Consent Document

Consent Document - Key Points

Olive Labs Inc. aims to make and support scientific discoveries and publish those discoveries in scientific journals. We invite you to take part in these projects, which we call Olive 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 Olive Research?

·       Take surveys or otherwise enter information about yourself into the Olive website or app (when available). You choose which surveys to take and which questions to answer.

Can my child take part in Olive Research?

·       Your child may take part in Olive Research if he or she gives assent to participate and a parent or legal guardian authorizes Olive to use his or her Biological & Self-Reported Information for research.

·       Here are some talking points to help you discuss Olive Research with your child.

Which of my personal information is used for research?

·       Your biological 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 biological and other personal information.

Who gets to see my personal information?

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

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

·       Outside of Olive: Olive 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. Olive 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 Olive's research findings, including how your answers compare with those of others and new discoveries made by Olive Research’s research program.

·       Sometime in the future you or your family may benefit indirectly from research discoveries made by Olive Research 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. Olive has policies and practices in place to minimize the chance of such an event.

Can I stop taking part in Olive Research?

·       Yes, you can withdraw from Olive 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 Olive's missions is to make and support meaningful scientific discoveries by enabling its customers to participate directly in research. Olive will enroll many participants from among its customers in this project, which we call Olive Research. Specifically, Olive Research refers to research aimed at publication in peer-reviewed journals and research funded by the federal government.  The Olive Research study, aims to:

·       Discover biological factors behind diseases and traits

·       Uncover connections among diseases and traits

·       Learn about human exposures through biological testing

·       Understand how people react to their personal biological information

For further details on Olive's other uses of personal information, see our Privacy Statement.

Olive seeks your voluntary participation in Olive Research.

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

1. What am I agreeing to if I consent?

Giving consent by signing below means that you agree to let Olive Research researchers use your Biological & Self-Reported Information for Olive Research, as described above. "Biological & Self-Reported Information" refers to:

·       Your biological data

·       Information you enter into surveys, forms and other features labeled with the The Olive Biosciences or  Canary Projects logo ( or  )·       Data you authorize us to import for research (if we request health information, we will ask you to review a separate Authorization form)

·       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 Olive Research. Your Biological & Self-Reported Information does not include identifying Registration Information you provided when you purchased the testing 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 Olive Research researchers to use your Biological & Self-Reported Information for Olive Research, and (2) entering data about yourself into Olive Research features on the Olive 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.

Olive 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 Biological & Self-Reported Information matches the area of interest.

For your participation, monetary, cash equivalents such as gift certificates or discounts on future Olive service purchases, or charitable donations (up to a value of $30 per half hour of expected time) may be provided as compensation for your time.

Your participation in the Olive Research study is completely voluntary.

3. How will my data be used in Olive Research?

Your Biological & Self-Reported Information may be used to discover links between biological markers, non-biological markers, traits, diseases, behaviors and other characteristics; to study human migrations and population history; or to assess how people respond to personal biological 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 simple states to serious diseases.  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.  These third parties will not be able to access your identifying Registration Information you provided when you purchased the testing service or created an account (such as name, address, email address, user ID, password, or credit card information). Third parties utilizing Olive data will be carefully evaluated for their efforts to provide the most good to you and the other participants. Only data relevant to their proposed studies will be made available.

This study may cover potentially sensitive topics such as sexual orientation, illicit drug use or other illegal behavior, or HIV/AIDS status. When Olive 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.

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

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

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

·       Olive Research 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

·       Olive Research researchers who interact with research participants and conduct interviews have access to names and contact information of participants, but only to very limited biological and other personal information

·       To minimize the chance that an external person can determine that any particular customer is part of a study, Olive Research researchers either

o   publish only data pooled across multiple customers or

o   publish only very limited, non-identifying information of a single individual

·       All Olive employees are trained on how to work with human research participants. In addition, all Olive Research researchers are trained on how to conduct research responsibly.

In addition, Olive has obtained a Certificate of Confidentiality from the National Institutes of Health (NIH). In some cases, if an external party demands access to customer data, Olive can exclude from release the data of customers who have consented to research.

The Certificate of Confidentiality cannot be used to resist a demand for information from personnel of the United States 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 NIH or the Institutional Review Board (IRB). The NIH and IRB have the right to audit this study's data, including information that identifies you.

5. What are the benefits and risks of participation?

Benefits:

One of Olive's missions is to make meaningful scientific contributions by enabling its customers to participate directly in biological research. If Olive or Olive Research 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 biological samples, biological research or the Olive study, and/or preliminary research findings

·       There may be additional benefits to participation that are currently unforeseeable.

Based on the results of this study, Olive may develop intellectual property, including but not limited to patents, copyrights and trademarks, and/or Olive may commercialize products or services, directly or indirectly. In such cases you will not receive any compensation at this time.

Risks:

There are some potential risks to participating in the Olive Research study, as described below.

·       Some survey questions or data comparisons may make you or your family members uncomfortable.

·       Your biological 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 biological data linked to your name or your family member's name in a public database, someone who has access to your Olive biological data might be able to link that data to your name or your family member's name through the publicly available biological data. Although Olive cannot provide a 100% guarantee that your data will be safe, Olive has strong policies and procedures in place to minimize the possibility of a breach.

·       When Olive Research researchers publish results from this ongoing study, they may include your Biological & 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 biological 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 Biological & 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 Olive 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 Olive Research study. If you choose not to give consent for Olive Research, your Biological & 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 Olive Research surveys or use other Olive Research features.

At any time, you may choose to change your consent status to either take part in Olive Research or to withdraw all or some of your Biological & Self-Reported Information from Olive Research. To do this write to the Human Protections Administrator at info@olivelabs.us). If you withdraw all or some of your Biological & Self-Reported Information, Olive will prevent that information from being used in new Olive 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 Olive Research will not affect your access to your Biological Information.

You may also discontinue participation by closing your Olive account, as described in the Terms of Service. Requests for account closure must be made in writing to Olive's business address or via or at info@olivebiosciences.com.

In addition, the Olive Research study may be terminated without your consent. In the following cases, Olive will maintain your Biological & Self-Reported Information according to the terms of our Privacy Statement.

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

2.    Termination of service. Olive may terminate your access to the Personal Genome Service for any of the five reasons described in the Terms of Service. If your access to the Personal Genome Service is terminated for any of these reasons, your participation in the Olive Research study may also be terminated.

7. Biobanking Consent

Consent Document for Sample Storage and Additional Analyses

By choosing to have Olive Biosciences store your sample, you are consenting to having Olive and its contractors access and analyze your stored sample, using the same or more advanced technologies,  in a manner consistent with our Terms of Service and Privacy Statement. Unless we notify you otherwise, we will store your sample indefinitely at our secure accredited laboratory.  We may contact you in the event we need to re-analyze your sample.  All of the same safeguards to any further use of your sample will be provided as in our Terms of Service and Privacy Statement.

Additional Analyses of Stored Participant Samples

In addition, a subset of research participants may have their sample reanalyzed using another technology. The analysis may focus on particular blood components.  While the field of large-scale blood analysis is still in its early stages, we can use methods that are being developed to compare sample data with large public databases of blood data to identify and characterize sample variation. The sample sizes needed for analysis vary considerably depending on the type of study. To identify the causal relationship for a rare disease may only require a small group of people. Identifying rare modifiers of risk will likely require significantly more people. The studies with sample screening analysis have been mainly descriptive and better estimates of appropriate sample sizes will come as the methods for analysis are established. In the short term, sample sizes may mostly be limited by the cost and capacity of current analysis protocols and equipment.

If additional data are collected, their use will follow the scope of topics currently approved by Olive's IRB. For example, research on sensitive topics using these data will not be performed unless specific IRB approval and participant consent has been obtained.

8. Individual Data Sharing Consent

Olive’s mission is to help people access, understand and benefit from the human blood component analysis. One of the ways we do this is through our research program. We seek your permission to share your de-identified individual-level Biological & Self-Reported Information with research collaborators outside of Olive.  We collaborate with researchers outside Olive when we believe they can help us accelerate research and drive scientific discoveries. We work with them to study many different topics including Biological factors behind diseases and traits, connections among diseases and traits, human migration and population history, and how people react to their personal Biological information.

What am I agreeing to if I consent?

Giving consent by signing the appropriate box below means that you agree to let Olive share your de-identified individual-level data with approved researchers outside of Olive. That is, you agree that we may share your Individual-level Biological & Self-Reported Information. This includes:

·       Your Biological data

·       Information you enter into surveys, forms and other features with the Olive Research

logo ( or  )· ​

·       Data you separately authorize us to import for research

·       Your age and ethnicity

What does “de-identified” mean?

De-identified means that we strip the data of information that could directly identify you (such as name, date of birth, and address) and connect any study information you provide by using a random code (for example a study ID). Any Biological & Self-Reported Information you allow us to share will be associated with that code, not with your name.

What does “individual-level” mean?

Individual-level means the data are related to a single person. This is different from the Olive Main Research Consent you may sign which allows us to share only information that has been combined or “pooled” with data from other research participants.

Allowing researchers to have access to individual-level data allows them to analyze the data more thoroughly, which may help them make more meaningful scientific discoveries.

Who are the research collaborators?

Research partners range from academic institutions and non-profit organizations to pharmaceutical and diagnostic companies. These research partners employ scientists who study many different health topics. Each partnership undergoes a rigorous screening process by an Olive scientific committee to ensure the goals and methods of the research are aligned with Olive’s mission and consistent with any of our associated research consent documents.

What can the research collaborators do with my data?

Our research partners must sign an agreement which describes what they can and can’t do with your data (for example, who can have access and what specific projects the data can be used for). We require strict data security measures which must be in place before we will release any data to them. The agreement also prohibits research collaborators from trying to identify you in any way or sharing your data outside the approved project.

We will not share your Biological & Self-Reported Information for marketing purposes with our collaborators. You can learn more about how we share information for marketing purposes in our Privacy Statement.

Can I find out who my data is shared with?

For the most part, we won’t be able to contact you every time we would like to share your data. We may ask you to volunteer to provide information or take a survey on a specific topic or for a specific collaboration. In that case we will provide you with that information. Collaborations may result in scientific publications. If your data are used in a publication, it will only be published in summary form (combined data from many individuals), or using very limited, non-identifying information (such comments or feedback participants may consent to release).

How are my data protected?

Olive takes seriously the trust you place in us. We have very strong security measures in place to ensure your data are transferred safely. Olive will also have agreements with all collaborators regarding the security and storage of data that we share. Although Olive cannot provide a 100% guarantee that your data will be safe, Olive policies and procedures minimize the chance that a breach could take place.

What are the additional benefits?

Sharing your individual-level data will allow more researchers to study and analyze the data more thoroughly. This may increase the chance that meaningful scientific discoveries are made such as greater understanding of human disease and biology, human populations, and possibly new ways to diagnose or treat diseases. Sometime in the future you, your family or friends may benefit directly or indirectly from the research discoveries made by Olive or our research partners.

Based on the information you provide and allow us to share, Olive or our research collaborators may make new discoveries. In the future, those discoveries could lead to new commercial products or services (for example, new drugs, devices, or screening tests). If this happens, these products or services will be the property of the researchers who developed them and you will not receive any compensation.

What are the additional risks?

Sharing your individual-level data means your data would be stored in more locations. This would increase the risk of a security breach that could lead to the leak of your data. In the event of such a breach, if some or part of your Biological or self-reported data is associated with your identity in a public database, someone could match your name with your Biological or self-reported data. This could impact you directly. For example, these data may be made public or released to insurance companies, which could have a negative effect on your ability to obtain insurance coverage.

If Olive shares your Biological or self-reported data with a research collaborator, this action cannot be undone and your data will not be returned to Olive.

Do I have any alternatives? Can I change my mind?

Your alternative is not to agree to share your individual data. You can still participate in our research program without sharing your individual-level data.

Choosing not to give consent or withdrawing your consent will not affect your access to your Biological Information or to the Personal Biological Service.

You can withdraw your consent to share individual-level data at any time by declining this consent through contacting Customer Care.  Olive will prevent your data from being shared after 30 days from receipt of your request (it may take up to 30 days to withdraw your information after you withdraw consent). If you withdraw your consent, any data that has been shared prior to this date cannot be reversed or undone.

 

9. Who do I contact if I have questions?

If you have general questions and need help with Olive's service, please contact:

·       Olive Customer Care

·       Email: info@olivelabs.us

If you have any questions or concerns about the Olive Research study, if you suffer a research-related injury, or if you have a question about subjects' rights, please contact the following:

·       Olive Human Protections Administrator

·       Email: info@olivelabs.us