Sleem Hany, Abdelhai Rehab Abdelhai Ahmed, Al-Abdallat Imad, Al-Naif Mohammed, Gabr Hala Mansour, Kehil Et-Taher, Sadiq Bakr Bin, Yousri Reham, Elsayed Dyaeldin, Sulaiman Suad, Silverman Henry
National Hepatology and Tropical Medicine Research Institute, Egypt.
J Empir Res Hum Res Ethics. 2010 Sep;5(3):85-96; quiz 97-8. doi: 10.1525/jer.2010.5.3.85.
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.
随着发展中国家开展的研究日益增多,许多研究伦理委员会(RECs)已经成立,但其伦理审查系统的质量仍不为人知。评估研究伦理委员会的绩效仍然是一项具有挑战性的任务。由于缺乏认证程序,自我评估机制将为研究伦理委员会提供一种对照公认国际标准审查其政策和流程的方式。我们描述了一种由中东地区的研究伦理委员会成员和研究人员开发并审核的自我评估工具。该工具反映了保护人类受试者的务实方面,基于国际标准,填写起来很简单,其项目与发展中世界许多研究伦理委员会现有的行政程序相关。