INFORMED CONSENT – CONSUMERS
Please provide your consent that you are aware of the benefits, limitations and potential risks of GeneYouIn’s Pillcheck™ Service
The Pillcheck Medication Optimization Service
Your overall health and well-being are in part determined by your genetic makeup. Similar to how genetics can affect your eye colour, genetics can also affect how you respond to medications. Because of genetic differences, two people can take the same dose of the same drug, but respond in very different ways. For example, the drug might work very well for one person, but not at all for another. Or the drug might cause side effects for one person, but not for someone else.
Pillcheck is a pharmacogenetic (PGx) service that assesses your genetic profile for known factors that influence response to medications. Pillcheck provides insights as to how your body is likely to respond to many commonly prescribed drugs and provides personalized, actionable recommendations for each medication that is covered by the service. Many health conditions can be effectively treated by several different medications. Thus, you can use Pillcheck, with the help of your physician and pharmacist, to find which of the possible, prescribed medications will be most effective for you based on your genetic profile. This can reduce the trial period on a medication and help you achieve successful pharmaceutical treatment results faster. The service includes a genetic test, which is used to generate your personalized Pillcheck Report, as well as a review of your medications and professional opinion letter from a PGx-trained consulting pharmacist.
Pillcheck does NOT assess any genes related to disease risk or diagnostics, and is only a tool to assist you and your healthcare providers to optimize your medications.
Potential Risks and Limitations
There are some consequences to Pillcheck that you should consider:
- In the absence of genetic counselling, some individuals may misunderstand the nature of PGx services and misinterpret their results.
- The Pillcheck service is based on current scientific knowledge of genetic variations involved in drug response. There may be other genetic variations potentially affecting your drug response that are not yet identified.
- There may be other risks that are currently unforeseen.
Accessing and Secure Sharing of your Data
By signing this consent, you agree to allow GeneYouIn and a PGx-trained consulting pharmacist to have access to your Pillcheck Report and related medication information (optionally provided by you) for the purpose of performing a personalized medication review. If you were referred to us by your physician, clinic, or pharmacy and you use their discount code, you allow us to share your report with the referring party. Through GeneYouIn’s electronic tools, you can also grant other trusted healthcare providers secure access to your Pillcheck Report. If at any time you decide to withdraw your consent, you may request deletion of your records, which will extend to your records on our clinical research database. Except as expressly set forth in this Informed Consent, your results will not be shared by GeneYouIn with any third party, including your insurance company and employer.
You will receive e-mail notifications of updates for your genetic data re-analysis as they become available over time. You can access your data and review updates at any time through GeneYouIn’s secure web application free of charge. Please keep your contact information up-to-date.
Conditions of Services
By signing this Informed Consent, you understand that:
- The Pillcheck service uses a Laboratory Developed Clinical Diagnostic Test (LDT). Similar to other LDTs used by physicians for guidance, Pillcheck can provide data to physicians and pharmacists that allow them to make more informed decisions about treatment optimization at their own professional discretion.
- GeneYouIn does not provide medical advice, diagnosis or treatment and does not replace your healthcare provider. Always consult your doctor if you have any questions regarding your medical condition, and before starting, stopping, and/or altering the dosage of any treatment that has been prescribed to you.
- The medication change and dosage recommendations provided by Pillcheck are based on current scientific knowledge. As scientists identify new genetic markers that affect your drug response, another analysis may be required. The sample you submitted is not stored, and re-analysis may require additional samples.
- Additional factors such as other medications or supplements you take, as well as your diet, lifestyle, and other health conditions may affect your drug response. Pillcheck recommendations do not account for these environmental influences.
- Ethnicity can influence the accuracy of our predictions for certain assessments. Since Pillcheck only analyzes known common variations, individuals with specific ancestries may have additional variations in their genome that are not captured by our analyses.
- The accuracy of DNA analysis depends on several factors outside of the laboratory’s control, including how carefully you follow the cheek swab collection instructions provided by GeneYouIn. Insufficient quantities of DNA and poor results are likely if you smoke, eat, drink or brush your teeth shortly before collecting the sample.
- Genetic data and personal identifying information are confidential, and will not be disclosed by GeneYouIn without your explicit consent, or without a legal order.
Consent for Research Purposes
Genetic and drug response data can be used to discover or validate associations between certain genetic variations and drug response. Studies aimed at discovering or validating such associations improve the accuracy of our predictions for you and our future clients. By signing this consent, you agree to allow GeneYouIn to use and share your anonymous genetic and drug response data with research organizations. You will not be compensated as a result of the analysis or research performed using your DNA, genetic or drug response data, and any discoveries resulting therefrom shall be the exclusive property of GeneYouIn.
By signing this document, you authorize GeneYouIn to use and share your anonymous DNA, genetic and drug response data with research organizations.
GeneYouIn Contact Information
If you have any other concerns or questions, please contact our privacy officer at Privacy@GeneYouIn.ca or 1-877-409-3629.