O consentimento livre e esclarecido para o sujeito de pesquisa

AUTOR(ES)
DATA DE PUBLICAÇÃO

2004

RESUMO

The Informed Consent (IC) has the objective to protect and to promote the individual autonomy, offering knowledge and orientation to the research subject. Therefore, it is much more than sim pIe document signature; it must be a process that involves information exchange, understanding, relationship and confidence between research subject and researcher. Although it has been observed, in the last decades, a significant increase in the use of the Consent Form (CF) in research involving human beings, there is the necessity of inquiry and improvement in the use of this instrument. This present qualitative research project aimed to know the subject of research and the IC process in our institution. In addition we would like to know which is the subject perception of the IC, and also to identify and understand the difficulties and the possible obstac1es in its application. The main instrument of data collection was a questionnaire elaborated by us, in order to get demographic information of the research subject, as well as investigating the opinion and perception of the interviewed about the research and the IC process. Additional instruments which generated data for comparison were the ROSS Test, the List of Words and Readability score. Four CF were evaluated, and their respective subjects were interviewed in a total of 160 subjects. They had a median of eight years of education, and salary of 2,5 minimum wages. The on1y demographic characteristic with some influence on comprehension of the CF was the study grade. Other variables like recognition of research inclusion, understanding its objectives; comprehension of the CF, and satisfaction with the information have been observed and described. More than half of the participants who had read the CF considered it a extensive and difficult documents. Therefore these were the most frequently referral barriers in understanding of CF, and the most frequently suggested aspects for improvement. Readability score corroborate these findings, since all the evaluated CF were considered as having difficult reading or very difficult reading. The emotional stress was observed as limitation of the understanding of the reading information. The relevance of the additional orientation given by researcher and his group was mentioned as a facilitator for understanding the IC, and also for the establishment of a positive relationship between researcher and research subject. In the four considered groups of research, barriers in the process of free and informed assent were observed, such as the use of an inadequate CF, the absence of information and of a professional to give orientation. The process of emotional stress during the CI process was an important and limiting factor and must be considered and worked out property. Therefore, we conc1ude that modifications are necessity, not on1y in the structure and the vocabulary used in the CF, but also in the nature of the interaction between the researcher and the research subject in our institution in order to establish an adequate CI process

ASSUNTO(S)

sujeito (filosofia) stress consentimento (direito)

ACESSO AO ARTIGO

Documentos Relacionados