General Population Screener and Consent Process (Youth and Parent)

ATTACHMENT 6_E1b: ExPECTT PARENT PERMISSION FOR YOUTH FOLLOW-UP INTERVIEW

The Evaluation of the Public Education Campaign on Teen Tobacco (ExPECTT) is a research study designed to collect data from approximately 6,800 youth about their experiences with tobacco products, media use, and other behaviors that are both legal and illegal. Your child has now completed a baseline and three follow-up interviews for this study. We would now like her or him to complete a fourth follow-up interview.

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.

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.

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 $25 if they complete the survey through the website on or before [Early Bird Data], or $20 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 provided will help researchers and policy makers understand the impact and effectiveness of public education activities aimed at reducing tobacco-related death and disease. 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.

Questions

If you have any questions about the study, you may call [Field Director] at the RTI, 1-800-334-8571 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).

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]

INCEN

Thank you for allowing your child [Fill: child’s first name] to take part in this important study. If your child completes this survey, he or she will receive a check for $25 if they complete the survey through the website on or before [close early bird date], or $20 if they complete it after [post-early bird date].

We will need to collect some information from you so that we can mail out this check. This information will be kept completely confidential in secure and protected data files and will be separate from the responses provided in the survey. If you would like to decline receiving this payment, you can leave the information blank and simply press “Next” to continue to the next screen.

[SOFT CHECK IF ANY FIELDS ARE MISSING]

Please provide your child’s first and last name

First name: YFNAME

Last name: YLNAME

What is the best address where we should mail the check?

Street: YSTREET

City: YCITY

State: YSTATE

Zip Code: YZIP

Press “Next” to continue.

CONTACT INFO

Your household might be contacted by RTI to verify that I followed the correct steps in completing this interview, and we would also like to be sure that we have the best contact information for you for future interviews. Can you provide the best telephone number, email address, and mailing address where you can be reached?

Phone ______________________________________

Email _______________________________________

Mailing Address_______________________________

____________________________________________

P_INTRO

It is important that your child be allowed to answer the questions in privacy. From this point on, your child should be able to read and answer all questions on his or her own. Press “Next” when your child is ready to begin.

GO TO Youth Assent

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