Human Tissue Act 2004: The age of consent arrives in the UK

Abstract

The organ collection scandals of Alder Hey and Bristol Royal Infirmary in the UK were the driving force for a comprehensive overhaul of the legislation and regulation of the handling and use of human tissues in the UK. The Human Tissue Act 2004 is due to come into force in April 2006 and will resolve a number of uncertainties for researchers. The adopted regulatory approach is not dissimilar to that adopted for the use of embryos in the UK. The legislation provides the framework but a body established under the Act – the Human Tissue Authority (HTA) – will be responsible for granting licences, determining what constitutes 'appropriate consent' and providing detailed guidance and regulations. The advantage of this approach is that it will allow the board of the HTA, whose members include experienced professionals in the medical and research communities, to adapt the system to keep up with scientific developments and possibly changes in public opinion more rapidly than would have been possible where guidance is set out within the legislation. Even before the HTA issues its first guidance, researchers can be clear that certain activities, such as those relating to cell lines, are not covered by the Act. Other processes, such as the anonymising and de-linking of patient data could be subject to additional regulation by the HTA although any guidelines must also conform with the provisions of the Data Protection Act 1998. This paper discusses the new regulatory framework and identifies the challenges for researchers in complying with an Act, which provides for criminal sanctions for breach.