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作 者:孙荣国 贾晓蓉 SUN Rongguo;JIA Xiaorong(Clinical Research Management Department,West China School of Medicine / West China Hospital,Sichuan University,Chengdu Sichuan 610041,P.R.China;Research Institute for Chengdu Food and Drug Inspection,Chengdu,Sichuan 610045,P.R.China)
机构地区:[1]四川大学华西临床医学院/华西医院临床研究管理部,成都610041 [2]成都市食品药品检验研究院办公室,成都610045
出 处:《华西医学》2018年第11期1441-1443,共3页West China Medical Journal
摘 要:为了全面地落实我国生物医学研究基本原则,更好地维护受试者的合法权益,该文从研究设计入手,紧密地结合生物医学研究伦理审查的实践,认真分析了免费与补偿原则的实施要点,包括干预研究、随机分配、随访和新医疗技术等诸多方面,也为今后全面制定有关生物医学研究伦理原则的实施细则提供有益的参考。In order to fully implement the ethical principles of biomedical researches and to better safeguard the legitimate rights and interests of the subjects, this paper begins from the research design and closely combines with the ethical practice of biomedical research review, seriously analyzes the key implementation points of the ethical free and compensation principles in biomedical research, including intervention study, random allocation, follow-up research and new medical techniques and so on, also will provide the beneficial reference for comprehensive formulation of enforcement regulation of ethics principle of biomedical research in the future.
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