Information about long-term storage of blood and urine samples
Click on the topics below for more information:- Blood and urine samples for future medical research
- What future research studies might be able to answer
- What are the risks of allowing my samples to be stored long-term?
- How much blood would be taken?
Blood and urine samples for future medical research
Thank you for agreeing to enter THRIVE (Treating HDL to Reduce the Incidence of Vascular Events). With your help and that of thousands of other people, we hope to be able to answer the important question about whether raising HDL (good) cholesterol with ER niacin/laropiprant prevents heart disease and strokes in people with circulatory problems.
You have already agreed to samples being collected for the study and these will be used for all trial related measures both in the clinic and in the central laboratory in Oxford. For example, at the beginning of THRIVE we need to measure certain things in the blood (such as cholesterol levels) which we know affect the risk of circulatory problems. This allows us to see whether the effects of the treatments being used in the study vary between different types of people taking part.
We would now like you to consider whether you are happy for these blood and urine samples to be stored long-term to help investigate the causes of heart disease, strokes and other circulatory diseases.
In order to participate in the study, you must have agreed to all the trial related measures in the clinic and at the central laboratory. However, you will still be eligible to continue in THRIVE even if you would prefer not to give permission for the long-term storage of your blood and urine samples.
Please take time to read the following information carefully and discuss it with your GP, friends or relatives if you wish. If there is anything that is not clear, or if you would like more information, please do not hesitate to telephone the THRIVE Freefone number (0800 585323) and speak to a study nurse or doctor.
What future research studies might be able to answer
Although THRIVE is aiming to discover whether ER niacin/laropiprant protect against heart disease and strokes in people with circulatory problems, there are likely to be many other causes of these conditions. Some causes, such as high LDL (bad) cholesterol, are already known and doctors are able to treat this problem with drugs. We suspect, however, that other factors also play a part in circulatory problems, but there is limited understanding of these processes. In particular, we have limited knowledge about the influence of genes on risk of heart disease, strokes or diabetes. If we were able to preserve your blood and urine samples in a very cold freezer (containing liquid nitrogen), then future advances in medical knowledge might eventually enable us to answer some of these questions by defrosting and analysing such samples.
What are the risks of allowing my samples to be stored long-term?
There are no risks at all to you. The study coordinators in Oxford University will be the only people who are able to link test results with individual patients, and the data will be held confidentially within a secure computer system. The information from your samples, including details of your genes, will not be provided to you, your doctors, or anybody else. In particular, having these samples stored and subsequently tested would not affect your ability to obtain insurance.
How much blood would be taken?
We only need about 2 teaspoons of blood for the immediate measurements and for the long-term-storage. Numbered samples would be stored indefinitely in liquid nitrogen at a secure location in Oxford University.
