ABSTRACT
The ethical principles govern clinical care and clinical research. The ethical implications of N-of-1 randomised trials (RCT) become evident when one considers the circumstances in which one would consider conducting an N-of-1 RCT, and the alternative ways of handling the problem. The N-of-1 RCT design is based on pairs of active/placebo, high dose/low dose or first drug/alternative drug combinations, the order of administration within each pair determined by random allocation. The N-of-1 RCT, then, minimises the bias of the conventional therapeutic trial, and makes it far less likely that the final conclusion will be spurious. Ethics committees at other hospitals considered N-of-1 RCTs to be very much research, and stipulated their requirements, including the obtaining of written, informed consent. Ethics committees have become increasingly attentive to ensuring that investigators respect patient or research-participant autonomy. Ethics committees should recognise the continuum of clinical care and clinical research, and set explicit standards which are consistent with this continuum.
