• F J de Abajo.
• División de Farmacoepidemiología y Farmacovigilancia Agencia Española del Medicamento Ctra. Majadahonda a Pozuelo, km. 2 28220 Majadahonda, Madrid. fabajo@agemed.es
• Rev. Esp. Salud Publica. 2001 Sep 1;75(5):407-19.

AbstractWith the fifth amendment of the Declaration of Helsinki (Edinburg, 2000), the World Medical Association took a fundamental step forward in the history of the document, after years of internal and external debate. The Declaration was firstly adopted in 1964 as a clear intent to show that the medical profession could manage the ethical control of medical research with human beings. However, several disgraced episodes, like the Tuskegee Syphilis study, showed the insufficiency of such a system. An external control in the form of legal regulation was then proposed. Paradoxically, the importance of the Declaration did not decrease because many national regulations included it as a reference, actually providing it a legal status. But, though formally important, the Declaration hardly had an impact on real-world terms, because it assumed an old-fashion logic of clinical research failing to incorporate the modern methodological developments. The amendment could not be put off longer. In the present paper, I analyse the main shortcomings of the Declaration before the 2000 amendment and to what extent the fifth revision has corrected them.

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