Resumo

RUEDA MARTINEZ, Gabriela  e  MONSORES DE SA, Natan. IMPACT OF THE ABSENCE OF THE COLOMBIAN NATIONAL COUNCIL OF BIOETHICS. rev.latinoam.bioet. [online]. 2015, vol.15, n.2, pp.144-155. ISSN 1657-4702.

This paper discusses the impact of the absence of the National Council of Bioethics (CNB) in the regulations of human research at Colombia, especially with regard to Resolution 8430/1993 of Ministry of Health. For this purpose, the approach to the topic was divided into three parts: the first deals with the experience of Colombia in the implementation of a CNB, the second topic reviews the current regulations on human experimentation, and the third topic analyses, in a critical way, the content of the aforementioned Resolution. In Colombia, discussions on topics that require the bioethical reflection occur at the level of the State, without the advice of a National Council of Bioethics, which provide guidance, from this perspective. For this reason, a regulation of the Law 1374/2010, which creates the CNB, is urgent. Whereas the protection of the participating of people in biomedical research, is relevant a transformation of bioethics in Colombia regarding its epistemological foundation, in order to adopt a bioethical referential connected to their social reality. We suggest the Universal Declaration on Bioethics and Human Rights, at UNESCO, as a leader guide in revision of Colombian directive on human's research.

Palavras-chave : Research ethics; bioethics; Resolution 8430/1993; Colombia; regulation.

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