Kidney Research UK

Statement on the consent to donate organs for transplantation

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, and in so doing, to ensure that it is conducted responsibly and to the highest standards. This particularly applies to ensuring that the use of human tissue and organs used in research has received the appropriate consent of donors.

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 and urine.

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 or urine samples. 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.

Most human tissue is removed for reasons other than research. Removal for diagnosis and treatment is not covered by the 2004 Act and consent for those purposes is not necessary if it is in the patient’s best interests.

Consent to donate tissue for research

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.

Research using human tissue should only go ahead if the potential benefits outweigh any potential risks to the donor and must be approved by an appropriate research ethics committee It is also of great importance that any human tissue specifically taken for research has been obtained, with the informed consent of the 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.

Subsequent research use of human tissue, which was originally removed for other reasons such as diagnosis for the patient’s benefit, remains lawful under the 2004 Act without consent if an ethics committee has given approval and the tissues are anonymised.

Human Tissue Act 2004

The Human Tissue Act was passed in 2004 with the aiming of ensuring that post mortem human tissue was not removed without appropriate consent. The removal of tissue from the living is covered by existing laws, and this remains unchanged with the arguable exception of live donation. This legislation was a response to the distress caused by actions at a hospital in Alder Hey and was aimed to improve public confidence in human tissue removal so that people would be more willing to agree to donation for transplantation and research.

We support the aims of the Act, but were also keen to ensure that the right balance struck between the legitimate need to reassure the public on issues of consent and transparency, and the vital need for medical research. We were pleased that the final Act sought to clarify the definition of, and process for, obtaining consent, whilst at the same time avoiding unreasonable limitations on researchers, which would have hindered their work.

Consent to donate organs for transplantation

To increase the rate of organ donation for transplantation, we support the proposal of a “presumed consent system. This view is backed is supported by a survey carried out by Kidney Research UK in 2000.

This system presumes that when a person dies, their organs could be removed for transplantation unless they have registered a wish to ‘opt out’. However, relatives would still be consulted in case they felt that the patient may have objected to donation or would themselves be particularly distressed by the removal of organs.

Alongside a package of measures designed to improve organ donation rates, change to this system of consent has been successful in increasing donation in countries such as Spain.

Other measures would include an increase in intensive care beds, transplant coordinators in every hospital, an efficient system of auditing potential donors and effective public communication and education programmes to raise awareness of the need for more organ donors.

In addition, we would like to see greater use of older donors, non-heart beating donors and living donors. The latter should include consideration of both related and non-related donation. However, we do not believe that compensating people for donating an organ, over and above that of reasonable expenses is the right approach to increasing this type of donation.