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Revista Cubana de Salud Pública

versión On-line ISSN 0864-3466


BARRIOS OSUNA, Irene; ANIDO ESCOBAR, Vivianne  y  MORERA PEREZ, Maricela. Helsinki Declaration: changes and interpretation. Rev Cubana Salud Pública [online]. 2016, vol.42, n.1. ISSN 0864-3466.

In the fields of medical and health sciences, the Helsinki Declaration is quoted very often. The Helsinki Declaration is used to evaluate the ethical aspects of research studies; however, literature devoted to critical assessment of those studies is scanty. Making reference to the declaration versions presupposes the knowledge about its historical development in order to construe its good things and limitations. The intention of this study is to help to update the health professionals' knowledge about the Helsinki Declaration. A literature review published between 2008 and August 2014 was made and collected on the following databases: Cumed, Lilacs, SciELO PubMed, MedLine, Clinical Key, Cochrane and Google, using controlled vocabulary with the f subject headings Helsinki Declaration, placebo, clinical trial, ethics and bioethics. The most controversial topics were the use of placebo, application of the double standard possition in clinical research, and guaranteed continuous treatment for the participating patients. The following 2013 version's merits were highlighted: insistence on the research transparency its new structural design, and the concern for ethical competence as a requirement for researchers. Comments about the Helsinki Declaration range from praise to disappearance or replacement suggestions. Some authors deem the controversy necessary but others think it is a wasteful argument. The hottest problems in the most recent versions come from the confrontation between the pharmaceutical industry interests and the rights of participants in research studies.

Palabras clave : Helsinki Declaration; placebo; clinical trial; ethics and bioethics.

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