伦理审查批准标准解读与探讨

Interpretation and Discussion on the Approval Criteria of Ethical Review

伦理审查的批准标准是伦理审查主要内容和重点问题的高度凝练。准确理解并恰当运用伦理批准标准是伦理委员会能力建设和质量改进的重中之重。为了更好地理解国内法规对伦理审查批准标准的相关要求,从解读《涉及人的生物医学研究伦理审查办法》提出的七个标准入手,分析探讨各个标准对应的伦理问题,并进一步尝试探讨伦理审查批准标准应用过程中应予以注意的事项,以期为伦理审查实践提供一定的参考。

The approval criteria of ethical review are the summary of main review content and key concerns. Accurately understanding and properly applications of ethical approval criteria is one of the top priorities of the capacity building and quality improvement of ethical committee. To better understand the regulatory requirement of ethical review approval criteria in China, this article tried to interpret the seven criteria set up by the ethical review guidelines of biomedical research involving human subject, related ethical problems were discussed and analyzed according to each criterion, furthermore, precautions were discussed during the application of such approval criteria to provide possible reference for the practice of ethical review.