Informed Consent: Genetic Data Collection, Data and Samples

Effective Date: November 6, 2017

About the Arivale Program

Arivale offers personal wellness services. You are about to embark on a journey to optimize your wellness. Your data will help establish your personal baseline for wellness and serve as the foundation for delivering personalized recommendations and coaching to help you achieve your unique wellness goals. Personal wellness services include the collection and analysis of health, lifestyle and activity information from Arivale’s health assessment questionnaire and the wearing of a Fitbit or comparable tracker device that tracks exercise and sleep; independent external CLIA certified clinical laboratory tests results for biological markers in your blood, saliva, and stool ordered and reviewed by an independent external consulting physician; a specific set of pre-selected genetic wellness markers from your lab tests ordered by and reported to an independent external physician; and coaching services, which may include recommendations for changes in diet, lifestyle, and behavior where such lifestyle choices may reduce the risk or impact of certain well-understood chronic diseases or conditions or help you optimize your wellness.

As a standard part of the Arivale program, you will be given information on your genes related to wellness, nutrition, and lifestyle and you’ll be discussing these results in the context of blood biomarkers and other data with an Arivale coach-Registered Dietitian, Certified Nutritionist or Registered Nurse. Your genes are not your destiny and your genetic makeup is complex. Knowing your genetic profile – when combined with information from your clinical labs and other factors – may help you in determining what lifestyle choices might be best for you. Your results will be provided to you on your coaching calls after initial review from our independent external physicians and our internal clinical team. Genetic testing can include: an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes and or the DNA analysis of a person to identify the presence and composition of genes in that person’s body.

The results will be reported to you via our secure dashboard network and your coach will discuss the results with you.

Uses and Disclosures of Personal Health Information (PHI)

We may use and disclose your PHI, including genetic information, in the following ways:

Providing our Services. We may use it to provide you with the Program. For example, a coach who is providing Services to you and members of our clinical team may discuss your personalized wellness plan roadmap so the coach can best support your active participation and wellness goals. We may share your PHI with independent CLIA labs or assay services, sample collection services, contracted independent physicians or other contractors in order to provide you with the Services. For example, we may share family health history that you provide to us with our contracted independent physicians who order your labs and provide and independent review of your results.

Payment. We may use your PHI, or share it with others, so that we can obtain payment for the Services we provide to you. For example, your first name, last name, and email address may be shared with the vendor that processes payments for the Services for the purpose of collecting payments as they come due.

Healthcare Operations. We may use your PHI, or share it with others, in order to conduct our operations. For example, the Coaching Management team may use your PHI to review the Services that we provide to you to evaluate the performance of our Coaches that provide you with our Services, and educate our staff on how to improve the Services.

Health-Related Benefits and Services. We may use and disclose your PHI, such as your email address, to tell you about health-related benefits or services that may be of interest to you or as reminders, such as a mobile number or text message, to contact you in an effort to provide appointment reminders regarding your use of the Services.

Business Associates. We contract with third parties known as “business associates” to provide certain Services on our behalf. For example, we contract with a vendor to process and collect payments for the Services. To protect your PHI, we require our business associates to appropriately safeguard your information.

As Required by Law, Public Health Reporting, or to Avert a Serious Threat to You or Public Safety.

We may disclose your PHI when required to do so by federal, state or local law, or health oversight activities, including, for example, audits, investigations, inspections and licensure or in response to a valid court or administrative order, subpoena or other lawful process.

PHI Authorization. Except as described above or as permitted by law, we will disclose your PHI only with your prior written authorization.

You have the right to inspect and receive a copy of your PHI collected as part of the Arivale program, through the Arivale Dashboard or through another reasonable means. Arivale may disclose your information to third parties or our providers. This includes records about your genetic tests. For more, see your rights under the Notice of Privacy Practices, available at https://www.arivale.com/legal/notice-of-privacy-practices/.

Possible Benefits

Possible benefits from learning wellness genetic results may include providing helpful information that could allow you to address a potential or current health and wellness issue. By combining genetic results with health coaching, you may gain greater understanding of your genetic predisposition for certain traits and lifestyle approaches you might take to optimize your wellness. Health coaching can provide education, accountability, support and guidance as you engage in a process of behavior change to address wellness goals.

Possible Risks

Possible negatives of genetic results are that they are not always accurate, and learning test results is potentially harmful to an individual and his/her family’s mental well-being. There is no anticipated physical harm posed by sample collection procedures outside of normal minimal risk of performing a blood draw / needle prick. There are no anticipated psychological harms, but participation in the program could include stress or emotions / upset upon receipt of results that may or may not provide clinically relevant or actionable information. Social harms are a potential risk such as stigmatization of a group to which the individual belongs. Depending on the nature of test results, any of these risks could also extend to biological family members of subjects if results are returned. You may learn something you did not want to know, such as a potential risk for obesity or high cholesterol. There may be risks that are not known at this time. You may want to discuss your options with your own doctor, a mental health professional, or a genetic counselor before or after you get your results.

In addition, despite all attempts to ensure the privacy of your genetic data, there is always a possibility that a data breach or “hack” could result in unintended release of your data. As feasible and appropriate, all information contributed to the database will be handled securely including, for electronic delivery, through encryption and password protection. However, if unauthorized use or release occurs, it could be harmful to you. For example, while certain laws protect a person from having his/her genetic data used against them as it relates to employment or healthcare insurance, it is important for you to understand that there is the possibility – however unlikely – that your genetic data could be linked back to you. Possible negative impact on insurability or employability of individuals due to results of testing or inappropriate disclosure of results of testing is protected 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. This may include implications for family members or potential stigmatization of you the individual or a group to which you may belong.

There may be a possible harm resulting from breach of privacy or confidentiality. 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 cyberattacks and hacking. Your samples are de-identified and security measures are in place to help protect against a loss of confidentiality. Arivale utilizes the method known as “Safe Harbor” de-identification, which requires that 18 specific identifiers, such as name, address, and phone number, be removed. Additional controls by Arivale are in place for increased effectiveness & protection of the de-identification process described above. Arivale’s organizational structure is such that employees with research roles do not have access to member-oriented systems, and vice versa. Data is encrypted in transit and at rest, and access to transfer mechanisms & intermediary storage locations is restricted. Arivale performs recurring review of de-identification processes & related software components. A wide range of security controls including access control, encryption, and monitoring have been implemented across the Arivale environment.

Arivale may also biobank your de-identified samples for future research if you agree in the separate authorization for research.

Limitations of Genetic Data

This program checks the most common genes and variants linked to the various wellness genetics we report. However, it does not check all genetic variants associated with these traits, nor all variants within a given gene. There are known genetic variants related to certain traits discussed by Arivale that are not included in your genetic report. Furthermore, there are likely genetic variants that have yet to be discovered that could impact trait reported in the Arivale program, so your results could change as science advances.

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 medical treatment, care and or regular checkups with a healthcare provider. Our programs do not test for medical genetics and won’t tell you if you have genetic variants associated with single-gene diseases like certain types of cancers.
Please see our Disclaimer of Medical Services here.

WHO CAN I TALK TO ABOUT THIS
If you have questions about our service, please contact the Arivale Concierge toll free at (855) 214-1401.

Consent to Obtain Genetic Information

By signing this form, you agree to the following:

  • I am not a NY State resident;
  • I am not pregnant;
  • I am 18 years old or the age of majority in my state;
  • I can speak, write and understand English;
  • I understand I will have individual access to my personal genetic information;
  • I have received an explanation of the purpose of the DNA analysis, the procedures, the benefits and risks that are involved in the DNA analysis;
  • I authorize Arivale to obtain my genetic information, conduct DNA analysis testing and genome sequencing, for the purposes of coaching on Scientific Wellness™;
  • I have read the Disclosure of Arivale’s Current Wellness Support and Limits to Medical Support at https://www.arivale.com/legal/disclosure/ and the Arivale Notice of Privacy Practices, available at https://www.arivale.com/legal/notice-of-privacy-practices/ and Arivale’s Terms of Service at https://www.arivale.com/legal/terms-of-service/.
  • I have been given the opportunity to ask questions about this consent and I understand that I can receive counseling from my own physician or from a genetic counselor on my genetic results;
  • I understand Arivale does not provide Genetic Counseling services and that Arivale does not provide medical services; and
  • I understand any results may not be conclusive.

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 this program. I have been given the opportunity to have my questions addressed. I consent to my voluntary participation and to this purchase. Arivale will release the results of your DNA analysis only to you, to Arivale staff involved in coaching me, or to persons authorized by you or as required by law.