The research imperative and bureaucratic control: the case of clinical research

This paper examines the development of Research Ethics Committees and explores some of the conflicts of value and role which surround the practice of medical research. The case of medical research on children is discussed as one which raises in an acute form concerns about consent and risk/benefit analysis. The paper draws on a survey of Research Ethics Committees to illustrate their variety of structure and functioning, and to relate current practice to a model of bureaucratic control. Bureaucracy is considered both in its common-sense understanding of officious rule-making and delay, and in its theoretical formulation in terms of specialisation, standardisation, formalization and centralisation of procedures. It is argued that the concept of bureaucracy can aid an understanding of the problems of control over research, as well as providing a model for more informed, consistent and open decision making.