Frequently Asked Questions

Find answers to frequently asked questions about Mayo Clinic's IBD Biobank Study, including information on:

• General information and participation
• Results
• Data privacy, insurance and discrimination

General information and participation

What is the purpose of the IBD Biobank Study?

The goal of the study is to help researchers at Mayo Clinic better understand the causes of inflammatory bowel disease (IBD) and other gastrointestinal conditions so they can work to develop new diagnostic tools and treatments.

Researchers can request to use samples and information from the study to investigate how different genetic traits and environmental factors, such as bacteria, influence the inflammatory process in IBD and other gastrointestinal conditions.

How many people are participating in the IBD Biobank?

The IBD Biobank Study team plans to enroll approximately 4,000 participants at Mayo Clinic's campuses in Phoenix/Scottsdale, Arizona; Jacksonville, Florida; and Rochester, Minnesota.

What are the inclusion criteria for this study?

Inclusion criteria are listed on the Participation page.

What are the exclusion criteria for the study?

Exclusion criteria are listed on the Participation page.

Can I choose to stop participating in this study?

You may choose to leave the IBD Biobank Study at any time by contacting the study team.

Who is funding the IBD Biobank Study?

Funding is provided by Mayo Clinic.

Can any Mayo Clinic patient volunteer to join the IBD Biobank Study?

Yes. Please contact the study team if you are interested in participating and unsure if you qualify. The study is enrolling patients with gastrointestinal conditions, healthy volunteers, adults and pediatric patients.

Healthy patients can contribute to the research by serving as a comparison group. This helps investigators further identify potential causes of gastrointestinal diseases and conditions.

Can children participate?

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. If you have an appointment at Mayo Clinic in Rochester, Minnesota, a member of the study team can meet you to sign you up. Contact the study team to arrange a meeting.

Results

What data or results will I receive?

You will not receive study results. No study results will become part of your electronic health record.

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.

What happens if future research using my genetic data finds additional health information that may impact my health?

You may be contacted by the study team conducting the research and given the option to learn these results. 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.

Will genetic results be entered into my electronic health record at Mayo Clinic?

No study results will become part of your electronic health record.

Data privacy, insurance and discrimination

Who will have access to my information as part of this study?

Mayo Clinic researchers will have access to your information and samples.

Researchers at Mayo Clinic who aren't involved with this study may ask to use your information, samples or both for future research. Researchers at other institutions may also ask for a part of your information, samples or both for future studies. The future research may be on any topic.

Your information and samples will only be shared with your consent and following all applicable laws and regulations.

Are there laws that protect the privacy of research participants?

Yes. Mayo Clinic adheres to federal privacy laws, and the IBD Biobank Study is overseen by an institutional review board whose job is to protect people participating in research.

Will my genetic data be used for other research at Mayo Clinic?

Yes. Your data and samples will be stored at Mayo Clinic. 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.

In addition, de-identified genetic data, with no names or other identifying information, may be used in a data registry for future research.

Can I request that my genetic data not be used?

Yes. You can contact the study team to request that the study stop using your data.

At your request, your information, samples or both will be removed from any biobank where they are stored, if possible. Information and samples that have already been distributed for use in research will not be retrieved.

How is my genetic data protected?

Mayo Clinic has dedicated teams that specialize in data security, encryption and storage.

Will my health insurance company have access to my results?

Genetic testing results are subject to access by health insurance companies in the same manner as other clinical information included in a person's health record. Therefore, health insurance companies may have access to participants' results if results are entered into the electronic health record. However, under the Genetic Information Nondiscrimination Act, it is illegal for health insurance companies to use genetic information to make decisions regarding eligibility or premiums.

Will Mayo Clinic share my genetic information with third parties?

Mayo Clinic and collaborators will only share your genetic information or other identified information with your consent. As part of the IBD Biobank Study, you will be asked to consent to allow your de-identified data to be securely shared with researchers at Mayo Clinic and approved researchers at other institutions.

For those who consent to this, no identifying information — such as your name, address, phone number or social security number — will be shared. The shared data will be guided by data transfer agreements that will be developed between Mayo Clinic and researchers from other institutions.

What is the Genetic Information Nondiscrimination Act (GINA)?

GINA is a federal law that protects some individuals from genetic information discrimination by health insurance companies and employers. GINA does not protect individuals from discrimination regarding life insurance, long-term care insurance or disability insurance. More information is available on the GINA website.

Biobanks and registries

What are biobanks and registries?

Biobanks are large collections of biological samples and medical information. Registries are libraries of medical information — often genetic information. A registry can be part of a biobank.

What is the purpose of biobanks and registries?

Biobanks and registries are meant to support future research for many years. By storing the information and samples of many people in one place, researchers save time because they can skip the step of finding new participants for each new project.

What are the benefits of having my data and samples in a biobank or registry?

The purpose is to benefit future generations by supporting research. The IBD Biobank is not intended to provide you with personal health information or other direct benefits.

Who can use the IBD Biobank?

Researchers from Mayo Clinic, researchers outside Mayo Clinic, and industry or private companies may request access to the biobank for new studies or commercial use. There are strict policies and procedures that must be followed to protect data privacy and use.

What are some examples of research being done with information and samples already collected in the IBD Biobank Study?

Examples of research so far include:

• Using epigenetics to improve understanding of Crohn's disease. "Epigenetics" refers to studying the chemical modifications of a cell's genetic material that can alter gene expression without changing the DNA sequence. Mayo Clinic gastroenterologist William A. Faubion, Jr., M.D., is leading a research team that uses genetic information, sequencing and analysis to identify epigenetic patterns associated with recurrent Crohn's disease.
• Predicting severity and progression of Crohn's disease. Researchers from Mayo Clinic's campuses in Arizona and Minnesota are working in collaboration with colleagues at Arizona State University to learn how certain molecules in blood ("biomarkers") can be used to predict how severe a patient's disease may be and whether and how fast it might progress. Biomarkers can also help researchers develop treatment approaches tailored to an individual patient's unique genetic or molecular makeup.

How long has the IBD Biobank existed?

The IBD Biobank Study was established in 2013 and involves researchers and resources at Mayo Clinic's campuses in Arizona, Florida and Minnesota. The study's goal is to advance research that might one day improve diagnosis, prognosis and treatment of IBD and other gastrointestinal diseases or conditions.

Could use of data in the genomic registry result in financial gain to Mayo Clinic or others (commercialization)?

Yes. Some examples of how the registry could be used for commercial purposes include:

• Charging a fee to researchers or private companies to cover the costs of sharing the data in the registry (for example, the cost of sending digital genetic information securely).
• Developing future agreements with outside groups or institutions to use IBD Biobank Study information.
• Discovering new medications, medical tests or other medical advances that are made possible by use of the registry data. This may result in Mayo Clinic or other groups profiting from these discoveries.

You will not profit from any of the above examples.

Can I withdraw from the IBD Biobank Study?

Yes. You have the right to leave the IBD Biobank Study at any time. If your genetic information has already been shared with researchers, it might not be possible to withdraw your information from that specific study, but your data can be withdrawn from future research.

You can request to stop having your data used by contacting the study team.