Consent to Participate in a Research Study
Title of Study: School-Related Seasonality in Pediatric Functional Abdominal Pain
Principal Investigator: Miranda van Tilburg, Ph.D.
UNC-Chapel Hill Department: Medicine, Division of Gastroenterology and Hepatology
Study Contact telephone number: 919 843 0688
Study Contact email: Tilburg@med.unc.edu
What are some general things you should know about research studies?
You and your child are being asked to take part in a research study. To join the study is voluntary. You and your child may refuse to join, or you may withdraw your consent to be in the study, for any reason, without penalty. Details about this study are discussed below. It is important that you and your child understand this information so that you and your child can make an informed choice about being in this research study.
What is the purpose of this study?
The purpose of this research study is to examine why some children complain more of stomachaches during the school year than in the summer.
How many people will take part in this study?
If you decide to be in this study, you will be one of approximately 200 parents in this research study. Since you will be asked to answer questionnaires about your child, your child will also be one of approximately 200 children in this research study.
What will happen if you take part in the study?
After reading this information sheet and discussing the study with your child, you will complete a brief online questionnaire to see if you and your child qualify for participation. If you do, you will be asked to complete another online questionnaire asking about your child's symptoms, anxiety, sleep, diet, exercise, stomach infections, as well as your usual ways of managing your child's symptoms. This will take about 15-30 minutes to complete. We will contact you again in the summer and ask you to complete the same online questionnaire one more time.
What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. You and your child may not benefit personally from being in this research study.
What are the possible risks or discomforts involved from being in this study?
We anticipate few risks in this study. At most, you may feel a little uncomfortable answering some of the questions. Breach of confidentiality is a risk, but will be minized by the privacy protection described below.
How will your privacy be protected?
All of the data you provide will be stored anonymously and securely. This means that there will be no way for anybody to ever link your data or the results of the study to your identity.
What if you want to stop before your part in the study is complete?
You can withdraw from this study at any time, without penalty and skip any question for any reason. The investigators also have the right to stop your participation if you have failed to follow instructions, or because the entire study has been stopped. We will notify you if you have been withdrawn.
Will you receive anything for being in this study? Will it cost anything?
You will be entered into a drawing for a $25 gift card after you've completed the first questionnaire, and entered, again, into a drawing for a $50 gift card after you've completed the second questionnaire. You have the option to opt out of these drawings if you wish. There are no costs associated with being in the study.
What if you have questions about this study?
You and your child have the right to ask, and have answered, any questions you and your child may have about this research. Contact the principal investigator listed above with any questions, complaints, or concerns you may have.
What if you have questions about your rights as a research participant?
All research on human volunteers is reviewed by a committee that works to protect your rights and welfare. If you have questions or concerns, or if you would like to obtain information or offer input, please contact the Institutional Review Board at 919-966-3113 or by email to IRB_subjects@unc.edu.