Thank you to all community members who made this lupus research possible.

Enrollment for this lupus study is now closed. We are busy analyzing data to better understand genetics and lupus.
Stay tuned for updates on our findings.

Genetics and lupus.

At 23andMe, we believe your genetic data can play a critical role in shaping research. Knowing more about how genetics relate to disease can provide additional information on how people might respond to treatment, which may eventually lead to a cure. Understanding the underlying genetics of lupus could lead to better diagnostics and more effective treatments with fewer side effects.

Lupus is a chronic, autoimmune disease that can affect many different parts of the body, such as the skin, joints and various organs. This happens when the body's immune system attacks its own tissue and organs, resulting in inflammation. It's a difficult disease to diagnose because symptoms vary significantly from person to person, and they often mimic other illnesses. Options for treatment are challenging given the lack of specific medicines to treat lupus and the side-effects of current medications.

Genetics has started to play an increasingly important role in medicine to understand disease characteristics and to develop new medicines. With your participation, we could provide insight as to why some people are more likely to get lupus, what triggers the onset of symptoms and why people respond differently to treatment options and drugs.

Our goal.

We want to find a better way to treat lupus through genetics. By partnering with Pfizer (a pharmaceutical company developing drugs to treat lupus) on this study, we will work together to learn how your genes and your environment could play a role in lupus drug treatment, and how they relate to lupus risk and progression. This will be the single largest genetics study of lupus anywhere in the world.

Our research objective is to understand the genetic associations found between lupus patients' DNA and their disease, and apply this understanding to Pfizer's drug development efforts.

Want to stay in touch about future lupus research opportunities?

Email us at
lupus-help@23andme.com

What makes us different.

We believe everyone who wants to participant in research should be able to, which makes how we do our research different.

You can participate in this study without leaving your home. Your full participation will take less than 90 minutes. And your participation is anonymous. With this study, you provide a small saliva sample and complete several online surveys ranging from 5 to 15 minutes each.

Participate without leaving home in less than 90 minutes.

Traditional research studies may involve out-of-home blood tests, visits to clinics, follow up calls, local research facility visits and even drug trials. And, if you don't live close to a research facility, you may not even have the opportunity to participate. Geography alone can slow down research and, ultimately, better treatment.

This study is also different in that it gives you the opportunity to participate in future lupus studies around the world. After this initial lupus partnership with Pfizer, your information may be provided more broadly to other lupus researchers. We believe researchers and scientists everywhere should have access to information which can accelerate research and may lead to better treatments.

Your Participation.

If you are eligible to participate, we will send you a 23andMe DNA-saliva kit at no cost along with a medical records release form. Our DNA kit includes detailed instructions on how to provide your saliva sample. We will also include a medical records release form that gives us permission to contact your physician to obtain your medical records pertaining to your lupus diagnosis (via Examination Management Services, Inc. a 23andMe service provider). Your privacy is important to us and your medical records will be protected and kept private in the same manner as your genetic and self-reported information. Once completed, you will send your kit and medical records release form back to us in the pre-paid packaging provided. We will also ask you to answer a short online survey (15 minutes) about your personal lupus journey, symptoms, response to treatments and more.

Within the 12 months after you join the study, we will ask you to complete five additional short surveys – one every other month. Each survey will take no longer than 5-10 minutes to complete and you will receive $5 in compensation for each one. There will also be one final survey at the completion of the study. This will take about 15 minutes to complete and your compensation will be $25. The total potential compensation (for completing five short bi-monthly surveys plus one final survey) of $50 will be paid out in an Amazon gift card by the end of the study.

Benefits for participants.

If you are not already a 23andMe customer:
  • You can help advance medical research and contribute to the scientific understanding of lupus
  • You will receive one 23andMe® Personal Genome Service DNA kit delivered to your home at no cost, which will give you access to:
    • Full DNA genotyping and analysis
    • Your personalized genetic reports
  • You will be compensated (a potential of $50 for full participation) for completing five bi-monthly surveys and one final study survey
If you are a current 23andMe customer:
  • You can help advance medical research and contribute to the scientific understanding of lupus
  • You will receive a $20 Amazon gift card for joining the study and agreeing to the terms
  • You will be compensated (a potential of $70 for full participation) for completing five bi-monthly surveys and one final study survey

Our promise to you.

We promise quarterly updates on our study progress and promise to answer questions you may have throughout the study. As we grow our participant base and analyze the data, there may be additional opportunities to participate in more research. If you would like to continue your participation, you will have the opportunity to make ongoing contributions in future studies. We will communicate any additional research opportunities in newsletters, emails or on your Home page.

We believe your genetic data can be used for good.

No one can promise a cure or a treatment, but we promise to be transparent in our research efforts. We will also empower other researchers and scientists with lupus genetic data in a time when resources and funding can be scarce.

We believe your genetic data can be used for good.

See if you're eligible.

In order to participate in the first study within the lupus community, you must meet all of the following criteria:

  1. You've been diagnosed with lupus* by a qualified physician.
  2. You consent to have 23andMe (via a partner) contact your physician to obtain your medical records.
  3. You're willing to submit a saliva sample for DNA testing and complete online surveys related to your condition.
  4. You are at least 6 years old (minors under 18 require parental consent to enroll).
  5. You have access to the Internet.
  6. You reside in the United States.

*Individuals diagnosed with systemic lupus erythematosus (SLE) are eligible to participate in this study. Individuals diagnosed with only cutaneous lupus such as discoid lupus, subacute cutaneous lupus, lupus tumidus, or lupus profundus are not eligible.

Our scientific advisors.

We believe Pfizer has access to great scientists and physicians in this field, and has experience in developing drugs to improve the lives of people. What's more, we believe lupus experts from around the world could also help play a critical role in our lupus research community.

Additionally, we've selected four advisors with a range of lupus expertise globally. They are not part of 23andMe, Pfizer or any other study partner. They are experts in the field of lupus and their experience can range from seeing patients to being a part of cutting edge research. They assist us with survey development and data analysis, and help guide our research so our goals are unbiased – not self-serving.

FAQ and other resources.

Participation


What is the 23andMe lupus study?

It is a 23andMe research study focused on lupus. The goal of this study is to answer two main questions:

  1. Why do people get lupus? Are there genetic factors that contribute to the cause and severity of lupus?
  2. How should people be treated? Do genes influence different responses to medications or other treatment?

Currently, the cause of lupus is unknown, but previous research suggests that there is a strong genetic component involved. The 23andMe web-based platform enables a large group of individuals with lupus to come together to provide valuable data for research. This research data includes genetic information (using DNA from saliva) and information about each participant’s unique experiences with the disease (using responses from online surveys). Conducting research using this data may help improve diagnosis and find better treatments.


What does it mean to be a "research participant" in the lupus study?

It means that you will agree to contribute your 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 lupus-help@23andme.com.

What will I be asked to do?
You will be asked to:

  1. Enroll and consent through the 23andMe website so you can contribute your genetic data, medical records, and survey answers to the lupus study.
  2. Respond to a short questionnaire to determine your eligibility to participate. This step is very important to ensure the integrity of the study.
  3. Provide us with your physician's contact information to allow Examination Management Services, Inc. (EMSI), to obtain and access your medical records on 23andMe's behalf. EMSI is an independent third party service provider specialized in contacting health providers to obtain medical records. Information from your medical record will be securely transferred to 23andMe and used by EMSI only for that purpose.
  4. Provide a DNA sample (from your saliva) for genetic analysis. We will keep this saliva/DNA stored in our laboratory.
  5. Complete 7 short online surveys about your experience with lupus over the course of a year. Surveys will include questions about your diagnosis, treatment, symptoms, medications and family history. We will email you to let you know when to take these surveys, and may send reminders and call you if you haven't finished all the available surveys.

How will 23andMe use my data?
We will use your data to answer two main questions:

  1. Why do people get lupus? Are there genetic factors that contribute to the cause and severity of lupus?
  2. How should people with lupus be treated? Do genes influence different responses to medications or other treatment?

We will compare your genetic data, your medical records and your survey answers with the genetic data and survey answers of the other research participants with lupus. This comparison will allow us to see if certain genetic factors are linked to specific features of lupus.

As part of this study, 23andMe may share your de-identified, individual-level data with qualified research partners. This means that the data we share about you with researchers will be stripped of identifying components (name, email, address, user ID and password).

What are the risks of being a research participant?

  • Being a research participant means that 23andMe and our qualified research partners store your genetic information and survey answers. If a security breach occurred, your data could be leaked. Please refer to How do you protect the confidentiality of my data? for more information about this risk.
  • If you are not already a 23andMe customer, 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, or surprising facts related to your ancestry).
  • Please refer to our Terms of Service 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 genetics research. As a research participant, you will:

  • Take a direct role in research that may benefit you and other individuals with lupus
  • Participate in web-based research from the comfort of your own home
  • Be kept informed of the discovery process as research advances
  • Have the option to learn more about your genetic ancestry.

What do I need to do to participate?

  1. Enroll, provide consent and answer questions to determine your eligibility through the 23andMe website: http://www.23andme.com/lupus/
  2. Provide a saliva sample and send it back in the prepaid postage box
  3. Complete 7 online surveys over the course of a year

What are the advantages of participating in this research?

23andMe provides a new opportunity to participate in genetics research. As a participant, you will:

  • Learn about yourself through the 23andMe Personal Genome Service at no cost. You will receive personalized reports on your health, traits and ancestry.
  • Take a direct role in research that may benefit you and other individuals with lupus
  • Participate in web-based research from the comfort of your own home
  • Be kept informed quarterly on study progress

Will my 23andMe account be different from other 23andMe customers' accounts?

As a participant in the Lupus Research Initiative, you will receive the 23andMe® Personal Genome Service DNA test kit which will give you access to valuable information on your genetics. You will also receive updates on project-related discoveries.

Your 23andMe account will not be eligible to post, reply to, or join Community groups.

Participants who purchased a Personal Genome Service DNA test kit and created a 23andMe account prior to joining the lupus study will lose access to the Community forums.

To learn more about this restriction please email lupus-help@23andme.com.


Will I have access to the community forums?

Upon enrolling in the Lupus Research Initiative, participants agree to lose access to the community forum.

Participants who purchased a Personal Genome Service DNA test kit and created a 23andMe account prior to joining the Lupus Research Initiative will lose access to the community forums. This means that once a participant enrolls and is accepted into the study, they will no longer be able to post on the community forums.


Who can I contact if I have more questions about the lupus study?

For questions regarding your eligibility to join this research initiative, saliva sample, the online survey[s], or your account with 23andMe, please contact lupus-help@23andme.com


Medical Records


Why does 23andMe need my medical records for this study?

Information from medical records will help to enhance the quality and relevance of data collected from study participants and increase the accuracy of the data analysis.


How will 23andMe obtain my medical records?

23andMe has selected Examination Management Services, Inc. (EMSI) as its service provider to obtain the medical records of the study's participants. Once you enroll, 23andMe will send you a medical records release form to complete. Your completed form is required to enable EMSI to contact your physician to obtain your medical records.

EMSI will contact your physician to request your medical records, which include your lab results, appointment summaries, and diagnoses. The transfer of your medical records from your physician(s) to EMSI will be done via a secure method. 23andMe has requested that EMSI pulls out the following information from your medical records: your lupus diagnosis, lupus-related medications, and lab results. EMSI will remove your name and other identifying information from your medical records and replace it with a unique identifier before securely transferring the information to 23andMe.

Participants must consent to have their physician share their medical records with 23andMe and Pfizer, who is sponsoring the study, in order to participate in the lupus study. Return of the completed authorization form is a required step in study participation.


How will 23andMe protect the confidentiality of my medical data?

EMSI will make all efforts to remove identifying information from your medical records before sending it to 23andMe.

23andMe will protect your actual medical records in the same manner that we protect your genetic and self-reported information. Please refer to our Privacy Statement to learn about 23andMe's privacy practices with respect to genetic and self-reported information. Please also refer to our Security and Data Sharing FAQs for more information on these policies.


Compensation


Are existing customers compensated for their participation in the study?

Existing customers are customers who purchased a kit prior to joining the study and were genotyped on the 23andMe's V3 or V4 platform. Customers genotyped before 2010 on older platforms will be considered new customers, and should refer to the New Customer Compensation FAQ.

Compensation will be sent to participants via email and provided in the form of an Amazon gift card. Participants will only receive compensation for the surveys that have been fully completed, and will be compensated up to $70 for their participation in the study.

A participant will receive follow up surveys only once the background survey has been completed. Participants who do not complete the background survey will not be able to take any of the follow up surveys, and therefore cannot receive compensation for those surveys.

Compensation will be provided to participants according to the schedule outlined below.

Compensation schedule:

  • Completion of the background survey and return of the completed medical records release form: $20
  • Completion of follow up survey 1: $5
  • Completion of follow up survey 2: $5
  • Completion of follow up survey 3: $5
  • Completion of follow up survey 4: $5
  • Completion of follow up survey 5: $5
  • Completion of follow up survey 6: $25

Sample compensation scenario: If the participant returns the completed medical records release form, completes the background survey and only follow up survey 1, he/she will receive a total of $25 by the end of the study.


Are new customers compensated for their participation in the study?

New customers will receive the Personal Genome Service DNA test kit and related services at no cost. This includes customers who did not purchase a DNA test kit from 23andMe prior to joining the study, as well as customers who were genotyped before 2010 on older 23andMe platforms.

Compensation will be emailed to participants and provided in the form of an Amazon gift card. Participants will only receive compensation for the surveys that have been completed, and will be compensated up to $50 for participation.

Follow up surveys will only appear once the background survey has been completed. Participants who do not complete the background survey will not be able to take any of the follow up surveys, and therefore cannot receive compensation for those surveys.

Compensation will be provided to participants according to the schedule outlined below.

Compensation schedule for new customers:

  • Completion of the background survey and return of the completed medical records release form: No compensation
  • Completion of follow up survey 1: $5
  • Completion of follow up survey 2: $5
  • Completion of follow up survey 3: $5
  • Completion of follow up survey 4: $5
  • Completion of follow up survey 5: $5
  • Completion of follow up survey 6: $25

Sample compensation scenario: If the participant returns the completed medical records release form, completes the background survey and only follow up survey 1, they will receive a total of $5 by the end of the study. Study participants will only be compensated for completing the lupus study surveys.


Why is compensation different for existing and new customers?

Existing customers will be compensated up to $70 for participation and new customers will be compensated up to $50 for participation.

Because existing customers purchased the Personal Genome Service DNA test kit prior to joining the study, they are offered additional compensation of $20 for completing the background survey and returning the signed medical records release form.


Who can I contact if I have not received compensation?

Please email lupus-help@23andme.com if you have not received your compensation at the end of the study. If you have withdrawn from the study and believe that you have completed study steps that make you eligible to receive compensation, please also contact us at lupus-help@23andme.com.


Research


Why is this study helpful to lupus research?

We believe that this study will enhance research for lupus by:

  • Bringing together a large group of people who have lupus to better understand how genes may influence age of diagnosis, disease progression, symptoms, and different responses to treatments.
  • 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.

What does it mean for Pfizer to sponsor this study?

We are working closely with Pfizer medical experts to ensure that the right research questions are being asked and with the patient advocacy community to ensure that patients' best interests are first and foremost.

If a commercial product is developed as a result of findings from this research, rights to the commercial product will belong to 23andMe and/or Pfizer and their collaborators (persons or companies partnering with Pfizer). 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.


Will there be more opportunities to contribute to lupus research?

Our lupus study with Pfizer includes 7 surveys - background survey, a longitudinal survey repeated 5 times, and a final survey. Participants are asked to complete these surveys over a period of 1 year. 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 surveys to enhance the research.

We will communicate any additional research opportunities in the study newsletters, emails, and in your 23andMe.com Home page.


23andMe® Personal Genome Service


What is the 23andMe Personal Genome Service?

As part of your participation in this research study, you will receive complimentary access to 23andMe's Personal Genome Service DNA test kit and related services (PGS). PGS provides you with your unique personal genetic profile, including reports on your health, traits and ancestry.


For how long will I have access to my account with 23andMe?

Your account will continue to receive updates as long as the genetic information referenced in those updates is among the data generated by your original DNA sample. If a future feature or report relies on DNA results not included in your initial analysis, access to that feature or report would require upgrading to the next platform. Any future upgrades beyond the current technology are not included as a benefit to participation.


Security and Data Sharing


Will you share my genetic data with third parties?

To increase the chance that meaningful scientific discoveries about your condition are made, 23andMe may share your de-identified, individual-level data with qualified research partners, such as Pfizer.

The shared data will be stripped of identifying components (name, email, address, user ID and password). If 23andMe shares your genetic or self-reported data with a qualified research partner, this action cannot be undone and your data will not be returned to 23andMe. Please refer to our Privacy Statement to learn more about our practices.


How do you protect the confidentiality of my data?

23andMe may share only your de-identified, individual-level data with qualified research partners.

We built all of our systems to maximize protections of individual level data 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 identifying information and are coded with a unique research ID.

23andMe research scientists who have access to your sensitive data (i.e. DNA results, survey responses) do not have access to your account or contact information. Conversely, 23andMe project managers who have access to your contact information do not have access to your sensitive individual-level data. 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.

A 100% guarantee in the field of information security does not exist since there are always unknown threats. However, we constantly update our security systems and protocols to deal with new threats, as they become known. We can protect against known factors by applying the best practices developed by the information security community to protect your data.

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 will also have agreements with all research partners regarding the security and storage of de-identified, individual-level 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.


Before you enroll, we recommend reading the below resources:

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