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

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.

What Is the Bioeconomy? A Review of the Literature

“…It is furthermore suggested that connections between these global bio-technology centres are very important for innovation in the bioeconomy and that certain regions in emerging and developing economies may also take advantage of the bioeconomy [8,42]. As a consequence of the focus on global competition in the bioeconomy, the notion of governance of innovation also constitutes a central feature in some of the research underpinning such a vision [43,44]. Associated with the geographies of the bioeconomy, it is also pointed out how value-creation in the bioeconomy comprises both a material component associated with bio-resources, but nonetheless also an immaterial component in terms of knowledge and an ability to develop new knowledge [45].…”

Traveling health-promoting infrastructures: A meta-ethnographic analysis

“…Rereading the studies, we identified the different types of HPIs and categorized them into two major categories: patient related and clinical research related. Within each category, five HPI subcategories were identified: management systems in relation to chronic diseases (Nielsen and Langstrup, 2014;Nielsen and Jensen, 2013;Rogvi et al, 2016); treatment procedures and protocols to assist reproduction and overcome infertility (Hörbst, 2012;Simpson, 2012), systems in relation to hospital management (Bruun Jensen, 2010), research regulations and protocols for developing new biomedical treatments (Kuo, 2009;Petryna, 2007b;Rosemann, 2014;Sunder Rajan, 2010), and bioethical regulatory frameworks for clinical research to promote safe and ethical drug development (Petryna, 2005(Petryna, , 2007aSariola and Simpson, 2011). Furthermore, through focused reading, we identified the health-promoting goal in each of the studies and mapped out the core components of each HPI.…”

Lost in Translation? Accountability and Governance of Clinical Stem Cell Research in China

“…For example, China's clinical stem cell research once depended on a host institution's discretionary adaptation of international guidelines [38]. But through the succession of new regulatory moves in 2009, 2013 and 2015, as discussed in the previous section, the accreditation and annual reviews of stem cell clinical research centers are centralized to the authorities of two state agencies, NHFPC and CFDA [28,29].…”