[Bioethics theories, the protection of life and natural law]. / Teorías bioéticas, protección de la vida y ley natural.

Principlist Bioethics by Beauchamp and Childress has reached a prominent status in contemporary Bioethics. Nevertheless, it includes some important theoretical problems: some lacks when defining some concepts, a tendency to ethical relativism, etc. Among the ethical alternative approaches from which such problems can be solved, we think that the most appropiate is the Natural Law theory. It offers a reasoned reflection on the concept of good and on human basic goods and their relation with moral general principles. From such goods, this ethical theory supports the existence of actions that are always maleficent acts, that is, intrinsically and universally evil acts. The article applies the Natural Law theory to issues related to the protection of human life (abortion, euthanasia, self-defense and genetic manipulation)..

The Daunting Economics of Therapeutic Genome Editing.

There is no shortage of enthusiasm for the clinical potential of CRISPR-based genome editing: many life-changing cures appear to be just around the corner. However, as mature genetic therapies reach the market, it seems that million-dollar price tags are the new normal. Several factors contribute to the extreme pricing of next-generation medicines, including the need to recoup development costs, the undeniable value of these powerful therapies, and the inherent technical challenges of manufacture and delivery. CRISPR technology has been hailed as a great leveler and a democratizing force in biomedicine. But for this principle to hold true in clinical contexts, therapeutic genome editing must avoid several pitfalls that could substantially limit access to its transformative potential, especially in the developing world.

Nature beyond control: how expectations should inform decisions about human germline engineering.

In the ongoing discussion about the risks of reproductive human germline modification, scant attention has been paid to whether it could be reconciled with theories of psychological well-being. Even if safety and feasibility challenges could be overcome and germline engineering technology could be implemented in ways that avoid exacerbating social inequality, we would still have to question whether germline modification would promote circumstances that lead to better psychological experiences for parents, society, and the genetically edited person. This paper posits that germline engineering would produce expectations of being able to control the manifestation of an individual's characteristics, which will inevitably be upset by our limited understanding of how genes interact with each other and with the environment. Drawing on self-discrepancy and relative deprivation theories, it is suggested that both editing and being edited could lead to unmet expectations and thus negative emotional states that would offset benefits of successful intended genetic changes.

Revisión comentada de la legislación colombiana en ética de la investigación en salud / Commented review of the Colombian legislation regarding the ethics of health research

Resumen La ética de la investigación en salud no se agota en el marco normativo y trasciende la Resolución 8430 de 1993. Las normas constituyen una herramienta fundamental que determina los estándares mínimos de protección de los sujetos de investigación y, por lo tanto, su conocimiento y aplicación, así como la reflexión sobre ellas, son deberes de todos los investigadores en salud. En este texto se presentan y discuten desde un punto de vista analítico las normas para el ejercicio de la investigación en salud, entendiendo por salud un proceso multidimensional y por investigación en salud, un proceso multidisciplinario que trasciende este campo y abarca la investigación básica, la clínica y de salud pública, la colectiva y la de ciencias afines. Las principales categorías analíticas que se presentan se relacionan con los principios y los participantes en la investigación, las entidades reguladoras, los comités de ética y los sujetos y poblaciones especiales o vulnerables, y con los códigos de ética profesional, el consentimiento informado y el tratamiento de los datos. A pesar de los aportes de las normas éticas a la cualificación del ejercicio investigativo en salud, se concluyó que la normatividad vigente en Colombia debe actualizarse con respecto a los desarrollos técnicos y científicos y las especificidades de los diversos tipos de investigación en salud.

Abstract The scope of ethics in health research transcends its legal framework and the regulations established in Resolution 8430 of 1993. These norms represent a fundamental tool to determine the minimum protection standards for research subjects, and, therefore, they should be known, applied properly, and reflect upon by all researchers in the field. Here I present and discuss from an analytical point of view the regulations that guide research in health. In this framework, health is understood as a multidimensional process, and research in health as a multidisciplinary exercise involving basic, clinical and public health research, collective health, and other related sciences. The main analytical categories are related to the principles and actors involved in research (regulatory authorities, ethical committees, and special or vulnerable subjects and populations), and to professional ethics codes, in addition to informed consents and data management. Despite the contribution of this legislation to the qualification of health research, my conclusion is that the national legislation in ethics for health research requires updating regarding technological and scientific developments, as well as specifications from the multiple types of health studies.

Commented review of the Colombian legislation regarding the ethics of health research.

The scope of ethics in health research transcends its legal framework and the regulations established in Resolution 8430 of 1993. These norms represent a fundamental tool to determine the minimum protection standards for research subjects, and, therefore, they should be known, applied properly, and reflect upon by all researchers in the field.Here I present and discuss from an analytical point of view the regulations that guide research in health. In this framework, health is understood as a multidimensional process, and research in health as a multidisciplinary exercise involving basic, clinical and public health research, collective health, and other related sciences.The main analytical categories are related to the principles and actors involved in research (regulatory authorities, ethical committees, and special or vulnerable subjects and populations), and to professional ethics codes, in addition to informed consents and data management.Despite the contribution of this legislation to the qualification of health research, my conclusion is that the national legislation in ethics for health research requires updating regarding technological and scientific developments, as well as specifications from the multiple types of health studies.

The Slippery Slope Argument in the Ethical Debate on Genetic Engineering of Humans.

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 (but defeasible) form of argument, but is often flawed when used in ethical debates because of failures to meet the requirements of its scheme.

Essential Features of Responsible Governance of Agricultural Biotechnology.

Agricultural biotechnology continues to generate considerable controversy. We argue that to address this controversy, serious changes to governance are needed. The new wave of genomic tools and products (e.g., CRISPR, gene drives, RNAi, synthetic biology, and genetically modified [GM] insects and fish), provide a particularly useful opportunity to reflect on and revise agricultural biotechnology governance. In response, we present five essential features to advance more socially responsible forms of governance. In presenting these, we hope to stimulate further debate and action towards improved forms of governance, particularly as these new genomic tools and products continue to emerge.

Driven to extinction? The ethics of eradicating mosquitoes with gene-drive technologies.

Mosquito-borne diseases represent a significant global disease burden, and recent outbreaks of such diseases have led to calls to reduce mosquito populations. Furthermore, advances in 'gene-drive' technology have raised the prospect of eradicating certain species of mosquito via genetic modification. This technology has attracted a great deal of media attention, and the idea of using gene-drive technology to eradicate mosquitoes has been met with criticism in the public domain. In this paper, I shall dispel two moral objections that have been raised in the public domain against the use of gene-drive technologies to eradicate mosquitoes. The first objection invokes the concept of the 'sanctity of life' in order to claim that we should not drive an animal to extinction. In response, I follow Peter Singer in raising doubts about general appeals to the sanctity of life, and argue that neither individual mosquitoes nor mosquitoes species considered holistically are appropriately described as bearing a significant degree of moral status. The second objection claims that seeking to eradicate mosquitoes amounts to displaying unacceptable degrees of hubris. Although I argue that this objection also fails, I conclude by claiming that it raises the important point that we need to acquire more empirical data about, inter alia, the likely effects of mosquito eradication on the ecosystem, and the likelihood of gene-drive technology successfully eradicating the intended mosquito species, in order to adequately inform our moral analysis of gene-drive technologies in this context.

Bioenhancements and the telos of medicine.

Staggering advances in biotechnology within the past decade have given rise to pharmacological, surgical and prosthetic techniques capable of enhancing human functioning rather than merely treating or preventing disease. Bioenhancement technologies range from nootropics capable of enhancing cognitive abilities to distraction osteogenesis, a surgical technique capable of increasing height through limb lengthening. This paper examines whether the use of bioenhancements falls inside or outside the proper boundaries of healthcare, and if so, whether clinicians have professional responsibilities to administer bioenhancements to patients. After explicating two theoretical approaches to the concept of health, one objectivist and the other constructivist, I contend that clinicians' corresponding professional responsibilities hinge on which philosophical account of health is endorsed, and illustrate how the lack of analytic clarity with respect to this concept can lead to defective positions on the place of bioenhancements in healthcare. With this conceptual framework in place, an account of health as a cluster concept that incorporates both constructivist and objectivist components is developed and defended.

Stocking the genetic supermarket: reproductive genetic technologies and collective action problems.

Reproductive genetic technologies (RGTs) allow parents to decide whether their future children will have or lack certain genetic predispositions. A popular model that has been proposed for regulating access to RGTs is the 'genetic supermarket'. In the genetic supermarket, parents are free to make decisions about which genes to select for their children with little state interference. One possible consequence of the genetic supermarket is that collective action problems will arise: if rational individuals use the genetic supermarket in isolation from one another, this may have a negative effect on society as a whole, including future generations. In this article we argue that RGTs targeting height, innate immunity, and certain cognitive traits could lead to collective action problems. We then discuss whether this risk could in principle justify state intervention in the genetic supermarket. We argue that there is a plausible prima facie case for the view that such state intervention would be justified and respond to a number of arguments that might be adduced against that view.

International regulatory landscape and integration of corrective genome editing into in vitro fertilization.

Genome editing technology, including zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and clustered regularly interspaced short palindromic repeat (CRISPR)/Cas, has enabled far more efficient genetic engineering even in non-human primates. This biotechnology is more likely to develop into medicine for preventing a genetic disease if corrective genome editing is integrated into assisted reproductive technology, represented by in vitro fertilization. Although rapid advances in genome editing are expected to make germline gene correction feasible in a clinical setting, there are many issues that still need to be addressed before this could occur. We herein examine current status of genome editing in mammalian embryonic stem cells and zygotes and discuss potential issues in the international regulatory landscape regarding human germline gene modification. Moreover, we address some ethical and social issues that would be raised when each country considers whether genome editing-mediated germline gene correction for preventive medicine should be permitted.

The question of disability in the post-human debate. Critical remarks.

The issue of disability represents a test case for the sustainability, practical and theoretical, of transhumanist theories that lead to the advent of a posthuman era. In fact, dealing with mankind implies also the possibility that man has a disability. So, seeing whether, in the posthuman debate, persons with disability are respected, will show us if every man is respected. In this paper we start by analyzing the definition of disability given by the posthuman theorists. As we will see, this definition is deficient because it is strictly linked with the transhumanists' refusal of the distinction between therapeutic treatment and enhancement. The field of enhancement is very wide, and the moral judgment on it cannot be generalized. Nowadays, many developments made possible by human enhancement theories remain only speculated upon. However, those theories are already influential in the field of studying the beginning of life. Indeed, the possibility "to choose children" is real: here the issue of disability is decisive and the risk of discrimination is very high. So, looking at the issue of disability will allow us to explore the ethical weight of the post-human project. In the background, it will be possible to glimpse the question of what is the essence of man, an issue not considered enough in the post-human debate. On the contrary, it is a fundamental question which should be answered before proceeding to a substantial alteration of humanity.

Do we have a moral obligation to synthesize organisms to increase biodiversity? On kinship, awe, and the value of life's diversity.

Synthetic biology can be understood as expanding the abilities and aspirations of genetic engineering. Nonetheless, whereas genetic engineering has been subject to criticism due to its endangering biodiversity, synthetic biology may actually appear to prove advantageous for biodiversity. After all, one might claim, synthesizing novel forms of life increases the numbers of species present in nature and thus ought to be ethically recommended. Two perspectives on how to spell out the conception of intrinsic value of biodiversity are examined in order to assess this line of thought. At the cost of introducing two separate capacities of human knowledge acquisition, the 'admiration stance' turns out to reject outright the assumption of a synthetic species' intrinsic value and of an imperative to create novel species. The 'kinship stance' by contrast does ascribe value to both synthetic and natural species and organisms. Nonetheless, while from this perspective creating novel species may become an ethical demand under certain conditions, it favours changing organisms by getting in contact with them rather than synthesizing them. It is concluded that neither the admiration nor the kinship stance warrants a supposed general moral obligation to create novel species to increase biodiversity.

Resistance to agricultural biotechnology: the importance of distinguishing between weak and strong public attitudes.

Empirical research shows that European governments and retailers are unlikely to be directly punished by taxpayers and consumers if they move away from their anti-GMO positions and policies. However, it is ultimately not the weak attitudes of taxpayers and consumers that matter to governments and retailers but the strong attitudes of the noisy anti-biotech movement. (Image: Highway signs: ©maxmitzu - Fotolia.com; woman and balance: ©lassedesignen - Fotolia.com).

Ethical consequences of the positive views of enhancement in Asia.

There are positive views towards use of science and technology in all Asian countries, and positive views towards use of enhancement in China, India and Thailand. After considering of the widespread use of cosmetic surgery and other body enhancements in Asian countries, and the generally positive views towards letting individuals make choices about improvement of themselves, the paper concludes that we can expect other enhancements to also be adopted rapidly in Asia. There will be future ethical dilemmas emerging from this with concepts of preservation of nature, flow with nature, and definitions of human-ness, along with concepts of harmony and social justice. Japan is less willing to engage in genetic enhancement compared to China, India and Thailand, despite widespread cosmetic surgery across Asia.