Consent and Screener: Adults (Ages 26+)

Investigation of Consumer Perceptions of Expressed Modified Risk Claims

5. Expressed Claims Informed Consent

Consent and Screener: Adults (Ages 26+)

OMB: 0910-0873

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ATTACHMENT 5. EXPRESSED CLAIMS INFORMED CONSENT



CONSENT FORM (Respondents age 18 OR OLDER)


You are one of about 6,000 people in the United States who are being asked to participate in a research study about tobacco. If you agree to take part in this research, you will be asked to view a tobacco product and answer some survey questions about it. The survey will also ask about you, and the survey will ask about your tobacco use if you use tobacco. You do not need to be a tobacco user to participate in this survey. This study is being conducted by RTI International, an independent nonprofit research organization. RTI is working with Lightspeed, LLC (Lightspeed) to conduct the survey but is not affiliated with Lightspeed, LLC in any way.


Possible Risks or Discomforts

There are minimal psychological, social, or legal risks to participating in this study. Because the survey asks a few questions about your use of tobacco products, you may or may not feel comfortable answering such questions. Your participation in this study is completely voluntary, and you may skip any questions you do not want to answer, or stop at any time. Your survey answers will always be stored separately from your name and email address. However, there is a risk of other people seeing your answers if your internet connection is not secure or if you are not alone while participating in the study.


Benefits

There is no direct benefit to you from participating. However, your responses are very important because they will help researchers understand what people think about tobacco products.


Incentive

This study will last about 20 minutes. In appreciation for your time, you will receive [$0.25-$7.00] in panel reward currency when you finish the study.


Confidentiality

As with other surveys you receive from Lightspeed, the privacy and confidentiality of your information is of the highest importance, and we are committed to maintaining a secure environment in which you can participate. All information collected on the survey will be kept confidential to the extent provided by law. Your answers will not be shared with family members, or used for any purpose other than this research. Your name and your e‑mail address will not be shared outside of Lightspeed, and they will not be associated with your answers or used in any report. The information obtained from all of the surveys will be combined into a summary report so that details of individual responses cannot be linked to a specific participant.


Persons to Contact

If you have questions about the study, you can call the project director, Jane Allen, at 1-800-334-8571, ext. 25115. Jane Allen can be reached between 9:00 am and 5:00 pm Eastern Time Monday to Friday.

If you have questions about your rights as a participant, you can call RTI’s Office of Research Protection toll-free at 1-866-214-2043.



[Prompt if skip]


[Adult_Consent1.] If you agree to participate, please click the Yes button. If not, click the No button.

1. Yes, I agree to participate. [Continue with next section]

2. No, I do not agree to participate. [Go on to next question]

99. Prefer not to answer [Go on to next question]



[New Screen]


[Prompt if skip]


[If Adult_Consent1=no, 99 or skip, ask Adult_Consent2.]


[Adult_Consent2.] Are you sure you don't want to participate? Your opinions are important to us. Please select the Yes button to continue with the study. Select the No button to exit.

1. Yes, I agree to participate. [Continue with next section]

2. No, I do not agree to participate. [End Survey]

99. Prefer not to answer [End Survey]



Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 2 minutes per response to complete the consent form (the time estimated to read, review, respond). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.


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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorBogus, Michelle
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File Created2021-01-20

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