Outcome Baseline via Social Media

Form Approved

OMB No. 0910-0808

Exp. Date 01/31/2019

ATTACHMENT 6: WEB-SURVEY INFORMED CONSENT FOR ALL RESPONDENTS INITIAL/BASELINE SURVEY

Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT LGBT):

The RESPECT LGBT survey asks young LGBT adults, ages 18-24 years, about opinions and behaviors related to tobacco, use of media and about their LGBT identity. The survey will take about 30 minutes to complete. About 12,600 people in 24 cities across the United States will take this survey.

Sponsor: This study is sponsored by the U. S. Food and Drug Administration’s Center for Tobacco Products (FDA-CTP). RTI International, a not-for-profit research organization, is conducting the study on the behalf of the FDA-CTP.

Financial Considerations: Within two days of completing the survey you will receive an email offering you the choice of one of 9 over 50 $20 electronic gift cards for your participation. [FILL FOR INTERCEPT RESPONDENTS: If you complete this survey within 48 hours of receiving the initial email invitation you will receive an additional $5, for a total of $25.]

Voluntary Participation: Your participation is completely voluntary. You can refuse to answer any and all questions. You can stop participation at any time.

Confidentiality: The protection of personal information is a primary concern to all institutions involved in this project. All members of the research team receive confidentiality training. Your answers to the survey questions will be kept confidential to the fullest extent allowable by law. Only we or other researchers involved in this project will have access to the answers you provide. Your name or email address will not be reported with any answers you provide. Your answers will be combined with answers of many others and reported in a summary form. All staff involved in this research are committed to confidentiality and have signed a Confidentiality Pledge. To help us ensure your answers are kept confidential and private, please complete the survey in a place where no one can look over your shoulder and view your answers. In addition, as is the case with all information transmitted online there is a possibility of a breach of confidentiality due to third parties illegally intercepting content. Your answers to questions will not be stored with any personally identifying information and will not be able to be connected with your identity by third parties.

Possible Benefits and Risks: There are no direct benefits to you for participating in this study. It is possible that some questions might make you feel mildly uncomfortable, but you can skip those if you choose.

Future Contacts

To help us understand changes over time, we may contact you in the future to invite you to participate in this study again. Each of these additional surveys will also be completely voluntary and you will be offered $20 for your participation.

Further Questions: If you have any questions about the research now or in the future you can contact the Project toll free number at 1-800-848-4072. If you have questions about your rights as a study participant, call RTI’s Office of Research Protection at 1‐866‐214-2043 (a toll‐free number).

CC1. Do you consent to participate in this web survey?

1. Yes

2. No

WEB-SURVEY INFORMED CONSENT FOR ALL LONGITUDINAL RESPONDENTS for FOLLOW-UP SURVEY

AA1. Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT LGBT):

Thank you for your continued interest in this study. The RESPECT LGBT survey asks young LGBT adults, ages 18-24, about opinions and behaviors related to tobacco, use of media and about their LGBT identity. The survey will take about 30 minutes to complete. We are conducting the study again to see what has changed and what has stayed the same. About 12,600 people in 24 cities across the United States will take this survey.

Sponsor: This study is sponsored by the U.S. Food and Drug Administration’s Center for Tobacco Products (FDA-CTP). RTI International, a not-for-profit research organization, is conducting the study on the behalf of the FDA-CTP.

Financial Considerations: Within two days of completing the survey you will receive an email offering you the choice of one of over 50 $20 electronic gift cards for your participation. If you complete this survey within 48 hours of receiving the initial email invitation you will be offered an additional $5, for a total of $25.

Voluntary Participation: Your participation is completely voluntary. You can refuse to answer any and all questions. You can stop participation at any time.

Confidentiality: The protection of personal information is a primary concern to all institutions involved in this project. All members of the research team receive confidentiality training. Your answers to the survey questions will be kept confidential to the fullest extent allowable by law. Only we or other researchers involved in this project will have access to the answers you provide. Your name or email address will not be reported with any answers you provide. Your answers will be combined with answers of many others and reported in a summary form. All staff involved in this research are committed to confidentiality and have signed a Confidentiality Pledge. To help us ensure your answers are kept confidential and private, please complete the survey in a place where no one can look over your shoulder and view your answers. In addition, as is the case with all information transmitted online there is a possibility of a breach of confidentiality due to third parties illegally intercepting content. Your answers to questions will not be stored with any personally identifying information and will not be able to be connected with your identity by third parties.

Possible Benefits and Risks: There are no direct benefits to you for participating in this study. It is possible that some questions might make you feel mildly uncomfortable, but you can skip those if you choose.

Future Contacts: To help us understand changes over time, we may contact you in the future to invite you to participate in this study again. Each of these additional surveys will also be completely voluntary and you will be offered $20 for your participation.

Further Questions: If you have any questions about the research now or in the future you can contact the Project toll free number 1-800-848-4072. If you have questions about your rights as a study participant, call RTI’s Office of Research Protection at 1‐866‐214-2043 (a toll‐free number).

CC1. Do you consent to participate in this web survey?

1. Yes

2. No

OMB No: 0910-0808 Expiration Date: 01/31/2019

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