从民法角度探讨药物临床试验质量管理规范中伦理委员会的职责  

Discussion on the duty of Good Clinical Practice ethics committee from the perspective of civil law

作　　者：范贞 FAN Zhen(Beijing Bairui(Dongcheng District)Law Firm,Beijing 100007,China)

机构地区：[1]北京市百瑞(东城区)律师事务所,北京100007

出　　处：《中国临床药理学杂志》2023年第20期3009-3012,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：《药物临床试验质量管理规范》规定伦理委员会的职责是保护受试者的权益和安全,应当特别关注弱势受试者。合法有效的知情同意是免除申办者和研究者(研究机构)因药物临床试验药物不良反应对受试者造成人身损害产生侵权责任的前提。合法有效的知情同意应该具备民事法律行为的有效要件,包括未成年人和精神疾病受试者的监护人履行知情同意;受试者(监护人)避免产生重大误解,避免可能外在干预致使意思表示不真实,为失明、聋哑等获取知识能力低下者提供辅助器具等,实现知情同意真实意思表示。欺诈、胁迫、重大误解等不符合民事法律行为有效要件的知情同意,受试者可以请求人民法院予以撤销。民法角度,伦理委员会的职责实质是保障受试者充分知情同意,保障申办者、研究者(研究机构)开展临床试验避免因知情同意缺陷而承担侵权责任。申办者向研究者和临床试验机构提供与临床试验相关的保险是保护临床试验机构权益,知情同意撤回不影响撤回前基于个人同意已进行的个人信息处理活动的效力属于保护申办者权益,受试者或其监护人无阅读能力的公正见证人制度更多保护研究者权益。民法角度,伦理委员会的职责确保受试者知情同意合法有效、保护临床试验参与各方的合法权益相对合理全面。Good Clinical Practice(GCP) states that the duty of the ethics committee is to protect the rights and safety of the subjects, and special attention should be paid to vulnerable subjects. Adverse reactions in drug clinical trials usually may cause personal injury to the subjects, and legal and effective informed consent is required to exempt the sponsor and investigators(research institutions) from tort liability. Effective informed consent should have the effective elements of civil juristic act: The actor has the corresponding capacity for civil conduct;the expression of intention is true;it does not violate the mandatory provisions of laws and administrative regulations, and does not violate public order and good customs. Specifically, the guardians of minors and mentally ill patients without civil capacity should perform informed consent, and for the vulnerable groups whose intentions are not true, the subjects or their guardians should be informed in a timely manner in plain language and expression to avoid major misunderstandings caused by information asymmetry, so as to ensure that they are not in the right position.Except for subjects with unique health or diseases,subjects with low ability to acquire knowledge such as blindness and deaf-mute should be excluded as far as possible,and assistive devices should be provided to help subjects acquire relevant information of clinical trials to achieve true expression of informed consent. Subjects with informed consent who do not meet the effective requirements of civil legal acts have the right to request the people's court to revoke them. From the perspective of effective elements of civil legal acts,the duty of ethics committee is essentially to enable sponsors and researchers( research institutions) to carry out clinical trials to avoid tort liability due to the defects of informed consent. The sponsor's provision of legal and economic insurance or guarantee related to clinical trials to researchers and clinical trial institutions is to protect the rights and

关 键 词：伦理委员会 民事法律行为 知情同意 弱势群体 

分 类 号：R95[医药卫生—药学]