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Patient Informed Consent for Genetic Testing
The accuracy of the genetic testing and reporting methods have been determined and verified to meet required regulatory performance standards by a licensed CLIA and CAP accredited laboratory.
I understand the following information regarding the general purpose, meaning and benefits of testing.
• I understand my specimen is being tested for genetic variations. Depending upon the specific genetic testing ordered by the healthcare professional on the testing Gene Tox Lab Solutions requisition form, the results of this testing can provide information that may help my healthcare professional and me learn more about how my genes affect carrier status, responses to some classes of medications, health factors and conditions, and diet, nutrition, and/or exercise, skin health or learn more about my ancestry.
• The information that can be learned from this testing may help me work with a healthcare professional to make changes to my medical care, mental health treatment or health maintenance. I understand that I should not make any such changes without consulting a qualified healthcare professional.
I understand the general risks and limitations of testing:
• Genetic testing should not be used as a substitute for treating and diagnosing conditions, or the provision of health care services by a physician or other healthcare professional.
• Genes ore one of many things that may contribute to health outcomes and development of certain medical conditions. Many other factors such as environmental factors, diet, personal and family medical history and lifestyle choices, also contribute to health status and outcomes.
• This testing may not provide informative results for ·other reasons, such as: (1) non-genetic factors; (2) individual genetic variation; (3) insufficient scientific information about the relationship between genetic information and health outcomes; and (4) various laboratory and non-laboratory technical reasons.
• Saliva or blood specimens may be used for testing, except Medication DNA Insight testing which only uses blood specimens. Side effects of having blood drawn are uncommon, but may include dizziness, fainting, soreness, pain, bleeding, bruising, and, rarely, infection.
• Other risks that may be experienced as a result of this testing include related emotional issues, impact on life-changing decisions, potential genetic discrimination (e.g., in employment and insurance areas) and loss of confidentiality. The testing results and information may become part of my permanent medical record and may be available to individuals and organizations with legal access to such records.
Informed Consent Acknowledgement
I understand that this testing is voluntary and freely consent to this testing. My signature below acknowledges that:
• I understand written English sufficiently well enough, have read and understood the front and back of this Consent, all of my questions have been answered to my satisfaction, and agree to have the testing completed. I understand I can receive a copy of this Consent.
• Genetic counseling services are available to me through a third party, DNAFeed, at no additional charge. I understand the following information regarding the results disclosure policy: Due to the complexity of DNA-based testing and the important implications of the test results, these results will be reported through our genetic counselor.
I grant the following physician or health care professional access to my genetic testing results:
• My personal information and test results are confidential. Gene Tox Lab Solutions has established reasonable administrative safeguards and policies to protect your privacy and data. This information and the test results will be released to the ordering healthcare professional. I may request a copy of my lab results from Gene Tox Lab Solutions Client Services (see below for contact information). For more information about my rights and Gene Tox Lab Solutions privacy practices, see Notice of Privacy Practices available on www.genetoxlabsolutions.com
• This information and the results may also be disclosed if required by law, such as in response to a subpoena.
• I understand that if I share this information or these test results with anyone, I am responsible for any compromise of confidentiality that may result from such sharing.
• The original specimen(s) may be securely stored for sixty (60) days from the date of collection and any remaining isolated DNA may be securely stored in accordance with applicable laws, regulations and standards. After such storage, the specimen(s) and the isolated DNA will be properly destroyed in accordance with applicable laws and regulations and the testing laboratory's standard operating procedures.
I understand I may withdraw my consent: Gene Tox Lab Solutions cannot destroy medical records. However, at my written request and according to my instructions, Gene Tox Lab Solutions can: a) destroy my DNA specimen(s) at the next regularly scheduled destruction cycle; b) delete my account; and c) move all medical information, including results report(s), into a secure, offline storage area with limited access. This means my account and results report(s) will not be searchable in Gene Tox Lab Solutions systems by regular means and I and my healthcare professional will not be able to obtain a copy of your account information and results report(s) from Gene Tox Lab Solutions. A request to withdraw my consent may be made to Gene Tox Lab Solutions Client Services (see phone number below).
California residents only: I understand I have a right to receive a copy of the Experimental Subject's Bill of Rights from my ordering healthcare professional.
If you have further questions about this testing, I understand that I can either contact a genetic counselor, other qualified healthcare professional or Gene Tox Lab Solutions.
Patient Informed Consent for Data Research
One of Gene Tox Lab Solutions’ mission is to help people access, understand and benefit from the human genome. One of the ways we do this is through our research program. We are asking for your consent to participate in our research and discovery programs that we will do individually as a company and also, from time to time, with research and development partners. We seek your permission to share your de-identified individual-level genetic & self-reported information with our research collaborators and business partners. We collaborate with researchers outside of Gene Tox Lab Solutions 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, connections among diseases and traits, human migration and population history, and how people react to their personal genetic information.
Giving consent by checking the appropriate box below means that you agree to let Gene Tox Lab Solutions share your de-identified individual-level data with approved researchers outside of Gene Tox Lab Solutions. That is, you agree that we may share your Individual-level genetic & self-reported information. This includes:
· Your genetic data
· Information you enter into health surveys and forms
· Data you separately authorize us to import for research
· Your age and ethnicity
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.
Individual-level means the data are related to a single person.
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.
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 our scientific committee to ensure the goals and methods of the research are aligned with our mission and consistent with any of our associated research consent documents.
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.
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.
We take seriously the trust you place in us. We have very strong security measures in place to ensure your data is transferred safely. We will also have agreements with all collaborators regarding the security and storage of data that we share and require that all collaborators have policies and procedures that minimize the chance that a breach could take place.
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 us or our research partners. Based on the information you provide and allow us to share, Gene Tox Solutions 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 that made the discoveries and you will not receive any compensation.
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. 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 we share your genetic or self-reported data with a research collaborator, this action cannot be reversed and your de-identified data will not be returned to us.