Consent Document

Key Points

uBioDiscovery Inc. aims to solve the large disconnect between the science community and the general population. The objective for our company is to create products that will provide everyone access to their own individual biology, make and support scientific discoveries and publish those discoveries as open source resources. We invite you to take part in this project, which we call SUPERBIOME. To get started you must agree to the terms in our full consent document (below).

IMPORTANT: The SUPERBIOME kit is intended for Research Use Only.

Here are key points of that document:

1. How do I take part in the SUPERBIOME project?

Take surveys or otherwise enter information about yourself into the uBioDiscovery website. You choose which surveys to take and which questions to answer. All your de-identified information regarding your biome will be part of an open research study. Your name will not be linked to the data.

2. Can my child take part in the SUPERBIOME project?

Your child may take part in the SUPERBIOME project if he or she gives assent to participate and both parents authorize uBioDiscovery Inc. to use his or her de-identified microbiome information for research.

Click on this link to find some talking points to help you discuss about the SUPERBIOME project with your child.

3. Which of my personal information is used for open source research?

Your biome 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 biome and other personal information.

4. Who gets to see my personal information?

uBioDiscovery’s privacy statement outlines who does and does not get access to the personal information of SUPERBIOME customers; here we list the additional individuals who will get access if you consent to take part in research.

Within uBioDiscovery: uBioDiscovery researchers who conduct analyses will have access to your biome and other personal information, but not to your name, contact, or credit card information. uBioDiscovery researchers who contact you will have access to names and contact information, but only to very limited biome or other personal information.

Outside of uBioDiscovery: uBioDiscovery will share the demographics compiled data with everyone (open source research). However, all participants will remain anonymous or de-identifiable. These data will be summarized across enough customers to minimize the chance that your personal information will be exposed. uBioDiscovery may need to share the information with other agencies as required by law.

5. How will I benefit from this research?

By taking surveys you may learn about SUPERBIOME’s research findings, including how your answers compare with those of others and new discoveries made by SUPERBIOME’s project.

Sometime in the future you or your family may benefit indirectly from research discoveries made by uBioDiscovery or open source research.

6. 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. uBioDiscovery has policies and practices in place to minimize the chance of such an event.

7. Can I stop taking part in the SUPERBIOME project?

Yes, you can withdraw from the SUPERBIOME project 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.

 


 Full Consent Document

One of uBioDiscovery’s missions is to make and support meaningful scientific discoveries by enabling its customers to participate directly in research. uBioDiscovery will enroll hundreds of thousands of participants from among its customers in this project, which we call SUPERBIOME project. Specifically, the SUPERBIOME project refers to research aimed at publication in open source reserach. The SUPERBIOME project, aims to:

  • Discover bacteria behind diseases and traits
  • Learn about human migration and population history through their microbiome
  • Understand how people react to their personal microbiome information

For further details on SUPERBIOME project other uses of personal information, see our Privacy Statement.

uBioDiscovery seeks your voluntary participation in the SUPERBIOME project.

IMPORTANT: The SUPERBIOME kit is intended for Research Use Only. The SUPERBIOME kit has not been evaluated by Health Canada. This product is not intended to diagnose, treat, cure or prevent any disease.

This document explains:

  1. What you are agreeing to if you consent
  2. How you can participate
  3. How your data will be used
  4. How we protect your data and keep it private
  5. The benefits and risks of participation
  6. Your options and how to withdraw
  7. Who to contact if you have questions

 

What am I agreeing to if I consent?

Giving consent by checking the appropriate box below means that you agree to let uBioDiscovery researchers use your Microbiome and Self-Reported Information for the SUPERBIOME project, as described above. “Microbiome and Self-Reported Information” refers to:

  • Microbiome data
  • Information you enter into surveys, forms and other features labeled with the uBioDiscovery logo:
  • Data you authorize us to import for open source 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 the SUPERBIOME project. Your Microbiome and Self-Reported Information does not include identifying Registration Information you provided when you purchased the SUPERBIOME kit or created an account (such as name, address, email address, user ID, password, or credit card information).

 

How do I participate?

Participation consists of (1) allowing uBioDiscovery researchers to use your Microbiome and Self-Reported Information for the SUPERBIOME project, and (2) entering data about yourself into the SUPERBIOME project features on the uBioDiscovery 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 SUPERBIOME project 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 Microbiome & Self-Reported Information matches the area of interest.

Your participation in the SUPERBIOME project is completely voluntary.

 

How will my data be used in uBioDiscovery Research?

Your Microbiome & Self-Reported Information may be used to discover links between bacteria, diseases, behaviors and other characteristics; to study human migrations and population history; or to assess how people respond to personal microbiome related 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. The topics to be studied span a wide range of traits and conditions, from common to rare. The topics include serious diseases such as IBS or diabetes, and less serious conditions such as migraine headaches or response to drugs, over-the-counter drugs and food. 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.

This study may cover potentially sensitive topics such as sexual orientation, illicit drug use or other illegal behavior, or HIV/AIDS status. When uBioDiscovery conducts studies on such sensitive topics, you will be provided additional information to help you decide whether you want to participate in research on these topics.

 

How do you keep my data protected and private (whether or not I consent)?

uBioDiscovery’s Privacy Statement outlines how the company protects your privacy while conducting business, such as providing our services to you. uBioDiscovery uses a range of physical, technical, and administrative procedures to protect the privacy of your personal information, including your microbiome data and your survey responses.

If you agree to this Consent Document, uBioDiscovery can use your information in additional ways. Specifically, uBioDiscovery 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 uBioDiscovery aims to minimize the chances of a privacy breach while conducting its business, uBioDiscovery researchers aim to minimize the chances of a privacy breach while conducting research. Here are the main ways we do that:

  • The uBioDiscovery 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.
  • uBioDiscovery researchers who interact with research participants and conduct interviews have access to names and contact information of participants, but only to very limited bacterial and other personal information.
  • To minimize the chance that an external person can determine that any particular customer is part of a study, uBioDiscovery researchers either:
    1. publish only data pooled across multiple customers or
    2. publish only very limited, non-identifying information of a single individual
  • All uBioDiscovery employees are trained on how to work with human research participants. In addition, all uBioDiscovery researchers are trained on how to conduct research responsibly.

uBioDiscovery cannot resist a demand for information from personnel of the Canadian Government that is to be used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of Health Canada. Health Canada has the right to audit this study’s data, including information that identifies you.

 

What are the benefits and risks of participation?

Benefits:

One of uBioDiscovery’s missions is to make meaningful scientific contributions by enabling its customers to participate directly in microbiome research. If uBioDiscovery 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 microbiomes, microbiome research or the SUPERBIOME study, and/or preliminary research findings.
  • Electronic, graphical “badges” that signify you have contributed to one or more research projects.
  • There may be additional benefits to participation that are currently unforeseeable.
  • Based on the results of this study, uBioDiscovery may develop intellectual property, including but not limited to patents, copyrights and trademarks, and/or uBioDiscovery may commercialize products or services, directly or indirectly. In such cases you will not receive any compensation.

Risks:

There are some potential risks to participating in the SUPERBIOME project, as described below.

  • Some survey questions or data comparisons may make you or your family members uncomfortable.
  • Your microbiome 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 microbiome data linked to your name or your family member’s name in a public database, someone who has access to your uBioDiscovery microbiome data might be able to link that data to your name or your family member’s name through the publicly available microbiome data. Although uBioDiscovery cannot provide a 100% guarantee that your data will be safe, uBioDiscovery has strong policies and procedures in place to minimize the possibility of a breach.
  • When uBioDiscovery researchers publish results from this ongoing study, they may include your Microbiome & 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 microbiome 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 Microbiome & 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 SUPERBIOME project is invasive or experimental. The procedures involved do not involve more than the minimal risks described above, and no compensation or treatment is available if injury occurs as a result of participation.

 

Do I have any alternatives? Can I withdraw from this study?

Your alternative is not to participate in the SUPERBIOME project. If you choose not to give consent for uBioDiscovery Research, your Microbiome & 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 uBioDiscovery Research surveys or use other uBioDiscovery Research features.

At any time, you may choose to change your consent status to either take part in uBioDiscovery Research or to withdraw all or some of your Microbiome & Self-Reported Information from uBioDiscovery Research. If you want to change your consent status, write to us at contact@uBioDiscovery.com. If you withdraw all or some of your Microbiome & Self-Reported Information, uBioDiscovery will prevent that information from being used in new uBioDiscovery Research initiated after 30 days from receipt of your request. 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 uBioDiscovery Research will not affect your access to your Microbiome Information.

You may also discontinue participation by closing your Personal Microbiome account, as described in the Terms of Service. Requests for account closure must be made in writing to uBioDiscovery’s business address or via Customer Care.

In addition, the SUPERBIOME project may be terminated without your consent. In the following cases, uBioDiscovery will maintain your Microbiome & Self-Reported Information according to the terms of our Privacy Statement.

Transfer of ownership. If uBioDiscovery undergoes a business transition such as an acquisition or merger, the SUPERBIOME project may be terminated. In such case, your information would remain subject to the promises made in any pre-existing Privacy Statement.

Termination of service. uBioDiscovery may terminate your access to your information for any of the reasons described in the Terms of Service. If your access to your information is terminated for any of these reasons, your participation in the SUPERBIOME project may also be terminated.

 

Who do I contact if I have questions?

If you have general questions and need help with uBioDiscovery’s service, please contact:

uBioDiscovery Customer Care: contact@ubiodiscovery.com

If you have any questions or concerns about the SUPERBIOME project, if you suffer a research-related injury, or if you have a question about subjects’ rights, please contact the following:

uBioDiscovery Customer Care : contact@ubiodiscovery.com

If you have any questions or concerns about research that you do not wish to discuss with uBioDiscovery, click here to contact the independent, impartial research review board for this study.

 

*This Privacy Statement was last updated on April 5, 2017.