HEALTH LITERACY AND UNDERSTANDING OF THE INFORMED CONSENT FORM IN CLINICAL RESEARCH

Abstract

Objective: To verify and analyze the Functional Health Literacy (FHL) test in 40 clinical research participants in view of the understanding of the Free and Informed Consent Term (FICT). Method: quantitative, observational, cross-sectional and descriptive research. A questionnaire containing specific questions and sociodemographic characterization was used to assess understanding of the FICT, and for the FHL, the validated instrument Brief Test of Functional Health Literary in Adults was used. Statistical analyzes were performed using the Stata® software, version 15.1. and considered statistically significant associations with p value <0.05. Results: 50% men, 65.5 years old on average, 40% did not know what the informed consent is, 19 people signed it without reading it, 60% did not know the meaning of placebo, 77.5% did not know the study period and 15% did not know that leaving the study had no implications, 55% attended incomplete elementary school. Gender, age and schooling were associated with the mean variation in the total FHL score. Women and more educated people had higher scores and increasing age was associated with a decrease in the average score (R² of the final model of 0.57). Conclusion: 52.5% had inadequate FHL. Additional studies must be carried out to spread a culture of respect for human dignity, with autonomous and informed participation in research.