ABSTRACT On 22 January 2001, the UK became the first country to approve of embryonic stem cell research by passing the Human Fertilisation (Research Purposes) Regulations 2001, which legislated new research purposes for which early embryos can be used, in addition to those approved by the Human Fertilisation and Embryology Act 1990. Legal advisory committees, most notably the Chief Medical Officer's Expert Group and the House of Lords’ Select Committee, have offered various reasons, which can also be found in the (...) ethics literature, to justify this change. Those examined here are the views that: 1. Early embryos lack relevant qualities (or ‘the argument from lack of qualities’) and 2. Early embryos only have a potentiality to become humans with moral status (or ‘the argument from potentiality’). The validity of these arguments is questioned and a case is made for egalitarian speciesism. Embryos have moral status (used here in the restricted sense of the status possessed by all members of the class of beings which deserve the greatest moral significance in equal measure). They have more value than the value that should be assigned to nonhuman beings from the start of fertilisation. Current UK legislation on embryo research is immoral. (shrink)

This paper explores the ethics of introducing genome-editing technologies as a new reproductive option. In particular, it focuses on whether genome editing can be considered a morally valuable alternative to preimplantation genetic diagnosis. Two arguments against the use of genome editing in reproduction are analysed, namely safety concerns and germline modification. These arguments are then contrasted with arguments in favour of genome editing, in particular with the argument of the child’s welfare and the argument of parental reproductive autonomy. In addition (...) to these two arguments, genome editing could be considered as a worthy alternative to PGD as it may not be subjected to some of the moral critiques moved against this technology. Even if these arguments offer sound reasons in favour of introducing genome editing as a new reproductive option, I conclude that these benefits should be balanced against other considerations. More specifically, I maintain that concerns regarding the equality of access to assisted reproduction and the allocation of scarce resources should be addressed prior to the adoption of genome editing as a new reproductive option. (shrink)

BackgroundThis article explores the reasons in favour of revising and extending the current 14-day statutory limit to maintaining human embryos in culture. This limit is enshrined in law in over a dozen countries, including the United Kingdom. In two recently published studies, scientists have shown that embryos can be sustained in vitro for about 13 days after fertilisation. Positive reactions to these results have gone hand in hand with calls for revising the 14-day rule, which only allows embryo research until (...) the 14th day after fertilisation.Main textThe article explores the most prominent arguments in favour of and against the extension of the 14-day limit for conducting research on human embryos. It situates these arguments within the history of the 14-day limit. I start by discussing the history of the 14-day limit in the United Kingdom and the reasons behind the decision to opt for a compromise between competing moral views. I then analyse the arguments that those who are generally in favour of embryo research put forward in support of extending the 14-day rule, namely the argument of the beneficence of research and the argument of technical feasibility. I then show how these two arguments played a role in the recent approval of two novel techniques for the replacement of faulty mitochondrial DNA in the United Kingdom. Despite the popularity and widespread use of these arguments, I argue that they are ultimately problematic and should not be straightforwardly accepted. I end by making a case for respecting value pluralism in the context of embryo research, and I present two reasons in favour of respecting value pluralism: the argument of public trust and the argument of democracy.ConclusionI argue that 14-day limit for embryo research is not a valuable tool despite being a solution of compromise, but rather because of it. The importance of respecting value pluralism needs to be considered in any evaluation concerning a potential change to the 14-day rule. (shrink)

When is it morally acceptable to expose others to risk? Most moral philosophers have had very little to say in answer to that question, but here is a moral philosopher who puts it at the centre of his investigations.

Role of the entrepreneur in a distinct role of profit.

This article applies tools from argumentation theory to slippery slope arguments used in current ethical debates on genetic engineering. Among the tools used are argumentation schemes, value-based argumentation, critical questions, and burden of proof. It is argued that so-called drivers such as social acceptance and rapid technological development are also important factors that need to be taken into account alongside the argumentation scheme. It is shown that the slippery slope argument is basically a reasonable form of argument, but is often (...) flawed when used in ethical debates because of failures to meet the requirements of its scheme. (shrink)

Germline Gene Editing has enormous potential both as a research tool and a therapeutic intervention. While other types of gene editing are relatively uncontroversial, GGE has been strongly resisted. In this article, we analyse the ethical arguments for and against pursuing GGE by allowing and funding its development. We argue there is a strong case for pursuing GGE for the prevention of disease. We then examine objections that have been raised against pursuing GGE and argue that these fail. We conclude (...) that the moral case in favour of pursuing GGE is stronger than the case against. This suggests that pursuing GGE is morally permissible and indeed morally desirable. (shrink)

In 2015 scientists called for a partial ban on genome editing in human germline cells. This call was a response to the rapid development of the CRISPR–Cas9 system, a molecular tool that allows researchers to modify genomic DNA in living organisms with high precision and ease of use. Importantly, the ban was meant to be a trust-building exercise that promises a ‘prudent’ way forward. The goal of this paper is to analyse whether the ban can deliver on this promise. To (...) do so the focus will be put on the precedent on which the current ban is modelled, namely the Asilomar ban on recombinant DNA technology. The analysis of this case will show (a) that the Asilomar ban was successful because of a specific two-step containment strategy it employed and (b) that this two-step approach is also key to making the current ban work. It will be argued, however, that the Asilomar strategy cannot be transferred to human genome editing and that the current ban therefore fails to deliver on its promise. The paper will close with a reflection on the reasons for this failure and on what can be learned from it about the regulation of novel molecular tools. (shrink)

Recent progress in synthetic biology has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including ‘risk’ minimization. These concerns are associated with any FIH trial, however, due to the (...) novelty of the approach, they become more pronounced for medical applications of emerging technologies like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using ‘risk assessment’ as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as ‘risk’ and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue. (shrink)

CRISPR germline editing therapies hold unprecedented potential to eradicate hereditary disorders. However, the prospect of altering the human germline has sparked a debate over the safety, efficacy, and morality of CGETs, triggering a funding moratorium by the NIH. There is an urgent need for practical paths for the evaluation of these capabilities. We propose a model regulatory framework for CGET research, clinical development, and distribution. Our model takes advantage of existing legal and regulatory institutions but adds elevated scrutiny at each (...) stage of CGET development to accommodate the unique technical and ethical challenges posed by germline editing. (shrink)

The publication of the first study to use gene editing techniques in human embryos (Liang et al., 2015) has drawn outrage from many in the scientific community. The prestigious scientific journals Nature and Science have published commentaries which call for this research to be strongly discouraged or halted all together (Lanphier et al., 2015; Baltimore et al., 2015). We believe this should be questioned. There is a moral imperative to continue this research.

Economist Frank Knight drew a distinction between decisions under risk and decisions under uncertainty. Despite the significance of this distinction for decision theory, we argue that there has been inadequate attention to the difficulties involved in classifying decision situations into these categories. Using the risk assessment of carbon nanotubes as an example, we show that it is often unclear whether there is adequate information to classify a decision situation as being under risk as opposed to uncertainty. We conclude by providing (...) two suggestions for responding to these difficulties: treating decisions as real-world experiments; and promoting broadly based deliberation about quantitative information. (shrink)