The case for a new system for oversight of research on human subjects

The increasing emphasis on evidence-based clinical practice has thrown into sharp focus multiple deficiencies in current systems of ethical review. Th is paper argues that a complete overhaul of systems for ethical oversight o f studies involving human subjects is now required as developments in medic al, epidemiological and genetic research have outstripped existing structur es for ethical supervision. It shows that many problems are now evident and concludes that sequential and piecemeal amendments to present arrangements an inadequate to address these. Ar their core present systems of ethical r eview still rely on the integrity and judgement of individual investigators . One possible alternative is to train and license research investigators, make explicit their responsibilities and have ethics committees devote much more of their time to monitoring research activity in order to detect thos e infringing the rules.