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/filed 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 scientific production SES/DF. There were some weaknesses such as difficulty 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 specific criteria.
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/filed 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 scientific production SES/DF. There were some weaknesses such as difficulty 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 specific criteria.
Authors: Ellen Hardy; Silvana Ferreira Bento; Maria José Duarte Osis; Eliana Maria Hebling Journal: Rev Assoc Med Bras (1992) Date: 2005-01-14 Impact factor: 1.209