| 中药上市后再评价研究设计的伦理学问题 |
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| 引用本文： | 汪秀琴,谢雁鸣.中药上市后再评价研究设计的伦理学问题[J].中国中药杂志,2011,36(20):2901-2903. |
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| 作者姓名： | 汪秀琴 谢雁鸣 |
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| 作者单位： | 1. 南京中医药大学附属医院GCP中心,江苏南京,210029
2. 中国中医科学院中医临床基础医学研究所,北京,100700 |
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| 基金项目： | 国家"重大新药创制"科技重大专项(2009ZX09502-030);中国中医科学院自主选题研究项目(Z0133) |
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| 摘 要： | 任何一项涉及人的研究都必须从科学性和伦理合理性2个方面来进行伦理考量,为此,伦理审查有一些共同的考量要素.但是,不同的研究设计会产生不同的伦理学问题,该文对中医药临床研究常见的几种研究设计方法(观察性研究、病历记录研究、调查问卷和访谈研究、流行病学研究、病例对照研究)中的主要伦理学问题进行阐述,以便对不同的研究设计进行有针对性的伦理学考虑,将受试者保护真正落到实处.
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| 关 键 词： | 研究设计 临床研究 伦理审查 伦理委员会 |
| 收稿时间： | 8/6/2011 12:00:00 AM |
Ethical consideration in several commonly used study design |
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| WANG Xiuqin and XIE Yanming.Ethical consideration in several commonly used study design[J].China Journal of Chinese Materia Medica,2011,36(20):2901-2903. |
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| Authors: | WANG Xiuqin and XIE Yanming |
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| Affiliation: | Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China |
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| Abstract: | Any study involving human subjects must undergo ethical review which covers scientific soundness and ethical resonance, for which, there are common elements to be considered when doing ethical review of research protocols involving human subjects.However, different study design accrue to different ethical considerations.This paper explores the main ethical considerations when reviewing study designs such as observational study, case record review; surveys, questionnaires and interviews. Ethical consideration well-targeted to study design will contribute to the human subjects protection. |
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| Keywords: | study design clinical research ethical review institutional review board |
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