肾脏病与透析肾移植杂志 ›› 2023, Vol. 32 ›› Issue (1): 45-48.DOI: 10.3969/j.issn.1006-298X.2023.01.010
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摘要： 任何涉及人的生物医学研究的开展,必须通过伦理审查。随着各项管理办法和标志性法律文件的出台,伦理审查的范围逐步明确。本文将围绕伦理审查遵循的原则、审批标准、审查材料准备及法律责任等进行阐述,为研究者开展临床和基础研究提供帮助。
关键词: 人, 生物医学研究, 伦理审查, 伦理原则
Abstract: The conduct of all the biomedical research involving human subjects must pass ethical review. With the introduction of various administrative approach and legal documents, the scope of ethical review is gradually becoming clear. This article focuses on principles of ethical review,standard of approval,review material preparation and legal liability,etc, offering help for researchers to carry out clinical and basic research in accordance with the ethical requirements.
Key words: human, biomedical research, ethical review, ethical principle
朱玲, 唐蓉, 郑春霞. 生物医学研究伦理审查要点解读[J]. 肾脏病与透析肾移植杂志, 2023, 32(1): 45-48.
ZHU Ling, TANG Rong, ZHENG Chunxia. Ethical review of biomedical research involving human subjects[J]. Chinese Journal of Nephrology, Dialysis & Transplantation, 2023, 32(1): 45-48.
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http://www.njcndt.com/CN/Y2023/V32/I1/45
