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Purpose, Composition and Function of the research ethical committee in the Sarah Rehabilitation’s Hospital

International Journal of Clinical Medicine 2016年第2期7卷 127-132页

作者： Kátia Torres Batista Eliane Maria Fleury Seidl Sarah Hospital and University of Brasilia Brasilia Brazil University of Brasilia Brasilia Brazil

Introduction: The research ethical committee (REC) is responsible for the ethical evaluation of the projects presented by the scientific community to inform and train the members and researchers. Objective: To describe the purpose, composition and function of the REC of the Association of Social Pioneers (APS) located in the Sarah Rehabilitation’s Hospital (Brasilia, Brazil). Methodology: Descriptive analysis of the REC/APS based on 2013’s collected data was done. Results: The REC/APS is an independent collegiate body, which was established in 1998 in accordance with Brazilian regulation. The main objective is promoting the application of ethical principles and human rights in research involving humans. The REC was composed by chairperson and a substitute;secretary, fourteen regular members and five substitutes. We analyzed 164 projects submitted. The minimum time to a committee member who came up with the first opinion has been estimated as 14 days and the insurance of the consolidation occurred in 30 days. We approved 64 projects, of which 25 had pendencies in the first analysis, one project failed and 99 were excluded. The main problems were related to the writing of informed consent and the multicenter projects that did not include aspects such as costs, schedule and methodological limitations. We observed that the researcher could provide assistance. We considered the important role of the REC/APS to ensure trust between researchers and participants in the research. Conclusion: Despite the purpose, composition and function of the APS research ethical committee, there were encountered many obstacles in its formation, considering monitoring the progress of the research, national normative, international researches and others. The ethical committee does a vital public service with the variety of the specialized views on the meeting. We need to strike a balance and we must weigh up risks and benefits related to knowledge, in its essence, to research’s participant a

关键词： Ethics Review research ethical committee Bioethics and research

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