UK Human Tissue Bill - Call for Clarity

Main Category: Cancer / Oncology
Article Date: 15 Jan 2004 - 0:00 PDT


THE UK GOVERNMENT risks hampering medical research and causing damaging confusion among doctors unless it clarifies crucial passages in its new Human Tissue Bill, Cancer Research UK claims today (Wednesday).

While the charity welcomes the introduction of the Bill - intended to provide a consistent legal framework for the use of human tissues and organs - it believes that key details have not been properly worked through and could cause unintended harm.

Cancer Research UK has particular concerns over plans to regulate human genetic research, which could prohibit studies on stored DNA samples taken before the introduction of the Bill.

Its warnings come at a special briefing for MPs this evening, in advance of the Bill's first debate in Parliament on Thursday.

Use of human tissue is crucial throughout medical research, in areas as diverse as drug development, diagnostics and training of doctors and nurses. Different areas of research use tissue taken from healthy people, patients or people who have died.

Regulations on the collection, storage and use of human tissues have been in limbo since 2001, when the Secretary of State for Health ordered a major review in response to the Redfern report on the events at Alder Hey.

Donations to Cancer Research UK's tumour banks have since dropped, as public suspicion has combined with the nervousness of doctors uncertain of their legal position.

The new Human Tissue Bill is an attempt at rebuilding public and professional confidence in tissue donation. It makes patient consent the underlying principle in governing whether the use of tissues is legal or not.

But while the introduction of the Bill should improve confidence in the use of tissues in some areas of research, Cancer Research UK believes other areas could suffer unless the Bill is modified.

The Human Tissue Bill requires 'appropriate consent' for the use of all 'relevant material'. In general, this seems to mean that doctors have to ask a patient in advance, before they can store tissue and use it for research.

But there are some occasions where gaining consent is not possible. Many hospitals and research institutes have banks of DNA, which are vital reservoirs of information for investigating the genetic influences on disease.

Cancer Research UK believes it is imperative that these DNA banks are excluded from the requirement for consent, to prevent the loss of an extremely important resource for future research. The Government has already made an exception for non-genetic analysis of banked tumours, where similar issues apply.

The charity is also very concerned that the rules governing licenses for tissue research are ambiguous. The Bill does not make clear how licensing would work and whether it would apply on an individual or institutional basis.

Cancer Research UK is worried that the procedure could be unnecessarily bureaucratic and expensive, with the potential to slow the pace of research and reduce the amount that medical organisations can afford to do.

Dr Richard Sullivan, Cancer Research UK's Head of Clinical Programmes, says: 'There's got to be a balance between the rights of individuals, who need to have a say in the use of their tissues, and the rights of society as a whole, which benefits from human tissue research in a wide variety of ways.

'The Human Tissue Bill makes a decent stab at getting the balance right, but in its current form there are some areas where it will make research slower or more expensive, or stop it happening at all.

'The Government needs to sit down with the major research organisations such as ourselves and iron out the creases in this legislation.'

As well as its specific concerns on the current draft, Cancer Research UK believes the Human Tissue Bill needs to clarify the central concept of consent, so that researchers can be fully confident that they are complying with the regulations when using tissue.

The charity believes legislation is only one part of the confidence building process, and is calling on the Government to support a programme of education about the use of human tissues in research.

Dr Sullivan adds: 'The issue with this legislation is one of clarity. Researchers have to be clear where they stand when they are collecting tissue and individuals have to be clear on their rights of consent. Without that clarity we will have confusion and medical research, and therefore patients, will suffer.

'But it's not just about legislation, it's about education and communication as well and we hope the Government will take that message on board when it implements this Bill.'

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