Theorising the ‘human subject’ in biomedical research: International clinical trials and bioethics discourses in contemporary Sri Lanka

The global spread of clinical trials activity is accompanied by a parallel growth in research governance and human subject protection. In this paper we analyse how dominant ideas of the ‘human subject’ in clinical trials are played out in countries that are deemed to be scientifically under-developed. Specifically, we show how rhetorics of individualism, rationality and autonomy implicit in international ethical guidelines governing human subject research are operationalised and localised. We give insights into the ways in which new knowledge forms become embedded in practice. Using the recent upsurge in clinical trials in Sri Lanka as a case study, based on interviews with 23 doctors and researchers carried out during ethnographic fieldwork between 2008-2009, this article explores the tensions that arise for doctors involved with the promotion of bioethics and the attempts to bring local research governance up to international standards. The doctors and researchers intercept, interpret and critique the notions of human subject implicit in new forms of research governance. From their accounts we have identified two concerns. The first is a critique of dominant ideas of the ‘human subject’ that is informed by ideas of patiency rooted in paternalistic notions of the doctor-patient relationship. Second, ‘human subjects’ are seen as gendered, and located within family relationships. Both of these bring into question the research subjects’ ability to give informed consent and compromise the ideal of an autonomous subject.

► Increasing clinical trials activity in countries that are ‘scientifically lagging’ brings significant challenges in relation to research regulation and governance.
► The article provides a detailed ethnographic account of this process among Sri Lankan doctors.
► The conceptual underpinnings of these modes of governance are brought into question by those involved in opreationalising the ethical conduct of clinical trials and an important area of contention arises in relation to the notion of human subject research.
► Social and cultural factors lead doctors to question an individualistic and autonomy-oriented research ethics, when set against their experience of working in contexts that are strongly family-centred and marked by paternalism.
► While recognising the importance of autonomy in medical decision-making, the doctors described various conceptual and practical difficulties in putting standardised models of research governance into practice.