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随着市场经济的不断深入 ,特别是《医疗事故处理条例》和最高人民法院关于医疗纠纷“举证责任倒置”的司法解释公布后 ,患者自我保护意识的增强与医务人员畏难情绪的滋生形成了很大的反差 ,临床研究工作面临着前所未有的严峻考验。本文以树立崇高的科研道德为主线 ,系统阐述了临床科研特别是人体试验应该坚持的道德和行为准则 ,并呼吁尽快建立与国际惯例和时代发展需求相适应的补偿机制。目的在于澄清现实工作中存在的模糊认识 ,与时俱进地规范科研管理 ,最大限度地避免医疗纠纷 ,确保临床科研工作的可持续发展。
With the continuous deepening of the market economy, especially after the “Medical Accident Handling Ordinance” and the Supreme People’s Court’s judicial interpretation of the medical dispute “the inversion of the burden of proof” was published, the patient’s self-protection awareness and the development of the fear of the medical staff have formed very In contrast, the clinical research work is facing an unprecedented severe test. This paper aims to establish a lofty research ethics as the main line, systematically expounding the moral and behavioral standards that clinical research, especially human trials, should adhere to, and calls for the establishment of a compensation mechanism that is compatible with international practices and the needs of the times. The purpose is to clarify the ambiguous knowledge in real work, standardize scientific research management with the times, avoid medical disputes to the maximum extent, and ensure the sustainable development of clinical research work.