Diagnomics Research Consent
Name of Sponsor Company: Diagnomics Inc.
Protocol Number and Title of Study: DR_CPLX_001
Name of Person in Charge of the research study (study doctor/investigator): Min Seob Lee
Telephone Number(s), daytime: (858) 345-4817
After hours: (925) 997-4666
Thank you for considering to participate in this scientific research study. Human genetics is a very rapidly developing field led by highly sophisticated genomics technologies. However, the participation of consumers like you is essential in making genetic studies more accurate and discovering the genetic factors related to traits and diseases. With your consent, we hope to contribute to the scientific research that will help scientists better understand human traits, population history and diseases.
Your consent to participate in the research is voluntary and you can withdraw this consent if you decide to do so in the future. When you withdraw the consent, your information will not be used except for the research that is in progress or completed. You can withdraw your consent at the your account management page at www.genomatch.me website.
Your genetic data and any other personal information we collect may be analyzed in the research. However, your Registration Information such as your name, contact information, and credit card information will not be used for research. The investigator is the sponsor, and is paying for this study.
1. What is the research project Diagnomics conducts? (“Purpose”)
One of Diagnomics’ mission is to advance research related to the study of human genetics and health. For that goal, we will be offering you the opportunities to participate in research which are designed for:
We refer to all research focused on the Purpose that Diagnomics or others may do over time as the Diagnomics Research Project (the “Project”). We refer to Diagnomics Inc. and its affiliated companies collectively as “Diagnomics,” “us,” “we,” or “our.”
2. What does Diagnomics do if I consent?
You are agreeing that all information and Biological Samples you share with Diagnomics through your use of our websites, mobile applications, and products including current products and future products (“Services”) can be collected, stored and used for research. The research project will be consistent with the Purpose, and your information will be used for the period of the Project. Any customer of Diagnomics can voluntarily participate in the Project.
3. Who conducts the research?
Diagnomics will perform the research. Diagnomics also works with other researchers from other institutions and companies sharing the same Purpose. This may include schools as well as non-profit, for-profit businesses or government institutions (“Collaborators”).
These Collaborators may also work with other entities to conduct research associated with our Purpose (“Collaborator Partners”). The research for the Project may be performed solely by us, or by Collaborators with or without help from Diagnomics researchers or Collaborator Partners. All researchers, whether affiliated with Diagnomics, our Collaborators, or Collaborator Partners are referred to in this Informed Consent as “Researchers.” Diagnomics will review all research requests for Biological and DNA Samples. In some instances, Diagnomics receives compensation from Collaborators who work on the Project.
4. What data is used?
With your consent, Researchers may use all data that you provide to us when you use our Services, including Biological Samples and any data derived from those samples (the “Data”). Data includes:
We take your privacy seriously. Our privacy statement describes how we manage and handle your data in compliance with applicable laws privacy protection standards.
5. How can I provide Biological Samples?
You will receive one of the kits for saliva or buccal swap collection. If you prefer proving the blood, you may need to visit a clinic to draw the sample. Diagnomics does not cover the cost for the blood drawing. Free return shipping label will be included in the package with the kit. Place collection tube in the box and ship using appropriate mail carrier.
6. How is my Data used and shared if I give consent?
Researchers may use your Data, including your sample, for:
research that is consistent with our Purpose; and
publication of research results in scientific or medical journals and in other publications and presentations. No personal information will be included in the publications.
Data and Biological Samples, may be shared with Collaborators and Collaborator Partners, but your name, contact information or other common identifying information will not be shared. When your Biological Sample is shared, it is labelled only with a code. We will gain your explicit approval before utilizing your data with a third party vendor or research organization.
Your data may be shared with others who review the quality and safety of the research such as U.S. Food and Drug Administration or Institutional Review Board. We will never knowingly disclose or share your data for use by employers or insurers for employment or insurance purposes.
When we collaborate with government agencies on research, we take all necessary steps to protect the privacy and integrity of your Genetic Data and Biological Samples in accordance with laws and regulations pertaining to government funded research. In some instances, if we partner with, or our research is funded by, certain U.S. agencies like the National Institutes of Health, we may be required to contribute certain Data to a national database that will be accessible by other researchers. In the event such contribution is required, we will only provide Data that has had identifying information removed in accordance with U.S. federal regulations.
7. How is my Data protected?
We use industry-standard data protection measures including multiple layers of physical, technical, and administrative procedures to protect your Data. This protection applies to every aspect of Diagnomics operations including providing the Service and performing research projects within Diagnomics and among Collaborators and Collaborator partners. The samples will be stored in Diagnomics’ repository under strictly controlled conditions depending on the type of the specimen for the full period of the research. The destruction of the biological specimens will be conducted according to health and safety guideline. The biological samples and the data will be stored in Diagnomics’ secure server for the full period of research. The genetic information will be destroyed according to data safety guideline.
8. Will I be at any risk?
There are no physical risks involved with providing a Sample and having your Data used in this Project.
There are some potential risks to participating in the Project as follows:
Your Data could become public as the result of a security breach. Even though we have strong policies and processes to minimize a security breach, we cannot guarantee that a security breach won’t happen.
Research publications may include your data but only as a part of aggregated results across many participants to minimize the possibilities of identifying personal information. But it is possible that third parties could identify you from research publications even though it will require combining the genetic data in the publication with other personal information from difference sources. The chance of identifying your individual data is extremely small.
Biological Samples can be lost or stolen while in transit to Collaborators or storage. However, your Biological Samples are not transferred with your personal information.
If we were to provide you with information about your Genetic Data, you may learn information about you or your genetic relatives that you do not expect or that makes you uncomfortable, such as potential health risks. There is a possibility of psychological injury from learning your genetic information. Diagnomics does not cover the cost/treatment of any such injury. If you concern about a research-related phycological injury, please do not participate in this study or contact us as indicated below.
If your Data is somehow made public or made available through a security breach, it may be used to identify you, and may negatively impact your ability to obtain certain types of insurance coverage, or used by law enforcement agencies to identify you if they have additional DNA data to compare to your Data. In addition, if you or a family member has Data linked to your name or your family member’s name in a public database, someone who has access to your Data might be able to link that data to your name or your family member’s name through the publicly available data.
However, in the United States, a federal law called the Genetic Information Non- Discrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and most employers to seek your genetic information without your consent, and to discriminate against you based on your genetic information. GINA does not protect you from discrimination with regard to life insurance, disability insurance, long-term care insurance, or military service.
In addition, there are laws in certain states and laws outside the United States that prohibit discrimination against an individual based on genetic data, which further minimize the risk of potential negative impacts to you or a relative through a third party identifying you based on publicly available information and your Data. Diagnomics will never disclose your Data to insurance providers, employers or law enforcement (unless compelled by valid legal process).
There may be additional risks to participation that are currently unforeseeable.
9. Are there any costs to participate in the Project?
No. There is no cost for the participating in Project.
10. How will I benefit from this Project?
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 additional information about genetics, genetic research or the Diagnomics study.
11. Are there any compensations?
No financial compensation will be provided to you for any commercial developments related to the Project that may be developed by Researchers.
12. Do I have to consent to the Project?
Your participation is voluntary. No one is required to participate in the Project. If you choose not to participate in the Project, you can still use our Services, including activating your DNA test and receiving your DNA results. You will not lose any of your legal rights by consenting to this project.
13. Can I withdraw from the Project?
Yes, you can withdraw your consent at any time from your account setting page in www,genomatch.me website. If you withdraw, we will cease using your Data for the Project within 30 days and the Data will not be used in future research. However, Data cannot be withdrawn from research already in progress or completed, or from published results and findings. In those cases, Researchers may have access to such Data about you indefinitely. There is no negative impact to you for withdrawal of your consent, and you will continue to be able to use our Services as before. Withdrawing your consent will not result in destruction of your DNA Sample or deletion of your Data from Diagnomics products and services, unless you direct us otherwise. If you want your DNA Sample destroyed or your Data deleted from Diagnomics products/services or research, we will promptly do so at your request. Please contact Diagnomics at email@example.com or at +1(858) 345-4817.
This Informed Consent will be expired in three years from the time you agree with a potential extension. If you do not withdraw consent, it will remain in effect until you withdraw or we end the Project.
The investigator, the collaborator, or IntegReview may take you out of the study without your permission, at any time, for the following reasons:
14. New Findings
If there is new information or any significant new findings that could relate to your willingness to continue participation we will tell you. You can then decide if you still want to be in the study.
15. Subject’s Bill of Rights
You will be given a separate copy of the California Experimental Research Subject’s Bill of Rights. If you have not received a copy of this document, please notify study staff.
16. Who can I contact about the Project?
Please contact us if you have any concerns, complaints, or questions about the Project.
In accordance with applicable law, you may have a right to seek access to, rectification of, or object to use of your Data. You may contact us should you wish to lodge a complaint about our handling of your Data.
This Informed Consent is also available on our Diagnomics website.
Phone: +1(858) 345-4817
If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact IntegReview. IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to:
|Mailing Address: OR Email Address:|
3815 S. Capital of Texas Highway
Austin, Texas 78704
If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office at:
toll free at 1-877-562-1589
between 8 a.m. and 5 p.m. Central Time
IntegReview has approved the information in this consent form and has given approval for the investigator to do the study. This does not mean IntegReview has approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.