干细胞转化研究的治理
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摘要
当今前沿的干细胞科学带给人们无限希望和期待,但是干细胞研究的进程中同时还伴随着很多风险和不确定性,这使干细胞研究的治理不断面临新的挑战。本论文提出,干细胞转化医学是一个复杂的技术系统,简单线性的、“从实验室到临床”的转化研究根本无法将实验室中获得的生物医学知识转移到临床应用。转化研究不仅需要解决科学内部的问题,也需要科学和社会秩序的共生产。从共生产的视角看,成功的干细胞转化研究需要一种治理模式,使不同的行动者在科学技术领域、医疗健康领域、产业经济领域、伦理法律领域和社会政治领域中相互合作,共同应对各种挑战。基于这种理论预设,本文针对高校研究所、干细胞公司、干细胞产业化三种不同类型的干细胞转化研究,建立了各自不同的干细胞转化研究的治理模型,然后根据这些治理模型对中国的案例展开具体分析。我的案例研究发现,除了基础的细胞培养、动物研究、临床试验,高校研究所的科学家还要在实验室之外寻求资源；干细胞公司还要建立商业模式,宣传干细胞；干细胞产业化还要利用创新系统,充分发挥各部门的优势。但它们都需要国家的政策支持、合理的医疗制度、公众理解干细胞,同时处理好知识产权问题,尊重和保护病人和受试者。最后,我结合干细胞转化研究的治理模型和一手的案例研究访谈材料,提出如何走向转化研究的治理的建议。西方人通常认为,中国在生物医学研究方面缺乏管理和伦理治理。中国因此而被他们指责为“野蛮的东方”。我的案例研究证明,实际的情况并非如此。和欧美其他国家一样,中国在干细胞研究和应用的管理方面曾经有过长期不确定的政策环境,但这并没有产生“野蛮的东方”管理格局,确切地说,这使得多个利益相关者采取不同的管理策略。中国最新出台的管理办法再次证明,中国已经采用有效的、合法的管理策略使干细胞科学进入临床应用。
The current cutting-edge stem cell science brings people immense hopes and expectations. However, there are also many risks and uncertainties in the advancement of stem cell research, which continuously pose new challenges for the governance of stem cell translational research. This thesis argues that stem cell translational medicine is a complex technological system. The simple linear "from bench to bedside" translation model ultimately is not able to move biomedical knowledge acquired from laboratory to clinical application. Translational research not only has to solve intra-scientific hurdles, but also needs the co-production of science and social order. From the perspective of co-production, I argue that the success of stem cell translational research needs a mode of governance, and multiple interactions of different actors in the scientific/technological field, the medical/health field, the industrial-economic field, the legal-ethical, and the socio-political field to face various challenges. Based on this hypothesis, I build three separate translation models of the university research institutions, the stem cell companies, and the stem cell industrialization to analyze the Chinese cases. My case studies find that besides in-vitro development, animal studies, and clinical trials, the scientists in university research institutions have to look for resources out of laboratory; the stem cell companies need business models, and represent stem cells in the public; the stem cell industrialization must build an innovation system to make full use of the advantages of each sector. As a whole, they all need favourable political culture, reasonable healthcare system, public understanding of stem cells, meanwhile, try to deal with intellectual property rights, and to protect and respect patients and research participants. Finally, I propose some recommendations on how to govern stem cell translational research according to my designed models and first-hand interviews. China tends to be blamed as "Wild East" by Western countries for the lack of regulation and ethical governance in biomedical research. My case studies show that it is not the real fact. In China, as in other European countries and America, the stem cell translational research had lengthy uncertain regulatory context in the past, but the absence of state regulation has not led to a "Wild East" regulatory constellation, but rather to individualized regulatory strategies by a variety of stakeholders. The new regulation recently issued by China proves again that China has adopted efficient and legitimate strategies in bringing stem cell science to clinical application.
The current cutting-edge stem cell science brings people immense hopes and expectations. However, there are also many risks and uncertainties in the advancement of stem cell research, which continuously pose new challenges for the governance of stem cell translational research. This thesis argues that stem cell translational medicine is a complex technological system. The simple linear "from bench to bedside" translation model ultimately is not able to move biomedical knowledge acquired from laboratory to clinical application. Translational research not only has to solve intra-scientific hurdles, but also needs the co-production of science and social order. From the perspective of co-production, I argue that the success of stem cell translational research needs a mode of governance, and multiple interactions of different actors in the scientific/technological field, the medical/health field, the industrial-economic field, the legal-ethical, and the socio-political field to face various challenges. Based on this hypothesis, I build three separate translation models of the university research institutions, the stem cell companies, and the stem cell industrialization to analyze the Chinese cases. My case studies find that besides in-vitro development, animal studies, and clinical trials, the scientists in university research institutions have to look for resources out of laboratory; the stem cell companies need business models, and represent stem cells in the public; the stem cell industrialization must build an innovation system to make full use of the advantages of each sector. As a whole, they all need favourable political culture, reasonable healthcare system, public understanding of stem cells, meanwhile, try to deal with intellectual property rights, and to protect and respect patients and research participants. Finally, I propose some recommendations on how to govern stem cell translational research according to my designed models and first-hand interviews. China tends to be blamed as "Wild East" by Western countries for the lack of regulation and ethical governance in biomedical research. My case studies show that it is not the real fact. In China, as in other European countries and America, the stem cell translational research had lengthy uncertain regulatory context in the past, but the absence of state regulation has not led to a "Wild East" regulatory constellation, but rather to individualized regulatory strategies by a variety of stakeholders. The new regulation recently issued by China proves again that China has adopted efficient and legitimate strategies in bringing stem cell science to clinical application.
引文
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3这三个目的是：1、增长关于胚胎发育的知识：2、增长关于严重疾病的知识；3、使这些知识应用于提高治疗严重的疾病。
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3访谈,2008年8月14日,上海交通大学,上海。
4访谈,2008年4月11日,中国科学院生命科学与生物技术局,北京。
5访谈,2008年4月11日,北京大学,北京。
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3考虑到本文的重点研究对象是干细胞转化研究的伦理和政策问题,关于人类胚胎干细胞研究的争论、伦理和政策问题在学术界已经有很多讨论,本章只做简单概括介绍。可参见Prainsack B, Geesink I, Franklin S. Stem cell technologies 1998-2008:Controversies and silences. Science as Culture.2008.17(4):351-362.
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2 Gottweis H, Salter B, Waldby C. The Global Politics of Human Embryonic Stem Cell Science:Regenerative Medicine in Transition Basingstoke:Palgrave Macmillan 2009.124
3这三个目的是：1、增长关于胚胎发育的知识：2、增长关于严重疾病的知识；3、使这些知识应用于提高治疗严重的疾病。
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2同上。
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