The ethics and governance of medical research: what does regulation have to do with morality?

Abstract

In the last thirty years the oversight of medical and health research has become increasingly formalised and institutionalised in an attempt to ensure that research is ‘ethical,’ specifically in terms of respecting individual rights. At the same time there continue to be high expectations of the professionalism and integrity of the medical profession and, among the public, high levels of trust in their own physicians. Ashcroft discusses these agent-oriented and process-oriented approaches to the regulation of research risk as two discourses; the moral and the regulatory. The moral discourse is agent-centred, concentrating on canons of duty, behaviour and character. The regulatory discourse focuses on standard-setting, operation processes, identification and control of systematic risks. From a moral point of view, regulatory discourse illegitimately plays down responsibility, reflection and human relationships, while overplaying the role of economics. From a regulatory point of view, the moral discourse is vague, impractical, ideologically suspect, and discretionary. The bioethical enterprise is meant to be action-guiding in the field of medicine but it is also meant to be critical of established institutions and not bound by their way of framing issues. The problem is to find ways of feeding into the regulatory framework in order to influence policy without necessarily subscribing to the set agenda. For those involved in health-related research there has been a plethora of detailed guidelines and procedures