Translational Bioethical Decision-Making: Human Brain Organoids as a Case Study.

In an earlier essay, I advocated that translational bioethics uses the public's values, determined through social science, in its analysis of translational science technologies. It may be unclear what those values might be, and whether such a translational ethics would necessarily conclude that cutting edge technologies should not be developed. In this essay, I show the public's values relevant to human brain organoids and argue that a translational bioethics analysis using these values would support continued organoid research.

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.

Translational bioethics: Reflections on what it can be and how it should work.

Translational ethics (TE) has been developed into a specific approach, which revolves around the argument that strategies for bridging the theory-practice gap in bioethics must themselves be justified on ethical terms. This version of TE incorporates normative, empirical and foundational ethics research and continues to develop through application and in the face of new ethical challenges. Here, I explore the idea that the academic field of bioethics has not yet sufficiently analysed its own philosophical foundation for how it can, and should, be practically relevant; neither has it comprehensively discussed the limitations on what impacts bioethicists should pursue. As a result, there has not been adequate training on how to suitably and appropriately impact real-world practices. Moreover, bioethical perspectives are often competing with other strong interests, for example, economic and political, which may weaken their impact on policy-making. The TE approach I propose can not only facilitate practical impacts of academic bioethics by being better informed by real-world ethical issues but it also supports targeted and ethical justifications of the actual impact of academic work in real-world contexts. In this paper, I clarify the premises for this TE approach, identify further challenges and sketch out potential solutions for the implementation of this methodological framework.

Moving to the Middle Ground: Redefining Genomic Utility to Expand Understanding of Familial Benefit.

Translational research has tended to ignore the question of whether receiving a genomic diagnosis provides utility in community care contexts outside of doctors' offices and hospitals. However, empirical research with parents has highlighted numerous ways that a genomic diagnosis might be of practical value in the care provided by teachers, physical or occupational therapists, speech-language pathologists, behavior analysts, and nonphysician mental health providers. In this essay, we propose a new conceptual model of genomic utility that offers the opportunity to better capture a broad range of potential implications of genomic technologies for families in various social and organizational systems. We explore crucial research directions to better understand how redefined utility might affect families and nonphysician professionals.

Providing ethics advice in a pandemic, in theory and in practice: A taxonomy of ethics advice.

The pandemic significantly raised the stakes for the translation of bioethics insights into policy. The novelty, range and sheer quantity of the ethical problems that needed to be addressed urgently within public policy were unprecedented and required high-bandwidth two-way transfer of insights between academic bioethics and policy. Countries such as the United Kingdom, which do not have a National Ethics Committee, faced particular challenges in how to facilitate this. This paper takes as a case study the brief career of the Ethics Advisory Board (EAB) for the NHS Covid-19 App, which shows both the difficulty and the political complexity of policy-relevant bioethics in a pandemic and how this was exacerbated by the transience and informality of the structures through which ethics advice was delivered. It analyses how and why, after EAB's demise, the Westminster government increasingly sought to either take its ethics advice in private or to evade ethical scrutiny of its policies altogether. In reflecting on EAB, and these later ethics advice contexts, the article provides a novel framework for analysing ethics advice within democracies, defining four idealised stances: the pure ethicist, the advocate, the ethics arbiter and the critical friend.

The myth of translational bioethics.

In recent years, the case has been made for special attention to be paid to a branch of research in the field of bioethics called 'translational bioethics'. In this paper, we start by considering some of the assumptions that those advancing translational approaches to bioethics make about bioethics and compare them to the reality of bioethics as an academic field. We move on to explain how those who make this case, implicitly or explicitly, for translational bioethics go awry because of how they understand the 'gap' between bioethical inquiry and practical settings that requires bridging. We consider three interpretations of this 'translation gap' in bioethics: (i) the gap between theory and practice, (ii) the gap between the force of normative claims and practical contextual realities and (iii) the gap between relevance or applicability to practice and actual application or implementation in practice. In each case, we show how a proper understanding of the nature of the academic field of bioethics undermines how these gaps have been formulated, and how any need for talk of 'translational bioethics' is removed.

Developing translational bioethics-Suggestions for ways forward.

This paper will take as its starting point the premise that developing translational bioethics is a worthwhile endeavour. I will develop an account of translational bioethics and discuss what implications this would have for the wider discipline of bioethics and argue that this would be a useful development for bioethics. The paper will conduct a form of 'translational meta-bioethics analysis', in the words of Baerøe. I will argue that if we are serious about instituting translational bioethics, then it will need to look and be organised in a very different way from current bioethics research, this will be a radically different form of bioethics from what we currently have. In this paper I will sketch what translational bioethics might look like. My proposal here is not that translational bioethics should supplant existing ways of doing bioethics, but rather that it should be an addition to it, another subdiscipline of bioethics.

From book to bedside? A critical perspective on the debate about "translational bioethics".

The concept of "translational bioethics" has received considerable attention in recent years. Most publications draw an analogy to translational medicine and describe bioethical research that aims at implementing and evaluating ethical interventions. However, current accounts of translational bioethics are often rather vague and seem to differ with regard to conceptual and methodological assumptions. It is not clear and scarcely analyzed what exactly "translation" in the field of bioethics means, in particular regarding goals and processes so that it is justified to appeal to translational medicine. In this article, we thus explore possible analogies and disanalogies between translational medicine and translational bioethics to establish whether the often occurring reference to concepts of translational medicine in the field of bioethics can be justified by substantial analogies. We will first provide an account of different models of translational medicine. In a second step, we will propose an analytic definition that explicitly articulates the essential characteristics of "translational research" irrespective of the research field (i.e., biomedicine, bioethics). Subsequently, we will explore whether and in how far general characteristics and phases of translational research in medicine can be applied to translational research in bioethics. Based on our analyses, we will come to the skeptical conclusion that at present there are considerable conceptual disanalogies and unsolved conceptual problems that disallow using "translational bioethics" in a meaningful analogy to respective accounts in biomedicine. Nevertheless, we will demonstrate that some insights gained by the conceptual accounts of translational medicine can contribute to advance current research activities in bioethics.

Translational bioethics as a two-way street. Developing clinical ethics support instruments with and for healthcare practitioners.

This article discusses an approach to translational bioethics (TB) that is concerned with the adaptation-or 'translation'-of concepts, theories and methods from bioethics to practical contexts, in order to support 'non-bioethicists', such as researchers and healthcare practitioners, in dealing with their ethical issues themselves. Specifically, it goes into the participatory development of clinical ethics support (CES) instruments that respond to the needs and wishes of healthcare practitioners and that are tailored to the specific care contexts in which they are to be used. The theoretical underpinnings of this participatory approach to TB are found in hermeneutic ethics and pragmatism. As an example, the development of CURA, a low-threshold CES instrument for healthcare professionals in palliative care, is discussed. From this example, it becomes clear that TB is a two-way street. Practice may be improved by means of CES that is effectively tailored to specific end users and care contexts. The other way around, ethical theory may be enriched by means of the insights gained from engaging with practice in developing CES in a process of co-creation. TB is also a two-way street in the sense that it requires collaboration and commitment of both bioethicists and practitioners, who engage in a process of mutual learning. However, substantial challenges remain. For instance, is there a limit to the extent to which a method of moral reasoning can be adapted in order to meet the constraints of a given healthcare setting? Who is to decide, the bioethicist or the practitioners?

Transformative medical ethics: A framework for changing practice according to normative-ethical requirements.

We propose a step-by-step methodological framework of translational bioethics that aims at changing medical practice according to normative-ethical requirements, which we will thus call "transformative medical ethics." The framework becomes especially important when there is a gap between widely acknowledged, ethically justified normative claims and their realization in the practice of biomedicine and technology (ought-is gap). Building on prior work on translational bioethics, the framework maps a process with six different phases and 12 distinct translational steps. The steps involve various research activities including conceptual philosophical inquiry and (socio-)empirical research. On the one hand, the framework can be used as a heuristic tool to identify barriers to the transformation process. On the other hand, it can provide guidance for researchers and practitioners to develop appropriate (conceptual action and practice) models, which are then implemented and evaluated in specific practice contexts. We use the example of realizing the norm of respect for autonomy in the practice of medical decision-making to illustrate the framework. Further research is required, for example, to theoretically underpin the framework, to apply it to other ought-is gaps, and to evaluate its feasibility and effectiveness in various practice areas. Overall, the framework of transformative medical ethics suggests a strategic process to investigate and promote practice change that is ethically informed in all phases.

The relationship between speculation and translation in Bioethics: methods and methodologies.

There are increasing pressures for bioethics to emphasise 'translation'. Against this backdrop, we defend 'speculative bioethics'. We explore speculation as an important tool and line of bioethical inquiry. Further, we examine the relationship between speculation and translational bioethics and posit that speculation can support translational work. First, speculative research might be conducted as ethical analysis of contemporary issues through a new lens, in which case it supports translational work. Second, speculation might be a first step prior to translational work on a topic. Finally, speculative bioethics might constitute different content altogether, without translational objectives. For each conception of speculative bioethics, important methodological aspects determine whether it constitutes good bioethics research. We conclude that whether speculative bioethics is compatible with translational bioethics-and to what extent-depends on whether it is being employed as tool or content. Applying standards of impact uniformly across bioethics may inappropriately limit speculative bioethics.

Translational Bioethics and Public Input.

Translational science is justified as advancing the public's interests but has no mechanism for determining these interests. Standard social science approaches would produce either unrepresentative descriptions or a cacophony of data not easily condensed into a concrete conclusion about moving forward with a translational-science project. Here, I propose that the simplifying and structuring ethics employed by institutional review boards (IRBs) be used to create social science reports of the four to six most prominent values or principles of the public regarding a biotechnology. A board of bioethicists would weigh and balance these values to conclude whether the public supports a given translational-science innovation.

Towards medicine of excellence in Mexico: the "Código Infarto" protocol, a view from the perspective of translational bioethics.

INTRODUCTION: Mexico is the country with the highest mortality due to ST-elevation acute myocardial infarction (STEMI), and the IMSS has therefore developed the protocol of care for emergency departments called Código Infarto (Infarction Code). In this article, aspects of translational medicine are discussed with a bioethical and comprehensive perspective. OBJECTIVE: To analyze the Código Infarto protocol from the perspective of translational bioethics. METHOD: A problem-centered approach was carried out through reflective equilibrium (or Rawls' method), as well as by applying the integral method for ethical discernment. RESULTS: The protocol of care for emergency services Código Infarto is governed by evidence-based medicine and value-based medicine; it is guided by a principle of integrity that considers six dimensions of quality for the care of patients with STEMI. CONCLUSION: The protocol overcomes some adverse social determinants that affect STEMI medical care, reduces mortality and global economic disease burden, and develops medicine of excellence with high social reach.

INTRODUCCIÓN: México es el país con mayor mortalidad por infarto agudo de miocardio con elevación del segmento ST (IAM CEST), por lo que el Instituto Mexicano del Seguro Social desarrolló el protocolo de atención para los servicios de urgencias denominado Código Infarto. En este artículo se discuten aspectos de la medicina traslacional con una perspectiva bioética e integral. OBJETIVO: Analizar el protocolo Código Infarto desde la perspectiva de la bioética traslacional. MÉTODO: Se realizó una aproximación centrada en el problema a través del equilibrio reflexivo, así como la aplicación del método integral para el discernimiento ético. RESULTADOS: El protocolo de atención para los servicios de urgencias Código Infarto se rige por la medicina basada en la evidencia y la medicina basada en valores; se orienta por el principio de integridad que considera las seis dimensiones de la calidad para la atención de pacientes con IAM CEST. CONCLUSIÓN: El protocolo supera algunos determinantes sociales adversos que afectan la atención médica del IAM CEST, disminuye la mortalidad, la carga económica global de la enfermedad y desarrolla una medicina de excelencia de alto alcance social.

Hacia una medicina de excelencia en México: el protocolo Código Infarto, una visión desde la bioética traslacional / Towards medicine of excellence in Mexico: the "Código Infarto" protocol, a view from the perspective of translational bioethics

Resumen Introducción: México es el país con mayor mortalidad por infarto agudo de miocardio con elevación del segmento ST (IAM CEST), por lo que el Instituto Mexicano del Seguro Social desarrolló el protocolo de atención para los servicios de urgencias denominado Código Infarto. En este artículo se discuten aspectos de la medicina traslacional con una perspectiva bioética e integral. Objetivo: Analizar el protocolo Código Infarto desde la perspectiva de la bioética traslacional. Método: Se realizó una aproximación centrada en el problema a través del equilibrio reflexivo, así como la aplicación del método integral para el discernimiento ético. Resultados: El protocolo de atención para los servicios de urgencias Código Infarto se rige por la medicina basada en la evidencia y la medicina basada en valores; se orienta por el principio de integridad que considera las seis dimensiones de la calidad para la atención de pacientes con IAM CEST. Conclusión: El protocolo supera algunos determinantes sociales adversos que afectan la atención médica del IAM CEST, disminuye la mortalidad, la carga económica global de la enfermedad y desarrolla una medicina de excelencia de alto alcance social.

Abstract Introduction: Mexico is the country with the highest mortality due to ST-elevation acute myocardial infarction (STEMI), and the IMSS has therefore developed the protocol of care for emergency departments called Código Infarto (Infarction Code). In this article, aspects of translational medicine are discussed with a bioethical and comprehensive perspective. Objective: To analyze the Código Infarto protocol from the perspective of translational bioethics. Method: A problem-centered approach was carried out through reflective equilibrium (or Rawls' method), as well as by applying the integral method for ethical discernment. Results: The protocol of care for emergency services Código Infarto is governed by evidence-based medicine and value-based medicine; it is guided by a principle of integrity that considers six dimensions of quality for the care of patients with STEMI. Conclusion: The protocol overcomes some adverse social determinants that affect STEMI medical care, reduces mortality and global economic disease burden, and develops medicine of excellence with high social reach.