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干细胞临床研究管理办法2020 -法律知识
释义
法律分析:
干细胞临床研究必须遵循科学、规范、公开、符合伦理、充分保护受试者权益的原则。
法律依据:
《干细胞临床研究管理办法(试行)》
第二条 本办法适用于在医疗机构开展的干细胞临床研究。
干细胞临床研究指应用人自体或异体来源的干细胞经体外操作后输入(或植入)人体,用于疾病预防或治疗的临床研究。体外操作包括干细胞在体外的分离、纯化、培养、扩增、诱导分化、冻存及复苏等,不包括基因水平的操作。
第三条 干细胞临床研究必须遵循科学、规范、公开、符合伦理、充分保护受试者权益的原则。
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