The ELMO Study
MINOR INFORMATION SHEET FOR CHILDREN 7-11 YRS
(version 1, 17/03/14)
1. What this study is about
· We are doing this study to find out the cause of epilepsy in children and to find out why sometimes treatments work for some children but not for others.
· Epilepsy is a condition affecting the way our brains work. We hope that what we learn from this study will help us to get better treatments and work out which children should be given which type of medicine to make them better.
· We are asking lots of children like you from all over Europe to take part in the study.
2. Do I have to take part in the study?
· You and your parents can decide if you want to go into the study, you don’t have to take part if you don’t want to.
· The doctors and nurses will take care of you just the same if you do or if you don’t take part in the study.
3. What do I have to do in the study?
· As part of your normal care in the hospital, you will have tests of your thinking and understanding, brainwave recordings, and blood tests.
· For the study you will have four blood tests spread over the next one and a half years. We will combine these blood tests with any blood tests that your doctor normally orders so that you don’t have two blood tests in one day.
· Your parents will be asked to fill in some forms about you, but otherwise there is nothing else that you have to do.
4. Will I feel uncomfortable during the study?
· Some people find blood tests slightly uncomfortable, but you can have a special cream on your arm to take away pain, and a band-aid afterwards.
5. Who will find out about me being in the study?
· All information about you will be kept private.
6. Will I get anything for taking part in the study?
· You will be helping lots of other children with epilepsy by taking part in the study.
· We will not pay you money, but you will get a token or voucher for £10 to spend on what you like at the last visit.
7. What do I have to do now?
· Your mum, dad and doctor know about this study and they think it’s OK for you to be in this study.
· If you want to be in this study, you can tell the interviewer and sign or write your name on this form.
· If you don’t want to be in the study, it’s OK to say no, we won't be upset. You can stop being in the study at any time later, and that’s OK too.
· Ask us any questions now if you want.
MINOR INFORMATION SHEET FOR CHILDREN 7-11 YRS
(version 1, 17/03/14)