Facing up to paternalism in research ethics

Abstract

This chapter argues that the basic features of research ethics and regulation are based on a fundamentally paternalistic foundation-one that is reasonable in view of the nature of clinical research. The paternalistic roots of research ethics and regulation are obscured by the antipathy to paternalism within bioethics, which began with a critique of traditional medical paternalism and championed the autonomy of patients and research subjects. Nevertheless, there would be no rationale for independent committee review and oversight, deploying the key subject-protection task of risk-benefit assessment, if research subjects in the aggregate were capable of protecting their interests by means of consent. This chapter explains and justifies the prevailing approach to research ethics and regulation in terms of "group soft paternalism." Even the requirement for informed consent has a paternalistic justification since a process of information disclosure is not required as a condition of valid consent in many other areas of social life.