In the clinical trials, the rights and interests of participants must be considered. Ethical principles including the Declaration of Helsinki for clinical research have been established, and the institutional review board (IRB) and informed consent are important for protecting the rights and interests of participants. Whether a clinical trial is in accordence with the ethics depends on if the available clinical evidence is valuable and credible. The better candomize controlled trial (RCT) is one of the best evidence which will make different results equal between the treatment group and the controlled group. Thus benefits and risks of participants are allocated equitably and useless treatment is prohibited when the effective treatment affirmed at the same time. Economic health evaluation and outcome measurements are emphasized in EBM, and the clinical evidence is updated regularly. It is EBM and its emphasis of evidence that need the high-quality clinical trials, therefore the problems of ethics involved in clinical trials is important.
Citation：
LI Tingqian,WANG Gang,WANG Lei. Evidence-based Medicine Guides the Performance of Ethics in Clinical Trials. Chinese Journal of Evidence-Based Medicine, 2005, 05(4): 266-270. doi:
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- 1. 医学伦理学教研室. 主编.生物医学研究伦理文献选编(CMB资助科研伦理项目)[Z]. 北京: 北京大学医学部;2004. 28～29, 30～34, 43～60.
- 2. 陈元方译. 涉及人的生物医学研究国际伦理准则(日内瓦)[Z]. 2002. 15 ～20.
- 3. 陈元方, 邱仁宗.主编. 生物医学研究伦理学[M]. 第1版. 北京: 中国协和医科大学出版社;2003. 12～18, 27～31, 83～102, 109～120, 117～118,141～146, 401～406.
- 4. 李廷谦, 王蕾, 王刚. 药品临床试验中的伦理学现状和思考[J]. 中国循证医学杂志, 2002; 2(3): 149～151.
- 5. Department of medical ethics. Editor-in-Chief. Ethics literatures of biomedical research (Supported by CMB)[Z]. Beijing: Medical Centre, Peking University;2004. 28-29, 30-34, 43-60.
- 6. Chen YF . International ethical guidelines for biomedical research involving human subjects (Genevese)[Z]. Translation edition. 2002. 15-20.
- 7. Chen YF, Qiu RZ. Biomedical research ethics[M]. 1st edition. Beijing: Chinese Academy of Medical Sciences & Peking Union Medical College Press; 2003. 12-18, 27-31, 83-102, 109-120, 117-118,141-146, 401-406.
- 8. State Food and Drug Administration. Quality guidelines of clinical trials for drugs[Z]. 2003.国家食品药品监督管理局. 药物临床试验质量管理规范[Z]. 2003.
- 9. Li TQ, Wang L, Wang G. Development and problems of medical ethics in clinical drug trials[J]. Chinese Journal of Evidence-based Medicine, 2002; 2(3): 149-151.
