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All capitalized have the same meaning as defined in the Terms and Conditions and Privacy Statement unless defined otherwise herein.
A. Storing your DNA Samples: Using your DNA Samples on further Analysis
2. Some research participants may have their DNA reanalyzed using additional technologies. Such reanalysis may focus on particular genes or regions, on particular portions of the genome, or on the whole genome. While the field of large-scale sequence analysis is still in its early stages, CRI Genetics can use methods currently being developed to compare sequence data with large public databases of genetic variation to identify and characterize functional genetic variation. Depending on the type of study, the sample sizes required may vary considerably. As the methods for analysis become better developed, the studies with whole exome and genome data will establish better estimates of appropriate sample sizes. Presently, cost and capacity of providers may be the most likely reason for limiting sample sizes. Any additional data collected will be used in accordance with CRI Genetics policies and with the prior written consent of the participant.
B. Informed Consent
1. Overview: What is the CRI Genetics Research Project, and What Are You Agreeing To?
At CRI Genetics, part of our mission is to make and support meaningful scientific discoveries in the world of human genetics, genealogy, anthropology, cosmetics, nutrition, and health. We seek to enable our customers to participate directly in such research. CRI Genetics is beginning to enroll participants from among its customers in this project, which we call the CRI Genetics Research Project (“GRP”). Specifically, GRP refers to research for potential future publication in peer-reviewed journals and research funded by the federal government (such as the National Institutes of Health - NIH). The GRP study aims to: (1) Discover genetic factors behind diseases and traits; (2) Uncover connections among diseases and traits; (3) Learn about human migration and population history through genetics; (4) Understand how people react to their personal genetic information; and (5) develop new or improved diagnostic tools and therapies to treat diseases or other conditions (collectively “GRP Objectives”).
By consenting to participation in the GRP, you agree that all Genetic Information and DNA Samples submitted by you to us (as further described below) through your use of the CRI Services (As defined in the Terms and Conditions) can be collected and used for any type of research consistent with the GRP Objectives. Such consent shall be deemed granted and in effect until the GRP has completed or has ended. You acknowledge that such end date may occur many years from now. Anyone who has purchased the DNA Service can voluntarily participate in the GRP at any time.
If you are the parent or guardian of a Minor who wishes to participate in the GRP, you should talk with the Minor and go over the information in this Consent Document with him/her before you and the Minor make a decision about whether to participate in the GRP.
This Consent Document is not applicable to the use of your data for product research and development. For information on that use, see our applicable privacy statements and terms and conditions.
2. How Do You Participate?
To participate in the GRP, you must review this Consent Document and choose to participate by doing the following: (1) Read and accept the Terms and Conditions and Privacy Statement for the CRI Services; and (2) Check the box indicating that you are providing your consent to participate in the GRP. Once you provide consent, we will use the information you provide for the GRP.
Participation consists of (1) allowing CRI Genetics researchers to use the Genetic Information extracted from your DNA Sample for research in connection with the GRP, and (2) entering data about yourself when creating your User Account by way of surveys, individual questions, and other methods where you provide information. Though all of the information collected will remain anonymous, 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 GRP 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 User Account. We might invite you to participate in a specific study if your Genetic Information matches a specific area of interest. Though CRI Genetics is not required to and is under no such obligation to do so, for your participation, monetary, cash equivalents such as gift certificates or discounts on future CRI Genetics service purchases, or charitable donations (up to a value of $30 per half hour of expected time) may be provided, at CRI Genetics sole discretion, as compensation for your time. Your participation in the GRP is completely voluntary.
3. What Data is Used and How is it Used?
The GRP collects preserves and analyzes genealogical lineage, historical records, surveys, Genetic Information, Personal Information, and other records (collectively, "GRP Research Data") provided by Users. The GRP Research Data, and specifically Your Genetic Information, may be used to discover links between genetic markers, non-genetic markers, traits, diseases, nutrition, behaviors and other characteristics; to study human migrations and population history; or to assess how people respond to personal genetic information. This research could lead to discoveries which better help us understand the basic causes of disease, or could develop drugs or other treatments and/or preventive measures, or predict a person's risk of disease. The intent of the GRP is to study topics spanning over a wide range of traits and conditions, from common to rare. Such topics include simple traits such as hair color or freckles, serious diseases such as Parkinson's disease or diabetes, and less serious conditions such as migraine headaches or responses to over-the-counter drugs. 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 CRI Genetics 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.
If we or a third party wants to conduct a study (1) on topics unrelated to the GRP, or (2) using GRP Research Data beyond what is described in this Consent Document, we will re-contact you to seek your specific approval. In addition, we may contact you to ask you to complete a questionnaire or to ask you if you are willing to be interviewed about the GRP or other matters.
4. How is Your Data Protected?
The CRI Genetics Privacy Statement describes how we protect your privacy while operating the CRI Services and other business matters. These same procedures are used by us to protect your GRP Research Data. CRI Genetics uses a range of physical, technical, and administrative procedures to protect the privacy of your Personal Information, including your GRP Research Data. GRP Research Data obtained through the GRP will be stored in our secure databases in the United States.
By agreeing to this Consent Document, you consent to our use of your GRP Research Data in additional ways. Specifically, CRI Genetics researchers may use your GRP Research Data for research that will be published in scientific journals, or that is sponsored by the National Institutes of Health and certain other organizations.
Similar to how CRI Genetics operates its business, CRI Genetics researchers aim to minimize the chances of a privacy breach while conducting research. We do that by:
i. Restricting CRI Genetics researchers who conduct the statistical analyses from access to Personal Information (name, address, email address, user ID, password, or credit card) of customers, and limiting the researchers who do interact with research participants and thus have access to names and contact information of participants, to a very limited amount of Genetic and Personal Information
ii. Only allowing CRI Genetics researchers to either:
a. publish only data pooled across multiple customers or
b. publish only very limited, non-identifying information of a single individual
iii. Training all CRI Genetics employees on how to work with human research participants. In addition, all CRI Genetics researchers are trained on how to conduct research responsibly.
5. What are the costs, risks, and benefits of participating?
There will be no cost to participants for participating in the GRP. There will be no financial compensation paid to you for your participation in the GRP. However, the GRP is intended to assist academics or researchers to better understand the human species, learn or confirm certain facts and make predictions about future trends. Your participation may help advance scientific or medical knowledge. It is not anticipated that the GRP will provide significant benefits to an individual participant, and research results will not be communicated by Researchers to you. Based on the results of this study, CRI Genetics may develop intellectual property, including but not limited to patents, copyrights and trademarks, and/or CRI Genetics may commercialize products or services, directly or indirectly. In such cases you will not receive any compensation.
There are no physical risks involved with participating in the GRP. None of the procedures or practices used by GRP researchers are invasive or experimental. However, there are some potential other risks to participating, such as:
i. Some survey questions or data comparisons may make you or your family members uncomfortable.
ii. Your GRP Research Data could become public as the result of a security breach. Although we have processes in place designed to prevent a security breach we cannot guarantee a breach will never happen.
iii. Third parties could, potentially, identify you from GRP research that is made publicly available. For example, even though GRP Research Data is not typically published in scientific journals, it is sometimes made available for review by peer scientists, journal editors or others. CRI Genetics takes steps to remove common identifying Personal Information (such as your name and contact information) from any GRP Research Data before publication, but GRP Research Data is different from other data because it can be used as an identifier in combination with other information. Currently, it is not common practice to do this but it can be done, particularly if GRP Research Data about you is available through other public genetic databases. In the future, new methods for this may be developed and it may become more common.
iv. As with any online service, if you disclose your account password to others, they may be able to access your User Account and your Genetic & Personal Information.
v. There may be additional risks to participation that are currently unforeseeable.
If GRP Research Data is obtained through these methods, it is possible that information about you could be revealed. Such information could be used by insurers to deny you insurance coverage, by law enforcement agencies to identify you or your relatives, and in some places, the data could be used by employers to deny employment.
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. There may be state laws and laws outside the United States that prohibit discrimination against you based on Genetic Information.
6. Do I have to consent to participation? Can I Withdraw from participation? What are my alternative options?
You do not have to consent to participation in the GRP. Participation in the GRP is completely voluntary. If you choose not to give consent for the GRP, your Genetic and Personal Information may still be used for other purposes, as described in the Privacy Statement. Additionally, if you do give consent to participate, you may, at a later time, choose to not partake any GRP surveys or other GRP activities.
At any time, you may choose to withdraw all or some of your Genetic and/or Personal Information from the GRP. To do so, contact us at 1-800-571-9216. Once your withdrawal of all or some of your Genetic and/or Personal Information is confirmed, CRI Genetics will prevent such information from being used in the GRP within 30 days of confirmation. 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 the GRP will not affect your access to your Genetic Information or to the CRI Services.
In addition, the GRP may be terminated, at any time, without notice to you or your consent. In such event, your GRP Research Data will continue to be protected as described in this Consent Document and the Privacy Statement.
7. Contact Information
You can contact CRI Genetics by the methods below if you have any concerns or questions about the GRP.