Resumen

GARRAFA, Volnei. The Helsinki statement and its continuous "adjustments"- an exhausting topic.... Rev. Lasallista Investig. [online]. 2014, vol.11, n.1, pp.35-40. ISSN 1794-4449.

This text discusses, critically, the many adjustments made to the Helsinki statement (HS) from its creation to 2013, some of which are necessary and others have no evident usefulness. After 2008, after the World Medical Assembly in Seoul, Korea, some substantial modifications to the HAS started to generate strong controversies. This study analyzes, specially, the topics related to the "double standard" in research and the lack of commitment of the sponsors of the clinical research works with the subjects of the studies once the tests are finished, plus the excessive use of placebos in the international clinical context. It also approaches to the concept of social vulnerability related to most of the patients that participate in these studies in peripheral countries. As the most recent meeting took place in Brazil in 2013, the text finishes with an analysis of the problems that occurred in this country due to the strong divisions registered between its two main medical entities concerning the denial or the approval of the changes and the official position, opposite to that of the government.

Palabras clave : clinical studies; Helsinki Statement; double standard; social vulnerability.

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