基于风险受益比的国内外临床研究伦理审查现状研究

Current Situations of Ethical Review of Clinical Research based on Risk-Benefit Ratio at Home and Abroad

通过研究整理和分析了国内外临床研究伦理审查法规指南、风险等级分级和风险受益评估模式等文献研究成果,发现国外发达国家在伦理审查风险受益评估和研究风险等级划分方面均有成熟研究,相比之下,国内缺乏最小研究风险的研究,缺乏系统性的伦理审查风险受益评估研究成果。因此,建议在借鉴国际经验基础上,明确临床研究最小风险概念,划分临床研究风险等级,并尝试以呼吸系统疾病为对象,开展基于风险受益比的临床伦理审查新模式研究。

Through sorting out and analyzing the domestic and foreign literatures on ethical review guidelines,risk grading and risk benefit assessment model of clinical research,this paper found that there are mature studies on risk benefit assessment and research risk grading of ethical review in foreign developed countries.In contrast,there was a lack of research on minimum research risk and systematic ethical review of risk benefit assessment research results in China.Therefore,on the basis of international experience,it is suggested to define the concept of minimum risk in clinical research,divide the risk level of clinical research,and try to carry out the research on the new model of clinical ethical review based on the risk-benefit ratio with respiratory diseases as the object.