Consent for childhood cancer tissue banking in the UK: the effect of the Human Tissue Act 2004.

The obtainment, storage, and use of human tissue taken from children for research purposes is an area that is notable for its complexity and legal uncertainties. In the UK, the controversy surrounding organ retention prompted radical legislative change in the form of the Human Tissue Act 2004, which came into force from September, 2006. This Review paper explores the effect of the Human Tissue Act on consent, in the context of childhood tissue banking. We take as our case study the UK Children's Cancer Study Group tumour bank. Although the Human Tissue Act provides a new, detailed statutory framework, it does not, by itself, resolve all the relevant issues in this area. Researchers and clinicians must, therefore, continue to work alongside the existing principles of common law relating to this issue. Consent for the removal of tumour tissue during a surgical procedure should be distinguished from consent for the retention of the tissue for future use in research or for other specified uses. Consent to surgery is regulated by the same common law procedures used for consent to treatment. By contrast, the requirements for consent to storage and specified uses of samples are predominantly, but not exclusively, regulated by the Human Tissue Act. Although the Human Tissue Act might, at first, seem to promote clarity, the new legislative provisions and resultant Codes of Practice on consent could possibly lead tumour banks to reassess the nature and process of obtaining consent for the use of samples from children in research.