ABSTRACT
For research involving competent adults, obtaining informed consent is a process that recognises and respects the autonomy of the individual. Its purpose is to enable adults to make informed choices about themselves and to safeguard their own best interests, in the full knowledge of risks versus potential benefits. In general, parents are charged with responsibility for protecting their infant from harm. In reality they clearly receive help in this, in various forms, be it in the provision of safe water, consumer protection legislation, road safety measures and so on. If the best treatment is unknown and there is a choice of treatments, the only approach that apportions the risk of benefit and the risk of unexpected side effect equally, is the randomised controlled trial. To accept a person's autonomy is to accept his right to make decisions about himself even if those decisions are not in his best interests. Translating the concept of autonomy to a newborn baby is difficult.
