患者知情同意权行使主体的司法认定——基于48份民事裁判文书的分析

Judicial Determination of the Subject of Exercise of Patient Informed Consent——An Analysis Based on 48 Civil Judgments

确定患者知情同意权行使主体是构建医疗知情同意权制度的基础。经实证分析,法院确定主体范围时,没有区别亲属、家属、近亲属概念;考察主体同意能力时,以行为能力制度代替意思能力审查,未区分不宜与不能;裁判主体顺位时,基本否定患者在意定代理下保有同意权,不认可近亲属行使决策权有顺位。针对实务中的认识偏差,应使用近亲属概念并扩充至丧偶儿媳、女婿,确立意思能力作为是否具有医疗同意权的判断标准,细化不能告知的考察因素及不宜告知的基本情形,明确他人代为医疗决定的原则是患者最佳利益,从关系亲疏、财产依附程度及决策能力高低角度规定近亲属顺位,废止负责人批准程序。

Determining the subject of exercise of the patient informed consent is the basis for building a medical informed consent system.After an empirical analysis,it was found that the courts did not distinguish the concept of relatives,family members,and close relatives when determining the scope of the subject.It was also found that the courts replaced the review of the mental capacity with the capacity system,and did not distinguish between inappropriateness and incapability when examining the subject's ability to agree.It was also found that the court basically denied that the patients have rights to consent under the intended agent,and did not recognize that the close relatives have the right to exercise decision-making authority when judging the subject order.Aiming at the misunderstanding in judicial practice,we should use the concept of close relatives and expand it to include widowed daughter-in-law,and son-in-law,establish mental capacity as a criterion for judging whether there is medical consent,add provisions that refine investigation factors that cannot be notified and basic situations that should not be notified,make clear that the principle of others making medical decisions is in the best interest of the patient,define the order of close relatives from the perspective of kinship,property dependence and decision-making ability,and abolish the approval procedure for the person in charge.