FDA Consumer Perception Research on New and Emerging Tobacco Products

Assent for Participation in Interview

Introduction and Purpose:
You have been asked to participate in an interview as part of a research project. The
purpose of the interview is to learn about your thoughts and knowledge 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 you will talk one-on-one with a member of the project team from
RTI International. You will be asked about your 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 you from being in this study. Though unlikely, there
is a small chance that you might feel embarrassed or upset by the things that are talked
about during the interview. You can say you do not want to talk about any topic for any
reason. You can also stop the interview at any time.
Benefits:
There is no direct benefit to you for being in this study. What we learn from the study
will help the FDA learn about tobacco use.
Privacy:
We will video tape the interview. The video files 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 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
anything that could identify you 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
could be broken.
Payment:
We will give you $30.00 for your time, effort and travel costs.
Right to Refuse or Withdraw:
It is your choice to be in this study. You can choose not to talk about any topic. You can

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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 if you have concerns or
complaints, or if you think you have been injured, you can call RTI’s Office of Research
Protection toll-free at 1-866-214-2043.
Your Assent:
I have read this assent form. I had a chance to ask questions and my questions were
answered. I was given a copy of this assent form.

Do you assent to participate in the interview now?
__Yes
__No

Participant Signature

Date

Participant Name (Print)

Interviewer Signature

Date