DESCRIPTION: You are invited to participate in a research study using a mobile phone application (“InvitaeHeart 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. 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 InvitaeHeart app to collect health and activity data from your phone or wearable device, followed by questions about your history of cardiovascular disease and risk factors. 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 your InvitaeHeart app data.

RISKS AND BENEFITS: There are no significant risks associated with this study. You will be asked to complete a survey on your health during study enrollment. Invitae follows strict-recommended guidelines for data safety and storage, however, there is always a slight risk of data breaches. Your privacy is very important to us and the study will make every effort to protect your privacy and the privacy of your data. We cannot and do not guarantee or promise that you will receive any benefits from this study. You may benefit directly from this study if the study results in the reclassification of genetic changes previously identified in your genetic testing at Invitae. 

Data pertaining to your participation in the study will be generated and recorded, including data about your health. We refer to such data as “Your Data.” 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, including requirements that data from this study, without information that could directly identify you, be made available to other researchers not affiliated with the study sponsor or with the study team. It is possible, for example, that as part of efforts to make research data more widely available to researchers, regulatory authorities in some countries may require that Your Data, without information that could directly identify you, be made publicly available on the internet or in other ways.

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;

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

  • Some of the entities listed above that receive Your Data for Data Analysis are located in the United States and potentially in other countries where the laws do not protect your privacy to the same extent as the laws in your country of residence. In such cases, Data Analysis that involves Your Data may be subject to the less restrictive data protection laws of these foreign countries rather than the laws of your own country. However, all reasonable steps will be taken to protect your privacy.

TIME INVOLVEMENT/COSTS: There is no cost for the InvitaeHeart app. If you participate in this study, it will require personal time to respond to the survey questions. The InvitaeHeart Study app and participation in this study are not a substitute for healthcare or health insurance. The data collected by the InvitaeHeart Study app will not be reviewed by a physician for medical evaluation. 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 Invitae Heart 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 voluntary and you have the right to withdraw your consent or discontinue participation at any time. 

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.