Research Consent Document
Consent Document - Key Points
Certainty Health aims to make and support scientific discoveries and publish those discoveries in scientific journals. We invite you to take part in this project, which we call Certainty Health Research. To get started you must agree to the terms in our full consent document (below). Here are key points of that document:
How do I take part in Certainty Health Research?
Take surveys or otherwise enter information about yourself into the Certainty Health website. You choose which surveys to take and which questions to answer.
Can my child take part in Certainty Health Research?
Which of my personal information is used for research?
Your genetic data and any other personal information you enter into the website, except for your Registration Information (name, contact information, and credit card information), may be analyzed in the research.
Your name and contact information may be used to communicate with you but are not analyzed in combination with your genetic and other personal information.
Who gets to see my personal information?
Certainty Health's privacy statement outlines who does and does not get access to the personal information of Certainty Health customers; here we list the additional individuals who will get access if you consent to take part in research.
Within Certainty Health: Certainty Health researchers who conduct analyses will have access to your genetic and other personal information, but not to your name, contact, or credit card information. Certainty Health researchers who contact you will have access to names and contact information, but only to very limited genetic or other personal information.
Outside of Certainty Health: Certainty Health may share some data with external research partners and in scientific publications. These data will be summarized across enough customers to minimize the chance that your personal information will be exposed. Certainty Health may need to share the information with other agencies as required by law.
How will I benefit from this research?
By taking surveys you may learn about Certainty Health's research findings, including how your answers compare with those of others and new discoveries made by Certainty Health's research program.
Sometime in the future you or your family may benefit indirectly from research discoveries made by Certainty Health or its research partners.
What are the risks of taking part in this research?
There is a very small chance that someone with access to the research data or results could expose personal information about you. Certainty Health has policies and practices in place to minimize the chance of such an event.
Can I stop taking part in Certainty Health Research?
Yes, you can withdraw from Certainty Health Research at any time. Any of your data that have already been entered into a study cannot be withdrawn, but your data will not be included in studies that start more than 30 days after you withdraw (it may take up to 30 days to withdraw your information after you withdraw your consent).
Full Consent Document
One of Certainty Health's missions is to make and support meaningful scientific discoveries by enabling its customers to participate directly in research. Specifically, Certainty Health Research refers to research aimed at publication in peer-reviewed journals and research funded by the federal government (such as the National Institutes of Health - NIH). The Certainty Health Research study aims to:
- Discover genetic factors behind diseases and traits
- Uncover connections among diseases and traits
- Learn about human migration and population history through genetics
- Understand how people react to their personal genetic information
- For further details on Certainty Health's other uses of personal information, see our Privacy Statement.
Certainty Health seeks your voluntary participation in Certainty Health Research.
This document explains:
- What you are agreeing to if you consent
- How you can participate
- How your data will be used
- How we protect your data and keep it private
- The benefits and risks of participation
- Your options and how to withdraw
- Who to contact if you have questions
1. What am I agreeing to if I consent?
Giving consent by checking the appropriate box below means that you agree to let Certainty Health researchers use your Genetic & Self-Reported Information for Certainty Health Research, as described above. "Genetic & Self-Reported Information" refers to:
- Your genetic data
- Information you enter into surveys, forms and other features labeled with the Certainty Health Research logo or
- Data you authorize us to import for research
- Your age and ethnicity
- Self-Reported Information includes any information you submitted prior to giving consent. If you have elected to have your sample stored, we may also use the results of further analysis of your sample in Certainty Health Research. Your Genetic & Self-Reported Information does not include identifying Registration Information you provided when you purchased your test or created an account (such as name, address, email address, user ID, password, or credit card information).
2. How do I participate?
Participation consists of (1) allowing Certainty Health researchers to use your Genetic & Self-Reported Information for Certainty Health Research, and (2) entering data about yourself into Certainty Health Research features on the Certainty Health website. These features include surveys, individual questions, and other features where you enter information. If you do not feel comfortable providing a piece of information, you may choose not to answer that question. You may choose to take all, some, or none of the surveys.
The Certainty Health Research study is open-ended: new surveys and features may be added on a continuing basis. If new surveys or features are added, you may receive an email update or see an announcement when you sign in to your account. We might invite you to participate in a specific study if your Genetic & Self-Reported Information matches the area of interest.
Your participation in the Certainty Health Research study is completely voluntary.
3. How will my data be used in Certainty Health Research?
Your Genetic & Self-Reported Information may be used to discover links between genetic markers, non-genetic markers, traits, diseases, behaviors and other characteristics; to study human migrations and population history; or to assess how people respond to personal genetic information. Discoveries made as a result of this research could be used to understand the basic causes of disease, develop drugs or other treatments and/or preventive measures, or predict a person's risk of disease. Some of these studies may be sponsored by or conducted on behalf of third parties, such as non-profit foundations, academic institutions or pharmaceutical companies.
4. How do you keep my data protected and private (whether or not I consent)?
Certainty Health's Privacy Statement outlines how the company protects your privacy while conducting business, such as providing our services to you. Certainty Health uses a range of physical, technical, and administrative procedures to protect the privacy of your personal information, including your genetic data and your survey responses.
If you agree to this Consent Document, Certainty Health can use your information in additional ways. Specifically, Certainty Health researchers can use your data for research that will be published in scientific journals, or that is sponsored by the National Institutes of Health and certain other organizations.
Just as Certainty Health aims to minimize the chances of a privacy breach while conducting its business, Certainty Health researchers aim to minimize the chances of a privacy breach while conducting research. Here are the main ways we do that:
- The Certainty Health researchers who conduct the statistical analyses do not have access to Registration Information (name, address, email address, user ID, password, or credit card) of customers
- Certainty Health researchers who interact with research participants and conduct interviews have access to names and contact information of participants, but only to very limited genetic and other personal information
- To minimize the chance that an external person can determine that any particular customer is part of a study, Certainty Health researchers either
- publish only data pooled across multiple customers or
- publish only very limited, non-identifying information of a single individual
5. What are the benefits and risks of participation?
One of Certainty Health's missions is to make meaningful scientific contributions by enabling its customers to participate directly in genetic research. If Certainty Health publishes study results in peer-reviewed journals, there may be an indirect benefit to you as scientific knowledge increases and/or new drugs or tests are developed.
You may also have the opportunity to acquire one or more of the following, in return for some level of participation in the research:
- Comparison of your personal survey responses to those of all responders, additional information about genetics, genetic research or the Certainty Health study, and/or preliminary research findings
There may be additional benefits to participation that are currently unforeseeable.
Based on the results of this study, Certainty Health may develop intellectual property, including but not limited to patents, copyrights and trademarks, and/or Certainty Health may commercialize products or services, directly or indirectly. In such cases you will not receive any compensation.
There are some potential risks to participating in the Certainty Health Research study, as described below.
- Some survey questions or data comparisons may make you or your family members uncomfortable.
- Your genetic data, survey responses, and/or personally identifying information may be stolen in the event of a security breach. In the event of such a breach, if your data are associated with your identity, they may be made public or released to insurance companies, which could have a negative effect on your ability to obtain insurance coverage. In addition, if you or a family member has genetic data linked to your name or your family member's name in a public database, someone who has access to your Certainty Health genetic data might be able to link that data to your name or your family member's name through the publicly available genetic data. Although Certainty Health cannot provide a 100% guarantee that your data will be safe, Certainty Health has strong policies and procedures in place to minimize the possibility of a breach.
- When Certainty Health researchers publish results from this ongoing study, they may include your Genetic & Self-Reported Information but only as part of a summary across enough people to minimize the chance that your personal information will be exposed. Identification of your individual-level data from those summaries would be extremely difficult, but it is possible that a third party that has obtained some of your genetic data could compare that partial data to the published results and infer some of your other personal information.
- As with any online service, if you disclose your account password to others, they may be able to access your account and your Genetic & Self-Reported Information.
- There may be additional risks to participation that are currently unforeseeable.
None of the surveys or other procedures used by the researchers in the Certainty Health Research study is invasive or experimental. The procedures involved do not involve more than the minimal risks described above.
6. Do I have any alternatives? Can I withdraw from this study?
Your alternative is not to participate in the Certainty Health Research study. If you choose not to give consent for Certainty Health Research, your Genetic & Self-Reported Information may still be used for other purposes, as described in our Privacy Statement. If you do give consent to participate in this study, you may choose not to take Certainty Health Research surveys or use other Certainty Health Research features.
At any time, you may choose to change your consent status to either take part in Certainty Health Research or to withdraw all or some of your Genetic & Self-Reported Information from Certainty Health Research. Write to the Human Protections Administrator at hpa@Certainty Health.com. If you withdraw all or some of your Genetic & Self-Reported Information, Certainty Health will prevent that information from being used in new Certainty Health Research initiated after 30 days from receipt of your request (it may take up to 30 days to withdraw your information after you withdraw your consent). Any research on your data that has been performed or published prior to this date will not be reversed, undone, or withdrawn.
Choosing not to give consent or withdrawing from Certainty Health Research will not affect your access to your Genetic Information.
In addition, the Certainty Health Research study may be terminated without your consent. In the following cases, Certainty Health will maintain your Genetic & Self-Reported Information according to the terms of our Privacy Statement.
Transfer of ownership. If Certainty Health undergoes a business transition such as an acquisition or merger, the Certainty Health Research study may be terminated. In such case, your information would remain subject to the promises made in any pre-existing Privacy Statement.
7. Who do I contact if I have questions?
If you have general questions and need help with Certainty Health's service, please contact:
Certainty Health Human Protections Administrator