FDA CTP Public Education Materials Study

Project Title: FDA CTP Public Education Materials Study

Appendix A. Informed Consent Information

Welcome to the FDA Center for Tobacco Products (CTP) PUBLIC EDUCATION MATERIALS STUDY!

You must be 18 years of age or older to be eligible to complete this survey.

The purpose of the research study, FDA CTP PUBLIC EDUCATION MATERIALS STUDY, is to assess how well the FDA CTP is serving recipients’ information needs.

Your participation in this 5 to 6 minute survey is anonymous and completely voluntary; you may quit, without penalty, at any time. No personally identifying information is collected, thus responses are anonymous. In addition, there are no foreseeable risks or discomforts by participating in this survey. There are no additional costs that may result from participating in this study.

Your data will be reported at the aggregate level. There are no direct benefits to your participation. If you feel like not answer any of the questions, you may skip the question or choose the response, “I prefer not to answer.” Participants may discontinue at any time without any consequences. Your participation will help FDA CTP to develop high-quality tobacco education information materials and posters. The Food and Drug Administration (FDA) is sponsoring this study. The mission of the FDA is to promote and protect public health. In conducting this study, FDA does not intend to sell tobacco, nor promote, condone, normalize, or encourage its use.

After you complete (or discontinue) the survey, you will receive an FDA CTP-branded giveaway.

If you have questions about your rights as a research participant or have an adverse event, please contact the Food and Drug Administration’s Research Involving Human Subjects Committee at [email protected] or 301-796-9605. This committee is a group of people who reviews research studies to protect the rights and safety of research participants. If you would like a copy of this informed consent form, please ask the FDA Center for Tobacco Products booth for a hardcopy.

If you click “Start survey now,” you are voluntarily agreeing to take part in this survey. Click one of the options below.

I have read, understand, and had time to consider all the information above. My questions have been answered, and I have no further questions.

_____ Start survey now / I voluntarily agree to participate in this study.

_____ Exit survey / I do not want to participate in this study. [TERMINATE SURVEY; GO TO TERMINATION TEXT 1]

[TERMINATION TEXT 1:] You have indicated that you do not want to participate in the FDA CTP PUBLIC EDUCATION MATERIALS STUDY and will now exit the survey. Thank you for your time and consideration.

Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 1 minute per response to review this informed consent 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].

Form Approved

OMB No. 0910-0810

Exp. Date11/2018

RIHSC #18-001