Cohort 2--Youth Baseline Questionnaire

ATTACHMENT 6_E2C: YOUTH ASSENT FORM (UNDER 18)

Form Approved

OMB No. 0910-0753

Exp. Date: 09/30/2019

RIHSC No. 17-XXXCTP

Youth Assent Form (under 18) for the Evaluation of the Public Education Campaign on Teen Tobacco (ExPECTT)

We are talking to kids all over the United States about a research study sponsored by the U.S. Food and Drug Administration’s Center for Tobacco Products.

The survey asks teenagers what they think about tobacco use, media use, and other behaviors that are both legal and illegal. About X,XXX youth are being asked to take this survey. This survey is voluntary and is part of a research study conducted by RTI International.

Your parent or legal guardian has given permission for you to take this survey. The survey will last between 35 and 45 minutes, depending on your responses. We may contact you again in the future. It is up to you to decide if you would like to take any future surveys.

You will enter your responses to the questions directly into the questionnaire. Your name will be kept private. Your answers will be labeled with a special number instead of your name so that only research staff will know these are your answers. No one will see your answers to any of these questions. We will not share any information you give us with your parents, or anyone outside the research team. All of your answers will be kept private to the fullest extent allowable by law by the technology used.  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 your data.

If you don't want to participate in this survey, that is okay. If you don't want to answer a certain question, that is okay too. You may also choose to drop out of the survey at any time, for any reason. If you want to take a break at any time, you can stop and return where you left off when you are ready.

IF COMPLETING ONLINE, FILL: We will offer you an incentive of [ADD INCENTIVE AMOUNT] if you complete the survey through the website before [ADD DATE], or [ADD INCENTIVE AMOUNT] after [ADD DATE], to thank you for taking time to complete the survey.

IF COMPLETING VIA CAPI, FILL: We will offer you an incentive of [ADD INCENTIVE AMOUNT] to thank you for taking time to complete the survey.   

If you have any more questions about this study, you can call the ExPECTT project assistance line at [ADD TOLL FREE PHONE NUMBER]. If you have a question about your rights as a study participant, you can call RTI’s Office of Research Protection toll-free at (866) 214-2043.

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 5 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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