INFORMED CONSENT AUTHORIZATION TO PARTICIPATE IN A RESEARCH PROJECT

INFORMED CONSENT AUTHORIZATION TO PARTICIPATE IN A RESEARCH PROJECT

TITLE: The Effect of Web-Based Support as an Adjunct to a Self-Help Smoking Cessation Program

Investigators: Jerry McGill, PhD & Jennifer Johs-Artisensi, MPH

Institutions: University of North Texas & University of North Texas Health Science Center

Subject Name: ____________________________________________ Date: __________

Before agreeing to participate in this research study, it is important that you read and understand the following explanation of the proposed procedures. It describes the procedures, benefits, risks, and discomforts of the study. It also describes alternatives that are available to you and your right to withdraw from the study at any time. It is important for you to understand that no guarantees or assurances can be made as to the results of the study.

I. PURPOSE OF THE STUDY AND HOW LONG IT WILL LAST

This purpose of this study is to investigate the effects of adding web-based support to a self-help smoking cessation program. Your smoking status, your rate of smoking, your dependence on nicotine, your readiness to quit smoking, and possibly your usage of the web-based materials will be measured via a short series of questionnaires. Once enrolled, you will be considered a participant in the study for approximately 12 weeks.

II. DESCRIPTION OF THE STUDY INCLUDING THE PROCEDURES TO BE USED

At the initial “kick-off” meeting the study will be explained, and if you meet the criteria, informed consent will be obtained, baseline data will be collected, and you will be assigned randomly (like the flip of a coin) to the web-based support group or the self-help only group. The baseline questionnaires will include questions intended to measure smoking history, nicotine dependency, and how ready you are to quit smoking at enrollment.

You will receive the Public Health Department’s “You Can Quit Smoking” cessation materials designed to guide smokers from the “Contemplation” stage of thinking about stopping smoking all the way to the “Maintenance” phase of staying away from cigarettes for good. It includes information about how to avoid temptation, what to do if you relapse or slip-up, and even how to avoid unwanted weight gain. It will inform you about what to expect as you go through the quitting process in an effort to help you through the day-to-day process of becoming a non-smoker.

If you are assigned to the web-based support group you will receive additional information about how to access the web-based support tools, including a username and password that you will use to access the site. This will ensure that only members of this group have access to the site and will help to maintain the confidentiality of the group. On the website you will have access to a variety of supportive information and tools. A copy of the “You Can Quit Smoking” materials will be posted. There will be access to downloadable “quit meters” that can be used to help you stay motivated so you will be able to see a current tally of your successes to date. Bulletin boards and a chat room will be available so you may communicate with other participants in a group forum to ask for and give support and advice. Based on participants’ postings, a Frequently Asked Questions page will be created and maintained. There will also be links to other websites that may have useful information for you as you work towards maintenance of your cessation.

The activity on the bulletin board and chat rooms will be moderated by the investigator. Although no “therapy” will be provided, the investigator will respond to postings when appropriate and may occasionally provide advice or encouragement to the individuals using the website.

Short follow-up questionnaires will be used to collect data from you via e-mail one week, four weeks, and twelve weeks after your attendance at a kick-off meeting. If you do not respond within one week, the questionnaire will be re-e-mailed to you, and if you still do not respond by two weeks after the initial contact, you will be contacted and interviewed by phone.

III. DESCRIPTION OF PROCEDURES/ELEMENTS THAT MAY RESULT IN DISCOMFORT OR INCONVENIENCE:

The primary focus of this study is to evaluate the effectiveness of self-help smoking cessation tools, and thus you are encouraged to quit smoking and remain smoke-free. There are several well-documented symptoms that are associated with smoking cessation, including: cravings for tobacco, irritability, anxiety, insomnia, lightheadedness, restlessness, increased appetite, and constipation. Anyone who attempts to quit smoking is at risk for developing these symptoms during the nicotine withdrawal period, including the participants of the study.

IV. DESCRIPTION OF THE PROCEDURES/ELEMENTS THAT ARE ASSOCIATED WITH FORESEEABLE RISKS:

Because this study is merely providing you with information to assist you through the process of smoking cessation and subsequently asking you questions regarding your smoking outcomes and experience with the provided materials, there is minimal to no risk to participating in it.

V. BENEFITS TO THE SUBJECTS OR OTHERS

The investigators do not guarantee that you will benefit from the study. It is not known whether you will be successful at quitting smoking, although it is hoped that this will occur. You will receive self-help materials to assist you in quitting smoking, which could lead to significant improvements in short and long term health. In addition, by participating in this study, you will be contributing essential scientific information in the field of smoking cessation. The information gained from this study will be used to understand how to better serve the millions of individuals who could benefit from an improved self-help program to assist them in quitting smoking.

VI. ALTERNATIVE TREATMENTS

There are other smoking cessation treatment methods available (e.g. aversion therapy, stimulus control, self-management, cognitive controls, hypnosis, etc.), should you choose not to participate in this study. You may discuss alternative methods with your primary health care provider.

VII. CONFIDENTIALITY OF RESEARCH RECORDS

You have a right to privacy, and all information obtained in connection with this study that can be identified with you will remain confidential as far as possible within state and federal law. Everything the investigator learns about you in this study will be confidential. The results of this study may be published in a scientific book or journal, but you won't be identified in any way. If the data is used for teaching purposes, no names will be used, and other identifiers, such as photographs, audio or video tapes, will be used only with your special written permission. You will be given a copy of the original consent form you have signed to keep for your records. Records kept regarding your participation in the study may be reviewed by members of the Institutional Review Board (IRB) and by federal regulatory personnel.

VIII. COMPENSATION FOR INJURY

The investigators will make every effort to prevent physical injury that could result from this research. Compensation is not available from the researchers as part of the research protocol, or from the University of North Texas or the University of North Texas Health Science Center. By signing this form you have not waived any of the legal rights to which you otherwise would have as a participant in a research study. Continuing medical care and/or hospitalization will not be provided free of charge to you. Neither the University of North Texas nor the University of North Texas Health Science Center at Fort Worth assume responsibility for your participation in this study.

IX. REVIEW FOR PROTECTION OF PARTICIPANTS:

This research study has been reviewed and approved by the UNT Committee for the Protection of Human Subjects (940) 565-3940 and the UNTHSC Institutional Review Board for the Protection of Human Subjects (817) 735-5483.

RESEARCH SUBJECTS’ RIGHTS: I have read or have had read to me all of the above.

Jennifer Johs-Artisensi, MPH has explained the study to me and answered all of my questions. I have been told the risks or discomforts and possible benefits of the study. I have been told of other choices of treatment available to me.

I understand that I do not have to take part in this study, and my refusal to participate will involve no penalty or loss of rights to which I am entitled. I may withdraw at any time without penalty or loss of benefits to which I am entitled. The study personnel can stop my participation at any time if it appears to be harmful to me, if I fail to follow directions for participation in the study, if it is discovered that I do not meet the study requirements, or if the study is cancelled.

If a study related problem should occur, or if I have any questions about the study, I understand I may contact Jennifer Johs-Artisensi, MPH at 940-565-2671 or Dr. Jerry McGill at 817-735-2235. If I have any questions about my rights as a participant in this study I may also contact Dr. Robert Gracy, Vice President for Research, UNTHSC at 817-735-5483 for more information.

I understand my rights as a research subject, and I voluntarily consent to participate in this study. I understand what the study is about and how and why it is being done. I will receive a signed copy of this consent form.

___________________________________________ ____________________

Participant’s Signature Date

___________________________________________ ____________________

Printed Name of Participant Date

For the Investigator or Designee:

I certify that I have reviewed the contents of this form with the person signing above, who, in my opinion, understood the explanation. I have explained the known benefits and risks of the research.

___________________________________________ ___________________

Jennifer Johs-Artisensi, MPH Date