知情同意原则下医疗过失损害赔偿责任的几个问题--从一起患者知情同意纠纷案说起

知情同意原则所保护的客体是自我决定权.知情同意原则下的损害赔偿责任不同于医疗事故损害赔偿责任.二者不能互相否认.医方违反知情同意原则的责任是一种侵权损害赔偿责任.该责任的构成要件可包括(1)医师存在法定的告知义务;(2)医师未能将对患者的决定产生实质性影响的风险/信息告知患者;(3)在告知不充分的情况下,患者由于选择了当前的治疗方案而受到伤害;(4)医师的义务违反与患者的伤害之间存在因果关系.其中,告知义务是否充分的判断应以处于同样情境的一个理性患者所需作为主要的标准;对信息"实质性"的判定应看一个与患者处于同一位置的合理审慎之人在决定是否对所建议的治疗做出同意时会对某一事实赋加重要性或将该事实作为一"决定性"影响因素加以考虑;在因果关系存无的认定上,则要考虑若患者被充分告知实情他是否会做出不同的选择决定.

On some issues concerning the doctrine of informed consent and medical negligence liability: a case report

What the doctrine of informed consent protects is the right of self-determination. The liability under this doctrine is different from other medical malpractice laws. The absence of this one cannot deny the existence of the other. The liability under the doctrine of informed consent, which is a kind of medical negligence liability, may be constituted by: (1) physicians have a statutory duty to inform; (2) physicians fail to inform patients the risks/information which would exert material influence on patients' decisions; (3) without sufficient information, patients made harmful medical choices; (4) there exists a causal link between a physician's breach of duty and a patient's harm. What a reasonable patient needs under the same circumstances is the main criterion of information sufficiency. If a reasonably prudent person under the same position will attach importance to a fact or deem it as decisive in deciding whether he accepts a proposed medical plan, this fact is material information. In judging causal relation, we should consider whether the patient would make a different choice if he were fully informed.