Participant Invitation and Information Sheet MRI Test Run

Transcription

1 ON QE TRUST HEADED PAPER A randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of Idiopathic Intracranial Hypertension: the IIH:WT Trial Participant Invitation and Information Sheet MRI Test Run Invitation to take part in a study for the limited purpose of MRI standardisation for a clinical trial using MRI. Please note: you do not have IIH, you are being asked to participate in MRI test scans only. You are being invited to take part in a clinical study. Whether you take part is voluntary, and before you decide it is important for you to understand why the research is being done and what it will involve. Please consider the following information carefully and discuss it with others, the MRI investigator, and your doctor if you wish. Do feel free to ask if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part. Thank you for reading this. Part 1 tells you why we are doing this study and what will happen if you take part. Part 2 gives you more detailed information about the conduct of the study. Local PI: Dr Alexandra Sinclair Local Nurse: Karen Boardman (0121) Local Patient Advice and Liaison Service (PALS): (0121) BCTU: Ryan Ottridge (0121) Cally Rick (0121) ISRCTN Page 1 of 5

2 Part 1 What is the purpose of the study? The researcher named on page 1 is taking part in a clinical trial in patients with Idiopathic Intracranial Hypertension, or IIH, which is a condition where raised brain pressure causes headaches and can lead to blindness. You do not have Idiopathic Intracranial Hypertension. The trial requires detailed magnetic resonance imaging (MRI) scans of participants brains. This MRI centre is required to confirm it can perform the scans correctly by performing test scans. You are being asked to participate ONLY in the MRI Test Run procedure in order to confirm the scans work correctly, and to make sure the scan methods used are standardised for all participants in the trial. This MRI scan does not allow you or commit you to participate in the trial itself, and you will not receive any trial treatment or any other trial investigation besides measurement of your height and weight. The purpose of this information sheet is to explain exactly what will happen if you choose to take part in the MRI Test Run. Do I have to take part? No, taking part in the research is entirely voluntary. You are free to choose not to take part. If you do decide to take part, you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part, you are still free to withdraw at any time and without giving a reason. What will happen to me if I take part? We are asking you to take part in a test group, so you will not receive any trial treatment. You will undergo 2 separate MRI test scans (at least 2 weeks apart) and then you will leave the study. An MRI is a medical scanning technique used to create images of the brain or other parts of your body. For the MRI scan you lie on a table confined to a small space inside a cylindrical machine, which uses magnetic fields and radio waves (but not x- rays) to take special pictures of your brain and spine. To obtain good pictures, it is extremely important that you do not move during the procedure. Special positioning aids will keep your head from moving and you should try to relax. You cannot talk during the actual scanning phase of the MRI scan, but you may communicate with the technician performing it by pressing a call button. At the first MRI test scan appointment you will get the chance to ask a member of the research team any further questions you might have. What will I have to do? During your participation in this MRI Test Run you will come to the centre for the scheduled visit and undergo an MRI scan of your brain. You will then be given a second appointment in 2 to 13 weeks time. Each appointment will take less than an hour. What are the possible disadvantages and risks of taking part? An MRI scan is a procedure that uses magnetic fields and radio waves (but not X-rays) to create images of the brain. The scan itself is a harmless, non-invasive procedure but can be noisy. Some people may feel uncomfortable whilst lying in the scanner tube. Pregnant women and people with pacemakers or certain other metallic implants should not undergo MRI. You should tell the research staff if you are pregnant or have a pacemaker or other metallic implant. ISRCTN Page 2 of 5

3 What are the possible benefits of taking part? You will not receive any benefit from taking part in the MRI Test Run. The information obtained from the scan will help the researchers standardise MRI procedures for the IIH:WT clinical trial. This MRI Test Run is not a diagnostic procedure, but if any abnormalities are found which require follow up you will be contacted by phone and if necessary invited to return to discuss the findings. The researcher will use their clinical judgement to decide if you need to be referred to an appropriate service. Will I be paid for taking part in the study? No, there will be no payments for participating. What happens when the study stops? When the clinical study stops the results will be published and the information we get from the study may help us to improve our understanding of IIH. What if there is a problem? Any complaint about the way you have been dealt with during this study or any possible harm you might suffer will be addressed. The detailed information is given in Part 2. Will my taking part in the study be kept confidential? Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. The detailed information is given in Part 2. Thank you for reading this far if you are still interested, please continue to Part 2 ISRCTN Page 3 of 5

4 Part 2 the details What if there is a problem? If you are harmed due to someone s negligence, then you may have grounds for a legal action but may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms should be available to you. Taking part in this study would not affect your legal rights. If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions. The contact details for the IIH:WT trial Chief Investigator are: Dr Alex Sinclair, Telephone If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details can be obtained from the hospital. Will my taking part in the study be kept confidential? If you decide to take part in the IIH:WT study all information which is collected about you during the course of the research will be kept strictly confidential in the same way as your medical records. The information taken about your weight, height, age and sex will be sent by your doctors out of this hospital trust to the IIH:WT trial office at the University of Birmingham Clinical Trials Unit, on paper and electronically, where it will be securely stored under the provisions of the 1998 Data Protection Act. If you agree to take part in this study, your GP and the other doctors involved in your clinical care will be notified of your participation. All researchers involved in this trial will have a duty of confidentiality to you as a research participant and will do their best to meet this duty. In line with clinical study guidelines, at the end of the study the data will be securely archived (stored) for up to 20 years. Arrangements for confidential destruction will then be made. Should you withdraw consent for your data to be used, it will be confidentially destroyed immediately. What will happen to my MRI scans? Your scans will be sent by the researcher out of this hospital trust to an MRI physicist in New York, USA, for evaluation to check the scanning procedures are suitable for use in the clinical trial. Your scans will be anonymised and will not include any personal information which might identify you. What will happen to the results of the clinical study? The MRI Test Run scans will help the research team standardise the MRI tests for all participants in the trial. Once the trial is finished and analysed, the results will be published in a scientific journal. Only anonymous data will be published and your name will not appear in any report, presentation or publication. Who is organising and funding the research? The IIH:WT trial is being co-ordinated by the Birmingham Clinical Trials Unit at the University of Birmingham and is sponsored by the University of Birmingham. The trial Chief Investigator is Dr Alex Sinclair of University Hospitals Birmingham NHS Foundation Trust. The study is being funded by the National Institute for Health Research. The research has been reviewed and approved by all these organisations. Your doctor will not be paid for including you in this study. ISRCTN Page 4 of 5

5 Who has reviewed the study? All research in the NHS is looked at by an independent group of people called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity. This study has been reviewed and approved by Black Country Research Ethics Committee. Research Ethics Committees include healthcare professionals as well as nonmedical people, and are completely independent from anyone organising the study. Further details about the National Research Ethics Service can be found at: Where can I get further information? For queries about the study or for further information please contact: Dr Alex Sinclair, IIH:WT Chief Investigator, Telephone or IIHResearch@uhb.nhs.uk. The IIH:WT trial co-ordinating centre is located at the Birmingham Clinical Trials Unit, College of Medical & Dental Sciences, Public Health Building, University of Birmingham, Birmingham B15 2TT. Tel , Fax: Web address: neuroscience@trials.bham.ac.uk. Thank you for considering participation in this study. You will be given a copy of this information sheet and your signed consent form to keep if you decide that you wish to take part in the study. ISRCTN Page 5 of 5