Clinical trials: Fact Value Dichotomy and bioethical black market

Abstract

The role of bioethics in clinical trials is strongly marked by the Fact Value Dichotomy, which ultimately leads to the opposition between “people’s rights, security and welfare” and “the interests of science and society”. For a long time the debate has focused mainly on the possibility (or not) of separating this pairing and its consequences. One of these consequences is the downgrading of ethical aspects in pharmacological research to merely safeguarding subject’s dignity, but at the same time excluding them from the discussion on the implications of the research. The article cites authors such as Dewey, Whitehead and Foucault in order to shed light on the topic and proposes the double function of bioethics in the context of this type of research. Firstly, it must safeguard medical necessities, in which the research subject has no opinion. Secondly, it must safeguard participants in research protocols that tend to be imprecise in terms of risks, benefits and the protection of the human being. This task is put forth to the institutional bioethical committees as they are called upon to understand the diversity of implications of that which they must assess.