Att 7 - Consent for Follow-up

Follow-up Data Collection Consent Form

Consent to Participate in Research

Cessation Study Oral Informed Consent (phone)

Title of Research: Comparing the Effectiveness of Traditional Evidence-Based Tobacco Cessation

Interventions to Newer and Innovative Interventions Used by Comprehensive Cancer Control Programs

RTI Project No. 0211965.014

Project Director: Jennifer Duke, PhD

Interviewer Name: [INSERT INTERVIEWER’S NAME]

Introduction

Hello. This is [Insert Interviewer’s Name] calling from RTI International, may I speak with [Participant’s Name]?

Approximately seven months ago, you completed an intake survey when you registered for the [insert Quitline/Web-based] smoking cessation program in the state of [insert state name]. At that time, you gave permission for RTI to contact you to conduct a brief follow-up survey.

May we do that now?

 No (when would be a better time for me to call you? ______________________)

 Yes (read below)

Great! Thank you for taking the time to speak with me today. Before you decide if you want to take part in this study, I will read to you a brief Informed Consent form so that you understand what the study is about and what you will be asked to do. This form also tells you the risks and benefits of the study and how we will protect your information, and who you can call if you have questions.

Purpose

The “Cessation” study is a research study paid for by the Centers for Disease Control and Prevention (CDC); and is being conducted by RTI International, a research organization located in Research Triangle Park, North Carolina. The purpose of this study is to learn more about your overall experiences with using your state’s cessation program, including the type(s) of services used and to what extent these services have influenced your decision to quit smoking [quit tobacco use]. You are one of approximately 2,000 users of the smoking cessation programs in [insert state name] being asked to participate in this study.

Procedures

If you agree to participate, I will ask you some questions about your use of the [insert Quitline/Web-based] services, how satisfied you are with the services you’ve received through the programand your efforts to stop smoking [tobacco use] since registering for services. It is important that you know that your participation is entirely voluntary. You may decide not to take part in or quit the survey at any time without penalty.

The survey should last about 15-20 minutes and we will respect your commitment of time. There are no right or wrong answers – we just want to know about your experiences with using the Quitline in your state. You can refuse to answer any questions you do not want to answer. Your participation in this study is voluntary, and you may stop at any time. There will be no negative consequences if you choose to stop or if you choose not to participate at all.

Confidentiality

Your answers will be kept private. Your name will not be stored with your responses to the survey nor will it be used in any reports or publications from this study. All survey data will be treated in a secure manner and will not be disclosed, unless otherwise compelled by law. The Institutional Review Board (IRB) at RTI International has reviewed this research. An IRB is a group of people who are responsible for assuring that the rights of participants in research are protected. The IRB may review the records of your participation in this research to assure that proper procedures were followed. A representative of the IRB may contact you for information about your experience with this research. This representative will be given your name, but will not be given any of your study data. If you wish, you may refuse to answer any questions this person may ask. Additionally, all RTI team members have signed a non-disclosure agreement ensuring that they will not discuss any data collected outside of the project team.

Potential Risks or Discomforts

There will be no risk or discomfort to you in providing responses to the questions asked in this survey, however should you feel uncomfortable in providing a response to a specific question, you may skip that question.

Benefits

Your participation will benefit the smoking cessation programs in [insert state name] and other tobacco users by providing useful information on the effectiveness of the assistance that was provided to you. To compensate you for your time, you will be given $40 for your participation in this study.

Participant Rights

If you have any questions about your rights as a study participant, you can call Dr. Jennifer Duke toll-free at 1-866-RTI-1958 then extension x2-2669 or you can call RTI's Office of Research Protection at (919) 316-3358 in Durham, NC or 1-866-214-2043 (a toll-free number).

Do you have any questions?

Do you consent to participate in this study?

 No (We thank you for your time. Have a good evening!)

 Yes (Good, thank you! ) Interviewer to proceed with survey.

Cessation Study informed consent (online)

Introduction

Approximately seven months ago, you completed an intake survey when you registered for the [insert Quitline/Web-based] smoking cessation program] in the state of [insert state name]. At that time, you gave permission for RTI to contact you to conduct a brief follow-up survey.

Before you decide if you want to take part in this study, please read a brief Informed Consent form (below) so that you understand what the study is about and what you will be asked to do. This form also tells you the risks and benefits of the study and how we will protect your information, and who you can call if you have questions.

Purpose

The “Cessation” study is a research study paid for by the Centers for Disease Control and Prevention (CDC); and is being conducted by RTI International, a research organization located in Research Triangle Park, North Carolina. The purpose of this study is to learn more about your overall experiences with using the [insert quitline/website] smoking cessation program, including the type(s) of services used and to what extent these services have influenced your decision to quit smoking [quit tobacco use]. You are one of approximately 2,000 users of the quit smoking services in [insert state name] being asked to participate in this study.

Procedures

If you agree to participate, you will be asked some questions about your use of the [insert Quitline/Web-based] services, how satisfied you are with the services you’ve received through the program and your efforts to stop smoking [tobacco use] since registering for services. It is important that you know that your participation is entirely voluntary. You may decide not to take part in or quit the survey at any time without penalty.

The survey should last about 15-20 minutes and your time commitment is respected. There are no right or wrong answers. You can refuse to answer any questions you do not want to answer. Your participation in this study is voluntary, and you may stop at any time. There will be no negative consequences for choosing to stop, or choosing not to participate.

Confidentiality

Your answers will be kept private. Your name will not be stored with your responses to the surveynor will it be used in any reports or publications from this study. All survey data will be treated in a secure manner and will not be disclosed, unless otherwise compelled by law. The Institutional Review Board (IRB) at RTI International has reviewed this research. An IRB is a group of people who are responsible for assuring that the rights of participants in research are protected. The IRB may review the records of your participation in this research to assure that proper procedures were followed. A representative of the IRB may contact you for information about your experience with this research. This representative will be given your name, but will not be given any of your study data. If you wish, you may refuse to answer any questions this person may ask. Additionally, all RTI team members have signed a non-disclosure agreement ensuring that they will not discuss any data collected outside of the project team.

Potential Risks or Discomforts

There will be no risk or discomfort to you in providing responses to the questions asked in this survey, however should you feel uncomfortable in providing a response to a specific question, you may skip that question.

Benefits

Your participation will benefit the smoking cessation programs in [insert state name] and other tobacco users by providing useful information on the effectiveness of the assistance that was provided to you. To compensate you for your time, you will be given $40 for your participation in this study.

Participant Rights

If you have any questions about your rights as a study participant, you can call Dr. Jennifer Duke toll-free at 1-866-RTI-1958 then extension x2-2669 or you can call RTI's Office of Research Protection at (919) 316-3358 in Durham, NC or 1-866-214-2043 (a toll-free number).

Do you consent to participate in this study?

 No (Display message: We thank you for your time. Have a good day!)

 Yes (Display message: Good, thank you! Please click “Continue” to begin the survey.)

Consent Version: [insert version date] page 5 of 5

RTI IRB ID: [TBD]

RTI IRB Approval Date: [TBD]