Abstract

SANCHEZ, Delia M.  and  BARCIA, Marianela. Amendment to the national law on ethical issues in research involving human subjects. Decree 158/019 of June 13, 2019. Rev. Méd. Urug. [online]. 2020, vol.36, n.3, pp.183-197.  Epub Sep 01, 2020. ISSN 0303-3295.  https://doi.org/10.29193/rmu.36.3.8.

Decree 158/019 introduced several amendments to the national law on ethical issues in research involving human subjects. Given the fact that these amendments are included in a decree that keeps most of the text of Decree 379/08, it may happen that at least some of them are not noticed by readers who are not directly involved in research involving human subjects.

Learning about the above mentioned amendments is important since it includes modifications in the operation of ethical committees on institutional research and the National Ethics Commission, and also significant affirmations in connection with concepts that have to do with the timely use of placebo, informed consent in epidemiological studies and requirements for research conducted from abroad.

Keywords : Investigación científica; Ética en investigación; Legislación médica.

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