生物医学研究伦理审查质量影响因素探讨

Factors Affecting the Quality of Ethical Review of Biomedical Research

伦理审查委员会对研究方案的审查是实现科技伦理治理体制健全的重要环节和关键要素。中国生物医学研究伦理审查质量存在问题,究其原因,可归结为以下核心因素:对伦理审查的道德判断性质缺乏认识、对伦理审查的独立性缺乏理解、伦理审查的重点被转移、伦理审查的能力缺乏、对可能的利益冲突审查不严格,以及对“伦理倾销”缺乏警惕。对影响因素的讨论,可为改善生物医学研究伦理审查质量提供依据,助推科技伦理治理体制的完善。

Ethical review of biomedical research is an important procedure and key point in the construction of ethics governance of science and technology.However,there are problems in the quality of ethical review of biomedical research in China.The core factors which affect the quality of ethical review,include the ignorance of the nature of ethical review being made the moral judgment on the protocol,lack of understanding of the independence of ethical review,the focus of the ethical review being shifted,lack of the capacity of ethical review,the possible conflicts of interest not strictly reviewed,and lack of vigilance at the“ethical dumping”.The study of the factors can provide preliminary analysis regarding how to improve the quality of ethical review of biomedical research and promote the mechanism of ethics governance.