Formative Research Support: Outcomes and Awareness Measurement Research

[PROTOCOL TITLE: Formative Research Support: Outcomes and Awareness Measurement Research
RTI PRINCIPAL INVESTIGATOR: Matthew Eggers
Version 03-02-22]
OMB# 0910-0810
EXP: 12/31/2024

[Text within brackets will not show to participants]

[Appendix D:
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). The mission of the FDA is to promote and
protect public health. In conducting this study, FDA does not intend to encourage tobacco
use, and FDA does not sell tobacco. The questions in this study are not meant to promote
risky behaviors such as drug use, binge drinking or smoking.
This research study is led by RTI International (RTI). About 2,400 teenagers are being asked
to participate in this study. 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
tobacco use and some television advertisements.
What will happen if I join this research study?
You will be asked to take an online survey that will take about 15 minutes. This is the second
survey, and it is similar to the one you took two weeks ago. The survey will ask you
questions about tobacco use and television advertisements. We will not ask you to take
anymore surveys as part of this study.
Your parent or guardian has given permission for you to take this survey. 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”.
For most of the questions, if you do not want to answer it, 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 survey 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

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[PROTOCOL TITLE: Formative Research Support: Outcomes and Awareness Measurement Research
RTI PRINCIPAL INVESTIGATOR: Matthew Eggers
Version 03-02-22]
OMB# 0910-0810
EXP: 12/31/2024

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.

In the future we may use or share survey data with other researchers for other studies. If we
do so, we will not contact you to ask for your permission.
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 or gifts for being in this research study. If you choose to
participate and complete the survey, your parent or guardian will receive reward points. If
you do not complete the online survey, your parent will not receive any reward points.
Who should you ask if you have any questions?
If you or your parents or guardians have questions or concerns about this survey, you may
call Matthew Eggers (RTI Researcher) at 919-990-8380, or at 1--800-334-8571, extension
28380. If you have any questions now, you should ask them before starting the survey. 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
print or take a screenshot of this form if you would like a copy for your records.
Do you agree to:
1. Take part in the study by answering questions in a survey?
1 Yes
2 No
[IF YES, GO TO SCREENER]
[IF NO, GO TO END]
[END]
Thank you for your time.

OMB No: 0910-0810

Expiration Date:12/31/2024

Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated
to average 2 minutes per response. 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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