Last Modified: February 11, 2019
This consent form (“Consent”) reviews the benefits, risks and limitations of you, as the person who has created a user account (referred to as “you” or “your”), utilizing the Services provided by Prevé Wellness, LLC (referred to as “Prevé”, “we”, “us” or “our”). It also explains how your information and sample(s) will be used after performance of the Services. Your sample(s) will not be processed unless you confirm that you have read and understood the contents of this form.
By clicking on the box, you indicate that this Consent is a binding agreement and that you have read and understood the following terms. Capitalized terms used but not defined in this Consent have the meaning given to them in our other policies.
By clicking your acceptance, you have chosen to use our Services and have given your informed consent to have your biological sample(s) tested for biomarkers and/or genes. Biological samples shall consist solely of human fluids, depending on the test purchased, that are intended to be analyzed for the individual’s sole use and as set forth in this Consent for Services.
Our Services are offered and available to users who are 18 years of age or older and are residents of the United States. Your use of Prevé’s Services is voluntary. It is your choice whether to utilize our Services or not. Prior to signing this Consent, you may wish to speak with your healthcare provider for further guidance about our Services.
Procedures and Protocol for PrevéTests
When you create your Account, we will collect some information from you. We cannot perform the Services without collecting information from you but we will only collect information that will assist us in providing the Services that you have requested. In order for the Services to be provided as intended, you must provide accurate and correct information. Failure to provide required information or to execute required documents may result in your sample(s) not being tested.
You will collect the biological sample(s) (i.e., blood, saliva, or urine) that will be provided to and tested by one of our designated testing laboratory affiliates (“Lab”). You will send the sample(s) directly to the Lab where your sample(s) will be tested for a number of biomarkers (including but not limited to vitamins, minerals, metabolites and hormones) and, if selected and purchased by you, genes that may inform your health choices.
The results of your test(s) will be made available to you through our Site. In the event we determine that a biological sample is not suitable for testing due to the content of the sample or because we believe the sample to have been submitted in violation of this Consent or the User Agreement, we reserve the right to withhold the results and to not provide a refund. We will determine and establish normal ranges for all tests in conjunction with our laboratory affiliates based on their validation and proficiency testing procedures. If your results are clinically significant or have a critical value that falls outside of our established normal ranges by at least a certain amount, a Prevé consultant will make reasonable efforts to contact you.
Utilizing our Services can help you gain a better perspective on your health and how your body functions. You may use this information to make more informed health care decisions and choices.
More information about the specific benefits of our tests and Services are available on our Site.
In order to utilize our Services, you must collect the appropriate biological sample(s) for the test(s). Some of our tests require a urine sample or a saliva sample; there are no risks associated with collecting urine or saliva samples using the containers provided in our test kit(s). Some of our tests require the collection of a blood sample. Although the risks and discomforts associated with a blood draw are very low, you might be at risk for excessive bleeding, fainting, feeling light-headed, bruising, hematoma (blood accumulating under the skin), or infection (a slight risk any time the skin is broken). If you have a history of excessive bleeding or fainting while having blood work done, we advise avoiding our tests that require blood collection.
Disclosing certain information may make you uncomfortable. Our Services include geneticand biomarker tests that may reveal sensitive information about your health. You may learn about a trait that is mostly genetic and not largely affected or controllable by your behaviors. Genetic testing may also reveal incidental, unsought information (e.g., non-paternity, or that someone with your genotype may have a higher than average chance of developing a specific condition or disease). This information may be distressing.
Genetic information that you share with others could be used against your interests. Currently very few business or insurance companies request genetic information, but this could change in the future. While the Genetic Information Nondiscrimination Act of 2008 (GINA) generally prohibits health insurance companies, group health plans, and most employers from discriminating against you based on your genetic information, GINA does not cover companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not protect you against discrimination if you have already been diagnosed with the genetic disease.
Geneticinformation that you choose to share with your physician or other healthcare providers may become part of your medical record and through that route may be accessible to other healthcare providers and/or insurance companies in the future. Information that you share with family, friends or employers may also be used against your interests. Even if you share genetic information that has no or limited meaning today, that information could have greater meaning in the future as new discoveries are made.
As a result of the Prevé Services, you may learn about health conditions and problems or potential health risks that you were not aware of before you utilized our Services. You may experience stress, anxiety, or emotional or physical discomfort when you learn about health problems or potential health problems. There may also be additional risks of utilizing our Services that are currently unforeseeable.
OUR SERVICES DO NOT PROVIDE MEDICAL ADVICE. The information and content provided, including but not limited to the laboratory test results, (and the text, graphics, images, videos, and other material contained in the Services), are for informational purposes only and are not intended as a substitute for professional medical advice, help, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you have regarding your medical care, and never disregard professional medical advice or delay seeking it because of something you have read on or via our Site. Nothing contained in the Services is intended to constitute a medical diagnosis or treatment. Reliance on any laboratory test results or information appearing in the Services, including but not limited to laboratory test results, information provided by Prevé or by other users of the Services, is solely at your own risk. By clicking your acceptance, you understand and agree that your results are not intended to be used for any diagnostic purposes and are not a substitute for professional medical advice. You understand that our Services, including the laboratory test results are for information and educational use only; Prevé does not provide medical services, diagnosis, treatment, or advice.
Prevé does not warrant the accuracy, completeness, timeliness or usefulness of the laboratory test results, opinions, content, services or other information provided through the Services or on the Internet generally. Prevé and its affiliates, licensors, and suppliers have no control over and accept no responsibility for your compliance with the laws applicable to your state of residence.
Prevé implements several safeguards to avoid technical errors, but as with all medical tests, there is a chance of a false positive or a false negative result. A false positive result means a genetic mutation or biomarker was detected, which is not in fact present. A false negative result means the test failed to identify a genetic mutation or biomarker that is in fact present. Other sources of error include sample mix-up, poor sample quality or contamination, inherent DNA sequence properties, and technical errors in the laboratory. Some biological factors, such as a history of bone marrow transplants or recent blood transfusions may limit the accuracy of the results or prevent the Services from being completed.
Laboratory test result, including without limitation, genetic result, interpretation is based on currently available information in the medical literature and scientific databases. The field of laboratory medicine and genetics is constantly changing and our understanding of genetics and biomarkers is evolving. New information may replace or add to the information that we used to interpret your results. We are not obligated to notify you if there is a new understanding of genetics or biomarkers that might result in a change to the interpretation of your results. We reserve the right to contact you, at our option, in the future.
Retention and Use of Your Information
We are subject to multiple laws on the retention of data. Accordingly, we retain any information collected about you for as long as we are required to maintain it for regulatory and compliance purposes or for a legal or business necessity.
Your biological sample(s) will be sent directly to our affiliate Lab that will conduct the test. Prevé has no obligations or liability regarding the retention of your sample(s). You understand that by providing any sample, having your sample processed, accessing your results, or providing information to us, you acquire no rights in any research or commercial products that may be developed by Prevé or its collaborating partners. You specifically understand that you will not receive compensation for any research or commercial products that include or result from your sample or information.
Your information and test results may be stored in a repository and used for validation, educational, and/or research and development purposes which may lead to a commercial product. By clicking your acceptance of this Consent, you acknowledge and agree that Prevé may de-identify the genetic information that is obtained from our Services and that we may aggregate this information with de-identified genetic information from other users. De-identification means that the personally identifiable information associated with your genetic information will be removed. (1) You understand that we would not disclose, sell and otherwise commercialize genetic information but (2) You understand that we may disclose, sell and otherwise commercialize de-identified non-genetic information / User Content without restriction.
We may incorporate different or additional technologies to test or analyze data in the future. We may, at our sole discretion, choose to test or analyze your data using such technologies. We are not obligated to notify you if we chose to conduct different or additional testing or analysis on your data. Your purchase of our Services does not automatically include any such different or additional technologies. You may have to pay additional fees in order to receive Services using any future or additional technologies or features.
The Genetic Information Nondiscrimination Act of 2008 (GINA) generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. Be aware that there are currently no United States federal laws that prohibit genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance, which may be governed by state law. GINA also does not protect you against discrimination if you have already been diagnosed with the genetic disease. You acknowledge that there are limitations to the protections afforded by this law and that the law and its protections may change in the future.
Withdrawal of Consent
Your use of Prevé’s Services is voluntary. You may choose to withdraw your Consent or to stop using Prevé’s Services at any time. Such requests should be sent to us by email firstname.lastname@example.org.
Please note that while any changes you make will be reflected in our databases within a reasonable period of time, we may retain your information in the ordinary course of business, for the satisfaction of our legal obligations, or where we otherwise reasonably believe that we have a legitimate reason to do so. Information that has already been de-identified, anonymized, or aggregated may not be retrievable or traced back for destruction, deletion, or amendment.
To ask questions or comment about our Services or this Consent to Services, contact us at: Prevé Wellness, LLC, 1100 Revolution Mill Dr. Suite 1, Greensboro, NC 27450. Phone: 336-235-0750; Email: email@example.com
© 2019 Preve Wellness, LLC. All rights reserved.
Preve is a trademark of Select Laboratory Partners, Inc. licensed to Preve Wellness, LLC.
Preve Wellness offers laboratory testing for wellness monitoring.
The tests we offer are not intended to diagnose or treat disease, or to substitute for a physician’s consultation. For regulatory reasons, our tests are not available in MD, NJ, NY, and RI.