General Population Screener and Consent Process (Youth and Parent)

AttacHMENT 6_R: Parent or Guardian Permission for Youth Interview

Form Approved

OMB No. 0910-0753

Exp. Date xx/xx/xxxx

Parent or Guardian Permission for Youth Interview for capi

The FDA Health and Media Study is designed to collect data from youth about their attitudes related to health, health behaviors, and advertisements they may have seen on TV, online, or heard on the radio.

If you recall, about 8 months ago your address was randomly chosen to take part in this study. Your [CALCULATE FROM DOB] year-old child, [YOUTHFNAME], was selected to be in this study and completed a survey at that time. This study is being conducted again to measure what might have changed over time or what has stayed the same. We are asking your permission for your child’s participation in this second survey.

We are using a special quality control system on my laptop that will record what we say to each other to ensure I am following the correct procedures. The recording will be reviewed by RTI to monitor the quality of my work.  The recordings will be deleted after my work has been reviewed and will be kept private just like all the other information you provide.  You can still participate in the study even if you do not agree to this recording. The system is set up so that your child will not be recorded.

May we use this quality control recording system? 

1=YES

2=NO

[If NO, then inactivate computer audio recorded interviewing for this case.]

Purpose of the Youth Survey

We want to interview your child about these topics again. The child’s answers combined with the answers of other youth in the study will improve our understanding of how public education campaigns affect youth.

Types of Questions for Youth

The interview will last about 45 minutes, depending on responses. The interviewer will ask the first few questions and then youth respondents will answer questions directly into a laptop. The interviews will be completed in a part of the household that allows your child to answer in private.

Voluntary Participation

Your child’s participation in this study is completely voluntary. He can refuse to answer any or all questions. Your child has the right to stop the interview at any time.

Risks

There are no physical risks to your child from participating in this interview. It is possible that some questions might make your child mildly uncomfortable, depending on responses. No absolute guarantees can be made regarding the interception of data sent via the Internet. However, we are taking extensive precautions to protect the confidentiality of all data.

Future Contacts

We will conduct two more voluntary follow-up surveys every eight months to understand changes over time.

Benefits

There are no direct benefits to your child from answering our questions. However, they will be contributing to important health research. Because your child’s contribution is important, we will offer your child $20 as a token of appreciation for participating. .

Privacy

The survey answers will be entered into a computer and labeled with a case identification number. Your name and that of your child will not be reported with any information your child provides. Information your child provides will be combined with answers of many others and reported in a summary form. All staff involved in this research are committed to privacy and have signed a Privacy Pledge.

Questions

If you have any questions about the study, you can call our project assistance line toll-free at (866) 214-2039, or email us at mediastudy@rti.org. If you have any questions about your rights as a study participant, you may call RTI's Office of Human Research Protections at 1-866-214-2043 (a toll-free number).

You will be given a copy of this consent form to keep.

OMB No: 0910-0753 Expiration Date: 10/31/2016

Paperwork Reduction Act Statement: The public reporting burden for this collection of information has been estimated to average 3 minutes per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

Parent or Guardian Permission for Youth Interview for WEB

Form Approved

OMB No. 0910-0753

Exp. Date xx/xx/xxxx

This text is to be read by the survey participant’s parent or guardian

The FDA Health and Media Study is designed to collect data from youth about their attitudes related to health, health behaviors, and advertisements they may have seen on TV, online, or heard on the radio.

If you recall, about 8 months ago your address was randomly chosen to take part in this study. Your [CALCULATE FROM DOB] year-old child, [YOUTHFNAME], was selected to be in this study and completed a survey at that time. This study is being conducted again to measure what might have changed over time or what has stayed the same. We are asking your permission for your child’s participation in this second survey.

Purpose of the Youth Survey

We want to interview your child about these topics again. The child’s answers combined with the answers of other youth in the study will improve our understanding of how public education campaigns affect youth.

The interview will last about 45 minutes, depending on responses.

Voluntary Participation

Your child’s participation in this study is completely voluntary. He can refuse to answer any or all questions. Your child has the right to stop the interview at any time.

Risks

There are no physical risks to your child from participating in this interview. It is possible that some questions might make your child mildly uncomfortable, depending on responses. No absolute guarantees can be made regarding the interception of data sent via the Internet. However, we are taking extensive precautions to protect the privacy of all data.

Future Contacts

We will conduct two voluntary follow-up surveys every eight months to understand changes over time.

Benefits

There are no direct benefits to your child from answering our questions. However, they will be contributing to important health research . Because your child’s contribution is important, we will offer your child $25 if he completes the survey by [EARLY BIRD DATE] or else $20 as a token of appreciation for participating.

Privacy

The survey answers will be entered into a computer and labeled with a case identification number. Your name and that of your child will not be reported with any information your child provides. Information your child provides will be combined with answers of many others and reported in a summary form. All staff involved in this research are committed to privacy and have signed a Privacy Pledge.

Questions

If you have any questions about the study, you can call our project assistance line toll-free at (866) 214-2039, or email us at mediastudy@rti.org. If you have any questions about your rights as a study participant, you may call RTI's Office of Human Research Protections at 1-866-214-2043 (a toll-free number).

If it is all right with you, please ask your child to answer the survey. Please give them privacy so they can answer the questions on their own. If you would rather they take the survey on a different device, they can log in on that device at the link on the study letter.

After you select your answer, please press “Next.”

1 Yes, I agree to allow my child to participate in this study.

2 No, I do not want my child to participate in this study.

OMB No: 0910-0753 Expiration Date: xx/xx/xxxx

Paperwork Reduction Act Statement: The public reporting burden for this collection of information has been estimated to average 3 minutes per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

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