Effects of educational intervention in the ethical quality of the free and informed consent

Abstract

Educational interventions have been used in order to improve the quality of understanding with regards to The Free and Informed Consent. However, some of these interventions have become ineffective, indicating the need of ensuring the ethical quality of consent. The aim of this study was to analyze the effects of an educational intervention for improving the ethical quality of consent. The study involved 148 participants who signed the Free and Informed Consent Form (FICF) for participation in a clinical trial conducted in the Northeast of Minas Gerais - Brazil. From this total, 105 participated in an educational intervention through a board game, while only 43 signed the informed consent form regarding that clinical trial. In order to assess the effects of an educational intervention, the Questionnaire on Quality Assessment of The Free and Informed Consent (QAQIC) was applied. The participants of the educational intervention showed greater knowledge about the information in the clinical trial, less influenced by the decision to participate in it. The results suggest that an educational intervention favors the quality of the free and informed consent in a clinical research.