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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. [ABSTRACT FROM AUTHOR]

Abstract: Definitions and theoretical models of the stigma construct have gradually progressed from an individualistic focus towards an emphasis on stigma''s social aspects. Building on other theorists’ notions of stigma as a social, interpretive, or cultural process, this paper introduces the notion of stigma as an essentially moral issue in which stigmatized conditions threaten what is at stake for sufferers. The concept of moral experience, or what is most at stake for actors in a local social world, provides a new interpretive lens by which to understand the behaviors of both the stigmatized and stigmatizers, for it allows an examination of both as living with regard to what really matters and what is threatened. We hypothesize that stigma exerts its core effects by threatening the loss or diminution of what is most at stake, or by actually diminishing or destroying that lived value. We utilize two case examples of stigma—mental illness in China and first-onset schizophrenia patients in the United States—to illustrate this concept. We further utilize the Chinese example of ‘face’ to illustrate stigma as having dimensions that are moral-somatic (where values are linked to physical experiences) and moral-emotional (values are linked to emotional states). After reviewing literature on how existing stigma theory has led to a predominance of research assessing the individual, we conclude by outlining how the concept of moral experience may inform future stigma measurement. We propose that by identifying how stigma is a moral experience, new targets can be created for anti-stigma intervention programs and their evaluation. Further, we recommend the use of transactional methodologies and multiple perspectives and methods to more fully capture the interpersonal core of stigma as framed by theories of moral experience. [Copyright &y& Elsevier]