Abstract
Ethical review by expert committee continues to be the first line of defence when it comes to protecting human subjects recruited into clinical trials. Drawing on a large scale study of biomedical experimentation across South Asia, and specifically on interviews with 24 ethical review committee [ERC] members across India, Sri Lanka and Nepal, this article identifies some of the tensions that emerge for ERC members as the capacity to conduct credible ethical review of clinical trials is developed across the region. The article draws attention to fundamental issues of scope and authority in the operation of ethical review. On the one hand, ERC members experience a powerful pull towards harmonisation and a strong alignment with international standards deemed necessary for the global pharmaceutical assemblage to consolidate and extend. On the other hand, they must deal with what is in effect the double jeopardy of ethical review in developing world contexts. ERC members must undertake review but are frequently made aware of their responsibility to protect interests that go beyond the ‘human subject’ and into the realms of development and national interest [for example, in relation to literacy and informed consent]. These dilemmas are indicative of broader questions about where ethical review sits in institutional terms and how it might develop to best ensure improved human subject protection given growth of industry-led research.
Highlights
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Drawing on a large scale study of biomedical experimentation across South Asia, and on interviews with 24 ethical review committee [ERC] members across India, Sri Lanka and Nepal, this article identifies some of the tensions that emerge for ERC members as the capacity to conduct credible ethical review of clinical trials is developed across the region
What we show through this analysis is the way that the growing engagement with pharmaceutical interests across South Asia produces significant tensions for ERC members
Summary
Asia [India, Nepal and Sri Lanka].1 In this study we identified key actors in the conduct, management and regulation of clinical trials in a variety of settings (See Table 1). We draw principally on extended interviews with a small sub-set of Ethical Review Committee [ERC] members from India [14], Sri Lanka [6] and Nepal [6]. The sample is unrepresentative of the wider body of reviewers at work in each of these countries as it was self-selecting and tended to be made up of people who were knowledgeable, articulate and keen to express their views on the rights and wrongs of clinical trials, the work of ERCs and their less responsible colleagues They were mostly from Institutional [hospital] and University settings. We draw to a lesser extent on interviews with regulators, policy-makers, academics and investigators involved in developing ethical review infra-structure Before considering these responses in detail it is necessary to consider briefly the three contexts in which our study took place. In 2007, the ICMR established its own clinical trials registry. At the time of writing, there over 650 ERCs registered via the Clinical Trials Registry of India. The workload of ERCs is unevenly spread with a relatively small number of ERCs dealing with the majority of trials and a disproportionate number using independent ERCs
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