Governing Accountability in China's Life Sciences: A Comparative Study of Stem Cell and GM Food Governance

中国在组织和提供科学创新方面的“领先影响力”的崛起是不争的事实(FCO和国际清算银行，2013年)。一方面，中国提出了在经济增长乏力的环境下最大限度地吸收和应用科学的新机遇。另一方面，在确保负责任的研究行为方面持续存在的缺陷，给公众对与中国一起进行的研究的态度投下了阴影。当地授权的干细胞治疗和无监督的转基因食品试验等案例不仅损害了中国自己的科学声誉，也损害了全球公众对生物技术的信任(Moreno，2010，邱晓华，2012)。本项目通过对干细胞研究和转基因食品的比较研究，提出了一项及时而雄心勃勃的研究，以期对中国生命科学治理中的问责问题进行研究。这得益于我广泛的人脉和之前在这两个领域的研究。通过半结构化访谈、焦点小组和国际研讨会的组合，该项目与中国和英国的监管机构、科学家和公民社会参与者进行了接触。它为共同制定解决生命科学公共问责问题的替代方法作出了重要贡献。分析的重点将集中在以下问题上：问题1：在定义、选择和维持中国在干细胞研究和转基因食品方面的负责任的研究实践时，使用了哪些监管标准和程序？国内和国际上的争论是如何影响“合法化手段”的发展的？RQ2：在干细胞和转基因食品法规中，科学家、监管者和生物伦理学家之间的权力动态是如何构建的？这两个领域的研究实践在合法化方面有什么相似之处和不同之处？RQ3：需要什么形式的沟通才能使干细胞和转基因研究更容易为公众所接受和评估？中国如何改进其对潜在研究用户和合作者的有效问责？干细胞研究和转基因食品是优秀的案例研究。他们就该项目的三个核心研究问题提供了互补的观点。在中国看来，干细胞和转基因技术都是高知名度和争议性的领域，但它们代表了风险框架的两端。虽然中国的转基因食品监管包含“强有力的预防因素”，但中国的干细胞监管可以说类似于一种“前瞻性”方法(Tiberghien，2010；Zhang，2012)。尽管存在这些差异，但中国的干细胞和转基因技术有着相似的监管历史和治理结构。这两种食品主要由卫生部、中国食品药品监督管理局和科技部监管。监管理念的差异和治理结构的重叠将为研究问题提供丰富的可比数据。解决问责问题不仅对于中国成为竞争激烈和持怀疑态度的全球社会中值得信赖的参与者的目标至关重要，而且对于促进有效的国际合作和促进生命科学研究的完整性也很重要。因此，这项研究将对许多非学术用户具有重要意义，例如1)中国和欧洲的监管者和研究资助者；2)跨国科学学会；3)国际民间社会组织，如患者权益倡导组织、环保非政府组织以及4)医院和生物技术企业。鉴于这项研究的跨学科性质，该项目还丰富了多个学科的学术辩论，如社会学、治理研究、生物伦理学、中国研究和生命科学。计划产出包括1部学术专著、6篇科学和社会科学期刊文章、1份中英文政策报告、1个面向公众的定期更新项目网站和2个国际研讨会。

China's rise as a 'leading influence' in the organization and delivery of scientific innovation is Janus-faced (FCO and BIS, 2013). On the one hand, China presents new opportunities of maximizing the uptake and application of science in a climate of sluggish economic growth. On the other hand, a persistent deficiency in ensuring responsible research conduct casts a shadow on the public attitude towards research conducted in, and with, China. Cases such as locally authorized stem cell therapy and unsupervised GM food trials not only has the effect of damaging China's own scientific reputation, but also impairs global public trust of biotechnologies (Moreno, 2010, Qiu, 2012).This project proposes a timely and ambitious study on the accountability problem in China's life science governance through a comparative study of stem cell research and GM foods. This draws on my extensive network and previous research in both fields. Through a combination of semi-structured interviews, focus groups and international workshops, this project engages with regulators, scientists and civil society actors in both China and the UK. It makes an important contribution to the co-production of alternative ways to address public accountability in the life sciences. The analytical focus will be on the following questions:RQ1: What are the regulatory standards and procedures used in defining, selecting and sustaining accountable research practice in stem cell research and GM foods in China? How are the development of the 'legitimation devices' shaped by domestic and international debates? RQ2: How are the power dynamics among scientists, regulators and bioethisists constructed in stem cell and GM food regulations? What are the similarities and differences in the legitimisation of research practice in both fields? RQ3: What forms of communication are needed to make stem cell and GM research more accessible to, and assessable by, the public? How can China improve its effective accountability to its potential research users and collaborators?Stem cell research and GM foods make for excellent case studies. They provide complementary views on the project's three core research questions. Stem cell and GM technologies are both highly visible and controversial fields in China, but they represent the opposite ends of risk framing. While China's GM food regulation consists of a 'strong precautionary element', China's stem cell regulation arguably resembles a 'proactionary' approach (Tiberghien, 2010; Zhang, 2012). Despite these differences, stem cell and GM technologies in China share a similar regulatory history and governing structure. Both are predominately regulated by the Ministry of Health, the China Food and Drug Authority and the Ministry of Science and Technology. This difference in regulatory rationales and overlap in governance structures will provide rich comparable data for the research questions.Addressing the accountability problem is not only crucial for China's goal of becoming a trusted player in the competitive and skeptical global community, but is also important for enabling efficient international collaborations and promoting research integrity in the life sciences. Thus, this research will be important to a number of non-academic users, such as 1) regulators and research funders in both China and Europe; 2) transnational scientific societies; 3) international civil society organisations, such as patient advocacy groups, environmental NGOs and 4) hospitals and biotechnology enterprises. Given the interdisciplinary nature this research, this project also enriches academic debates in a variety of disciplines, such as sociology, governance studies, bioethics, China studies and the life sciences.Planned outputs includes 1 academic monograph, 6 articles in science and social science journals, 1 policy report in both English and Chinese, 1 regularly updated project website for public audiences and 2 international workshops.