You are being asked to participate in an anonymous research study by Starseed Medicinal. Starseed Medicinal is creating a research database that will be used to measure the effectiveness of medical cannabis as an alternative treatment for chronic pain. NO personal identifiers or information (information about you and your health that identifies you as an individual) will be used or available to the researchers.
PURPOSE OF STUDY
As part of the Starseed Medicinal medical cannabis program, we are looking to understand if, and to what extent medical cannabis may be improving health outcomes and displacing opioids and other medications. There are no medical benefits to you from your taking part in this database. However, by participating, you may assist us in determining whether cannabis is able to reduce the average prescription burden for medications relating specifically to what is known as the ‘chronic pain triad’ - pain, sleep, and emotional distress. Specifically, those medications with significant side effects, such as: opioids, benzodiazepines, and the depression medication classes known as SNRIs. We will also examine whether cannabis provides additional benefits, such as helping with sleep, anxiety and depression, in individuals living with chronic pain.
WHAT IS EXPECTED OF ME?
There are no required visits for this study. At your regularly scheduled follow-up visits for medical cannabis, your healthcare provider will gather health and medical information by obtaining standardized scores for your pain, sleep and emotional well-being. A study team member will then record relevant health and medical information into the study database from the information obtained by your healthcare provider, which will be documented within your medical records.
Your data will be collected for this study for a 2-year period.All data and records generated during this study will be kept confidential in accordance with institutional and applicable laws and/or regulations. They will not be made publicly available. The data and records will not be used for any purpose other than conducting the study. The results of the study and the aggregate data collected will be kept anonymous.
Your participation in this study is voluntary and you will continue to receive the best possible care whether or not you choose to participate in the study. You may leave the study at any time without affecting your care and will have the option of removing your data from the study. Inform your healthcare provider or contact the Research Coordinator if you would like to withdraw from the study.
HOW IS MY PERSONAL INFORMATION BEING PROTECTED?
We will respect your privacy. Your data will not be shared with anyone except with your consent or as required by law. All personal information such as your name and phone number, will be removed from the data and will be replaced with a number. The data will be abstracted through a secure log in process, and all personal data will be collected, used, transferred, protected, disposed of, handled, stored, and analyzed in accordance with rigorous privacy, data security, and protection requirements.
The result of the study may be published. If the results of the study are published, the information we report in publications or presentations will be aggregate and data collected will be kept anonymous.
For the purposes of ensuring the proper monitoring of the research trial, it is possible that a member of the study Ethics Board may consult your research data and medical records. However, no records which identify you by name or initials will leave the server. It is important to note that this original signed consent form and the data which follows, may be included in your health record.
IF I HAVE ANY QUESTIONS OR PROBLEMS, WHOM CAN I CALL?
If you have any questions, concerns or would like to speak to the research team for any reason, please contact the Research Coordinator, Sara Ryan by email email@example.com.
By signing this consent form, you confirm that you have read and understood to your satisfaction the information regarding participation in the study and agree to participate in the study. You agree to give Starseed Medicinal permission to collect, use and disclose the study records as outlined in this consent form.
I have read the preceding information thoroughly and understand to my satisfaction the information regarding participation in the study. I have had the opportunity to ask questions, and all of my questions, if any, have been answered to my satisfaction. I consent voluntarily to participate in the study and agree to have my personal health information included in the database. I understand that I will receive a signed copy of this form and that I can withdraw and have my data removed at any time.