Decision Letters from a Kyrgyz Research Ethics Committee (2018-2022): An Empirical Review of Transparency, Rigor, and Communication.

IF 1.1
Tamara Kudaibergenova, Nityanand Jain
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Abstract

Research Ethics Committees (RECs) safeguard participants, yet little is known about how their decisions are communicated to study investigators in low- and middle-income countries (LMICs). We analysed 138 decision letters from a public-health REC in Kyrgyzstan (2018-2022) using descriptive statistics and documentary review. REC panel consisted predominantly of clinical and biomedical experts, with identifying data missing for 51% (n = 506/991) of panelists. Lay member participation was absent despite being mandated in SOPs. The first-review approval rate was 55.1%. Communication in decision letters tended to be prescriptive rather than advisory, with critical ethical deficiencies often not flagged. Furthermore, there was a lack of explicit citation of national or international guidance. Our observations point to opportunities to improve transparency, review quality, and stakeholder engagement through standardized templates, targeted reviewer training, and the inclusion of lay members. Strengthening these practices may enhance consistency, quality, and trust in REC decision-making in comparable post-Soviet LMICs contexts.

从吉尔吉斯研究伦理委员会(2018-2022)的决定书:透明度,严谨性和沟通的实证审查。
研究伦理委员会(rec)保护参与者,然而人们对他们的决定如何传达给低收入和中等收入国家(LMICs)的研究研究者知之甚少。我们使用描述性统计和文献回顾分析了吉尔吉斯斯坦公共卫生REC(2018-2022)的138封决定书。REC小组主要由临床和生物医学专家组成,51% (n = 506/991)的小组成员缺少识别数据。非专业成员没有参与,尽管在标准操作程序中有规定。审批率为55.1%。决定函中的沟通往往是说明性的,而不是咨询性的,关键的道德缺陷往往没有被标记出来。此外,没有明确引用国家或国际指南。我们的观察指出了通过标准化模板、有针对性的审查人员培训和外行成员的参与来提高透明度、审查质量和涉众参与的机会。在苏联解体后的中低收入国家背景下,加强这些实践可以提高REC决策的一致性、质量和信任度。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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