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Frequently Asked Questions

 

Am I eligible?

To be eligible for the study you must be a UCSF patient, 18 years and above

  • You should be able to sign a consent for yourself (in English)

  • You should have access to a computer or mobile phone to complete online requests

  • No prior genetic diagnosis. A “prior genetic diagnosis” means:

    • You were evaluated by a physician and got diagnosed with a genetic condition. For example, Marfan Syndrome, Cystic Fibrosis, Down syndrome, etc.

    • And/or you had a genetic test with a finding that explains your symptoms.

How do I enroll?

If the information on our website sounds satisfactory, please click “JOIN NOW” on the upper right corner of your screen and a study team member will contact you within two weeks with next steps.

Who will have access to my genetic information?

Your genetic information will be maintained and protected by the study team at UCSF. We will follow standard protocols to keep it confidential. Only a few authorized members of the research team will have access to your identifiable information.

 

During the consent process, you will get to make a choice and define how you want us to handle your genetic information. With your permission, other academic researchers may request access to your de-identified genetic information and your de-identified data may become part of a national database. Additionally, some results from this study (like, ACMG 59 and ancestry) will become part of your medical chart at UCSF, so only members of your care team at UCSF will have access to them, once released.

How does it benefit me?

 

Your participation will help us understand how genes relate to health problems. This could lead to new treatments for certain diseases through future research.

You will also receive your personal results and learn about:

  • Your ancestry

  • Any specific findings from a set selected genes that can impact your current or future health. This means that if there is a variation in one of the genes, your physician will be able to use this information in your health management.

  • This study is also creating a biorepository, and any specific research on the samples and data that we gather, will be communicated to you separately. All personal information will be removed before sharing your sample or data (with your permission).

What is Whole Genome Sequencing?

Whole genome sequencing (WGS) is a method for analyzing your entire genetic information, not just looking at individual genes.

Our genes are pieces of information that we inherit from our parents that tell our body
how to grow and develop. Genetic testing like WGS looks at our genes to identify any spelling mistakes, and missing or extra pieces that can help identify future health risks (like risks for certain heart disease, cancer, etc.). The purpose of this study is to understand how to best recruit patients, consent and share the results from this test.

Will I receive results? When?

  • Our goal is to return results that will help inform your health and potential lifestyles changes. We will return actionable results in different phases of the study. In the first phase, we are returning results for a subset of genes (ACMG 59) and your ancestry.

  • The study team will contact you within six to nine months after you submit your saliva sample to discuss the details of your results

What type of ancestry results will I get?

You will receive a report detailing the percentage(s) of your ancestral background. For example, what percentage of you is Asian, African, European, etc. However, the results may not be as detailed as a DTC test (e.g., Ancestry.com) because we do not link to public databases.

I did 23nMe testing, how is your test different?

We are doing a whole genome sequencing test. It will sequence your entire genetic material. Most Direct to Consumer Tests (DTC) like 23nMe, ancestry.com, etc. only look at a small section or specific regions of your entire genetic material and use a different technology. Whole genome sequencing is more complete test. As part of this study, we trying to understand how we can use this technology to better inform your health.

Will my participation affect my insurance?

  • The federal law called the Genetic Information Nondiscrimination Act (GINA) protects you against discrimination from health insurance companies and most employers based on your genetic information. This means that if we find new information from this genetic test that potentially leads to a diagnosis, then your health insurance company and most employer(s) cannot use your genetic information to make decisions about you or against you.

  • There are exceptions to GINA protections. GINA does not protect you against genetic discrimination from long-term care insurance, disability insurance, and life insurance companies.

  • The 3D Health study team will not share any information with insurance companies, but the results of the test can become a part of your health record. If you sign a separate medical release to an insurance company, then they might get to see the results of your test (with your permission).

Can I get a copy of the raw data from the genetic test?

UCSF Institutional Review Board (IRB) oversees our research activities and in its current version of the protocol, this capability was not included, hence, we are not able to release raw data at this time. We are actively working on incorporating this capability in the future.

Will I get paid for my participation? Will it cost me anything?

  • There is NO cost to you for participating in our study and undergoing the genetic test (whole genome sequencing).

  • You won’t get paid for participating in the study.

  • If we find any genetic variants in genes we investigated, you will be provided genetic counseling upon return of results at no cost and you will be referred to your primary care provider.

  • Any follow-up care or treatment by your primary care provider or specialist will be charged in the same way any other healthcare visit is charged.

How does it benefit my community?

 

The learning's from this study will help in:

  • Incorporating diverse genetic make-ups in research to increase knowledge.

  • Understanding which diseases are more common in a particular ethnic background. And why?

  • How to better communicate genetic findings in different populations from different cultural backgrounds.

  • Inform doctors and other practitioners on how to better care for patients from different ethnic and cultural backgrounds.

  • Understand the barriers in learning new health information and its impact.

How does COVID19 affect me joining the study?

  • Your safety is very important to us and we will take all precautions to protect you through the process. We can complete your enrollment and sample collection remotely. We do not require you to meet us in person or visit a UCSF lab or hospital.

  • You can stay home and interact with us via email or phone.

  • Here are a few steps we will take:

    • We will schedule remote consultation via phone or through a secured video conference line.

    • All required forms like the consent form and health questionnaire will be sent to you via DocuSign or a secured email.

  • We will mail a saliva kit to you to your home address with instructions. It’s a very simple and quick saliva swab. You will get a paid return label to ship your saliva sample to the laboratory performing the WGS test.

  • We will contact you when the results are available.

Who will have access to my genetic information?

Your genetic information will be maintained and protected by the study team at UCSF. We will follow standard protocols to keep it confidential. Only few authorized members of the research team will have access to your identifiable information.

 

During the consent process, you will get to make a choice and define how you want us to handle your genetic information. With your permission, other academic researchers may request access to your de-identified genetic information and your de-identified data may become part of a national database. Additionally, some results from this study (like, ACMG 59 and ancestry) will become part of your medical chart at UCSF, so only members of your care team at UCSF will have access to them, once released.

How is my data protected?

Your privacy is important to us. We follow strict security guidelines and standards set by the University to keep your data private and confidential. Here are a few of the steps we will take:

  • Information we collect will be stored on protected computers at UCSF. Only authorized personnel will be able to access the information.

  • We will remove your name and other direct identifiers (like your Social Security number, date of birth) from your information and replace them with a code. There is a master list linking codes to names. This list is kept secure, and very few people have access to it.

  • To work with your health information, researchers must promise not to try to find out who you are.

  • We will tell you if there is a data breach.

Still, loss of privacy is a risk of taking part in the 3D Health Study. Even without your name, there is a chance someone could figure out who you are. Your information could be misused. We believe the chance of this is very small, but not zero.

What will happen to my genetic data if I withdraw from the study?

Your participation in the study is voluntary. You can change your mind any time during the study. Depending on where you are in the study, your identifiable data and samples will be destroyed.  

De-identified data and samples might be still retained for future research use (if you give us permission to do so).