O consentimento informado e a adequação de seu uso na pesquisa em seres humanos

Abstract

O objetivo deste estudo foi o de verificar a adequação do uso do Consentimento Informado em participantes de projetos de pesquisa na área da saúde, através da avaliação integrada de seus componentes de informação e consentimento. Foram realizados três estudos. Os dois primeiros envolveram aspectos da avaliação da capacidade das pessoas e do repasse de informações, sendo preparatórios ao terceiro. A amostra do terceiro estudo foi constituída por 59 participantes de seis projetos de pesquisa. Os dados foram analisados estatisticamente utilizando testes paramétricas, não-paramétricas e Análise de Correspondência. A avaliação do componente de informação incluiu a análise da dificuldade de leitura dos Termos de Consentimento Informado. Dois destes documentos apresentaram estrutura de texto considerada difícil e os outros quatro, estrutura muito difícil, utilizando-se os Índices de Legibilidade. Todos os 59 indivíduos foram considerados capazes de tomarem decisões para participarem de uma pesquisa. A maioria dos participantes afirmou ter recebido explicações prévias (52,8%), ter compreendido as informações (55,9%), não ter recebido resposta às suas dúvidas (76,3%) e achado inacessível o Termo de Consentimento Informado (74,6%). Os participantes não lembraram, seletivamente, dos riscos do projeto. As conclusões foram: que os Termos de Consentimento Informado tinham textos compatíveis com escolaridade mais elevada que a da maioria dos participantes; que os riscos não foram relembrados pela maioria dos participantes; que 44,1% das pessoas convidadas autorizaram a sua participação nos projetos de pesquisa sem terem compreendido o que lhes estava sendo proposto em termos de procedimentos, riscos ou benefícios.

The objective of this dissertation is to examine the adequacy of informed consent instruments used in health research projects involving human subjects, through an integrated analysis of the information and consent components which are part of informed consent. The project was divided into three studies. The first two studies were related to the evaluation of people' s capabilities and of how information was given. These were carried out in preparation for the third study. The sample for this third study was constituted of 59 people who had participated in six different research projects carried out at Hospital de Clínicas de Porto Alegre (HCPA). The data were statistically analyzed using parametric and non-parametric tests, as well as correspondence analysis. The evaluation of the information component included an analysis of the degree of difficulty involved in reading and understanding the six different lnformed Consent Forms analyzed. For that, the Flesch-Kincaid Grade Levei was used. The textual structure of two of these documents was considered difficult, whereas the structure of the remaining four documents was considered very difficult. Ali of the 59 participants were considered capable of deciding whether or not to participate in a research project. The majority of the participants reported that they had received explanations prior to signing the consent form (52.8%), that they had understood the information (55.9%), that they had not received answers to questions raised (76.3% ), and that they were unable to understand the lnformed Consent form (74.6%). The participants did not selectively remember the risks involved in the particular research projects they had participated in. Based on the results, it is possible to conclude that the lnformed Consent Forms had been written for readers with more schooling than most of the participants; that most participants were not able to remember the risks involved in the research projects they had participated in; that 44.1 °/Ó of those invited to participate in a project had consented to do so without understanding what was being proposed in terms of procedures, risks, or benefits.