Informed Consent Form
Introduction and Brief Summary
You are being invited to participate in the Project Twenty21 (T21) Medical Cannabis National Registry, set up and run by the charity Drug Science. This registry aims to develop a body of evidence to document efficacy and safety data on the use of medical cannabis.
You are being invited to participate in this registry because you have a condition that medical cannabis can be prescribed for. This document provides you with information about the registry to help you make an informed decision about your participation. Please read this document carefully and take as much time as you need to make your decision. You should ask your prescribing doctor or admin staff to explain anything that you do not understand and make sure that all of your questions have been answered before signing this consent form. Reading this form and talking to your prescribing doctor or study staff may help you decide whether to take part or not. If you decide to take part in this registry, you must sign your name at the end of this form.
What is the purpose of this registry?
This registry has been established in order to develop a body of real-world data to inform on the use of medical cannabis for the conditions prescribed for by our participating clinics. Although there is evidence regarding the efficacy of medical cannabis for some conditions, additional research is needed that has a specific focus on the United Kingdom. Your data will assist Drug Science in populating this body of real-world data, utilising this data to decipher cannabis’ role in treating a wide range of conditions, plan and improve the quality of care, and help mainstream cannabis into traditional healthcare.
Why am I being asked to participate?
You are being invited to participate in the registry because you have one of the conditions that can be treated with medical cannabis such as Pain conditions, Neurological conditions, Psychiatric conditions, Gastrointestinal conditions, Cancer-related conditions, Other conditions or for Palliative care.
What am I expected to do as a participant?
As a participant in the registry, you will be asked to complete a few questionnaires once every 3 months for up to four years. These questionnaires will take approximately 10 minutes to complete.
What is the length of time/time commitment involved?
You will be monitored for four years, or as long as you continue treatment with medical cannabis at any T21 clinic if less than four years.
How many people will be in the registry?
There will be up to 20,000 people included in the registry in the United Kingdom.
What are the benefits of taking part in the research?
There is no direct medical benefit to participating in this registry. The information learned as a result of this registry may help patients with your condition in the future.
Will I receive any compensation for taking part in the registry?
If you choose to participate in the registry, the cost of your medical cannabis prescription will be discounted. You will receive a prescription from an industry partner that will subsidise the cost.
Do I have to take part?
Participation in any research study is completely voluntary. You may choose to not participate, or you may withdraw from the registry for any reason without any effect on your future medical care. If you decide not to participate in the registry, you may do so without giving a reason. If you choose not to participate or end your participation in the future, your prescription will no longer be discounted.
Will my information be kept confidential?
Records of your participation in this study will be held confidential and your data will not be shared with anyone except as described in this consent form or as required by law. Any identifiable information about you, including your name, address and phone number, will be removed from any data sets that will be distributed for analysis. You will be allocated a unique identification number when you are enrolled in this registry and this will be used to identify you throughout your participation.
For the purposes of monitoring, the investigator, Drug Science or persons working on behalf of Drug Science will be able to inspect confidential registry-related records which identify you by name. They may also access your medical records at a later date to further investigate any adverse events that you experience while using medical cannabis. This means that absolute confidentiality cannot be guaranteed. However, no records which identify you by name will be distributed or published, and any results or reports from the registry that are published or presented will not identify you.
We want to make sure you feel comfortable with providing us with your data and assure your peace of mind. Queries about how Drug Science protects data it collects for this registry can be directed to Drug Science by emailing twenty21@drugscience.org.uk.
How long will my data be retained?
Drug Science will maintain Project Twenty21 (T21) for the foreseeable future and keep the data indefinitely.
What happens if I decide to withdraw from the registry?
You have the right to withdraw from participation at any time, with or without reason, without your medical care or legal rights being affected. However, if you decide to withdraw yourself from the registry at a later date, any data collected prior to your withdrawal will remain in the database for research purposes.
Whom should I contact with any questions?
If you have questions, concerns or complaints regarding this registry, please contact twenty21@drugscience.org.uk.
