Compensation for harm: the implications for medical research.

The rising incidence of medical litigation in the 1980's led to a relatively minor modification in January 1990 of the United Kingdom's negligence-based system of medical compensation, as a result of which employing Health Authorities now accept full vicarious liability for the negligent (but not other) actions of employed clinicians (Crown indemnity). During the same period, by contrast, bodies such as the Royal College of Physicians have strongly influenced locally established Research Ethics Committees towards favouring no-fault compensation for harm resulting from medical research. The discordance between these two approaches to compensation has caused anxiety during the last year. There has been particular concern about the possible discouragement of non-commercially sponsored research. Hitherto however, no data has been available to inform this discussion. This paper reports the findings of a questionnaire survey of all research ethics committees in the United Kingdom (64% response rate), which indicates that 61% of committees require no-fault compensation for at least some projects and that 33% of these committees have rejected projects solely or mainly due to the lack of such provision. Rejection is significantly more common in Health Districts which contain teaching hospitals. Our critical analysis of the arguments advanced in favour of no-fault provision for research subjects suggests that they do not place adequate emphasis upon respect for the autonomy of individuals. We consider that it is in general more consistent with such respect fully to inform research subjects of the available compensation arrangements, rather than for ethics committees to make no-fault compensation a general requirement before ethical approval is given.