DECLARACION DE HELSINKI PDF

Principles[ edit ] The Declaration is morally binding on physicians, and that obligation overrides any national or local laws or regulations, if the Declaration provides for a higher standard of protection of humans than the latter. Investigators still have to abide by local legislation but will be held to the higher standard. The recognition of the increased vulnerability of individuals and groups calls for special vigilance Article 8. Operational principles[ edit ] Research should be based on a thorough knowledge of the scientific background Article 11 , a careful assessment of risks and benefits Articles 16, 17 , have a reasonable likelihood of benefit to the population studied Article 19 and be conducted by suitably trained investigators Article 15 using approved protocols, subject to independent ethical review and oversight by a properly convened committee Article

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Consentimiento Informado. The Declaration was firstly adopted in 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 amendment and to what extent the fifth revision has corrected them. Key words: Bioethics. Helsinki Declaration. Informed Consent. Pero el enfoque fue radicalmente distinto.

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La Declaración de Helsinki VI: una revisión necesaria, pero ¿suficiente?

See Article History Declaration of Helsinki, formal statement of ethical principles published by the World Medical Association WMA to guide the protection of human participants in medical research. Although not without its controversies, it has served as the standard in medical research ethics. The influence of the declaration is far-reaching. Although not a legally binding document, it has been codified into the laws that govern medical research in countries across the world and has served as a basis for the development of other international guidelines. As the declaration was expanded and made more prescriptive , it became more controversial, which caused some organizations to alter some of its standards or abandon it entirely.

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La Declaración de Helsinki

Consentimiento Informado. The Declaration was firstly adopted in 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.

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Sitio Web Oficial del Comité de ética en investigación

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