Frequently Asked Questions
- Who is currently eligible to enroll directly with Helix?
- Is there a cost involved to participate?
- Do I have to participate in The Helix Research Network?
- How do I get tested?
- I provided my sample. What’s next?
- Will I get results back from The Helix Research Network?
- How often do participants test positive for one of these conditions and who helps me interpret the results and the next steps?
- How long does it take to receive results?
- In some cases, ancestry and/or trait results may be different from what is expected. Why might this be?
- My ancestry and/or trait results differ from what I expected. Does this mean my Helix Health results are wrong?
- What if I have a personal or family history of heart disease (such as Familial Hypercholesterolemia (FH)) or cancer?
- Will my results impact my health insurance?
- How will my information be used?
- How do you protect my privacy and confidentiality?
- Will my results of my participation in the study impact my employment?
- Will my results of my participation in the study impact my life insurance, disability insurance, or long-term care insurance?
- What measures does Helix take to keep research study data safe?
- Who do I contact for help?
What is The Helix Research Network?
The Helix Research Network is a community health research program aiming to help improve the health of the patients and the community. Through no-cost genetic screening, the program looks at how your DNA could impact your health. The information we gain may help us improve personalized healthcare and support new research discoveries.
Who is currently eligible to enroll directly with Helix?
Enrollment directly with Helix is currently limited to people, over the age of 18, who have a diagnosis of myocarditis and do not have a history of a bone marrow or stem cell transplant from a donor. The Helix Research Network is open to enrollment at other locations where they welcome participants over the age of 18 regardless of diagnosis. Please note these participants must also not have a history of a bone marrow or stem cell transplant from a donor. To learn more about what Sites are currently open to enrollment you may visit www.clinicaltrails.gov and search for the Helix Research Network.
Is there a cost involved to participate?
No. Participation is at no-cost and the genetic testing provided will not be billed to your health insurance or to you.
Do I have to participate in The Helix Research Network?
No. Research studies include only people who choose to participate. It is your choice whether or not you want to take part in this study.
How do I get tested?
If you are interested in joining The Helix Research Network please indicate interest by clicking here and completing the requested information. You will then receive an email invitation to confirm your eligibility and to sign the research consent form, followed by instructions for how to provide a small saliva sample at home. You will use the prepaid label provided to send your sample back to Helix for analysis. You will also have the opportunity to create a free account with Helix to gain access to additional information such as your ancestry and certain inherited traits.
I provided my sample. What’s next?
Once your sample is received, Helix will analyze your DNA. This is also known as sequencing. Sequencing reads the code contained within the DNA so that it can be used for research. You will also receive emails from Helix notifying you about the progress of your sample and offering you the opportunity to create a Helix account. This account is how you can receive your results about your genetic ancestry and traits and view your Helix Health results.
Will I get results back from The Helix Research Network?
Yes. You will be notified by email that your health results are ready. These results will indicate if you have inherited certain risk factors in your DNA, meaning that the risk may have been passed from generation to generation in your family. Your family history alone, and standard medical screening tests, do not always identify risks for these conditions. Specifically, the test will tell you about your genetic risk for the following three conditions that the US Centers for Disease Control and Prevention (CDC) and other medical professionals consider to be important enough to warrant further investigation of treatment:
- Familial hypercholesterolemia (FH): A hereditary form of very high cholesterol that causes heart disease at an earlier age than the general population, but is not known to be related to myocarditis.
- Hereditary breast and ovarian cancer (HBOC): A hereditary form of breast and ovarian cancer, specifically linked with abnormalities in the two most common genes (BRCA1 and BRCA2)
- Lynch syndrome: The most common cause of hereditary colorectal (colon) cancer - people with Lynch syndrome are more likely to get colorectal cancer and at a younger age and this syndrome is associated with an increased risk for endometrial, ovarian, upper GI, brain and pancreatic cancers.
Note: You will not receive any results directly related to your myocarditis diagnosis. In addition, if you choose to sign up for a Helix account, you’ll receive information about your genetic ancestry and how your DNA may influence certain traits, such as your caffeine metabolism.
How often do participants test positive for one of these conditions and who helps me interpret the results and the next steps?
You will receive health results from the genetic screening that will indicate if you have inherited certain risk factors in your DNA. About 1-2% (1 to 2 people out of 100) will be found to have a risk for one of the inherited cancer or heart conditions that are part of this study. If your results show you are at an increased risk for certain conditions, a member of the Helix study team will contact you about your results and you will be able to schedule a genetic counseling appointment at no cost to you or your insurance.
It is important to note that since Helix is not associated with a health care system, neither Helix nor the genetic counselor you may talk to as part of this study can provide recommendations for specific physicians or locations to visit for appropriate follow up care. But you can bring these results to your health care provider. Your health care provider may refer you to a specialist for more information, genetic counseling and/ or additional screenings, if needed. If you do not currently have a health care provider you may be encouraged to consider establishing care.
How long does it take to receive results?
The process takes about 12 weeks: from Helix receiving your saliva collection kit to the time you receive your health test results. Typically, your Ancestry and Traits results are ready within 8 weeks of the Helix lab receiving your sample. These results are available to you if you have created an optional Helix account. It may take another month before your health results are ready to view, as extra steps are taken to ensure your health results are accurate.
In some cases, ancestry and/or trait results may be different from what is expected. Why might this be?
Genetic variations linked to ancestry and traits occur throughout the genome. They are responsible for the natural genetic diversity among people. These genetic variants estimate the most likely ancestry or traits that a person will have. They are not definitive and do not guarantee the occurrence of specific ancestry or traits. Sometimes, the ancestry and traits we express do not match what is expected based on DNA testing. There are a few reasons for this. First, Helix testing may not include all of the genetic variants linked to a specific trait or ancestry. Also, there may be interactions between genes that are not yet fully understood. Genetic traits are often influenced by multiple genes making it difficult to predict precise outcomes. Finally, genetic traits can be influenced by the environment or other factors. These factors can interact with your genetic makeup and contribute to differences between the traits you express and the traits expected based on your DNA testing.
My ancestry and/or trait results differ from what I expected. Does this mean my Helix Health results are wrong?
No. The results of your ancestry and traits may be different from what you understand to be true about yourself. This does not mean the information provided to you about these results or your health results is inaccurate. It is important to understand that trait and ancestry results are estimates based on DNA patterns rather than definitive information. These results give insights into a person's genetic origins or predispositions. They do not guarantee the occurrence of specific ancestry or traits. While some traits are easy to predict based on genetic information, other traits are more complex and therefore more challenging to predict based on genetic data alone. Trait and ancestry results are different from Helix Health results. Helix Health testing looks for the presence or absence of specific genetic variants. Such variants have extensive evidence from the medical community linking them to risk for disease.
What if I have a personal or family history of heart disease (such as Familial Hypercholesterolemia (FH)) or cancer?
If you have a personal or family history of a condition covered by this test, it is important to know the results of this test do not change a previous diagnosis or any family history risk you might have. This is because there are other causes of cancer and heart disease that were not evaluated as part of this test. For example, lifestyle, family history, environment, personal medical history, and other genetic conditions all contribute to your overall health and personal risk for disease. In addition, the screening test provided as part of The Helix Research Network does not evaluate all genes associated with cancer and heart disease. Also, this test may not identify all DNA variants in the genes that were tested.
You may want to speak with a genetic counselor or your healthcare provider about the results of this test and whether additional or different genetic testing and general screening may be appropriate for you. In particular, participants with a negative genetic test and a clinical diagnosis of one of the conditions screened for by this test are recommended to consider a diagnostic genetics consultation to identify whether additional genetic testing or screening recommendations are indicated. A genetic counselor is a medical professional specifically trained to help you understand how your genetic information may impact your health and the health of your family members, discuss medical recommendations, and discuss how you can approach sharing any important information with others. Those communications would be separate from The Helix Research Network.
Will my results impact my health insurance?
No. The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law that makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. However, this law doesn’t protect you against genetic discrimination by companies when they consider selling you life insurance, disability insurance, or long-term care insurance. You should think carefully about this when considering whether or not to participate in the Helix Research Network.
How will my information be used?
The information you contribute to The Helix Research Network will be used by researchers to study a wide range of questions, including learning more about myocarditis, around how DNA can impact health. The databases created in this research program will be used for future research by Helix and by other members of the Helix Research Network. That means, by agreeing to participate in the study, you are agreeing to have your information included in future research projects that are approved by Helix.
Researchers outside of the Helix Research Network may also study your coded information and samples but will not have access to information that directly identifies you. These researchers may work for health systems, universities, government agencies, companies like life sciences companies and other foundations or groups interested in research. Any sharing of information outside of the network will be carefully reviewed and approved to make sure it is ethical, secure and protects your privacy.
We may share discoveries that are made by Helix researchers through our website and newsletters.
How do you protect my privacy and confidentiality?
Your privacy is very important to us, and we take many steps to ensure it is protected, such as:
- Your information (your genetic information and health records) will be stored in secure databases.
- We limit and closely monitor who can access your data.
- We limit who is allowed to see information that could identify you, like your name or contact information.
- You can choose to withdraw and stop sharing your information at any time.
Will my results of my participation in the study impact my employment?
With few exceptions, GINA prohibits employers from discriminating against their employees on the basis of genetic information in any aspect of employment, including hiring, firing, pay, job assignments, promotions, layoffs, training, fringe benefits, or any other term or condition of employment. The law similarly prohibits labor organizations from excluding, expelling, or otherwise discriminating against an individual based on genetic information.
Importantly, GINA’s employment protections do not extend to all employees or in all circumstances. Most notably, these protections do not apply to employees at companies with fewer than 15 employees or to active members of the U.S. military.
Will my results of my participation in the study impact my life insurance, disability insurance, or long-term care insurance?
Currently, federal and state law protections against discrimination based on genetic information by health insurers do not extend to providers of life, disability, and long-term care insurance. That means companies offering these kinds of insurance may request access to genetic information in your medical record as part of the insurance application process (including information generated as part of your participation in this study, if it is incorporated into your medical record) and may legally consider this information in deciding whether to extend your coverage or in determining the price they charge you.
If you already have an existing life insurance, disability insurance, or long-term care insurance policy, new information about your health (including genetic information) generally may not be used to deny you continuing coverage under those policies. However, the terms of individual policies vary significantly and you should read your policy carefully to understand how results could impact your coverage or insurance rates.
What measures does Helix take to keep research study data safe?
If you decide to participate in the The Helix Research Network study, your information will be stored in databases that are maintained and monitored by a team of IT and security professionals who are committed to safeguarding the information stored in those systems. These systems include numerous technical, physical and administrative safeguards that meet, and in some cases exceed, industry best privacy and cybersecurity practices, including standards established by the National Institutes of Science and Technology (“NIST”), the Association of International Certified Professional Accountants (“AICPA”), and applicable state and federal laws. Helix’s privacy and security programs are reviewed annually by third party auditors to ensure our safeguards are operating as expected and in a manner consistent with industry standards.
Who do I contact for help?
For any general questions related to your participation in this study, please contact the study team at HRNstudyteam@helix.com or [phone number]
For questions related to the informed consent process and using the informed consent website (including updates to email and phone number), and for questions related to the shipment of a sample collection kit, or creating or accessing an optional Helix account, please contact Helix customer support by phone, email or by filling out an online request: (844) 430-0468 // email@example.com // Online Request Form.