Quantitative
Study of Tobacco Facts Designed to Inform Youth Tobacco Prevention
Messaging
RIHSC No. 18-049CTP
OMB
No. 0910-0810
Exp.
Date: 10/31/2021
Attachment
F2: AI/AN
Youth Assent Form (Online Panel Recruit)
You
have been asked to take part in a research study called [STUDY
NAME]. The study is being led by Fors Marsh Group, which is a
company that does research. The online survey will ask
approximately 400 youth ages 13-17 about several tobacco-related
facts. Your
answers will help us make ads that keep kids from using tobacco.
It
will take about 20 minutes for you to complete this survey.
You
will not be harmed by being in this study. There is a small
chance that you might feel embarrassed or upset by the questions
asked in the survey. However, you can skip any questions you
don't want to answer.
If
you decide to take the survey, your parent will receive ‘points’
that are about $10 in value. The points can be redeemed for items
or gift cards through the Lucid system. There are no additional
benefits from completing the survey.
It
is your choice to take part in this study. You may stop taking the
survey at any time without penalty. Your identity will not be
known in the results of the study. The researchers will not have
access to any of your personal information (such as your name).
Everything you share will be kept private to the extent allowed by
law. Your
answers will not be shared with your parent. The
"Lucid Privacy & Terms of Use Policy" explain the
ways your information will be kept private.
If
you have any questions about the study, you may contact the
research team through Shane Mannis of FMG at 571-858-3757
(24 Hours) or pi@forsmarshgroup.org.
If
you have any questions about your rights as a study participant,
you may contact FDA IRB at RIHSC@fda.hhs.gov.
This
research is covered by a special protection (called a Certificate
of Confidentiality) from the Food and Drug Administration (FDA).
This special protection requires that researchers involved in this
study protect your privacy. This means researchers generally
cannot provide your name or any other information that could
identify you, to anyone who is not connected with the research.
Researchers cannot share this information in court or during other
legal proceedings, unless you or your parent agree, even if there
is a court order for the information. However, in other
settings, researchers may share study information that could
identify you if:
•
you
or your parent agree to share information (for example, to get
medical treatment);
•
the
study information is used for other scientific research that
follows federal law;
•
the
FDA, which is paying for the study, needs information to check how
their research money is being spent; or
•
a
law requires sharing information (for example, when researchers
must report to FDA, or if researchers hear threats of harm to
yourself or others or reports of child abuse).
The
Certificate of Confidentiality does not prevent you from sharing
any personal information or information about your involvement in
this study with others. For example, you can share that you are in
this research study or your history of tobacco use.
I understand the study purpose and process.
Would
you like to participate in this survey?
Yes, I want to take the survey.
No, I do NOT want to take the survey.
If
you choose YES, we will email you a copy of the form.
Paperwork Reduction Act
Statement:An
agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a
currently valid OMB control number. The public reporting burden for
this information collection has been estimated to average 5 minutes
per response to complete the Informed Assent Form (the time estimated
to read, review, and complete). Send comments regarding this burden
estimate or any other aspects of this information collection,
including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.
