评估越南和老挝的研究伦理委员会：经过验证的自我评估工具的结果。
Evaluating research ethics committees in Vietnam and Laos: Results of a validated self-assessment tool.
机构信息
School of Medicine, Duke University, Durham, North Carolina, United States of America.
Department of Biostatistics, Hanoi University of Public Health, Hanoi, Vietnam.
出版信息
PLoS One. 2024 Aug 22;19(8):e0309084. doi: 10.1371/journal.pone.0309084. eCollection 2024.
BACKGROUND
There is an increase in human subject research in developing countries and conducting them in an ethical manner depends on the research ethics oversight in these countries. The purpose of this study is to evaluate the operational, financial, and educational characteristics of research ethics committees (RECs) at institutions in Vietnam and Laos.
METHODS
A validated self-assessment tool designed to assess nine major characteristics of RECs was translated into Vietnamese and Laotian. The translated surveys were delivered to and completed by representatives from RECs at institutions in Vietnam and Laos. The surveys were collected, translated back into English, and scored. The data was analyzed to identify potential areas of strength and areas for improvement.
RESULTS
The mean survey score for the 19 RECs surveyed was 165.3 out of a maximum of 200 points with a standard deviation of 22.9. Committees scored the highest in the review of specific protocol items (95.6%), submission arrangements and materials (89.5%), and the policies referring to review procedures (85.6%) domains. RECs scored the lowest in the resources domain (65.5%), with only 26.3% of committees having an annual budget. Nearly all RECs have standard operating procedures (94.7%) and policies for disclosing conflicts of interest (89.5%). Most committees use prior ethics training as a criterion to select REC chairs (78.9%) and members (73.7%), with the majority of committees requiring a training course in ethics (76.5%). 68.4% of committees have continuing education in ethics for members and only 42.1% of committees have a budget for member training.
CONCLUSION
This study demonstrated that RECs in Vietnam and Laos have strong foundational review processes for research protocols. Important areas of improvement include improved institutional oversight, financial and administrative resources, and the continued ethics education for current committee members.
背景
发展中国家的人类受试者研究有所增加，能否以合乎伦理的方式进行这些研究取决于这些国家的研究伦理监督。本研究旨在评估越南和老挝机构的研究伦理委员会（REC）的运作、财务和教育特点。
方法
翻译和改编了一个评估 REC 九个主要特点的自我评估工具，该工具被翻译成越南语和老挝语。翻译后的调查问卷分发给越南和老挝机构的 REC 代表填写，完成后回收。调查问卷被收回并翻译成英文，然后进行评分。分析数据以确定潜在的优势领域和需要改进的领域。
结果
在接受调查的 19 个 REC 中，平均得分为 200 分中的 165.3 分，标准差为 22.9。委员会在审查具体方案项目（95.6%）、提交安排和材料（89.5%）以及审查程序政策（85.6%）方面得分最高。委员会在资源领域（65.5%）得分最低，只有 26.3%的委员会有年度预算。几乎所有的 REC 都有标准操作程序（94.7%）和披露利益冲突的政策（89.5%）。大多数委员会使用事先的伦理培训作为选择 REC 主席（78.9%）和成员（73.7%）的标准，大多数委员会要求进行伦理学培训课程（76.5%）。68.4%的委员会对成员进行伦理学继续教育，只有 42.1%的委员会有成员培训预算。
结论
本研究表明，越南和老挝的 REC 对研究方案有很强的基础性审查流程。需要改进的重要领域包括加强机构监督、财务和行政资源以及对现任委员会成员的持续伦理教育。
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