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.

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.

Clinical Trials Abroad: The Marketable Ethics, Weak Protections and Vulnerable Subjects of EU Law

This chapter explores how the EU is a largely overlooked exporter of normative power through its facilitation and use of clinical trials data produced abroad for the marketing of safe pharmaceuticals at home; a move that helps to foster the growing resort to pharmaceuticals as a fix for public health problems. This is made possible by the EU’s (de)selection of international ethical frameworks in preference to the international technical standards it co-authors with other global regulators. Clinical trials abroad underscore how ethics are contingent and revisable in light of market needs, producing weak protections for the vulnerable subjects of EU law. I argue that these components and effects of the regime are ultimately about that which undergirds, shapes and directs regulatory design. That is, I point to the use, infiltration, perpetuation and extension of market-oriented ideas, values and rationalities into formally non-market domains like biomedical knowledge production and public health. I explain how these are central to efforts at producing and legitimating the EU, its related imagined socio-political order based on a more innovative, profitable and competitive pharmaceutical sector in order to foster economic growth, jobs and prosperity, and with them the project of European integration. ‘Bioethics as risk’ is highlighted as a way to reshape and redirect the regulatory regime in ways that are more consistent with the spirit and letter of the ethical standards (and through them the human rights) the EU claims to uphold.

From gendered organizations to compassionate borderspaces: Reading corporeal ethics with Bracha Ettinger

In this article, we propose a new way of approaching the topic of ethics for management and organization theory. We build on recent developments within critical organization studies that focus on the question of what kind of ethics is possible in organizational contexts that are inevitably beset by difference. Addressing this ‘ethics of difference’, we propose a turn to feminist theory, in which the topic has long been debated but which has been underutilized in organization theory until very recently. Specifically, we draw on the work of Bracha Ettinger to re-think and extend existing understandings. Inspired by gender studies, psychoanalysis, philosophy and art, Ettinger’s work has been celebrated for its revolutionary re-theorization of subjectivity. Drawing on a feminist ethics of the body inspired by psychoanalysis, she presents a concept of ‘trans-subjectivity’. In this, subjectivity is defined by connectedness, co-existence and compassion towards the other, and is grounded in what Ettinger terms the ‘matrixial borderspace’. An ethics of organization derived from the concept of the matrixial suggests that a different kind of ethical relation with the Other is possible. In this article, we demonstrate this through examining the issue of gender in the workplace. We conclude by outlining the implications of this perspective for rethinking ethics, embodiment and gender, and in particular for the development of a corporeal ethics for organization studies.