Biobank donation in search of public benefits and the potential impact of intellectual property rights over access to health-technologies developed: A focus on the bioethical implications.

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.

Tribal Healing, Suicide, Ethical Issues, Cancer and Measuring Religiosity and Spirituality.

This issue of JORH considers the 'good, the bad and the ugly' of tribal or traditional healers, as well as articles relating to ethical challenges due to contemporary medicine and environmental issues. The concluding series on suicide (Part 2) is also finalized in this issue, as well as a number of research articles from multiple countries relating to cancer. Similar to previous issues, JORH once again adds to its increasing collection of articles relating to the empirical measurement of religion, spirituality and health. Readers are also reminded of the European Congress on Religion, Spirituality and Health (ECRSH) (Salzburg, Austria, May 2024), as well as the inaugural International Moral Injury and Wellbeing Conference (IMIWC) (Brisbane, Australia, September 2024).

Language Variations in Describing Nutrition and Hydration Interventions in State Physician Orders for Life Sustaining Treatment Forms and the Implications for Advanced Dementia Patients.

Background: Research suggests that language can impact medical decision-making, but few studies exist describing the variations in language to describe end-of-life nutrition and hydration interventions. The language contained in the Physician Orders for Life Sustaining Treatment (POLST) form varies across states, but this variation has not yet been fully analyzed. This investigation has implications for communicating with surrogates about the insertion of feeding tubes in advanced dementia patients, a common procedure in this population despite its potentially high risks and low benefits. Objective: Identify and analyze the variations in language related to end-of-life nutrition and hydration interventions in state POLST forms. Design: Descriptive study. Measurements: The most up-to-date POLST forms for each of the 50 US states and the District of Columbia as of August 2022 were analyzed for their descriptions of end-of-life nutrition and hydration interventions. Results: Fifty out of 51 (98%) forms referenced nutrition and/or hydration interventions. Four main modifiers of the word "nutrition" and/or "hydration" were identified: artificial (32%), artificially administered (56%), medically administered (14%), and assisted/medically assisted (18%). Forty-eight (96%) forms indicated an explicit option to forgo feeding tubes, and all of these forms described doing so with negatively valenced language. Conclusions: The language describing end-of-life nutrition and hydration interventions and feeding tubes in state POLST forms is insufficiently specific and varies significantly across the country. These terms are at best ambiguous and at worst imply incorrect information. More precise language may assist in the difficult discussion between physicians and surrogates about inserting feeding tubes in advanced dementia patients.

Critical analysis of the AI impact on the patient-physician relationship: A multi-stakeholder qualitative study.

Objective: This qualitative study aims to present the aspirations, expectations and critical analysis of the potential for artificial intelligence (AI) to transform patient-physician relationship, according to multi-stakeholder insight. Methods: This study was conducted from June to December 2021, using an anticipatory ethics approach and sociology of expectations as the theoretical frameworks. It focused mainly on three groups of stakeholders; namely, physicians (n = 12), patients (n = 15) and healthcare managers (n = 11), all of whom are directly related to the adoption of AI in medicine (n = 38). Results: In this study, interviews were conducted with 40% of the patients in the sample (15/38), as well as 31% of the physicians (12/38) and 29% of health managers in the sample (11/38). The findings highlight the following: (1) the impact of AI on fundamental aspects of the patient-physician relationship and the underlying importance of a synergistic relationship between the physician and AI; (2) the potential for AI to alleviate workload and reduce administrative burden by saving time and putting the patient at the centre of the caring process and (3) the potential risk to the holistic approach by neglecting humanness in healthcare. Conclusions: This multi-stakeholder qualitative study, which focused on the micro-level of healthcare decision-making, sheds new light on the impact of AI on healthcare and the potential transformation of patient-physician relationship. The results of the current study highlight the need to adopt a critical awareness approach to the implementation of AI in healthcare by applying critical thinking and reasoning. It is important not to rely solely upon the recommendations of AI while neglecting clinical reasoning and physicians' knowledge of best clinical practices. Instead, it is vital that the core values of the existing patient-physician relationship - such as trust and honesty, conveyed through open and sincere communication - are preserved.

Betraying, Earning, or Justifying Trust in Health Organizations.

Health care and public health programs increasingly rely on, and often even require, organizational action, which is facilitated, if not dependent on, trust. Case examples in this essay highlight trust, trustworthiness, and distrust in public and private organizations, providing insights into how trust in health-related organizations can be betrayed, earned, and justified and into the consequences of organizational trust and trustworthiness for the health of individuals and communities. These examples demonstrate the need for holistic assessments of trust in clinicians and trust in organizations and for organizations, public health, and the medical profession to address questions concerning their own trustworthiness. Normative and empirical assessments of trust and trustworthiness that capture the experiences of those treated within the walls of a health care organization, as well as the care of those outside, will contribute to more trustworthy systems of care.

Parenteral nutrition in cancer patients outside of oncologic treatment: Bioethical perspective.

BACKGROUND AND AIMS: The medical care of a patient with an end-stage disease focus on the pursuit of the patient's quality of life. Many treatments can be used to achieve this goal. In this study, the benefits, and burdens of providing parenteral nutrition to patients diagnosed with end-stage cancer were reviewed and analyzed from a bioethical perspective with the aim of issuing a useful recommendation for decision making. METHODOLOGY: A qualitative convergent study through interviews and a multiple case study was performed. The study is on the decisions to provide parenteral nutrition as an end-of-life treatment for terminal cancer patients treated in Mexico City. Eight physicians specialized in Oncology and Palliative Care were interviewed and 10 clinical records of patients diagnosed with terminal cancer, who were out of oncologic treatment, who received palliative care and were prescribed parenteral nutrition at the end of life were analyzed. RESULTS: The physicians considered parenteral nutrition as an advanced life-sustaining medical treatment and, therefore, susceptible to not being initiated or being withdrawn, according to the patient's clinical situation. Minor complications secondary to parenteral nutrition were found in all the records reviewed, all these patients died in hospital instead of at home. CONCLUSION: When death is certain in the short term and cannot be avoided, the role of feeding and nutrition becomes questionable, especially in cancer patients at the end of life, where parenteral nutrition causes more burden than benefit.

"Dogs on Call": A Community-Engaged Human Subjects Training with Hospital Based Therapy Dog Teams.

Problem: As community-engaged research (CER) methods evolve, Institutional Review Boards (IRBs) must adapt policies to facilitate CER research. This paper describes a novel collaboration between hospital-based therapy dog volunteer teams (CERs), academic faculty, and an IRB. Subjects: CER volunteers delivered a canine-assisted intervention to hospitalized adults in a clinical trial. Methods: IRB members and faculty developed a human subjects protections training tailored to the volunteer handlers' role as study interventionists including an interactive video- and discussion-based training with a knowledge assessment. Findings: Fourteen volunteer handlers were trained. The expedited IRB review period was similar to national average rates (18 days.) Volunteer handlers have conducted 107 research visits with little patient attrition. Conclusion: Tailored human subjects trainings facilitate research with interventions delivered by people who are not typically involved in research. Bespoke CER human subjects training requires collaboration between researchers and IRBs and flexibility in IRB policy regarding CER.

Mitochondrial Replacement Therapy: An Islamic Perspective.

Mitochondrial replacement technology (MRT) is an emerging and complex bioethical issue. This treatment aims to eliminate maternal inherited mitochondrial DNA (mtDNA) disorders. For Muslims, its introduction affects every aspect of human life, especially the five essential interests of human beings-namely, religion, life, lineage, intellect, and property. Thus, this technology must be assessed using a comprehensive and holistic approach addressing these human essential interests. Consequently, this article analyses and assesses tri-parent baby technology from the perspective of Maqasidic bioethics-that is, Islamic bioethics based on the framework of Maqasid al-Shariah. Using this analysis, this article suggests that tri-parent baby technology should not be permitted for Muslims due to the existence of third-party cell gametes which lead to lineage mixing and due to the uncertain safety of the therapy itself and because the major aim of the technology is to fulfil the affected couples interest to conceive their own genetically healthy child, not to treat and cure mtDNA disorders sufferers.

Aspectos bioéticos relacionados aos cuidados de fim de vida: uma revisão integrativa

esta é uma revisão integrativa da literatura que tem como objetivo ressaltar e discutir os aspectos bioéticos relacionados com a atenção ao paciente no final da vida no contexto brasileiro. Em específico, pretende-se identificar as circunstâncias relacionadas com esses aspectos bioéticos, bem como seus fatores desencadeantes. Foram selecionadas publicações de autores brasileiros, publicadas entre 2014 e 2020. A busca foi realizada em outubro de 2020, por meio das bases de dados eletrônicas PubMed e SciELO. Dos 231 artigos encontrados, 24 foram selecionados. Da análise temática, surgiram duas categorias que compreendem os aspectos bioéticos: "(não) morrer com dignidade" e "obstinação e futilidade terapêuticas". Foram identificadas seis circunstâncias relacionadas com esses aspectos bioéticos e 15 fatores desencadeantes. Os aspectos foram associados principalmente à não aceitação da morte, às falhas na formação acadêmica dos profissionais de saúde e ao insuficiente conhecimento sobre os conceitos e práticas em cuidados paliativos. Portanto, integrar o ensino da bioética na formação e na prática profissionais se torna fundamental para o cuidado dos pacientes no final da vida.

this integrative review of the literature aims to highlight and discuss the bioethical aspects of end-of-life patient care in the Brazilian context. Specifically, it seeks to identify the circumstances related to these bioethical aspects and their triggering factors. Publications by Brazilian authors published between 2014 and 2020 were selected. The search was conducted in October 2020 through PubMed and SciELO electronic databases. Of the 231 articles found, 24 were selected. Two categories comprising bioethical aspects emerged from the thematic analysis: "(not) dying with dignity" and "therapeutic obstinacy and futility." Six circumstances related to these bioethical aspects and 15 triggering factors were identified. The aspects were mainly associated with the non-acceptance of death, failures in the academic training of health professionals, and insufficient knowledge about palliative care concepts and practices. Therefore, integrating bioethics teaching in professional training and practice becomes fundamental for the care of patients at the end of life.

esta es una revisión integradora de la literatura que tiene como objetivo resaltar y discutir los aspectos bioéticos relacionados con la atención al paciente al final de la vida en el contexto brasileño. Específicamente, busca identificar las circunstancias relacionadas con estos aspectos bioéticos, así como sus factores desencadenantes. Se seleccionaron publicaciones de autores brasileños, publicadas entre 2014y 2020. La búsqueda se realizó en octubre de 2020, a través de las bases de datos electrónicas PubMed y SciELO. De los 231 artículos encontrados, 24 fueron seleccionados. Del análisis temático surgieron dos categorías que comprenden los aspectos bioéticos: "(no) morir con dignidad" y "obstinación y futilidad terapéuticas". Se identificaron seis circunstancias relacionadas con estos aspectos bioéticos y 15 factores desencadenantes. Los aspectos se asociaron principalmente a la no aceptación de la muerte, las fallas en la formación académica de los profesionales de salud y el insuficiente conocimiento sobre los conceptos y prácticas en cuidados paliativos. Por lo tanto, integrar la enseñanza de la Bioética en la formación y práctica profesionales se vuelve fundamental para el cuidado de los pacientes al final de la vida.

Traditional Health Care Practitioners' Perspectives on Applying Informed Consent During African Traditional Medical Practice in Akwa Ibom State, Nigeria: A Cross-Sectional Qualitative Study.

Introduction: This study explored the perspectives of traditional health care practitioners (THPs) practicing in the areas of herbalism, bone setting, and traditional birth attendance, from Akwa Ibom state, Nigeria, on the possibility and implications of applying informed consent (IC) during African traditional medicine (ATM) practice. Methods: Semistructured interviews were conducted with 11 THPs, consisting of 5 herbalists, 3 traditional bone setters (TBS), and 3 traditional birth attendants (TBAs), who represented the diverse groups that the study intended to cover. In-depth interviews were conducted using a semistructured guide and were recorded, transcribed, and analyzed using thematic analysis with the assistance of NVivo® qualitative analysis software. Results: Participants were seven males (64%) and four females (36%), 35-67 years of age, with 5-25 years of experience as THPs. Forty-six percent of participants were herbalists (27%), TBS, and TBAs (27%). Most participants (82%) were Annang, and (18%) were Ibibio first-language speakers. Three major themes emerged from the data analysis: (i) Existing ethical framework related to IC, (ii) knowledge of consent, and (iii) application of IC during traditional medical practice. These themes and relevant subthemes were explored. All (100%) THPs agreed that it was essential to communicate risks and benefits while allowing patients to ask questions before treatment. All participants (100%) stated that risk communication is essential in ATM, whereas 36% said they communicated all therapy benefits to their patients. Respondents believed patients could make an informed choice if they had complete information disclosure. However, THPs in this study had limited knowledge of formal IC rules and regulations. Conclusions: This study revealed that THPs in this setting disclose a diagnosis, risks, some benefits, and treatment options to patients. Consent/agreement was obtained verbally and voluntarily during ATM practice, consistent with IC doctrine. THPs had limited knowledge of the critical elements of IC. However, they suggested that a form of IC that does not conflict with traditional African norms could be applicable in ATM. IC could facilitate documentation and help reduce risks in ATM practice.

Finding more constructive ways forward in the debate over vaccines with increased disability cultural competence.

The aim of this article is to study the discursive construction of disability that takes place in the vaccine-autism controversy from the 1990s to 2000s, and an attempt to develop a more holistic framework to understand vaccine decisions and their motivations. It is argued that the debate over vaccines produces knowledge and meanings about disability, and that the vaccine-autism controversy is kept alive largely because of how it reproduces stigmatising accounts of disability and autism. The suggestion is that if the stigmatising elements of disability were removed in the debate over vaccines, there would be no controversy to keep alive in the broader vaccine debate. Hence, this article is an attempt to increase disability cultural competence in the media and among health authorities and health professionals and therethrough broaden the shared understanding of what it means to be or become disabled. By investigating the driving forces for past vaccine controversies, the goal is to find more constructive ways forward in present day and future debates over vaccines.

The production of medicoethical misconduct: medical ethics and vivisection in Wilkie Collins's Heart and Science.

Even as Wilkie Collins's Heart and Science continues in the tradition of cautionary tales of medicine and science, it also integrates nineteenth-century discussions of medical ethics, vivisection and women, further building on earlier criticisms of scientific hubris. By indicting a fictional medical doctor and his methodology, Heart and Science depicts the extremes of good and bad, ethical and unethical medicine-whether the doctor can care, and not simply solve the medical enigma-in light of a changing medical field that prized objectivity and distance from the subject over the old holistic way of listening to a patient in order to understand her malady. In reading Collins within his historical context and against a changing environment within the medical sciences, literary critics discern a gendered doctor-patient relationship and observe a Victorian author's attempts to combat the fears of scientific advancement by using or aligning himself with a proto-feminist perspective.

Implicações bioéticas do uso terapêutico da Cannabis sativa L. no Brasil / Bioethical implications of the therapeutic use of Cannabis sativa L. in Brazil

A utilização medicinal da Cannabis sativa L., usualmente chamada de maconha, é conhecida desde tempos remotos devido a suas elevadas propriedades terapêuticas. As discussões acerca de seu uso medicinal no Brasil são urgentes, notadamente porque já há comprovação científica dos benefícios relacionados ao tratamento de diversas enfermidades. Este artigo teve como foco demonstrar que os argumentos apresentados para criminalizar a C. sativa, além de concorrerem para uma conjuntura racista e criminalizadora de classes sociais baixas, violam os princípios bioéticos da beneficência, autonomia e justiça, ao impedir que o sujeito tenha acesso a prescrições médicas adequadas e menos onerosas, a fim de proporcionar o alívio de suas dores físicas e psíquicas. Para tanto, utilizou-se da metodologia qualitativa, por meio da qual se realizou revisão bibliográfica de artigos científicos publicados em português, entre os anos de 2015 e 2020, nas bases de dados Google Scholar e Scientific Electronic Library Online, juntamente com pesquisa de resoluções da Agência Nacional de Vigilância Sanitária e do Conselho Federal de Medicina. De posse desses dados, constatou-se a necessidade de democratização no acesso à C. sativa medicinal, sendo imprescindível o fornecimento gratuito de canabidiol pelo Sistema Único de Saúde, bem como uma normatização que permita o cultivo da C. sativa para fins medicinais para a produção de medicamentos no país.

The medicinal use of Cannabis sativa L., usually called marijuana, has been known since ancient times, due to its enhanced therapeutic properties. Discussions about its medicinal use in Brazil are urgent, especially because there is already scientific proof of the benefits that it can produce in treatment of various diseases. Therefore, it is essential that there is support from the State so that access to C. sativa for medicinal purposes is universal, considering the right to health treatments as a fundamental right, provided for in the Constitution. However, the use and possession for own consumption are still criminalized. Thus, the article seeks to demonstrate that the justifications presented to criminalize this plant, in addition to contributing to a racist marginalization of low social classes, violate Bioethical precepts, by preventing patients from accessing medical prescriptions that are adequate and less costly, to provide relief from their physical and mental pain. For that, we used a qualitative methodology. A bibliographic review of scientific articles published in Portuguese, between the years 2015 and 2020, was carried out in the Google Scholar and Scientific Electronic Library Online databases. Resolutions of the Brazilian Health Regulatory Agency, as well as of the Federal Council of Medicine were also considered. With these data, this article concludes that the need for democratization in access to medicinal C. sativa is imperative, by supplying patients with CBD compounds through the Brazilian National Public Health System, and by enacting legislation that allows for the cultivation of C. sativa for medicinal purposes and for medicine production in Brazil.

Reflexión bioética sobre especímenes vegetales: trascendencia de los intereses antropocéntricos ligados a las plantas medicinales

Propósito/Contexto. El presente artículo expone el enigma referente a ciertas perspectivas culturales que han abarcado a las plantas medicinales, desde su valor intrínseco y uso en distintos panoramas sociales, teniendo en cuenta dos líneas de acción: la holística y la antropocéntrica. Metodología/Enfoque. Se realizó una revisión de material bibliográfico, desde el enfoque cualitativo del análisis cultural y la técnica del análisis documental, teniendo en cuenta los ejes temáticos ética de la tierra, antropocentrismo y plantas medicinales. Resultados/Hallazgos. Las plantas medicinales han generado una alta incidencia en el campo de la salud, frente a su valor intrínseco, visualizado desde la autopoiesis y su importancia en el ecosistema. Por otro lado, los usos establecidos en diferentes áreas del conocimiento (medicina, biotecnología, agricultura, entre otras) y las prácticas ejercidas (culturales) logran beneficios para el hombre desde las dimensiones físicas, biológicas y del entendimiento. Discusión/Conclusiones/Contribuciones. La posición bioética estuvo apoyada desde los fundamentos ambientales visualizados en la Ética de la Tierra de Aldo Leopold y la Bioética Global de Van Rensselaer Potter, sin dejar de lado autores como Fritz Jahr, Gilberto Cely, entre otros. Los planteamientos analizados enfatizan la necesidad de fomentar el paso del antropocentrismo al ecocentrismo, sobre la base de una interacción responsable entre humanos y no humanos, generando armonía, interrelación y equilibrio que se debe consolidar dentro de un ecosistema, donde es esencial convivir con plantas medicinales y su valor intrínseco.

Purpose/ Context. This article exposes the enigma concerning certain cultural perspectives that have covered medicinal plants, from their intrinsic value and use in different social scenarios, taking into account two lines of action: the holistic and the anthropocentric. Methodology/Approach. A review of bibliographic material was carried out, from the qualitative approach of cultural analysis and the technique of documentary analysis, taking into account the thematic axes land ethics, anthropocentrism and medicinal plants. Results/Findings. Medicinal plants have generated a high incidence in the field of health, due to their intrinsic value, visualized from autopoiesis and their importance in the ecosystem. On the other hand, the uses established in different areas of knowledge (medicine, biotechnology, agriculture, among others); and practices exercised (cultural), achieve benefits for man from the physical, biological and understanding dimensions. Discussion/Conclusions/Contributions. The bioethical position was supported from the environmental foundations visualized in A. Leopold's Earth Ethics and V. Potter's global bioethics; without leaving aside authors such as F. Jahr, G. Cely, among others. The approaches analyzed emphasize the need to promote the transition from anthropocentrism to ecocentrism, based on a responsible interaction between humans and non-humans, generating the harmony, interrelation and balance that must be consolidated within an ecosystem, where it is essential to coexist with medicinal plants and their intrinsic value.

Objetivo/ Contexto. Este artigo expõe o enigma relativo a certas perspectivas culturais que abraçaram as plantas medicinais, a partir de seu valor intrínseco e uso em diferentes cenários sociais, levando em conta duas linhas de ação: a holística e a antropocêntrica. Metodologia/Abordagem. Foi realizada uma revisão do material bibliográfico, a partir da abordagem qualitativa da análise cultural e da técnica de análise documental, levando em conta os eixos temáticos da ética fundiária, do antropocentrismo e das plantas medicinais. Resultados/Descobertas. As plantas medicinais têm gerado uma alta incidência no campo da saúde, devido ao seu valor intrínseco, visualizado a partir da autopoiese e sua importância no ecossistema. Por outro lado, os usos estabelecidos em diferentes áreas do conhecimento (medicina, biotecnologia, agricultura, entre outras); e as práticas exercidas (culturais), obtêm benefícios para o homem a partir das dimensões física, biológica e de compreensão. Discussão/Conclusões/Contribuições. A posição bioética foi apoiada a partir dos fundamentos ambientais visualizados em A. Leopold's Earth Ethics e V. Potter's global bioethics; sem deixar de lado autores como F. Jahr, G. Cely, entre outros. As abordagens analisadas enfatizam a necessidade de promover a transição do antropocentrismo para o ecocentrismo, com base na interação responsável entre humanos e não-humanos, gerando a harmonia, a inter-relação e o equilíbrio que devem ser consolidados dentro de um ecossistema, onde é essencial a coexistência com as plantas medicinais e seu valor intrínseco.

Zoonoses and Animal Culling: The Need for One Health Policy.

One Health (OH) as a biomedical and social movement calls to reorient public health approaches toward more holistic, nonanthropocentric approaches that do not exclude the interests of animals and ecosystems. OH thus urges reexamination, from both scientific and moral perspectives, of the practice of culling pet, farm, or wild animals in the face of a zoonosis. Pandemics such as Covid and monkeypox highlight the need for more rigorous analysis of the justifications traditionally provided to back these culling practices. Such analyses should then ground reasonable OH policies and legislation that consider the rights of humans, animals, and the environment. Bill S.861, "Advancing Emergency Preparedness through One Health Act of 2021," which was introduced in the U.S. Congress, is a step in the right direction.

A theoretical framework for ethical decision-making during public health emergencies / Un marco teórico para la toma de decisiones éticas durante emergencias de salud pública / Um referencial teórico para tomada de decisão ética durante emergências de saúde pública

Abstract: The new theoretical ethical framework is a general frame or tool for ethical agents, developed to guide ethical reasoning during public health emergency preparedness and response. The TEF is based on the assumption that no existing ethical discourse in medical ethics alone is sufficient to address ethical issues of a PHE. The solutions suggested by existing approaches are limited in practicability and effectiveness, because they cannot address root problems and interplay among ethical problems. The reason for this insufficiency rests on the argument that ethical problems of PHEs have causal and reciprocal relationships, and any ethical decision-making framework should provide a wide enough perspective to consider relevant ethical norms and theories to suggest practical, implementable, coherent solutions compatible with the communal values and cultural norms. The TEF we suggest for PHEs embraces a holistic and integrated ethical perspective that enables us to comprehend that ethical problems that arise in various settings caused by PHE phenomena are in relationship with each other instead of addressing them as a standalone problem. The TEF provides decision-makers to achieve a coherent web of considered judgements compatible with ethical values and principles in various settings. This type of conceptualization offers a wide perspective to see causal and relational relationships among problems and produce outcomes that would not be possible by eclectic approaches.

Resumen: El nuevo Marco Ético Teórico (MET) es una estructura general o herramienta para eticistas, desarrollada para guiar el razonamiento ético durante la preparación y respuesta a emergencias de salud pública (ESP). Supone que no existe un discurso ético en la ética médica que por sí solo sea suficiente para abordar temas éticos de ESP. Las soluciones sugeridas de aproximaciones existentes son limitadas en la práctica y en la efectividad, debido a que no pueden abordar problemas de raíz sin considerar las interacciones entre los problemas éticos. Esta insuficiencia es porque los problemas éticos de ESP tiene relaciones causales y recíprocas, y cualquier estructura de toma de decisiones éticas debería proporcionar una perspectiva suficientemente amplia como para considerar normas éticas y teorías relevantes, y sugerir soluciones prácticas que sean coherentes y compatibles con valores comunes y normas culturales. El MET que sugerimos para ESP abarca una perspectiva ética integral e integrada, que posibilita la comprensión de que los problemas éticos que surgen en varías situaciones causadas por fenómenos ESP se hallan en relación entre ellos, en vez de abordarlos como un problema aislado. El MET proporciona a los que toman decisiones el lograr una red coherente de juicios compatibles con los valores y principios éticos en varias situaciones. Este tipo de conceptualización ofrece una amplia perspectiva para ver relaciones causales y relacionales entre problemas y producir resultados que no serían posibles mediante aproximaciones eclécticas.

Resumo: O novo referencial ético teórico (NT: TEF, sigla em inglês) é um referencial geral ou instrumento para agentes éticos, desenvolvido para guiar o raciocínio ético durante o preparo e resposta a emergências de saúde pública (NT: PHE, sigla em inglês). O TEF é baseado na suposição de que nenhum discurso ético existente em ética médica sozinho é suficiente para abordar aspectos éticos de uma PHE. As soluções sugeridas pelas abordagens existentes são limitadas em praticabilidade e efetividade, porque elas não podem abordar problemas fundamentais e inter-relacionar problemas éticos. A razão para essa insuficiência repousa no argumento de que problemas éticos de PHEs têm relações causais e recíprocas, e qualquer referencial para tomada de decisão ética deve propiciar uma perspectiva ampla o suficiente para considerar normas e teorias éticas relevantes para sugerir soluções práticas, implementáveis e coerentes, compatíveis com valores comunitários e normas culturais. A TEF que sugerimos para PHEs abarca uma perspectiva ética holística e integrada que nos permite compreender que os problemas éticos que surgem em diversos ambientes causados pelo fenômeno da PHE estão em relação entre si, ao invés de abordá-los como um problema isolado. O TFE propicia a tomadores de decisões alcançar uma rede de julgamentos considerados compatíveis com valores e princípios éticos em ambientes diversos. Esse tipo de conceitualização oferece uma perspectiva ampla para observar relações causais e relacionais entre problemas e produzir desfechos que não seriam possíveis por abordagens ecléticas.

Dose banding - Weighing up benefits, risks and therapeutic failure.

AIMS: Dose banding is a method of dose individualisation in which all patients with similar characteristics are allocated to the same dose. Dose banding results in some patients receiving less intensive treatment which risks a reduction in therapeutic benefit (iatrogenic therapeutic failure) because of variability not predicted by dose banding. This study aims to explore the effects of dose banding on therapeutic success and failure. METHODS: This was a simulation study. Virtual patients were simulated under a simple pharmacokinetic model where the response of interest is the steady-state average concentration. Clearance was correlated with a covariate used for dose banding. Dose individualisation was based on: one-dose-fits-all, covariate-based dosing, empirical dose banding, dose banding optimised for net therapeutic benefit and optimised for both benefit and minimising iatrogenic therapeutic failure. RESULTS: The lowest and highest probability of target attainment (PTA) were 44% for one-dose-fits-all and 72% for covariate-based dosing. Neither dosing approach would result in iatrogenic therapeutic failure as lower dose intensities do not occur. Empirical dose banding performed better than one-dose-fits-all with 59% PTA but not as good as either optimised method (64-69% PTA) while carrying a risk of iatrogenic therapeutic failure in 25% of patients. Optimising for benefit (only) improved PTA but carried a risk of iatrogenic therapeutic failure of up to 10%. Optimising for benefit and minimising iatrogenic therapeutic failure provided the best balance. CONCLUSION: Future application of dose banding needs to consider both the probability of benefit as well the risk of causing iatrogenic therapeutic failure.

Drug delivery and anticancer activity of biosynthesised mesoporous Fe2 O3 nanoparticles.

Mesoporous magnetic nanoparticles of haematite were synthesised using plant extracts according to bioethics principles. The structural, physical and chemical properties of mesoporous Fe2 O3 nanoparticles synthesised with the green chemistry approach were evaluated by XRD, SEM, EDAX, BET, VSM and HRTEM analysis. Then, their toxicity against normal HUVECs and MCF7 cancer cells was evaluated by MTT assay for 48 h. These biogenic mesoporous magnetic nanoparticles have over 71% of doxorubicin loading efficiency, resulting in a 50% reduction of cancer cells at a 0.5 µg.ml-1 concentration. Therefore, it is suggested that mesoporous magnetic nanoparticles be used as a multifunctional agent in medicine (therapeutic-diagnostic). The produced mesoporous magnetic nanoparticles with its inherent structural properties such as polygonal structure (increasing surface area to particle volume) and porosity with large pore volume became a suitable substrate for loading the anti-cancer drug doxorubicin.

The "One Health" approach in the face of Covid-19: how radical should it be?

BACKGROUND: The 2020-2021 coronavirus (Covid-19) pandemic is just the latest epidemic event that requires us to rethink and change our understanding of health. Health should no longer be conceived only in relation to human beings, but in unitary terms, as a dimension that connects humans, animals, plants, and the environment (holistic view, One Health). In general, alterations occurring in this articulated chain of life trigger a domino effect. METHODOLOGY: In this paper, we review the One Health paradigm in the light of the Covid-19 pandemic and distinguish two approaches within it that might be dubbed the Prudent one and the Radical one. Each approach is structured in three levels - epistemological, medical, and ethical. RESULTS: In this way, we show how we humans can better address the pandemic today and how, in the future, we can treat the whole living system better, by renouncing our anthropocentric perspective on health. CONCLUSION: We hold that the Prudent approach can be very helpful, and we discuss the medical and ethical issues related to it. We also consider the Radical view and the epistemological turn it requires compared to the Prudent one.

Landscape of pediatric cancer treatment refusal and abandonment in the US: A qualitative study.

Objective: To describe United States (US) pediatric oncologists' experiences with treatment refusal or abandonment, exploring types and frequency of decision-making conflicts, and their impact. Study design: We conducted exploratory qualitative interviews of pediatric oncologists (n = 30) with experience caring for a pediatric patient who refused or abandoned curative treatment. Interviewees were recruited using convenience and nominated expert sampling, soliciting experiences from diverse geographic locations and institution sizes across the US. We analyzed transcripts using applied thematic analysis to identify and refine meaningful domains. Results: Many oncologists reported multiple experiences with refusal and abandonment. Most anticipated case frequency would increase due to misinformation, particularly on the internet. Interviewees described cases of treatment refusal and abandonment, but also a wider variety of cases than previously described in existing publications, including cases involving: non-adherence; negotiations for different treatments; negotiations for complementary and alternative medicine; delayed treatment initiation; and refusal of a component of recommended therapy. Cases often involved multiple stages or types of conflicts. Recurring patient/family behaviors emerged: clear opposition to treatment from the outset; hesitancy about treatment despite initiating therapy; and psychosocial circumstances becoming an obstacle to treatment completion. Oncologists revealed substantial professional and personal repercussions of these cases. Conclusion: Oncologist interviews highlight a broad range of conflicts, yielding a taxonomy of treatment refusal, non-adherence and abandonment (TRNA) that accounts for the heterogeneity of situations described. Cases' complexity and interrelatedness points to a functional model of TRNA that includes families' behaviors. This preliminary taxonomy and model warrant further research and examination to refine the model and generate strategies to prevent and mitigate TRNA.