The free and clarified consent and research subject’s vulnerability

Abstract

The Resolution CNS 196/96 of the Brazilian Health Ministry establishes conditions for research involving human subjects and it establishes subject’s protection with free and informed term of consent (FITC). The paper investigated subjects’ profile, establishing the relationship between subjects’ knowledge about the research and their social background. To safeguard confidentiality and privacy of researchers, the institutional ethics committee invited researchers to participate in the study, but only released their contact information upon their acceptance to be in the study. The population more frequently investigated includes patients, health workers, health course students and elderly both from groups of patients and from nursing homes. 75% of subjects were from lower income classes (D and E) and despite higher education of 49% of subjects, 60% never read the informed consent. It is necessary to renew the importance of informed consent as to educate volunteers, including information about their health conditions, thus allowing for better communication between subjects and researchers and further consideration of social vulnerability.