Focus Group Study of Adolescent and Young Adult Perceptions Related to Cigarette Smoking

Informed Consent for Participation in a
Discussion Group
ADOLESCENT INTERVIEW

Please read this assent form carefully. Take time to ask as many questions as you want. If there are
any words or information you do not clearly understand, study personnel will be happy to explain
them to you. This assent form must be signed before you can participate in the interview. Your
parent/guardian must also sign this form before you can participate.
INTRODUCTION
Your child has been asked to participate in an interview as part of a research project.
The purpose of the group is to hear thoughts from youth ages 15-17 about tobacco
products. ICF Macro is conducting discussion groups on behalf of the U.S.
Department of Health and Human Services to better understand adolescents’ thoughts
and knowledge about cigarette smoking. We have invited your child to participate in a
discussion to share their thoughts and knowledge about cigarettes. Their part in this
study involves being interviewed. The interview will be guided by an adult who is
trained to get their opinion and encourage everyone to take part. The research is
sponsored by the Food and Drug Administration (FDA).
Your child’s participation is entirely voluntary.
PURPOSE OF THE RESEARCH STUDY
The purpose of this study is to better understand adolescents’ thoughts and knowledge about
cigarettes.
INFORMATION ABOUT THE STUDY
This research involves 12 interviews. If you and your child agree, they will participate in one of the
12 interviews. This interview will last about 1 hour. The discussion will be recorded, and notes will
be taken. Only your child’s first name will be used to help protect your privacy. All recordings will
be destroyed at the end of the project.
YOUR CHILD’S ROLE IN THE STUDY
Participating in a research study can be an inconvenience. Please consider the study time
commitments and responsibilities when your child is deciding whether or not they should
participate. These include:
•
•

Coming to the study site for the interview at the planned time;
Providing truthful information about what they think about cigarette smoking

Subject’s Initials_________

REIMBURSEMENT FOR STUDY PARTICIPATION
If you accompany your child to the facility, we will give you $25.00 for your time and effort. Your
child will receive $30.00 in cash for their time and effort regarding their participation in the study.
This will be given to you and your child at the end of the focus group session.
PRIVACY
As part of this study, the study staff may record personal information about your child that contains
their name and other personal identifiers. Transcripts of the interview will only include their first
name.
The collection and submission of the information will be accomplished with strict adherence to
professional standards of privacy. Information from this study may be published in professional
journals or at scientific conferences, but your child’s privacy will be respected and no names will be
used in any report or presentation.
RESEARCH QUESTIONS AND CONTACTS
You or your child may freely ask questions about this assent form or the study now or at any time
during the study. If you or your child have any questions about the research, or compensation,
during this study you or your child may contact the study staff.
VOLUNTARY NATURE OF STUDY
Entering a research study is voluntary. It is your child’s choice to be in this study, and anyone who
is asked to be in a research study may so no. No one has to become a research subject, and your
child can choose not to talk about any topic.. If your child starts a research study, they may stop the
interview at any time. They do not need to give a reason.
ASSENT STATEMENT BY PARTICIPANT 17 AND UNDER
I have read this assent form. I understand what I am being asked to do. I had a chance to ask
questions, and my questions have been answered and any words I did not understand have been
explained to me. I agree to be in this research study for the purposes listed above. I will receive a
copy of this assent form for my records.
___________________________
Print your name here if you want to be in this study
___________________________
____________________________
Sign your name here if you want to
Signature
be in this study

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Date

Subject’s Initials_________

CONSENT STATEMENT BY PARENT OR GUARDIAN
I have read this consent form. I had a chance to ask questions, and my questions have been
answered. I agree to allow my child to be in this research study for the purposes listed above. I will
receive a copy of this consent form for my records.
By signing this consent form I am not giving up any of my or my child’s legal rights. I also
understand that nothing in this consent is intended to change any applicable federal, state or local
laws regarding informed consent.
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Printed Name of Minor Research Subject (Child)
___________________________
Name of Guardian (Print)

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Signature

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Date

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Name of Person Obtaining
Signature
Date
Informed Consent

_____________________________ _____________________________ ____________
Name of Person Obtaining
Signature
Date
Informed Consent

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Subject’s Initials_________