FDA Consumer Perception Research on New and Emerging Tobacco Products

Parental Written Permission for Youth Interview

Introduction and Purpose:
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.
RTI International, a non-profit research company in North Carolina will be doing the
interview. The research is sponsored by the Food and Drug Administration (FDA).

Procedures:
During the interview your child will talk one-on-one with a member of the project team
from RTI International about their thoughts about tobacco products. The interview will
take about 1 hour.
We will be talking to a total of 12 people across 3 cities.
Some of the people working on the project may watch the interview through a one-way
mirror and take notes. The interview will also be video recorded and given to the FDA.
All recordings will be destroyed at the end of the project.

Risk/Discomforts:
There is no known physical risk to your child from being in this study. Though unlikely,
there is a small chance that your child might feel embarrassed or upset by the things that
are talked about during the interview. Your child can say they do not want to talk about
any topic for any reason. Your child can also stop the interview at any time.
Benefits:
There is no direct benefit to your child for being in this study. What we learn from the
interview will help the FDA learn about what teens think about tobacco products.
Privacy:
We will video tape the interview. The videos will be destroyed at the end of the project.
Notes will be made of the recordings. We will only use first names in the notes. Your
child’s comments will be kept private as it is allowed by law. The notes will be kept on a
password-protected computer. Only certain project staff who have been trained on the
project will be able to see them. Any forms for the project that have your name or your
child’s name or anything that could identify you or your child will be kept in a locked file
cabinet. These forms will be destroyed once the project ends. However, there is still a
small chance that your privacy or your child’s privacy could be broken.
Payment:
If you accompany your child to the facility, we will give you $25.00 for your time, effort,
and travel costs. Your child will be provided with $30.00 for their time, effort, and travel
costs.

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Right to Refuse or Withdraw:
It is your child’s choice to be in this study. Your child can choose not to talk about any
topic. Your child can stop the interview at any time without penalty.
Persons to Contact:
If you have questions about the group, you can call Julia Kish Doto at 1-800-334-8571
(Extension x28280). If you have questions about your rights or your child’s rights, or if
you have concerns or complaints, or if you think you or your child has been injured, you
can call RTI’s Office of Research Protection toll-free at 1-866-214-2043.
Your Permission:
I have read this permission form. I had a chance to ask questions and my questions were
answered. I was given a copy of this permission form.

Do you give your permission for your child to participate in the interview now?
__Yes
__No

Parent Signature

Date

Print Name

Print Child’s Name

Interviewer Signature

Date