Tobacco Retailer Education Program: In-depth Interviews to Inform the Development of Educational Materials

OMB# 0910-0674

Exp. 3/31/2016

Informed CONSENT FORM

TITLE OF INFORMATION COLLECTION: Tobacco Retailer Education Program:
In-depth Interviews to Inform the Development of Educational Materials

Sponsor: The Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP)

Principal Investigator: Kara Marsh, PhD

Telephone: 571-858-3757 (24 Hours)

Address: Fors Marsh Group, LLC (FWA00011194)

1010 N. Glebe Road

Suite 510

Arlington, VA 22201

You are being asked to take part in this study because you work at a retail location that sells tobacco products. This form explains the study. After reading this form, you can decide to be in the study or you can decide not to be in the study. Either choice is OK. If you decide to start the study and then change your mind, you can stop being in the study at any time.

Please ask the study staff to explain anything you do not understand. They will answer all the questions you have. You can ask questions about the study at any time.

You must complete this form before you can take part in the study.

About this study

The goal of this study is to understand reactions to two program versions and assess the clarity, comprehension, and usability of specific educational materials.

FCB Garfinkel is an advertising company partnering with the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) to create an educational program. We would like your thoughts to help us create materials to raise awareness of FDA tobacco regulations and engage retailers to work with FDA to protect youth from tobacco. We are working with two research partners, Fors Marsh Group and Doyle Research. We plan to hold sixty in-depth interviews (IDIs) in three markets (urban, suburban, and rural). Interviews will be with tobacco retailer managers and clerks aged 18 years and older working in convenience and convenience/gas stores; grocery, discount, and drug stores; and tobacco outlets.

What will I do during this study?

The interview will take place at a location near your work. Study staff will tell you when and where your assigned interview is scheduled. During the session, you will be asked to share your thoughts with the interviewer about educational materials designed to raise awareness of FDA tobacco regulations and engage retailers to work with FDA to protect youth from tobacco. The interview will last about 90 minutes.

There will be other people observing the session. They will take notes and listen, but they won’t bother you. You will only be talking to the interviewer.

Study Benefits: What good comes from my participation?

There is no direct benefit to you. Your feedback will help us decide what ideas, images, and messages may best educate people about tobacco regulations.

Will I be paid for being in this study?

You will receive $75 as a token of appreciation for your participation. A gift card that functions as a pre-paid debit card will be issued upon completion of the interview. You do not have to answer any questions that you don’t want to. You will receive the gift card incentive for your time even if you choose not to answer some questions.

Anticipated Risks: Could anything bad happen to me during this study?

We will be very careful to only let people working on the study see your information. There is a small risk that others might find out what you say, despite all of our best efforts.

If you have any questions about tobacco use or prevention before, during, or after the interview, you can ask the interviewer.

If you have any questions about this study, you may call Kara Marsh of Fors Marsh Group at 571-858-3757. Remember that you can stop being in this study at any time.

Privacy: Who will see the results of this study?

Everything you say during the interview can be heard by the interviewer, research assistants, and FDA study monitors.

The interviews may be video reordered or livestreamed so that other researchers who could not travel can watch too. You will be told at the start of the interview if it is being recorded. The interview will also be audio recorded and transcribed. You will have the chance to choose not to be recorded at the start of the interview.

Only the interviewer, staff from FCB Garfinkel, and researchers from Fors Marsh Group and Doyle Research will have access to your responses. Your name and other personal information will not be linked your responses. This means that no one outside of the research team will know what you said. Everything you share will be kept private to the extent allowed by law. This means that we will not share anything you provide with anyone outside the study unless it is required to protect you, or if required by law. However, if you show a direct threat of harm to yourself or others, we have the right to take action out of concern for you and concern for others. What you choose to share about your attitudes, beliefs, and behaviors related to tobacco sales and regulations will not be shared with anyone outside the research team.

All of the information we collect, including anything you say in the interview and data collected during screening, will be kept for three years. The information, video/audio files, and transcripts will be stored on a password-protected computer and/or in locked cabinets that only the research team can access. We will collect some personal information from you, like your age and race, but we will not collect any information that could identify you, like your full name, address, or social security number. After three years, all of the collected data will be destroyed by securely shredding documents or permanently deleting electronic information.

Results from this study may appear in professional journals or at scientific conferences. No individual participants will be identified or linked to the results. We will not disclose your identity in any report or presentation.

Results may also be used in future research or shared with other researchers. Other researchers will not have your name or any identifying information.

Participation and Withdrawal: Do I have to be in this study? What if I want to stop participating?

This study is completely voluntary. You can stop at any time. You can decide not to participate at any time by contacting Kara Marsh of Fors Marsh Group at 571-858-3757.

You also do not have to answer any questions that you do not want to. You will receive the gift card incentive for your time in the interview even if you choose not to answer some questions.

Who do I contact if I have questions about the study?

If you have questions or concerns about the study, you can contact:

Kara Marsh, Fors Marsh Group

571-858-3757

pi@forsmarshgroup.com

Yes, I agree to participate in this study. I have read, understand, and had time to consider all of the information above. My questions have been answered and I have no further questions.

No, I do not agree to participate in this study. I have read, understand, and had time to consider all of the information above. My questions have been answered and I have no further questions.

The study staff will provide you a copy of this form for your records.

Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 5 minutes per response to complete the Informed Consent 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.