PATIENT CONSENT FORM
Pharmacogenomic (PGx) testing is used to help understand why some people respond better than others to certain medications and why some people develop side effects while others do not. Aura Genetics is a lab authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform pharmacogenomic (PGx) testing which is high-complexity testing. Pharmacogenomic (PGx) testing involves the testing of DNA, RNA or other products. As the patient/(guardian if under 18), I understand the following and freely give my consent to this genetic testing:
• You are providing a buccal (mouth/cheek) swab to examine pharmacogenomic (PGx) information which may help your provider understand how you may respond to different medications.
• Pharmacogenomic (PGx) testing may yield uninterpretable results for the following reasons: 1) Buccal sample contamination 2) Insufficient sample collection 3) Incomplete knowledge of the available genetic markers 4) Technical reasons.
• The Genetic Information Nondiscrimination Act (GINA) generally protects you against discrimination based on your genetic information when it comes to health insurance and employment.
• Your results will be released to clinicians directly involved in your care. Because of the important implications, your results are confidential to the extent required by law, and may only be released to other medical professionals with your written consent.
By signing the test requisition form, I am confirming that I have read or have had read to me, the above information and that I fully understand. I give my consent to Aura Genetics of Ohio LLC (hereinafter referred to as “Aura Genetics”) to proceed with Pharmacogenomic (PGx) Testing for testing and interpretation purposes. I understand I should consult with a provider before stopping or making any medication changes. Changing medication or dosages on my own could be harmful to my health. When signing the test requisition form, I may voluntarily choose the option to allow my identifying information to be removed from my sample (de-identify) and my sample be kept for further laboratory use or studies. If I do not choose to permit my de-identified sample from being used for further laboratory use or studies, Aura Genetics will retain the sample (swab/saliva and/or extracted DNA) only for the maximum duration permitted under applicable law or regulation (“Retention Period”), after which point it will be destroyed.