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How long is the study?

We would like to see you at least once a year for your lifetime. However, you can leave the study at any time, for any reason, without any effects on your future medical care and without being obliged to give a reason for your decision to withdraw from the study.

What will happen to my samples?

Your blood will used to assess your immune response further to try to understand further why levels of IgG4 are high in some people. Some blood or blood cells will be frozen down to use in this project in the future. Genetic tests may be performed only to answer questions about IgG4 disease. All your samples will be labelled with a number rather than your name, so that research staff and investigators in the laboratory will not be able to identify you.

If you have had previous tissue samples taken, for example, liver, colon and kidney biopsies, we would like to use these to look to see if they have IgG4 in them, or perform other tests that are relevant to the diagnosis of IgG4 related disease. These will be returned to storage after use.

If necessary to achieve the aims of this study, and if you consent, your samples and data may also be used anonymously in additional studies with aims similar to this study. This would only take place if the Principal Investigator approves additional studies as having aims that would be beneficial in improving our understanding of what happens to people with IgG4 related disease or why IgG4 levels are sometimes high. 

What are the possible disadvantages of taking part?

The only procedure will be blood tests. These may be associated with bruising. It may be that we make a diagnosis of IgG4 related disease. If this happens we will inform your doctor who may refer you for appropriate treatment.

What are the benefits of taking part?

The information we obtain may not be of direct benefit to you but it will help us to understand this disease. You will be tested for helicobacter pylori. The doctor who usually looks after you will be informed and you may be offered treatment if this is present.  

What will happen if I don’t want to carry on with the study?

You can leave the study at any time, for any reason, without any effects on your future medical care and without being obliged to give a reason for your decision to withdraw from the study. Should this happen, we will destroy the research samples or continue to use them and data about you, depending on your preference. In the unlikely event that you lose the ability to give consent during the study, data or tissue/blood already collected with consent would be retained and used in the study.

Will my taking part in the study be kept confidential?

Your data and blood samples will be collected by clinical researchers and anonymised which means that it will be coded and only the study investigators will have access to the code. All the investigators have a duty of confidentiality towards you. Your research records may be inspected by University staff for audit purposes to ensure that researchers are following good research practice guidelines. All will have a duty of confidentiality to you as a research participant. All study data will be stored for twenty years and then disposed of securely unless we obtain further ethical committee approval to use it in a subsequent study. Data will be kept on a secure, password protected computer with restricted access in a locked room and also kept on an online web portal.