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Ethical Conduct in Research Involving Human Beings In Brazil: Diagnosis of Research Ethics Committee

Keywords: clinical research, ethics conduct in research in brazil, evaluation.

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Abstract:

objective: diagnose ethical conduct in research involving human beings in brazil and the last 10 years of activity by the human research ethics committee of the health department - federal district - cep/ses/df. methods: this work was based on a documentary research, descriptive and retrospective. it examined the database containing records of cases brought before the cep/ses/df, corresponding the period of june 1997 to december 2007. results were generated in excel program, version 2007. results: cep/ses/df has presented increasing number of research projects submitted to appreciation (n = 1129), composing: 90.4% approved 1.7% disapproved, 7.4% removed/?led and 0.5% excluded. of these projects, 83% belonged to group iii, 18% multi-centered projects and 10% protocols with foreign participation. time for approval has decreased over the years (30 to 60 days). frequent pendencies: end of free and informed consent (30%), cover sheet (25%), methodology (20%), curriculum vitae (12%), budget (9%), and others (4%). conclusion: the assessment of the cep/ses/df activities, during a ten-year period has shown its commitment to the legitimacy of research ethics review and scienti?c production ses/df. there were some weaknesses such as dif?culty in monitoring the accompaniment of the research; interruption of works due to adverse drug reaction; gaps or errors in the protocol submitted by the researcher. these situations are the achieving targets for the elaboration of speci?c criteria.

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