CONSENT FOR PARTICIPATION IN A RESEARCH PROJECT
200 FR. 1 (2014-4) YALE UNIVERSITY SCHOOL OF MEDICINE
Study Title: An Examination of Body Image following Body Contouring Surgery among Post-Bariatric Surgery Patients
Principal Investigator: Valentina Ivezaj, Ph.D. (valentina.ivezaj@yale.edu)
Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Online Participants
Invitation to Participate and Description of Project
You are invited to participate in a research study designed to examine body image, eating behaviors, mood, and quality of life following bariatric surgery and body contouring (plastic) surgery. You have been asked to participate because you are an adult 18 years of age or older, and had bariatric surgery and then had body contouring surgery to remove loose skin within the past five years. We know that many changes take place after bariatric surgery, but we do not know the nature of those changes following body contouring surgery among bariatric surgery patients. We expect up to 400 individuals who have had bariatric surgery and subsequent body contouring surgery to participate in this study.
Description of Procedures
If you agree to participate in this study, you will be asked to complete online surveys once. This is expected to take 30-60 minutes. These surveys will ask you questions about your experiences after bariatric surgery and body contouring surgery. Questions will be about health, mood, body image, pain, substance use, and attitudes about eating and weight.
Risks and Inconveniences
There is the possibility that some of the questions during the interviews or in the questionnaires may make you mildly uncomfortable. You may choose to skip any question by selecting the “I choose not to respond” option.
Benefits
There may be no direct benefit to you from your participation in this study. It is anticipated that some of the knowledge obtained in this study can be used to improve the health and quality of life of individuals who have had bariatric surgery and body contouring surgery.
Economic Considerations
Upon completion of this survey, you will be included in a raffle to receive a $50 electronic gift certificate to Amazon.com. Your chances of winning the certificate are 1 in 20. At the end of the survey, you will have the option to redirect to a second (unlinked) survey and submit an email address to be included in the raffle. Your email address will not be traceable to your survey responses in any way. If you win the raffle, a $50 gift certificate from Amazon.com will be sent to the email address you provide.
Confidentiality
No identifying information will be provided by participants on this survey. Therefore, all information collected will remain anonymous and confidential. You will have the option to skip any items you wish on the surveys. You can choose to provide an email address for a chance to win a $50 electronic Amazon gift card. Your email will not be traceable to the answers you provide on the surveys.
When the results of the research are published or discussed in conferences, no information will be included that would reveal your identity.
Representatives from the Yale Human Research Protection Program, the Yale Human Investigation Committee (the committee that reviews, approves, and monitors research on human subjects) may inspect the study.
Voluntary Participation and Withdrawal
Participating in this study is voluntary. You are free to choose not to take part in this study. Refusing to participate will involve no penalty or loss of benefits to which you are otherwise entitled (such as your health care outside the study, the payment for your health care, and your health care benefits). You are free to stop and withdraw from this study at any time during its course.
You do not give up any of your legal rights by agreeing to participate in this study.
Questions
We have used some technical terms in this form. Please feel free to ask the principal investigator [Valentina Ivezaj, Ph.D. (valentina.ivezaj@yale.edu)] about anything you don't understand and to consider this research and the consent form carefully – as long as you feel is necessary – before you make a decision.
APPROVED BY THE YALE UNIVERSITY HIC ON 16 MARCH 2015
Approved - Valid through 16-MAR-2016
HIC#: 1501015172