规范医疗知情同意书的探讨

《侵权责任法》为医疗机构实施医疗知情同意提供了法律依据，但缺少如何落实知情同意的具体操作方法和要求。文章分析了在知情同意管理中的问题，如特殊情况下医疗知情同意主体不明确、个别医务人员向患者或家属交待病情不仔细，只是完成将知情同意书交给患者签字的手续，没有认真履行知情告知义务以及知情同意书的内容及项目有遗漏等问题。探讨规范医疗知情同意书和知情同意管理的具体做法，如制定《医疗知情同意管理办法》，制作统一的医疗知情同意书项目和模板，规范医疗知情同意的履行手续，明确特殊情况下医疗知情同意的主体，划分医疗知情同意的形式，开展培训与考核，确保医疗知情同意落实到实处。

A Discussion on Standardizing Medical Informed Agreement

Laws of Tort and Responsibility provides legal basis for medical institutes implementing medical informed agreement while lack of concrete operation methods and requirements.This paper analyzes problems in informed agreement management,for example,unclear subject of medical informed agreement under special situation,without carefully telling patients and their families about disease situation from some medical staffs.They just let patients to sign informed agreement without carefully implementing informed obligation and the lack of some items in the contents of informed agreement.It discusses concrete practice for medical informed agreement and informed agreement management,such as Management Methods of Medical Informed Agreement,establishment of uniform medical informed agreement items and template,standardization of implement procedure of medical informed agreement,confirm of subject of it under special situation,division of its mode,development of training and evaluation for making sure medical informed agreement has been implemented.