Achim Rosemann

University of Exeter | UoE · Department of Sociology, Philosophy and Anthropology

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 repro...

The international landscape of medical research is in the midst of a process of diversification and change. The randomized controlled trial (RCT), long considered the global gold standard for clinical research, has become increasingly contested and is partly replaced by alternative methodologies, standards and forms of evidence. The contours of mai...

This paper aims to analyze innovation pathways for stem cell technology in Argentina. Firstly, we present a theoretical perspective on the co-construction of regulation and technology development, positing four main tensions that underlie regulatory building and the shaping of national strategies for regenerative medicine. Regulation is understood...

Medicine regulation worldwide has undergone a process of regulatory diversification. The evidence-based medicine (EBM) paradigm, centered on multi-phase randomized controlled trials, is increasingly contested and replaced by new models of clinical validation. To explain these changes, STS research has cited just a few factors, e.g. growing pressure...

Health, Culture and the Human Body Principles of Biomedical Ethics, Genetics and Human Enhancement The frontlines of biomedical developments are expanding at an increasing speed. Novel technologies such as genome editing or repairing tissues in the human body or changing behavior through drugs are promoted with great emphasis on how they might impr...

This chapter explores regulatory developments for nonhematopoietic stem cell therapies in Japan, China, India, Argentina, Brazil, the USA, and the European Union. The chapter illustrates that the research methods, ethical standards, and approval procedures for the market use of nonhematopoietic stem cell interventions that have undergone an importa...

Bioethical debates on the use of human embryos and oocytes for stem cell research have often been criticized for the lack of empirical insights into the perceptions and experiences of the women and couples who are asked to donate these tissues in the IVF clinic. Empirical studies that have investigated the attitudes of IVF patients and citizens on...

While other works have explained difficulties in applying 'international' guidelines in the field of regenerative medicine in so-called low- and middle-income countries (LMICs) in terms of 'international hegemony', 'political and ethical governance' and 'cosmopolitisation', this article on stem cell regulation in China emphasizes the particular com...

In this article, we examine processes of ethical deliberation, legislative developments, and social and political factors that have contributed to the emergence of human embryo gene editing as a field of life science research in China. For this purpose, we examine conceptions of the legal status of the human embryo in three domains of China’s legal...

While other works have explained difficulties in applying ‘international’ guidelines in the field of regenerative medicine in so-called low- and middle-income countries (LMICs) in terms of ‘international hegemony’, ‘political and ethical governance’ and ‘cosmopolitisation’, this article on stem cell regulation in China emphasizes the particular com...

This chapter addresses challenges to the organization and conduct of international stem cell clinical trials in a context of regulatory pluralism. Multi-country clinical trial collaborations in stem cell medicine have the potential to speed up clinical developments and to widen access to new treatments among patients. However, the regulatory proced...

This chapter reviews the regulatory situation for clinical stem cell research in the People’s Republic of China since the early 2000s. The paper is structured in four parts. Part I examines the regulatory conditions for the donation of human gametes and embryos and their use in basic and preclinical research. This involves an overview of China’s re...

The continued significance of human embryonic stem cell research and recent advances in human somatic cell nuclear transfer and human gamete and embryo gene editing have given rise to renewed debates on the donation and use of human embryos and oocytes for research, therapies, and commercial applications. Sociological studies of cell and tissue don...

En Argentina las células madre son identificadas por científicos y funcionarios de Ciencia, Tecnología e Innovación (cti) como una prioridad estratégica. Esta definición de políticas se ve traducida en el creciente esfuerzo estatal para promover la construcción de capacidades en esta tecnología a través de programas, financiamiento y debates para g...

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 diversifi...

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 i...

The article explores the formation of an international politics of resistance and ‘alter-standardization’ in regenerative stem cell medicine. The absence of internationally harmonized regulatory frameworks in the clinical stem cell field and the presence of lucrative business opportunities have resulted in the formation of transnational networks ad...

On 22 August 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 applica- tions that involve human stem cells [1–3]. In China, regulation usually starts out as a draft or trial regulation. A draft regula- tion should be r...

Highlights • The paper tackles the organizational challenges of international stem cell trials • It explores the obstacles that result from regulatory variation across countries • The article argues for the formation of an international support structure • Such a structure will be of use to academic and corporate trial sponsors • Five steps throug...

Stem cell research has been acclaimed to revolutionize the future of medicine, and to offer new treatments for previously incurable diseases. Despite years of research, however, the therapeutic potential of stem cell research has not yet been fully realized. By June 2014 the US Food and Drug Administration had approved only five stem cell-based med...

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...

The article explores the contemporary dynamics of global scientific multipolarisation, and the empirical and theoretical implications of this trend for international clinical research collaborations. The focal point of the article is an ethnographic study of the China Spinal Cord Injury Network (China SCI Net), a transcontinental clinical research...

The article focuses on the integration process of clinical stem cell research in China in the international arena of high-profile science. This development is analyzed against the background of a well-established landscape of informal and frequently for-profit forms of clinical experimentation with stem cells. In doing so, I trace the institutional...

The donation of embryos for human embryonic stem cell (hESC) research is commonly framed as an act of solidarity, exemplifying a selfless expression of help from present-day citizens for public health improvements in the future. As I will show at the case of hESC research in the People's Republic of China, however, such discourse conceals the compl...