Abstract

The Human Tissue Act 2004 presents a radical change to the legal regulation of the use of human material in England and Wales. The Act presents a broad regulatory framework but much in the practical operation of the legislation will depend upon regulations to be enacted and a new Code of Practice. This article examines 'appropriate consent' for the use of human tissue for research purposes in the context of the living competent adult. It examines the provision of information as part of the consent process for the use of human materials for research purposes, the question of when consent can be withdrawn, and the controversial exception enabling the use without consent of anonymized material for research purposes where the research has been ethically approved. The paper concludes by highlighting some of the problems which may remain after the legislation comes into force