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The article discusses the complexity of clinical research in critically ill patients, due to incompetency and inability to give valid consent. It relates on the legislative decree in Italy, wherein an informed consent may be granted by either the legal representatives or by the patients. However, it concludes that clinical research in critically ill patients in Italy is complicated, because the official consent requirement of a legal representative is not legally identified.

The author reflects on the implementation of the reformed regulations on specialization in anesthesia and intensive care in Italy in May 2007, which is a move by the Ministry of Education and Universities to update the 1996 regulations. He believes that the extensive description of the training curriculum for intensive care physicians includes only scant consideration of the ethical aspects of intensive medicine, particularly on the ability to communicate with the patients and their families.