Addressing Potential Exploitation In Clinical Research on Human Subjects

Abstract

Numerous claims have been made to the effect that clinical research on human subjects can be exploitative — and hence morally problematic — even if there is informed consent and in the absence of any harm. If such claims are true, it follows that research ethics bodies ought to include avoidance of exploitation amongst their guiding principles. In order to evaluate these claims and provide guidance to implement a principle of avoidance of exploitation, three main questions must be addressed: what exactly do we mean by “exploitation”; how does exploitation affect the morality of clinical trials on human subjects; and what can be done to tackle exploitation in clinical trials. Chapter 2 provides an expository account of the historical context of the claims that sparked the current debate. Chapter 3 addresses the first main question by outlining three main types of exploitation accounts — namely micro fairness exploitation, macro fairness exploitation, and mere use exploitation — with examples of each from the literature. This typology is used in subsequent chapters to conduct a type-by-type analysis in order to determine whether or not particular controversial practices could constitute exploitation. Chapter 4 examines the nature of the connections (if any) between the three types of exploitation and a) concerns about standards of care and placebo controls, as well as b) concerns about participants’ post-trial access to successfully tested interventions. Both of these concerns arose in the context of international research conducted in Low and Middle Income Countries, but neither is necessarily unique to that context. Chapter 5 examines if and when benefits to entire communities might be necessary to avoid exploitation of either the communities themselves or individual trial participants. Chapter 6 advances a proposal aimed at reducing exploitation in commercial clinical trials by recognizing commercial clinical trial participation as a form of labour, which ought to be financially compensated, and suggesting the adoption of a locally indexed “living wage” model as a minimum standard of compensation.