What will I contribute?
Participants in Mayo Clinic's IBD Biobank Study contribute to a large collection of medical information and biological samples, known as a biobank.
How will I benefit from participating?
You won't benefit directly from taking part in the IBD Biobank Study, but your contribution will support current and future research. Other patients with inflammatory bowel disease (IBD) or gastrointestinal conditions may benefit in the future from what investigators learn in this research study.
Your samples and medical information will be stored at Mayo Clinic in the IBD Biobank for future research. Mayo Clinic may collaborate with other institutions using your data and samples.
In the future, investigators from Mayo Clinic or other organizations may request to access data or samples for research purposes or commercial use. This may include studies examining your DNA, the genetic information you inherited from your parents. No personal information, such as your name or other identifying details, will be shared with external parties.
The conduct of future research will be guided by a separate research protocol that will be submitted to, reviewed and approved by Mayo Clinic's institutional review board.
Can I participate?
You may be able to participate in the IBD Biobank Study if you are:
- 18 years old or older. You can participate if you are under 18 years old, but you need to enroll in person, not via the electronic form on this website. A member of the study team can meet you on Mayo Clinic's campus in Rochester, Minnesota, to sign you up. Contact the study team to arrange a meeting.
- A registered Mayo Clinic patient. If you would like to participate but are not yet registered as a Mayo Clinic patient, the study team can help you register. Contact the team for assistance.
- You have been diagnosed with a gastrointestinal disease or condition. This includes, but is not limited to, IBD, Crohn's disease, ulcerative colitis, and indeterminate colitis or unclassified IBD.
- You have not been diagnosed with a gastrointestinal disease or condition. Patients without IBD or other gastrointestinal conditions are valuable to the research as a comparison group. Being able to make comparisons with healthy people helps investigators further identify potential causes of gastrointestinal diseases and conditions.
What to expect
If you join the IBD Biobank Study, participation can be at your convenience. The study team will work to obtain clinical information and research samples at the time of already scheduled office visits and tests. There will be no additional cost to you for the procedures to take any samples for the study.
The IBD Biobank Study may collect information from you in these ways:
- The study team will ask you to fill out a questionnaire to collect information about your medical history, medications, symptoms and other topics.
- The study team may call or mail you additional questionnaires to update its clinical information, but will not do so more than once a year.
The IBD Biobank Study may collect one or more of the following samples from you:
- Blood sample
- Stool sample
- Urine sample
- Tissue sample (at the time of a colonoscopy for your regular care)
- Tissue sample (as the time of bowel surgery as part of your regular care)
You can stop participating at any time.
You will not receive study results. No study results will become part of your electronic health record.
Future genetic results
Some future studies may use genetic testing to examine your DNA, the genetic information you inherited from your parents. If there are findings that may be useful for your health care, the researchers may contact Mayo Clinic so Mayo Clinic can give you the option of learning the results. If this happens, you will be given information on the potential risks, benefits and costs of choosing to learn about the findings.
Please visit the IBD Biobank Study's Resources page to learn more before deciding to take part in this research study.
You won't need to pay for tests and procedures that are done just for this research study. These tests and procedures are:
- Blood draws in addition to those needed for your regular care
- Stool collections in addition to those needed for your regular care
- Urine collection
- Research biopsies in addition to those needed for your regular care
However, you or your insurance will need to pay for all other tests and procedures that you would have as part of your regular care, including copayments and deductibles. These tests and procedures are:
- Blood draws ordered by your regular doctor
- Stool collections ordered by your regular doctor
- Surgery, colonoscopy or any other procedures your doctor may order
Giving informed consent to participate in Mayo Clinic's IBD Biobank Study includes being aware of the following risks:
- Confidentiality. As with all research, there is a chance that the confidentiality of your medical information could be compromised. However, the IBD Biobank Study team takes your privacy seriously and takes precautions to decrease this risk.
- Blood draw. The risks of drawing blood include pain, bruising, lightheadedness and fainting. Rarely, infection at the site of the blood draw can occur.
- Biopsies of the intestine. Biopsies may be obtained during endoscopy procedures. Bleeding can occur from biopsies, but it is usually minimal and stops quickly or can be controlled. Major bleeding episodes that require blood transfusions or hospitalization are extremely rare.
- Colonoscopy. There may be risks associated with performing a colonoscopy. Your doctor will discuss these risks, as colonoscopies are part of standard clinical care.
- Genetic testing. The risks of learning genetic test results may include emotional upset or insurance or job discrimination.
Genetic Information Nondiscrimination Act (GINA)
A federal law called the Genetic Information Nondiscrimination Act (GINA) makes it illegal for health insurance companies, group health plans and most employers to discriminate against you based on your genetic information. More information can be found on the GINA website or on the IBD Biobank study's Resources page.