Quantitative Study of Tobacco Facts Designed to Inform Youth Tobacco Prevention Messaging

Quantitative Study of Tobacco Facts Designed to Inform Youth Tobacco Prevention Messaging

RIHSC No. 18-049CTP

OMB No. 0910-0810

Exp. Date: 10/31/2021

Attachment F2: AI/AN Youth Assent Form (Online Panel Recruit)

You have been asked to take part in a research study called [STUDY NAME]. The study is being led by Fors Marsh Group, which is a company that does research. The online survey will ask approximately 400 youth ages 13-17 about several tobacco-related facts. Your answers will help us make ads that keep kids from using tobacco. It will take about 20 minutes for you to complete this survey.

You will not be harmed by being in this study. There is a small chance that you might feel embarrassed or upset by the questions asked in the survey. However, you can skip any questions you don't want to answer.

If you decide to take the survey, your parent will receive ‘points’ that are about $10 in value. The points can be redeemed for items or gift cards through the Lucid system. There are no additional benefits from completing the survey.

It is your choice to take part in this study. You may stop taking the survey at any time without penalty. Your identity will not be known in the results of the study. The researchers will not have access to any of your personal information (such as your name). Everything you share will be kept private to the extent allowed by law. Your answers will not be shared with your parent. The "Lucid Privacy & Terms of Use Policy" explain the ways your information will be kept private.

If you have any questions about the study, you may contact the research team through Shane Mannis of FMG at 571-858-3757 (24 Hours) or [email protected]. If you have any questions about your rights as a study participant, you may contact FDA IRB at [email protected].

This research is covered by a special protection (called a Certificate of Confidentiality) from the Food and Drug Administration (FDA). This special protection requires that researchers involved in this study protect your privacy.  This means researchers generally cannot provide your name or any other information that could identify you, to anyone who is not connected with the research. Researchers cannot share this information in court or during other legal proceedings, unless you or your parent agree, even if there is a court order for the information.  However, in other settings, researchers may share study information that could identify you if:

• you or your parent agree to share information (for example, to get medical treatment);

• the study information is used for other scientific research that follows federal law;

• the FDA, which is paying for the study, needs information to check how their research money is being spent; or

• a law requires sharing information (for example, when researchers must report to FDA, or if researchers hear threats of harm to yourself or others or reports of child abuse).

The Certificate of Confidentiality does not prevent you from sharing any personal information or information about your involvement in this study with others. For example, you can share that you are in this research study or your history of tobacco use.

I understand the study purpose and process.

Would you like to participate in this survey?

Yes, I want to take the survey.

No, I do NOT want to take the survey.

If you choose YES, we will email you a copy of the form.

Paperwork Reduction Act Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The public reporting burden for this information collection has been estimated to average 5 minutes per response to complete the Informed Assent 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 [email protected].