Objetivos de Tràmec

Consent to Participate in a Research Study

Consent Form for Participants (Phase 1)—Genetics

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IRB Study # 10-0363

Consent Form Version Date: 1/20/2011

Title of Study: Improving Lifestyle to Reduce the Risk of Heart Attack and Stroke

Principal Investigator: Thomas C. Keyserling, MD, MPH (UNC-Chapel Hill)

UNC-Chapel Hill Department: Center for Health Promotion and Disease Prevention

UNC-Chapel Hill Phone number: 919-966-2276, Ext 238

Co-Investigators:

-- UNC-Chapel Hill: Alice Ammerman, DrPH, MPH, RD; Katrina Donahue, MD, MPH; Kelly Evenson, PhD; Jacquie Halladay, MD, MPH; Alexandra Lightfoot, EdD; Carmen Samuel-Hodge, PhD, MPH, RD; Maihan Vu, DrPH, MPH

--East Carolina University, Greenville, NC: Doyle Cummings, PharmD; Stephanie B. Jilcott, PhD

Funding Source and/or Sponsor: National Institutes of Health

Study Contact telephone number: 919-966-6088

Study Contact email: [email protected]

What are some general things you should know about research studies? You are being

asked to take part in a research study. You are free to join the study or not. If you don’t want to take part in the study at all, or if you don’t want to answer some questions, that’s okay. There is no penalty if you change your mind after you start the study. If you decide not to join the study, it will not affect the care you receive at this health clinic.

Research studies are designed to obtain new facts. These new facts may help people in the future. You may not receive any direct benefit from being in the research study. There also may be risks to being in research studies.

We want you to understand the details about the study so that you can make an informed choice about being in it. You will be given a copy of this consent form. Please ask questions if there is anything you do not understand.

Being in the Study is Your Choice

Before you learn about the study, you should know that: 1. Your choice to be in the study is voluntary. 2. You may decide not to join the study.

3. If you choose to be in the study, you may stop at any time.

What is the purpose this study? Our main study goal is to try to understand how our genes

and family history work together with our environment to affect health. Before we begin the study, we want to talk with men and women who live in Lenoir County to better understand their thoughts, feelings, and concerns about genetics and heart health. You are being asked to take part in this discussion group.

How many people will take part in Phase 1 of the study? In this study, we will talk to four

groups of 10 to 12 men and women who live in Lenoir County.

How long will your part in Phase 1 of the study last? It should take about two hours to

answer the questions.

What will happen if you take part in Phase 1 of the study? A member of our research team

will lead the group discussion which should last no more than two hours. The group will be asked some questions about their thoughts and feelings about genetics and heart health. No questions will be directed to you individually, but instead will be posed to the group. You may choose to respond or not respond at any point during the discussion. The group discussion will be audiotaped so we can capture comments in a transcript for analysis. Your information will not be shared with anyone but the research staff.

What are the possible benefits from being in this study? Research like this helps others by

making clear how we can best help men and women like you. You may not benefit directly from this study.

What are the possible risks or discomforts involved from being in this study? You should

not have any discomfort from being in this study. We think you will be at ease answering the questions we will ask you. Although we will be careful to protect your privacy, loss of privacy is a potential risk of being in this study. Also, there is always a chance of unknown risks. You should report any problems to the research staff.

How will your privacy be protected? To make sure what you say is confidential, you can use a

different name during the project so that nobody connected with the study will know your real name. Also, what other people say during the discussions is confidential, so you should not share anything you hear or see in the group with people outside the group. Your name will not appear on the transcript from the tape recording. Instead, we will make up and use an ID number. The key that links your name and ID number and the study data we collect from you will be stored in a locked file cabinet and/or password protected computer. The tape recording of the discussion session will be promptly transferred to a password protected computer and will be erased from storage in the tape recorder.

Will you receive anything for being in this study? You will receive a $25 gift card for taking

part in this study. You will also be given an information sheet about the Heart-Healthy Lenoir Project.

Will it cost you anything to be in this study? It is free for you to be in this study, other than your costs to travel to the meeting site or child care if needed.

What if you have questions about this study? You have the right to ask and have answered

any questions you may have about this research. If you have questions, or concerns, you should contact Thomas Keyserling, MD, MPH (919-966-2276, Ext. 238; [email protected]). He is the leader of this project and will be happy to answer your questions.

What if you have questions about your rights as a research participant?

All human research is reviewed by a group of people that works to protect your rights and welfare. If you have questions or concerns about your rights as a research subject you may contact, anonymously if you wish, the Institutional Review Board at the UNC-Chapel Hill at 919-966-3113 or by email to [email protected].

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Title of Study: Improving Lifestyle to Reduce the Risk of Heart Attack and Stroke

Principal Investigator: Thomas C. Keyserling, MD, MPH

Participant’s Agreement: I have read the information above. I have had all of my questions

answered.

By placing a check here, I agree that the researchers may call me by phone to see if I am willing to take part in a follow-up study or interview. (If you check yes, we will ask for your phone number.)

By signing this form, I agree to be in the study. If I decide I do not want my information to be used, I will tell you in writing.

Signature of participant Date

Printed name of participant

Signature of person obtaining consent Date