Retreat from Nuremberg: can we prevent unethical medical research?

The prosecution of doctors guilty of appalling human rights abuses at Nuremberg was achieved on the mistaken premise that the research community already had a code of conduct which, if applied, would have made such abuses impossible. In fact, not only was there no such code but when the 'Nuremberg Code' was published after the trial it continued to be ignored by many doctors for some thirty years afterwards. Indeed its central principle of informed consent has itself been eroded by subsequent international agreements on the ethics of medical research. This review shows that the mechanisms for approval of medical research which have now been promulgated in England and Wales, in practice, are applied on a very variable basis. Research in vulnerable groups unable to give fully informed consent such as children, prisoners and the incompetent elderly require the application of more rigorous standards of ethical control than those currently in operation. The use of vulnerable populations in the developing world and the application of international standards to them is also considered. A number of suggestions for improvements in current procedures in all these areas are put forward. The proposals for the United Kingdom would meet the requirements of the European Convention on bioethical research and the recent government consultation paper on medical treatment and research in incompetent adults.