Cohort 2--Youth Aged 11 to 18

ATTACHMENT 6_E2d: FOLLOW-UP YOUTH CONSENT FORM (18+ Years)

Form Approved

OMB No. 0910-0753

Exp. Date: 09/30/2019

RIHSC No. 18-009CTP

Youth (18+) Follow up Consent Form for the Evaluation of the Public Education Campaign on Teen Tobacco (ExPECTT II)

We are talking to kids all over the United States about a research study sponsored by the U.S. Food and Drug Administration’s Center for Tobacco Products.

The survey asks teenagers what they think about tobacco use, media use, and other behaviors that are both legal and illegal. About [ADD NUMBER] youth are being asked to take this survey. This survey is voluntary and is part of a research study conducted by RTI International.

You will be asked to provide your consent to participate in this survey. Because you are 18 years old, it is not necessary for your parent or legal guardian to give their permission for you to take this survey.

To help us protect your information, we have obtained a Certificate of Confidentiality. This means that the researchers cannot provide information that may identify you in a court of law or other legal proceeding. However, researchers may share your information with the FDA or individuals who are responsible for evaluating this study. You should understand that the Certificate does NOT stop reporting that some federal, state or local laws require such as reporting of child abuse, communicable diseases, and threats to harm yourself or others. The Certificate also does NOT prevent your information from being used for other research if allowed by federal regulations. However, no information will be shared or used for other research that could identify you, such as name or date of birth. Finally, you should understand that the Certificate does not prevent you or a member of your family from willingly releasing information about yourself or your involvement in this research.

The survey will last between 35 and 45 minutes, depending on your responses. 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 will enter your responses to the questions directly into the questionnaire. Your name will be kept private. Your answers will be labeled with a special number instead of your name so that only research staff will know these are your answers. No one will see your answers to any of these questions. We will not share any information you give us with your parents, or anyone outside the research team. All of your answers will be kept private to the fullest extent allowable by law by the technology used.  No absolute guarantees can be made regarding the interception of data sent via the Internet. However, we are taking extensive precautions to protect the confidentiality of your data.

If you don't want to participate in this 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. If you want to take a break at any time, you can stop and return where you left off when you are ready.

IF COMPLETING ONLINE, FILL: We will send you a [BEFORE [DATE] FILL: $25 check if you complete the survey through the website on or before [ADD DATE], or $20 after [ADD DATE]; ELSE ON AND AFTER [DATE] FILL: $20 check] to thank you for taking time to complete the survey.

IF COMPLETING VIA CAPI, FILL: We will give you $20 in cash to thank you for taking time to complete the survey.

If you have any more questions about this study, you can call the ExPECTT project assistance line at (800) 608-2955. If you have a question about your rights as a study participant, you can call RTI’s Office of Research Protection toll-free at (866) 214-2043.

Do you agree to participate in the study?

1      Yes

2      No

CONTACT INFO [IF 18+ CONSENT = 1 (YES)

You might be contacted by RTI to verify this interview, and we would also like to be sure that we have the best contact information for you for future interviews. Can you provide the best name, telephone number, email address, and mailing address where you can be reached?

First Name:___________________________________________________

Last Name:___________________________________________________

Telephone Number: ________________________________________________

Email Address:_____________________________________________________

Mailing Address:

Street _______________________________

City_________________________________

State____________________________________

Zip code___________________________________

____________________________________________

IF COMPLETING ONLINE:

INCEN [IF 18+ CONSENT = 1 (YES) AND MODE = CAWI]

Thank you for taking part in this important study. If you complete the survey you will receive a check for [BEFORE [DATE] FILL: $25] if the survey is completed through the website on or before [DATE], or $20 if it is completed after [DATE]; ELSE (ON AND AFTER [DATE] FILL: $20.

We will need to collect some information from you so that we can mail out this check. This information will be kept completely confidential in secure and protected data files and will be separate from the responses provided in the survey. If you would like to decline receiving this payment, you can leave the information blank and simply press “Next” to continue to the next screen.

Please provide your first and last name.

First name: YFNAME

Last name: YLNAME

What is the best address where we should mail the check?

Street: YSTREET

City: YCITY

State: YSTATE

Zip Code: YZIP

Press “Next” to continue.

GO TO P_INTRO

ASK: Youth 18+ that have consented to complete online survey (Mode = CAWI).

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.

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