Editorial
- News From The Scripted Offices
Findlay Stark, pp.242-243
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Reviewed Articles
- “Beyond the Embryo: Transnational, Transdisciplinary and Translational Perspectives on Stem Cell Research”
Rosario Isasi and Bartha M Knoppers, pp.244-247
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- Open Access and the Regulation of Commercialisation of Human Stem Cell Lines in the UKSCB
Carol C. George, pp.248-264
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Although the United Kingdom is well regarded internationally for its initiative with the UKSCB, its regulatory framework poses significant issues for the realisation of therapies from human stem cell lines. A reassessment of the operations of the Bank in the wider context of stem cell line governance provides an opportunity to examine the relationship between the considerations that shaped HFEA policy on embryo research and their impact on the subsequent use of stem cell lines.
The proposal of this paper is that governance of the use of stem cell lines is not an integral part of the UK regulatory framework for embryo research and that commercial considerations are not necessarily subordinated to this regime. On the contrary, commercial considerations are highly relevant and should be given close attention by policymakers and the Steering Committee of the Bank in the process of development of an open access production system for stem cell lines in the United Kingdom.
- Clinical Translation of Stem Cell Therapies – Intellectual Property and Anticipatory Governance
Yann Joly, pp.265-273
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Though promoted as the next pillar of medical care, stem cell research has yet to make a major clinical impact. After an extremely difficult period in the late 90’s and the early 2000’s, the potential for clinical translation of stem cell therapies has been portrayed in a more positive light for the past three years. However, evidence demonstrates that the recovery of the stem cell industry is still incomplete and that recent success has been modest. There is still considerable reluctance to invest in stem cell research. One of the factors causing this reluctance is the uncertainty surrounding stem cell patents. In this paper we discuss the impact of patents on stem cell research and propose an anticipatory governance/real-time monitoring platform to promote the technology transfer of stem cell research. This approach would provide an ideal framework to anticipate hurdles raised by patents, select reflexive strategies and develop a shared vision of the role intellectual property should play in the clinical translation of stem cell research.
- Stem Cell Tourism: Assessing the State of Knowledge
Aaron D. Levine, pp.274-282
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Policy concern about patients travelling in search of unproven stem cell based interventions (SCBIs) – a practice known as “stem cell tourism” – has grown in recent years. These concerns are driven by the lack of convincing evidence of the safety or efficacy of these interventions and the resulting worry that individuals pursuing these unproven treatments may be putting themselves unnecessarily at risk and, perhaps, hindering legitimate translational stem cell research. This article reviews existing literature on stem cell tourism, focusing in particular on what is known about the providers of unproven SCBIs, the patients who pursue these interventions, and the outcomes of such interventions. The article concludes by highlighting gaps in the existing literature base and suggesting questions for future investigation.
- Lost in Translation: China’s Struggle to Develop Appropriate Stem Cell Regulations
Dominique McMahon and Halla Thorsteinsdóttir, pp.283-294
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This paper examines the regulations that govern stem cell use in China. We draw our findings from an analysis of government policies and documents, formal and grey literature, and thirty-nine interviews with Chinese stem cell experts. Although China developed research guidelines for embryonic stem cell research early on, it is still struggling to develop appropriate regulations surrounding the clinical translation of stem cell research. We identify the lessons that can be learned from China’s experiences developing appropriate regulations for their stem cell sector, and show the importance of timely regulation and of regulation for each stage of product development from research through to clinical applications. We discuss the development of appropriate regulation, and the international significance of Chinese stem cell regulations.
- Bionetworking: Between Guidelines and Practice in Stem Cell Therapy Enterprise in India
Prasanna Kumar Patra and Margaret Sleeboom-Faulkner, pp.295-310
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Many stem cell therapies, even though largely unproven, are widely viewed as promising to global healthcare provision. India is a leading proponent of the practice of making this therapy available as a last resort to patients from around the world, who are prepared to risk their remaining health and financial resources in exchange for hope. Stem cell therapy service centers, labeled as ‘rogue’ or ‘maverick’ by some, are vigorously promoting such therapies as ‘safe’ modes of treatment in the guise of ‘experimental’ therapy. This has been carried on in India even since its promulgation of the Guidelines for Stem Cell Research and Therapy in 2007. This article is based on a multi-site ethnographic study carried out at several locations in India between September and December 2008. It raises two questions: why the use of unproven therapies is becoming common practice in jurisdictions in which regulatory apparatus is in place; and, how these service providers are succeeding in sustaining and proliferating such therapeutic practices. By employing the concept of bionetworking, we have tried to describe the gap between regulation and implementation. This article divides service providers into three categories – public sector, private sector and individual practitioner – on the basis of their institutional embeddedness. It explores how service providers are able to exploit the gray areas of regulatory systems to their own entrepreneurial ends. The article highlights how local actors engaged in stem cell therapy draw on international norms of bioethics but adopt them according to various underlying rationales, shaped by local patterns of governance, institutional development and policy-making.
- Stem Cell Research in the News: More than a Moral Status Debate?
Christen Rachul, Amy Zarzeczny, Tania Bubela and Timothy Caulfield, pp.311-323
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The interest and controversy generated by stem cell research over the past decade has raised hopes for scientific breakthroughs and debates regarding the limits of ethical research. In particular, the debate surrounding the moral status of the embryo has received considerable attention in scientific and political arenas. However, coverage in the public arena of the elite press is less clear. We explore and reflect on the coverage of this debate in the public realm of the elite press in the United States, the United Kingdom, and Canada, by examining newspaper articles from each jurisdiction collected over a period of two decades.
- Human Embryonic Stem Cell Research in Iran: The Role of the Islamic Context
Mansooreh Saniei, pp.324-334
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Human embryonic stem cell (ESC) research is highly contentious in many societies, as it makes use of human embryos. Due to their varying socio-cultural, religious and political backgrounds, individual countries have different regulatory approaches which play an important role in international human ESC research collaborations. Thus, studying the complexity of regulatory frameworks in different parts of the world highlights differences and similarities between nations, the variety of views on specific issues, and the range of regulatory uncertainties. I will therefore review the ethical, social and legal implications of human ESC research in Iran, which has assumed a leadership role in this area among the Middle Eastern Muslim countries. In this essay, I shall first describe how human ESC research is both shaped and regulated by Islamic law and ethics. I will then discuss the current state of this field and its ethics in Iran. In conclusion, I will argue that, although both science and religion are key factors in the current debate surrounding human ESC research, additional factors influence the manner in which new knowledge is taken up in countries with the same religious background or scientific interests.
Analysis
- ZOMBIES! Not Just the Undead, but the Near-Dead and the Never-Living: An Introduction to SCRIPTed’s “Zombie” Analysis Section
Shawn H.E. Harmon, pp.335-337
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- Technology Convergence: Governance and Gaps in the Era of Enhancement (or “ZombAIs ante Portas!”)
Shawn H.E. Harmon and Wiebke Abel, pp.338-350
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Within the context of a given scenario, the authors undertake a preliminary exploration of issues around the convergence of several technologies: artificial intelligence technology, nanotechnology, and red biotechnology. First, we consider the state of these technologies and where they appear to be headed, identifying current capabilities, desired future objectives, and known technical shortcomings to the realisation of the scenario. Second, we identify some of the key social, ethical and legal issues raised by the scenario, highlighting the regulatory instruments that are currently most influential on the development of these techno-sciences and their capacity to address the issues raised (i.e. to address the development of moral machines and socially acceptable intelligent implants). We conclude that there is a need for further and better – more “joined-up” – regulation to govern the convergence of these fields, which will see the science fiction of today (both utopian and dystopian) become a reality.
- The Zombie from Myth to Reality: Wade Davis, Academic Scandal and the Limits of the Real
David Inglis, pp.351-369
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The figure of the zombie is one of the most ubiquitous in contemporary popular culture. They are also beginning to be more at the centre of academic attention in a range of areas, beyond specialists in ethnology and folkloric beliefs. The image of the zombie seems to symbolise and embody a diverse range of phenomena. But the figure of the zombie was not always so intellectually respectable, especially if it was claimed that zombies were not just symbols but were in fact “real”. In the mid-1980s the ethnobotanist Wade Davis claimed that far from being only folkloric images, zombies were in fact “made” in Haiti. Actual cases of zombification could be demonstrated, and proven to result from the particular religious, social, moral and legal codes of Haitian peasant society. Davis’s publication of the claims caused a storm of controversy that in some ways has still not subsided. This paper traces out the nature both of Davis’s claims, and the scandal they gave rise to. Reasons are offered as to why the zombie subject matter seemed at the time to be so scandalous. The implications of Davis’s unintended contribution to the development of taking zombies seriously within the academy are presented and reflected upon.
- Zombie Botnets
Alana Maurushat, pp.370-383
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Zombie botnets are the greatest Internet threat of the current generation. Botnets are said to be involved in most forms of cybercrime and civil wrongdoing ranging from sending spam, to denial of service attacks, to child pornography distribution to key-logging technology and traffic-sniffing which captures passwords and credit card numbers. This article traces the rhetoric of the term zombie in the world of computer security, describes the inner workings of a botnet, and argues that one method of botnet curtailment will be through Internet Service Provider bot remediation programs that slow down the propagation methods of botnets and act as a catalyst to clean up infected computers.
- ZombAIs: Legal Expert Systems as Representatives “Beyond the Grave”
Burkhard Schafer, pp.384-393
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This paper explores the possibility of computer assistance for the interpretation of wills and testaments. It draws from experience with legal expert systems developed for the interpretation of laws and other legal norms.
- In Vitro Meat: Zombies on the Menu?
Neil Stephens, pp.394-401
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In April 2008 the In Vitro Meat Consortium held its first meeting at the Norwegian Food Research Institute. They are a group of scientists and advocates who seek to turn the techniques of tissue engineering to the production of food, producing meat in laboratories that has at no point been part of a living animal. This is a fascinating technology, and one that fits well with the topic of this SCRIPTed analysis section: the ‘zombification’ of meat products. I have been conducting interviews with scientists who are involved in In Vitro Meat research at the three main research sites to explore the emergent social, ethical and regulatory issues of the technology. In this discussion I first provide detail on the current level of scientific development in the field and then describe the social context and promise of In Vitro Meat, before finally returning to the central question of what exactly In Vitro Meat is: zombie or not?
Reports
- The Leibniz Center for Law
Tom van Engers and Radboud Winkels, pp.402-405
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- Governance of Stem Cell Science: Multiple Models & Similar Outcomes
Geoffrey Lomax, pp.406-408
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Book Reviews
- The Law of Electronic Commerce
By Alan Davidson
Reviewed by Luca Escoffier, pp.409-411
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- Law and Society Approaches to Cyberspace
By Paul Schiff Berman
Reviewed by Andres Guadamuz, pp.412-413
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- Speaking For the Dead: The Human Body in Biology and Medicine
By D. Gareth Jones and Maja I. Whitaker
Reviewed by Ken Mason, pp.414-418
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- Trade Mark Law And Sharing Names: Exploring Use Of The Same Mark By Multiple Undertakings
By Ilanah Simon Fhima (ed)
Reviewed by Abdallah Ziadat, pp.419-420
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