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 paper 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 it's 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 used here 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, an analytical distinction between donating and benefiting communities was made 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.

"(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.

Governance of stem cell research: public participation and decision-making in China, Japan, South Korea and Taiwan.

This article compares and explores forms of 'public' participation in the development of bioethical governance of human embryonic stem cell research (hESR) in four Asian societies, and in doing so it contributes to the wider discussions on expertise and public inclusion. The article aims to add nuance to the concept of 'public consultation' by focusing on the contested meanings and relationships through which public roles and public debates are defined. The analysis seeks to go beyond a straightforward comparison by interpreting public discussions of hESR as being influenced by both local conditions and interconnected global science institutions. An adequate understanding of the public participation in debates on science requires the analysis of (a) particular reasons for scientific issues to require public discussion; (b) pressures of transnational forces; (c) variability of publics relevant to bioethical regulation; and, (d) the effects of institutionalization of bioethics. This study uses data from fieldwork conducted between 2006 and 2010 in four Asian countries. Most of the interviews were conducted in the local languages and concerned various kinds of public participation in bioethics activities, as well as the views of stem cell scientists on the need to involve the public in discussions on the acceptability of their research.

Meanings of the embryo in Japan: narratives of IVF experience and embryo ownership.

This article explores the sociocultural meanings of the embryo implied in the narratives of 58 women who have undergone in vitro fertilisation in Japan over a period from 2006 to 2008. We argue that a lack of sufficient analysis of the sociocultural meanings of the embryo result in a situation where the use of reproductive technologies in Japan advances without reflecting upon the voices of women and couples that use them. Additionally, we argue that the often-heard view that pre-implantation genetic diagnosis causes less pain to women and couples than selective abortion in which foetuses are discarded, should be reviewed in the light of the new empirical evidence offered in this article. Furthermore, this article shows that the view often expounded by Japanese scientists that in Japan the cultural meanings attached to the embryo are insignificant, is incorrect. Consequently, the argument that Japan has no need for an active national debate on the status of embryos should be questioned. Though agreeing with some feminist views on the embryo debate, this article is also critical of feminist views that discuss embryo donation in terms of the loss of ownership of the embryo and the alienation of the embryo due to commodification.

Tensions between medical professionals and patients in mainland China.

In China, state investment into public hospitals has radically decreased since the early 1980s and has brought on the dismantling of the healthcare system in most parts of the country, especially in rural areas. As a result of this overhaul, the majority of public hospitals have needed to compete in the so-called socialist market economy. The market economy stimulated public hospitals to modernize, take on highly qualified medical professionals, and dispense new therapies and drugs. At same time, liberalization has clearly affected the attitude and behavior of both medical professionals and the general public. The public has many concerns about the healthcare system for various reasons: there are long hospital waiting lists, patients experience difficulties in obtaining an appointment to see a qualified doctor, and, over the past decades, there has been an increase in out-of-pocket healthcare expenditure. These and other changes in post-reform China have radically reshaped the doctor­patient interaction, which is increasingly eroded by tension and violence.

Experimental stem cell therapy: biohierarchies and bionetworking in Japan and India.

This article concerns new developments in autologous adult stem cell research in Japan and India through the notions of biohierarchy and bionetworking. It conceptualizes how human subject research in one country may be turned into experimental stem cell therapies in another through bionetworks. We analyse the processes that enable researchers in Japan to discard a therapy as being of reputational risk, while researchers in India employ it so that it becomes reputation enhancing. At the same time, scientists from both countries collaborate in and potentially benefit from the same bionetwork. Explaining how the recruitment of patients and scientists is organized through bionetworking, this article analyses how experimental research in India thrives using Japanese technologies. The concept of biohierarchy illustrates how inequalities in health and standards of living in India and in Japan underpin the methods by which researchers, medical professionals, managers and patients collaborate in bionetworks. The concept of 'boundary object' here captures the ways in which the meaning of experimental therapy is defined by subjective categories projected onto it by patients and scientists alike. The article is based on fieldwork conducted by both authors during 3 months between September and December 2008 at various locations in India and Japan. Data for this article were collected from a wide range of interviews with stem cell researchers, medical doctors, coordinators, managers and patients, primary and secondary sources gathered at these centres, and through web and archival research.

Reproductive technologies and the quality of offspring in Asia: reproductive pioneering and moral pragmatism?

This paper highlights a number of theoretical issues relevant to this special issue of Culture, Health & Sexuality on the quality of offspring, including gender selection, ecofeminism, eugenics, reproductive agency, moral pioneering and reproductive pragmatism in China, India and Japan. First, it discusses various approaches to choice in sex selection, focusing on an instrumentalist and an ecofeminist approach. Second, it discusses issues of reproductive choice in the light of various concepts of eugenics and power, which have been used to characterise the relationship between the state, the individual and prenatal genetic testing. Third, it queries Foucault's notion of biopower in relation to reproductive agency. In reviewing the evidence, the chapter raises questions about how women and parents in Asian societies can be understood in terms of 'reproductive pragmatism', 'empowerment' and/or 'moral pioneering' when faced with the use of new reproductive technologies in modern societies.

Choosing offspring: prenatal genetic testing for thalassaemia and the production of a 'saviour sibling' in China.

This paper focuses on the pre-natal genetic testing and reproductive decision-making around thalassaemia in China. Findings are based on fieldwork conducted in hospitals and research institutions, interviews with families with thalassaemia-affected children, interviews with geneticists and genetic researchers and a literature review conducted between September and November 2007. The paper aims to provide insight into the ways in which those who carry thalassaemia decide to have a test for the condition and the choices available to prospective parents. The paper also analyses factors affecting reproductive choices and the decision to produce a 'saviour sibling', including financial implications, state family planning policy, images and information conveyed through the media and propaganda, advice and counselling from doctors, psychological pressure from the community and social discrimination. The paper concludes with a discussion on the issues involved in the creation of saviour siblings, some of which are particular to China.

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.

Heritable Genome Editing in a Global Context: National and International Policy Challenges.

A central problem for the international governance of heritable germline gene editing is that there are important differences in attitudes and values as well as ethical and health care considerations around the world. These differences are reflected in a complicated and diverse regulatory landscape. Several publications have discussed whether reproductive uses would be legally permissible in individual countries and whether clinical applications could emerge in the context of regulatory gaps and gray areas. Systematic comparative studies that explore issues related to the governance of this technology from different national and international perspectives are needed to address the lack of knowledge in this area. In this research report, we contribute to filling this gap by presenting views of stakeholders in the United Kingdom on challenges to the governance of heritable genome editing. We present findings from a multistakeholder study conducted in the United Kingdom between October 2016 and January 2018 and funded by the Wellcome Trust. This research included interviews, literature analysis, and a workshop. We involved leading U.K. scientists, in vitro fertilization clinicians, and representatives from regulatory bodies, patient organizations, and other civil societal organizations, as well as fertility companies. Part one of this article explores stakeholder perceptions of possible global developments in heritable genome editing and associated risks and governance challenges. Part two presents a range of policy options that were generated during the workshop in relation to the challenges discussed in part one.

Marketing of unproven stem cell-based interventions: A call to action.

Commercial promotion of unsupported therapeutic uses of stem cells is a global problem that has proven resistant to regulatory efforts. Here, we suggest a coordinated approach at the national and international levels focused on engagement, harmonization, and enforcement to reduce the risks associated with direct-to-consumer marketing of unproven stem cell treatments.

Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations.

In this article, we explore regulatory developments in stem cell medicine in seven jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the EU. We will show that the research methods, ethical standards and approval procedures for the market use of clinical stem cell interventions are undergoing an important process of global diversification. We will discuss the implications of this process for international harmonization and the conduct of multicountry clinical research collaborations. It will become clear that the increasing heterogeneity of research standards and regulations in the stem cell field presents a significant challenge to international clinical trial partnerships, especially with countries that diverge from the regulatory models that have been developed in the USA and the EU.

Comparing national home-keeping and the regulation of translational stem cell applications: An international perspective.

A very large grey area exists between translational stem cell research and applications that comply with the ideals of randomised control trials and good laboratory and clinical practice and what is often referred to as snake-oil trade. We identify a discrepancy between international research and ethics regulation and the ways in which regulatory instruments in the stem cell field are developed in practice. We examine this discrepancy using the notion of 'national home-keeping', referring to the way governments articulate international standards and regulation with conflicting demands on local players at home. Identifying particular dimensions of regulatory tools - authority, permissions, space and acceleration - as crucial to national home-keeping in Asia, Europe and the USA, we show how local regulation works to enable development of the field, notwithstanding international (i.e. principally 'western') regulation. Triangulating regulation with empirical data and archival research between 2012 and 2015 has helped us to shed light on how countries and organisations adapt and resist internationally dominant regulation through the manipulation of regulatory tools (contingent upon country size, the state's ability to accumulate resources, healthcare demands, established traditions of scientific governance, and economic and scientific ambitions).

Translating 'Asian' Modes of Healing and Biomedicine.

This review article discusses the 'translation of Asian modes of healing and medicine' in six recently published books by raising seven questions. They serve both to review the volumes and to ask how we have moved from understanding systems of healing in terms of tradition and modernity, science and nonscience, globalization and locality, innovation and cultural heritage, to translating them in terms of assemblages, products, modes of resistance, social (dis-)harmony, and ecological balance. The questions span subjects ranging from the meaning of 'Asian' in Asian modes of healing, the object of healing and classifications of systems of healing to their relation with 'biomedicine,' modernization and the state, the extents to which communities share healing tradition, and their existential meaning in context.

From global bioethics to ethical governance of biomedical research collaborations.

One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered 'emerging biotech' locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of 'global bioethics'. Such a 'global', 'Western' or 'universal' bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four 'spheres' - deliberation, regulation, oversight and interaction - as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved.