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 children's 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. (shrink)

The current rise in malpractice litigation has led to concern in the research community as to the prospect of litigation against researchers. Clearly as the responsibility for the day-to-day conduct of the research falls upon the researchers they will be potentially liable should there be negligence in the conduct of the research project itself. But to what extent can the research ethics committee and its members be held liable should harm result to the research subject? How far does the prospect (...) of the threat of litigation equate with the reality of the prospect of liability? Although the NHS research governance framework suggests that primary responsibility for the conduct of the trial is with the researcher this does not mean that REC members will be immune from actions in tort where research subjects suffer harm in the conduct of a research project approved by their NHS REC. This paper focuses upon the prospect for liability in the law of tort of NHS RECs and their members. While in practice the vast majority of such claims are unlikely to be successful members of RECs may incur resultant legal costs as a consequence of involvement in proposed litigation. It is submitted that the scope of indemnity provision provided to RECs and their members should be precisely determined, otherwise there is a real prospect that the risk of malpractice litigation may deter individuals from serving on such committees. (shrink)

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. (shrink)

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. (shrink)

In this article we consider some of the implications of the UK Human Rights Act 1998 for nurses in practice. The Act has implications for all aspects of social life in Britain, particularly for health care. We provide an introduction to the discourse of rights in health care and discuss some aspects of four articles from the Act. The reciprocal relationship between rights and obligations prompted us to consider also the relationship between guidelines in the United Kingdom Central Council’s Code (...) of professional conduct and the requirements of the Human Rights Act 1998. We conclude with the recommendation that the new legislation should be welcomed for its potential to support good practice and to urge critical and reflective practice rather than as yet another burdensome bureaucratic imposition. (shrink)

The use of traditional ethical methodologies is inadequate in addressing a constructed maternal–fetal rights conflict in a multicultural obstetrical setting. The use of caring ethics and a relational approach is better suited to address multicultural conceptualizations of autonomy and moral distress. The way power differentials, authoritative knowledge, and informed consent are intertwined in this dilemma will be illuminated by contrasting traditional bioethics and a caring ethics approach. Cultural safety is suggested as a way to develop a relational ontology. Using caring (...) ethics and a relational approach can alleviate moral distress in health-care providers, while promoting collaboration and trust between providers and their patients and ultimately decreasing reproductive disparities. This article examines how a relational approach can be applied to a cross-cultural reproductive dilemma. (shrink)

Whistleblowing in the NHS engages the fundamental right to free speech and as the paper makes clear is a means of ensuring individual patient safety. The discourse around the whistleblower is not simply about individuals being safeguarded if they blow the whistle on poor standards of patient care but that they may indeed be obliged as healthcare professionals to positively make the decision to blow the whistle to raise concerns. As noted in the paper, the NHS is an organisation in (...) which many—though not all—individuals who work there are bound by their own professional codes of practice in addition to broader employment requirements in relation to ethical and safety issues. But having an obligation to raise concerns and actually doing so are very different things. Individuals who blow the whistle have often found that following their conscience comes with consequences. They may ultimately be vindicated, as, for example in the 1990s, Stephen Bolsin the anaesthetist who blew the whistle in relation to Bristol Royal Infirmary in the 1990s.1 But getting such vindication can in many instances be over a long and very painful period of time and be exceedingly costly in both financial and emotional terms. Does …. (shrink)

Next SectionThe precise nature and scope of healthcare confidentiality has long been the subject of debate. While the obligation of confidentiality is integral to professional ethical codes and is also safeguarded under English law through the equitable remedy of breach of confidence, underpinned by the right to privacy enshrined in Article 8 of the Human Rights Act 1998, it has never been regarded as absolute. But when can and should personal information be made available for statistical and research purposes and (...) what if the information in question is highly sensitive information, such as that relating to the termination of pregnancy after 24 weeks? This article explores the case of In the Matter of an Appeal to the Information Tribunal under section 57 of the Freedom of Information Act 2000, concerning the decision of the Department of Health to withhold some statistical data from the publication of its annual abortion statistics. The specific data being withheld concerned the termination for serious fetal handicap under section 1(1)d of the Abortion Act 1967. The paper explores the implications of this case, which relate both to the nature and scope of personal privacy. It suggests that lessons can be drawn from this case about public interest and use of statistical information and also about general policy issues concerning the legal regulation of confidentiality and privacy in the future. (shrink)

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 children's 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. (shrink)

The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally. Each area of research on human subjects has been the subject of a vast academic literature and extensive public policy debate, from issues of informed consent to that of regulatory structures. Professor Bernard Dickens has provided an outstanding contribution to this debate internationally through his many innovative and incisive papers in this area. This paper provides an English lawyer’s perspective upon the (...) increasing regulation of clinical research practices and asks – does regulation equate with effective rights protection? From Nuremberg onwards, there has been concern to ensure that research practices are ethical and in accordance with legal principles. So, for example, there have been statements such as the Declaration of Helsinki, which was initially produced in 1964. In the European context in particular, notably influential statements have been the European Convention on Human Rights, which has been followed by the Council of Europe Convention on Human Rights and Biomedicine and, more recently, a Draft Additional Protocol on medical research. (shrink)

The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally. Each area of research on human subjects has been the subject of a vast academic literature and extensive public policy debate, from issues of informed consent to that of regulatory structures. Professor Bernard Dickens has provided an outstanding contribution to this debate internationally through his many innovative and incisive papers in this area. This paper provides an English lawyer’s perspective upon the (...) increasing regulation of clinical research practices and asks – does regulation equate with effective rights protection? From Nuremberg onwards, there has been concern to ensure that research practices are ethical and in accordance with legal principles. So, for example, there have been statements such as the Declaration of Helsinki, which was initially produced in 1964. In the European context in particular, notably influential statements have been the European Convention on Human Rights, which has been followed by the Council of Europe Convention on Human Rights and Biomedicine and, more recently, a Draft Additional Protocol on medical research. (shrink)

First Published in 2004. Routledge is an imprint of Taylor & Francis, an informa company.

First Published in 2004. Routledge is an imprint of Taylor & Francis, an informa company.

First Published in 2004. Routledge is an imprint of Taylor & Francis, an informa company.

While the decision of the House of Lords in Re F in [1990] clarified somewhat the law concerning the treatment of the mentally incapacitated adult, many uncertainties remained. This paper explores proposals discussed in a recent government green paper for reform of the law in an area involving many difficult ethical dilemmas.

" This book focuses on the relationship between human rights and nursing in these changing times.

The Mental Capacity Act 2005 placed for the first time research concerning adults lacking mental capacity upon a statutory footing. However, while the legislation which regulates the inclusion of such adults in ‘intrusive research’ safeguards researchers and research participants alike some controversy remains as to its implementation. This paper focuses upon two specific issues raised by the legislation. First, what constitutes ‘intrusive’ research and whether all issues concerning research involving adults lacking mental capacity should be referred to NHS research ethics (...) committees. Secondly, the role of one of the statutory safeguards–the ‘consultee’. These are individuals who are to be consulted regarding the inclusion of adults lacking mental capacity in research. It contrasts the ‘personal’ and ‘nominated’ consultees and considers whether there is a risk that the legislation may result in a new ‘quasi profession’ of consultees in the future. (shrink)

In this article we consider some of the implications of the UK Human Rights Act 1998 for nurses in practice. The Act has implications for all aspects of social life in Britain, particularly for health care. We provide an introduction to the discourse of rights in health care and discuss some aspects of four articles from the Act. The reciprocal relationship between rights and obligations prompted us to consider also the relationship between guidelines in the United Kingdom Central Council’s Code (...) of professional conduct and the requirements of the Human Rights Act 1998. We conclude with the recommendation that the new legislation should be welcomed for its potential to support good practice and to urge critical and reflective practice rather than as yet another burdensome bureaucratic imposition. (shrink)

The huge potential of biobanks/genetic databases for the research community has been recognised across jurisdictions in both publicly funded and commercial sectors. But although there is tremendous potential there are likewise potential difficulties. The long-term storage of personal health information and samples poses major challenges. This is an area is fraught with ethical and legal uncertainties. Biobanks raise many questions of the control of rights, of consent, of privacy and confidentiality and of property in human material. It is thus unsurprising (...) then that there has been a lively debate as to how biobanks should operate, the boundaries of participation and what governance structure, if any they should adopt, a debate which has been engaged in across the academic community and by funders and researchers alike. This paper asks despite the good intentions can ad hoc ethics and ethics and governance committees long term provide an effective solution to the legal and regulatory challenges arising from biobanks. (shrink)

This paper considers the way in which English law safeguards fundamental rights to respect for faith and belief in relation to the delivery of health care. It explores the implications of the Human Rights Act 1998 and the Equality Act 2010. It explores some of the challenges in attempting to reconcile fundamental rights to faith and belief and the delivery of health care, both now and in the future and whether this is a realistic aspiration in a state funded health (...) care service. (shrink)

Limited resources and rationing are "buzz words" today in health care across the globe. This book, a collection of essays that discuss particular problems relating to health care allocation in the light of experiences drawn from a number of jurisdictions, is thus a timely publication.