Research Ethical Clearance Number: MRS-17/18-7120
TITLE OF STUDY
Perspectives on using cannabis-based medicines as treatment for Multiple Sclerosis (MS) in the UK
I would like to invite you to participate in this research project which forms part of my undergraduate dissertation research. This research has approved ethical clearance from King’s College London. Before you decide whether you want to take part, it is important for you to understand why the research is being done and what your participation will involve. Please take time to read the following information carefully and discuss with others if you wish. Ask me if there is anything that is not clear or if you would like more information.
WHAT IS THE PURPOSE OF THIS STUDY?
The purpose of this study is to understand perspectives on using cannabis-based medicines as treatment for Multiple Sclerosis. Multiple Sclerosis (MS) is a disabling neurological condition that affects the brain and spinal cord affecting more than 100,000 people in the UK. People affected by this lifelong condition suffer from several symptoms including muscle weakness, spasticity and coordination difficulties.
In June 2010, a drug called ‘Sativex’ became the first cannabis-based medicine to be licensed in the United Kingdom as a treatment for MS-related spasticity. ‘Sativex’ is only available through the National Health Service (NHS) in Wales, however patients in England, Ireland and Scotland can access Sativex through a costly private prescription.
This study will help us collect a pool of family/carer perspectives on whether cannabis-based medicines such as Sativex should be made more widely available and accessible in the UK through the NHS.
WHY HAVE I BEEN INVITED TO TAKE PART?
You have been invited to take part as a family/carer as your perspective on using cannabis-based medicines is highly valued due to your personal experience with knowing someone affected by Multiple Sclerosis (MS). This study will give you the unique opportunity to express your views on using cannabis-based medicines as treatment for MS.
DO I HAVE TO TAKE PART?
Participation in this project is voluntary and you are free to withdraw at any time during the questionnaire; there will be no penalty for doing so. If you do choose to take part, you will be asked to provide your consent and to indicate that you have read and understood the information provided. Once you submit the survey, it will no longer be possible to withdraw from the study as the data submitted is fully anonymous. Please do not include any form of identifiable personal information in your responses.
WHAT WILL HAPPEN TO ME IF I TAKE PART AND HOW LONG WILL IT TAKE?
If you agree to take part you will complete a survey anonymously. The survey consists of four subsections: 1. Background Information 2. Knowing someone with Multiple Sclerosis 3. Quality of life and current form of treatment 4. Perspectives on cannabis-based medicines
The survey consists of short-answer questions, yes/no questions, and questions which will ask you to respond on a scale of 1 to 5.
Please answer the questions best as you can. If, however you feel uncomfortable answering a question or would like to erase a response, you can do so by leaving it blank. The survey should take roughly 5-10 minutes to complete.
WHAT ARE THE POSSIBLE BENEFITS AND RISKS OF TAKING PART?
By taking part you will be contributing your valuable views to research on whether cannabis-based medicines should be made wider available and more accessible throughout the UK on the NHS. You will also help us to address how current MS treatment affects quality of life in those with Multiple Sclerosis. The data collected from questionnaires may help to guide policy makers in assessing the availability and accessibility of cannabis-based medicines in the future.
I do not anticipate any risks associated with participating in this research.
WILL MY TAKING PART BE KEPT CONFIDENTIAL?
All information collected during the research project will be treated confidentially and will be coded so that you remain anonymous. Anonymised data will be held securely on a King’s College London drive for a period of one year after collection and will not be shared with third parties. Your data will be processed in accordance with the standards set by the General Data Protection Regulation 2018 (GDPR).
WHAT WILL HAPPEN TO THE RESULTS OF THE STUDY?
The information will be presented in the researchers' written undergraduate dissertation for their BSc Global Health and Social Medicine degree. The dataset collected will not be shared with third parties or made publicly available.
WHO SHOULD I CONTACT FOR FURTHER INFORMATION?
If you have any questions or require more information about this study, please contact me using the following contact details:
WHAT IF I HAVE FURTHER QUESTIONS OR SOMETHING GOES WRONG? If this study has harmed you in any way or if you wish to make a complaint about the conduct of the study you can contact King's College London using the details below for further advice and information:
Thank you for reading this information sheet and for considering taking part in this research