Fresh Empire Campaign: Wave 2 Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use

OMB# 0910-0810

Exp. Date: 11/30/18

PARTICIPANT ASSENT FORM

TITLE OF INFORMATION COLLECTION:

Fresh Empire Campaign: Wave 2 Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use

Sponsor:	U.S. Food and Drug Administration’s Center for Tobacco Products
Principal Investigator:	Dana Wagner, PhD
Email Address of Investigator:	dana@rescuescg.com
Telephone:	619-231-7555 ext. 331 (24 Hours)
Address:	Rescue Social Change Group 660 Pennsylvania Ave SE Suite 400 Washington, DC 20003

Please read this form carefully. You must submit this form by clicking the button at the bottom of the last page before you can take part in the study.

Introduction: About this study

The purpose of this research is to determine whether TV ads designed to prevent youth from using tobacco are understandable and engaging.

Rescue Social Change Group (Rescue SCG) is a health communications and research company. We are working with the U.S. Food and Drug Administration’s Center for Tobacco Products to conduct a study with youth ages 12 to 17. The study includes youth in multiple cities across America. The study will show draft versions of TV ads. We then try to learn if the messages are understood. Some participants will view 2 TV ads. Others will not view any ads. Whether or not you see the TV ads are randomly assigned. If you see the TV ads, they will be close to final version that still needs small edits. You will complete a survey to help make the TV ads final. We want to know which TV ads you think are understandable and engaging.

What will I do during this study?

You are invited to do a survey. You will be one of a group of 855 youth participating in this study. The survey will take up to 20 minutes to complete, plus the screener survey you completed previously.

You may be asked to view 2 TV ads and tell us your opinions about them. If you are not shown any ads, the survey will take no longer than 5 minutes. Additionally, you will be asked questions related to tobacco use and your attitudes about tobacco. We may collect information you provide from both the screener and the study survey.

You can choose to take part in the study or not, regardless of what other teens choose to do. You can choose to stop taking the survey at any time. This will not affect your grades at school in any way.

Who will see the information I provide during this study?

We will take care to protect your privacy. The survey will be on a secure website that is password protected. Your answers will be kept private to the extent allowable by law. That means we will not share your answers with anyone outside the study unless it is necessary to protect you, or if required by law. Some personal information, like gender, age, race, and ethnicity, will be gathered. We will also record your thoughts, opinions, and reactions to TV ads designed to prevent youth from using tobacco. Any personal information that identifies you will be destroyed at the end of the study. No one will know what answers you gave us. Information you share about your tobacco attitudes, beliefs and behaviors will not be shared with others. This includes your parent(s)/guardian(s).

We will keep answers you provide for three years after the completion of the study. The data will be stored on a password-protected computer or in a locked cabinet. Three years after the completion of the study, we will destroy all of the data by securely shredding and permanently deleting records.

Data from this study may appear in professional journals or at scientific conferences. We will not disclose your identity in any report or presentation. Data from this study may be used in future research. We may share the data with other researchers. Anyone who looks at this data will not have your name or any other data that could reveal your identity.

Will I be paid for being in this study?

If you are taking the survey after school at a study session, you will receive a $25 VISA or American Express gift card from a researcher. You will receive this gift card even if you decide you do not want to complete the survey.

If you are completing this survey on your own device or computer, you will receive an electronic $25 electronic gift card after you submit the survey. You will receive the gift card via email within 72 hours of submitting the survey.

There is no cost to you for taking part in this study.

What good will come from this study?

This study is not expected to directly benefit you. Your answers will help us determine whether TV ads about the harms of tobacco use are understandable and engaging.

Could anything bad happen to me during this study?

We will take care to protect the data you provide. However, as with all studies, there is a chance that privacy could be broken because of an accident or a security breach.

All images will be presented in the context of tobacco use prevention. You should talk to your parents, guardian, or school counselors about any concerns you have about how these images made you feel. You should also talk with them about any questions or concerns you have about using tobacco. If you have any questions about this research study, you may call or email the Principal Investigator at the telephone number or email address listed on the first page of this form.

Remember that you can stop participating in this study at any time.

Do I have to be in this study? What if I want to drop out?

This study is completely voluntary. You can choose to take part in the study or not, regardless of what other teens choose to do. You can choose to stop taking the survey at any time. You do not have to answer any questions you do not want to. You will receive the $25 gift card even if you do not complete the survey during the study session or you choose to not answer some questions during the study session or the online survey.

Questions and Contacts: Who do I call if I have questions now or later?

If you have any questions about this study, please contact the principal investigator or the study staff at the telephone number or email address listed on the first page of this form. If you have any concerns about this study, please contact:

• By mail:

Study Subject Adviser

Chesapeake IRB

6940 Columbia Gateway Drive, Suite 110

Columbia, MD 21046

• or call toll free: 877-992-4724

• or by email: adviser@chesapeakeirb.com

Please reference the following number when contacting the Study Subject Adviser: Pro00009799.

An IRB is a group of people who review research studies to protect the rights and safety of research participants.

I have read, understand, and had time to consider all of the information above. I have no more questions about this study at this time. I agree to take part in this study.

Do you want to continue?

○ Yes, I want to participate.

○ No, I do NOT want to participate.

*If you choose YES, we will email you the 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 review this 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