Genetics & Systemic Sclerosis
Systemic sclerosis is a form of scleroderma that can not only affect the skin and underlying tissue, but also the internal organs. In this study, 23andMe researchers aim to learn more about the genetics of people living with the disease in order to search for clues that could ultimately lead to the development of better treatments.
By choosing to participate in this research, YOU have the power to potentially make a difference in the lives of people living with this condition. If not now, for the future.
At 23andMe, we are committed to advancing research through the power of genetics. Our goal for this specific study is simple–we want to improve the lives of people living with systemic sclerosis by developing an effective drug treatment. But reaching that goal is not as simple. Your participation is vital.
Why your participation is so important
Systemic sclerosis is considered a rare disease. And because rare diseases affect fewer people, a lack of market incentive often makes treatments just as rare. We are hoping to change that. Through our study, people living with this condition can provide genetic information and invaluable insight that can bring us closer to future treatment discovery. Your time and effort are pivotal in achieving this goal. We know living with this disease, on top of daily life in these times, brings about its own struggles. So we cannot thank you enough should you choose to participate.
You are eligible to participate in this study if you:
- Have been diagnosed with systemic sclerosis
- Are 18+ years old
- Live in the US
How It Works
Participation in the study is simple and can be done entirely from home. If you are eligible, you will receive a 23andMe Health + Ancestry kit at no cost. After providing a saliva sample, you will be invited to answer survey questions about your overall health and your experience with systemic sclerosis.
Who We Are
The name 23andMe refers to the fact that human DNA is organized into 23 pairs of chromosomes. Founded in 2006, it is our mission to help people access, understand and benefit from the human genome. With the help of our 23andMe community we believe we can accelerate research and make an impact with our genetic data
If you choose to consent to participate in this study you will be asked to agree to the sharing and transfer of your individual-level genetic and self-reported Information to qualified third-party collaborators including advocacy organizations, clinical research centers, pharmaceutical companies and patient registries and/or databases. Your data will be stripped of identifying information, such as your name and contact information. If you agree, your de-identified individual-level data may be accessible by other qualified researchers for the purpose of research on autoimmune diseases like systemic sclerosis.
This is a research study focused on better understanding the underlying genetic and environmental factors that contribute to systemic sclerosis. The ultimate goal of this research is to help develop an effective treatment for systemic sclerosis that can improve the lives of those living with the condition. Your help is vital.
Currently, the cause of systemic sclerosis is unknown, but previous research suggests that there is a strong genetic component. The 23andMe online platform enables a large group of individuals to come together to provide valuable data to researchers. This research data includes genetic information (using DNA from saliva) and information about each participant's unique experiences (using responses from online surveys). Conducting research using this data may help find better treatments for systemic sclerosis or similar conditions.
Our goal is to enroll 1,000 participants with systemic sclerosis.
You can participate in this study if:
- You are over 18 years old and live in the United States.
- You have been diagnosed with systemic sclerosis.
- You are willing to provide a saliva sample for DNA testing.
- You are willing to complete two online surveys. We may also ask you to complete short follow-up surveys regarding your experience with systemic sclerosis over time.
If you have been diagnosed with systemic sclerosis by a medical professional and you meet the other criteria listed above, you may be eligible to participate in this study.
- Enroll and consent through the 23andMe website so you can contribute your genetic data and survey responses to the Systemic Sclerosis Research Study.
- Respond to a short questionnaire to determine your eligibility to participate.
- Provide a DNA sample (from your saliva) for genetic analysis, if you are eligible to participate. We will securely store this saliva sample/DNA in our laboratory.
- Complete two short online surveys about your overall health and your experience with your condition. This survey will include questions about your diagnosis, treatment, symptoms, medications and family history. We may also ask you to complete short follow-up surveys regarding your experience with systemic sclerosis over time.
Being a 23andMe research participant means that you will agree to contribute your genetic and Self-Reported Information for research purposes. There are many aspects to being a research participant. We have summarized the most important ones below. If you have more questions, you can contact us at email@example.com.
What will I be asked to do?
You will be asked to:
- Enroll and consent through the 23andMe website so you can contribute your genetic data and survey answers to the Systemic Sclerosis Research Study.
- Respond to a short questionnaire to determine your eligibility to participate.
- Provide a DNA sample (from your saliva) for genetic analysis, if you are eligible to participate. We will keep this saliva/DNA stored in our laboratory.
- Complete 4 short online surveys about your experience with your condition. These surveys will include questions about your overall health, diagnosis, treatment, symptoms, medications and family history. We may also ask you to complete short follow-up surveys regarding your experience with systemic sclerosis over time.
How will 23andMe use my data?
If you choose to participate in this study, 23andMe will use your data in accordance with our Privacy Statement, namely in two key ways: 1) to provide you Services as a customer of 23andMe and 2) for research purposes as a Systemic Sclerosis Research Study research participant.
We use your data to operate, provide, analyze and improve our services. These activities may include, among other things, using your information to:
- Open your account, enable purchases and process payments, communicate with you, and implement your requests (e.g., referrals).
- Process and deliver your genetic testing results.
- Offer new products or services to you, including through emails or promotions.
In order to enroll in our Systemic Sclerosis Research Study, you will need to agree to several consent documents which enable us to use and share your data in the following ways:
If you agree to the main 23andMe Research Consent Document, you are giving consent for 23andMe to include your Genetic and Self-Reported Information in data summaries we share with qualified third party researchers.
23andMe may share your de-identified data , which is bundled (or aggregated) with data from other research participants (so you cannot be easily identified), with qualified research partners for this study and potentially for other studies in the future. This research could cover many different topics studied by 23andMe and our research collaborators.
Non-summarized, individual-level data:
If you agree to the Systemic Sclerosis Research Study Consent Document, you will consent to share individual, non-aggregated data with our qualified third party partners including advocacy organizations, clinical research centers, and patient registries and/or databases. Your data will be stripped of identifying information, such as your name and contact information. If you agree, your de-identified individual-level data may be accessible by other qualified research collaborators for the purpose of autoimmune disease research.
This means we can share your individual genetic and self-reported data with qualified third party researcher collaborators without bundling it. The information we share about you with our research collaborators will be stripped of identifying components (name, email, address, user ID and password). These researchers will only be able to use your data to study systemic sclerosis and related autoimmune conditions.
We encourage you to read these consent documents carefully. For your records, you can print each of the consent documents or review them at any time by going to your account settings. If you have any questions, don't hesitate to reach out to us at firstname.lastname@example.org.
What are the risks of being a research participant?
- Being a research participant means that 23andMe will collect and store your Genetic Information and Self-Reported Information (this includes survey answers you might feel are sensitive in nature), and securely transfer them to qualified research partners. Although 23andMe implements physical, technical, and information administrative measures to prevent unauthorized access to or disclosure of your information, in the event of a data breach, your information may be compromised.
- Please refer to How do you protect the confidentiality of my data? for more information about this risk.
- If you choose to access the health, traits and ancestry reports resulting from your use of the 23andMe Service, you may learn information about yourself that you do not anticipate (e.g., that you are not related to a family member in the way you thought, surprising facts related to your ancestry, or that you could pass on an inherited genetic condition to your children). Your 23andMe reports are not intended to diagnose a disease, or tell you anything about your risk or likelihood for developing a disease in the future. Please contact a qualified medical provider if you have any questions or concerns about the results contained in your reports.
- Please refer to our Terms of Service and Privacy Statement for more details about the risks of being genotyped.
What are the benefits of being a research participant?
This is a new opportunity to participate in systemic sclerosis genetics research. As a research participant, you:
- Could play a role in helping researchers understand the relationship between systemic sclerosis and genetics.
- Will be kept informed of the discovery process as research advances.
- Will have the option to learn more about your genetic health and ancestry.
Do the 23andMe Terms of Service apply to participants in the Systemic Sclerosis Research Study?
If you agree to participate in the Systemic Sclerosis Research Study, your participation includes the use of a 23andMe DNA kit and optional access to the 23andMe Service at no cost. As part of joining this study you will be required to agree to the 23andMe Terms of Service document.
We want to make sure you understand that while participating in the study activities described below, the following sections of the Terms of Service will not apply to the extent they prevent you from pursuing a claim if you suffer a research-related injury:
- Section 14 ("Indemnity")
- Section 23 ("Disclaimer of Warranties"), Subsections (1), (3), (4), and (5)
- Section 24 ("Limitation of Liability")
- Section 28(f) ("Term for Cause of Action")
Study activities include:
- Providing a saliva sample for genetic analysis using a 23andMe DNA kit.
- Completing the Systemic Sclerosis Research Study and Health Profile surveys. We may also ask you to complete short follow-up surveys regarding your experience with systemic sclerosis over time.
Please note, however, that if you choose to use any of 23andMe's products, software, services, and website, outside of your participation in these study activities, you will be, just like all users of 23andMe's products, software, services, and website, subject to the 23andMe Terms of Service.
Joining this study will not affect your diagnosis or treatment options today. Participation allows you to contribute to an effort to develop more effective treatments that can improve the lives of those living with systemic sclerosis.
At this time, the 23andMe® Personal Genetic Service does not include health reports on systemic sclerosis or related conditions.
At this time, enrollment in the Systemic Sclerosis Research Study is limited to United States residents. We currently do not have plans to expand this study to residents of other countries.
Research projects like this must be carried out under the supervision of a research ethics committee. In the United States this is called an Institutional Review Board (IRB), which is an independent ethics panel that ensures all research is conducted in accordance with government and ethical guidelines. 23andMe has approval from our IRB to conduct the Systemic Sclerosis Research Study only in the United States, and therefore we are not authorized to enroll participants who live outside the United States at this time.
If you misplace your kit, don't worry. Email us at email@example.com and we will mail you a new one at no cost. Once you're enrolled, we'll send you reminders to return your kit.
You can withdraw from research at any time by changing your consent status in your account settings. Email us at firstname.lastname@example.org and we can help you.
We are here to answer your questions. Email us at email@example.com and we will do our best to get back to you within two weeks.
We believe that this study will enhance research into systemic sclerosis by:
- Bringing together a large group of people to better understand how genes may influence systemic sclerosis.
- Expanding the geographic reach of the research study by enabling participation from home.
- Removing some of the time and cost barriers that can slow progress in other types of studies.
The Systemic Sclerosis Research Study includes completing two surveys. As more people join the study and our research scientists start to look at the data, there may be an opportunity to participate in additional studies to enhance the research. For example, we may also ask you to complete short follow-up surveys regarding your experience with systemic sclerosis over time.
If there are any additional study or survey opportunities, we will let you know about them through your 23andMe.com account and/or email.
If a commercial product is developed as a result of findings from this research, rights to the commercial product will belong to 23andMe and their collaborators. You and your family will not receive any financial benefits or compensation from or have any rights in any developments, inventions or other discoveries that might come out of this research.
Existing customers are individuals who have been genotyped by 23andMe prior to joining the study, and we welcome them to complete the Systemic Sclerosis Research Survey. There is no need to complete the study enrollment process; you can get started now by taking the survey here.
However, please know that the product experience will not change as a result of an existing customer's participation in a study. For example, if an existing customer purchased the Ancestry + Traits Service, they will not gain access to the Health + Ancestry Service without purchasing an upgrade.
New customers have not yet participated in 23andMe’s services and have not had their saliva analyzed prior to enrolling in a study. If they enroll in this study and meet the eligibility criteria, new customers will receive the 23andMe® Health + Ancestry Service, including a DNA test kit, at no cost. Learn more about the 23andMe Health + Ancestry Service here and read important test information here.
23andMe®'s Personal Genetic Service offers over 150 personalized genetic reports on your health, traits and ancestry based on your DNA. You can learn more about this service at 23andMe.com.
If you are new to 23andMe, as part of your participation in this research study, you will receive complimentary access to 23andMe®'s Personal Genetic Service. Learn more about the 23andMe Health + Ancestry Service here and read important test information here.
If you are already a customer of 23andMe, you will not be eligible to receive an additional complimentary 23andMe®'s Personal Genetic Service kit.
You will continue to have access to your 23andMe account and will receive report updates as long as the genetic information referenced in those updates is generated from your original DNA sample. If a future feature or report relies on DNA results not included in your initial analysis, you may need to purchase a chip upgrade and/or subscription to access that feature or report. Any future upgrades beyond the current technology are not included as a benefit to participation.
If you consent to participate in the Systemic Sclerosis Research Study, 23andMe may share your de-identified, individual-level data with qualified research collaborators including advocacy organizations, clinical research centers, pharmaceutical companies, and patient registries and/or databases. Your data will be stripped of identifying information, such as your name, email, address, user ID and password. If you agree, your de-identified individual-level data may be accessible by other qualified researcher collaborators for the purpose of autoimmune disease research.
You may withdraw your consent at any time from your Account Settings. If 23andMe shares your Genetic or Self-Reported Information with a qualified research partner prior to your withdrawal, any research involving your data that has already been performed or published prior to your withdrawal from 23andMe Research will not be reversed, undone, or withdrawn. Please refer to our Privacy Statement to learn more about our practices.
23andMe may share de-identified, individual-level data with qualified research collaborators or upload these data to a genetic database. This means you cannot be easily identified by others whom we may collaborate with in the future (researchers, scientists, etc.).
We built all of our systems with the privacy and security of our research participants at the center and we have a number of safeguards in place to ensure confidentiality. All data in the research computing environment are disconnected from your contact or registration information and are coded with a unique research ID.
23andMe research scientists who have access to your Genetic or Self-Reported Information (i.e. DNA results, survey responses) do not have access to your Registration Information (i.e. account or contact information). Conversely, 23andMe project managers who have access to your contact information do not have access to your sensitive individual-level Genetic or Self-Reported Information. Thus, it would be extremely difficult for 23andMe employees or any external party to link your individually identifying information to your DNA results and survey response data.
However, there are always unknown threats in information security. Therefore, we cannot fully guarantee the security of your data. However, we constantly update our security systems and protocols to deal with new threats as they become known. We protect against known factors by applying industry practices in all of our information security procedures.
All 23andMe Research is performed in a secure computing environment with access restricted to research scientists and system administrators. All 23andMe servers are protected by technical, physical, and administrative procedures. Our servers are monitored for unauthorized activity. Your genetic data and sensitive account information such as passwords are encrypted, as are all data transfers between our servers and your computer(s).
23andMe also has agreements with research collaborators regarding the security and storage of data that is shared outside 23andMe. Although 23andMe cannot provide a 100% guarantee that your data will be safe, 23andMe policies and procedures minimize the chance that a breach could take place.
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