Youth Assent--Main: Baseline & Follow-up 1,2,3

RTI International

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OMB Control Number 0910-XXXX

Expiration Date XX/XX/XXXX

YOUTH ASSENT (Main Data Collection)
For Participants Ages 11 – 13

Sponsor / Study Title:	RTI International / “The Real Cost Campaign Outcomes Evaluation Study: Cohort 3”
Principal Investigator: (Study Investigator)	Anna MacMonegle
Telephone:	866-800-9177 (24 Hour)
Address:	RTI International 3040 Cornwallis Rd Research Triangle Park, NC 27709
Email Address:	HealthAndMediaStudy@rti.org

Key Information

We are talking to young people about a study sponsored by the United States Food and Drug Administration (“FDA”). We would like you to be part of a study called the “Health and Media Study”, which involves completing an online survey. RTI International (RTI) is a research company doing this study for the FDA to learn about how young people use media, tobacco (cigarettes), and marijuana. We’re asking about 7,500 people in the United States to take this survey.

Your parent or legal guardian (the person who takes care of you) said you can do the survey, but you don’t have to. It is your choice to take part in this study or not. You do not have to take this survey if you don’t want to.

If you take this survey, we might ask you to take another survey at another time. Taking this survey won’t give you any benefits, but you will be helping the FDA learn important things about how people your age use tobacco. The mission of FDA is to promote public health. The FDA does not support or encourage tobacco use.

You can take the survey on a computer, smartphone, or tablet. It should take about 30 minutes. You won’t be able to go back to questions you already answered, and you will be logged out if you don’t answer any questions for 20 minutes. This is to make sure other people don’t see your answers.

You can take a break any time and start again when you’re ready. Take the survey where no one can see your answers.

Some of the questions might make you feel bad or upset. You can choose “prefer not to answer” for any question. You may not move on to the next question in the survey if an item is left blank, but you may move on to the next question if you select “prefer not to answer”.

If you are doing the survey and decide you don’t want to anymore, you can stop. If you don't want to answer a certain question, that is okay too. You can drop out of the survey at any time, for any reason. There is no penalty if you do not take this survey.

We’ll keep your answers private. Your parent or guardian won’t see them. We will share your answers with the FDA, but we won’t share your name or anything else about you with the FDA. We won’t share anything about you with people who don’t work at the FDA or RTI.

We’ll do everything we can to keep what you share private, but we can’t say for sure that what you share online won’t be seen by others.

If you do this survey before [ADD DATE], we’ll mail you $30 at the address your parent gave us. If you do it after [ADD DATE], we’ll mail you $25 You can choose whether you want cash or a Visa gift card. If you do not complete the survey, you won’t get a Visa gift card or cash. If you are asked to take another survey at a later time, you will receive a Visa gift card or cash for each additional survey you complete.

Whom to Contact About This Study

If you have questions about the study, you can call the study investigator at the phone number listed at the top of this form.

During the study, if you have questions, concerns, or complaints about the study such as:

• Payment or incentive for being in the study, if any;

• Your responsibilities as a research participant;

• Eligibility to participate in the study;

• The Investigator’s or study site’s decision to withdraw you from participation;

Certificate of Confidentiality

This study is protected by something called a Certificate of Confidentiality (CoC). This means that the people who work on this study have to protect your privacy. We can’t share anything that would tell people who don’t work on the study who you are. We can’t share anything about you in legal settings (for example, in a court case) unless you say we can. We may share things about you if:

• You say we can share it (for example, if you want your doctor to have it).

• The study information is used for other studies that follow federal law.

• The FDA, which is paying for the study, needs to check how their money is being spent.

• A law says we have to share information (for example, when we must report to the FDA, or if we hear that a person is going to hurt someone or has hurt a child).

The CoC does not apply to what you do. You can choose whether to tell others you are in this study or if you have used tobacco.

Would you like to participate in this survey?

Yes, I want to take the survey.

No, I do NOT want to take the survey.

CONTACT INFO

Thank you for taking part in this important study. You will be offered a $25 Visa gift card or $25 cash if you complete the survey before [END DATE] [IF DATE IS BEFORE EARLY BIRD DATE ADD: and a bonus $5 if you complete it on or before [EARLY BIRD DATE].

The gift card or cash will be mailed to you within 2 weeks of when you complete the survey, but first we need to collect your name and mailing address. This information will be kept completely confidential in secure and protected data files and will be separated from the responses provided in the survey.

Please provide your name, address, and telephone number.

First Name: ___________________________________________________

Last Name: ___________________________________________________

Mailing Address:

Street _______________________________

City_________________________________

State____________________________________

ZIP code___________________________________

Telephone Number: __________________________________________________

E-mail Address: _________________________________________

OMB No: [FILL NUMBER] Expiration Date: [FILL DATE]

Paperwork Reduction Act Statement: The public reporting burden for this collection of information has been estimated to average 1 minute 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.

Anna MacMonegle

Advarra IRB Approved Version 18 Aug 2022