Consent to Participate in a Research Study, In-depth interviews, Men ages 15-19 ________________________________________________________________________ IRB Study # 07-0225
Consent Form Version Date: July 13, 2007
Title of Study: Mradi wa Vijana Vijiweni (means Project of Youth in Venues) Principal Investigator: Nina Yamanis, MPH
Tanzania Partner: Muhimbili University Collage of Health Sciences, Department of
Psychiatry
UNC-Chapel Hill Department: Health Behavior and Health Education Email Address: [email protected]
Faculty Advisors: Suzanne Maman, Ph.D. and Jessie Mbwambo, M.D.
Funding Source: University of North Carolina at Chapel Hill Center for AIDS Research,
Center for Infectious Diseases, Injury Prevention Research Center, and C.V. Starr International Award
Study Contact telephone number: +0784339747 (Dr. Mbwambo in Dar es Salaam) 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. To join the study is voluntary.
You may refuse to join, or you may withdraw your consent to be in the study, for any reason, without penalty.
Research studies are designed to obtain new knowledge. This new information 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.
Details about this study are discussed below. It is important that you understand this information so that you can make an informed choice about being in this research study. You will be given a copy of this consent form. You should ask me or the researchers named above any questions you have about this study at any time.
What is the purpose of this study?
The purpose of this research study is to learn about the sexual partnerships and behaviors within sexual partnerships of men ages 15-19 who socialize in venues where it is common to meet new sexual partners in Dar es Salaam. The first phase of the study will involve interviews with up to 400 informants to identify venues where it is common for young men to meet new sexual partners in Manzese and Tandale wards, Dar es Salaam. We then will conduct in-depth interviews with 40 men ages 15-19 who socialize in the venues to describe sexual behavior among this age group. This study will inform future studies in which men frequenting the venues will be interviewed about sexual behaviors.
Are there any reasons you should not be in this study?
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How many people will take part in this study?
If you decide to be in this study, you will be one of approximately 400 community informants and 40 young men recruited from venues who will be interviewed for this study.
How long will your part in this study last?
Participants for this part of the study will be interviewed for about 1 hour in a private location.
What will happen if you take part in the study?
If you decide to take part in this research study, I will interview you in a private location nearby. If you give me your permission to do so, I will audio-record your interview and I will take notes during the interview. The interview will explore information about the places in Dar es Salaam where you spend time and meet sexual partners, the social activities you engage in at these places, the types of sexual partnerships you have, and your behavior in your sexual partnerships.
What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. The study aims to benefit society by gaining knowledge to help young people prevent the transmission of HIV. You may not benefit personally from being in this research study.
What are the possible risks or discomforts involved from being in this study?
There are no known risks to you for participating in this study. However, I will be asking some questions about topics that may feel uncomfortable to you. You have the right to not answer any question that feels uncomfortable to you. There may also be uncommon or previously unknown risks for participating in this study. If you experience any problems or risks as a result of participation in this study, you should report these to me or the other researchers listed on the front of this form.
How will your privacy be protected?
Your identity and information about your identity will not be collected as part of this study. The research staff of this study will not talk with your parents or ask your parents for approval for your participation. You will be assigned a confidential identification number to protect your identity. I will record your responses to the study questions and identify them only by your confidential identification number. The written copy of your interview will be stored in a locked filing cabinet in the study supervisor’s office and destroyed once the study is completed. The consent form you signed and audiotape from your interview will be stored in separate locked cabinets. Your responses and confidential identification number will also be entered into an encrypted data file that will be used by study personnel for analysis. Only study personnel and research collaborators will have access to the encrypted data file. Participants will not be identified in any report or publication about this study. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect the privacy of personal information. In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or government agencies for purposes such as quality control or safety.
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Will you receive anything for being in this study?
You will be receiving a small gift, a hat,for taking part in this study. Should you withdraw from the study prior to completion, you will still receive the gift.
Will it cost you anything to be in this study?
There will be no costs for being in the study
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 ask me or contact the researchers listed on the first page of this form.
What if you have questions about your rights as a research participant?
All research on human volunteers is reviewed by a committee 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 +1-919- 966-3113 or by email to [email protected].
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Title of Study: Mradi wa Vijana Vijiweni (means Project of Youth in Venues) Principal Investigator: Nina Yamanis, MPH
Participant’s Agreement:
I have read the information provided above. I have asked all the questions I have at this time. I voluntarily agree to participate in this research study.
_________________________________________ _________________ Signature of Research Participant Date
_________________________________________ _________________
Signature of Study Interviewer Date
_________________________________________ Printed Name of Study Interviewer
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