论中国侵权法上的知情同意规则

A Study on the Institute of Informed Consent in Chinese Tort Law

知情同意规则起源于美国法,后来被许多国家所采纳。中国《医疗机构管理条例》、《执业医师法》等法律法规都确立了这一规则,《侵权责任法》在总结既有立法经验和借鉴比较法经验的基础上,予以发展完善。知情同意规则,应当包括两项要素,即医务人员的告知义务(也称说明义务)、患者或其近亲属的同意。医务人员违反知情同意规则承担的责任应当是过错责任,其所保护的权益包括受害人的隐私权(即自主决定权)、生命权和健康权。在符合责任构成要件时,医务人员要对患者承担责任。医疗机构要依据雇主责任制度对患者承担责任。

The institute of informed consent originated in America,and is accepted in some jurisprudences.Before the Chinese Tort Law is promulgated,this institute is accepted in regulations,which also is the result of comparative law.Informed consent includes two elements,namely,physician＇s duty to inform and consent by patient or his family.The physician should take fault liability when he has not fulfilled the duty,which protects the rights of privacy,health or life,of the patient.And the hospital in which the physician works,should also take vicarious liability.