Theorising the 'human subject' in biomedical research: International clinical trials and bioethics discourses in contemporary Sri Lanka
Theorising the 'human subject' in biomedical research: International clinical trials and bioethics discourses in contemporary Sri Lanka
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DOI：
10.1016/j.socscimed.2010.11.024
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发表时间：
2011-08-01
影响因子：
5.4
通讯作者：
Simpson, Bob
中科院分区：
文献类型：
--
作者：
Sariola, Salla;Simpson, Bob
临床试验活动在全球范围内的扩展伴随着研究管理和人类受试者保护的平行增长。在本文中，我们分析了如何在临床试验中的“人类受试者”的主导思想，被认为是科学欠发达的国家。具体而言，我们将展示如何在管理人类受试者研究的国际伦理准则中隐含的个人主义，理性和自主性的操作和本地化。我们深入了解新的知识形式如何嵌入实践。以斯里兰卡最近的临床试验热潮为案例研究，基于2008-2009年人种学实地考察期间对23名医生和研究人员的采访，本文探讨了参与促进生物伦理学的医生所面临的紧张局势，以及将当地研究治理提升到国际标准的尝试。医生和研究人员拦截、解释和批评新形式的研究治理中隐含的人类主体概念。从他们的叙述中，我们发现了两个问题。第一个是对“人类主体”的主导思想的批判，这种思想是由植根于医患关系的家长式观念中的耐心思想所告知的。第二，“人类主体”被视为性别，并位于家庭关系中。这两种情况都对研究对象给予知情同意的能力提出了质疑，并损害了自主受试者的理想。(C)2010爱思唯尔有限公司保留所有权利。
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. (C) 2010 Elsevier Ltd. All rights reserved.