Algunas reflexiones sobre el Convenio de Oviedo y los productos sanitarios. Responsabilidad y certificación en el caso de los cíborgs / Some reflections on the Oviedo Convention and medical devices. Liability and certification in the case of cyborgs

El Convenio de Oviedo constituye un marco genérico para las diversas aplicaciones de la biomedicina sobre el ser humano. Si por un parte sus disposiciones son de aplicación genérica, debe conjugarse, por otra parte, con otras normas especiales, las que regulan actividades particulares o ámbitos concretos. En el presente estudio nos cuestionamos acerca del encaje entre el marco genérico del convenio y la regulación de los productos sanitarios, en particular, nos centramos en la aplicación de tales productos sobre el cuerpo humano, integrándose en el organismo. Este es el caso de los cíborgs, o de la temática ya acuñada bajo el término transhumanismo. La reflexión nos lleva a evaluar las distintas normas y a ofrecer una propuesta de certificación atendiendo al régimen de responsabilidad respecto a este tipo de productos (AU)

The Oviedo Convention constitutes a generic framework for the various applications of biomedicine on human beings. If, on the one hand, its orders are of generic application, it must be combined, on the other hand, with other special regulations which regulates particular activities or specific areas. In this study, we question the fit between the generic framework of the Oviedo Convention and the regulation of medical devices, in particular, we focus on the application of such products on the human body, meanly, their integration into the body. This is the case of cyborgs, or the theme already coined under the term transhumanism. Our reflection leads us to evaluate the different standards and to offer a certification proposal based on the liability regime for this type of products (AU)

El Conveni d'Oviedo constitueix un marc genèric per a les diverses aplicacions de la biomedicina sobre l'ésser humà. Si per un comunicat les seves disposicions són aplicable genèrica, ha de conjugar-se, d'altra banda, amb altres normes especials, les que regulen activitats particulars o àmbits concrets. En el present estudi ens qüestionem sobre l'encaix entre el marc genèric del conveni i la regulació dels productes sanitaris, en particular, ens centrem en l'aplicació de tals productes sobre el cos humà, integrant-se en l'organisme. Aquest és el cas dels cíborgs, o de la temàtica ja encunyada sota el terme transhumanismo. La reflexió ens porta a avaluar les diferents normes i a oferir una proposta de certificació atès el règim de responsabilitat respecte a aquesta mena de productes (AU)

Regulating biobanks: an ethical analysis of the Spanish law and the new challenges of the bigdata-driven biomedical research / Regulando los biobancos: un análisis ético de la ley española y los nuevos retos de la investigación biomédica con datos masivos

In the European landscape, Spain represents a positive reference point when it comes to biobank regulation. Indeed, at the beginning of XXI century, the Spanish legislation has promptly responded to challenges posed by new biotechnologies and advances in genomics in the field of biomedical research by enacting in 2007 the Ley de Investigación Biomédica in order to keep up with the paradigm shift. Over the past 10 years, this Spanish framework along with the Real Decreto 1716/2011 has hold the merit to tackle the most controversial ethical issues related to use of human samples and personal data in biomedical research and biobanking (e.g. broad consent, secondary uses, governance, etc.). However, today the regulation of biomedical research and biobanks has to deal with big data, artificial intelligence and data-intensive research which have brought a number of challenges and controversies. The aim of this paper is two-fold. First, I will analyse from an ethical point of view the merits of Spanish regulation on biobanking in order to draw some lessons for the still unregulated situation in other Member States. Secondly, I will discuss the big data paradigm shift in biomedical research and question if the ethical and legal framework introduced the Spanish law at the beginning of the century is still able to hold the ground with the new contextual and societal challenges. In this respect, I will identify some opportunities for implementation and suggest strategies to achieve them in the specific context of biobanks (AU)

En el panorama europeo, España representa un punto de referencia positivo en lo que respecta a la regulación de los biobancos. De hecho, a principios del siglo XXI, la legislación española ha respondido rápidamente a los retos planteados por los avances de la biotecnología y la genómica en el campo de la investigación biomédica mediante la promulgación en 2007 de la Ley de Investigación Biomédica para mantenerse al día con el cambio de paradigma. Durante los últimos 10 años, este marco español junto con el Real Decreto 1716/2011 ha tenido el mérito de abordar las cuestiones éticas más controvertidas relacionadas con los biobancos. Sin embargo, hoy la regulación de la investigación biomédica y los biobancos tiene que lidiar con la inteligencia artificial e investigaciones con gran cantidad de datos que han planteado una serie de desafíos y controversias. El objetivo de este artículo es doble. En primer lugar, analizaré desde un punto de vista ético los méritos de la regulación española sobre biobancos con el fin de extraer algunas lecciones de la situación aún no regulada en otros Estados miembros. En segundo lugar, trataré el cambio de paradigma en la investigación biomédica y me preguntaré si el marco ético y legal que introdujo la ley española a principios de siglo todavía es capaz de mantenerse firmeante los nuevos desafíos contextuales y sociales. En este sentido, identificaré algunas oportunidades de implementación y sugeriré estrategias para lograrlas en el contexto específico de los biobancos (AU)

En el panorama europeu, Espanya representa un punt de referència positiu pel que fa a la regulació dels biobancs. De fet, a principis del segle XXI, la legislació espanyola ha respost ràpidament als reptes plantejats pels avanços de la biotecnologia i la genòmica en el camp de la recerca biomèdica mitjançant la promulgació en 2007 de la Llei de Recerca Biomèdica per a mantenir-se al dia amb el canvi de paradigma. Durant els últims 10 anys, aquest marc espanyol juntament amb el Reial decret 1716/2011 ha tingut el mèrit d'abordar les qüestions ètiques més controvertides relacionades amb els biobancs. No obstant això, avui la regulació de la recerca biomèdica i els biobancs ha de bregar amb la intel·ligència artificial i recerques amb gran quantitat de dades que han plantejat una sèrie de desafiaments i controvèrsies. L'objectiu d'aquest article és doble. En primer lloc, analitzaré des d'un punt de vista ètic els mèrits de la regulació espanyola sobre biobancs amb la finalitat d'extreure algunes lliçons de la situació encara no regulada en altres Estats membres. En segon lloc, tractaré el canvi de paradigma en la recerca biomèdica i em preguntaré si el marc ètic i legal que va introduir la llei espanyola a principis de segle encara és capaç de mantenir-se ferm davant els nous desafiaments contextuals i socials. En aquest sentit, identificaré algunes oportunitats d'implementació i suggeriré estratègies per a aconseguir-les en el context específic dels biobancs (AU)

What Pacemakers Can Teach Us about the Ethics of Maintaining Artificial Organs.

One day soon it may be possible to replace a failing heart, liver, or kidney with a long-lasting mechanical replacement or perhaps even with a 3-D printed version based on the patient's own tissue. Such artificial organs could make transplant waiting lists and immunosuppression a thing of the past. Supposing that this happens, what will the ongoing care of people with these implants involve? In particular, how will the need to maintain the functioning of artificial organs over an extended period affect patients and their doctors and the responsibilities of those who manufacture such devices? Drawing on lessons from the history of the cardiac pacemaker, this article offers an initial survey of the ethical issues posed by the need to maintain and service artificial organs. We briefly outline the nature and history of cardiac pacemakers, with a particular focus on the need for technical support, maintenance, and replacement of these devices. Drawing on the existing medical literature and on our conversations and correspondence with cardiologists, regulators, and manufacturers, we describe five sources of ethical issues associated with pacemaker maintenance: the location of the devices inside the human body, such that maintenance generates surgical risks; the complexity of the devices, which increases the risk of harms to patients as well as introducing potential injustices in access to treatment; the role of software-particularly software that can be remotely accessed-in the functioning of the devices, which generates privacy and security issues; the impact of continual development and improvement of the device; and the influence of commercial interests in the context of a medical device market in which there are several competing products. Finally, we offer some initial suggestions as to how these questions should be answered.

Cochlear Implantation, Enhancements, Transhumanism and Posthumanism: Some Human Questions.

Biomedical engineering technologies such as brain-machine interfaces and neuroprosthetics are advancements which assist human beings in varied ways. There are exciting yet speculative visions of how the neurosciences and bioengineering may influence human nature. However, these could be preparing a possible pathway towards an enhanced and even posthuman future. This article seeks to investigate several ethical themes and wider questions of enhancement, transhumanism and posthumanism. Four themes of interest are: autonomy, identity, futures, and community. Three larger questions can be asked: will everyone be enhanced? Will we be "human" if we are not, one day, transhuman? Should we be enhanced or not? The article proceeds by concentrating on a widespread and sometimes controversial application: the cochlear implant, an auditory prosthesis implanted into Deaf patients. Cochlear implantation and its reception in both the deaf and hearing communities have a distinctive moral discourse, which can offer surprising insights. The paper begins with several points about the enhancement of human beings, transhumanism's reach beyond the human, and posthuman aspirations. Next it focuses on cochlear implants on two sides. Firstly, a shorter consideration of what technologies may do to humans in a transhumanist world. Secondly, a deeper analysis of cochlear implantation's unique socio-political movement, its ethical explanations and cultural experiences linked with pediatric cochlear implantation-and how those wary of being thrust towards posthumanism could marshal such ideas by analogy. As transhumanism approaches, the issues and questions merit continuing intense analysis.

Engineering the Brain: Ethical Issues and the Introduction of Neural Devices.

Neural devices now under development stand to interact with and alter the human brain in ways that may challenge standard notions of identity, normality, authority, responsibility, privacy and justice.

An ethics toolbox for neurotechnology.

Advances in neurotechnology will raise new ethical dilemmas, to which scientists and the rest of society must respond. Here I present a "toolbox" of concepts to help us analyze these issues and communicate with each other about them across differences of ethical intuition.

From Darwininan to technological evolution: forgetting the human lottery / Desde la evolución darwiniana a la tecnológica: olvidar la lotería humana

The GRIN technologies (-geno, -robo, -info, -nano) promise to change the inner constitution of human body and its own existence. This transformation involves the structure of our lives and represent a -brave?- new world that we have to explore and to manage. In this sense, the traditional tools of humanism seems very inadequate to think the biotech century and there is a strong demand of a new thought for the evolution and the concrete history of life. The posthuman philosophy tries to take this new path of human existence in all of its novelty since GRIN technologies seem to promise new and unexpected paths of evolution to living beings and, above all, man. For this, the post-human thought, as we see, is a new anthropological overview on the concrete evolution of human being, an overview that involves an epistemological revolution of the categories that humanism uses to conceptualize the journey that divides the Homo sapiens from the man. But, is this right?

Las tecnologías GRIN (-geno, -robo, -info, nano) prometen cambiar la constitución interna del cuerpo humano y su propia existencia. Esta transformación consiste en la estructura de nuestras vidas y representan un -¿valiente?- nuevo mundo que tenemos que explorar y administrar. En este sentido, lo instrumentos tradicionales del humanismo parecen bastante insuficientes para pensar el siglo de la biotecnología y existe una fuerte demanda de un nuevo pensamiento para la evolución y la historia concreta de la vida. La filosofía posthumana intenta tomar este nuevo camino de la existencia humana en toda su novedad ya que las tecnologías GRIN parecen prometer caminos nuevos y inesperados de la evolución de los seres vivos y, sobre todo, humanos. Por esto, el pensamiento post-humano, como vemos, es una nueva visión antropológica sobre la evolución concreta del ser humano, una visión general que implica una revolución epistemológica de las categorías que el humanismo utiliza para conceptualizar el viaje que divide a los Homo sapiens del hombre. ¿Pero, serà correcto?

Lessons learned from undergraduate students in designing a science-based course in bioethics.

Columbia University offers two innovative undergraduate science-based bioethics courses for student majoring in biosciences and pre-health studies. The goals of these courses are to introduce future scientists and healthcare professionals to the ethical questions they will confront in their professional lives, thus enabling them to strategically address these bioethical dilemmas. These courses incorporate innovative pedagogical methods, case studies, and class discussions to stimulate the students to think creatively about bioethical issues emerging from new biotechnologies. At the end of each course, each student is required to submit a one-page strategy detailing how he or she would resolve a bioethical dilemma. Based on our experience in teaching these courses and on a qualitative analysis of the students' reflections, we offer recommendations for creating an undergraduate science-based course in bioethics. General recommendations include: 1) integrating the science of emerging biotechnologies, their ethical ramifications, and contemporary bioethical theories into interactive class sessions; 2) structuring discussion-based classes to stimulate students to consider the impact of their moral intuitions when grappling with bioethical issues; and 3) using specific actual and futuristic case studies to highlight bioethical issues and to help develop creative problem-solving skills. Such a course sparks students' interests in both science and ethics and helps them analyze bioethical challenges arising from emerging biotechnologies.

Tightening of ethical standards in bioengineering brings teaching the fore: in a realm noted for puzzlement, a rare consensus is achieved.

While the practice of ethical pondering has a formal academic history more than several thousand years old, and its pedigree within the human heart is undoubtedly much older, the somewhat specialized field of bioethics goes back approximately only 50 years in the United States. And while practitioners in the field-known as much for their painstaking pondering as for their acrimonious tendency to disagree-rarely achieve quick consensus on the pressing issues of the day, it would appear that in the United States we have reached some consensus on the best way of teaching biomedical ethics to undergraduate students.

Clinical ethical concerns in the implantation of brain-machine interfaces: part I: overview, target populations, and alternatives.

Recently, implantable brain-machine interfaces (BMIs) for the severely disabled have generated a great deal of excitement in the biomedical community, and clinical trials investigating their use as communication aids have already begun in the United States (these trials are discussed in the "Existing Devices and Trials" section). While the hypothetical societal implications of such devices are often discussed, the relative risks and benefits associated with their clinical use, as well as the alternative options available to patients, are not always part of this discussion. This article therefore seeks to outline the associated ethical concerns of the devices, the user populations for which the devices are intended, and existing noninvasive alternatives.

Reflections on the ethics of biomaterials science.

The subject of biomaterials science concerns artificial materials used in medical devices to repair or reconstruct natural human tissue damaged by disease or trauma. It embraces the emerging field of tissue engineering, where artificial materials are used as scaffolds to provide the architecture for replacement organs. As such, the field raises numerous ethical issues, which are reviewed in this paper. These include the use of animal models, the testing materials and devices in patients, and what may be viewed as potential abuses, where augmentation and repair are carried out for cosmetic as opposed to clinical reasons. The paper gives detailed consideration of the recent problems of metal-on-metal hip replacements as an exemplar of some of the key ethical issues that arise in this field.

Ethical guidance for the management of conflicts of interest for researchers, engineers and clinicians engaged in the development of therapeutic deep brain stimulation.

The clinical promise of deep brain stimulation (DBS) for neuropsychiatric conditions is coupled with the potential for ethical conflicts of interest because the work is so heavily reliant upon collaborations between academia, industry and the clinic. To foster transparency and public trust, we offer ethical guidance for the management of conflicts of interest in the conduct of DBS research and practice so that this nascent field can better balance competing goods and engineer new and better strategies for the amelioration of human suffering. We also hope that our ethical analysis will be of relevance to those working with other related neuroprosthetic devices, such brain-computer interfaces and neural arrays, which naturally share many of the same concerns.

A retrospective analysis of 10-year authorship trends in biomedical engineering journals.

Studies have indicated that academic research has become increasingly complex and multidisciplinary. There seems to be an increasing trend of multiple author articles published across most journals. As the field of biomedical engineering also encompasses multidisciplinary-based knowledge, it is interesting to understand the authorship trend over time. In this study, six journals were carefully chosen from the Journal Citation Report of the Thomson Scientific based on predefined criteria (year 1999 to 2008). The data pertaining to authorships for the articles published in these journals were then acquired from the PubMed database. The results show that there is a general upward trend for the number of author per article, but it is not significant (p > .01) despite a 64.5% increase in the total number of article published in the six chosen journals. Thus, the expected increase is not observed in this field, and it may be due to the stringent guidelines by journals in defining the contributions of an author. Particularly, contributing factors like the impact of authorship irregularities is discussed herein.

[Should medicine encourage doing? Biomedical engineering ideals and the issue of improving humans]. / La médecine doit-elle encourager le dopage? L'idéal de l'ingénieur en biomédecine et la question de l'amélioration de l'humain.

In the contemporary biomedicine, the new medicines and technologies can be used not only to cure the patients but also to enhance human capacities: genetic design, alteration of cognitive and emotional functions, increase in life-span, or to boost performances in sport... This evolution represents a paradigmatic change in the medical practice. It is not the mere restoration of health which is expected anymore. What is required is "the perfectibility of the human being". In this article, the emergence of the "enhancement technologies" is examined from an ethical and philosophical perspective.

Enhancing who? Enhancing what? Ethics, bioethics, and transhumanism.

Transhumanists advance a "posthuman" condition in which technological and genetic enhancements will transform humankind. They are joined in this goal by bioethicists arguing for genetic selection as a means of "enhancing evolution," improving if not also the species then at least the potential lives of future individuals. The argument of both, this paper argues, is a new riff on the old eugenics tune. As ever, it is done in the name of science and its presumed knowledge base. As ever, the result is destructive rather than instructive, bad faith promoted as high ideal. The paper concludes with the argument that species advancement is possible but in a manner thoroughly distinct from that advanced by either of these groups.