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首页> 外文期刊>AJOB Primary Research >The Brazilian Ethics Research Review System: An Evaluation from the Perspectives of Institutional Review Boards
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The Brazilian Ethics Research Review System: An Evaluation from the Perspectives of Institutional Review Boards

机译：巴西伦理研究审查系统：制度审查委员会的评估

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摘要

Background: In Brazil, all studies involving human beings must be evaluated by an institutional review board (IRB) registered with the National Commission for Ethics in Research (CONEP), the entity responsible for coordinating all IRBs in the country. Methods: In 2007, a broad quantitative evaluation of Brazilian IRBs was carried out, followed by a qualitative component conducted using a semistructured interview technique during the last three months of 2008. Twenty IRBs situated in five geographical regions of the country and located within different social and institutional contexts were selected. Eighty interviews were conducted. Results: In general, the functioning of all the IRBs was similar. Problems were found related to the infrastructure provided for their work and noncompliance with the Resolution 196/96 recommendation that IRB members be given time off from their normal duties for their work with the IRB. The research protocols were usually evaluated by only one or two members. It was mentioned that investigators tended to be resistant to sending their projects for evaluation and to challenging the reports issued. In general, the IRBs did not follow up on the studies that they approved because they lacked the means to be able to do so. Conclusions: Although a large network of IRBs has been created in Brazil, many of these IRBs confront serious difficulties in attempting to comply with the regulations established by the National Health Council (NHC), which may affect the ability of some IRBs to fulfill their role.
机译：背景：在巴西，所有涉及人类的研究都必须由向国家伦理研究委员会（CONEP）注册的机构审查委员会（IRB）进行评估，该委员会负责协调该国的所有IRB。方法：在2007年，对巴西的IRB进行了广泛的定量评估，然后在2008年的最后三个月中使用半结构化访谈技术进行了定性分析。二十个IRB位于该国五个地理区域，并且位于不同的社会并选择了机构环境。进行了80次访谈。结果：总体而言，所有IRB的功能均相似。发现与为他们的工作提供的基础设施有关的问题，以及不符合第196/96号决议的建议，即IRB成员应从其正常职责中休假。研究方案通常仅由一个或两个成员进行评估。提到调查人员倾向于抵制将其项目提交评估和质疑所发布的报告。总体而言，IRB没有对他们批准的研究进行跟进，因为他们缺乏进行研究的能力。结论：尽管在巴西已经建立了一个庞大的内部评级机构网络，但许多内部评级机构在尝试遵守国家卫生委员会（NHC）制定的法规时仍面临严重困难，这可能会影响某些内部评级机构履行其职责的能力。

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