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 09/30/2019

Parent or Guardian Permission for Youth Interview for CAPI

The FDA Health and Media Study is designed to collect data from boys 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, previously, your address was randomly chosen to take part in this study. [YOUTHFNAME] was selected to be in this study and has completed at least one survey to date. 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 next round of the 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 answers may be shared with the FDA but not your child’s personal information.

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 interview 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 their 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, he will be contributing to important health research.

Incentive

Because your child’s contribution is important, we will offer your child $20 in cash as a token of appreciation for completing the survey.

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 the RTI Office of Research Protection at 1-866-214-2043 (a toll-free number).

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

Do you give him permission to participate in the survey?

YES

NO

OMB No: 0910-0753 Expiration Date: 09/30/2019

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 09/30/2019

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 boys 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, previously, your address was randomly chosen to take part in this study. [YOUTHFNAME] was selected to be in this study and has completed at least one survey to date. 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 next round of the 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 answers may be shared with the FDA but not your child’s personal information.

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, he will be contributing to important health research.

Incentive

Because your child’s contribution is important, we will offer your child a check for $25 if he completes the survey by [EARLY BIRD DATE] or a check for $20 after [EARLY BIRD DATE], as a token of appreciation for completing the survey. Your child will receive $20 in cash if he completes the survey in person.

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 the RTI Office of Research Protection 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 him privacy so he can answer the questions on his own. If you would rather he take the survey on a different device, he 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: 09/30/2019

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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