Jean V. McHale

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 Childrens 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.

Regulating Human Body Parts and Products

This special volume of Health Care Analysis is dedicated to a consideration of the status of body parts and products and the roleof law in regulating them. We argue that such a discussion is timely giventhe conflation of technological and academic concerns posed by thecomplex legal framework within which these issues are currentlyaddressed and in the light of debates such as those regardingthe storage of childrens organs addressed by inquiries atAlder Hay and Bristol, United Kingdom. The contributors addressspecific legal problems which have been brought before the courts in the UK and other jurisdictions, something which wesuggest is likely to occur with increasing regularity oncethe Human Rights Act 1998 comes into force in October 2000.The issues are also considered on a more theoretical level with papers exploring the role of concepts such as property, donation, commodification and kinship in these debates.While the volume focuses principally upon the manner inwhich these issues have arisen in a UK context, though withreference to certain comparative examples, the concepts discussed here are of more general application acrossother jurisdictions.

Law, Patient’s Rights and NHS Resource Allocation: Is Eurostar the Answer?

Historically attempts to use the courts as a means of challenging decisions to refuse NHS resources have met with little success. However two recent developments, that of the Human Rights Act 1998 and the development of European Union law through the application of Article 49 of the EC Treaty have provided the prospect for a challenge to this position. This article examines the impact of a recent case that of Watts v Bedford PCT in which a woman sought to by-pass NHS waiting lists by seeking treatment in France and then claimed reimbursement of the cost of the operation and the possible impact of this case in the context of patients’s rights and resource allocation.

Standards, quality and accountability – the NHS and mental health: a case for joined‐up thinking?

The proposals for the reform of the Mental Health Act contained in the Draft Mental Health Bill Consultation Document recommend that the Mental Health Act Commission should be abolished and its functions be dispersed; with many of its existing roles being entrusted to the Commission for Health Improvement and its successor body, the Commission for Health Audit and Inspection. These proposals can be seen in terms of the Governments emphasis upon ‘joined‐up thinking’ and can be regarded as being a positive step in terms of aligning scrutiny of standards in relation to mental health, mental disability and physical illness, particularly at a time when prison health care is being brought within the scope of the NHS. Nonetheless, they have come under considerable criticism. This paper charts the development of the proposals in the light of the approach taken to the scrutiny of standards, quality and accountability for health care provision in the NHS today.