Research Consent

Consent Document – Key Points

Fertility Genomics 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 Fertility Genomics 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 Fertility Genomics Research?

Give consent through the Fertility Genomics website, or other written means, for use of your de-identified genetic data for use in scientific research. Additionally, you can consent through the Fertility Genomics website to be contacted to participate in Fertility Genomics Sperm Studies research programme.

 

Can my child take part in Fertility Genomics Research?

  • Individuals must be 18 or over to participate.

 

Which of my personal information is used for research?

  • Your genetic 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 analysed in the research.
  • Your name and contact information may be used to communicate with you but are not analysed in combination with your genetic and other personal information.

 

Who gets to see my personal information?

  • Fertility Genomics’ privacy statement outlines who does and does not get access to the personal information of Fertility Genomics customers; here we list the additional individuals who will get access if you consent to take part in research.
  • Within Fertility Genomics: Fertility Genomics researchers who conduct analyses will have access to your genetic and other personal information, but not to your name, contact, or credit card information. Fertility Genomics researchers who contact you will have access to names and contact information, but only to very limited genetic or other personal information.
  • Outside of Fertility Genomics: Fertility Genomics may share some data with external research partners and in scientific publications. These data will be summarised to minimise the chance that your personal information will be exposed. Fertility Genomics 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 Fertility Genomics’ research findings, including how your answers compare with those of others and new discoveries made by Fertility Genomics’ research program.
  • Sometime in the future, you or your family may benefit indirectly from research discoveries made by Fertility Genomics 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. Fertility Genomics has policies and practices in place to minimise the chance of such an event.

 

Can I stop taking part in Fertility Genomics Research?

  • Yes, you can withdraw from Fertility Genomics 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

A founding mission goal of Fertility Genomics’ is to make and support meaningful scientific discoveries to improve the diagnosis and treatment of infertility. We aim to do this by enabling our customers to participate directly in Fertility Genomics Research. Specifically, Fertility Genomics Research refers to research aimed at publication in peer-reviewed journals and research funded by government and research councils.

For further details on Fertility Genomics’ other uses of personal information, see our Privacy Statement.

Fertility Genomics seeks your voluntary participation in Fertility Genomics 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. Participation in sperm studies research.
  8. Who to contact if you have questions.
  9. Individual data sharing consent.

 

1. What am I agreeing to if I consent?

Giving consent by checking the appropriate box below means that you agree to let Fertility Genomics researchers use your Genetic & Self-Reported Information for Fertility Genomics Research, as described above. “Genetic & Self-Reported Information” refers to:

  • Your genetic data.
  • Information you enter into surveys and forms.
  • Data you authorise us to import for research (if we request health information, we will ask you to review a separate Authorisation form).
  • Your age and ethnicity.

Self-Reported Information includes any information you submitted prior to giving consent. If you have elected to have your saliva sample stored, we may also use the results of further analysis of your sample in Fertility Genomics Research. Your Genetic & Self-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 Fertility Genomics researchers to use your Genetic & Self-Reported Information for Fertility Genomics Research, and (2) entering data about yourself into Fertility Genomics Research features on the Fertility Genomics 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 Fertility Genomics Research study is open-ended: new surveys and 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 Genetic & 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.

Your participation in the Fertility Genomics Research study is completely voluntary.

 

3. How will my data be used in Fertility Genomics Research?

Your Genetic & Self-Reported Information may be used to discover links between genetic markers, non-genetic markers, traits, diseases, behaviours and other characteristics. Discoveries made as a result of this research could be used to understand the basic causes of infertility but also other diseases, develop drugs or other treatments and/or preventive measures, or predict a person’s risk of disease beyond infertility. 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.

 

4. How do you keep my data protected and private (even if I don’t consent)?

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

If you agree to this Consent Document, Fertility Genomics can use your information in additional ways. Specifically, Fertility Genomics researchers can use your data for research that will be published in scientific journals.

Just as Fertility Genomics aims to minimise the chances of a privacy breach while conducting its business, Fertility Genomics researchers aim to minimise the chances of a privacy breach while conducting research. The main ways we do that are;

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

 

5. What are the benefits and risks of participation?

Benefits:

One of Fertility Genomics’ missions is to make meaningful scientific contributions by enabling its customers to participate directly in genetic research. If Fertility Genomics 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 genetics, genetic research or the Fertility Genomics study, and/or preliminary research findings.
  • There may be additional benefits to participation that are currently unforeseeable.

Based on the results of this study, Fertility Genomics may develop intellectual property, including but not limited to patents, copyrights and trademarks, and/or Fertility Genomics may commercialise 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 Fertility Genomics Research study, as described below.

  • Some survey questions or data comparisons may make you or your family members uncomfortable.
  • Your genetic 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 genetic data linked to your name or your family member’s name in a public database, someone who has access to your Fertility Genomics genetic data might be able to link that data to your name or your family member’s name through the publicly available genetic data. Although Fertility Genomics cannot provide a 100% guarantee that your data will be safe, Fertility Genomics has strong policies and procedures in place to minimise the possibility of a breach.
  • When Fertility Genomics researchers publish results from this ongoing study, they may include your Genetic & Self-Reported Information but only as part of a summary across enough people to minimise 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 genetic 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 Genetic & Self-Reported Information.
  • There may be additional risks to participation that are currently unforeseeable.

 

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

Your alternative is not to participate in the Fertility Genomics Research study. If you choose not to give consent for Fertility Genomics Research, your Genetic & 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 Fertility Genomics Research surveys or use other Fertility Genomics Research features.

At any time, you may choose to change your consent status to either take part in Fertility Genomics Research or to withdraw all or some of your Genetic & Self-Reported Information from Fertility Genomics Research. Your consent status is located in the Fertility Genomics “Settings” page  (if you experience problems changing your consent status, write to the Human Protections Administrator at admin@fertilitygenomics.com). If you withdraw all or some of your Genetic & Self-Reported Information, Fertility Genomics will prevent that information from being used in new Fertility Genomics 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 Fertility Genomics Research will not affect your access to your Genetic Information.

You may also discontinue participation by closing your account, as described in the Terms of Service. Requests for account closure can be made directly within your Account Settings.

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

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

 

7. Participation in sperm studies research

If you chose to click the option to participate in sperm studies research, you agree to be contacted by email to discuss participation. Participation is contingent upon you being selected by Fertility Genomics and referral from your assisted conception clinic who must be willing and able to send us a frozen semen sample. Alternatively you may have the opportunity to provide a fresh semen sample if you are local to Tayside, Scotland, UK (use the contact page for more details). If you wish to attend in person you do so at no cost to Fertility Genomics Ltd. You will be given a research (pseudo-anonymising) code identifier which will be used to identify your sample during research. You can withdraw at any time by contacting admin@fertilitygenomics.com.

The type of tests we conduct on your sperm may include one or more of and are not limited to; computer assisted motility analysis, intracellular calcium measurement, electrophysiological analysis, zona pellucida binding, viscous media penetration assay, immunocytochemistry, western blot analysis and acrosome reaction induction.

Our tests are strictly for research purposes, but you have the option of knowing the outcome of our in vitro laboratory tests. Due to the inherent variability of the methods of isolation of sperm from semen, we cannot guarantee that your sample will be suitable for laboratory testing, e.g. if the number of cells recovered following preparation is extremely low, sperm are immotile/dead, or there are no sperm in the semen. Our research laboratory results are purely for research purposes only and not for diagnosis.

 

8. Who do I contact if I have questions?

If you have general questions and need help with Fertility Genomics’ service, please contact admin@fertilitygenomics.com.

 

Individual Data Sharing Consent

Fertility Genomics’ mission is to help people access, understand and benefit from the human genome. We seek your permission to share your de-identified individual-level Genetic & Self-Reported Information with research collaborators outside of Fertility Genomics. We collaborate with researchers outside Fertility Genomics when we believe they can help us accelerate research and drive scientific discoveries. We work with them to study many different topics, including genetic factors behind diseases and traits and connections among diseases and traits. For example, it is hypothesised that infertility is a marker for future health risk. We wish to investigate this link at a genetic level.

 

What am I agreeing to if I consent?

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

  • Your genetic data.
  • Information you enter into surveys, forms.
  • Data you separately authorise 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 Genetic & 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 Fertility Genomics Main Research Consent you signed 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 analyse 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 organisations to pharmaceutical and diagnostic companies. These research partners employ scientists who study many different health topics. Each partnership is subject to Fertility Genomics’ quality assurance process.

 

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 Genetic & Self-Reported Information for marketing purposes with our collaborators. You can learn more about how we share information in our Privacy Statement.

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.

 

How is my data protected?

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

 

What are the additional benefits?

In addition to the benefits described above, sharing your individual-level data will allow more researchers to study and analyse the data in greater detail. Based on the information you provide and allow us to share, Fertility Genomics 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?

In addition to the risks described above, 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 genetic or self-reported data is associated with your identity in a public database, someone could match your name with your genetic or self-reported data. This could impact you directly.

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

 

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 Genetic Information or to the Personal Genetic Service.

You can withdraw your consent to share individual-level data at any time by declining this consent through your account settings.

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