Bioethical perspective of justice in clinical trials

Authors

  • Cecilia Ferreira Silva Instituto Nacional de Câncer - Ministério da Saúde http://orcid.org/0000-0003-4691-4505
  • Miriam Ventura Universidade Federal do Rio de Janeiro (UFRJ).
  • Claudia Garcia Serpa Osorio de Castro Escola Nacional de Saúde Pública Sérgio Arouca (Ensp).

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.

Keywords:

Biomedical research, pharmaceutical preparations, social justice, ethics, research.

Author Biography

Cecilia Ferreira Silva, Instituto Nacional de Câncer - Ministério da Saúde

- Doutorando em Saúde Pública da ENSP/Fiocruz

- Mestre em Bioética, Ética aplicada e Saúde Coletiva pela ENSP/Fiocruz.

- Monitora de pesquisa clinica da Coordenação de Pesquisa Clínica e Incorporação Tecnológica do Instituto Nacional de Câncer.

- Especialista em Pesquisa Clínica pelo Instituto Nacional de Câncer;

- Graduada em Enfermagem pela Universade Federal de Goiás;

Vol. 24 No. 2 (2016): Rev. bioét. (Impr.). 2016; 24 (2)

Published:

2016-07-20

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How to Cite

1.
Silva CF, Ventura M, Castro CGSO de. Bioethical perspective of justice in clinical trials. Rev. bioét.(Impr.). [Internet]. 2016 Jul. 20 [cited 2024 May 17];24(2). Available from: http://revistabioetica.cfm.org.br/revista_bioetica/article/view/1119