[Points of view in comparison on the 5ht revision of the Declaration of Helsinki].
The horror for the scientific crimes of the nazi period led the World Medical Association (WMA), in 1964, to settle by the Helsinki declaration, an ethical code for the medical research on human beings. The code was successively modified in order to account for the developments of the medical science in the past decades. In October 2000, the last revision, the 5th one, has been approved in Edinburgh. Its preparation lasted three years and entailed a passionate, but also profitable dispute between who believes that ethical principles must be followed even though they can hamper the scientific progress, and who thinks that more articulate evaluations should prevail. The initial victory of the more intransigent party resulted in the maintenance of the norm which entails the greatest restriction in using placebo, but, after one year and half, it was partially reshaped by a more permissive interpretation of the same WMA, while waiting for a new revision that is scheduled for this year.
Rosmini
Francesco
F
Laboratorio di Epidemiologia e Biostatistica, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Roma. rosmini@iss.it
D002986:Clinical Trials as Topic / Q000941:ethics*; D004992:Ethics, Medical; D006381:Helsinki Declaration; D012107:Research Design