A “no” answer will not disqualify you from this research.)

Yes __________initials	No __________initials

If you elect “yes”, please keep in touch with [insert name of investigator] and maintain a current address and telephone number on file. Please notify [insert name of investigator] if your legal name changes.

Omit the next paragraph if minors are not eligible to participate.

It is your responsibility to inform a child that samples of his or her DNA may be kept in a research laboratory at this medical center or possibly other medical centers. The child will not be asked to sign another consent form when he/she reaches age 18.

What are the possible benefits of this study?

If you agree to take part in this study, there is usually no direct benefit to you.

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 other options do I have?

You may choose to not participate in this study. If you decide not to take part in this research study, it will have no effect on your medical care.

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 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).

However, the expenses for routine health check-ups or standard medical care for your any medical problem (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.

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

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

Insert either Option 1 or 2.

Option 1: Medical care to treat the illness or injury will be provided. The sponsor [insert sponsor name] has expressed a willingness to pay these medical expenses. Other 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 applicable performance site such as Children’s Medical Center, Parkland Health & Hospital System, and/or Texas Scottish Rite Hospital for Children].

or

Option 2: 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

Will my information be kept confidential?

Insert this section for studies without 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 Food and Drug Administration (FDA), involved in keeping research safe for people

•	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.

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 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. This Certificate does not mean the government approves or disapproves of our project.

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, that legally require disclosure, 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 or it is required by law (as mentioned 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.

Is there anything else I should know before I decide?

If applicable, please include:

[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 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 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 health care providers and 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