Frequently Asked Questions
How long does the study last?
The study is set to in end around the year 2035. Your involvement in the study will last no longer than the time required to complete the questionnaire and a scheduled colonoscopy. Participants can be approached at any future scheduled colonoscopy to provide additional samples for the study. There are no additional study related activities after your questionnaire and colonoscopy. If you would like to participate in future studies, you can indicate this in your consent form. Future contact is not necessary to participate in this study.
What happens if I decide not to take part in the study?
Participation in the study is voluntary. You do not need to take part in order to receive care at the University of Pennsylvania. Your current and future care will not be affected if you decide not to participate.
Can I only fill out the questionnaire without giving the biopsies and blood?
Yes, as every component of the study is voluntary. There are two parts to the study: one which is the questionnaire, and two which is the additional blood and tissue samples during your routine colonoscopy. The questionnaire can be completed while you wait to be taken back for the procedure, and you can choose to only complete the questionnaire and opt-out of the additional biopsies.
Can I withdraw my consent at anytime?
Yes, you can withdraw your consent at anytime, as long as you let one of the I3 team members know. The best person to contact in this situation would be the Clinical Research Coordinator. In addition, during the day of your scheduled colonoscopy, if you chose to provide additional blood and tissue biopsies, one of the I3 team members will approach you to confirm your study involvement. At that point you can provide the additional research samples or change your mind.
Will I be paid?
No payment will be given to volunteers of this study. However, there may be compensation for associated studies, for more information, please visit our "Associated Studies" page.
Will I have to pay more for the study?
No, all the costs for the additional biopsies and the one vial of blood is taken care by the I3 team.
How will my records and data be kept safe?
The I3 study uses a patient de-identification system in which all the answers of a questionnaire is associated with a number rather than a name. Your data will only be recognized by a number, so all patient information is confidential.
What will be done to my samples?
Your samples will be put into a de-identified biobank, which means that the samples will not be able to be traced back to you by name. The samples will then be analyzed and compared to draw conclusions on inflammatory bowel disease. Different allergens will be tested on the samples to see how they react.
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