Research Consent Document
Consent Document - Key Points
MenoLabs 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 MenoLabs Research. To get started you must agree to the terms in our full consent document (below). Here are the key points of that document:
How do I take part in MenoLabs Research?
- Take surveys, enter symptom data via our app, log personal health data, or otherwise enter information about yourself into the MenoLabs website or mobile application. You choose which surveys to take, which symptoms to enter, and which questions to answer.
Which of my personal information is used for research?
- Your self-reported data, health data, and any other personal information you enter into the website or mobile application, 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 personal information.
Who gets to see my personal information?
- MenoLabs's privacy statement outlines who does and does not get access to the personal information of MenoLabs customers; here we list the additional individuals who will get access if you consent to take part in the research.
- Within MenoLabs: MenoLabs researchers who conduct analyses will have access to your self-reported health data and other personal information, but not to your name, contact, or credit card information. MenoLabs researchers who contact you will have access to names and contact information, but only to very limited personal information.
- Outside of MenoLabs: MenoLabs 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 individual-level health data will be exposed. MenoLabs 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 MenoLabs's research findings, including how your answers compare with those of others and new discoveries made by MenoLabs's research program.
- Sometime in the future, you or your family may benefit indirectly from research discoveries made by MenoLabs 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 health data that includes health data about you. MenoLabs has policies and practices in place to minimize the chance of such an event.
Can I stop taking part in MenoLabs Research?
- Yes, you can withdraw from participating MenoLabs Research at the individual health data level 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 Research Consent Document
One of MenoLabs' missions is to make and support meaningful scientific discoveries by enabling its customers to participate directly in research. MenoLabs has enrolled hundreds of thousands of participants from among its customers in this project, which we call MenoLabs Research. Specifically, MenoLabs 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). For further details on MenoLabs's other uses of personal information, see our Privacy Statement.
MenoLabs seeks your voluntary participation in MenoLabs 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 MenoLabs researchers use your Self-Reported Information for MenoLabs Research, as described above. "Self-Reported Information" refers to:
- Information you enter into surveys, forms, questionnaires, forums, our health tracking app, and other digital interfaces.
- Data you authorize us to import for research via 3rd party API connections or database connections ( such as other health, food, exercise tracking apps and tools)
- Your age, reproductive status, birth control use, medication, health history, stage of menopause, gender, and ethnicity
Self-Reported Information includes any information you submitted prior to giving consent.YourSelf-Reported Information does not include identifying Registration Information you provided when you purchased the Personal Genome Service 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 MenoLabs researchers to use your Self-Reported Information for MenoLabs Research, and (2) entering data about yourself into the MenoLabs website or mobile application. 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 MenoLabs Research study is open-ended: new surveys and app features may be added on a continuing basis. If new surveys or features are added, we may invite you to complete these activities. We may also invite you to participate in a specific study if your Self-Reported Information matches the area of interest. Such invitations will be sent using routine communication methods, such as email, push notifications, or announcements when you sign in to your account.
For your participation, monetary, cash equivalents such as gift certificates or discounts on future MenoLabs products or service purchases may be provided as compensation for your time.
Your participation in the MenoLabs Research study is completely voluntary.
3. How will my data be used in MenoLabs Research?
Your Self-Reported Information may be used to discover links between symptoms, triggers, medications, and personal health history and traits, diseases, behaviors, and other characteristics. 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, symptoms, or other outcomes. The topics to be studied span a wide range of traits and conditions, from common to rare. 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, or private research entities.
4. How do you keep my data protected and private (whether or not I consent)?
MenoLabs's Privacy Statement outlines how the company protects your privacy while conducting business, such as providing our services to you. MenoLabs uses a range of physical, technical, and administrative procedures to protect the privacy of your personal information, and your survey responses.
If you agree to this Consent Document, MenoLabs can use your information in additional ways. Specifically, MenoLabs 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 MenoLabs aims to minimize the chances of a privacy breach while conducting its business, MenoLabs researchers aim to minimize the chances of a privacy breach while conducting research. Here are the main ways we do that:
- The MenoLabs 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
- MenoLabs researchers who interact with research participants and conduct interviews have access to names and contact information of participants, but only to very limited personal information
- To minimize the chance that an external person can determine that any particular customer is part of a study, MenoLabs researchers either
- publish only data pooled across multiple customers or
- publish only very limited, non-identifying information of a single individual
- All MenoLabs Research employees and partners are trained on how to work with human research participants. In addition, all MenoLabs researchers are trained on how to conduct research responsibly.
5. What are the benefits and risks of participation?
One of MenoLabs' missions is to make meaningful scientific contributions by enabling its customers to participate directly in research. If MenoLabs publishes study results in peer-reviewed journals, there may be an indirect benefit to you as scientific knowledge increases and/or new drugs, treatments, 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 women’s health research or the MenoLabs study, and/or preliminary research findings
- There may be additional benefits to participation that are currently unforeseeable.
Based on the results of this study, MenoLabs may develop intellectual property, including but not limited to patents, copyrights, and trademarks, and/or MenoLabs 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 MenoLabs Research study, as described below.
- Some survey questions or data comparisons may make you uncomfortable.
- Your 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. Although MenoLabs cannot provide a 100% guarantee that your data will be safe, MenoLabs has strong policies and procedures in place to minimize the possibility of a breach.
- When MenoLabs researchers publish results from this ongoing study, they may include your 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 personal 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 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 MenoLabs 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 MenoLabs Research study. If you choose not to give consent for MenoLabs Research, your 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 MenoLabs Research surveys or use other MenoLabs mobile applications, or web features.
At any time, you may choose to change your consent status to either take part in MenoLabs Research or to withdraw all or some of your Self-Reported Information from MenoLabs Research. Your consent status is located in the MenoLabs "Settings" page (if you experience problems changing your consent status, write to the Human Protections Administrator at email@example.com). If you withdraw all or some of your Self-Reported Information, MenoLabs will prevent Individual Level Information from being used in new MenoLabs 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 MenoLabs Research will not affect your access to your MenoLabs informational content, commerce site or loyalty programs, but may result in lack of access to health tracking tools.
You may also discontinue participation by closing your MenoLabs mobile application account, as described in the Terms of Service. Requests for account closure can be made directly by emailing firstname.lastname@example.org
In addition, the MenoLabs Research study may be terminated without your consent. In the following cases, MenoLabs will maintain your Self-Reported Information according to the terms of our Privacy Statement.
- Transfer of ownership. If MenoLabs undergoes a business transition such as an acquisition or merger, the MenoLabs Research study may be terminated. In such a case, your information would remain subject to any pre-existing Privacy Statement.
- Termination of service. MenoLabs may terminate your access to the MenoLabs mobile application for any of the five reasons described in the Terms of Service. If your access to the MenoLabs mobile application is terminated for any of these reasons, your participation in the MenoLabs Research study may also be terminated.
7. Who do I contact if I have questions?
If you have general questions and need help with MenoLabs's service, please contact:
If you have any questions or concerns about the MenoLabs Research study, if you suffer a research-related injury, or if you have a question about subjects' rights, please contact the following:
- MenoLabs Human Protections Administrator
- Email: email@example.com