Questions and answers

In this section the most relevant questions are answered.

• What is the purpose of this study?
• I have diabetes, why have I been chosen?
• I am healthy, why have I been chosen?
• Do I have to take part?
• What will happen to me if I take part?
• What are the possible disadvantages and risks of taking part?
• What are the possible benefits of taking part?
• Will my taking part in this study be kept confidential?
• What will happen to the results of the research study?

What is the purpose of this study?

The purpose of this study is to find the genes that cause insulin-dependent (also called type 1) diabetes to enable us to identify individuals at risk of developing the disease and to understand its basic causes. Ultimately we hope this will lead to preventive treatment in these at risk individuals.

I have diabetes, why have I been chosen?

You have been selected to take part in this study based on your presenting condition, type 1 diabetes, and its use in further research in our study, the causes of type 1 diabetes.

I am healthy, why have I been chosen?

For the study we require a group of healthy controls. We need to compare diabetic patients with people like you without diabetes. This will enable us to establish differences between those who develop diabetes and those who do not. You yourself will not have diabetes and this is why we are asking you as a non-diabetic to consider participating in our study.

Do I have to take part?

Taking part in this research study is entirely voluntary. It is up to you to decide whether or not you wish to take part. If you decide to take part you will be given this information sheet to keep and will be asked to sign a consent form. If you do decide to take part you are still free to withdraw from the study at any time without giving a reason. A decision to withdraw or not to take part, will not affect the standard healthcare you receive. If you choose to withdraw from the study your sample will be destroyed.

What will happen to me if I take part?

If you agree to take part, you will be invited to donate a blood sample of up to 40 ml (1-3 tablespoons) for our research study when you attend your routine clinic appointment. You will also be asked a few questions on details of your medical history.

What are the possible disadvantages and risks of taking part?

Blood sampling can cause some discomfort, when the needle is placed in the vein and the blood is drawn and there is the possibility that a bruise may develop. Light-headedness and fainting may also result from blood sampling. By donating your sample during your routine clinic appointment the blood sample can be drawn at the same time as your routine clinic bloods thereby eliminating any additional discomfort from further skin puncturing.

What are the possible benefits of taking part?

There are no direct benefits to the patients that take part in this study but we hope the research will help us to identify the genes that cause diabetes and to enable us to identify individuals at risk of developing the disease. Ultimately we hope this may lead to preventive treatment in these at risk individuals. The project has no direct therapeutic value but is a contribution to science. The research study may also lead to discoveries of relevance to diseases and conditions other than type 1 diabetes.

Will my taking part in this study be kept confidential?

Yes, in order to maintain confidentiality, each individual participating in the study will be assigned a study number which will be maintained throughout the study; all specimen samples will be stored and referred to by the study number only; and the identity of patients will not be made available to anyone in the research team who will use the samples. The study will be carried out in a completely anonymous fashion.

What will happen to the results of the research study?

Cambridge University and the sponsors of the study, the Juvenile Diabetes Research Foundation and the Wellcome Trust, both research charities, may have an interest in using the genetic and biological information found from the testing or analysis of your blood (and its derivatives) for the development of new products that might help the diagnosis, treatment and prevention of the disease. Patent applications may be made in these respects.