Using the Emanuel et al. Framework to Assess Ethical Issues Raised by a Biomedical Research Ethics Committee in South Africa
Using the Emanuel et al. Framework to Assess Ethical Issues Raised by a Biomedical Research Ethics Committee in South Africa
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DOI：
10.1177/1556264614553172
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发表时间：
2014-12-01
影响因子：
1.3
通讯作者：
Wassenaar, Douglas R.
中科院分区：
文献类型：
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作者：
Tsoka-Gwegweni, Joyce M.;Wassenaar, Douglas R.
Emanuel，Wendler，and Grady框架被设计为一个通用工具，可在包括发展中国家在内的许多环境中使用。然而，目前尚不清楚非洲卫生研究伦理委员会的工作是否符合这一框架。在这一框架内缺乏对八项原则的规范或经验加权，这表明不同的卫生区域经济共同体在审查协议时可能会比其他人更频繁地提出一些伦理问题。我们使用Emanuel等人的框架对2008年至2012年研究方案审查期间生物医学REC考虑的最常见伦理问题进行评估、编码和排名。我们从2008年至2012年南非生物医学REC的记录中提取数据，根据Emanuel等人的框架设计数据收集表，并在数据处理和分析过程中删除所有标识符。从我们评估的98个协议中，最常见的问题是知情同意，科学有效性，公平的参与者选择和对参与者的持续尊重。这项研究代表了第一个已知的尝试，以分析REC响应/分钟使用伊曼纽尔等人。框架，并表明，该框架可能是有用的描述和分类的核心活动的REC。
The Emanuel, Wendler, and Grady framework was designed as a universal tool for use in many settings including developing countries. However, it is not known whether the work of African health research ethics committees (RECs) is compatible with this framework. The absence of any normative or empirical weighting of the eight principles within this framework suggests that different health RECs may raise some ethical issues more frequently than others when reviewing protocols. We used the Emanuel et al. framework to assess, code, and rank the most frequent ethical issues considered by a biomedical REC during review of research protocols for the years 2008 to 2012. We extracted data from the recorded minutes of a South African biomedical REC for the years 2008 to 2012, designed the data collection sheet according to the Emanuel et al. framework, and removed all identifiers during data processing and analysis. From the 98 protocols that we assessed, the most frequent issues that emerged were the informed consent, scientific validity, fair participant selection, and ongoing respect for participants. This study represents the first known attempt to analyze REC responses/minutes using the Emanuel et al. framework, and suggests that this framework may be useful in describing and categorizing the core activities of an REC.