Ethical issues and public communication in the development of cell-based treatments for COVID-19: Lessons from the pandemic.

The significant morbidity and mortality of coronavirus disease 19 (COVID-19) prompted a global race to develop new therapies. These include interventions using cell- or cell-derived products, several of which are being tested in well-designed, properly controlled clinical trials. Yet, the search for cell-based COVID-19 treatments has also been fraught with hyperbolic claims; flouting of crucial regulatory, scientific, and ethical norms; and distorted communication of research findings. In this paper, we critically examine ethical issues and public communication challenges related to the development of cell-based therapeutics for COVID-19. Drawing on the lessons learned from this ongoing process, we argue against the rushed development of cell-based interventions. We conclude by outlining ways to improve the ethical conduct of cell-based clinical investigations and public communication of therapeutic claims.

How Should Clinicians Execute Critical Force Interventions With Compassion, Not Just Harm Minimization, as a Clinical and Ethical Goal?

Responsibly determining whether and when to use potentially lifesaving force when caring for patients who are acutely mentally ill typically requires carefully applying 2 key ethical standards. First, short-term morbidity or mortality risk must be minimized. Second, potential long-term harm to a patient who is traumatized during a forcibly performed intervention and potential long-term consequences to a patient's trust in clinicians must be seriously considered. This article suggests these minimum standards in mental health care decision making are necessary but insufficient. It is proposed that clinicians' intentions and motivations should not be grounded merely in harm minimization; rather, they should be grounded in compassion maximization. The article then proposes criteria for what compassion maximization would look like in response to a case.

Drawing the line in clinical treatment of companion animals: recommendations from an ethics working party.

Modern veterinary medicine offers numerous options for treatment and clinicians must decide on the best one to use. Interventions causing short-term harm but ultimately benefitting the animal are often justified as being in the animal's best interest. Highly invasive clinical veterinary procedures with high morbidity and low success rates may not be in the animal's best interest. A working party was set up by the European College of Veterinary Anaesthesia and Analgesia to discuss the ethics of clinical veterinary practice and improve the approach to ethically challenging clinical cases. Relevant literature was reviewed. The 'best interest principle' was translated into norms immanent to the clinic by means of the 'open question argument'. Clinical interventions with potential to cause harm need ethical justification, and suggest a comparable structure of ethical reflection to that used in the context of in vivo research should be applied to the clinical setting. To structure the ethical debate, pertinent questions for ethical decision-making were identified. These were incorporated into a prototype ethical tool developed to facilitate clinical ethical decision-making. The ethical question 'Where should the line on treatment be drawn' should be replaced by 'How should the line be drawn?'

Un dilema ético actual: ¿Ensañamiento terapéutico o adecuación del esfuerzo terapéutico? / A current ethical dilemma: therapeutic savageness or adequate therapeutic effort?

La medicina está estrechamente relacionada con el uso cada vez más de modernas tecnologías, muy sofisticadas y poderosas, que ofrecen posibilidades sin precedentes, en cuanto a la prolongación de la vida. En consecuencia, surgen y abundan nuevos conflictos de carácter ético. La práctica de la adecuación del esfuerzo terapéutico continúa siendo un tema de reflexión médica vigente, demandado no solo por la comunidad científica, sino también por toda la sociedad. El trabajo tiene como objetivo fundamental realizar una breve reflexión teórica, desde un análisis ético acerca del desarrollo alcanzado por la ciencia y la tecnología a partir de la Revolución Científico Técnica y de su influencia en el campo de la medicina, específicamente en las unidades de atención al paciente grave, ante los problemas éticos que ocasiona este avance científico - tecnológico y el poder que se le otorga al equipo de salud que labora en este tipo de unidades para decidir entre la vida o la muerte, entre el ensañamiento terapéutico y la adecuación del esfuerzo terapéutico (AU).

La medicina está estrechamente relacionada con el uso cada vez más de modernas tecnologías, muy sofisticadas y poderosas, que ofrecen posibilidades sin precedentes, en cuanto a la prolongación de la vida. En consecuencia, surgen y abundan nuevos conflictos de carácter ético. La práctica de la adecuación del esfuerzo terapéutico continúa siendo un tema de reflexión médica vigente, demandado no solo por la comunidad científica, sino también por toda la sociedad. El trabajo tiene como objetivo fundamental realizar una breve reflexión teórica, desde un análisis ético acerca del desarrollo alcanzado por la ciencia y la tecnología a partir de la Revolución Científico Técnica y de su influencia en el campo de la medicina, específicamente en las unidades de atención al paciente grave, ante los problemas éticos que ocasiona este avance científico - tecnológico y el poder que se le otorga al equipo de salud que labora en este tipo de unidades para decidir entre la vida o la muerte, entre el ensañamiento terapéutico y la adecuación del esfuerzo terapéutico (AU).

Elementos necesarios al consentimiento informado en pacientes con esquizofrenia / Elements necessary for informed consent in patients with schizophrenia

En este artículo queremos analizar la teoría del consentimiento informado aplicado a la esquizofrenia. Para ello, exponemos cuáles son los elementos necesarios: que sea un proceso autónomo, voluntario, informado en cantidad y calidad suficiente, y que la persona tenga competencia para tomar decisiones. Finalmente, analizamos las excepciones que se aceptan, tanto a nivel de praxis médica como de normativa jurídica, para realizar una intervención médica sin el consentimiento del paciente: urgencia, renuncia del paciente a ser informado, privilegio terapéutico e incapacidad para tomar decisiones.

Neste artigo se pretende analisar a teoria do consentimento informado aplicada à esquizofrenia. Para tanto se apresentarão os elementos necessários: que seja um processo autônomo, voluntário, informado em quantidade e qualidade suficiente e que a pessoa tenha competência para tomar decisões. Finalmente, analisamos as exceções aceitáveis, tanto ao nível da práxis médica como de normativa jurídica, para realizar uma intervenção médica sem o consentimento do paciente: urgência, renúncia do paciente a ser informado, privilégio terapêutico e incapacidade para tomar decisões.

In this paper we want analyze informed consent theory as applied to schizophrenia. To that end, we identify the necessary elements for a process to be autonomous, voluntary and reported in sufficient quality and quantity, and for delegation of decision making authority. Finally, we analyze the exceptions that are accepted, in both medical praxis and legal norms, for medical intervention without the patient’s consent: urgency, patient’s waiver to be communicated, therapeutic privilege, and incapacity to make decisions.

Rawlsian Justice and Palliative Care.

Palliative care serves both as an integrated part of treatment and as a last effort to care for those we cannot cure. The extent to which palliative care should be provided and our reasons for doing so have been curiously overlooked in the debate about distributive justice in health and healthcare. We argue that one prominent approach, the Rawlsian approach developed by Norman Daniels, is unable to provide such reasons and such care. This is because of a central feature in Daniels' account, namely that care should be provided to restore people's opportunities. Daniels' view is both unable to provide pain relief to those who need it as a supplement to treatment and, without justice-based reasons to provide palliative care to those whose opportunities cannot be restored. We conclude that this makes Daniels' framework much less attractive.

Ética, bioética e deontologia no ensino da naturologia no Brasil / Ethics, bioethics and deontology in naturology teaching in Brazil

Objetivou-se discutir, pelo prisma da bioética social, como se configura a inserção das disciplinas de ética, deontologia e bioética no ensino da naturologia no Brasil. Sob abordagem qualitativo-descritiva e por meio de investigação documental e de campo, realizou-se o estudo em duas universidades brasileiras. Participaram seis docentes mediante entrevistas semiestruturadas que permitiram analisar os seis planos de ensino, três de cada curso. Os dados foram submetidos à análise de conteúdo e resultaram em quatro categorias: 1) características gerais das disciplinas que envolvem o estudo da ética, bioética e deontologia; 2) bioética como disciplina no curso de naturologia: temas e referenciais de análise; 3) abordagens teóricas da ética estudadas na naturologia; 4) estudo da deontologia no ensino da naturologia. Considera-se necessário ampliar a carga horária das disciplinas de ética e bioética e assinala-se a necessidade da constante reflexão sobre a prática profissional voltada para a realidade social brasileira...

The aim of this study was to discuss how the disciplines of ethics, deontology and bioethics are configured within the scope of Naturology teaching in Brazil from a Social Bioethics point of view. A qualitative-descriptive approach was used by means of documental and field investigations, based on two Brazilian universities. Six lecturers participated in this study via semi-structured interviews analyzing six teaching projects, three from each of the two courses. The data collected underwent content analysis, which resulted in four categories: 1) General aspects of the disciplines that include the subjects of ethics, bioethics and deontology; 2) Bioethics as a discipline in the course of Naturology: themes and references for analyses; 3) Theoretical approaches in ethics within Naturology; 4) The study of deontology in Naturology teaching. The need to increase teaching hours in the disciplines of ethics and bioethics was highlighted, as well as the need for constant reflection on professional practice within the social reality of Brazil...

Se objetivó discutir, bajo el prisma de la bioética social, cómo se configura la inserción de las asignaturas de ética, deontología y bioética en la enseñanza de la naturología en Brasil. Bajo un abordaje cualitativo y descriptivo y a través de investigación documental y de campo, se llevó a cabo el estudio en dos universidades brasileñas. Los participantes fueron seis docentes, por medio de entrevistas semi-estructuradas que pertieron sus planes de enseñanza, tres de cada curso. Los datos recogidos fueron sometidos al análisis de contenido y resultaron cuatro categorías: 1) características generales de las disciplinas que involucran el estudio de la ética, la bioética y la deontología; 2) bioética como disciplina en el curso de naturología: temas y marcos de análisis; 3) abordajes teóricos de la ética estudiados en la Naturología; 4) el estudio de la deontología en la enseñanza de la naturología. Se considera la necesidad de ampliar la carga horaria de las asignaturas de ética y bioética y se señala la necesidad de constante reflexión acerca de la práctica profesional centrada en la realidad social brasileña...

[Would you mind a little bit less? Methodological and ethical challenges posed by the reduction of overtreatment]. / Darf es auch weniger sein? Methodische und ethische Herausforderungen bei der Verringerung von Überversorgung.

The present paper outlines two central challenges that should be taken into account when making a concerted effort to reduce excessive medical care (overdiagnosis and overtreatment): first, the inevitability of value judgements in the risk-benefit assessment of medical treatment measures in conjunction with the need to go beyond the individual doctor-patient relationship and make these value judgements while, at least in part, assuming the role of acting deputy; and second, the need for a sufficient level of competence and trust in evidence-based medicine on the part of both physicians and patients. The paper will explain how one can say in a methodologically reasonable and ethically acceptable manner that a certain medical measure - in the context of the regular care setting - will objectively cause a "net harm" to the patient. Relevant institutions in the German healthcare system will be described that are currently conducting risk-benefit assessments (by different means and with different purposes). Taking the known entity of clinical guidelines as an example, the paper will demonstrate that the subjects of overdiagnosis and overtreatment as well as shortage of medical care can be more explicitly communicated by employing certain additional methodological tools. Finally, some central implementation barriers to a successful application of "Less is more!" will be presented and critically discussed. (As supplied by publisher).

On decoding and rewriting genomes: a psychoanalytical reading of a scientific revolution.

In various documents the view emerges that contemporary biotechnosciences are currently experiencing a scientific revolution: a massive increase of pace, scale and scope. A significant part of the research endeavours involved in this scientific upheaval is devoted to understanding and, if possible, ameliorating humankind: from our genomes up to our bodies and brains. New developments in contemporary technosciences, such as synthetic biology and other genomics and "post-genomics" fields, tend to blur the distinctions between prevention, therapy and enhancement. An important dimension of this development is "biomimesis": i.e. the tendency of novel technologies and materials to mimic or plagiarize nature on a molecular and microscopic level in order to optimise prospects for the embedding of technological artefacts in natural systems such as human bodies and brains. In this paper, these developments are read and assessed from a psychoanalytical perspective. Three key concepts from psychoanalysis are used to come to terms with what is happening in research laboratories today. After assessing the general profile of the current revolution in this manner, I will focus on a particular case study, a line of research that may serve as exemplification of the vicissitudes of contemporary technosciences, namely viral biomaterials. Viral life forms can be genetically modified (their genomes can be rewritten) in such a manner that they may be inserted in human bodies in order to produce substances at specific sites such as hormones (testosterone), neurotransmitters (dopamine), enzymes (insulin) or bone and muscle tissue. Notably, certain target groups such as top athletes, soldiers or patients suffering from degenerative diseases may become the pioneers serving as research subjects for novel applications. The same technologies can be used for various purposes ranging from therapy up to prevention and enhancement.

Las tecnologías de manipulación de genes humanos como imperativo tecnológico: análisis desde la óptica del principalismo bioético y el principio de la responsabilidad / As tecnologias de manipulação de genes humanos como imperativo tecnológico: análise pela ótica do principialismo bioético e do princípio da responsabilidade / Human gene manipulation technologies as technological imperative: analysis from the perspective of bioethical principalism and the principle of responsibility

Se ejemplifica, mediante el análisis de las nuevas tecnologías de manipulación de genes humanos como la terapia génica y el clonaje, lo que es común a la mayor parte de las ramas de la ciencia: El imperativo tecnológico de aplicar toda la capacidad técnica adquirida sin considerar las implicaciones éticas que éstas puedan presentar. La clonación por transferencia nuclear, por ejemplo, ha comenzado a ser una realidad científica y la presión ejercida por sectores de la comunidad científica y por determinados grupos está creando un imperativo tecnológico contra el que parece imposible oponerse o, al menos, establecer un diálogo reflexivo. Se argumenta que la validez del principalismo bioético anglosajón está limitada a la esfera de los efectos humanos recíprocos, considerando sólo la humanidad presente. Por lo anterior, tecnologías como la terapia génica con células somáticas, pueden ser apoyadas por los principios y no presentan problemas éticos diferentes a los de otro tipo de terapia experimental. Una decisión ética con repercusión para el futuro debe tener en cuenta las razones a favor y en contra de hacer o no hacer una investigación y por ello nuevas bases de sustentaciones teórico-metodológicas más abarcadoras que las del principalismo. Se demuestra la validez del Principio de la Responsabilidad de Hans Jonas que, como evaluación crítica de la ciencia y la tecnología modernas, llama a actuar con cautela y humildad frente al enorme poder transformador de la tecnociencia pues el orden ético está presente, no como realidad visible, sino como un llamado que pide calma, prudencia y equilibrio...

In this paper we exemplified by the analysis of new technologies of manipulation of human genes such as gene therapy and cloning, which is common to most branches of science: the technological imperative to apply all the technical capabilities acquired without considering the ethical implications they may have. Cloning by nuclear transfer, for example, has begun to be a scientific reality and the pressure exerted by sections of the scientific community and certain groups are creating a technological imperative against which it seems impossible to oppose or at least set a reflective dialogue. It is argued that the validity of anglo bioethical principles is limited to the sphere of reciprocal human effects, considering only the present humanity. Therefore, technologies such as somatic cell gene therapy can be supported by the principles and have no ethical problems different from other experimental therapy. An ethical decision with implications for the future must take into account the reasons for and against doing or not doing an investigation and thus new theoretical and methodological bases more comprehensive than the principles. We demonstrate the validity of Hans Jonas' principle of responsibility as and critical evaluation of science and modern technology, called to act with caution and humility in face of the tremendous transforming power of technoscience as the ethical order is present, not reality visible, but as an appeal that calls for calm, caution and balance...

Exemplifica, mediante análise das novas tecnologias de manipulação de genes humanos como a terapia gênica e a clonagem, o que é comum à maior parte dos ramos da ciência: o imperativo tecnológico de aplicar toda a capacidade técnica adquirida sem considerar as implicações éticas que disso podem advir. A clonagem por transferência nuclear, por exemplo, começou a ser uma realidade científica, e a pressão exercida por setores da comunidade científica e por determinados grupos vem criando um imperativo tecnológico contra o qual parece impossível se opor ou, ao menos, estabelecer um diálogo reflexivo. Argumenta que a validez do principialismo bioético anglo-saxão está limitada à esfera dos efeitos humanos recíprocos, considerando apenas a presente humanidade. Dado o exposto, tecnologias como a terapia gênica em células somáticas podem ser apoiadas pelos princípios, e não apresentam problemas éticos distintos aos de outro tipo de terapia experimental. Uma decisão ética com repercussão no futuro deve levar em conta as razões a favor e contra de ser feita ou não uma investigação, e com isso novas bases de sustentação teórico-metodológicas mais abrangentes que as do principialismo. Demonstra a validez do Principio da Responsabilidade de Hans Jonas, que como avaliação crítica da ciência e da tecnologia modernas chama para que se atue com cautela e humildade diante do enorme poder transformador da tecnociência, pois o preceito ético está presente não como realidade visível, mas como um chamado que pede calma, prudência e equilíbrio...

On the notion of (medical) invasiveness.

The relation between the notions of (medical) invasiveness and (actual or potential) harm has not been systematically discussed nor theoretically grounded, despite its importance to clinical-ethical practice. This paper aims to clarify the notion of invasiveness beyond the traditional notion of invasiveness as breaking skin or inserting mechanical objects into the body. The traditional notion of invasiveness is challenged by counterexamples. Three approaches to the notion of disorder applied here are: deviation from what is common; deviation from what is considered ideal; and disruption of self-organization. Assuming that more extreme measures are related to more harm, all three approaches to the notion of disorder suggest that invasiveness is proportional if not identical to harm, and show no clear relation to the traditional notion of invasiveness. In conclusion, the notion of invasiveness may best be eliminated from medical terminology, replacing it with a detailed understanding of the notion of harm.

[Ethical problems in the selection of embryos with therapeutic usefulness]. / Problemas éticos en la selección de embriones con finalidad terapéutica.

The first saviour sibling produced entirely in Spain was born in Hospital Virgen del Rocío of Seville in October 2008. The consequente mass media coverage has unleashed multiple requests for similar treatments to be carried on throughout the country. The process, its methodology and efficiency are revised. Their anthropological, ethical and deontological foundations are explored in order to assess their fulfillment. Umbilical cord banking blood is proposed as an alternative.

Bioetica Neonatal: limites en el tratamiento del recien nacido extremadamente prematuro. (sin improvisación moral a pesar de la incertidumbre) / Neonatal Bioethics: limits in the treatment of extremely premature newborn. (no moral improvisation despite uncertainty)

A partir de una encuesta, se ha revisado el proceder de 42 médicos especialistas en neonatología en la ciudad de Córdoba respecto del tratamiento de prematuros extremos, Desde los resultados se permite inferir que la mayoría de los profesionales médicos aplica la estrategia: “tratamiento intensivo provisorio” para todo el que supera el límite de las 23 semanas de gestación y los 500 gramos de peso al nacer. Se encontraron diferencias significativas en la participación activa de los padres en el proceso de toma de decisiones, aunque la totalidad de los padres recibe información adecuada. La práctica de limite del esfuerzo terapéutico (tanto la abstención como en el retiro de medidas de soporte vital) se llevan a cabo tanto en la esfera privada como pública pero existen diferencias significativas a favor de la abstención y retiro en las instituciones privadas. Es unánime el reclamo por recomendaciones ó pautas que faciliten la toma de decisiones en las situaciones difíciles, habiendo aceptación de recomendaciones propuestas en la encuesta .Resulta llamativo el hallazgo de considerar la práctica de “eutanasia activa” entre los encuestados en situaciones especiales...

We have reviewed in a survey the procedures of 32 Board Certified Neonatologists in the City of Córdoba, Argentina, regarding treatment of extreme preterm newborns. The results suggest that the majority of physicians use the strategy “ full support provisory¨ for preterms that were born at 23 weeks or more and weigh above 500 gms. We found significant statistical differences in parents participation in the decision taking process, although all receive the appropriate information. The practice of limit to therapeutical effort ( even in abstention or retire of life support) are both being taken at private and public health institutions, but there are significant differences in terms of abstention or retire of measures in private practice. There is a unanimous claim for recommendations that might facilitate to make decisions in difficult situations, having been accepted proposals made in the survey. It is important to mention that we found active euthanasia in special situations considered among the respondents in the survey...