STUDY DESCRIPTION AND GOALS:

You are invited to participate in a research study using the Invitae Discover mobile phone application (referred to in this document as the “App”) to collect research data on your activity and cardiovascular health, including heart rate and irregular heart rhythm event data collected by an Apple Watch or other wearable devices connected to the Apple Health app. We call this the “Study” throughout this informed consent and authorization form.  At your election, the Study may also obtain medical record data that you store in Apple Health.    

The goal of this Study is to combine health and activity data that is widely available from mobile devices with clinical genetic testing results to enhance our understanding of the genetic basis of cardiovascular disease and improve the interpretation of genetic testing results. If you agree to participate in the Study and provide informed consent, a copy of this consent form will be emailed to you. You will then be asked to allow the App to collect health and activity data (including, in some cases, medical record data) from your phone or wearable device, followed by Invitae sending you questions about your history of cardiovascular disease and risk factors. Invitae will combine your genetic test data with the additional data generated through this Study with the goal of gaining insights into genetics and cardiovascular health.  We will NOT access your personal contacts, other applications, personal photos, text messages, or emails. At times during the Study, the App may prompt you to complete additional survey questions. You may also be re-contacted in the future about additional research opportunities, including adding other health data to the App. You may choose at any time to opt out of such future re-contacting.

 

RISKS AND BENEFITS: 

The purpose of this informed consent and authorization form is to tell you about what will happen during the Study and these possible risks and benefits in more detail, so that you can make an informed decision about whether to participate.  The informed consent and authorization form also includes other important information about the Study, including an explanation of the Protected Health Information (“PHI”) the Study team will collect and use during the Study. The Study team includes the Principal Investigator listed above and anyone else assisting Invitae in conducting the Study.  This informed consent and authorization form will explain with whom the Study team may share that information during the Study and even after the Study is completed. Your participation in this Study is entirely voluntary and there are no consequences if you choose not to participate. 

The main risk from this Study is the risk to your privacy, including the risk that the data obtained and generated through this Study may be misused, but Invitae will take extensive steps to secure your information and protect it from being used or disclosed in an unauthorized manner. 

You will not receive any direct benefits from participating in this Study.  Other people may benefit in the future as a result of this Study, because one of our goals for this Study is better understand cardiovascular health and the genetic basis of cardiovascular disease. There is no intent to use the data obtained from you for the purpose of updating the clinical report you already received.  However, the Study may ultimately lead to Invitae updating its guidelines on how it classifies variants.

 

HOW WILL MY DATA BE USED:

Data pertaining to your participation in the Study will be generated and recorded, including data about your health.  Your data may be processed or used for the following purposes, which we refer to, collectively, as “Data Analysis”:

  • to carry out the Study;

  • to confirm the accuracy of the Study;

  • to monitor that the Study complies with applicable laws as well as best practices developed by the research community;

  • to comply with legal and regulatory requirements

The following entities and organizations may engage in Data Analysis that uses your data:

  • the Study team, including other people who, and organizations that assist the Study team;

  • the ethics committee or institutional review board that approved this Study;

  • other people or groups working for or with Invitae in connection with the Study (Invitae will ensure that any such third party groups supporting this Study will abide by all requirements set out in this informed consent and authorization form); and 

  • regulatory agencies and government officials who have a duty to monitor or oversee studies like this one.

 

HOW IS MY PRIVACY PROTECTED: 

All data generated through this Study will be recorded and stored in a secure, password-protected, data platform.  Only the Principal Investigator, Study coordinator, and select personnel at Invitae supporting the Study will have the ability to access the data. 

 

TIME INVOLVEMENT/COSTS:

There is no cost for the App. If you participate in this Study, it will require personal time to respond to the survey questions. The App and participation in this Study are not a substitute for healthcare or health insurance. The data collected by the App will not be reviewed by a physician for medical evaluation and it is not anticipated that any data collected from you during this Study will be used to update your existing clinical report or to send you a new clinical report. Consult a physician for any medical questions. You and/or your health insurance must pay for any services, supplies, procedures, and care that you require during this Study for routine medical care.

 

PAYMENTS:

You will not receive any payment for your participation.

 

FUNDING:

The Study is funded by Invitae Corporation, a genetics information healthcare company headquartered in San Francisco, California.

 

PARTICIPANT’S RIGHTS:

If you have read this form and have decided to participate in this project, please understand your participation is completely voluntary and you have the right to withdraw your consent or discontinue participation at any time by clicking on the “stop participation” button on the App home page.  At that point, Invitae will no longer collect any additional data from your phone but will retain the data from you that has previously been collected for use in the Study. The duration of this Study is anticipated to be ongoing; however, approximately every six months that you participate in this Study, you will receive an email or Push notification on your Apple device reminding you that your data is still being collected by Invitae and giving you the opportunity to opt out of such further collection. 

The results of this research Study may be presented at scientific or professional meetings or published in scientific journals. However, your identity will not be disclosed and the information will only be presented in a de-identified format. 

You may refuse to sign or may withdraw (at any time) this informed consent and authorization form for any reason, and such refusal or withdrawal will not affect the beginning, continuation or quality of your treatment at Invitae or result in any penalty or loss of benefits to which you are otherwise entitled.

This informed consent and authorization will remain in effect until you provide a written notice of revocation to the Principal Investigator at the address listed on the first page.   Otherwise, this authorization has no expiration date.    

Your revocation will not impact any actions that Invitae has already taken in reliance on your informed consent and authorization, such as Data Analysis conducted using your data obtained from your phone. 

 

QUESTIONS:

You may ask questions at any time.  Should you have any questions, you can contact the Principal Investigator: Dr. Ed Esplin, by phone at (800) 436-3037 or by email at afib.cause@invitae.com

This Study is being overseen by the Western Institutional Review Board (IRB).  You may speak to a member of the IRB at (360) 252-2500 or (800) 562-4789, or by email at clientservices@wirb.com, if: 

  • Your questions, concerns, or complaints are not being answered by the Study team; 

  • You want to talk to someone besides the Study team; 

  • You have questions about your rights as a research subject; and

  • You want to get more information or provide input about this Study.