Parent Of Youth Baseline Survey Participants

ATTACHMENT 6_E2e: ExPECTT PARENT/GUARDIAN CONSENT

Form Approved

OMB No. 0910-0753

Exp. Date: 09/30/2019

RIHSC No. 17-XXXCTP

Parent Consent Form for the Evaluation of the Public Education Campaign on Teen Tobacco (ExPECTT)

The Evaluation of the Public Education Campaign on Teen Tobacco (ExPECTT) is sponsored by the U.S. Food and Drug Administration’s Center for Tobacco Products and designed to collect data from youth about tobacco use, media use, and illegal behaviors. Follow-up surveys will be conducted to assess awareness of the campaigns and receptivity to campaign messages.

[IF NOT ADMINISTERED DURING SCREENER] We are using a special quality control system 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.

May we use this quality control recording system? 

1=YES

2=NO

IF NO, DEACTIVATE COMPUTER AUDIO RECORDED INTERVIEWING FOR THIS CASE]

Types of Questions for Parents

The parent interview takes approximately 10 minutes, depending on your answers. The interviewer will ask questions about household characteristics and media use.

Voluntary Participation

Your participation in this study is also completely voluntary. You can refuse to answer any and all questions. You can stop the interview at any time.

Risks

There are no physical risks to you from participating in this interview.

Benefits

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

Future Contacts

To help us understand changes over time, we may contact you in the future to update our information. Each of these additional interviews will also be completely voluntary.

Privacy

Your 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 you provide will be combined with answers of many others and reported in a summary form. To protect the privacy of both you and your child, neither of you will know the other’s interview answers. All staff involved in this research are committed to privacy and have signed a Privacy Pledge. Information collected will be kept private to the fullest extent allowable by law.

Questions

If you have any questions about the study, you may call the ExPECTT project assistance line toll free at [ADD TOLL FREE PHONE NUMBER]. If you have a question about your rights as a study participant, you may call RTI's Office of Human Research Protections toll free at 1-866-214-2043.

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

Do you agree to participate in the study?

1. YES

2. 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 10 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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