INFORMED CONSENT 

Purpose

This course helps you learn about weight loss and exercise through Continuous Quality Improvement.  You are asked to apply the principles of continuous quality improvement to improve yourself.   

Eligibility

You must meet the following eligibility requirements to participate:

• You must choose for yourself what you want to do (lose weight, exercise more, etc.). 

• You must be more than 18 years old.

• You must be in good health.

• You must be taking a course in which the principles of Continuous Self Improvement is taught.

What are you agreeing to do?

 Your instructor is asking you to: 

• Select a habit that you want to change.
• Identifying process owners that can help you with the change.
• Examine with your process owners how daily routines affect the habit.
• Brainstorm with your process owners how to change your habit by modifying your environment.
• Implement a number of changes
• Monitor your success. Plot your success in a control chart
• Share your data (storyboard) with  process owners and the instructor.
• If you choose and if you remove your name and image from the storyboard, you may share your storyboard with others in class.
• Complete an exit interview evaluating the success of the effort.  No personal identifying information are requested in the Exit interview.     

In addition, keep the following in mind:

• Your grade does not depend on your success in bringing about the change in your habit. 
• Your self-improvement will be evaluated based on the process you used to bring about the change and not based on the outcomes you achieved.
• You do not have to do this project.  If you do not wish to learn about quality improvement through a personal project, you can select to work on other projects. 

Risks you face

You may face several risks by participating in this course: 

• Sudden changes in a personal habit, e.g. exercising, may put you at additional health risks.  Consult your doctor before you deciding to engage in strenuous exercise or sudden changes in your diet.  If you feel distressed about achieving your resolution, contact your primary clinician, or the resources described at the following site:  http://www.gmu.edu/departments/csdc/eat/resources.htm. 
• Success is not guaranteed.  You may not succeed in brining about changes you want to accomplish.  You may be disappointed.  Keep in mind that habits are difficult to change.  Any relapse to old habits is a new learning opportunity.  You can investigate what caused the relapse and take steps to reduce the frequency of relapse. 
• You may feel uncomfortable in sharing your personal habits with others in class.  You do not need to do so.  While sharing with other students provides additional learning opportunities, it is not required. 
• Your instructor is not a counselor or a clinician.  He is not providing you with medical or mental health advice.  If you need medical advice or mental health counseling, seek information from your health care professional and not from your instructor. 
• We collect information about you through the web.  No computer transmission can be perfectly secure.  We are asking you to take reasonable efforts to protect the confidentiality of your transmissions.  In particular, we ask that you do not provide your name or identity or student ID number in any of the survey responses.  Instead, your instructor will provide you with a code that you can use in responding to online surveys.   
• We post the story of your improvement on the web so that other students could learn from your experience.  To reduce the possibility of releasing your identity to others, we ask that you do not provide your name, image or any identifying information on any storyboards or material you supply to the instructor.  If you do not wish to post your storyboard on the web, please indicate your preference to your instructor by writing on the material you provide to the instructor.
• YOU SHOULD NOT USE THE COURSE OR THE INSTRUCTOR FOR AN EMERGENCY.  All communications to the instructor are delayed and are not received at the time sent.  In case of an emergency, you should go to the emergency room or call 911.

Voluntary nature of participation

Your participation is voluntary and you may withdraw from the personal project at any time and for any reason.  There is no penalty for not participating or withdrawing.  If you choose to withdraw, in order to meet the requirements of the course you may need to provide an alternative project in which system change is used to bring about behavior change in others. 

Data disposition

You will be asked to respond to an online survey as well as to provide a storyboard about your improvement effort.  No personal identifying information should be on either document.  The information provided by you will be maintained on the web for at least 3 years.   The only document that will contain your personal identity is this informed consent.  This informed consent will not be linked to your reports of personal improvement.  The written consent will be maintained under lock at Dr. Alemi’s office and will be destroyed within a month after you complete your course.

Benefits

The personal benefits for participation include:

• A better understanding of your habits and the process of changing the habit.   

• A hands-on experience of process improvement (Continuous Quality Improvement).

There are no costs to you nor will you receive money for your participation in this project.    Except for the benefits listed above, there are no other benefits for participating in the study. 

Who is conducting the study?

Farrokh Alemi Ph.D. at George Mason University is conducting this study.  He may be reached at 703-993 4226 for questions or complaints.  You may also contact the George Mason University Office of Sponsored Programs at 703-993-2295 if you have any questions or comments regarding your participation in this research. 

SIGNATURE

I have read this entire form, or it has been read to me, and I understand it completely.  All of my questions regarding this form or this study have been answered to my complete satisfaction.  I agree to participate in this study.

Where to Send Signed Consent?

Please print and sign this consent form.  Send the signed consent to your instructor.   

This page is part of the course on Quality/Process Improvement the lecture on Personal Improvement.  This document was last revised on 01/19/2021 by Farrokh Alemi, Ph.D.  Approval for the use of this document expires on Jun 22^nd 2005 protocol 3606 of George Mason University Institutional Review Board (IRB)