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Rosemann, Achim (2014)
Publisher: Elsevier
Journal: Social Science & Medicine
Languages: English
Types: Article
Subjects: Q, R, Health(social science), H, H1, R1
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.
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    • Barry, A., 2006. Technological zones. Eur. J. Soc. Theory 9 (2), 239e253.
    • Bharadwaj, A., 2013. Ethics of consensibility, subaltern ethicality: the clinical application of embryonic stem cells in India. BioSocieties 8 (1), 25e40.
    • Birch, K., 2012. Knowledge, place, and power: geographies of value in the bioeconomy. New Genet. Soc. 31 (2), 183e201.
    • Boeije, H., 2002. A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Qual. Quant. 36 (4), 391e409.
    • Brhlikova, P., Harper, I., Jeffery, R., Rawal, N., Subedi, M., Santhosh, M.R., 2011. Trust and the regulation of pharmaceuticals: South Asia in a globalised world. Glob. Health 7 (10).
    • Brunsson, N., Jacobsson, B., 2000. A World of Standards. Oxford Univ. Press, Oxford.
    • Chen, H., 2009. Stem cell governance in China: from bench to bedside? New Genet. Soc. 28 (3), 267e282.
    • Chen, H., Gottweis, H., 2013. Stem cell treatments in china: rethinking the patient role in the global bio-economy. Bioethics 27 (4), 194e207.
    • Cooper, M., 2008. Experimental labourdoffshoring clinical trials to China. East Asian Sci. Technol. Soc. 2 (1), 73e92.
    • Cribb, A., Wainwright, S., Williams, C., Farsides, B., Michael, M., 2008. Towards the applied: the construction of ethical positions in stem cell translational research. Med. Health Care Philos. 11 (3), 351e361.
    • Ellis, S., 2014. Neuralstem doses ischemic stroke patient with stem cells directly into the brain. Neuralstem Website, 5 February, 2014; URL: http://neuralstem.com/ pharmaceuticals?id¼206 (last accessed 10.9.14.).
    • Federal Register, 2008. Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Fed. Regist. 73 (82), 22800e22816. URL: http://www.gpo.gov/fdsys/pkg/FR-2008-04-28/pdf/E8- 9200.pdf (last accessed 20.4.14.).
    • Faulkner, A., 2012. Law's performativities: shaping the emergence of regenerative medicine through European Union legislation. Soc. Stud. Sci. 42 (5), 753e774.
    • Gikonyo, C., Bejon, P., Marsh, V., Molyneux, S., 2008. Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Soc. Sci. Med. 67, 708e720.
    • Halme, D.G., Kessler, D.A., 2006. FDA regulation of stem-cellebased therapies. N. Engl. J. Med. 355 (16), 1730e1735.
    • Keating, P., Cambrosio, A., 2011. Cancer on Trial: Oncology as a New Style of Practice. University of Chicago Press.
    • Leach, M., Hilton, S., Greenwood, B.M., Manneh, E., Dibba, B., Wilkins, A., et al., 1999. An evaluation of the informed consent procedure used during a trial Haemophilus Influenzae type B conjugate vaccine undertaken in the Gambia, West Africa. Soc. Sci. Med. 148 (2), 139e148.
    • Mackey, T.K., Liang, B.A., 2011. The global counterfeit drug trade: patient safety and public health risks. J. Pharm. Sci. 100 (11), 4571e4579.
    • Martin, P., Brown, N., Kraft, A., 2008. From bedside to bench? Communities of promise, translational research and the making of blood stem cells. Sci. Cult. 17 (1), 29e41.
    • McMahon, D.S., 2014. The global industry for unproven stem cell interventions and stem cell tourism. Tissue Eng. Regen. Med. 11 (1), 1e9.
    • Petryna, A., 2009. When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. Princeton University Press.
    • Rosemann, A., 2011. Modalities of value, exchange, solidarity: the social life of stem cells in China. New Genet. Soc. 30 (2), 181e192.
    • Rosemann, A., 2013a. Medical innovation and national experimental pluralism: insights from clinical stem cell research and applications in China. Biosocieties 8 (1), 58e74.
    • Rosemann, A., 2013b. Scientific multipolarisation: its impact on international clinical research collaborations and theoretical implications. Sci. Technol. Soc. 18 (3), 339e359.
    • Sariola, S., Simpson, B., 2011. Theorising the 'human subject' in biomedical research: international clinical trials and bioethics discourses in contemporary Sri Lanka. Soc. Sci. Med. 73 (4), 515e521.
    • Sleeboom-Faulkner, M., Patra, P.K., 2011. Experimental stem cell therapy: biohierarchies and bionetworking in Japan and India. Soc. Stud. Sci. 41 (5), 645e666.
    • Sleeboom-Faulkner, M., 2013. Latent science collaboration: strategies of bioethical capacity building in Mainland China's stem cell world. BioSocieties 8 (1), 7e27.
    • Sleeboom-Faulkner, M., 2014. Regulation of Cell Research and Therapy International Standardisation and National Home-Keeping. Presentation, China Cell Therapy Conference, June 20, 2014, Shanghai.
    • Smith, D.E., 2005. Institutional Ethnography: a Sociology for People. Rowman Altamira.
    • Song, P., 2011. The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation. New Genet. Soc. 30 (2), 141e153.
    • Strathern, M., 2000. Audit Cultures: Anthropological Studies in Accountability, Ethics and the Academy. Routledge.
    • Timmermans, S., Berg, M., 1997. Standardization in action: achieving local universality through medical protocols. Soc. Stud. Sci. 27, 273e305.
    • Timmermans, S., Epstein, S., 2010. A world of standards but not a standard world: toward a sociology of standards and standardization. Annu Rev. Sociol. 36, 69e89.
    • Wahlberg, A., Rehmann-Sutter, C., Sleeboom-Faulkner, M., Lu, G., Do€ring, O., Cong, Y., et al., 2013. From global bioethics to ethical governance of biomedical research collaborations. Soc. Sci. Med. 98, 293e300.
    • Wainwright, S.P., Williams, C., Michael, M., Farsides, B., Cribb, A., 2006. From bench to bedside? Biomedical scientists' expectations of stem cell science as a future therapy for diabetes. Soc. Sci. Med. 63 (8), 2052e2064.
    • Webster, A., Haddad, C., Waldby, C., 2011. Experimental heterogeneity and standardisation: stem cell products and the clinical trial process. BioSocieties 6 (4), 401e419.
    • Wilson-Kovacs, D.M., Weber, S., Hauskeller, C., 2010. Stem cells clinical trials for cardiac repair: regulation as practical accomplishment. Sociol. Health Illn. 32 (1), 89e105.
    • Young, W., 2008. SCI: Is the Cure in China? Video of Conference Presentation, Spinal Cord Injury e What Are the Barriers to Cure?. Workshop, Bedford Massachusetts, March 29, 2008, URL: http://www.spinalcordworkshop.org/portfoliotype/wise-young-md-phd-spinal-cord-injury-is-the-cure-in-china/ (last accessed 27.04.14.).
    • i Interview Kwok-Fai So, Hong Kong, January 7, 2011. ii Interview Wise Young, Hong Kong, June 24, 2010. iii Interview Kent Tsang, Hong Kong, January 7, 2011. iv Interview Wise Young, Hong Kong, June 24, 2010.
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