Frequently Asked Questions

Find answers to frequently asked questions about the Tapestry DNA Sequencing Research Study, including information on:

  • General information and participation
  • Helix
  • Results
  • Data privacy, insurance and discrimination
  • The Tapestry Genomic Registry
  • Technical requirements

General information and participation

What is the purpose of the Tapestry study?

Mayo Clinic researchers are seeking to understand the short-term and long-term impacts of genetic testing on people's health care when their DNA results are part of the electronic health record. Genetic data from participants will also be used to create a library of genetic information (registry) for future research.

How many people are participating in Tapestry?

The Tapestry DNA Sequencing Research Study team plans to enroll approximately 100,000 Mayo Clinic participants.

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.

Why did I receive an invitation to enroll in the Tapestry study?

To achieve the study's goal of creating a diverse library of genetic information, the study team needs to recruit participants from multiple departments with different medical histories. The study team has an automatic system that sends invitations to individuals from departments whose care teams believe their patients are eligible for the study and may be willing to contribute to research.

Can I participate if I have had genetic testing related to one or more of the conditions included in the Tapestry study?

You are welcome to participate in the Tapestry study regardless of previous genetic testing. If you have had a previous gene change identified, there is a chance the technology used in Tapestry will not find it, as the study uses a screening test. If you have a personal or family history of disease, you should speak with your doctor.

Can I participate if I have a family member who has a genetic diagnosis of one of the conditions included in the Tapestry study?

You are welcome to participate in the Tapestry study regardless of family history of previous genetic testing. However, it is not meant to replace clinical genetic testing for individuals who have a personal or family history of one of the conditions included in the screening. People who are interested in genetic testing for a genetic disorder previously identified in their family should speak with their health care or genetic testing provider.

Can I choose to stop participating in this study?

You may choose to leave the Tapestry study at any time. Please contact the study team at tapestry@mayo.edu.

Who is funding the Tapestry study?

Funding is provided by the Mayo Clinic Center for Individualized Medicine.

Who should I contact if I did not receive my saliva collection kit?

Contact the study team at tapestry@mayo.edu.

Can any Mayo Clinic patient volunteer to join the Tapestry study?

At this time, participation in Tapestry is by invitation only to those who meet certain criteria. If other individuals who are Mayo Clinic patients want to learn more about how to be invited, they can contact the study team at tapestry@mayo.edu. However, Mayo Clinic researchers will make the final decision on offering enrollment to interested participants based on eligibility criteria and scope of the study.

Helix

Who is Helix?

Helix is a population genomics company that Mayo Clinic has collaborated with to sequence participants' DNA and securely store the genetic data. Learn more on the Helix website.

What is the relationship between Mayo Clinic and Helix?

The Mayo Clinic Center for Individualized Medicine is collaborating with Helix and has a small ownership position in Helix.

Does Helix conduct other research?

Yes. Helix conducts independent research and collaborates with other researchers and institutions outside of Mayo Clinic.

What is the difference between the Tapestry study and the Helix DNA Discovery Project?

Tapestry is a research study coordinated by Mayo Clinic. The Helix DNA Discovery Project is a research study coordinated by Helix.

Do I have to take part in the Helix DNA Discovery Project to take part in the Mayo Clinic Tapestry study?

No. These are separate and independent studies. If you choose to participate in the Helix DNA Discovery Project, you will need to sign an authorization to allow Helix to access and use your genetic data for their research.

If I close my Helix account, does that mean I'm no longer part of the Tapestry study?

No. Closing your Helix account will not withdraw you from the Tapestry study. However, it does mean you will no longer have access to genetic results through your Helix account.

If I decide to no longer take part in the Tapestry study, does that mean I can no longer access my Helix account?

No. Deciding to no longer take part in the Tapestry study will not restrict you from accessing your Helix account and related DNA products.

Results

What data or results will I receive?

Initial results will include results for several health conditions, including familial hypercholesterolemia, Lynch syndrome, and hereditary breast and ovarian cancer (PDF). You may also choose to receive results for ancestry and genetic traits. Genetic data will also be used for ongoing research and to create a data registry.

Why do I need to sign an authorization form to receive ancestry and genetic traits information?

Both Helix Ancestry and Helix Traits are Helix products. If you would like to receive these products, you will need to sign an authorization to allow Helix to access and use your genetic data to provide you these products.

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

Results that may impact your health will be entered into your electronic health record. If you do not want your results to be part of your health record, you should not take part in this study.

What happens if I have a positive result, which may impact my health?

The Tapestry study team will attempt to contact you via email, phone or certified letter to discuss next steps.

Genetic counseling will be offered at no cost. Further testing to confirm your result may be recommended. The follow-up test uses a new DNA sample to confirm the gene change identified through the Tapestry study. Discussion and coordination of additional testing can be completed with the Tapestry study's genetic counselor; however, the cost of completing the additional testing would be your responsibility, either through your insurance provider or through personal payment.

The Tapestry study team will also notify your Mayo Clinic primary care provider if you have one on record. These results will be scanned into your electronic health record.

What happens if I have a negative result, which may not impact my health?

Any negative result significantly reduces the chance that you are at risk for the conditions tested but does not completely eliminate the risk. You should talk to your physician about your results, especially if there is a family history for any of the conditions tested. These results may be scanned into your electronic health record.

Please note that genetic testing done through Tapestry does not replace genetic testing you may have as part of your clinical care. The genetic testing performed as part of Tapestry is generally not as comprehensive as testing ordered for a specific medical or family history concern.

Your Tapestry results will be scanned into your electronic health record. If you do not want your results to be part of your health record, you should not take part in this study.

What happens if I already have a genetic diagnosis of one of the conditions included in the Tapestry study results?

All Tapestry participants are offered the same screening test through Helix. If you were previously found to have a gene change in one of the genetic disorders included in this study, this will likely be reported as a positive result through Tapestry. The Tapestry study team can review these results to make sure it is the same gene change. Clinical confirmation may not be needed.

It is also possible to receive an unexpected negative genetic test result through Tapestry. If you have had a previous gene change identified, there is a chance the technology used in Tapestry may not identify it. Certain gene changes are outside of the analytical range of Tapestry's screening test. Clinical genetic test results ordered by your doctor are valid, along with any previous genetic diagnoses made outside of the Tapestry study.

If you receive an unexpected negative test result, we recommend you contact the Tapestry Study first so that the study team can help determine the reason for the result.

Will results for any of the health conditions tested be available through the Mayo Clinic online portal?

No. The Mayo Clinic online portal is not able to show clinical results that are ordered as part of a research study.

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 have to be submitted, reviewed and approved by Mayo Clinic's institutional review board.

Should I share my results with my family?

Your results, both positive and negative, could be important information for the health of your blood relatives. Speaking with a genetic counselor will help you understand what this impact may be and decide whether you would like to share the results with your blood relatives.

Data privacy, insurance and discrimination

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

Both Mayo Clinic and Helix will have access to your genomic data. Some of your Tapestry results will be entered into your Mayo Clinic electronic health record.

Are there laws that protect the privacy of research participants?

Mayo Clinic adheres to federal privacy laws, and the Tapestry study is overseen by an institutional review board as governed by the National Institutes of Health human participants' research protections.

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

Yes. Tapestry is a resource meant to serve the research community at Mayo Clinic — and at other institutions — indefinitely. Your participation will enable researchers to examine the roots of disease and novel treatments for many years to come.

Researchers at Mayo Clinic may request to use identifiable information to further their research. Researchers outside of Mayo Clinic may also ask for a part of your information, samples, or both for future studies or commercial use. Mayo Clinic may send the information, the samples collected here or both to researchers who request them.

However, Mayo Clinic will not send your name, address, phone number, social security number or any other identifying information with the information or samples. Your information or samples would be sent with a code, and only Tapestry study team at Mayo Clinic would be able to link the code to you.

Can I request that my genetic data not be used by either Mayo Clinic or Helix?

Yes. Participants can request that the Tapestry study team stop using their data by emailing tapestry@mayo.edu.

Participants can also choose to stop their relationship with Helix at any time, including requesting deletion of their data, by contacting Helix Customer Care at support@helix.com.

Will my genomic data be made public?

No. Neither Mayo Clinic nor Helix will make your genomic data public.

However, it is helpful for researchers to share information they get from studying samples and information. They do this by putting it into scientific databases. Researchers can study the shared information to learn even more about health and disease.

If you agree to take part in the Tapestry study, some of your genetic and health information may be placed into one or more scientific databases. Your name and other information that could directly identify you, such as your address or social security number, will never be placed into a scientific database.

How will Helix use any of my remaining DNA after sequencing is complete?

Helix may use your de-identified DNA, with name and date of birth removed, for quality control purposes in the laboratory. Read about Helix's privacy policy on the Helix website.

How is my genetic data protected?

Both Mayo Clinic and Helix have 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 the results are entered into the electronic health record. However, under the Genetic Information Nondiscrimination Act (GINA), it is prohibited for most health insurance companies to use genetic information to make decisions regarding eligibility or premiums. More information is available on the GINA website.

Will Mayo Clinic or Helix share my genetic information with third parties?

Mayo Clinic and Helix will only share your genetic information or other identified information with your consent.

Researchers at Mayo Clinic may request to use identifiable information to further their research. Researchers outside of Mayo Clinic may also ask for a part of your information, samples, or both for future studies or commercial use. Mayo Clinic may send the information, the samples collected here or both to researchers who request them.

However, Mayo Clinic will not send your name, address, phone number, social security number or any other identifying information with the information or samples. Your information or samples would be sent with a code, and only Tapestry study team at Mayo Clinic would be able to link the code to you.

What is the Genetic Information Nondiscrimination Act (GINA)?

GINA is a federal law that protects most individuals from genetic information discrimination by health insurance companies and employers. GINA does not protect from discrimination regarding life insurance, long-term care insurance or disability insurance, meaning genetic information can be used for policy decision-making in similar ways as other health information and medical issues. More information is available on the GINA website.

Tapestry Genomic Registry

What is the purpose of a genomic registry?

A genomic registry is meant to support future research for many years. By storing the genetic information of many people in one registry, researchers save time because they can skip the step of finding new participants for each new project.

What are the benefits of having my genetic data in a genomic registry?

The purpose is to benefit future generations by supporting genomic research. A genomic registry is not intended to provide you with personal health or other direct benefits.

Who can use the Tapestry Genomic Registry?

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

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

Yes. Some examples of how the genomic 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 Tapestry Genomic Registry 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.

What happens to my samples and information when I die?

Once you die, your sample will be considered a gift to Mayo Clinic. That means Mayo Clinic can continue using it in the ways described in the consent form forever, even if your family wishes that you had not donated a sample. Since this study involves your genetic information, your family may want access to it after you die. On the consent form, you can choose whether you would like to allow a representative of your choice to receive information from the study team about genetic results that may impact health.

Can I withdraw from the Tapestry Genomic Registry?

Yes. You have the right to leave the Tapestry Genomic Registry at any time. If your genetic information has already been shared with researchers, it might be difficult 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 emailing tapestry@mayo.edu.

Technical requirements

Do I need to use a specific internet browser to access the Helix platform and access my results?

The minimum versions of supported browsers are as follows:

Supported browsers Minimum version
Chrome 60
Edge 15
Firefox 60
Safari 10.1
Safari (mobile) 10.3
Samsung Internet 7
Internet Explorer (IE) Not supported