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Ethical Guiding Principles for the Research of Human Embryonic Stem Cell [Effective]
人胚胎干细胞研究伦理指导原则 [现行有效]
【法宝引证码】

 
Ethical Guiding Principles for the Research of Human Embryonic Stem Cell
(January 14, 2004 Ministry of Science and Technology and the Ministry of Public Health)
 

人胚胎干细胞研究伦理指导原则


 
Article 1 The present Guiding Principles are formulated for the purpose of keeping the research of human embryonic stem cell in the biomedical field of our country in line with the ethical criterion of life, ensuring the respect to and observance of internationally recognized ethical standards of life and the relevant provisions of our country, as well as promoting the healthy development of the research on human embryonic stem cell.   第一条 为了使我国生物医学领域人胚胎干细胞研究符合生命伦理规范,保证国际公认的生命伦理准则和我国的相关规定得到尊重和遵守,促进人胚胎干细胞研究的健康发展,制定本指导原则。

 
Article 2 The human embryonic stem cell as mentioned in the present Guiding Principles shall include the stem cell originated from human embryo, the stem cell originated from germ cell, and the stem cell obtained from the transplant of nucleus.   第二条 本指导原则所称的人胚胎干细胞包括人胚胎来源的干细胞、生殖细胞起源的干细胞和通过核移植所获得的干细胞。

 
Article 3 All those engaging in activities concerning the research of human embryonic stem cell within the territory of the People's Republic of China shall abide by the present Guiding Principles.   第三条 凡在中华人民共和国境内从事涉及人胚胎干细胞的研究活动,必须遵守本指导原则。

 
Article 4 Any research on reproductive cloning is prohibited.   第四条 禁止进行生殖性克隆人的任何研究。

 
Article 5 The human embryonic stem cell used for research may only be obtained through the following ways:   第五条 用于研究的人胚胎干细胞只能通过下列方式获得:

 
1. The unwanted gametes or blastula in vitro fertilization; (一)体外受精时多余的配子或囊胚;

 
2. The fetal cells from natural abortion or voluntary abortion; (二)自然或自愿选择流产的胎儿细胞;

 
3. The blastula and asexual split blastula obtained through the technology of body nucleolus transplant; or (三)体细胞核移植技术所获得的囊胚和单性分裂囊胚;

 
4. The germ cell donated on one's own initiatives. (四)自愿捐献的生殖细胞。

 
Article 6 The following criterions must be observed for making research of human embryonic stem cell:   第六条 进行人胚胎干细胞研究,必须遵守以下行为规范:

 
1. For the blastulas obtained from in-vitro fertilization, transplant of body nucleolus, asexual reproduction technology or genetic modification, the time for their in-vitro breeding shall not exceed 14 days from the date of fertilization or nucleus transplant. (一)利用体外受精、体细胞核移植、单性复制技术或遗传修饰获得的囊胚,其体外培养期限自受精或核移植开始不得超过14天。

 
2. No human blastula obtained as mentioned in the preceding paragraph, which has been used for research shall be transplanted into the genital system of human or any other creatures. And (二)不得将前款中获得的已用于研究的人囊胚植入人或任何其它动物的生殖系统。

 
3. No human germ cell may be combined with the germ cell of other species. (三)不得将人的生殖细胞与其他物种的生殖细胞结合。

 
Article 7 No human gamete, germ cell, embryo or fetus tissues may be bought or sold.   第七条 禁止买卖人类配子、受精卵、胚胎或胎儿组织。

 
Article 8 The principles of "informed consent" and "informed choice" shall be implemented earnestly for the research of human embryonic stem cell, and the informed consent letter shall be signed to protect the privacy of the test person (TP).   第八条 进行人胚胎干细胞研究,必须认真贯彻知情同意与知情选择原则,签署知情同意书,保护爱试者的隐私。

The "informed consent" and "informed choice" as mentioned in the preceding paragraph mean that the researchers shall, before making the experiments, tell the test persons according to facts the aim and the results and risks possibly occur in accurate, clear and popular language, and sign the informed consent letters with them after gaining their consent.
 
前款所指的知情同意和知情选择是指研究人员应当在实验前,用准确、清晰、通俗的语言向受试者如实告知有关实验的预期目的和可能产生的后果和风险,获得他们的同意并签署知情同意书。

 
Article 9 The entities engaging in the research of human embryonic stem cell shall set up an ethic committee consisting of researchers and managers in the relevant fields including biology, medicine, law, or sociology, etc., whose function is to make overall examination, consultation and supervision over the ethic and science groundings of the research of human embryonic stem cell.   第九条 从事人胚胎干细胞的研究单位应成立包括生物学、医学、法律或社会学等有关方面的研究和管理人员组成的伦理委员会,其职责是对人胚胎干细胞研究的伦理学及科学性进行综合审查、咨询与监督。

 
Article 10 The entities engaging in the research of human embryonic stem cell shall formulate implementation rules or administration regulations of their own in pursuance of the present Guiding Principles accordingly.   第十条 从事人胚胎干细胞的研究单位应根据本指导原则制定本单位相应的实施细则或管理规程。

 
Article 11 The administrative department in charge of science and technology and public health of the State Council shall be responsible for the interpretation of the present Guiding Principles.   第十一条 本指导原则由国务院科学技术行政主管部门、卫生行政主管部门负责解释。

 
Article 12 The present Guiding Principles shall be implemented as of their promulgation.   第十二条 本指导原则自发布之日起施行。
 
科学技术部
 
卫生部
 
二00三年十二月二十四日
 
     
     
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