Consideraciones bioéticas en el manejo de la esclerosis lateral amiotrófica: Una aproximación al quehacer fonoaudiológico

Introducción: La esclerosis lateral amiotrófica (ELA) es la forma más común de enfermedad degenerativa de motoneurona en la edad adulta y es considerada una enfermedad terminal. Por lo mismo, el accionar del fonoaudiólogo debe considerar el respeto a los principios bioéticos básicos para garantizar una asistencia adecuada. Objetivo: Conocer aquellas consideraciones bioéticas relacionadas al manejo y estudio de personas con ELA para luego brindar una aproximación hacia el quehacer fonoaudiológico. Método: Se efectuó una búsqueda bibliográfica en las bases de datos PubMed, Scopus y SciELO. Se filtraron artículos publicados desde 2000 hasta junio de 2023 y fueron seleccionados aquellos que abordaban algún componente bioético en población con ELA. Resultados: Aspectos relacionados al uso del consentimiento informado y a la toma de decisiones compartidas destacaron como elementos esenciales para apoyar la autonomía de las personas. Conclusión: Una correcta comunicación y una toma de decisiones compartida son claves para respetar la autonomía de las personas. A su vez, la estandarización de procedimientos mediante la investigación clínica permitirá aportar al cumplimiento de los principios bioéticos de beneficencia y no maleficencia, indispensables para la práctica profesional.

Introduction: Amyotrophic lateral sclerosis (ALS) is the most common form of degenerative motor neuron disease in adulthood and is considered a terminal disease. For this reason, the actions of the speech therapist must consider respect for basic bioethical principles to guarantee adequate assistance. Objective: To know those bioethical considerations related to the management and study of people with ALS to then provide an approach to speech therapy. Methodology: A bibliographic search was carried out in the PubMed, Scopus, and SciELO databases. Articles published from 2000 to June 2023 were filtered and those that addressed a bioethical component in the population with ALS were selected. Results: Aspects related to the use of informed consent and shared decision-making stood out as essential elements to support people's autonomy. Conclusion: Proper communication and shared decision-making are key to respecting people's autonomy. In turn, the standardization of procedures through clinical research will contribute to compliance with the bioethical principles of beneficence and non-maleficence, essential for professional practice.

Ethical implications of developing RNA-based therapies for cardiovascular disorders.

The awareness concerning RNA-based therapies was boosted significantly after the successful development of COVID-19 vaccines. However, they can potentially lead to significant advances in other areas of medicine, such as oncology or chronic diseases. In recent years, there has been an exponential increase in the number of RNA-based therapies that were evaluated as potential treatments for cardiovascular disorders. One of the areas that was not explicitly assessed about these therapies is represented by their overall ethical framework. Some studies evaluate ethical issues of RNA-based treatments in general or targeting specific disorders (especially neurodegenerative) or interventions for developing RNA-based vaccines. Much less information is available regarding the ethical issues associated with developing these therapeutic strategies for cardiovascular disorders, which is the main aim of this study. We will focus our analysis on three main topics: risk-benefit analysis (including the management of public awareness about these technologies), and justice (in both research and clinical medicine).

Recent Developments in the Regulation of Heritable Human Genome Editing.

In 2018, the Chinese scientist He Jiankui presented his research at the Second International Summit on Human Genome Editing in Hong Kong. While it was intended that he facilitate a workshop, he was instead called on to present his research in heritable human genome editing, where he made the announcement that he had taken great strides in advancement of his research, to the extent that he had gene-edited human embryos and that this had resulted in the live births of two children. While his research ethic and methodology was interrogated, he insisted that two children, twin girls, had been born healthy and that there was another pregnancy (at the time) where birth of a third gene edited child would be imminent. This announcement generated a ripple effect in the scientific community and exposed the gaps in regulation and absence of law relating to the technology. This resulted in a flurry of activity and conversation around regulation of the technology, which scientists stated was not ready for human trials. This article reviews the Third Summit which was held in London in March 2023 and comments on the latest developments in the regulation of heritable human genome editing.

Biliary atresia in Uganda: Current ethical challenges and advancement of public policy.

Biliary atresia is a progressive cholangiopathy in neonates, which often results in liver failure. In high-income countries, initial treatment requires prompt diagnosis followed by Kasai portoenterostomy. For those with a late diagnosis, or those in whom Kasai portoenterostomy fails, liver transplantation is the only lifesaving treatment. Unfortunately, in low- and middle-income countries, timely diagnosis is a challenge and liver transplantation is rarely accessible. Here, we discuss the ethical dilemmas surrounding treatment of babies with biliary atresia in Uganda. Issues that require careful consideration include: risk of catastrophic health expenditure to families, ethical dilemmas of transplant tourism, medical risks of maintaining the transplant in a low-resourced health system, and difficult decisions encountered by the surgeon caring for these patients. Four distinct models of the patient-physician relationship are applied to biliary atresia in Uganda. These models describe differences in patient and physician roles, and patient values and autonomy. Solid organ transplantation is a rapidly evolving segment of healthcare in Uganda and ongoing policy advancements may shift ethical considerations in the future.

Conceptual competence in psychiatric training: building a culture of conceptual inquiry.

Building a culture of conceptual inquiry in psychiatric training requires the development of conceptual competence: the ability to identify and examine assumptions that constitute the philosophical foundations of clinical care and scientific investigation in psychiatry. In this article, we argue for the importance of such competence and illustrate approaches to instilling it through examples drawn from our collective experiences as psychiatric educators.

Values-Based Medicine Is an Ethical Concept for Implementing the Ethical Principles in Daily Practice.

Values-based medicine (VsBM) is an ethical concept, and bioethical framework has been developed to ensure that medical ethics and values are implemented, pervasive, and powerful parameters influencing decisions about health, clinical practice, teaching, medical industry, career development, malpractice, and research. Neurosurgeons tend to adopt ethics according to their own values and to what they see and learn from teachers. Neurosurgeons, in general, are aware about ethical codes and the patient's rights. However, the philosophy, concept, and principles of medical ethics are rarely included in the training programs or in training courses. The impact of implementing, observing the medical ethics and the patients' value and culture on the course, and outcome of patients' management should not underestimate. The main principles of medical ethics are autonomy, beneficence, nonmaleficence, justice, dignity, and honesty, which should be strictly observed in every step of medical practice, research, teaching, and publication. Evidence-based medicine has been popularized in the last 40-50 years in order to raise up the standard of medical practice. Medical ethics and values have been associated with the medical practice for thousands of years since patients felt a need for treatment. There is no conflict between evidence-based medicine and values-based medicine, as a medical practice should always be performed within a frame of ethics and respect for patients' values. Observing the principles of values-based medicine became very relevant as multicultural societies are dominant in some countries and hospitals in different corners of the world.

[Non-therapeutic hysterectomy in Mexican young females with intellectual disability: a problematized reality]. / Histerectomía no terapéutica en jóvenes mexicanas con discapacidad intelectual: una realidad problematizada.

Background: Non-therapeutic hysterectomy in girls and adolescents with intellectual disability (ID) is an acceptable practice, even when there is a lack of prescriptive ethical reason. Objectives: To determine the magnitude of the practice of hysterectomy in girls and adolescents with ID, and explore the emic factors associated with this procedure. Material and methods: Multicenter, intersectoral study with a mixed methods design. Results: The quantitative results showed that 50 of 234 reported hysterectomies corresponded to females with ID. Average age at the time of surgery was 15 ± 2.9 years. Prophylactic abdominal hysterectomy was the most common procedure, and the justifications for it were "fertility control", "menstrual hygiene management", and "risk of sexual abuse". A qualitative analysis of 15 focus groups revealed that parents' main concern was how to manage their daughters' index disease and reproductive health; they perceived menstruation positively; they expressed their fear of dying and leaving them without support, and emphasized fertility control; none of them approved hysterectomy. Conclusions: The bodies that define health policies need to create a new philosophy that avoids the reductionist approach of current biomedical model, which separates (in the health-disease process) our interdependence with other humans.

Antecedentes: La histerectomía no terapéutica en niñas y adolescentes con discapacidad intelectual (DI) es una práctica aceptable, aun cuando se carece de razón ética prescriptiva. Objetivos: Determinar la magnitud de la práctica de la histerectomía en niñas y adolescentes con DI, y explorar los factores emic asociados a esta práctica. Material y métodos: Estudio multicéntrico e intersectorial con método mixto. Resultados: Los resultados cuantitativos mostraron que 50 de 234 histerectomías reportadas correspondieron a mujeres con DI. El promedio de edad a la cirugía fue de 15 ± 2.9 años. La histerectomía abdominal profiláctica fue el procedimiento predominante y las justificaciones fueron control de fertilidad, manejo de la higiene menstrual y riesgo de abuso sexual. El análisis cualitativo de 15 grupos focales reveló que la principal preocupación de los padres fue cómo manejar la enfermedad índice y la salud reproductiva de sus hijas; percibieron positivamente la menstruación, expresaron su miedo a morir y dejarlas sin ayuda, resaltaron el control de la fertilidad y ninguno aprobó la histerectomía. Conclusiones: Los organismos que definen políticas de salud necesitan crear una nueva filosofía que evite el enfoque reduccionista del actual modelo biomédico, el cual separa (en el proceso salud-enfermedad) la interdependencia entre los seres humanos.

A Biophilosophical Approach to the Determination of Brain Death.

Technical and clinical developments have raised challenging questions about the concept and practice of brain death, culminating in recent calls for revision of the Uniform Determination of Death Act (UDDA), which established a whole brain standard for neurologic death. Proposed changes range from abandoning the concept of brain death altogether to suggesting that current clinical practice simply should be codified as the legal standard for determining death by neurologic criteria (even while acknowledging that significant functions of the whole brain might persist). We propose a middle ground, clarifying why whole brain death is a conceptually sound standard for declaring death, and offering procedural suggestions for increasing certainty that this standard has been met. Our approach recognizes that whole brain death is a functional, not merely anatomic, determination, and incorporates an understanding of the difficulties inherent in making empirical judgments in medicine. We conclude that whole brain death is the most defensible standard for determining neurologic death-philosophically, biologically, and socially-and ought to be maintained.

Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow, and William B. Feldman Reply.

The authors respond to a letter by Mitchell Berger in the March-April 2024 issue of the Hastings Center Report concerning their essay "Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines."

Additional Steps for Maintaining Public Trust in the FDA.

This letter responds to the essay "Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines," by Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow, and William B. Feldman, in the special report "Time to Rebuild: Essays on Trust in Health Care and Science," in the September-October 2023 issue of the Hastings Center Report.

Holding the Guardrails on Involuntary Commitment.

In response to the increasing number of mentally ill people experiencing homelessness, some policy-makers have called for the expanded use of involuntary commitment, even for individuals who are not engaging in behaviors that are immediately life-threatening. Yet there is no evidence that involuntary commitment offers long-term benefits, and significant reasons to believe that expanding the practice will cause harm. In addition, these proposals ignore research showing that most people with mental illness have the capacity to make medical decisions for themselves. Rather than expanding the use of involuntary commitment, policy-makers should support approaches proven to decrease the prevalence of homelessness, such as supportive housing. In addition, states should reevaluate their commitment standards for persons who pose no risk of harm to others. One promising approach is Northern Ireland's Mental Health Capacity Act of 2016, which establishes a uniform standard for imposing nonconsensual health care interventions, without any distinction between mental illnesses and other conditions in which capacity might be compromised.

Might the bioethical principle of individual decisional autonomy have a politically liberalizing effect on soft authoritarian communities?

According to the bioethical principle of individual decisional autonomy, the patient has a right of informed consent to any medical or experimental procedure. The principle is politically liberal by advocating significant individual freedom as guaranteed by law and secured by civil liberties. When practiced in illiberal communities, might it have a political liberalizing effect? I respond first by analyzing cross-national norms of individual decisional autonomy to identify tensions with illiberal community; second, by examining examining Singapore in a single case study to show that liberal bioethics does not promote political liberalization; and third, by showing that the possibility of practicing liberal bioethics in research, clinically as well as in education, does not require a democratic order, and that liberal bioethics is unlikely to encourage the liberalization of illiberal political communities. Hence, it may never contribute to the development of globally effective cross-national norms for the legal regulation of bioethical research and clinical practice. Fourth, to bolster this analysis, I anticipate several possible objections to various of its aspects.

The Hamas massacre of Oct 7, 2023, and its aftermath, medical crimes, and the Lancet commission report on medicine, Nazism, and the Holocaust.

BACKGROUND: The report of the Lancet Commission on medicine, Nazism, and the Holocaust, released in November 2023, calls for this history to be required for all health professions education, to foster morally courageous health professionals who speak up when necessary. MAIN BODY: The report was released a month after Hamas' October 7 invasion of Israel, with the accompanying massacre of over 1200 people, taking of civilian hostages, and gender-based violence. These acts constitute crimes against humanity including genocide. Post-October 7, war in Gaza resulted, with a legitimate objective of Israel defending itself within international law. The authors discuss an accompanying Statement to the report condemning Hamas crimes and denouncing the perpetrators' use of their own civilians as human shields, including in healthcare facilities, and with the Hamas attack unleashing immense and ongoing suffering in Israel and beyond. With some exceptions, the medical literature shows a marked absence of condemnation of Hamas atrocities and includes unsubstantiated criticisms of Israel's military. A significant surge in global antisemitism including on university campuses since October 7, 2023, has occurred; and health professionals, according to the Commission, have a special responsibility to fight antisemitism and discrimination of all kinds. In this context, the authors discuss the controversy and criticism regarding diversity, equity, and inclusion education programs ("DEI") including such programs failing to protect Jews on campuses, especially as the U.S. President Biden's "The U.S. National Strategy to Counter Antisemitism," released in May 2023, calls for the inclusion of issues of antisemitism and religious discrimination within all DEI education programs. The authors support an evidence-based approach to the Hamas massacre, its aftermath and its relevance to health professionals both within medicine and their global citizenship, including refuting the international community accusations and anti-Israel libel. CONCLUSIONS: The report of the Lancet Commission on medicine, Nazism, and the Holocaust has striking relevance to the Hamas massacre of October 7, 2023 and its aftermath. This is further conveyed in an accompanying Statement, that describes the report's implications for contemporary medicine, including: 1) provision of skills required to detect and prevent crimes against humanity and genocide; (2) care for victims of atrocities; (3) upholding the healing ethos central to the practice of medicine; and (4) fostering history-informed morally courageous health professionals who speak up when necessary.

Prescription for Love: An Experimental Investigation of Laypeople's Relative Moral Disapproval of Love Drugs.

New technologies regularly bring about profound changes in our daily lives. Romantic relationships are no exception to these transformations. Some philosophers expect the emergence in the near future of love drugs: a theoretically achievable biotechnological intervention that could be designed to strengthen and maintain love in romantic relationships. We investigated laypeople's resistance to the use of such technologies and its sources. Across two studies (Study 1, French and Peruvian university students, N after exclusion = 186; Study 2, Amazon Mechanical Turk sample, N after exclusion = 693, pre-registered), we found that the use of love drugs designed to strengthen and maintain love in romantic relationships are considered as more morally problematic than psychological therapy with the same aim. In Study 2, we show that this last effect is partially due to the fact that the love resulting from the use of love drugs is perceived as less authentic, intense, and durable. We discuss the specific role of authenticity in the relative moral disapproval of love drugs.

Establishing and Defining an Approach to Climate Conscious Clinical Medical Ethics.

An anthropocentric scope for clinical medical ethics (CME) has largely separated this area of bioethics from environmental concerns. In this article, we first identify and reconcile the ethical issues imposed on CME by climate change including the dispersion of related causes and effects, the transdisciplinary and transhuman nature of climate change, and the historic divorce of CME from the environment. We then establish how several moral theories undergirding modern CME, such as virtue ethics, feminist ethics, and several theories of justice, promote both a flourishing of human medical practice and the environment. We conclude by defining an expanded the scope of CME as inclusive of not only patients, families, physicians, and other health professionals but other humans, non-humans, and their shared environment. We then apply this scope and theory to a widely used framework for applying CME, the Four Topics model, to construct a climate conscious approach to CME.

Informed Consent and Digit Replantation: Current State and Recommendations for Ethical Patient Care.

The importance of informed consent and the value of shared decision-making in hand surgery are well-established and particularly critical in the setting of digit amputation when considering replantation. Informed consent requires an understanding of not only the immediate and long-term risks and benefits of surgery, as well as the risks and alternatives involved, but also the capacity of the patient to make a medical decision. However, patients who have acutely sustained a disfiguring trauma are often in distress and may not fully process the consent discussion. Digit replantation is an "elective emergency"-the decision must be made immediately but is not lifesaving-which poses a difficult dilemma: are surgeons acting in patients' best interests by pursuing replantation if we engage those patients in informed consent discussions when they may not have capacity? This article explores the relevant bioethical principles associated with digit replantation, summarizes updated literature regarding informed consent and shared decision-making, and provides recommendations for patient education materials to standardize informed consent discussions for surgeons approaching patients at this unique intersection of considering revision amputation versus replantation.

Should Children Be Included in Human Challenge Studies?

Human challenge studies, in which human research subjects are intentionally exposed to pathogens to contribute to scientific knowledge, raise many ethical complexities. One controversial question is whether it is ethically permissible to include children as participants. Commentary of the past decades endorses the exclusion of children, while new guidance suggests that pediatric human challenge studies can be ethically permissible. This paper argues that neither children's exclusion nor their inclusion are well justified. I examine and reject three arguments for exclusion, but suggest that these arguments establish pediatric human challenge studies as a complex ethical category of research that requires caution. I then argue for a strong presumption against children's inclusion, by drawing on an analogy to children's inclusion in phase I trials, emphasizing a requirement of necessity, and suggesting that accommodating children's vulnerability promotes an age de-escalation approach for pediatric human challenge studies research. In the final section, I suggest a procedure for ethics review.

Translational Research and Health Equity: Gene Therapies for Sickle Cell Disease as a Case Study.

In August of 2023, the National Academies of Science, Engineering, and Medicine published a timely report titled "Toward Equitable Innovation in Health and Medicine: A Framework." Here, we review some of the key contributions of the report, focusing on two dimensions of equity: input equity and deployment equity. We then use the example of new gene therapies to treat sickle cell disease (SCD) as a case study of input and deployment equity in translational research. The SCD case study illustrates the need for a kind of translational bioethics with deep understanding of lived experiences and clinical realities as well as a high degree of economic and policy sophistication.

Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research.

BACKGROUND: The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. METHODS: The GFBR is an annual meeting organized by the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was "Ethics of AI in Global Health Research". The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022. RESULTS: We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships. CONCLUSIONS: The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research.

Bioethical knowledge in students and health professionals: a systematic review.

Introduction: Bioethics training is essential for healthcare professionals as it enables them to address ethical dilemmas in their clinical practice. However, there is still a lack of rigorous teaching programs, and assessing bioethical knowledge poses challenges. Methodology: Systematic review using the PRISMA method. Results: Analysis of 27 studies reveals a lack of ethical knowledge and skills among healthcare professionals and students. Specific training in bioethics is effective in developing bioethical competencies. Different approaches have been employed, including integrated training in academic curricula and intensive or ongoing programs. The results demonstrate improvements in knowledge, attitudes, and ethical values, although regularly updating these courses is recommended. Conclusion: Specific training, institutional support, and considering regional and disciplinary differences are necessary to enhance ethics in the practice of healthcare professionals. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023437146, identifier CRD42023437146.