Kidney Research UK

Background

Founded in 1961, Kidney Research UK (formerly the National Kidney Research Fund) is the largest funder of research into the prevention, treatment and management of kidney disease. Every year we allocate around 75% of our total charitable income to research funding, awarding around 20 new grants every year.

We are committed to understanding the causes of, and treatments for, kidney disease, and to making life better for the millions of patients suffering from it. Our mission is therefore to fund life-saving research into kidney disease, but in so doing, to ensure that it is conducted responsibly and to the highest standards. This particularly applies to research involving the use of human tissue.

Human Tissue

Human Tissue includes a range of different types of material from whole organs and large pieces of tissue, to surgically removed tissue such as tumours, and small samples of body fluids such as blood.

Tissue used for research can either come from healthy, living people or those that have recently died. In the case of the former, it is very common for tissue samples to be obtained as part of the diagnosis of an illness, such as blood. They can also be collected as part of treatment for an illness, such as blood transfusions, tumour removal or organ transplants.

Human tissue can also be obtained from patients who have died, during the post mortem process carried out to establish the cause of death. Some of this tissue is then retained and managed in archives, which provide a valuable resource for medical research.

Research involving human tissue

Much medical research depends on the use of human biological material. It often provides the best way of understanding how the body works and reacts to treatment, and can help alleviate the need to use animals in research.

Using human tissue is particularly important for research into the causes and treatment of kidney disease. It would not have been possible for the pioneering discoveries that Kidney Research UK has funded to be made without researchers being able to use donated tissue.

However, we support the views of the AMRC and MRC that research involving human tissue should only be funded if it complies with a number of key principles. First, research using human tissue should only go ahead if the potential benefits outweigh any potential risks to the donor. The human body should always be treated with respect, and tissue obtained for use in research should be considered as gifts. As such, researchers should always take into consideration the wishes of the donor and be sensitive to any cultural or religious differences, where applicable.

Researchers should also refrain from offering financial incentives to donate, and should ensure that donors' details are kept confidential, and that donors are informed if any of their details need to be used in the research and with whom they will be shared. Donors also have the right to be informed of any results arising from the research that affects their interests, and should be allowed to exercise their choice in this. Finally, all research involving the use of human tissue must be approved by an appropriate research ethics committee.

In addition to these key principles, it is paramount that when any human tissue is obtained specifically for research this is done with the informed consent of the donor or of the relatives in the case of the deceased donor. This means that, in seeking the consent of a patient, it is important to ensure that they have sufficient understanding, not only of the process involved in obtaining the tissue sample, but also what it is to be used for and how the results of the research might impact upon them.

Under the Human Tissue Act 2004 there is provision for use of excess biopsy tissues to diagnostic requirements to be used for research purposes as long as the specimens are anonymised and the research has been approved by a research ethics committee.

Human Tissue Act 2004 (HTA 2004)

The Human Tissue Act was passed by the Government in 2004 with the aim of ensuring that hospitals did not remove or retain human tissue without appropriate consent, in order to prevent a recurrence of the distress caused by events at Alder Hey and Bristol. In so doing, the Government also aimed to improve public confidence in tissue removal so that people would be more willing to agree to donation for transplantation and research.

We supported the aims of the initial Human Tissue Bill, but were also keen to ensure that the right balance was struck between the legitimate need to reassure the public on issues of consent and transparency, and the vital need for medical research to be carried out to save lives. We were pleased that the final Act sought to clarify the definition of, and process for, obtaining consent, whilst at the same time avoided placing unreasonable limitations on researchers, which would have hindered their ability to carry out crucial research.

Kidney Research UK

April 2007