%0 Journal Article
%T Ethical Conduct in Research Involving Human Beings In Brazil: Diagnosis of Research Ethics Committee
%A Novaes
%A Maria Rita Garbi
%A Guilhem
%A Dirce
%A Lolas
%A Fernando
%J Arquivos de Medicina
%D 2009
%I Scientific Electronic Library Online
%X 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.
%K clinical research
%K ethics conduct in research in brazil
%K evaluation.
%U http://www.scielo.gpeari.mctes.pt/scielo.php?script=sci_abstract&pid=S0871-34132009000400002&lng=en&nrm=iso&tlng=en