Parental Consent

“Evaluating a HIV/AIDS Focused Video Game for Young People”

OMB No. 0920-0840

Expiration Date 2/29/2016

Attachment 2a. Parental Consent

Flesch-Kincaid Grade Level 7.2

Centers for Disease and Control Prevention

Parent Consent for Youth to be in a Research Study

Centers for Disease and Control Prevention

Parent Consent for Youth to be in a Research Study

Thank you for your interest in this research study. Before you decide whether to agree to give permission to your child (11-17) to be in this study, please read this form and ask as many questions as you need to be sure you know what the youth will be asked to do. If you have any questions about the study before signing the form please contact the CDC investigator listed at the end of the form. You may either turn this form in at the place you were recruited from or return the form via your child. We will call you to confirm your consent.

Introduction: This study is being done by researchers from the Centers for Disease Control and Prevention.

What is the purpose of this study? The purpose of this study is to test an HIV/AIDS educational video game designed to be an effective method for HIV/AIDS and Sexually Transmitted Infections (STI) prevention for youth ages 11 and 17. This study is important because youth are at higher risk for HIV/AIDS particularly, and African American and Hispanic heterosexual youth.

Why is my child being asked to be in this study? We are asking your child to be in this study because they are a youth between the ages of 11-17.

What is going to happen during the study? Your child will complete 2-3 surveys and possibly play an HIV/AIDS prevention video game. Participants will be chosen to play the game based on the age, race, and sex of participants recruited at a site. They will be able to play the game after the study is over. Specifically, your child will be asked to complete up to 3 surveys with questions about HIV/AIDS knowledge, sexual behaviors and the video game if they played it. If your child plays the game they will take 2 surveys the day they begin the study. They will take another survey 30 days after they complete the first survey. If your child does not play the game, they will take a survey the day they begin the study and second one 30 days after. The questions will be about HIV/AIDS knowledge and sexual behaviors.

What do you want my child to do if they decide to be in this study? If they are asked to complete surveys, we would like for them to respond to the questions in the survey. On the survey, they will be asked questions about HIV/AIDS knowledge, their sexual behaviors and their impressions on the video game if they play it.

How long will you need my child? The time commitment will depend on whether your child plays the game or not. If selected to play the game we will need your child for 60 minutes. If they are not selected to play the game we will need your child for 30 minutes.

If selected to play the game, we expect it will take up to 45 minutes to complete 2 surveys the day they play the game. We expect it will take them up 15 minutes to take another survey 30 days after playing the game. If they do not play the game, they will take 1 survey that should take up to 15 minutes the day they begin the study and another 30 days after taking the first survey.

Are there any risks to my child from being in this study? There is low risk to them if they decide to be in this study. Questions during the surveys may make them feel uneasy or have some concerns. They do not have to respond to any questions they do not want to on the survey.

Are there any benefits from being in this study? By being in this study your child will learn more about HIV/AIDS and how to prevent it. They will be helping to test an educational video game that can help other young people in the community and the nation.

Will the things my child tells you be kept private? What they tell us will be kept private to the extent allowed by law. Your child’s responses to the survey will be kept secure by the research staff. We will safeguard their identity and information that they supply. That is, we will not tell anyone what he or she said and we will not tell anyone that they completed a survey about the study. However, if we think there may be child abuse or that they may cause harm to themselves or others, we are required by law to report this concern to the proper authorities.

What if I want to know my child’s comments or survey responses?

The researcher does not plan to share the specific information with the parent. However, the overall, summary findings of the study will be shared with parents, if requested. If this makes you uncomfortable, you have the option of refusing to let your child participate in the study. Young adult and adolescent participants will not be forced to answer any questions, and participants may elect to discontinue their participation in the survey if they are uncomfortable at any time.

What will you do with the responses to the surveys?

The responses to the surveys will be used to write papers on what we have found. We will share our findings with the people working on the study. These people will review the survey responses to help us understand what we have found. We also hope to make public our findings in a journal magazine, so that we can share what we found with other people. At no time, will anyone be able to know what your child said or that they were in this study from anything that we write. We will also share our overall findings with you if you would like. You may also have a copy of any of the overall reports by getting in touch with us or giving us a number where we can call you.

Is there any cost if I take part in this study? The only cost to your child for being in this study is their time for coming here today and again in 30 days.

Is there any reimbursement if I take part in this study? There is no reimbursement for taking part in this study, although your child will receive a token of appreciation of $10 if they participate in the study, complete the 1-2 surveys depending on if they play the game, and an additional $15 if they complete the 30-day follow-up survey. The tokens of appreciation will be in the form of gift cards.

Who should I call if I have questions about this study or think I my child has been harmed by this study? If you have any questions about this study you may call Dr. Leigh Willis, MPH, 404-639-8447. If you have questions about your rights for being in this study, you may call the CDC Institutional Review Board at 1- 800-584-8814.

Does my child have to be in this study? Your child does not have to be in this study, it is up to you and your child if they want to or not. Your child can stop being in this study at any time without any penalty or loss of benefits.

Do you have any further questions about this study? Please print and sign your name below if you agree to have your child be in this study. By signing your name you also agree that you have read this form and have had a chance to ask any questions you may have about the study. You will be given a copy of this consent form for you to take with you.

__________________________________

Parent/Guardian of Youth - Print your Name Date

Parent/ Guardian of Youth - Sign your Name Date

Parent/ Guardian Contact Phone Number (for verification of consent signature)

Will you allow us to keep your contact information so we can provide you the general results of the study? Circle yes or no.

Yes No (Please do not contact me again)

I observed the process of consent. The prospective participant read or was read this form, was given the chance to ask questions, appeared to accept the answers, and signed to enroll in the study.

Signature of Research Staff Date