Attach7_SFTXT_REVISED_Consent Form_v2 5222013

SSA SFTXT Attachment 7

CONSENT FORM

[Please click here to print a copy of this document for your records]

Introduction and Purpose:

You are invited to take part in a research study to evaluate a tobacco cessation program funded by the National Cancer Institute (NCI).

You have been chosen to participate because you said that you currently smoke and are interested in quitting. What we learn from this study will be used to improve the tobacco cessation program. RTI International, a non-profit company in North Carolina, is conducting the study. In total, we expect about 4,000 people to participate.

Procedures:

As part of this study, you will be asked to participate in a tobacco cessation program that involves receiving educational and motivational text messages on your cell phone. You will receive between 0 to 5 messages per day (or up to a total of 130 messages) over 8 weeks. After you complete a first survey about your smoking and cessation experiences, you will be asked to select a date you will quit smoking (a “quit date”) that will be between 2 and 3 weeks after the first survey. The tobacco cessation program will begin shortly after you’ve selected your quit date.

To provide feedback on the tobacco cessation program, you will be asked to complete a total of five online questionnaires, including the first survey before you start the cessation program, one while you are participating in the program, and three more after you’ve completed the program. Each survey will take approximately 10-20 minutes to complete and will ask questions on your current smoking status, thoughts on smoking, thoughts on quitting smoking, and your mood. Each survey will be sent to you via email. You may receive reminders via email or telephone to complete the survey. To compensate you for the time it takes you to complete each survey, you will receive an iTunes or Amazon gift card. Please note that if you do not complete each survey, you will not receive the gift card thank-you for that survey. Here is a list of when you will be asked to take each survey and the amount you will receive for completing each survey honestly:

Questionnaire	Amount of Gift Card
Initial Survey	$20
1 week after your quit date	$15
6 weeks your quit date	$15
12 weeks after the end of the program	$20
24 weeks after the end of program	$30

As part of this study, we will ask you to provide contact information such as a cell phone number that can send and receive text messages and where we can call you if necessary, an alternate phone number, and your email address.

Taking part in this study is up to you. You may decide to stop at any time and you do not have to give a reason for stopping. Choosing not to be in the study or leaving the study once you start will not affect your right to use any of the resources of the National Cancer Institute in the future.

To opt out of the tobacco cessation program but still remain in the evaluation study, simply text “STOP” to stop receiving text messages from the program. You will still be considered a study participant and have the opportunity to complete a total of five questionnaires. If you wish to discontinue participation in both the program and evaluation study, you can call [project number] or email [project email account] to leave the study completely.

Benefits:

There is no guarantee of a direct benefit to you for being in this evaluation. However, you will be exposed to resources designed to help you quit smoking. You may find the tobacco cessation program helpful in your attempt to quit smoking. What we learn from the study will help us to improve the tobacco cessation program for others trying to quit smoking.

Risks:

There are no known significant medical risks to quitting smoking, but some people experience withdrawal symptoms including; nicotine cravings, anger, frustration, irritability, anxiety, depression, and weight gain. However, if you experience problems during the study, you should contact your primary medical provider or our study information line listed at the end of this form. Costs associated with additional medical care would be your responsibility.

There is a chance that you may feel discomfort about some of the questions we ask. You can always choose not to answer any question you wish and can end your participation at any time.

Please keep in mind that if other people have access to your phone, they may see the text messages you receive. In order to ensure your privacy of the text messages you receive, we suggest you take the following steps:

1. do not share your phone with others, and

2. password protect your mobile device.

We do not know of any other risks related to taking part in this study. If you decide you no longer want to participate in the surveys, we will send you information on how you can still receive smoking cessation tools made available to you during the study.

Privacy:

Your responses will be kept private to the extent allowable by law and will only be used for the purpose of this research. Many precautions have been taken to protect your information. Identifiable information such as address and phone numbers will be kept separate from your responses and will not be included in any reports, publications, or presentations. For the purpose of data collection, we will replace your contact information with a unique number. Only the core research group will have access to your contact information, and we will not share your contact information with anyone outside this group. The findings from this study will be reported in summary form so that the participants cannot be identified. However, there is still a small risk that your privacy could be compromised.

Token of Appreciation:

After each survey, we will give you an iTunes or Amazon gift card as a thank-you for your time. You be asked to select your preference (iTunes or Amazon gift card) at the beginning of the study. The amount of the gift card will vary depending on which questionnaire you are answering (see table under Procedures section). After you complete each survey, you will be able to claim the gift card right away. You will also receive an email with the same link to claim your gift card, in case you prefer to claim it at a later time. It is important that you check email regularly to access the surveys and receive your thank-you gifts.

Terms and Conditions

Please click here to view the Terms of Service. [insert link to page for Terms of Service]

Persons to Contact:

If you have questions about the interview, you can call Dr. Linda Squiers at [project phone number TBD]. She can be reached between 9 AM and 5 PM Eastern Standard Time Monday - Friday. If you have questions about your rights as a participant, you can call RTI’s Office of Research Protection toll-free at 1-866-214-2043.

Your Consent:

I have read this entire consent form. I had a chance to ask questions and my questions were answered. I agree to participate in this study.

I agree to participate in this study

I do not agree to participate in this study [terminate]

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