Ten years of experience with the research ethics committee of the

Authors

  • Maria Rita C. G. Novaes Coordenadora do Comitê de Ética em Pesquisa
  • Dirce Guilhem Comités de Ética en Investigación em Salud (Flaceis)
  • Fernando Lolas Centro Interdisciplinario de Estudios en Bioética

Abstract

The objective of this article is to relate the experience of the Research thics Committee of the Secretary of Health, Federal District, Brazil (CEP/SES/DF) during 10 years (1997-2007) from its creation.

It deals with a descriptive and documentary evaluation, in the form of case studies, utilizing all projects subject to protocol in CEP/SES/DF (Number 052/08) during that period.

The most frequent conflicts were: terms of free and informed consent (30%), identification page (25%), methodology (20%), curriculum vitae (12%), budget (9%), others (4%).

The activity report of CEP/SES/DF in 10 years revealed, as a result of its productivity, legitimacy in the process of ethical analysis of protocols which confirms the protection of research participants.

Keywords:

ethics in investigation, ethics committees, validation

Author Biographies

Maria Rita C. G. Novaes, Coordenadora do Comitê de Ética em Pesquisa

Coordenadora do Comitê de Ética em Pesquisa, Secretaria de Saúde do Distrito Federal, Brasil

Dirce Guilhem, Comités de Ética en Investigación em Salud (Flaceis)

Presidente do Foro Latinoamericano de Comités de Ética en Investigación em Salud (Flaceis), Brasil

Fernando Lolas, Centro Interdisciplinario de Estudios en Bioética

Diretor do Centro Interdisciplinario de Estudios en Bioética, Universidad de Chile, Chile.