MORALITY, RISK AND INFORMED CONSENT IN CLINICAL DRUG TRIALS
It might appear that risk/benefit calculation is more akin to the world of business and insurance than biomedical ethics. Yet, if we think about risk as a strategy for governing conduct, both of others and ourselves then its use as an ethical tool does not seem so strange (O’Malley 1996, 2000).2 Indeed, as any scholar of moral philosophy will know, Bentham’s calculus is the cornerstone of Utilitarian ethics and Utilitarianism in turn is the basis of contemporary bioethical theory.3 Determination and management of risk have become major strategies in bioethical discourses and regimes designed to govern practice in biomedical research involving the use of human subjects. How does this strategy work in practice? Using the case of clinical drug trials, this chapter will examine the ethical regulatory discourse of risk, the expert assessment and management of risk as
conducted by research ethics committees, the information that is given to research subjects about potential risk and how this is interpreted and understood by them. In particular, this chapter explores the way this domain of risk is governed by regulatory guidelines applied by ‘experts’ and contrasts this with the extent to which those on whom the risk impacts directly, the research subjects, engage with and manage their own risk. The chapter suggests that very different moral spaces are occupied by those experts who administer the field and those who ultimately bear the risk. First, let us briefly look at the context within which a plethora of ethical guidelines and an explosion of strategies designed to manage such risk has emerged.