Adult smokers ages 25 to 54; Wave 1 Questionnaire

ATTACHMENT 3A: CONSENT FOR WAVE 1 EVALUATION QUESTIONNAIRE

Consent Form: Point of Sale Intervention for Tobacco Evaluation (POSITEv)

Form Approved

OMB No. 0910-####

Exp. Date ##/##/20##

RIHSC No. 17-082CTP

The Point of Sale Intervention for Tobacco Evaluation (POSITEv) is a research study sponsored by the U.S. Food and Drug Administration. This study is designed to collect information from approximately 4,500 adults across the country about advertisements they have seen and their attitudes towards smoking and programs that help smokers who want to quit. You have been selected to participate because you are a current cigarette smoker between the ages of 25 and 54.

If you choose to participate, we will ask you to complete one in-person interview now that will take approximately 30 to 40 minutes to complete. We may invite you to participate in three additional interviews in-person or online over the next 2 years. For each questionnaire you complete, we will give you $25-$30 for your participation in appreciation for your time. At the end of today’s survey, we will offer you the option to participate in a smartphone application-based component of the study, if applicable. We will give you information about this additional component of the study and ask you to consent to participate if you are interested.

We are using a special quality control system on my laptop that will record some of what we say to each other to ensure I am following the correct procedures. The recording will be reviewed by RTI to monitor quality on this project. The recordings will be deleted after my work has been reviewed and will be kept private just like all the other information you provide. The audio files will not be provided to anyone outside of the research team for any purpose. You can still participate in the study even if you do not agree to this recording.

May we use this quality control recording system? 

1=YES

2=NO

[IF NO, DEACTIVATE COMPUTER AUDIO RECORDED INTERVIEWING FOR THIS CASE]

Types of Questions

The interviewer will ask questions about your tobacco use, your attitudes towards tobacco, tobacco-related advertising, and personal and household characteristics.

Voluntary Participation

Your participation in this study is completely voluntary. You can refuse to answer any and all questions. You can stop the interview at any time, however, you will only receive the $25 token of appreciation if you complete the survey. If we contact you for additional interviews, each of these interviews will also be completely voluntary. We will ask you to provide your consent for each of these interviews if you choose to participate in them. After completing these interviews, if you give us your permission, we may contact your household to verify that the interviewer followed the correct steps in completing the interview.

Risks

There are no physical risks to you from participating in this interview. Some questions are personal in nature and therefore may make you slightly uncomfortable.

Benefits

There are no direct benefits to you from answering our questions. However, you will be contributing to important research.

Confidentiality

You will answer the questions by reading the questions on a computer and entering your answers. Your answers will be labeled with a special number instead of your name. Your name and contact information will be kept separate from your survey responses. We will only use your name and contact information to stay in touch with you. All of your answers will be kept private to the fullest extent allowable by law and by the technology used.  All staff involved in this research are committed to confidentiality. The interviewer will not see the answers to the questions that you enter into the computer, and we will not share your specific answers with anyone else outside the research team. Instead, information you provide will be combined with answers of many others and reported in a summary form. We may send your data over the internet. It is not completely safe to send data through the Internet but we use encrypting and a secure broadband connection to protect your data.

Questions

If you have any questions about the study, you may call our project assistance line at 1-800-957-6457 between 9 am and 5 pm, Eastern Time, Monday through Friday or email us at fdastudy@rti.org. If you have any questions about your rights as a POSITEv study participant, you may call RTI's Office of Research Protection at 1-866-214-2043 (a toll-free number). This research study was reviewed and approved by RTI International’s Institutional Review Board (IRB), a committee that evaluates research that involves human participants.

You will be given a copy of this consent form to keep.

Do you agree to participate in this study?

1. Yes

2. No

ASK: All respondents

[PROGRAMMING NOTE:

IF YES, GO TO SECTION A INSTRUCTIONS; IF NO GO TO END.]

2