1. Informed Consent for Participation

Title of Study: A Qualitative Analysis of Episodes of Irritable Bowel Syndrome.
Principal Investigator: Stephan R. Weinland, Ph.D.
UNC-Chapel Hill Department: Program in Digestive Health
UNC-Chapel Hill Phone number: 966-0141
Email Address: stephan_weinland@med.unc.edu
Funding Source: Investigator Sponsored Study
Study Contact telephone number: 843-4422
Study Contact email: mhoupe@med.unc.edu

What are some general things you should know about research studies?
You are being asked to take part in a research study. To join the study is voluntary.
You may refuse to join, or you may withdraw your consent to be in the study, for any reason.
Deciding not to be in the study or leaving the study before it is done will not affect your relationship with the researcher, your health care provider, or the University of North Carolina-Chapel Hill.

What is the purpose of this study?
The purpose of this research study is to examine qualitative reports of episodes of IBS. We are compiling written reports of episodes in order to gain a better understanding of how patient symptoms change over the course of an episode and whether or not there are patterns in symptom experience. You are being asked to be in the study because you have been diagnosed with Irritable Bowel Syndrome (IBS).

How many people will take part in this study?
As this is an online study, we are unsure of how many participants we will obtain. However, we are hoping to keep data collection open until at least 100 participants have filled out the survey.

How long will your part in this study last?
This will be a one time online survey that may take up to 90 minutes to complete.

What will happen if you take part in the study?
If you agree to take part in this study, you will continue with this online survey and answer questions to the best of your ability. If at any time you wish to terminate participation, simply close your web browser and your responses will be terminated.

What are the possible risks or discomforts involved with being in this study?
The only known risks of participating in this study include minimal psychosocial embarrassment that might accompany writing about or describing your symptoms of IBS. No other significant risks are believed to accompany this protocol.

How will your privacy be protected?
No subjects will be identified in any report or publication about this study. All responses will be kept anonymous, no personal health information will be collected, and no one will have the ability to link any of your answers to you as an individual.

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.

Will you receive anything for being in this study?
There will be no financial compensation or remuneration for participating in this study.

Who is sponsoring this study?
This study has been initiated by Stephan R. Weinland, Ph.D. and Dr. Douglas A. Drossman.

What if you have questions about this study?
You have the right to ask, and have answered, any questions you may have about this research. If you have questions, or if a research-related injury occurs, you should contact the researchers listed on the first page of this form.

What if you have questions about your rights as a research subject?
All research on human volunteers is reviewed by a committee that works to protect your rights and welfare. If you have questions/concerns about your rights as a research subject you may contact the Institutional Review Board at 919-966-3113 or by email to IRB_subjects@unc.edu.

Subject’s Agreement:
I have read the information provided above. I voluntarily agree to participate in this study.

* 1. Do you consent to participate in this study?

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