A DIMENSÃO ÉTICA DO PROCESSO DE CONSENTIMENTO LIVRE E ESCLARECIDO NA PESQUISA QUE ENVOLVE SERES HUMANOS.

Abstract

The respect due to the human dignity and autonomy requires that all scientific research involving human subjects may only be conducted with due consent of the participant. It could say that for the Ethics Committee (EC), in Brazil, the most important for verifying the adequacy of the ethics of research projects involving human beings is the Informed Consent (IC) .Therefore, as shown by the literature, it is common ground point between most ethics committees of research centers in the world, the need for obtaining informed consent for any research involving human beings. Therefore, those shown by the literature, it is common ground point between ethics committees of most research centers in the world, the need for Obtaining informed consent for any research Involving human beings. Due to the risks related to privacy and confidentiality of data and that such waiver must be requested by the researcher to the CEP, with justification. Aimed to select, interpret, and critically evaluate studies that were focused understanding and readability of the informed consent; identify factors associated with the process of obtaining valid consent factors; identify the inner relationship between the principle of respect for autonomy and informed consent. The methodological procedures were performed in two stages: the first was used an integrative review to check the guiding question of the study, which to question the readability and understanding of informed consent in research involving humans. Included in the sample selected eleven of this review, national and international articles, four of which were in Portuguese (36.36%), one in Spanish (9.09%) and six in English (54.54%). The second was used content analysis to the verification of changes in guidelines for research involving humans in Brazil, referring to the principle of respect for autonomy of the research participant. From the themes "consent and approval", "document / consent" and "consent process", which allow the inference of the changes brought by the new rules on ethics in research involving human beings. The study results suggest that the informed consent should contain simple vocabulary, clarity of language, considering the socioeconomic, educational and cultural participant. Similarly suppose that the four necessary conditions for an autonomous decision are: intentionality, proper knowledge, the absence of external and internal control and authenticity. Concluded that the IC well understood is the key to autonomous decision making and, that authenticity gives the informed consent the essential nature of validity. It was found that the amount of related to informed consent in research involving humans, studies are still very low in the scientific community. Making is therefore a need for greater mobilization of the scientific and academic community for this matter of major interest to society.