How Neurotech Start-Ups Envision Ethical Futures: Demarcation, Deferral, Delegation.

Like many ethics debates surrounding emerging technologies, neuroethics is increasingly concerned with the private sector. Here, entrepreneurial visions and claims of how neurotechnology innovation will revolutionize society-from brain-computer-interfaces to neural enhancement and cognitive phenotyping-are confronted with public and policy concerns about the risks and ethical challenges related to such innovations. But while neuroethics frameworks have a longer track record in public sector research such as the U.S. BRAIN Initiative, much less is known about how businesses-and especially start-ups-address ethics in tech development. In this paper, we investigate how actors in the field frame and enact ethics as part of their innovative R&D processes and business models. Drawing on an empirical case study on direct-to-consumer (DTC) neurotechnology start-ups, we find that actors engage in careful boundary-work to anticipate and address public critique of their technologies, which allows them to delineate a manageable scope of their ethics integration. In particular, boundaries are drawn around four areas: the technology's actual capability, purpose, safety and evidence-base. By drawing such lines of demarcation, we suggest that start-ups make their visions of ethical neurotechnology in society more acceptable, plausible and desirable, favoring their innovations while at the same time assigning discrete responsibilities for ethics. These visions establish a link from the present into the future, mobilizing the latter as promissory place where a technology's benefits will materialize and to which certain ethical issues can be deferred. In turn, the present is constructed as a moment in which ethical engagement could be delegated to permissive regulatory standards and scientific authority. Our empirical tracing of the construction of 'ethical realities' in and by start-ups offers new inroads for ethics research and governance in tech industries beyond neurotechnology.

Kazuto Kato: the ethics of editing humanity.

Gary Humphreys talks to Kazuto Kato about the ethical and societal challenges posed by biotechnologies that allow for the editing of the human genome.

Playing God and tampering with nature: popular labels for real concerns in synthetic biology.

Public engagement in science with diverse cross-sections of the community is considered a critical aspect of responsible biotechnological innovation. While the research community shows willingness to engage with both ambivalent and supportive audiences about potentially disruptive technological advances, there is less enthusiasm for engaging with groups who hold deeply opposing views to such advances. 'Playing God' and 'tampering with nature' are popular examples of intrinsic objections often made in opposition to the development or use of novel genetic technologies. Historically appearing in arguments against the pursuit of genetically modified organisms in agriculture and food industries, intrinsic objections have previously been labelled by the science community as inconsistent, non-scientific, and vague. Now found in a range of innovation contexts, the domain of synthetic biology appears to attract such objections consistently. We present the findings from a large Australian study (N = 4593) which suggests 'playing God' objections and their variants can be multilayered and, at times, accompanied by meaningful information about risk perceptions. We use qualitative analysis of open-ended responses from an online survey to show how these objections are articulated in response to selected synthetic biology applications across environmental and health domains. Our research invites a rethink of how the synthetic biology community perceives, and engages with, people who express intrinsic objections. These people may additionally hold extrinsic concerns that may be potentially addressed, or at least reasonably considered, through dialogue. We offer some concluding remarks for engaging with publics who employ these types of arguments to communicate unease with aspects of technology development and use.

[The crispr / cas9 techniques applied to human genetic enhancement: a biotechnological, anthropological-philosophical and legal dialogue]. / Las técnicas crispr/cas9 aplicadas al mejoramiento genético humano: un diálogo biotecnológico, antropológico-filosófico y jurídico.

The CRISPR editing method is revolutionary. This technique opens the possibility of countless operations in the genome of living beings. However, the risks are high and, in some cases, unpredictable. Therefore, based on an anthropology that recognizes the human person with an inherent dignity that includes the body, this article intends to propose bases for a regulation capable of facing the challenge of CRISPR, especially, given the possibility of confusing its therapeutic resource with the eugenics, also before the imminent risk of unleashing unforeseen consequences such as mutations, malformations and side effects that could be devastating for human life.

Emerging moral status issues.

Many controversies in bioethics turn on questions of moral status. Some moral status issues have received extensive bioethical attention, including those raised by abortion, embryo experimentation, and animal research. Beyond these established debates lie a less familiar set of moral status issues, many of which are tied to recent scientific breakthroughs. This review article surveys some key developments that raise moral status issues, including the development of in vitro brains, part-human animals, "synthetic" embryos, and artificial womb technologies. It introduces the papers in this Special Issue, contextualises their contributions to the moral status literature, and highlights some enduring challenges of determining the moral status of novel types of beings.

Pregnant people, inseminators and tissues of human origin: how ectogenesis challenges the concept of abortion.

The potential benefits of an alternative to physical gestation are numerous. These include providing reproductive options for prospective parents who are unable to establish or maintain a physiological pregnancy, and saving the lives of some infants born prematurely. Ectogenesis could also promote sexual equality in reproduction, and represents a necessary option for women experiencing an unwanted pregnancy who are morally opposed to abortion. Despite these broad, and in some cases unique benefits, one major ethical concern is the potential impact of this emerging technology on abortion rights. This article will argue that ectogenesis poses a challenge to many common arguments in favour of a pregnant woman's right to choose, but only insomuch as it highlights that their underlying justifications for abortion are based on flawed conceptions of what the foetus and pregnancy actually are. By interrogating the various interests and relationships involved in a pregnancy, this article will demonstrate that the emergence of artificial gestation need not impact existing abortion rights or legislation, nor definitions of independent viability or moral status.

Human cerebral organoids and consciousness: a double-edged sword.

Human cerebral organoids (HCOs) are three-dimensional in vitro cell cultures that mimic the developmental process and organization of the developing human brain. In just a few years this technique has produced brain models that are already being used to study diseases of the nervous system and to test treatments and drugs. Currently, HCOs consist of tens of millions of cells and have a size of a few millimeters. The greatest limitation to further development is due to their lack of vascularization. However, recent research has shown that human cerebral organoids can manifest the same electrical activity and connections between brain neurons and EEG patterns as those recorded in preterm babies. All this suggests that, in the future, HCOs may manifest an ability to experience basic sensations such as pain, therefore manifesting sentience, or even rudimentary forms of consciousness. This calls for consideration of whether cerebral organoids should be given a moral status and what limitations should be introduced to regulate research. In this article I focus particularly on the study of the emergence and mechanisms of human consciousness, i.e. one of the most complex scientific problems there are, by means of experiments on HCOs. This type of experiment raises relevant ethical issues and, as I will argue, should probably not be considered morally acceptable.

Beginning of life ethics at the dawn of a new era of genome editing: are bioethical precepts and fast-evolving biotechnologies irreconcilable?

The amazing and almost unimaginable advances that have unfolded over the past decades in biotechnologies (heritable germline editing in particular) have brought bioethical issues to the forefront, sparking public debate and increasing attention worldwide. Such mind-blowing progress has already resulted in major improvement and enhancements for humans, and holds the potential for even more. Technology and bioengineering have begun to take over in the life sciences industry. Man's capacity to genetically engineer the biological world is nothing short of mind-boggling in its current magnitude, and may even evolve, in a not too distant future, into attempts to fuse man and machine into a cohesive bioengineered entity; a "super human being", endowed with enhanced cognitive and physical capabilities and impervious to disease, may be not too far down the road. That will not come without caveats, however. In fact, scientific advancements at such an accelerated pace have already negatively affected our cultural, ethical, and legal values and our ability to harness the opportunities and face the dangers posed by such developments. As a matter of fact, science seems to consistently outpace public morals, ethics and policymaking, which calls for a high degree of caution and common answers.

'It's not worse than eating them': the limits of analogy in bioethics.

Bioethicists often defend novel practices by drawing analogies with practices that we are already familiar with and currently tolerate. If some novel practice is less bad than some widely-accepted practice, then (it is argued) we cannot rightly reject it. Using the bioethics literature on xenotransplantation and interspecies blastocyst complementation as a case study, I show how this style of argument can go awry. The key problem is that our moral intuitions about familiar practices can be distorted by their seeming normality. When considering the ethics of emerging technologies and novel practices, we should remain open to the possibility that our moral views about familiar practices are mistaken.

Creating Bioethics Distance Learning Through Virtual Reality.

Bioethics education is a central element in the biotechnology curriculum. Re-imagining distance learning, virtual reality (VR) is taking student involvement to the next level of interaction, offering a real classroom experience and a new way to gain ethical reasoning skills. Here, we explore a new paradigm for bioethics education that involves VR.

Options to Reform the European Union Legislation on GMOs: Post-authorization and Beyond.

We discuss options to reform the EU genetically modified organism (GMO) regulatory framework, make risk assessment and decision-making more consistent with scientific principles, and lay the groundwork for international coherence. In this third of three articles, we focus on labeling and coexistence as well as discuss the political reality and potential ways forward.

The Promise of CRISPR for Human Germline Editing and the Perils of "Playing God".

In the midst of the media and professional exuberance regarding the potential benefits of CRISPR technology, voices of criticism and caution have also arisen. One of the thorniest such cautions has been the common objection that CRISPR allows bioscientists to "play God," particularly when it comes to potentially editing the human germline. Many in the biotechnology field are unsure how to address this concern. What does it mean, particularly for bioscientists who may not have any rational or rhetorical categories for God? In this article, I explore possible meanings of "playing God" and the arguments for how those meanings might be applied in the utilization of CRISPR technology for human germline editing. I then test the validity of those arguments and explore potential counterarguments. Finally, I discuss how members of the bioscience community might respond to the objection of "playing God" and contribute to that dialogue in ways that could impact the future of CRISPR development and applications.

Industrial Biotechnology: To What Extent Is Responsible Innovation on the Agenda?

The UK Industrial Biotechnology (IB) Strategy presents a consistent plan to develop the IB sector but fails to endorse an innovation process that allows for input from multiple publics. This could be disadvantageous for the bioeconomy: there are notable cases where negligence to address societal dimensions has caused innovation failure.

Societal and Ethical Issues in Industrial Biotechnology.

In this chapter we aim to give an overview of the main societal and ethical issues that are currently voiced around industrial biotechnology. We will illustrate this with some recent cases, such as the development of synthetic artemisinin, synthetic vanillin and vegetable oil produced by engineered algae. We show that current societal and ethical issues in industrial biotechnology centre on the following five themes: sustainability, naturalness, innovation trajectories, risk management and economic justice. In each of these themes, clashing public opinions fuel the public debate on the acceptability of new industrial biotechnology. In some cases this has led to the failure of otherwise promising innovations. In the last part, we provide suggestions on how to deal with these ethical and societal aspects based on the approach of Responsible Research and Innovation (RRI).

Avoiding the potentiality trap: thinking about the moral status of synthetic embryos.

Research ethics committees must sometimes deliberate about objects that do not fit nicely into any existing category. This is currently the case with the "gastruloid," which is a self-assembling blob of cells that resembles a human embryo. The resemblance makes it tempting to group it with other members of that kind, and thus to ask whether gastruloids really are embryos. But fitting an ambiguous object into an existing category with well-worn pathways in research ethics, like the embryo, is only a temporary fix. The bigger problem is that we no longer know what an embryo is. We haven't had a non-absurd definition of 'embryo' for several decades and without a well-defined comparison class, asking whether gastruloids belong to the morally relevant class of things we call embryos is to ask a question without an answer. What's the alternative? A better approach needs to avoid what I'll refer to as "the potentiality trap" and, instead, rely on the emergence of morally salient facts about gastruloids and other synthetic embryos.

El presente número 47 de la Revista de Bioética y Derecho contiene una sección monográfica titulada "Edición genómica, responsabilidad y bioética"... [editorial] / No disponible

No disponible

Gene editing in translational research / La edición de genes en la investigación traslacional / L'edició de gens en la recerca traslacional

DNA read and write technologies have accelerated biotechnology at an unprecedented pace. This enhanced capacity to engineer living beings has accelerated not only scientific research, but also the translation into novel therapies. New approved medicinal products include the correction of the diseased genome and synthetic enhancement to fight diseases. These practices are widely supported socially and scientifically. Applications beyond therapy have also be attempted. In 2018, researcher He Jiankui reported on the edition of human germline during the Second International Summit on Human Genome Editing. On the other hand, during the last years, there have also been attempts at somatic genetic enhancement without the provision of detailed outcomes. Reading and writing DNA empowers us to change our world, even ourselves. The social benefits may be enormous. We need to accelerate the debate, including the stakeholders, to foster a responsible use of these technologies and maximize the positive impact on society

Las tecnologías de lectura y escritura de ADN han acelerado la biotecnología a un ritmo sin precedentes. Esta capacidad mejora para diseñar seres vivos no solo ha acelerado la investigación científica, sino también la translación a terapias novedosas. Nuevos medicamentos aprobados incluyen la corrección del genoma enfermo y la mejora sintética para combatir las enfermedades. Estas prácticas son ampliamente apoyadas social y científicamente. También se han intentado aplicaciones más allá de la terapia. En 2018, el investigador He Jiankui informó sobre la edición de la línea germinal humana durante la Segunda Cumbre Internacional sobre la Edición del Genoma Humano. Por otro lado, en los últimos años también se han producido intentos de mejora genética somática. Leer y escribir ADN nos permite cambiar nuestro planeta, incluso cambiarnos a nosotros mismos. Los beneficios sociales

Les tecnologies de lectura i escriptura d'ADN han accelerat la biotecnologia a un ritme sense precedents. Aquesta capacitat millorada per dissenyar éssers vius no només ha accelerat la recerca científica, sinó també la translació a teràpies noves. Nous medicaments aprovats inclouen la correcció del genoma malalt i la millora sintètica per a combatre les malalties. Aquestes pràctiques són àmpliament recolzades social i científicament. També s'han intentat aplicacions més enllà de la teràpia. El 2018, l'investigador He Jiankui va informar sobre l'edició de la línia germinal humana durant la Segona Cimera Internacional sobre l'Edició del Genoma Humà. D'altra banda, en els últims anys també s'han produït intents de millora genètica somàtica. Llegir i escriure ADN ens permet canviar el nostre planeta, fins i tot canviar-nos a nosaltres mateixos. Els beneficis socials poden ser enormes. Necessitem accelerar el debat, incloent-hi les parts interessades a fi de fomentar un ús responsable d'aquestes tecnologies i maximitzar-ne l'impacte positiu en la societat