The UK government has caved in to the demands of biomedical researchers and watered down controversial measures in its Human Tissue Bill that would have required the consent of patients for the storage and use for research of any human tissue or bodily fluids taken from living persons.
Scientists had warned that the requirements of the bill, introduced in response to an outcry over the widespread retention of children's organs without parents' consent, could prevent potentially life saving research.
They argued that obtaining express consent for the storage and use of tissue and bodily fluids would be hugely costly in money and human resources. Some three million solid tissue samples and over 100 million blood samples are taken in the United Kingdom each year.
In its original form the bill made it a criminal offence, punishable by a maximum 12 months' prison sentence, for a doctor to use any leftover material from a living patient for research without the patient's written consent. Among the projects that would have been severely affected is the national anonymous tonsil archive, which hopes to collect 100000 tonsils in an attempt to discover the incidence of Creutzfeldt-Jakob disease in the United Kingdom.
Figure 1.
Wellcome Trust director Mark Walport: “We now have a proper and sensible balance”
Credit: WELLCOME INSTITUTE
The government plans to amend the bill at report stage next week to allow research using material from living patients without consent but with safeguards. The research will have to be approved by a research ethics committee, and there will be a requirement that the researcher must not possess any information that would enable the person from whom the tissue was taken to be identified.
Organisations that lobbied for the change include the BMA, the General Medical Council, the Medical Research Council, the Royal College of Pathologists, and the Wellcome Trust, the largest biomedical research charity in the United Kingdom.
Mark Walport, director of the Wellcome Trust, said, “This has been a priority for the Wellcome Trust, and we are delighted by these amendments. We now have a proper and sensible balance between protecting the rights and confidentiality of patients and their families and the need to safeguard research that will provide benefits for health in the future.”
The bill will have its final stages in the House of Commons on 28 June and will then go to the House of Lords. (See p 1510.)