We are conducting a research study to increase our understanding of how pharmacogenomics (the study of how genes affect a person’s response to drugs) is perceived and used by those living in long-term care homes and those who have loved ones living in long-term care homes.
Currently, physicians are limited to assessing a resident’s symptoms and conditions in order to prescribe medications. However, physicians now have the opportunity to personalize medications and reduce negative side effects, according to an individuals’ genetic make-up.
Pillcheck® is a test that assesses 14 genes that are believed to impact how your body reacts to some commonly prescribed medications. Over 50% of Pillcheck users have had their prescriptions modified based on their test results. Pillcheck may help your loved one’s pharmacist and doctor to determine the most effective medications for your loved one. Since a person’s DNA stays the same, the Pillcheck test results may help the doctor decide on which medications are appropriate for your loved one now and in the future. After reviewing the Pillcheck report, your loved one’s pharmacist or doctor may recommend a change to your loved one’s medications and doses based on their genetic profile. Personalizing your loved one’s medications based on this genetic profile may improve drug therapy outcomes and minimize negative side effects.
Approximately 200 subjects who are residents in long-term care homes will be included in this study. We will compare the results with up to 400 different subjects who are residents in long-term care homes but were not included in this study.
The Pillcheck test only requires that your loved one provide a non-invasive cheek swab to collect the DNA sample. The sample is sent to a lab for analysis and destroyed after the test is complete. The results of the test, including a detailed medication report, are then sent to your loved one’s physician and to you after two weeks. Upon completing this consent form, you will receive a secure, online account in the Pillcheck Portal, where you can view the test results when they are complete. Your loved one’s physician may make recommendations to change his/her medications based on the Pillcheck report.
Participation in this study is voluntary. You can choose to not have your loved one participate or you may withdraw them at any time without affecting their medical care at a Responsive Inc. home. In no way does signing this consent form waive your or your loved one’s legal rights nor does it relieve the investigators, sponsors or involved institutions from their legal and professional responsibilities.
Your participation requires you:
There is no risk associated with the cheek swab sample collection.
The Pillcheck service is based on current scientific knowledge of how genes affect response to drugs. There may be other genetic variations potentially affecting your loved one’s drug response that are not yet identified. As scientists discover new genetic markers that affect your loved one’s drug response, results may change or another pharmacogenomic test may be required.
Additional factors such as other medications or supplements taken, as well as diet, and other health conditions may affect drug response. Pillcheck recommendations do not account for these factors
The main risk associated with genetic analysis is misuse of personal genetic information. The sponsor has taken special precautions to keep your genetic information confidential. However, absolute confidentiality cannot be guaranteed.
You will be informed if new information is obtained about the risks or benefits of participating in this study.
Your loved one’s physician and pharmacist may have more information available to them to feel more confident about the drugs that are being prescribed. As a result of the Pillcheck Medication Review, your loved one’s physician or pharmacist may recommend a change in their medication, dosage, or to stop taking some medications altogether in order to reduce negative side effects. However, in most cases, your loved one’s long-term health outlook, most likely, will not substantially improve.
All information obtained during the study will be held in strict confidence, except where disclosure is required by law. No test will be completed without personal or family consent. No names or identifying information will be recorded on any evaluation materials or used in any publications or presentations. Any data collected during the study from your loved one’s electronic medical record or pharmacy records will be de-identified and coded with a unique study ID in order to protect your loved one’s privacy. Identifiable records (such as this consent form) or the separate Subject Identification Code List will be kept in a secure location accessible only to authorized personnel at Think Research and GeneYouIn. You have full ownership of your loved one’s Pillcheck test results and all information is kept confidential. No medical changes will occur without your consent.
By completing this form, you give permission for the Responsive Group to release your contact information to Think Research so they can provide you with more information about the study and answer any of your questions.
Study records including confidential information about your loved one collected during the study will be kept at a secure location. Information from this study will be submitted to the sponsor. Information sent from the study site will contain a code number, but will not contain your or your loved one’s name. Representatives of the research ethics review board - IRB Services (an independent ethics committee that reviewed the ethical aspects of this study to help protect the rights and welfare of study participants), may have access to the information collected for this study, at the study site.
A federal law, called the Genetic Non-discrimination Act (GNA), prohibits genetic discrimination across Canada. It bars any person from requiring individuals to undergo a genetic test or disclose the results of a genetic test as a condition of providing goods or services, or entering into a contract. By signing this information and consent form, you consent to the collection, access, use and disclosure of your or your loved one’s information, including DNA samples, as described above.
There is no cost to you or your loved one. The funding provided by the Centre for Aging and Brain Health Innovation (CABHI) will enable your loved one to receive the Pillcheck test and provide their physician with a detailed report with recommendations of the appropriate dosage and/or medication changes.
Should you have any questions or concerns, please contact Zainab Ali, Project Manager at (877) 302-1861 x 552.
An institutional review board (IRB) is an independent committee established to help protect the rights of research subjects. If you have any questions about your rights as a research subject, and/or concerns or complaints regarding this research study, contact:
Please reference the following number when contacting IRB Services: Pro00024409.
The purpose of the study and the risks and benefits of participating have been explained to me. I understand that my and/or my loved one’s confidentiality will be maintained, and that I have a right to withdraw from the study without penalty. I understand that a copy of this Informed Consent will be available in my Pillcheck Portal account.