Youth Baseline Questionnaire (Male Rural Smokeless)

Attachment 8: Study Description

Form Approved
OMB No. 0910-0753
Exp. Date 10/31/2016

FDA Health and Media Study

Your address is one of several in this area randomly chosen for the U.S. Food and Drug Administration’s (FDA) Health and Media Study. This study, sponsored by the FDA, is collecting information from boys across the United States about their attitudes related to health, health behaviors, and advertisements they may have seen on TV and/or online.

You cannot be identified by any of the information you give to us. Your name and address will never be connected to your answers. Also, federal law requires that we keep all of your responses private to the fullest extent allowable by law. Any data you provide will only be used for statistical purposes and reported in aggregate form.

The screening questions take just a few minutes to determine if anyone in your household is eligible. One or possibly more children in your household may be asked to voluntarily participate in the survey. If anyone is chosen, the interview itself will take approximately 30-40 minutes. We would also like to ask you a few questions about your household’s characteristics and media use. You and your child can refuse to answer any questions, and you can quit at any time. Your child will be offered $20 upon completing the interview.

We will conduct three follow-up surveys every eight months to understand changes in health-related attitudes and behaviors over time. Each of these additional interviews will also be completely voluntary. If your child participates in future rounds, he will be offered a $20 incentive for participating in each of the three in-person interviews.

If you have any questions about the study, please contact the project representative Melissa Helton, at 800 334-8571 extension 27168. If you have questions about your rights as a study participant, call toll-free: RTI’s Office of Human Research Protections at 1-866-214-2043.

Thank you for your cooperation and time.

OMB No: 0910-0753 Expiration Date: 10/31/2016

Paperwork Reduction Act Statement: The public reporting burden for this collection of information has been estimated to average 3 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.

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