At Invitae, we empower patients to use their health records to seek the best possible treatments for themselves and to drive change for the wider community. When you join the Ciitizen Research Initiative and agree to share your health information from your Ciitizen Profile for research, you are joining a community of people who share your commitment to fighting disease.
Your consent to participate in this research initiative is completely voluntary and is not required to use any of our products or services. Even if you consent to participate, you may withdraw your consent at any time, but your information will not be removed from research that is in progress or completed. We encourage you to carefully read the full text below before deciding whether to give consent.
You can consent below for yourself – or for someone for whom you are legally responsible (your “loved one”) (e.g., a child or an adult for whom you make medical decisions).
1. What is the Ciitizen Research Initiative?
The heart of the Ciitizen Research Initiative is to advance research related to finding treatments and cures for health conditions. One way we do that is to offer you (on behalf of yourself or a loved one) the opportunity to participate in scientific research designed to:
- understand diagnoses and treatments of conditions across different demographics;
- explore the connection between genetics and diagnoses;
- develop new or improved diagnostic tools and therapies to treat diseases or other conditions;
- improve the lives of all persons living with a health condition; and
- add to the general knowledge base and science of each condition (together, the “Purpose”).
We refer to all research that Invitae or others may do over time as the Ciitizen Research Initiative (the “Initiative”). We refer to Invitae Corporation affiliated companies collectively as “Invitae,” “Invitae’s Ciitizen platform,” “us,” “we,” or “our.”
2. What type of research will be conducted with my data?
Invitae leverages the Ciitizen platform to advance the treatment of health conditions and help find cures. This consent is intended to allow you to consent broadly – and in advance – to the use of de-identified data from your Ciitizen account for any research that has the potential to improve the understanding of diagnoses, such as cancer or neurological conditions, or could help lead to new or better treatments. If you or your loved one has a specific condition, then your (or your loved one’s) data may be made accessible to researchers studying the same diagnosis.
By agreeing to participate in the Ciitizen Research Initiative, your data (or the data of your loved one) will be made accessible to all Invitae research partners conducting relevant research. Note: because you are broadly consenting in advance to sharing your (or your loved one’s) summary data with researchers, you will not receive advance notice of the specific research initiatives being conducted with your (or your loved one’s) data. Although providing this broad consent does not give you the chance to vet research opportunities individually, it does give you the advantage of assuring that your data (or the data of your loved one) will be part of a broad range of research initiatives.
3. Who conducts the research?
Research conducted as part of Invitae’s Ciitizen Research Initiative includes partnerships with researchers from academic medical centers, patient advocacy organizations, nonprofit research institutions, pharmaceutical companies, independent clinical research organizations and others who share our Purpose. This might include academic institutions as well as non-profit and for-profit businesses or government agencies. The research for the Initiative may be performed solely by employees of Invitae, or solely by outside researchers or by a combination of both. We refer to all researchers, whether affiliated with Invitae or our partners as “Researchers” within this Consent. In some instances, Invitae receives compensation from collaborators who work on the Initiative.
4. What type of information is shared?
As part of the Ciitizen Research Initiative, Invitae uses our patent pending machine learning engine to:
- take the thousands of medical and claims records (including images) collected from your (or your loved one’s) medical providers and health plans as well as information you share with us, such as symptoms, treatment side effects, mood, quality of sleep or fitness and nutrition, plus biosensor data recorded by mobile phones or activity trackers, or health and wellness data collected from other devices, and
- summarize the most important elements in a research summary.
You are under no obligation to share this data with us. However, if you do and you have given consent to participate in the Initiative, this research summary may be used by the Researchers. The elements in this summary are then matched with clinical terminology codes so that researchers can immediately make use of this data.
Summary data to be shared with Researchers will not include your (or your loved one’s) name, contact information or other common identifying information. When we collaborate with government agencies on research, we take all necessary steps to protect your (and your loved one’s) privacy in accordance with laws and regulations pertaining to government-funded research. In some instances, if we partner with, or our research is funded by, certain U.S. agencies like the National Institutes of Health, we may be required to contribute certain data to a national database that will be accessible by other researchers. In the event such contribution is required, we will only provide summary data that has had identifying information removed in accordance with U.S. federal regulations.
Your (or your loved one’s) summary data may also be shared with others who review the quality and safety of the research (for example, the U.S. Food and Drug Administration, other regulatory agencies). We will never knowingly disclose or interpret your (or your loved one’s) data for use by employers or insurers for employment or insurance purposes.
5. Are there any risks to participating in the Ciitizen Research Initiative?
6. What are the benefits to participation in the Ciitizen Research Initiative?
It can take a long time for research to produce results, so participation in the Ciitizen Research Initiative may not change your treatment options (or the options available for your loved one). No financial compensation will be provided to you or your loved one for any commercial developments related to the Initiative that may be developed by Researchers. But by participating, you will help power scientific discoveries that could help others. For some (but not all) research projects, Invitae will publish the results. If your (or your loved one’s) data was used, we let you know so you can review the research for yourself.
7. How long will my data be part of the Ciitizen Research Initiative?
Your (or your loved one’s) data will be available in the Ciitizen Research Initiative indefinitely, until you withdraw your consent to participate (see below), or in the case of a child, when your child reaches the age of 18 years. When your child reaches the age of 18 years, he/she/they (or his/her/their legal representative) will have an opportunity to decide whether or not to continue to participate in the Ciitizen Research Initiative.
8. Do I have alternatives? Can I withdraw from participation?
Your participation (or the participation of your loved one) in the Ciitizen Research Initiative is completely voluntary. You can decide not to participate and still enjoy all of the benefits of having a Ciitizen profile for yourself or a loved one.
You can withdraw your consent to participate (or for your loved one to participate) in the Ciitizen Research Initiative at any time. It can take up to thirty (30) days for your withdrawal to take effect, and your withdrawal will prevent researcher access from occurring after this processing period. Summary data that has already been shared with researchers as part of the Ciitizen Research Initiative may not be recovered.
9. What if I have questions or concerns?
Please contact firstname.lastname@example.org or call 855-244-8493 if you have questions about the Ciitizen Research Initiative, or if you believe you or your loved one have/has experienced a research-related injury.