DEVELOPMENT OF AN ACCESSIBLE SELF-ASSESSMENT TOOL FOR RESEARCH ETHICS COMMITTEES IN DEVELOPING COUNTRIES
DEVELOPMENT OF AN ACCESSIBLE SELF-ASSESSMENT TOOL FOR RESEARCH ETHICS COMMITTEES IN DEVELOPING COUNTRIES
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DOI：
10.1525/jer.2010.5.3.85
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发表时间：
2010-09-01
影响因子：
1.3
通讯作者：
Silverman, Henry
中科院分区：
文献类型：
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作者：
Sleem, Hany;Abdelhai, Rehab Abdelhai Ahmed;Silverman, Henry
为了应对发展中国家研究的增加，许多研究伦理委员会（REC）已经成立，但其伦理审查系统的质量仍然未知。评价区域经济委员会的业绩仍然是一项具有挑战性的任务。在没有认证程序的情况下，自我评估机制将为区域经济共同体提供一种根据公认的国际标准审查其政策和程序的途径。我们描述了一个自我评估工具，是由REC成员和研究人员从中东开发和审查。这一工具反映了人类受试者保护的务实方面，以国际标准为基础，完成起来简单明了，其项目与发展中国家许多区域经济共同体的行政程序有关。
IN RESPONSE TO INCREASED RESEARCH being performed in developing countries, many research ethics committees (RECs) have been established, but the quality of their ethics review systems remains unknown. Evaluating the performance of an REC remains a challenging task. Absent an accreditation process, a self-assessment mechanism would provide RECs a way to review their policies and processes against recognized international standards. We describe a self-assessment tool that was developed and reviewed by REC members and researchers from the Middle East. This tool reflects pragmatic aspects of human subjects protection, is based on international standards, is straightforward in its completion, and its items are relevant to the administrative processes that exist in many RECs in the developing world.