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
F1: AI/AN
Email Invitation and Parental Permission Form (Online Panel Recruit)
[FIRST
SCREEN]
Dear Lucid participant,
Your
[INSERT CHILD’S AGE] year-old SON/DAUGHTER is invited to
participate in a research study conducted by Fors Marsh Group on
behalf of the U.S. Food and Drug Administration. The study will
ask approximately 400 youth ages 13-17 to complete and online
survey about their perceptions of tobacco-related facts. Your
child’s answers will help inform messaging for future youth
tobacco prevention campaigns. It
will take about 20 minutes for HIM/HER to complete. The [STUDY
NAME] survey will be quite similar to the kinds of surveys your
child may have already been involved in as a Lucid Member.
The
potential risk to respondents from completing the survey is
minimal. Some questions might make him or her feel uncomfortable,
but they have the right to skip any questions they don't want to
answer. Participation is completely voluntary and your child may
withdraw HIS/HER consent or discontinue participation at any time
without penalty. If your child decides to take the survey, you
will receive ‘points’ with approximate value of $10
for their participation. The points can be redeemed for items or
gift cards through the Lucid system.
[SECOND
SCREEN]
As always, his or her identity will be unknown in all
data resulting from the study. The researchers will not have
access to any of your child’s identifying information (such
as his or her name). Everything your child shares will be kept
private to the extent allowed by law.
All of the conditions and terms described in the "Lucid
Privacy & Terms of Use Policy" document that you received
when you got your recruitment packet are in effect for this study.
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 child’s 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 child’s privacy. This means
researchers generally cannot provide your child’s name, or
any other information that could identify your child, 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 child agree, even if there is a court order for
the information. However, in other settings, researchers may
share study information that could identify your child if:
•
you
or your child 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
others or reports of child abuse).
The
Certificate of Confidentiality does not prevent you and your child
from sharing any personal information or information about your
child’s involvement in this study with others. For example,
you can share that your child is in this research study or your
child’s history of tobacco use.
I have read and understand this information, and the study purpose
and process are clear to me.
Do
you give your consent for your child to complete this survey?
Yes No
If
“Yes”, please provide your child’s email address
so we can send him/her a link to the survey:
__________________________________________ (Child’s email
address)
A
copy of the form will also be sent to the email address that Lucid
has for you on file.
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 Parental Permission 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.
