医学伦理学研究的相关问题通常会涉及生物伦理学的4个基本原则,包括研究的价值和完整性、尊重人、风险-受益比的衡量以及公正选择受试者。该原则是以评价涉及人的研究中相关伦理学问题为出发点,也适用于包括针灸和中药在内的传统医学和替代医学研究。WHO对补充和替代医学(CAM)临床研究指南中指出“应考虑到因社会、文化和历史问题所致的不同价值体系里所涉及到人类的权利”,而且“对CAM临床研究中涉及的伦理问题应在进一步研究中应予以妥善处理”。本文围绕上述医学伦理学的4个基本原则进行展开论述并结合中国传统文化的若干特点,探讨具有西方文化的医学伦理学中关于知情同意、风险受益等问题的认识与设定,在引入对于中医药临床研究的伦理审查中可能出现的问题进行分析,以期为中医药临床试验的伦理学认识和伦理审查实践提供参考。
Issues related to bioethics research often involve four basic principles , which are the value and integri-ty of the research, respect for human being, risk to benefit ratio, and the justice in subject selection. These prin-ciples contribute to the basis of bioethics for human-involved studies and they are capable of being applied to other relevant fields including complementary and alternative medicine (CAM) researches. The World Health Orga-nization (WHO) guidelines related to CAM studies clarify that "the consideration should be taken for the human rights based on different value systems caused by social, cultural and historical problems," and "the ethical prob-lem involved in CAM clinical studies should be properly handled in the further studies." Based on the four prin-ciples and Chinese traditional culture, the author attempted to discuss controversial bioethical issues such as the understanding and setting of informed consent, risk and benefit in western culture bioethics in order to analyze possible issues in the ethical review of Chinese medicine clinical research. We hoped that these considerations can provide references to the bioethical understanding of Chinese medicine clinical studies and ethical review on Chinese medicine practice .