Form to be on Trust headed paper
Patient Information Sheet (PIS) for Children aged 6-10 years
The United Kingdom Thrombotic Thrombocytopenic Purpura Registry (TTP Registry)
We are asking if you would like to join in a research project called the UK TTP Registry. This information sheet tells you what will happen if you agree to take part.
The decision to take part is up to you.
Please ask any questions that you have about the study.
Why are we doing the research project?
You have been in hospital with TTP. Your doctor and parents/guardians will have explained what TTP means, but to say it simply, it is an illness that very few people get and it makes different people sick in different ways.
Research is a way we try to find out the answers to questions. We want to collect some information about people like you who had TTP so we can understand this illness better.
What will happen to me if I take part in the research?
When you came to hospital with TTP you had a blood test so your doctor could see how much of an enzyme called ADAMTS 13 you had in your blood.
Now you have left hospital and feel better your doctor will take another blood test to measure ADAMTS13, and you will be asked if you would like to take part in this TTP research project.
Your doctor will ask if we can keep some information about you, like how ill you were when you came to hospital, what medicines you were given and what your blood test measurements were.
Your doctor will also ask if it’s OK to takesome extra blood from you for the UK TTP Registry, to look at the genetics of TTP. This blood will be taken at the same time as the blood test for ADAMTS13,so you will only have one blood test which will take about 2 minutes to do. 3 teaspoons of blood will be taken in total. The blood test will not hurt, it will not make you ill afterwards and you will not have to stay off school. We also want to know if it’s OK to keep two of your blood samplesat UCL.
You will be looked after in the same wayeven if you decide not to do this research.
Who do I contact if I have any questions or need further information?
Please ask usor your parents/guardians if you do not understand the research project or do not understand thewords used.
Do I have to take part?
If at any time you don’t want to do the research anymore, just tell your parents, doctor or nurse. They will not be cross with you and you will be looked after in the same way.
Will joining in help me?
We cannot promise the study will help you but the information we get might help treat children with TTP with better medicines in the future.
What if new information becomes available?
Sometimes during research, new things are found out about the research topic. Your doctor will tell you about this if it happens.
Who is organising and funding the research?
The hospital and your doctor are not being paid to include you in this research. University College London Hospitals (UCLH) is acting as the sponsor.
Will information about me be kept private? Will anyone else know I’m doing this?
We will keep information about you private. This means we will only tell those who need to know you are taking part in the research.
Did anyone check this study is OK to do?
Before any research is allowed to happen, it has to be checked by a group of people called a Research Ethics Committee. They make sure that the research is fair. Your project has been checked by the Lewisham Research Ethics Committee (now known as South East London REC 5).
Thank you for reading this – please ask any questions if you need to.
UK TTP Registry: PIS Children 6-10years, version 2.0, 6th October 2010
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