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. Just as 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 service that assesses your genetic profile for known factors that influence response to medications. Pillcheck provides insights on 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 medications will be safest and 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 pharmacogenetics-trained consulting pharmacist. DNA is collected by gently swabbing the inside of your mouth (cheek) with a small sponge (similar to a Q-tip).
Only specific, well-identified DNA variations related to drug response are analyzed by Pillcheck. The results are used to generate a personalized report listing your body’s predicted response to all Pillcheck-covered medications. Pillcheck does NOT assess any genes related to disease risk or disease diagnostics and is only a tool to assist you and your healthcare providers to optimize your medications. Once the test is complete, any remaining DNA is destroyed after 30 days.
Your genetic summary data related to drug response will be stored in Pillcheck systems for the purpose of updating reports as required to reflect the most up-to-date clinical guidelines and expanded drug list over time. You will receive e-mail notifications about your report updates when they are available. 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.
Potential Risks and Limitations
You should be aware of the following potential risks:
- In the absence of counselling from a licensed healthcare practitioner, some individuals may misunderstand the nature of pharmacogenetic 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 pharmacogenetics-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 personally identifying results will not be shared by GeneYouIn with any third party, including your insurance company and employer.
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 medication 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 to use Data for Process Improvement
By signing this consent, you agree to allow GeneYouIn to use and share your anonymous genetic and health data to improve service delivery for you and other clients. You will not be compensated as a result of the analysis or research performed using your anonymous genetic or drug response data, and any discoveries resulting therefrom shall be the exclusive property of GeneYouIn.
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.