Exploitation and clinical trials in developing countries

This thesis discusses comprehensively the issue of exploitation from a normative perspective specifically relating to clinical trials within developing countries using a normative definition. Exploitation is defined from an unfairness perspective as the unfair use of an individual (group of individual) by another. In order to ease the flow of the arguments within this thesis, unfairness will be assessed from two different perspectives: a procedural perspective and an outcome perspective. The procedural perspective discusses whether the procedures followed when obtaining informed consent from the potential participants fulfilled the requirements of informed consent or failed to do so. Though the use of this approach it is concluded that informed consent is not a necessary condition for the avoidance of exploitation. Similarly, it is concluded that even if morally transformative, valid consent is given by potential participants, exploitation may still be lurking in the shadows of the interaction between the trial participants and the researchers/sponsors. The outcome perspective of unfairness focuses on the effect of the interaction on the parties involved within it and whether they benefit from their interaction with each other, are not affected by it, or are actually harmed as a result of the interaction. As an extension of this argument, the thesis will also consider the post-trial perspective of the interaction. The thesis concludes that post-trial access (reasonable availability) has a very narrow view of benefit and does not ensure that there is a fair share of the benefits between the parties involved. Instead of this narrow approach, a wider, post-trial benefit approach is adopted in order to prevent exploitation. Further discussion within the thesis will include, the requirements of an ethical review, the makeup of the review boards, and priority decision making in keeping with the current research ethics discussion in the literature