CAJ | 학술논문

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。
의학윤리학연구적상관문제통상회섭급생물윤리학적4개기본원칙，포괄연구적개치화완정성、존중인、풍험-수익비적형량이급공정선택수시자。해원칙시이평개섭급인적연구중상관윤리학문제위출발점，야괄용우포괄침구화중약재내적전통의학화체대의학연구。WHO대보충화체대의학（CAM）림상연구지남중지출“응고필도인사회、문화화역사문제소치적불동개치체계리소섭급도인류적권리”，이차“대CAM림상연구중섭급적윤리문제응재진일보연구중응여이타선처리”。본문위요상술의학윤리학적4개기본원칙진행전개논술병결합중국전통문화적약간특점，탐토구유서방문화적의학윤리학중관우지정동의、풍험수익등문제적인식여설정，재인입대우중의약림상연구적윤리심사중가능출현적문제진행분석，이기위중의약림상시험적윤리학인식화윤리심사실천제공삼고。
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 .