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pdf[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 A:
Online Survey Parental Permission]
Parental Permission for Youth to Participate in Research Study
We are talking to teenagers ages 13-17 all over the United States for a study sponsored by
the Center for Tobacco Products at the U.S. Food and Drug Administration (FDA). 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 asks people about their beliefs and behaviors related to vaping. About
2,400 teenagers are being asked to take 2 surveys over the course of 2 weeks as part of this
research study conducted by RTI International. This is the first survey for your child (ages
13-17); you will receive another invitation in two weeks for the second survey. The first
survey is estimated to take your child 20 minutes to complete. Your child will take the
surveys online.
Please note that the surveys are being conducted with the help of Lightspeed Research, a
company not affiliated with RTI and with its own privacy and security policies that you can
find at its website. We anticipate that your child’s participation in this survey presents no
greater risk than everyday use of the Internet.
We need permission from a parent or guardian before we survey your child. Your child will be
asked what they think about health behaviors like tobacco and marijuana use and for their
opinions about some television and social media advertisements.
There are minimal psychological or social risks to participating in this study. Your child may
or may not feel comfortable answering some of the questions in these surveys, such as those
about tobacco or marijuana use. There is no direct benefit to your child from participating.
However, your child’s responses are very important because they will help researchers
understand how people interpret tobacco product information.
The information that your child provides in the study will be handled confidentially. To help
ensure your child’s answers are kept private, please have your child complete the surveys in
a place where no one can look over his or her shoulder and view his or her answers.
We have procedures in place that are designed to ensure that RTI International and FDA will
not connect your name or your child’s name to his or her answers. Although there is a
chance his or her data could be seen by someone who shouldn’t have access to it, we’re
minimizing this risk in the following ways:
• The surveys will not ask for your child’s name. Lightspeed Research, the company
hosting this survey, will identify your child only with a code number. Your name and
your child’s name will not be part of this study’s dataset. Only Lightspeed Research
maintains a link between code numbers and personally identifying panel profile
information for Lightspeed Research panelists. Although we cannot guarantee that no
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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
•
•
one can reidentify this data, it is highly unlikely that this will occur.
If you are a panelist for one of Lightspeed Research’s partner panels, the partner
panel will never have access to your child’s survey responses. Lightspeed Research
will only share code numbers with partner panels for the purpose of distributing your
compensation.
The dataset from this survey will be kept on a secure RTI server with access only to
authorized project staff members.
Information from this study may be published in professional journals or presented at
meetings, but no names will ever be used. In the future we may use or share the survey
dataset with other researchers for other studies. If we do so, we will not contact you to ask
for your additional informed consent.
Your child’s participation in this research study is completely voluntary. If your child doesn’t
want to take the first or second survey, that is okay. Determining your child’s eligibility for
the surveys requires that he or she answer certain screening questions. If your child chooses
not to answer one or more of those screening questions, your child will be routed out of the
survey. Based on your child’s answers to the screening questions, if your child is eligible for
the surveys, he or she will be routed directly to the current survey.
If your child gets to a question on a survey that he or she does not want to answer, he or
she can skip it. Your child can drop out of a survey at any time for any reason by closing the
Internet browser. If your child completes the first or both the first and second surveys your
account will be credited with the reward points stated in each communication. If your child
withdraws after completing the screener and does not complete the first survey, you will not
receive an invitation for the second survey. You will also not receive reward points for the
first survey.
This project is funded by FDA and holds a Certificate of Confidentiality that offers additional
legal confidentiality protections. The most important protection is that members of the
research team cannot be forced to disclose or provide any of your child’s private identifiable
information, in any Federal, State, or local civil, criminal, administrative, legislative, or other
proceeding unless you provide permission. Disclosure of your child’s research information
may only occur in limited instances, such as:
•
You can freely discuss your child’s involvement in this research.
•
The researchers cannot refuse requests for information from the FDA, the survey’s
sponsor.
•
In situations involving imminent danger, the law requires the researchers to disclose
certain information.
The Institutional Review Board (IRB) at RTI International has reviewed this research. An IRB
is a group of people who are responsible for ensuring that the rights of participants in
research are protected. The IRB may review the records of your child’s participation in this
research to ensure that proper procedures were followed. We have procedures in place to
limit who can connect your child’s name to their answers.
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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
If you have any questions about this study, you may call Matthew Eggers of RTI at 919-9908380, or at 1--800-334-8571, extension 28380. If you have any questions about your child’s
rights as a study participant, you may call RTI’s Office of Research Protection at 1-866-2142043. You can print or take a screenshot of this form if you would like a copy for your
records.
1. What is the date of birth of the child you will invite to participate in this study?
If you have more than one child between the ages of 13-17, we recommend
choosing the one who is currently available to take the survey.
[P_BMONTH] Month: _ _
[P_BDAY] Day: _ _
[P_BYEAR] Year: _ _ _ _
[VALIDATE CORRECT DATE FORMAT. DO NOT ALLOW FUTURE DATES. IF THE DATE IS NOT
VALID, PLEASE DISPLAY A HARD ERROR, “Please enter a valid date.”]
[GENERATE CALCULATED VARIABLE FOR AGE OF CHILD [AGE]. TERMINATE IF AGE < 13 OR
>17.]
2. Do you give permission for your child to participate in the screening survey to
determine your child’s eligibility and (if they are eligible) do you also give
permission for your child to participate in the longer survey?
1 Yes
2 No
[IF YES, GO TO P_INTRO]
[IF NO, GO TO END]
[P_INTRO]
Now we will be asking your child screening questions to see if he or she is eligible for a
longer survey. If eligible, he or she will be directed to begin the longer survey. It is important
that your child be allowed to answer all questions in privacy. From this point on, your child
should be able to read and answer all questions on his or her own. Please bring your child to
this device, and press “Continue” when your child is ready to begin.
[GO TO ASSENT]
[END]
If you are a tobacco user or have a friend or family member who is a tobacco user, and you would like
information on how to quit, please visit https://smokefree.gov/.
Thank you for your time.
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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
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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| File Type | application/pdf |
| File Modified | 2022-04-19 |
| File Created | 2022-04-19 |