Legal

Research Consent

Effective date: March 1, 2025

At Heartgene, we are focused on moving human research forward to advance medical developments. We believe everyone should benefit from the knowledge of the human genome and research is an important part of that goal. Here are some highlights from our Research Consent (“Consent”). Please read the entire consent document below carefully before making your informed decision to participate. This document explains how Heartgene engages in research.

Remember that your use of Heartgene’s Services, including but not limited to your participation in Heartgene’s research, is at all times subject to our Terms of Use (“Terms”) and our Privacy Policy. Any terms we use in this Consent without defining them have the definitions given to them in the Terms or Privacy Policy.

Key information:

The purpose of Heartgene’s research is to make new discoveries about genetics and other factors behind diseases and traits.
By consenting to participate in this research, you are agreeing to give access of your genetic information to Heartgene and its research partners. This information may include your genetic test results, genetic test orders, consulting reports and records, your health history and certain demographic information.
You can opt-out of participating in research at any time and may still access the Heartgene product and Services. However, opting-out will not impact any use or disclosures that may have taken place prior to your opt-out.
If you agree to participate in the research program, you are affirmatively allowing Heartgene to use and share certain genetic information with Heartgene’s research partners, who are contractually required to hold your information confidentially and privately. To protect your privacy, in accordance with the requirements of HIPAA (45 CFR 164.514), please know that your information will be anonymized and stripped of any information that may correlate the information to you, such as your name, contact information, etc.
In the scope of research, we may contact you to inquire whether you would like to participate in a specific research study. Once contacted, you may elect to participate in that study at your sole discretion or you may choose to opt-out. Such specific studies may require additional consents from you and may be managed specifically by a research partner. To the extent a publication results from the research, Heartgene may share summaries of research results. However, such results and the scientific publications will not identify any particular individual.
We conduct whole genome sequencing, which allows researchers to study genetic information more thoroughly. Those third parties include non-profit organizations, pharmaceutical companies, and academic institutions. Before we partner with any third party, our research committee thoroughly investigates and vets potential partners to ensure that we are confident in and comfortable with working with that third party. When we choose a third party research partner, they are contractually obligated to keep all the data used for research confidential, and are only allowed to use this data for the purposes of that research. Once the research is complete, the third parties must delete and/or return all data and they no longer have access to it.
You allow Heartgene and its research partners to use certain information (including your genetic data, your research data, and your responses to research surveys) to study a wide variety of research topics.
It is unlikely that you will directly benefit from your participation, though you and others may benefit in the future from discoveries that lead to healthcare advances.
While we take measures not to share your genetic data in an identifiable manner with third parties or research partners except as set forth in the Privacy Policy, like most data, there is a small risk that someone could get access to your personal data without your permission in the event of a privacy breach.

Purpose: why is Heartgene doing research?

Heartgene’s research aims to make and support scientific discoveries about genetics, the human genome, and other factors behind diseases and traits. To do this, we support the work of researchers by collaborating and publishing our findings in scientific journals. Results of our research may be used to help develop new ways to diagnose and treat certain diseases. We study:

The genetic and other factors behind diseases and traits
Ways to diagnose and treat diseases

Heartgene and our research partners make discoveries by analyzing genetic information across large numbers of research participants to find patterns. These patterns might tell us, for instance, if people with a particular set of genetic factors are more likely to get a disease such as cancer or diabetes, or asthma. Another pattern might point to a new way to treat a disease. Results of our research may be used to help develop new drugs. Some discoveries could help researchers better understand disease and may guide diagnosis and treatment decisions.

What does it mean to take part in Heartgene research?

You may be asked to take surveys and/or enter information about yourself into the Heartgene website or mobile app or through our research partners. You choose which surveys to take and which questions to answer. You agree to let Heartgene and our research partners use certain information (including such information provided prior to giving consent) for Heartgene research.

There is no cost to be a research participant. You may not be paid for agreeing to participate. By participating, you are helping answer important questions, and are receiving your genetic data at no charge.

Heartgene research is sponsored by and conducted by our third parties such as our research partners. Sometimes research discoveries lead to products or inventions that have value if they are made or sold. In situations where your information contributed to an invention or product that profited Heartgene or any of its research collaborators, you will not receive any financial benefits.

Recontacting You.

Heartgene research is open-ended: we may inform you of new surveys and research opportunities as they are added or otherwise become available at www.clinicaltrials.gov, if we think that they might be relevant for you. We may also invite you to participate in specific studies based on information you’ve previously provided, including any genetic variants that are detected through your use of the Services. We use routine communication methods to inform you of research opportunities. We may send you email invites and/or notifications in your account or on your mobile device. It is totally up to you to participate or not, or decide the extent and nature of your participation. You may at any time elect to opt out from further communication from Heartgene regarding these research opportunities. To opt out, please send an email legal@heartgene.com. Please understand, opting-out will not impact any communication that have already been sent or in queue to be sent prior to your opt-out.

How is my privacy protected?

Heartgene uses physical, technical, and administrative security measures to protect your information. We regularly review and improve our privacy and security practices to help ensure the safety of your information. These practices include, but are not limited to, the following:

Heartgene research analyses are conducted with de-identified information that has been stripped of your contact information and some other directly identifying information.
When we publish research results or share results with collaborators, we only publish or share summary information aggregated with data about many other individuals, so that the results do not identify any particular individual.
All Heartgene employees and the employees of our research partners are trained on how to work with human research participants, and Heartgene researchers receive additional training on how to conduct research responsibly.

Can children participate in Heartgene research?

The Children’s Online Privacy Protection Act (“COPPA”) requires that online service providers obtain parental consent before they knowingly collect personally identifiable information online from children who are under 13 years of age. As discussed in our Terms of Use and Privacy Policy, we do not knowingly collect or solicit personally identifiable information from a child under 13 without obtaining Parental Consent, except for the Required Information. You may always revoke your consent with respect to the use of your Child’s personal data for research purposes, as described in the “Can I change my mind?” section below.

Who will have access to my information?

We may share your information with our research partners, who may publish their eventual results in scientific and other publications. We will not ask you for separate permission everytime we share summary information with qualified research collaborators or publish in journals. However, any research that is made publicly available will solely be provided in an aggregated and de-identified form as Research Data.

Can I change my mind?

If you change your mind at any time about participating, you can withdraw your consent and Heartgene will prevent your genomic data from being used in new Heartgene research within a reasonable time period, but we cannot remove your data from research and activities that have commenced prior to your withdrawal of consent. However, once your data is de-identified, we cannot remove it from any data sets in which your data has been included, because there is no way to identify that the data came from you.

Your participation in Heartgene research could be terminated without your consent in the case of a transfer of ownership of Heartgene (described in our Privacy Policy), or termination of Heartgene products or services (described in our Terms of Use).

Who do I contact if I have questions?

If you have questions and need help with Heartgene product or services, please contact:

support@heartgene.com
Heartgene, Inc., 55 Post Road West, 2nd Floor Westport, CT 06880

You can also print a copy of this consent document if you would like to review it in paper form.

Affirmative Consent

By agreeing to Heartgene's Terms, I am agreeing to the terms and conditions set out in this Consent, including to be contacted about future research opportunities.