临床试验中儿童知情同意的国内外研究比较

Comparison of Domestic and International Studies on Informed Consent in Children in Clinical Trials

目的通过国内外对儿童知情同意的比较,发现双方之间存在的不同与差距,寻找国内实际操作儿童知情同意提出改进建议。方法通过文献回顾法,分析比较中外儿童知情同意的相关文献。结果虽然中外在儿童知情同意研究上有共同点,但在文化角度、讨论内容上存在较大的差异。结论建议把年龄作为儿童独立性判断的一个主要依据,并建立更规范的知情同意流程。

Objective Based on the comparison of informed consent to children at home and abroad,this paper looks for the differences and gaps between the two parties,and puts forward some suggestions for improving the practical operation of informed consent to children in China.Methods This paper used literature review method to analyse and compared the relevant literature on children's informed consent in China and foreign countries.Results Though there were similarities between China and foreign countries in the research on informed consent of children,there were great differences in culture perspective and discussion consents.Conclusion It is suggested to take age as a main basis of children's independence judgment and establish more standardized informed consent process.