General Population Screener and Consent Process (Youth and Parent)

ATTACHMENT 6_E2b1: ExPECTT PARENT PERMISSION FOR YOUTH BASELINE INTERVIEW

Form Approved

OMB No. 0910-0753

Exp Date: 09/30/2019

RIHSC No. 17-XXXCTP

Parent Permission for Youth Baseline Interview for the Evaluation of the Public Education Campaign on Teen Tobacco (ExPECTT)

The Evaluation of the Public Education Campaign on Teen Tobacco (ExPECTT) is a research study designed to collect data from approximately [ADD NUMBER] youth about their experiences with tobacco products, media use, and other behaviors that are both legal and illegal.

Because your chid is not yet 18 years old, we must have your permission as the parent or legal guardian before your child participates in either a web or in person interview. Once we have your permission, your child may choose whether or not to participate in the study. Since the survey is based on a random sample, your child will represent thousands of other youth in the United States. We may ask your child to participate in follow-up surveys to assess awareness of campaigns and receptivity to campaign messages.

Selection of Youth

A random sample of household addresses was selected throughout the United States. A professional RTI interviewer will visit each sampled address to ask a few questions about whether any eligible youth live in the household. One or possibly two eligible children in your household might be asked to voluntarily participate in the survey. We must have permission from a parent before we talk with the child. At that point, your child may choose whether or not to participate in the study. Since the survey is based on a random sample, your child will represent thousands of other United States youth.

Purpose of the Youth Interview

We want to interview your child about his or her views and experiences with tobacco use. Your child’s answers combined with the answers of other youth in the study will improve our understanding of how public education campaigns affect youths’ attitudes, beliefs, and behaviors toward tobacco use.

Types of Questions for Youth

The interview with your child will last about 30-40 minutes. Your child will be asked about his or her media use, as well as his or her attitudes and beliefs towards tobacco use. The interviewer will ask the first few questions and then youth respondents will answer questions directly into a laptop computer. The youth interviews will be completed in a part of their household that allows them to answer in private.

Voluntary Participation

Your child’s participation in this study is completely voluntary. He or she can refuse to answer any and all questions. Your child has the right to stop the interview at any time. Because your child’s contribution is important, we will offer your child [ADD INCENTIVE AMOUNT] if they complete the survey through the website on or before [Early Bird Date], or [ADD INCENTIVE AMOUNT] after [Early Bird Date], as a token of appreciation for participating. For each follow-up your child completes in the future, he or she will receive a token of appreciation for participating in those additional interviews.

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 his or her responses.

Benefits

There are no direct benefits to your child from answering our questions. However, he or she will be contributing to important research related to tobacco use among youth. The information youth provide will help researchers and policy makers understand the impact and effectiveness of public education activities aimed at reducing tobacco-related death and disease.

Privacy

Your child’s 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 confidentiality and have signed a Privacy Pledge. Information will be kept private to the fullest extent allowable by law. No absolute guarantees can be made regarding the interception of data sent via the Internet.

Future Contacts

Follow-up surveys are planned in order to help us better understand how youth aged 11 to 16 begin using tobacco, how much and what kinds of tobacco they use, and whether they think about quitting tobacco use. Each of these additional interviews will also be completely voluntary.

Questions

If you have any questions about the study, you may call [Field Director] at the RTI, [FILL NUMBER] extension [extension] (toll-free number). 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 form to keep.

Do you agree to allow your child to participate?

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.

[HARD CHECK IF THIS QUESTION ISN’T ANSWERED]

[IF YES, GO TO P_INTRO

[IF NO, GO TO END AND SAVE]

[IF WEB RESPONDENT, GO TO INCEN, IF IN-PERSON RESPONDENT, GO TO CONTACT INFO]

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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