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      Como consentir sem entender? Translated title: How consent without knowing?

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          Abstract

          INTRODUÇÃO: Termo de Consentimento Livre e Esclarecido (TCLE) é o documento que informa sobre os benefícios e riscos de um estudo. Alguns autores concluíram que os TCLE são de difícil compreensão. OBJETIVO: Correlacionar grau de dificuldade dos TCLE, pelos índices de Flesch (IF) e Flesch-Kincaid (ILFK), utilizados num ambulatório de oncologia ao perfil de escolaridade dos usuários desse mesmo serviço, bem como verificar a legibilidade e a presença das informações obrigatórias segundo o item IV.1 da Resolução 196/96 do Conselho Nacional de Saúde. RESULTADOS: Foram obtidos 10 TCLE; segundo o IF e ILFK, a média foi de 38,5 e 18,16 respectivamente, mostrando ser necessário aproximadamente 18 anos de estudo para a compreensão, dado incompatível com a realidade de nossa população, em que mais de 50% tem menos de oito anos de estudos. Em relação à qualidade dos termos, estes eram bem elaborados tecnicamente, contendo a maior parte dos itens necessários. Ao correlacionarmos o ILFK com a qualidade dos TCLEs, pôde-se observar que a qualidade dos termos não apresentou correlação com a legibilidade (p= 0.884, coeficiente de correlação de Pearson 0.053). CONCLUSÃO: O grau de dificuldade dos TCLE é incompatível com a escolaridade de nossa população e nossos TCLE apresentavam informações suficientes. Esperávamos relacionar a quantidade de informações ao grau de dificuldade de compreensão do texto, não sendo confirmada, mostrando a possibilidade de um TCLE ser completo ao mesmo tempo fácil de ler.

          Translated abstract

          BACKGROUND: The Consent Form (CF) is an important document that informs patients about benefits and risks of a study, it assures patients the right to accept or reject participation in a procedure related to their health. Some authors believe that Consent Forms are complex and difficult to read for most people. OBJECTIVE: Correlate the difficulty of understanding CF, through the Flesch Index (FI) and Flesch-Kincaid Index (FKI), used in our oncology outpatient clinic, with the profile of our patient's education. We also wanted to verify readability and presence of the information which must be part of these CF according to item IV.1 from Resolution 196/96 of the Brazilian Health Council. RESULTS: We obtained 10 CFs, according to FI and FKI the mean was 38.5 and 18.16 respectively, indicating that, at least, 18 years of study are needed for the comprehension. This result is incompatible with the Brazilian population where more than 50% have less than 8 years of study. According to the quality of the CF, they were well elaborated, and had most of the necessary contents. When the authors correlated FKI and quality of CF, they concluded that the quality of CF does not correlate with readability (p= 0.884, Pearson correlation coefficients 0.053). CONCLUSION: Despite the good content quality of most of the analyzed CF, their level of reading difficulty is not compatible with the literacy skills of a major part of the Brazilian population.

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          Most cited references 47

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          Resolução no 196 de 10 de outubro de 1996. Diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos

           BR da Costa (1996)
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            International ethical guidelines for biomedical research involving human subjects.

              (2002)
            The CIOMS guidelines have been developed and revised with the problems of conducting medical research in less developed countries particularly in mind. The proposed guidelines were first published in 1982, revised in 1993, and have now been published in a third version after a revision process lasting three years. Last month the Bulletin published just one guideline and accompanying commentary. There now follow all the guidelines, without commentary, but with an appendix detailing what should be in a protocol.
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              Lei nº 10.406, de 10 de janeiro de 2002. Institui o código civil

              (2002)
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                ramb
                Revista da Associação Médica Brasileira
                Rev. Assoc. Med. Bras.
                Associação Médica Brasileira (São Paulo )
                1806-9282
                2009
                : 55
                : 3
                : 328-334
                Affiliations
                [1 ] Faculdade de Medicina do ABC
                [2 ] Universidade Federal de São Paulo Brazil
                [3 ] Hospital Israelita Albert Einstein
                Article
                S0104-42302009000300028
                10.1590/S0104-42302009000300028
                Product
                Product Information: website
                Categories
                MEDICINE, GENERAL & INTERNAL

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