RESEARCH CONSENT

Information About the Study

GUTSY service from HSKG enhances the understanding of your gut microbiome to weight management and health. We have affiliated with researchers to study the data we collect from customers like you. In particular the research seeks to draw links between genetic information from the samples you provide with answers you provide to surveys and questionnaires.

As part of the HSKG service, and as part of the research, we will ask you to fill out various surveys about different topics. These topics may include your medical history, your diet and information about your family members. You will also be collecting a sample. Make sure to wear gloves, wash your hands before and after you collect the sample.

Participation in the research will be very similar to normal use of the HSKG service. It consists of:

(i) allowing HSKG investigators to use your information for research; and

(ii) entering data about yourself into HSKG Research features on the HSKG website.

You do not have to participate in this research, and you will still have full access to your microbiome if you chose not to. This document sets out how we conduct our research, and in particular how we process, store and share your data with others. New surveys and features may be added to HSKG Research on a continuing basis.

Data Usage and Sharing

HSKG uses a range of physical, technical, and administrative procedures to protect the privacy of your personal information and your survey responses.

A key protection is that personally identifying Registration Information (such as name, address, email address, user ID, password, or phone number) is only available to a small group of people that need access to this information for particular purposes where access to that data is necessary.

HSKG may collaborate on research with external members of our research consortium or with the public. External parties will only have access to pooled data stripped of identifying information, with the following exceptions:

1. HSKG may release your individual-level data to a third party if we ask for, and receive, your explicit authorization to do so.
2. HSKG’s partners or service providers (e.g. Sample courier or our contracted laboratory) may process and/or store your information in order to provide you with HSKG's services.
3. Researchers invited by HSKG to conduct research may access your information (but not your name or contact information) for the purpose of scientific research.
4. HSKG may release individual-level information in response to requests from law-enforcement agencies, courts of law, regulatory and government agencies, and if otherwise required to do so by law.
5. The Institutional Review Board and government officials responsible for monitoring our study may inspect the study records.

 

Benefits of Participating

Scientific researches help enhance our understanding of disease and various health conditions. HSKG does not seek to and does not treat or cure any medical condition, and participation should not be used as a substitute for any medical treatment.

Risks of Participating

There are some potential risks to participating in the HSKG research study:

• Some survey questions may make you or your family members uncomfortable.
• Your data, survey responses, and/or personally identifying information may be compromised in the event of a security breach or failure to follow protocol. Such security breaches may include physical compromising of lab and storage facilities, compromising of data storage, as well as failure to adhere to study protocol by employees and contractors. In the event of such a breach, if your data are associated with your identity they may be made public and it may have social and psychological consequences for you or your loved ones. Furthermore, if a physical sample is stolen or mishandled by an employee or contractor they may obtain additional information from the sample, such as sequencing data from human DNA in the sample.
• When HSKG investigators publish results from this study, your information may be included within pooled summaries that are made public. Identification of your individual-level data from those summaries would be extremely difficult, but it is possible that a third party that has obtained partial data from you could compare their partial data to the published results and indirectly determine some of your survey responses.
• While the information we keep will not include names, and the microbiome is not uniquely identifiable, human genetic information is unique and can be used to identify people by linking or tracing DNA in public databases. It may also identify your family since your DNA is shared with your family.
• As with any online service, if you disclose your account password to others, they may be able to access your account and your information. There may be additional risks to participation that are currently unforeseeable.
• Data that you choose to share with others for any reason could be used against your interests.
• HSKG is a private company and the Chief Scientific Officer of the company is also the Primary Investigator (head of research) of this study. There may be a conflict of interest between these two roles; however, the Primary Investigator is obligated to hold the interests of research above those of the company for purposes of the research study.
• Information that participants choose to share with their physician or other health care provider may become part of their medical record and through that route be accessible to other health care providers and/or insurance companies in the future.

None of the surveys or other procedures used by the investigators in the HSKG Research study are invasive or experimental. The procedures involved do not involve significant risks, and no compensation or treatment is available if injury occurs as a result of participation. Swabs and other materials used for sample collection are sterilized prior to shipment and must be handled with proper care and hygiene.

Should you be uncomfortable handling the collection kit and accepting responsibility for its use, please reconsider your participation in this study.

 

Withdrawing from the Study

At any time, you may choose to withdraw all or some of your information from HSKG Research. By sending a request HSKG via email (HSKG will notify you if additional ways to withdraw consent become available.)

Choosing not to give consent or withdrawing from HSKG Research will not affect your access to your information or to microbiome sequencing service. You will still be allowed full access to the microbiome sequencing service, but HSKG will prevent the requested information from being used in new HSKG research occurring 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. Your information may still be used for other purposes as described in the HSKG Privacy Statement.

In addition, the HSKG Research study may be terminated without your consent. In that case, HSKG will maintain your information according to the terms of our Privacy Statement.

 

Contact Information

If you have any questions or concerns about the study, if you suffer a research-related injury, or if you have a question about participants' rights, please contact HSKG at info@hskgene.com