Despite intense academic debate in the recent past over the use of ‘sham surgery’ control groups in research, there has been a recent resurgence in their use in the field of neurodegenerative disease. Yet the primacy of ethical arguments in favour of sham surgery controls is not yet established. Preliminary empirical research shows an asymmetry between the views of neurosurgical researchers and patients on the subject, while different ethical guidelines and regulations support conflicting interpretations. Research ethics committees faced with a (...) proposal involving sham surgery should be aware of its ethical complexities. An overview of recent and current placebo-controlled surgical trials in the field of Parkinson's Disease is provided here, followed by an analysis of the key ethical issues which such trials raise. (shrink)

Consent can only be voluntary, freely given and uncoerced. Can this legal adult standard also apply to children? High-risk surgery is seldom a wanted choice, but compared with the dangers of the un...

Background Best interests is a ubiquitous principle in medical policy and practice, informing the treatment of both children and adults. Yet theory underlying the concept of best interests is unclear and rarely articulated. This paper examines bioethical literature for theoretical accounts of best interests to gain a better sense of the meanings and underlying philosophy that structure understandings. Methods A scoping review of was undertaken. Following a literature search, 57 sources were selected and analysed using the thematic method. Results Three (...) themes emerged. The first placed best interests within the structure of wider theory, noting relationships with consequentialism, deontology, prudential value theory, rights and political philosophy. The second mapped a typology of processes of decision-making, among which best interests was ambiguously positioned. It further indicated factors that informed best interests decision-making, primarily preferences, dignity and quality of life. The final theme considered best interests from a relational perspective. Conclusions Characterisation of best interests as strictly paternalist and consequentialist is questionable: while accounts often suggested a consequentialist basis for best interests, arguments appeared philosophically weak. Deontological accounts, found in law and Kantianism, and theories of political liberalism influenced accounts of best interests, with accounts often associating best interests with negative patient preferences (i.e. individual refusals). There was much more emphasis on negative interests than positive interests. Besides preference, factors like dignity and quality of life were held to inform best interests decisions, but generally were weakly defined. To the extent that preferences were unable to inform decision making, decisions were either made by proxy authority or by an intersubjective process of diffuse authority. Differing approaches reflect bifurcations in liberal philosophy between new liberalism and neo-liberalism. Although neither account of authority appears dominant, bias to negative interests suggests that bioethical debate tends to reflect the widespread ascendancy of neo-liberalism. This attitude was underscored by the way relational accounts converged on private familial authority. The visible connections to theory suggest that best interests is underpinned by socio-political trends that may set up frictions with practice. How practice negotiates these frictions remains a key question. (shrink)

Assent is an important ethical and legal requirement of paediatric research. Unfortunately, there are significant differences between the guidelines on the details of assent.

Bioethics can be considered as a topic, an academic discipline, a field of study, an enterprise in persuasion. The historical specificity of the forms bioethics takes is significant, and raises questions about some of these approaches. Bioethics can also be considered as a governance practice, with distinctive institutions and structures. The forms this practice takes are also to a degree country specific, as the paper illustrates by drawing on the author’s UK experience. However, the UNESCO Universal Declaration on Bioethics can (...) provide a starting point for comparisons provided that this does not exclude sensitivity to the socio-political context. Bioethics governance practices are explained by various legitimating narratives. These include response to scandal, the need to restrain irresponsible science, the accommodation of pluralist views, and the resistance to the relativist idea that all opinions count equally in bioethics. Each approach raises interesting questions and shows that bioethics should be studied as a governance practice as a complement to other approaches. (shrink)

This article argues that hope is of value in clinical ethics and that it can be important for clinicians to be sensitive to both the risks of false hope and the importance of retaining hope. However, this sensitivity requires an understanding of the complexity of hope and how it bears on different aspects of a well-functioning doctor-patient relationship. We discuss hopefulness and distinguish it from three different kinds of hope, or ‘hopes for’, and then relate these distinctions back to differing (...) accounts of autonomy. This analysis matters because it shows how an overly narrow view of the ethical obligations of a clinician to their patient, and autonomy, might lead to scenarios where patients regret the choices they make. (shrink)

Australian law affirms a binary construction of fertility/infertility. This model is based upon the medical categorization of infertility as a disease. Law supports medicine in prioritizing technology, such as in vitro fertilization, as treatment for infertility. This prioritization of a medico-legal model of infertility in turn marginalizes alternative means of family creation such as adoption, fostering, traditional surrogacy, and childlessness. This paper argues that this binary model masks the impact of medicalization upon reproductive choice and limits opportunity for infertile individuals (...) to create families. While medical technology should be available to enhance reproductive opportunity, infertile individuals will benefit from regulatory change which disentangles the medico-legal construct of infertility as a disease from the desire to create a family. This paper suggests that the medico-legal model of infertility should be reframed to support all opportunities for family creation equally, including non-medical opportunities such as adoption, fostering, and childlessness. (shrink)

In the first five of these articles I have questioned the justice, and effectiveness, of total dependence in clinical research on willing volunteers. I have explored ways that might better and more equitably spread the burden of participating in clinical research as subjects of it. Here I consider this question: if consent is the barrier, must we regard consent as indispensable?

What relationship between investigators and subjects of clinical research would best meet the needs and wants of both – and of society, which has an interest not only in clinical research being done but also in its being done well? This series of articles argues that investigators and subjects should work together in a partnership based in shared aims. Other relationships are possible, however, and here I examine two.