Bioethical perspective of justice in clinical trials

Cecilia Ferreira da Silva Miriam Ventura Claudia Garcia Serpa Osorio de Castro About the authors

Abstract

Brazil has a welcoming setting for clinical trials, with national regulations and a well-developed and institutionalized monitoring system. Resolution 466/2012 of the Conselho Nacional de Saúde (Brazilian National Health Council) adopted the principle of justice as a fundamental requirement for ethics in research. The aim of the present study was to investigate the bioethical meanings attributed to this principle in clinical trials with drugs in the country. The study was conducted through a thorough literature review, which was performed in two phases: understanding trial regulations and systematically researching the issue. Discussions regarding the principle of justice vary greatly when addressing the different stages of trials. The authors’ perceptions were organized into three categories, which are interchangeable to a certain degree. Empirical studies and discussions must be conducted in relation to the application of this principle during the ethical analysis of clinical trials, while also addressing the adequacy and effectiveness of this principle in reducing social injustices in the health sector.

Biomedical research; pharmaceutical preparations; social justice; ethics; research

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