药物临床试验的责任伦理考量  

Ethical considerations for drug clinical trials

作　　者：赵越 姜健 张洪江 ZHAO Yue;JIANG Jian;ZHANG Hongjiang(School of Medical Humanities,Jinzhou Medical University,Jinzhou 121000,China;Department of Student Work of the Party Committee,Jinzhou Medical University,Jinzhou 121000,China;School of Marxism,Jinzhou Medical University,Jinzhou 121000,China)

机构地区：[1]锦州医科大学医学人文学院,辽宁锦州121000 [2]锦州医科大学党委学生工作部,辽宁锦州121000 [3]锦州医科大学马克思主义学院,辽宁锦州121000

出　　处：《中国医学伦理学》2024年第8期890-895,共6页Chinese Medical Ethics

基　　金：2022年辽宁省社会科学规划基金项目“患者知情同意权的行使主体问题及治理机制研究”(L22BFX009)。

摘　　要：在药物临床试验过程中,针对其引发的法律及现实问题提出积极应对措施之际,应该更加关注其责任伦理问题。如受试者个人责任意识迷失,监管主体监管不足,责任主体契约责任履行瑕疵、研究者职业责任与个人私欲相冲突等问题。针对上述问题,基于责任伦理原则,提出培养受试者个人责任伦理意识、加强责任监管机制建设、完善知情同意补偿条款、提升研究主体职业责任感等具体对策,从而完善药物临床试验受试者权益保障,保护受试者的生命健康权益。In the process of drug clinical trials,while proposing positive countermeasures to the legal and practical issues they raise,more attention should be paid to the ethical aspects of their responsibility,such as loss of the subjects’sense of personal responsibility,insufficient supervision by regulatory bodies,responsible parties of researcher ignoring the spirit of the contract,and conflicts between professional requirements and individual requirements.In response to the above issues,based on the principle of responsible ethics,specific countermeasures were proposed,such as cultivating personal awareness of responsibility ethics,strengthening the standards of industry ethical review,improving informed consent compensation clauses,and cultivating research subjects’awareness of responsibility ethics,thus to enhance the protection of the rights and interests of drug clinical trials’subjects,as well as to protect the subjects’rights and interests of life and health.

关 键 词：药物临床试验 受试者 责任伦理 知情同意 

分 类 号：R-052[医药卫生]