药物临床试验中研究者的责任伦理探究  

Exploring the Responsibility Ethics of Researchers in Drug Clinical Trials

作　　者：师明阳 卢岩[3] SHI Mingyang;LU Yan(The Department of Discipline Inspection,The Second Hospital of Dalian Medical University,Dalian 116023,China;School of Medical Humanities,China Medical University,Shenyang 110122,China;The Department of Human Resources,Shengjing Hospital of China Medical University,Shenyang 110136,China)

机构地区：[1]大连医科大学附属第二医院纪检工作部,辽宁大连116023 [2]中国医科大学医学人文学院,辽宁沈阳110122 [3]中国医科大学附属盛京医院人力资源部,辽宁沈阳110136

出　　处：《医学与哲学》2024年第19期22-26,共5页Medicine and Philosophy

摘　　要：作为药物临床试验的关键主体,研究者是保证试验质量和受试者安全的直接责任人。对于研究者的责任缺失,“法律治理”固然重要,更要关注“医者仁心”的“伦理治理”。传统的伦理治理已经不能完全消除伦理问题,应向现代的责任伦理治理转变。提出制度伦理研究、德性伦理培养、责任机构监管、医院伦理建设等治理对策。通过伦理治理规范研究者的伦理行为,引导其开展“负责任的研究”,维护受试者权益与安全,为医药卫生事业高质量发展和建设健康中国贡献力量。As key participants in drug clinical trials,researchers bear direct responsibility for ensuring the quality of trials and the safety of participants.While"legal governance"is essential in addressing researchers'neglect of responsibility,more attentions should be paid to the"ethical governance"of"medical benevolence".Traditional ethical governance can no longer completely resolve ethical issues and should shift towards modern responsibility ethics governance.This article proposes governance strategies such as institutional ethics research,moral ethics cultivation,regulatory oversight by responsible bodies,and hospital ethics construction.By regulating the ethical behaviors of researchers through ethical governance,guiding the conduct of"responsible research",safeguarding the rights and safety of participants,the high-quality development of the medical and health industry and the construction of a healthy China will be achieved.

关 键 词：药物临床试验 研究者 责任伦理 伦理治理 

分 类 号：R-05[医药卫生]