Arquivos de medicina : revista de ciencia e arte medicas最新文献

筛选

英文中文

Ethical Conduct in Research Involving Human Beings In Brazil: Diagnosis of Research Ethics Committee. 巴西涉及人类的研究中的伦理行为:研究伦理委员会的诊断。

Arquivos de medicina : revista de ciencia e arte medicas Pub Date : 2009-01-01

Maria Rita Garbi Novaes, Dirce Guilhem, Fernando Lolas

{"title":"Ethical Conduct in Research Involving Human Beings In Brazil: Diagnosis of Research Ethics Committee.","authors":"Maria Rita Garbi Novaes, Dirce Guilhem, Fernando Lolas","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":88828,"journal":{"name":"Arquivos de medicina : revista de ciencia e arte medicas","volume":"23 4","pages":"145-150"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2963082/pdf/nihms222240.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29382611","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0