Youth 1st, 2nd, and; 3rd (Male, Rural Smokeless) follow up questionnaire

Attachment 24_R: Consent Forms

Consent for Youth 18 and over for CAPI

Form Approved

OMB No. 0910-0753

Exp. Date 09/30/2019

FDA Health and Media Study

We are talking to boys in 30 cities across the United States. The study is sponsored by the U.S. Food and Drug Administration. You have previously taken part in this study by completing at least one survey. In past surveys, your parent provided permission for you to participate. Now that you are 18 or older, we are asking for your consent to participate in this survey.

The survey asks boys ages 11-19 about their attitudes related to health behaviors. The survey asks about advertisements they may have seen on TV or online. The advertisements may have also been heard on the radio. The survey will take about 45 minutes to complete. Up to 2,200 boys will take this survey. The survey is part of a research study being conducted by RTI International. There are no direct benefits for answering our questions but you will be helping with important health research.

Your name will be kept private. Your answers will be labeled with a number instead of your name. This makes it so only research staff will know these are your answers. Your answers may be shared with the FDA but not your personal information. We will not share any information you give us with your parents or anyone outside the FDA and RTI research teams. All of your answers will be kept private. It is not completely safe to send data through the Internet but we are doing everything we can to protect your data.

There are no physical risks but some questions might make you uncomfortable. If you don't want to take the survey, that is okay. If you don't want to answer a certain question, that is okay too. You may also choose to drop out of the survey at any time, for any reason and you may take a break at any time.

We will offer you $20 in cash to thank you for taking time to complete the survey.

We may contact you again in the future. It is up to you to decide if you would like to take any future surveys.

You can call us if you have questions about the study. The phone number is (866) 214-2039. You can also email us at mediastudy@rti.org. You may also have questions about your rights as a study participant. For those questions call the RTI Office of Research Protection. Their phone number is (866) 214-2043. You can send them an email at orpe@rti.org.

Do you agree to take this survey?

1 YES -> GO TO OMB

2 NO -> GO TO CAPIREF3

OMB No: 0910-0753 Expiration Date: 09/30/2019

Paperwork Reduction Act Statement: The public reporting burden for this collection of information has been estimated to average 5 minutes per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

Consent for Youth 18 and over for WEB

Form Approved

OMB No. 0910-0753

Exp. Date 09/30/2019

FDA Health and Media Study

This screen is meant to be read by [YOUTH FNAME]

We are talking to boys in 30 cities across the United States. This study is sponsored by the U.S. Food and Drug Administration. You have previously taken part in this study by completing at least one survey. In past surveys, your parent provided permission for you to participate. Now that you are 18 or older, we are asking for your consent to participate in this web survey.

The survey asks boys ages 11-19 about their attitudes related to health behaviors. The survey asks about advertisements they may have seen on TV or online. The advertisements may have also been heard on the radio. The survey will take about 45 minutes to complete. Up to 2,200 boys will take this survey. The survey is part of a research study being conducted by RTI International. There are no direct benefits for answering our questions but you will be helping with important health research.

Your name will be kept private. Your answers will be labeled with a number instead of your name. This makes it so only research staff will know these are your answers. Your answers may be shared with the FDA but not your personal information. We will not share any information you give us with your parents or anyone outside the FDA and RTI research teams. All of your answers will be kept private. It is not completely safe to send data through the Internet but we are doing everything we can to protect your data.

There are no physical risks but some questions might make you uncomfortable. If you don't want to take the survey, that is okay. If you don't want to answer a certain question, that is okay too. You may also choose to drop out of the survey at any time, for any reason and you may take a break at any time.

We will offer you a check for $25 if you complete the survey before [EARLY BIRD DEADLINE]. If you complete the survey after that we will offer you a check for $20. You will receive $20 in cash if you complete the survey in person.

We may contact you again in the future. It is up to you to decide if you would like to take any future surveys.

You can call us if you have any questions about the study. The phone number is (866) 214-2039. You can also email us at mediastudy@rti.org. You may also have questions about your rights as a study participant. For those questions call the RTI Office of Research Protection. Their phone number is (866) 214-2043. You can send them an email at orpe@rti.org.

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

1 Yes, I agree to participate in this study.

2 No, I do not wish to participate in this study.

OMB No: 0910-0753 Expiration Date: 09/30/2019

Paperwork Reduction Act Statement: The public reporting burden for this collection of information has been estimated to average 5 minutes per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

Page 4 of 4