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Improving the Level and Quality of ethics review in Chinese Medicine and Integrative Medicine

Chinese Journal of Integrative Medicine 2018年第4期24卷 315-319页

作者： ZHANG Cheng-bin LI En-chang Health and Bioethics Research Center Wenzhou Medical University

Three features of ethics review in Chinese medicine（CM） and integrative medicine（IM） were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.

关键词： Chinese medicine integrative medicine ethics review medical research

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Principles of ethics review on Traditional Medicine and the Practice of Institute review Board in China

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Chinese Journal of Integrative Medicine 2011年第8期17卷 631-634页

作者：王小云梁兆晖黄慧玲梁伟雄 Guangdong Provincial Hospital of Chinese Medicine

As one of the significant parts of medical science research in China,the research on Chinese medicine（CM） reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies the values of Chinese ***,in the practice of ethics review on CM research protocols,besides abiding by the contemporary prevalent international principles and guidelines on bioethics, which emphasizes the scientific and bioethical value of the study,we should also stress the CM theoretical background and relevant clinical experience in the framework of Chinese culture and *** this paper, we went over the traits of CM clinical research and the experience from the practice of ethics review by the institution review board for bioethics,and then attempted to summarize the key points for the bioethics review to CM researches in China,so as to serve as reference for the bioethics review to traditional and alternative medicine researches.

关键词： ethics review traditional medicine research institute review board

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非人灵长类动物研究能否得到伦理学辩护?

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伦理学 2024年第8期

作者：邱仁宗

伦理学研究者的基本工作之一是伦理学辩护。伦理学辩护是通过运用逻辑推理用证据或理由证明已经采取的或建议采取的行动或决策是正确的或合乎伦理的，并可在此基础上，提出政策或法规法律方面的建议。因非人灵长类动物与人类相似，再加... 详细信息

伦理学研究者的基本工作之一是伦理学辩护。伦理学辩护是通过运用逻辑推理用证据或理由证明已经采取的或建议采取的行动或决策是正确的或合乎伦理的，并可在此基础上，提出政策或法规法律方面的建议。因非人灵长类动物与人类相似，再加上“高保真”观念的影响，所以估计每年有超过10万的非人灵长类动物被用于生物医学研究。但是，越来越多的人认为这种研究不符合伦理，因为非人灵长类动物跟人一样能够敏感地感受到痛苦，而不能从研究中受益。此外，一些研究表明，人与非人灵长类动物在各种组织和基因类别方面的差异性明显超过相似性，这让一些科学家坚持的“高保真”观念遭到质疑。从伦理学角度，之所以反对非人灵长类动物实验，一是风险-受益比、成本-效益比并不理想，非人灵长类动物受到了非常明显、严重且不可逆的伤害；二是非人灵长类动物的感受能力接近于人，拥有接近于人所具有的完全的道德地位和边缘性人格地位，将其囚禁于实验室，并用于自身不能受益的研究，不符合伦理规范。综合来看，人类应该逐渐用符合伦理、对科学实际有益、更实用、可重复以及风险-受益比和成本-效益比理想的模型取代非人灵长类动物研究。在逐渐取代过程中，若必须使用非人灵长类动物，则需进行伦理审查和风险-受益比的评估，并坚持3R原则。

关键词：非人灵长类动物伦理审查 “高保真”观念风险-受益比 non-human primate ethics review "high-fidelity" concept risk-benefit ratio

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Purpose, Composition and Function of the Research Ethical Committee in the Sarah Rehabilitation’s Hospital

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International Journal of Clinical Medicine 2016年第2期7卷 127-132页

作者： Kátia Torres Batista Eliane Maria Fleury Seidl Sarah Hospital and University of Brasilia Brasilia Brazil University of Brasilia Brasilia Brazil

Introduction: The Research Ethical Committee (REC) is responsible for the ethical evaluation of the projects presented by the scientific community to inform and train the members and researchers. Objective: To describe the purpose, composition and function of the REC of the Association of Social Pioneers (APS) located in the Sarah Rehabilitation’s Hospital (Brasilia, Brazil). Methodology: Descriptive analysis of the REC/APS based on 2013’s collected data was done. Results: The REC/APS is an independent collegiate body, which was established in 1998 in accordance with Brazilian regulation. The main objective is promoting the application of ethical principles and human rights in research involving humans. The REC was composed by chairperson and a substitute;secretary, fourteen regular members and five substitutes. We analyzed 164 projects submitted. The minimum time to a committee member who came up with the first opinion has been estimated as 14 days and the insurance of the consolidation occurred in 30 days. We approved 64 projects, of which 25 had pendencies in the first analysis, one project failed and 99 were excluded. The main problems were related to the writing of informed consent and the multicenter projects that did not include aspects such as costs, schedule and methodological limitations. We observed that the researcher could provide assistance. We considered the important role of the REC/APS to ensure trust between researchers and participants in the research. Conclusion: Despite the purpose, composition and function of the APS research ethical committee, there were encountered many obstacles in its formation, considering monitoring the progress of the research, national normative, international researches and others. The ethical committee does a vital public service with the variety of the specialized views on the meeting. We need to strike a balance and we must weigh up risks and benefits related to knowledge, in its essence, to research’s participant a

关键词： ethics review Research Ethical Committee Bioethics and Research

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