ABSTRACT
The regulation of clinical trials on neonates varies markedly across Europe. Some countries have statutory regimes, whilst others do not. The procurement of consent prior to medical interventions is usually a legal requirement, but there is no uniform norm concerning the level of information that patients should be given to ensure that consent is adequate or informed. The origin of modem international bioethics has been traced to the brutal abuse of human lives in the holocaust. Part of the brief of the Radiation Committee was to develop an ethical framework to evaluate, retroactively, the ethical soundness of the experiments under suspicion. In the post-war era, the thesis has come under pressure from both multiculturalism and postmodernism. The principle of the non-maleficence is common to all ethical theories. The principle has a major limiting effect on the conduct of non-therapeutic research.
