Informed Consent Agreement
This Informed Consent reviews the benefits, risks and limitations of undergoing genetic testing as selected on your order through this site (“Test(s)”, as described on the applicable page of this site) provided by or through Desert Jewel Medspa, Inc., d/b/a Genetic Protocoltm. and its contractors (“Company”).
This Informed Consent explains Company will use your information and sample in connection with the Test. Throughout this Informed Consent, “you”, “your”, “me”, “my”, and “I” refer to the person whose information and sample is being provided for this Test. If you are a parent or guardian requesting a Test for a minor, “you” will refer to “your child”, as appropriate in the given context.
You must confirm by signing below or otherwise acknowledging that you have read, understood, and agree to this Informed Consent in order for Company to process your sample and provide you and your healthcare provider with your results. Testing is not required. Company recommends that you speak with a healthcare provider about the Test prior to signing this Informed Consent.
Laboratory and Test Information
Company contracts with a testing laboratory that is accredited by the College of American Pathologists and meets the certification requirements for high complexity testing established under the Clinical Laboratory Improvement Amendments. Company continues to make new testing available. To learn more about new testing, please contact the Company using the “Contact Us” information on the Company’s home page of this website.
What Company Collects From You and How Company Uses What Is Collected
You will be asked to provide your Personal and Family Health Information (PFHI) if you order a Test. In order for the Test to perform as intended, you must provide accurate and correct information. If someone other than yourself is submitting PFHI or related information on your behalf, by signing this Informed Consent, you represent and warrant that such person is authorized to provide such information, and that all such information is accurate and correct. If you are providing personal information about relatives, you represent and warrant that you have obtained permission from such relatives to disclose such information to Company.
Company will arrange to have an authorized provider review your information, and if the authorized provider determines the Test is appropriate for you, the Test will be ordered for you.
You will be asked to provide a saliva or blood sample in accordance with Company’s collection procedures. In order to be processed, the sample you provide and your PFHI will be transferred to Company’s laboratory. DNA will be extracted from the submitted sample and sequenced. Sequence data includes information about genes and regions relevant to the ordered Test, as well as other regions up to and including the entire genome. Because saliva samples frequently include DNA from other sources (e.g., bacteria, food), Company may also sequence and collect information about this DNA if present. All sequence data may be used for regulatory compliance, and de-identified for internal quality control, validation studies, and internal research and development purposes. Analysis and reporting on genes and regions beyond those relevant to the ordered Test will not occur unless you consent to future products or services (e.g. Company Discovery), or unless you opt into third party research and Company’s research database as described below.
Upon successful completion of the Test, you hereby request that a report be made available to you and the ordering authorized provider (which may be supplied by Company) for review. You should consult with an authorized provider about your results. Such consultation will be made available through Company for an additional cost as mutually determined by you with Company by contacting Company using the “Contact Us” information on the Company’s home page of this website.
Test – Benefits
The Test results may show you have an increased risk of developing certain types of hereditary disorders. Obtaining the Test results may help you and your authorized provider make more informed healthcare decisions to prevent or detect hereditary disorders at an earlier and potentially more treatable stage. The results of your Test may also show that the genes we analyzed and reported on may impact how you process or respond to certain medications or foods. Knowing this information may help your authorized provider make more informed prescribing or dosing decisions. The Test results may also be informative to your biological relatives because relatives share some genetic features.
Test – Risks
Genetic testing generally and the Test(s) ordered through Company may cause you to discover sensitive information about your health or disease risks, including risk for hereditary disorders other than the one for which you are testing, or for disorders that currently have no treatment. The US Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits discrimination on the basis of genetic information with respect to health insurance and employment. However, certain exceptions apply, and we encourage you to review GINA and related laws and regulations. There are currently no US federal laws that prohibit discrimination in life insurance, disability insurance or long-term care insurance, which may be governed by state law. If you live outside of the US, depending on your country of residence, there may be significant differences in the laws and regulations governing the use and disclosure of genetic information, or there may not yet be any laws or regulations governing the use or disclosure of genetic information.
Test – Limitations
Depending on the Test selected by you, such Test is intended to detect variants within a specified reportable range of selected genes known to be associated with an increased risk for certain types of inherited disorders; and/or such Test is intended to detect gene alleles and variants (within a specified reportable range) known to impact your ability to process and respond to medications. However, this test may not detect every variant associated with disease risk, or every variant or allele that may impact how a person processes or responds to medications.
Analysis of Test results is based on information currently available in the medical literature and scientific databases, as well as laboratory methods and processes that may be subject to change. New information may replace or add to the information that was used to analyze your Test results. Based on new information and/or modifications that may be obtained by our laboratory informatics and algorithms, you understand and agree that Company may, at its sole discretion, amend or modify your Test report. This may result in a change in your risk assessment; the reclassification of a variant; a change or update to a previously reported pharmacogenomic allele; or a reclassification of a reported diplotype. Company will attempt to notify you of any material modifications or amendments. You hereby irrevocably waive any and all claims against Company for any modification or amendment of the Test report in accordance with Company’s standard operating procedures.
To avoid technical errors Company implements several safeguards, but as with all medical tests, there is a chance of a false positive or a false negative result. A false positive result means that genetic variation was reported which is not in fact present. A false negative result means the Test failed to identify a genetic variation that is in fact present and within the reportable range.
Other sources of error, while rare, include sample mix-up, poor sample quality or contamination, inherent DNA sequence properties, and technical errors in the laboratory. In addition, if you have certain rare biological conditions or have had certain bone marrow, kidney, liver or heart transplants, transfusions, or hematologic malignancies, these conditions may limit the accuracy or relevance of the results or prevent the Test from being completed. Company expressly disclaims any liability for the inaccuracy of Test results resulting from such conditions or the failure to provide accurate, correct or complete PFHI (including your medication history), and you expressly waive any claims against Company with respect thereto.
For genes related to disease risk, a positive result means that Company identified a genetic variant that may increase your risk for a certain type of disorder, and a negative result means that no variants that are known to increase risk were found. The Test is not a diagnostic test. Positive results do not necessarily mean that you have that hereditary disorder or that you will develop the disorder in your lifetime. Negative results do not eliminate your risk of developing a disorder, and do not guarantee that you will be healthy or will never develop any of the disorders that Company tests for.
For genes having pharmacogenomic relevance, your results may reveal that you may process or respond to certain medications more or less effectively than average. Genetics is only one of the factors influencing medication effectiveness. Your physician can consider this information along with other factors like the influence of other genes, your health history, environmental factors, and other medications. Always consult with an authorized provider before stopping or making any other medication changes. Changing medications on your own could be harmful to your health.
You should consult with an authorized provider, a genetic counselor, or a pharmacist to ensure you understand your Test results and how they may inform your personalized healthcare plan going forward. By signing this Informed Consent, you understand and agree that your Test results must be considered in the context of broader medical management by an authorized provider, and that you should not make medical decisions without consulting an authorized provider. Company does not provide medical services, diagnosis, treatment, or advice; however, Company, for an additional cost, may assist in arranging such services.
Data Security and Privacy
Your privacy is important to Company. Details about Company’s policies governing patient privacy and health information, including patient rights regarding such information, will be made available to you upon request by contacting the Company using the “Contact Us” information on the Company’s home page of this website. Company cannot guarantee the security of any information you transmit to Company or store on the Company website, and you do so at your own risk. You agree that Company is not liable for the unauthorized release of your information, unless such release was the result of gross negligence or willful misconduct on the part of Company. In the event of a data breach, we intend to comply with all applicable reporting requirements. If you are domiciled outside of the US, you should consult with your physician because genetic testing may be subject to specific regulatory constraints, or be prohibited, in certain countries. By agreeing to this Informed Consent you agree that the laws and regulations of the US regarding collection, use, processing, and storage of patient information shall govern Company’s performance of the Test and handling of your sample and information, even if they may differ from those of your country of residence. You further agree that by providing your sample, you are not violating any export ban or other legal restriction in your country.
How Company May Use Your Information and Samples After Completion of Test
Upon completion of the Test, you are requesting that your results be made available to you and the applicable authorized provider. By agreeing to this Informed Consent, you also agree that your genetic information, PFHI, and results can be shared with the authorized provider used in determining whether the Test is right for you, and with any healthcare provider that you or the ordering authorized provider designates. You also agree that Company may communicate with you about your collection kit, order, results, account details, and other Test logistics and procedures.
We store your genetic sequencing and related data as required by applicable laws and regulations, and we may use this data to conduct subsequent testing or analysis in the event that (a) you consent to any new product or service offering; or (b) our review of medical literature and/or changes in technology indicate that such analysis is useful or necessary to confirm results provided. Such subsequent testing or analysis may also require an updated physician order.
Company will retain the sample (saliva, blood, and/or extracted DNA) only for the maximum duration permitted under applicable law or regulation (“Retention Period”), after which point it will be destroyed. Samples from New York clients will be destroyed within 60 days after Company’s receipt of the sample (or upon completion of all Tests), unless you opt into the sample storage option set forth below. Until such time that your sample is destroyed, Company may de-identify your sample and use or store it for regulatory compliance purposes; internal quality control; laboratory validation studies; or internal research and development.
I confirm that I have read or have had read to me, all of the information in this Informed Consent document, and I understand what it says. I have had the opportunity to ask any questions I may have about the Company, the Test and related issues, and all of my questions have been answered to my satisfaction. I freely and voluntarily consent to undergo the Tests ordered by me or my authorized provider, and I specifically acknowledge and consent to the following:
The sample being provided is mine and I am at least 18 years of age, or if consenting for someone else, I have the legal authority to consent for such person whose sample is being provided. If the sample being provided is from someone under the age of 18, I represent that I am the parent or legal guardian of the person being tested.
This Test is not intended to diagnose whether I have or will get a certain disorder in the future. It is intended to tell me about how my genetics may impact my ability to process and respond to certain medications and foods, as indicated above.
The reported results and information are intended solely for use by an authorized provider and do not constitute medical advice by Company. I should not make any medical decisions or medication changes based on these results without speaking to my authorized provider first. My authorized provider remains ultimately responsible for all diagnosis and treatment decisions.
My sample will be sequenced for the genes and regions identified in the Test(s) selected. Company will also sequence additional genes and regions, up to and including the entire genome, and any other DNA present in the submitted sample. My genetic information, PFHI, personal data and results may be stored and used by Company for regulatory compliance purposes.
My sample and all my related personal information will be transferred to Company’s laboratory in the United States for analysis, use, processing, and storage, and will be subject to the laws, rules, and regulations of the United States.
All samples (including those received from New York clients) will be destroyed after the end of the applicable Retention Period.
If a minor will be tested, I further acknowledge and understand that while genetic report information may be similar for adults and minors, the consequences of genetic testing of minors are relatively new and less understood. The National Society of Genetic Counselors recommends that the social, psychological and legal risks and benefits of early identification of genetic issues from the perspective of the minor and parent/guardian be carefully considered and include genetic counseling when discussing adult onset disorders.
For patients domiciled outside the US: Clients who are domiciled outside of the United States in certain jurisdictions may have the option of requesting that their personal information be deleted at any time from our active databases, subject to the applicable laws and regulations of such jurisdiction. Please note that deletion of this information prior to completion of the Test will result in a cancellation of the Test, and no results will be provided to you or your authorized provider. Although we can delete your personal information from our active databases, some or all of your personal information will remain archived in back-ups for compliance with legal, regulatory, and other requirements. Information that has already been de-identified, anonymized, and/or aggregated may not be retrievable or traced back for destruction, deletion, or amendment. If you choose to have your personal information deleted from our active databases, please contact us using the “Contact Us” information on the Company’s home page of this website.