Standardization as situation-specific achievement: Regulatory diversity and the production of value in intercontinental collaborations in stem cell medicine

AbstractThe 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