Youth - Screener

[PROTOCOL TITLE: Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products

RTI PRINCIPAL INVESTIGATOR: Jessica Pepper

Version 3-4-20]

OMB# 0910-0880

EXP: 11/30/2022

[Text within brackets will not show to participants]

[Appendix I:
Online Survey Youth Assent]

Research Study Assent Form

If you want to, you can be a part of this research study. This research study is sponsored by the U.S. Food and Drug Administration (FDA) and led by RTI International (RTI). People do research to try to find answers to questions. Research studies help us learn new things.

Why are we doing this research study?

The reason we are doing this research is to learn people’s thoughts and opinions about the chemicals in cigarettes and cigarette smoke.

What will happen if I join this research study?

You will first be asked to take an online survey that will take about 3 to 5 minutes. After that, you may be asked to take a longer survey that will take about 20 minutes. The surveys will ask you questions about the chemicals in cigarettes and cigarette smoke.

Your parent or guardian has given permission for you to take these two surveys. You do not have to be in this study if you don’t want to, even if your parent or guardian has already given us permission.

What are the problems that might happen in this research study?

Some of the questions might be hard to answer or make you feel uncomfortable. You should know that:

• You get to decide if you want to take part in this research study. You can say “No” or you can say “Yes”.

• If you do not answer some of the questions on the shorter survey, you cannot take the longer survey. That is okay.

• If you do not want to answer a question on the longer survey, you can skip it. That is okay.

• You can stop taking the surveys at any time by closing your Internet browser.

Who will be told the things we learn about you in this study?

Your name will not be in any report of the results of this study, and your parents or guardians will not be told how you answered the questions. Please take the surveys in a place where no one can look over your shoulder and view your answers.

This research study has a Certificate of Confidentiality. This means that the researchers cannot be forced to provide any of your private identifiable information if a court or a lawyer asks for it. Disclosure of your research information may only occur in limited specific instances such as:

• The FDA can request information from the researchers.

• If someone is in serious danger, the law may require the researchers to disclose information to keep people safe.

What are the good things that might happen in this study?

People may have good things happen to them because they are in research studies. These good things are called “benefits.” There are no benefits to you from being in this research study.

Will you get any money or gifts for being in this research study?

You will not receive any money of gifts for being in this research study. If you chose to participate, your parent or guardian will get compensated. Even if you are not eligible for the longer survey or do not answer all the survey questions, your parent or guardian will still get compensated.

Who should you ask if you have any questions?

If you have questions, you should ask us. If later, you or your parents or guardians have questions or complaints, you may call the contact me, Jessica Pepper (RTI Researcher), at 919-316-3180, or at 1‑800-334-8571, extension 23180. If you or your parents or guardians have any questions about your rights as a study participant, you may call RTI’s Office of Research Protection at 1-866-214-2043. You can take print or take a screenshot of this form if you would like a copy for your records.

Do you agree to participate in the screening survey to determine your eligibility and (if you are eligible) do you also agree to participate in the study?

1 Yes

2 No

[IF YES, GO TO SCREENER]
[IF NO, GO TO END]

[END]
Thank you for your time.

Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 3 minutes per response to complete the screener (the time estimated to read, review, respond). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.

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