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.