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MEDISAN

On-line version ISSN 1029-3019

Abstract

SAUMELL NAPOLES, Yaimarelis; BATISTA ROMAGOZA, Maritza  and  SAGARO DEL CAMPO, Nelsa María. Estimate of the understanding reached by individuals from clinical investigation when obtaining the informed consent. MEDISAN [online]. 2014, vol.18, n.6, pp.784-792. ISSN 1029-3019.

A descriptive and cross-sectional study of 51 patients included in clinical trials made in Santiago de Cuba was carried out from January to December, 2012, in order to know the understanding reached by them regarding the information which they received during the process of informed consent, for which a structured questionnaire was applied and was the understanding was defined by means of 3 categories, correlating it with the person's school level and the methodology for applying the consent. It could be concluded that most of the participants in the clinical trials with products of the Center for Molecular Immunology of this province, received the information required in the process of informed consent. The school level of the participants and the appropriate methodology for the application of the informed consent, determine the higher understanding of the investigation

Keywords : informed consent; clinical trial; understanding.

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