Abstract
The article examines the role and challenges of scientific self-governance and standardization in inter-continental clinical research partnerships in stem cell medicine. The paper shows that – due to a high level of regulatory diversity – the enactment of internationally recognized standards in multi-country stem cell trials is a complex and highly situation-specific achievement. Standardization is imposed on a background of regulatory, institutional and epistemic-cultural heterogeneity, and implemented exclusively in the context of select clinical projects. Based on ethnographic data from the first trans-continental clinical trial infrastructure in stem cell medicine between China and the USA, the article demonstrates that locally evolved and international forms of experimental clinical research practices often co-exist in the same medical institutions. Researchers switch back and forth between these schemas, depending on the purposes of their research, the partners they work with, the geographic scale of research projects, and the contrasting demands for regulatory review, that result from these differences. Drawing on Birch's analysis of the role of standardization in international forms of capital production in the biosciences, the article argues that the integration of local knowledge institutions into the global bioeconomy does not necessarily result in the shutting down of localized forms of value production. In emerging fields of medical research, that are regulated in highly divergent ways across geographical regions, the coexistence of distinct modes of clinical translation allows also for the production of multiple forms of economic value, at varying spatial scales. This is especially so in countries with lenient regulations. As this paper shows, the long-standing absence of a regulatory framework for clinical stem cell applications in China, permits the situation-specific adoption of internationally recognized standards in some contexts, while enabling the continuation of localized forms of value production in others.
Highlights
In this article, I focus on processes of scientific self-governance and standardization in the context of intercontinental clinical research collaborations in the field of regenerative stem cell medicine
The empirical focal point of this article is an ethnographic study of the China Spinal Cord Injury Network (China SCI Net), an academic clinical trials infrastructure that involves more than twenty spinal cord injury (SCI) centers in mainland China, Hong Kong, and Taiwan
What we are trying to do is to bring the international standards of clinical trials to China. [W]hat we are doing is to bring in the concept of using all the modern standards on how to run a clinical [stem cell] trial, as it is recognized in the West, in the current time
Summary
I focus on processes of scientific self-governance and standardization in the context of intercontinental clinical research collaborations in the field of regenerative stem cell medicine. I will explore, the implications of these processes on local clinical innovation practices, and the production of localized forms of economic value The paper explores these issues by focusing on the formation of the China Spinal Cord Injury Network (China SCI Net), the first intercontinental clinical trials infrastructure in the stem cell field that has emerged between. Exterior to the activities of the China SCI Net, we see that locally evolved and newly adopted (i.e. internationally accepted) forms of experimental clinical research practices exist side by side with each other, often in the same medical institutions Researchers shift between these divergent schemas, depending on the purposes of their research, the partners they work with, the geographic scale of research projects, and the contrasting demands for regulatory review, that result from these differences. The long-standing absence of a comprehensive regulatory framework for clinical stem cell applications in China permits the situation-specific adoption of internationally recognized standards in some contexts, while enabling the continuation of local forms of value production in others
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