The Socio-genetic marginalization in Asia programme (SMAP)

SMAP, the Socio-genetic Marginalization in Asia Programme, which started off in August 2004, is a research programme set up with the support of the Netherlands Science Organisation (NWO), IIAS, and the Amsterdam School for Social Science Research (ASSR). Exploring cultural, social and economic aspects of the role of genetic technologies played in the area of state organisation, population policies, health care systems and research regulation in China, India and Japan, SMAP is expected to shed light on how differences in the application of modern genetic technologies generate different practices. The programme focuses on: (I) the ways in which (universal) regulation for genetic sampling by international companies and universities leads to disputable research practices among vulnerable populations; (II) how bioethical differences between healthcare systems are expressed in the different meanings allocated to concepts, such as informed consent, health, and family values; and, (III) the consequences of development priorities and practices of genetic screening for the livelihood and identities of diverging social groups

Regulatory brokerage: competitive advantage and regulation in the field of regenerative medicine

This article concerns the roles of entrepreneurial scientists in the co-production of life science research and regulation. Regulatory brokerage, defined as a mode of strategic planning and as the negotiation of regulation based on comparative advantage and competition, is expressed in scientific activities that take advantage of regulatory difference. This article is based on social science research in Japan, Thailand, India and the UK. Using five cases related to Japan’s international activities in the field of regenerative medicine, I argue that, driven by competitive advantage, regulatory brokerage at lower levels of managerial organization and governance is emulated at higher levels. In addition, as regulatory brokerage affects the creation of regulation at national, bilateral and global levels, new regulation may be based on competition in regulatory advantage rather than on ethical and scientific values. I argue that regulatory brokerage as the basis for regulatory reform bypasses issues that need to be decided by a broader public. More space is needed for international and political debate about the socio-political consequences of the global diversity of regulation in the field of the life sciences

The justification of studies in genetic epidemiology: political scaling in China Medical City

Genetic epidemiology examines the role of genetic factors in determining health and disease in families and in populations to help addressing health problems in a responsible manner. This article uses a case study of genetic epidemiology in Taizhou, China, to explore ways in which anthropology can contribute to the validation of studies in genetic epidemiology. It does so, first, by identifying potential overgeneralizations of data, often due to mismatching scale and, second, by examining its embedding in political, historical and local contexts. The example of the longitudinal cohort study in Taizhou illustrates dimensions of such ‘political scaling’. Political scaling is a notion I use to refer to the effects of scaling biases in relation to the justification of research in terms of relevance, reach, and research ethics. The justification of a project on genetic epidemiology involves presenting a maximum of benefits and a minimum of burden for the population. To facilitate the delineation of political scaling, I make an analytical distinction between donating and benefiting communities, using the notions of ‘scaling of relevance’, ‘scaling of reach’ and ‘scaling of ethics’. Political scaling results at least partly from factors external to research. By situating political scaling in the context of historical, political and local discourses, anthropologists can play a complementary role in genetic epidemiology

‘Have we become too ethical?’: International symposium at Sussex and colloquium at Durham Universities

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

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

Bionetworking and strategic linking between India and Japan: how clinical stem cell intervention continues despite new regulatory guidelines

Based on a case study of a clinical stem cell intervention (CSCI) center in Chennai, India, this article explores distinct entrepreneurial strategies for the promotion of unrecognized clinical stem cell applications in India. It shows that the center—an Indo-Japanese joint-venture—is able to promote the CSCI due to its central position in a network relationship, its possession of specialized skills and knowledge, and its ability to maneuver other actors in the network and to identify and utilize their latent value. We examine the developmental history of the making and remaking of regulation and the shift in the way clinical stem cell application providers function—from institutional embedment to strategic linking through collaborative networks. We ask why and how unauthorized clinical applications are sustained and promoted in India. We conclude that this is possible as a result of a number of factors: jurisdictional ambiguity, institutional inability, issues concerning the legal enforceability of the relevant guidelines, the complexity of the collaborative network structure that facilitates the circumvention of the regulation, and the nonfunctioning of apex-level committees

Guidelines for data management and scientific integrity in ethnography

New protocols for scientific integrity and data management issued by universities, journals, and transnational social science funding agencies are often modelled on medical or psychological research, and do not take account of the specific characteristics of the processes of ethnographic research. These guidelines provide ethnographers with some of the most basic principles of doing such research. They show that the primary response of ethnographers to requests to share research materials with third parties should be to remain aware of the fact that these research materials have been coproduced with their research participants; that the collaborative ethnographic research process resists turning these materials into commodified, impersonal ‘data’ that can be owned and shared publicly; and that therefore the primary response of ethnographers should be to retain custody of research materials

'(East) Asia' as a platform for debate: grouping and bioethics

This article examines the use of the notions of “Asian” and “East Asian” in definitions of bioethics. Using examples from East Asia, I argue that the verbal Asianization of bioethics is based on the notion of “Asia” as a family metaphor and serves as a platform of bioethical debate, networking, and political change. I maintain that the use of “Asia” and “East Asia” to shape bioethics is not so much a sign of inward-looking regionalism, but an attempt to build bridges among Asian countries, while putting up a common stance against what educated elites interpret as undesirable global trends of Westernization through bioethics. Using the notions of “grouping” and “segmentary systems” to show the performative nature of characterizations of (East) Asian bioethics, allowing users to mark regional identity, share meanings, take political positions, and network. Deploying Peter Haas’s notion of “epistemic communities,” I argue that academic and political elites translate “home” issues into “Asia speak,” while at the same time, introducing and giving shape to “new” bioethical issues. Although the “Asianisms” and group-marking activities of Asian networks of bioethics are ideological, thereby engaging in the politics of in/exclusion, they succeed in putting politically sensitive topics on the agenda

Genomics and genetic medicine: pathways to global health?

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New regulation for clinical stem cell research in China: expected impact and challenges for implementation

On August 22, 2015 the Chinese National Health and Family Planning Commission (NHFPC, the former Ministry of Health, MOH) have issued the long awaited “draft” regulation on clinical research and applications that involve human stem cells [1] [2] [3]. In China, regulation usually starts out as a draft (草案) or trial regulation (试行). A draft regulation should be regarded as valid as formal regulation, but it is flexible enough to leave space for change. The document announces the central elements of a regulatory foundation for the clinical translation of stem cell-based medicinal products and procedures. What does China’s future regulation for clinical stem cell trials look like? What challenges can be expected with regard to its implementation? And what impacts will the regulation have for domestic researchers, clinics and corporations in China and at an international level