Agomoni Ganguli Mitra

Off-shoring clinical research: exploitation and the reciprocity constraint.

The last 20 years have seen a staggering growth in the practice of off-shoring clinical research to low-and middle-income countries (LICs and MICs), a growth that has been matched by the neoliberal policies adopted by host countries towards attracting trials to their shores. A recurring concern in this context is the charge of exploitation, linked to various aspects of off-shoring. In this paper, I examine Alan Wertheimers approach and offer an alternative view of understanding exploitation in this context. I will suggest that the justification for the enterprise of research is largely dependent on its integration within a health system from which participants regularly benefit and I argue that an attention to a principle of reciprocity will enable us to better recognize and address exploitation in international research.

Beyond regulatory compression: Confronting the liminal spaces of health research regulation

ABSTRACT Biomedicine and the life sciences continuously rearrange the relationship between culture and biology. In consequence, we increasingly look for a suitable regulatory response to reduce perceived uncertainty and instability. This article examines the full implications of this ‘regulatory turn’ by drawing on the anthropological concept of liminality. We offer the term ‘regulatory compression’ to characterise the effects of extant regulatory approaches on health research practices. With its focus on transformation and the ‘in-between’, liminality allows us to see how regulatory frameworks rely on a silo-based approach to classifying and regulating research objects such that they: (1) limit the flexibility necessary in clinical and laboratory research; (2) result in the emergence of unregulated spaces that lie between the bounded regulatory spheres; and (3) curtail modes of public participation in the health research enterprise. We suggest there is a need to develop the notion of ‘processual regulation’, a novel framework that requires a temporal-spatial examination of regulatory spaces and practices as these are experienced by all actors, including the relationship of actors with the objects of regulation.

A Social Connection Model for International Clinical Research

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Elberte v. Latvia: Whose tissue is it anyway – Relational autonomy or the autonomy of relations?

A European Court of Human Rights decision rendered in January 2015 (Elberte v. Latvia) has raised a curious question regarding the nature and scope of the right for relatives to consent to or to oppose the removal of a deceased person’s tissues. The decision suggests that Council of Europe member states must clearly define the scope of the right for relatives to express their preferences for removal of a deceased’s tissue or organs – provided such a right has been created in law – and member states must define the corresponding obligation or margin of discretion conferred on experts or other authorities to explain these rights to the relatives. Notwithstanding, this article asks whether the decision could open the door to a free-standing right for relatives to oppose removal of their deceased relative’s tissues or organs, regardless of the deceased person’s own wishes, in the name of the relatives’ human ‘right to respect for private life’.

Off-shoring Clinical Research

The last 20 years have seen a staggering growth in the practice of off-shoring clinical research to low-and middle-income countries (LICs and MICs), a growth that has been matched by the neoliberal policies adopted by host countries towards attracting trials to their shores. A recurring concern in this context is the charge of exploitation, linked to various aspects of off-shoring. In this paper, I examine Alan Wertheimers approach and offer an alternative view of understanding exploitation in this context. I will suggest that the justification for the enterprise of research is largely dependent on its integration within a health system from which participants regularly benefit and I argue that an attention to a principle of reciprocity will enable us to better recognize and address exploitation in international research.