Nutrigenomix – DNA Test – Client Consent Form
Each client is required to read, acknowledge, and agree to the terms in this Consent Form before his/her sample can be processed. This ensures each client knows what to expect, understands the process, is aware of the benefits, limitations and potential risks, and understands fully the service being provided before agreeing to proceed.
By agreeing to the conditions in this form, the client authorizes Nutrigenomix to:
•Analyze his/her DNA for specific nutrition and physical activity‐related genetic markers.
•Store his/her anonymized DNA sample in a safe and secure location, so that as the science developshe/she will have the option of having additional tests.
What is Nutrigenomix testing? Nutrigenomix testing is a safe and non‐invasive saliva collection kit or buccal swab developed for use by healthcare professionals to provide their clients with comprehensive, reliable, genomic information with the ultimate goal of improving the client’s health through the provision of personalized nutrition and physical activity recommendations. The Nutrigenomix test kit involves saliva or buccal swab collection, testing of the client’s DNA for specific nutrition‐related markers, and generation of a personalized nutrition and fitness report. The test analyzes variations in 45 genes that impact nutrient metabolism, eating habits, weight management and body composition, food intolerances and physical activity. The accuracy of the genetic test results are between 99.7 – 100%. What are the benefits? Following the nutrition and physical activity recommendations based on the results of the genetic test has been shown to reduce the risk of chronic disease and promote optimal health. Research also shows that individuals who receive DNA‐based dietary advice find the information more motivating to adopt healthier eating habits, and make more changes to their diet compared to when they are given general population‐based dietary advice. What are the risks? There are no known risks associated with Nutrigenomix testing. Some individuals may worry that their genetic information could be used to discriminate against them in their job or for health insurance coverage. In the United States, the Genetic Information Non‐discrimination Act (GINA) was signed into law in May of 2008 and offers federal protection against such discrimination. The federal Health Insurance Portability and Accountability Act (HIPAA) of 1996 prohibits employers and health insurers from excluding individuals from group coverage due to genetic predisposition to certain diseases. Neither HIPAA nor GINA prohibits life insurance policies from using this information. Most states in the US have additional and varied legislation intended to safeguard genetic information. In Canada, the Genetic Non‐Discrimination Act (GNA), formally known as Bill S‐201, was passed into law on May 4, 2017. GNA protects individuals from insurance companies and employers from using, requesting or requiring genetic test results. Under GNA, employers cannot use a person’s genetic test results to make decisions about hiring, firing, job assignments, or promotions. Under GNA, the Canadian Human Rights Act bans discrimination based on genetic characteristics. GNA does not prohibit insurers from using information about an individual’s current symptoms and diagnoses, even if the condition has a genetic basis. Family medical history is not protected by GNA. Note: Nutrigenomix does not test for genetic predisposition to certain disease. The test only includes genes related to nutrition and physical activity. Nevertheless, if an individual has a Nutrigenomix test, he/she is required to answer ‘yes’ on any legal forms or questionnaires that ask whether they have had a genetic test.
What are the limitations? Nutrigenomix testing is not intended to prevent, mitigate, or cure disease. Nutrigenomix does not provide medical advice, diagnosis or treatment. The test looks at 45 genes that have been shown to modify response to dietary intake and/or to impact nutrition and physical activity recommendations. The development of chronic diseases can be influenced by many factors, including genetics, diet and lifestyle. Following the recommendations provided does not guarantee absence of disease. The test results are based upon probabilities, and may not provide a 100% definitive conclusion to either elevated or typical risk. How will the information be protected? All personal health information, including Nutrigenomix test results, is protected by the healthcare professional or clinic providing the test. Each sample is anonymized using a barcode and this is entered into a password protected online system. Nutrigenomix uses a Secure Socket Layer (SSL) protocol to encrypt information that is transmitted over the Internet. This technology uses 256‐bit encryption, which ensures that confidential information and transactions cannot be viewed, intercepted or altered. Nutrigenomix will never reveal client information or genetic data to a third party except as required to provide the services requested, or as required by law. What will happen to the DNA sample once the client has received the results? After testing is completed, Nutrigenomix will store the anonymized sample under secure conditions to enable future testing as new markers are discovered. Will the level of care the client receives by his/her healthcare professional change if the decision is made not to do Nutrigenomix testing? No, the client will receive the same level of care. However, the dietary advice the client receives will not be tailored to his/her genetic profile. Client Consent I have read, or have had read to me, all of the above statements and understand the information regarding Nutrigenomix testing. I have had the opportunity to ask any questions I have about the testing, procedure or risks prior to providing my consent. By providing my saliva or buccal swab sample I am consenting to Nutrigenomix testing and storage of my sample for future testing.