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Young_persons_info_sheet_v3.1_2207201

YOUNG PERSON INFORMATION SHEET (Guide age 11-18)
Title of Project: Biologics for Children with Rheumatic Diseases Name of Researcher: Dr Kimme Hyrich We would like you to take part in a research study. Please take time to read this leaflet carefully and discuss it with others if you wish. Ask us if anything is unclear, or if you would like more information. Take time to decide if you wish to take part. What is the purpose of this study? Biologic drugs and methotrexate are both treatments for severe Juvenile Idiopathic Arthritis (JIA). Biologic drugs are often used when methotrexate has been unable to help the arthritis. However, more information is needed on long term effects of these biologic drugs; we especially need more information on the side effects they may produce as they have not been in use for very long. Why have you been chosen? You have been chosen because either you are taking a biologic drug or because you are taking methotrexate for Juvenile Idiopathic Arthritis. We intend to invite as many children and young people as possible who are taking these drugs to take part. You do not have to take part if you do not want to. If you decide not to take part it will not affect how your doctors treat you. If you do decide to take part, and your parents agree, you can sign a form to show You can change your mind at any time without saying why What information will we collect from you? The study will collect information about you, your arthritis, medical treatment and tests, how well you are and how you grow. All this information will come from the team you see for your normal hospital visits and you will not usually have to answer any questions from us on your own. This type of study is called an ‘observational study’ which means that we simply watch what happens to people - the study does not affect the treatment that you get from your doctor. We will ask you to provide a small blood sample, which will be taken at a time when blood is also needed for routine purposes during a regular hospital visit. If you do not need a blood sample for routine clinical purposes, you will be asked to provide a saliva sample (we will get you to spit into a small cup). We may contact youthrough your doctors about other studies you may be interested in, or regarding a later follow-up of this study. We would want to flag you with the NHS Information Centre, which will provide the study with information about your health status. Why are you taking my blood, and what will you do with the sample? The research blood or saliva sample will be sent to the Arthritis Research UK laboratories at the University of Manchester, where the DNA will be extracted. The exact genes to be studied cannot be identified now but will include ones we already know are important in childhood arthritis and ones discovered during the time the study is being undertaken. Some of the blood and saliva samples may be provided to other bona-fide researchers working in the field for future research of Juvenile Idiopathic Arthritis and response to treatment. You can refuse permis-sion for this if you want and you can still take part in the study. No identifiable data would be stored directly with the sample, and the sample will be stored under se-cure conditions. Genetics is the study of genes. DNA is a molecule contained within nearly all your body’s cells and it contains genes within it. It is our genes that help determine certain characteristics, such as hair colour and gender as well as the likelihood that we will develop certain diseases. Genes vary between people and one of the purposes of this study is to investigate whether variation in genes affect how children with arthritis respond to treatment. Are there any risks to me if I take part? The study will run alongside your routine arthritis care; it will not influence this proc-ess. Therefore, there are no foreseeable risks associated with this study. There would be no extra risk or additional discomfort to you when the blood sample is taken for the study, as this will be taken at a time when blood is also needed for routine pur-poses during a regular hospital visit. What are the possible benefits of taking part? Although there is no clinical benefit gained by participation in the research, the information obtained from this study may result in changes in future treatment of patients with JIA. What will happen to the results of this study? The results of the study will be presented at scientific meetings and published in medical journals but no identifying information will be used. Will anyone know I have been involved with this research? All information used in the study is kept under secure conditions and is strictly confidential. . Your GP will be informed that you are in the study. The research is funded by Arthritis Research UK and is based at the University of Manchester. If you want to ask about anything please get in touch with the Chief Investigator Dr Kimme Hyrich (Kimme.hyrich@manchester.ac.uk) Thanks for reading this information leaflet. If you do decide to take part in the study, you will be given a copy of this leaflet to keep and will be asked to sign a consent form.

Source: http://www.bcrdstudy.org/Downloads/InformationSheets/YOUNG_PERSONS_INFO_SHEET_V3.1_22072011.pdf

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