Offshoring Clinical Trials: The Mutable Ethics, Weak Protections and Vulnerable Subjects of EU Law

In this paper I engage with science and technology studies work on pharmaceuticalisation to explore how European Union (EU) law helps to produce and support the preference for pharmaceutical responses in public health governance, while authorising the production of vulnerable subjects through the growing off-shoring of clinical trials. Drawing on the analysis of legal and policy documents, I demonstrate how EU law allows and legitimates the use of data procured from vulnerable subjects abroad for market authorisation and corporate profitability at home. This is possible because the EU has (de)selected international ethical frameworks in order to support the continued and growing use of clinical trials data from abroad. This has helped to stimulate the revision of international ethical frameworks in light of market needs, inscribing EU public health law within specific politics (that often remained obscured by the joint workings of legal and technological discourses). I suggest that law operates as part of a broader ‘technology’ – encompassing ethics and human rights discourses – that functions to optimise life through resort to market reasoning. Law is thereby reoriented, instrumentalised and deployed as part of a broader project aimed at (re)defining and limiting the boundaries of the EU's responsibility for public health, including the broader social production of public health problems and the unequal global order that the EU represents and helps to depoliticise and perpetuate. Overall, this limits the EU's responsibility and accountability for these failures, as well as another: the weak and mutable protections and insecure legacies for vulnerable trial subjects abroad.

Counselling for sight loss: Using systematic case study research to build a client informed practice model

There is compelling evidence to suggest that acquired sight loss negatively impacts on emotional well-being. Despite increasing recognition of the need to provide emotional support for people with sight loss, we still do not fully understand what counselling interventions help and why they help. The aim of this study was to examine the process and outcome of counselling for a 70-year-old client who had experienced complete, irreversible, post-operative sight loss in order to gain a deeper understanding of client-defined helpful aspects of therapy. A Hermeneutic Single-Case Efficacy Design study was undertaken having received ethical approval from the University's Research Ethics Committee. The client received six sessions of counselling from a vision-impaired counsellor working within a pluralistic framework. Measures were completed by the client at every session, as well as at pre-and post-counselling. All sessions were recorded and transcribed. The client also participated in pre-and post-counselling interviews. Data formed a rich case record that was analysed by a quasi-judicial enquiry team. Results suggested that this was a successful outcome case. Client-defined helpful aspects of therapy were (1) feeling understood; (2) being able to express emotions around the loss of sight; (3) finding a new identity; (4) finding ways to cope with fear, loss, dependency, and other people's perceptions; (5) exploring the possibility of a positive future without sight; (6) making sense of things; and (7) finding ways to become more socially connected. Relevant therapeutic tasks are proposed, and four key aspects of therapy are identified, which may have implications for the development of a practice model.

Attitudes and Ethics: Evaluating Knowledge and Regulatory Constructs in Planning Enforcement Practice

The departure point for the paper is the need to scrutinise previously unconsidered dimensions which are fundamental to understanding the dynamics of the planning enforcement system. Drawing upon emerging themes in regulation theory the paper fuses these with knowledge constructs. The rationale is that regulatory regimes must be informed by knowledge imparted from a range of sources and the resultant quality of decision making is inextricably linked to the robustness and completeness of the evidence base collated.
The theoretical analysis, coupled with proposed radical legislative changes, provides a lens for an empirical investigation which scrutinises tactics, strategies, operational mechanisms, attitudinal dimensions and ethics with a view to identifying key factors impacting upon enforcement efficacy. Prizes and pitfalls are identified in the course of the analysis and evaluation, with evidence-based remedies suggested where appropriate. The paper concludes by reflecting on the importance of theoretical synergy, epistemological advancement, taking cognisance of ethical and attitudinal challenges facing the planning profession; and, stresses the importance of identifying and bringing to book those who flagrantly breach the Code of Professional Conduct.

Community Arts and Appropriate Internet Technology: Participation, Materiality, and the Ethics of Sustainability in the Digitally Networked Era

This thesis establishes appropriate internet technology as a matter of sustainability for the community arts field. It begins with a contextual review that historicises community art in relation to technological, cultural, and political change. It goes on to identify key challenges for the field resulting from the emerging socio-cultural significance of the internet and digital media technologies. A conceptual review of the literature positions these issues in relation to Internet Studies, integrating key concepts from Software Studies and the computational turn with approaches from the fields of ICT for Development (ICT4D), Critical Design, and Critical Making. Grounded in these intersecting literatures the thesis offers a new pragmatic ethics of appropriate internet technology: one involving an alternative philosophical platform from which suitable internet-based technologies can be designed and assembled by practitioners. I interrogate these ideas through an in-depth investigation of CuriousWorks, an Australian community arts organisation, focusing on their current internet practices. The thesis then reflects on some experimental interventions I designed as part of the study for the purpose of provoking shifts in the field of community arts. The research findings form the foundation of a series of recommendations offered to practitioners and policy makers that may guide their critical and creative uses of internet technologies in the future.