Adult smokers ages 25 to 54; Wave 2 - 4 Questionnaires

Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign

Attachment_03c_POSITEv_Waves_2_3_4_consent clean

Adult smokers ages 25 to 54; Wave 2 - 4 Questionnaires

OMB: 0910-0851

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AttacHMENT 3c: CONSENTS for evaluation questionnaires (POSITEv)


CONSENT FOR IN PERSON EVALUATION QUESTIONNAIRE


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


Form Approved

OMB No. 0910-####

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

RIHSC No. 17-082CTP


INTERVIEWER, HAND RESPONDENT HARDCOPY CONSENT FORM TO FOLLOW AS YOU READ THE CONSENT TEXT ALOUD.


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 completed at least one interview for this study. This study is being conducted again to measure what might have changed over time or what has stayed the same.


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 interview will last about 30-40 minutes and 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. Because your contribution is important, we will offer you $25 cash as a token of appreciation for participating. You can stop the interview at any time, however, you will only receive the token of appreciation if you complete the survey. For each follow-up you complete in the future, you will receive a token of appreciation for participating in those additional interviews. Each of these additional interviews will 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

Your name and contact information will be kept separate from your survey responses. 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. 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 the project assistance line toll-free 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 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.


Shape1 Please keep this copy of the consent form for your records.


Do you agree to participate in this study?


Yes, I agree to participate in this study

No, I do not want to participate in this study


[PROGRAMMING NOTE:

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


CONSENT for Online 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 completed at least one interview for this study. This study is being conducted again to measure what might have changed over time or what has stayed the same.


Types of Questions

The interview will last about 30-40 minutes and 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. Because your contribution is important, we will offer you $30 by check if you complete the survey through the website on or before [Early Bird Date], or $25 by check after [Early Bird Date], as a token of appreciation for participating. You can stop the interview at any time, however, you will only receive the token of appreciation if you complete the survey. For each follow-up you complete in the future, you will receive a token of appreciation for participating in those additional interviews. Each of these additional interviews will be completely voluntary. We will ask you to provide your consent for each of these interviews if you choose to participate in them.


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. 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. 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.


Questions

If you have any questions about the study, you may call the project assistance line toll-free 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 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.


A copy of this consent form is included in the letter we sent you. Or, if you do not have that letter, you can print a copy for your records.


After you select your answer, please press “Next.”


Yes, I agree to participate in this study

No, I do not want to participate in this study


[PROGRAMMING NOTE:

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


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