Compreensão e legibilidade do termo de consentimento livre e esclarecido em pesquisas clínicas
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Data
2014-08
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Este artículo es una revisión integradora de la literatura cuyo objetivo fue analizar la comprensión y la legibilidad
de los consentimientos informados de los participantes de las investigaciones con seres humanos; y
comprobar cuáles son los factores que influyen en su comprensión y legibilidad. Por lo tanto, se buscó identificar
los factores asociados con el problema de la obtención del consentimiento válido. Forman parte de
la muestra de esta revisión once artículos seleccionados, nacionales e internacionales, de los cuales cuatro
eran en portugués (36, 36%), uno en español (9,10%) y seis en inglés (54,54%). Se concluyó que la mayoría
de los estudios analizados confirma la hipótesis de que los participantes no entienden lo que leen en el consentimiento
informado. Así, los factores deducidos como responsables de la dificultad para la lectura y la
comprensión de los consentimientos informados fueron el nivel educativo de los participantes y el lenguaje
usado en los términos.
This article is an integrative literature review whose aims were to analyze the understanding and readability of informed consent forms applied to participants of researches involving humans, and to check the factors that influence their understanding and readability. Therefore, it intended to identify factors associated with the problem of obtaining a valid consent. The sample included eleven articles selected for this review, national and international, four of which were in Portuguese (36,36%), one in Spanish (9,10%) and six in English (54,54%). It was concluded that most of the studies analyzed confirms the hypothesis that the participants do not understand what they read in the informed consent form. Thus, the factors inferred as responsible for the difficulty in reading and understanding the informed consent forms were the educational level of the participants and the language used in the terms.
This article is an integrative literature review whose aims were to analyze the understanding and readability of informed consent forms applied to participants of researches involving humans, and to check the factors that influence their understanding and readability. Therefore, it intended to identify factors associated with the problem of obtaining a valid consent. The sample included eleven articles selected for this review, national and international, four of which were in Portuguese (36,36%), one in Spanish (9,10%) and six in English (54,54%). It was concluded that most of the studies analyzed confirms the hypothesis that the participants do not understand what they read in the informed consent form. Thus, the factors inferred as responsible for the difficulty in reading and understanding the informed consent forms were the educational level of the participants and the language used in the terms.
Descrição
Palavras-chave
Consentimiento informado, Consentimento livre e esclarecido, Informed consent, Lectura-comprensión, Leitura-compreensão, Reading-comprehension
Citação
RODRIGUES FILHO, Eurípedes; PRADO, Mauro Machado do; PRUDENTE, Cejane Oliveira Martins. Compreensão e legibilidade do termo de consentimento livre e esclarecido em pesquisas científicas. Revista Bioética, Brasília, DF, v. 22, n. 2, p. 325-336, ago. 2014.