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When the use of embryos in vitro for research was regulated under the Human Fertilisation and Embryology Act 1990 (as amended), regulators tried to navigate the various thresholds that occur in embryonic and research processes through providing clear-cut boundaries – the most well-known of these being the 14-day rule. This chapter offers an examination of this rule as a contemporary example of an existing mechanism in health research that is being pushed to its scientific limits. This steadfast legal boundary, faced by a relatively novel challenge, requires reflection on appropriate regulatory responses to embryo research, including the revisitation of ethical concerns, and an examination of the acceptability of carrying out research on embryos for longer than 14 days ? I argue that recognising the inherent link between processes and the regulation of the margins of human life, enables us to ask us to ask more nuanced questions about what we want for future frameworks, for example, ‘when is human?’, one that legal discussion often shies away from. Instead I will argue that viewing regulation of embryo research as instance of both processual regulation and regulating for process has the potential to disrupt existing regulatory paradigms in embryo research, and enable us to think about how we can, or perhaps whether we should, implement lasting frameworks in this field.
The first ever interdisciplinary handbook in the field, this vital resource offers wide-ranging analysis of health research regulation. The chapters confront gaps between documented law and research in practice, and draw on legal, ethical and social theories about what counts as robust research regulation to make recommendations for future directions. The Handbook provides an account and analysis of current regulatory tools - such as consent to participation in research and the anonymization of data to protection participants' privacy - as well as commentary on the roles of the actors and stakeholders who are involved in human health research and its regulation. Drawing on a range of international examples of research using patient data, tissue and other human materials, the collective contribution of the volume is to explore current challenges in delivering good medical research for the public good and to provide insights on how to design better regulatory approaches. This title is also available as Open Access on Cambridge Core.
This chapter considers how a liminal lens help inform contemporary discussions surrounding embryos in vitro and beyond using three case studies: 1) the 14-day rule, 2) in vitro gametogenesis, and 3) ectogenesis. The first case study is important as it is the principal manifestation of law’s attempt to reflect ‘special status’ on the embryo, and because it is also an example of legal attempts to deal with embryonic processes. This example is used to examine what the context-based approach developed in this book could bring to contemporary debate about the nature of such a rule, as well as its retention, reduction, or extinction. The second example enables us to consider what the analysis offered in this book says about these relatively new technologies in relation to their regulation, and the key biological and legal thresholds involved. The final case study focuses specifically on partial ectogenesis, a technology which not only introduces new thresholds, but leads us to question our existing understanding of meaningful legal thresholds, most notably birth as the moment in which the foetus/baby attains personhood. By these means, the analysis engages with the entire trajectory of embryonic development as this is driven by scientific possibilities, both current and near future.
This chapter draws parallels to the gothic trope that surrounded discussions on embryos in vitro in the 1980s as a frame of analysis that has grown in counter-response to law’s tendency to place entities either within the category of a ‘liberal, individual self,’ or outwith it (rarely in between). To explain, the gothic self is characterised by disorder, chaos, and dependency. It cannot be subsumed under the traditional ‘self’ that the law presupposes of its subjects. Further, within ‘the gothic’ lies the key concept of ‘monstrosity’, at the margins of what we deem to be human: ‘we stake out the boundaries of our humanity by delineating the boundaries of the monstrous’. While the gothic trope does not explicitly centre around ‘the in between,’ it is argued that we should see gothic entities as such, because of their common placement - legally, and sometimes socially - on the boundary between liberal, individualised human, and something akin to a science-fiction-esque ‘monster.’ The controversy that causes rhetorical parallels between new research and monstrous beings and mad scientists to be drawn is a major contributor to policy-makers reluctance to revisit the legal status of embryos in vitro.
In this introduction, McMillan introduces key concepts and definition discussed throughout the book, including: liminality, ‘the embryo’, process, and ‘legal status’. The regulation of emerging technologies may be described as the governance of processes in persistent flux, and in some cases, it is the regulation of what we do not yet know or fully understand. Reconciling process with progress, therefore, has not been easy. Nonetheless, the regulation of the embryo in vitro, and all the practices that law currently allows are, in essence, regulating for processes of change. Considering that it has been over 30 years since the 1990 Act was passed in its original form, is it time to legally reconceive ‘the embryo’? In this book McMillan calls for, and considers, the basis for a more coherent and robust intellectual defence of the ways in which we justify the different manners in which law treats different types of embryos created purposively towards different ends. The main questions that this analysis seeks to answer are the following: Overall, does law reflect and embody processual regulation, if so, what does this look like? And if not, what form could it take if reform were thought to be desirable?