人胚胎干细胞建系研究中的伦理管理

目的：建立国人胚胎干细胞系递交国际干细胞库,并在此基础上建立既符合中国国情又得到国际认可的相关伦理管理体系。方法：在比尔盖茨基金会的资助下,与北京大学生命科学院再生生物学实验室合作,募集胚胎建立人胚胎干细胞系,在此过程中探讨可行的符合国际伦理原则的相关伦理管理机制。结果：成功建立了国人胚胎干细胞系及相关伦理管理体系。结论：进行干细胞研究时应充分重视伦理问题,国际干细胞伦理管理与中国相关伦理原则是可以有机结合的。     

人胚胎干细胞研究伦理指导原则

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。     

孤雌生殖和孤雌胚胎干细胞研究进展

孤雌生殖是没有精子参与的卵母细胞激活分裂和发育过程。孤雌生殖技术是获得组织相容性胚胎干细胞系的一项重要技术。孤雌胚胎干细胞既具有与正常胚胎干细胞相同的自我更新和多向分化潜能,又规避了人胚胎干细胞面临的伦理问题,日益受到重视。但孤雌胚胎干细胞系存在建系率低、分化能力有限和异常基因印迹等诸多问题,原因可能与缺乏父本基因有关。目前已经建立了小鼠、猴和人类的孤雌胚胎干细胞系。就近年孤雌生殖和孤雌胚胎干细胞的研究进展综述。     

孤雌生殖和孤雌胚胎干细胞研究进展

孤雌生殖是没有精子参与的卵母细胞激活分裂和发育过程.孤雌生殖技术是获得组织相容性胚胎干细胞系的一项重要技术.孤雌胚胎干细胞既具有与正常胚胎干细胞相同的自我更新和多向分化潜能,又规避了人胚胎干细胞面临的伦理问题,日益受到重视.但孤雌胚胎干细胞系存在建系率低、分化能力有限和异常基因印迹等诸多问题,原因可能与缺乏父本基因有关.目前已经建立了小鼠、猴和人类的孤雌胚胎干细胞系.就近年孤雌生殖和孤雌胚胎干细胞的研究进展综述.     

胚胎干细胞专利相关信息分析

目的对1985年至2004年12月的胚胎干细胞相关专利信息进行详细阅渎和分析,了解国内、外胚胎干细胞相关专利的情况。方法以干细胞及胚胎干细胞为主题词,以德文特(Der- went)数据库为背景,对多个专利数据库进行检索、筛查和分类,建立胚胎干细胞专利数据库。从专利的角度入手,对数据库中的630篇国际及44篇国内胚胎干细胞专利文献进行分类分析。结果胚胎干细胞研究领域的专利申请情况总体呈上升趋势;申请范围主要涉及动物细胞或组织、修饰的细胞、脊椎动物新品种及未分化的人类/动物细胞等方面,国际(13.4%)和国内(20.9%)申请均以涉及动物细胞或组织的占据首位;国内申请中涉及未分化的人/动物细胞的专利较多(19.8%);转基因动物、细胞建系及核移植技术相关的专利申请是胚胎干细胞相关专利中的重要组成部分。结论国内外胚胎干细胞相关信息的分析表明,目前我国在胚胎干细胞研究申请专利方面相对比较宽松,我们应该在涉及胚胎干细胞的分离、建系、在基因工程及细胞组织工程学方面的用途和方法以及胚胎干细胞在药物筛选过程中的用途等方面集中投入力量,争取有新的突破。     

浅析我国人胚胎干细胞发明的可专利性

本文对人胚胎干细胞发明在我国专利制度下的可专利性进行分析.目前,我国专利制度与欧洲专利制度相似,对于发明是否能被授予专利权都添加了道德因素的考量.通过比较中国与西方对"胚胎是否等同于人"的观念、国家对人胚胎干细胞研究的立场、<人胚胎干细胞研究伦理指导原则>在相关研究中的作用等,说明以违反社会公德为由一概否定人胚胎干细胞发明的可专利性略显武断.基于我国专利法的立法目的 以及TRIPs 协议中对公众健康予以保护的规定,笔者认为应进一步完善我国专利制度并以是否具有全能性为界限对人胚胎干细胞发明的可专利性予以区分处理.     

胚胎干细胞和成体干细胞的鉴定

胚胎干细胞是一种具有在体外不分化的无限增殖能力,而在一定条件下又能分化为体内多种细胞类型的原始细胞。自1998年美国Thomson等建立人胚胎干细胞系以来,对人胚胎干细胞的建系及开发利用引起了国内外的高度重视。而人胚胎干细胞系的建立以及定向分化的成功与否必须通过鉴定来确定。现就胚胎干细胞和成体干细胞的鉴定如下综述。     

人胚胎干细胞研究伦理指导原则

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.……     

胚胎干细胞和成体干细胞的鉴定

胚胎干细胞是一种具有在体外不分化的无限增殖能力，而在一定条件下又能分化为体内多种细胞类型的原始细胞。自1998年美国Thomson等建立人胚胎干细胞系以来，对人胚胎干细胞的建系及开发利用引起了国内外的高度重视。而人胚胎干细胞系的建立以及定向分化的成功与否必须通过鉴定来确定。现就胚胎干细胞和成体干细胞的鉴定如下综述。     

胚胎干细胞和成体干细胞的鉴定

胚胎干细胞是一种具有在体外不分化的无限增殖能力，而在一定条件下又能分化为体内多种细胞类型的原始细胞，自1998年美国Thomson等建立人胚胎干细胞系以来，对人胚胎干细胞的建系及开发利用引起了国内外的高度重视，而人胚胎干细胞系的建立以及定向分化的成功与否必须通过鉴定来确定，现就胚胎干细胞和成体干细胞的鉴定如下综述。     

Ethical boundary-work in the embryonic stem cell laboratory

Most accounts of the ethics of stem cell research are de- contextualised reviews of the ethical and legal literature. In this chapter we present a socially embedded account of some of the ethical implications of stem cell research, from the perspectives of scientists directly involved in this area. Based on an ethnography of two leading embryonic stem cell laboratories in the UK, our data form part of the findings from a larger project mapping the scientific, medical, social and ethical dimensions of innovative stem cell treatment, focusing on the areas of liver cell and pancreatic islet cell transplantation. We explore three key issues: what individual scientists themselves view as ethical sources of human embryos and stem cells; their perceptions of human embryos and stem cells; and how scientists perceive regulatory frameworks in stem cell research. We argue that these dimensions of laboratory practice are all examples of 'ethical boundary-work', which is becoming an integral part of the routine practice and performance of biomedical science. Our work adds to the relatively few sociological studies that explore ethics in clinical settings and to an even smaller body of work that explores scientists' views on the ethical issues relating to their research.     

An Ethical Framework for Stem Cell Research in the European Union

The European Union is a nightmare from the perspective of the ethics and regulation of science. A hitherto insoluble problem has been the task of drafting ethical principles which do not founder on the radically different attitudes taken to the question of the moral status of the human embryo. Following the conclusions reached in an international project, EUROSTEM, we suggest that this problem can be solved by concentration on the scope of principles and we emphasize that European research should be funded in a way that does not discriminate between individual states and researchers in the EU. Finally, we observe that the availability of any eventual embryonic stem cell therapies will pose a dilemma for those countries and those people that have declared stem cell research to be unacceptable.     

Embryo futures and stem cell research: the management of informed uncertainty

In the social worlds of assisted conception and stem cell science, uncertainties proliferate and particular framings of the future may be highly strategic. In this article we explore meanings and articulations of the future using data from our study of ethical and social issues implicated by the donation of embryos to human embryonic stem cell research in three linked assisted conception units and stem cell laboratories in the UK. Framings of the future in this field inform the professional management of uncertainty and we explore some of the tensions this involves in practice. The bifurcation of choices for donating embryos into accepting informed uncertainty or not donating at all was identified through the research process of interviews and ethics discussion groups. Professional staff accounts in this study contained moral orientations that valued ideas such as engendering patient trust by offering full information, the sense of collective ownership of the National Heath Service and publicly funded science and ideas for how donors might be able to give restricted consent as a third option.     

Fresh or frozen? Classifying ‘spare’ embryos for donation to human embryonic stem cell research

United Kingdom (UK) funding to build human embryonic stem cell (hESC) derivation labs within assisted conception units (ACU) was intended to facilitate the 'In-vitro fertilisation (IVF)-stem cell interface', including the flow of fresh 'spare' embryos to stem cell labs. However, in the three sites reported on here, which received this funding, most of the embryos used for hESC research came from long term cryopreservation storage and/or outside clinics. In this paper we explore some of the clinical, technical, social and ethical factors that might help to explain this situation. We report from our qualitative study of the ethical frameworks for approaching women/couples for donation of embryos to stem cell research. Members of staff took part in 44 interviews and six ethics discussion groups held at our study sites between February 2008 and October 2009. We focus here on their articulations of social and ethical, as well as scientific, dimensions in the contingent classification of 'spare' embryos, entailing uncertainty, fluidity and naturalisation in classifying work. Social and ethical factors include acknowledging and responding to uncertainty in classifying embryos; retaining 'fluidity' in the grading system to give embryos 'every chance'; tensions between standardisation and variation in enacting a 'fair' grading system; enhancement of patient choice and control, and prevention of regret; and incorporation of patients' values in construction of ethically acceptable embryo 'spareness' ('frozen' embryos, and embryos determined through preimplantation genetic diagnosis (PGD) to be genetically 'affected'). We argue that the success of the 'built moral environment' of ACU with adjoining stem cell laboratories building projects intended to facilitate the 'IVF-stem cell interface' may depend not only on architecture, but also on the part such social and ethical factors play in configuration of embryos as particular kinds of moral work objects.     

Stem cell research: licit or complicit? Is a medical breakthrough based on embryonic and fetal tissue compatible with Catholic teaching?

In November 1998 biologists announced that they had discovered a way to isolate and preserve human stem cells. Since stem cells are capable of developing into any kind of human tissue or organ, this was a great scientific coup. Researchers envision using the cells to replace damaged organs and to restore tissue destroyed by, for example, Parkinson's disease, diabetes, or even Alzheimer's. But, since stem cells are taken from aborted embryonic and fetal tissue or "leftover" in vitro embryos, their use raises large ethical issues. The National Institutes of Health (NIH) recently decided to fund research employing, not stem cells, but "cell lines" derived from them. The NIH has essentially made an ethical determination, finding sufficient "distance" between cell lines and abortion. Can Catholic universities sponsoring biological research agree with this finding? Probably not. In Catholic teaching, the concept of "complicity" would likely preclude such research. However, Catholic teaching would probably allow research done with stem cells obtained from postpartum placental tissue and from adult bone marrow and tissue. These cells, which lack the pluripotency of embryonic and fetal stem cells, are nevertheless scientifically promising and do not involve the destruction of human life.     

Humane embryonale Stammzellen im Kontext internationaler Forschungsaktivitäten

Research involving pluripotent human embryonic stem cells (hESCs) is a rapidly growing field of science. Since hESCs originate from early human embryos, alternative methods for producing pluripotent cells have been developed. This article introduces some of those strategies and, in addition, covers international efforts to establish consistent international standards for cultivation, characterization and preservation of hESCs. Furthermore, global trends to form networks in the field of stem cell research as well as endeavors to harmonize ethical standards for hESC research are presented. Finally, potential applications of hESCs in the field of pharmacology/toxicology are discussed as well as recent results of animal studies using hESCs.     

Fresh or frozen? Classifying ‘spare’ embryos for donation to human embryonic stem cell research

United Kingdom (UK) funding to build human embryonic stem cell (hESC) derivation labs within assisted conception units (ACU) was intended to facilitate the ‘In-vitro fertilisation (IVF)-stem cell interface’, including the flow of fresh ‘spare’ embryos to stem cell labs. However, in the three sites reported on here, which received this funding, most of the embryos used for hESC research came from long term cryopreservation storage and/or outside clinics. In this paper we explore some of the clinical, technical, social and ethical factors that might help to explain this situation. We report from our qualitative study of the ethical frameworks for approaching women/couples for donation of embryos to stem cell research. Members of staff took part in 44 interviews and six ethics discussion groups held at our study sites between February 2008 and October 2009. We focus here on their articulations of social and ethical, as well as scientific, dimensions in the contingent classification of ‘spare’ embryos, entailing uncertainty, fluidity and naturalisation in classifying work. Social and ethical factors include acknowledging and responding to uncertainty in classifying embryos; retaining ‘fluidity’ in the grading system to give embryos ‘every chance’; tensions between standardisation and variation in enacting a ‘fair’ grading system; enhancement of patient choice and control, and prevention of regret; and incorporation of patients’ values in construction of ethically acceptable embryo ‘spareness’ (‘frozen’ embryos, and embryos determined through preimplantation genetic diagnosis (PGD) to be genetically ‘affected’). We argue that the success of the ‘built moral environment’ of ACU with adjoining stem cell laboratories building projects intended to facilitate the ‘IVF-stem cell interface’ may depend not only on architecture, but also on the part such social and ethical factors play in configuration of embryos as particular kinds of moral work objects.