Consent for Arivale-Helix Insights Programs

Effective Date: September 12, 2017

Glossary:

  • DNA: Deoxyribonucleic acid. DNA is the hereditary set of instructions that every parent passes on to their biological children and contains the genetic instructions for how our bodies grow and function over time.
  • Genes: Sections of DNA that provide the instructions, or “code,” to make proteins. Proteins are essential for the proper structure, function, and regulation the different cells in the body. For instance, one gene could code for a certain type of protein that is needed for the proper function of the lungs, heart, or liver.
  • Variant: In the context of this test, a variant is a change in the DNA that can lead to increased odds that a person might experience a certain trait or health condition or have a particular response to a dietary or lifestyle factor.
  • Trait: An observable or measurable characteristic resulting from both the information encoded in the genes and the impact of dietary or lifestyle factors. Examples of traits include “brown eyes,” “body weight,” and “LDL cholesterol levels.
  • Polygenic Profile: A genetic result that is based on the addition of multiple genetic variants, some of which may raise the odds of a particular trait, and others that may lower those odds. Individually, these genetic variants tend to have a low impact on the odds of a particular trait on their own, but combined with other genetic variants and non­genetic factors, such as diet or lifestyle, they can have a meaningful impact.

Purpose

Starting with your genetic data, you will have the opportunity to work 1-on-1 for 30 days with an Arivale Registered Dietitian to outline either 1) a weight loss plan personalized to you (Arivale Weight Loss Insight), or 2) lifestyle strategies to support optimal cholesterol and blood pressure you (Arivale Heart Optimizer Insight).

Traits like body weight, cholesterol, and blood pressure are determined by a combination of genetics and lifestyle choices such as diet and exercise, among a number of other factors. The interaction between your lifestyle choices and many genetic variants relating to these traits provides insight on the daily choices we make that may work for or against our goals.

When it comes to traits like body weight or cholesterol, genes aren’t your destiny. They show your potential. In this program, you will explore curated genetic profiles related to either 1) body weight, or 2) lipids and blood pressure.  For either Insight, you will work with an Arivale Registered Dietitian to outline lifestyle changes designed to work for your body. Knowing your genetic profile may help you spend less time and energy determining what lifestyle choices might be best for you.

What to expect

By purchasing an Arivale Insight, you authorize Helix to perform genetic sequencing and to share the portion of genetic info that Arivale needs to offer you the Insight.

You will be notified when your results are ready. On average this takes approximately 6-10 weeks if your genes are being sequenced for the first time. If you’ve already had genetic sequencing done by Helix, your results will be available within 3 days. You will be able to login to view your results through the Arivale website or app.

Results from this test are treated with confidentiality. Reports are rendered only to the customer.

Possible Benefits

By combining genetic results with expert coaching, you may gain greater understanding of your genetic predisposition for either 1) excess body weight, or 2) increased cholesterol or blood pressure.  You may also benefit by talking to a coach and outlining strategies for lifestyle approaches that could help you improve your wellness.

Limitations

This program checks the most common genes and variants linked to either body weight (Arivale Weight Loss) or blood lipids and blood pressure (Arivale Heart Optimizer). However, it does not check all genetic variants associated with these traits.  There are known genetic variants related to the traits discussed in the Arivale Insights that are not included in this profile.  Furthermore, there are likely genetic variants that have yet to be discovered that could impact body weight, cholesterol or blood pressure so the results of your polygenic profiles could change as science advances.

Complex traits like body weight, blood lipids, and blood pressure are the result of a combination of genes, environment, lifestyle, and many other factors. The Arivale programs attempt to take as many of these factors into account as possible to provide you with the most comprehensive information. Some of these factors are not yet well understood. Discoveries made in the future may continue to improve the overall quality and comprehensive nature of these programs.

In certain cases, we look at genetic variants that have primarily been studied in European populations. As such, results for customers from other backgrounds may not be as accurate. In other cases (e.g. the polygenic profiles), variants from multiple ethnic groups have been included.  Nevertheless, there is a possibility that the results may be less accurate for your unique ancestral background.

Genetics is a field that is evolving quickly. Scientists are always discovering new details about how to interpret DNA data. They are also learning that some previous discoveries are not valid.  Our programs are based on the current state of knowledge. As our knowledge improves, the insights may change. We may also be able to give you new insights based on the same genetic information.

Our programs do not eliminate the need for regular checkups with a clinician, including regular cholesterol checks. Our programs also do not test for a form of hereditary high cholesterol called “familial hypercholesterolemia” or a form of hereditary high triglycerides called “familial hypertriglyceridemia.” Our programs will not show if you have or don’t have these conditions.

The information and suggestions in our programs are not intended to provide a medical diagnosis, including the presence or absence of any disease or condition, or to treat or cure a disease. If you would like to discuss any concerns about possible medical conditions, genetic or otherwise, consult with a healthcare professional.

Possible Risks

You may learn something you did not want to know, such as a potential risk for obesity, high cholesterol or high blood pressure. There may be risks that are not known at this time. You may want to discuss your options with your doctor, a mental health professional, or a genetic counselor before or after you get your results.

Despite precautions we take and safeguards we apply, including encryption, it is possible that data not intended to be disclosed will be accessed, used or disclosed due to unintended data breaches, such as sophisticated cyber attacks and hacking.

Under the Genetic Information Nondiscrimination Act (GINA), no employer with at least fifteen workers can ask for your Genetic Information. Neither can any health insurer. However, this does not apply to other groups, such as the US military or companies that offer life, long-­term care, or disability insurance. Some states have safeguards for those types of insurance. You should be aware of the laws in your state and be careful with whom you choose to share your Genetic Information.

Use of your Account/Data

Your information may be used and disclosed for purposes like providing you with the Insights service and processing your payment. See our Notice of Privacy Practices  (https://www.arivale.com/legal/notice-of-privacy-practices/ ) for more information.

To use the Arivale programs, you must let Helix share portions of your genetic information with Arivale, Inc. Helix will share only the portions that we need to give you your results.

We will also ask you to provide some self-­reported information. This information includes your current weight and height, personal or family history of certain health conditions, and some information about your diet and lifestyle. Sharing this information with us may improve the insights you get from Arivale. Whether you share self­-reported information with us is up to you, but doing so will help your coach better understand your unique biology and lifestyle so that recommendations can be more tailored.

We may be required to release some of your information under a specific and narrow set of circumstances. These circumstances are fully described in the Arivale Notice of Privacy Practices. For example, we may need to release your personal information if Arivale receives valid legal process from a law enforcement or regulatory agency that is operating within its jurisdiction. We will notify you of this release unless we are legally barred from doing so.

Account Cancellation and Data Deletion

We’re sorry to see you go. To cancel your account, contact the Arivale Concierge at 206-981-5834 or toll free at (855) 214-1401 or email concierge@arivale.com. They will process your cancellation and will ensure, if you so request, that your Insights data is deleted from our servers. There is no fee to rejoin the Insights Program, so you can reactivate at any time by visiting your Dashboard. To have Helix stop sharing your information with Arivale, contact Helix’s Customer Care.

Questions

If you have questions about our service, please contact the Arivale Concierge toll free at (855) 214-1401.

Consent

By signing this form, you consent to the services offered in the Arivale Insight program.

In addition, you agree to the following:

  • You are over 18 years of age
  • You can speak and read English,
  • You are not pregnant,
  • You do not live in the State of New York (Arivale is unable to provide services in this state)
  • Helix can transmit the necessary genetic data to Arivale,
  • You may be contacted for ongoing communications from Arivale about related programs.

I have read this consent form or have had the form read to me. I understand and agree to the purpose, risks, benefits, and limitations of the insights. I have been given the opportunity to have my questions addressed. I consent to my voluntary participation and to this purchase.