研究伦理委员会如何帮助加强利益相关者对南非健康研究的参与?REC文件评估

Abigail Wilkinson, C. Slack, C. Crews, N. Singh, J. Salzwedal, D. Wassenaar
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引用次数: 5

摘要

背景伦理法律框架明确鼓励南非的所有卫生研究人员让利益相关者有意义地参与他们的研究。研究伦理委员会(REC)在塑造研究人员在这方面的实践方面可以发挥作用,但很少有研究探讨REC如何最好地实现这一点。目标。探讨SA REC文件是否促使研究人员计划让利益相关者参与健康研究。方法。我们审查了在SA国家健康研究伦理委员会注册的REC的公开文件。截至2019年11月,在46家注册的REC中,有37家的文件可以公开获取。其中包括72份文件(例如标准作业程序和申请表)。我们根据提到的参与的道德原因、利益相关者和强调的参与策略对这些进行了编码。我们使用了语义编码,接近REC文档的实际措辞。我们利用主题分析来确定关键主题。结果。我们发现,许多REC文件鼓励研究人员以与伦理指导产生共鸣的方式计划参与(主题1:“鼓励良好的参与”)。然而,我们发现在这方面浪费了许多机会(主题2:“错失机会”)。对于一些区域经济共同体而言,其关于这一重要问题的关键文件几乎没有协调一致(主题3:“走向协调”)。结论。在短期内,我们建议REC应修改其申请表,特别是更好地“触发”研究人员深思熟虑地规划合理的利益相关者参与。从长远来看,我们建议REC的文件在内部更好地协调其对利益相关者参与的立场。
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How can research ethics committees help to strengthen stakeholder engagement in health research in South Africa? An evaluation of REC documents
Background. All health researchers in South Africa (SA) are explicitly encouraged by the ethicolegal framework to engage stakeholders meaningfully in their research. Research ethics committees (RECs) have a role to play in shaping researchers’ practices in this regard, but very little research has explored how RECs might best achieve this.  Objectives. To explore whether SA REC documents are prompting researchers to plan sound stakeholder engagement in health research.  Methods. We reviewed publicly available documents of RECs registered with the SA National Health Research Ethics Council. Of the 46 registered RECs as of November 2019, the documents of 37 were publicly accessible. These comprised 72 documents (e.g. standard operating procedures and application forms). We coded these according to ethical reasons mentioned for engagement, stakeholders and strategies highlighted for engagement. We used semantic coding, staying close to the actual wording of REC documents. We utilised thematic analysis to identify key themes.  Results. We found that many REC documents encouraged researchers to plan engagement in a way that resonates with ethics guidance (theme 1: ‘encouraging sound engagement’). However, we found many wasted opportunities in this regard (theme 2: ‘missing opportunities’). For some RECs, there was little harmonisation across their key documents regarding this important issue (theme 3: ‘moving towards harmonisation’).  Conclusion. In the short term, we recommend that RECs should amend their application forms in particular to better ‘trigger’ researchers to thoughtfully plan sound stakeholder engagement. In the longer term, we recommend that RECs’ documents be better harmonised internally regarding their stance on stakeholder engagement.
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来源期刊
CiteScore
1.10
自引率
11.10%
发文量
18
审稿时长
14 weeks
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