Abstract

Research ethics committees, while in many ways an excellent innovation, do have some drawbacks. This paper examines three of these. The first problem of such committees is that their approval of specific projects in their own institutions acquires intrinsic value.

The second problem relates to the possible devolution of responsibility from the investigator to the committee. The committee approves, the investigator feels relieved of some responsibility and things can be done to patients which neither the committee nor the investigator might countenance if they had sole responsibility.

The third problem arises directly from the bureaucratic nature of the committee itself. And one consequence of the resulting rigid guidelines is the insistence, by most committees, on the written consent of patients. Demanding this can, in some circumstances, mean giving the patient very disturbing information. The paper suggests that in patients with a fatal disease where trials compare two accepted therapies committees dispense with written consent.

There is a commentary on this paper by Dr D J Weatherall of the Nuffield Department of Clinical Medicine, University of Oxford.