Medical ethics, clinical research, and special aspects in nuclear medicine

Medical ethics is the science of survival. It studies the working out of judgments on right or wrong referred to the human being as a biological entity interacting with the whole ecosystem. Medical ethics in clinical research raises numerous moral and technical issues. Methodological aspects are essential for carrying out the aim of clinical research. Medical ethics documents are inspired by the Nuremberg Code and culminate in the recently updated Helsinki Declaration of 1964. In Italy 2 ministerial decrees in 1997 and 1998 laid the basis for the work of a medical ethics committee. They acknowledge the European Good Clinical Practice Guidelines and set professional needs within ethical committees. In clinical research the use of ionising radiation merits special consideration. In the recent past, serious human rights abuses in radiation experiments of the 1950s and 1960s have been found. As regards research in this field we can refer to the publication of the International Commission on Radiological Protection (ICRP) and to the report of the World Health Organisation (WHO). Legislative decree no. 187 of May 26, 2000, which transposed the 97/43/ EURATOM Directive represents the most comprehensive and recent normative reference to clinical research using ionising radiation. However, law no. 39 of March 1, 2002 is important for the partial modifications of previous decrees (art. 108 of L.D. no. 230 of March 17, 1995 and, art. 4 and attachment III of L.D. no. 187 of May 26). In this paper medical ethics, research, methodological issues and aspects of ionizing radiation are discussed.