Developing and Implementing new TB Technologies: Key Informants' Perspectives on the Ethical Challenges.

OBJECTIVE: To identify the ethical challenges associated with the development and implementation of new tuberculosis (TB) drugs and diagnostics. METHODS: Twenty-three semi-structured qualitative interviews conducted between December 2015 and September 2016 with programme administrators, healthcare workers, advocates, policymakers, and funders based in the Americas, Europe, and Africa. Interviews were analysed using thematic analysis. RESULTS: Divergent interests and responsibilities, coupled with power imbalances, are a primary source of ethical challenges; the uncertain risk profiles of new drugs present an additional one. Although this challenge can be partially mitigated through stringent pharmacovigilance, respondents highlighted that high-burden countries tend to lack the resources to facilitate safe implementation. Increased advocacy and community engagement are considered an ethical imperative for future TB development and implementation. CONCLUSIONS: This project helps identify some of the ethical challenges of new TB technologies. It demonstrates that investigating ethical challenges through qualitative research is one way to apprehend the difficulty of implementing new TB technologies. Addressing this difficulty will require that those in positions of power reconsider their interests in relation to disempowered communities. POLICY IMPLICATIONS: Efforts to build consensus regarding what values should underpin the global governance of TB research, prevention, and care are essential to facilitate the ethical implementation of new TB technologies.

Psychosis, vulnerability, and the moral significance of biomedical innovation in psychiatry. Why ethicists should join efforts.

The study of the neuroscience and genomics of mental illness are increasingly intertwined. This is mostly due to the translation of medical technologies into psychiatry and to technological convergence. This article focuses on psychosis. I argue that the convergence of neuroscience and genomics in the context of psychosis is morally problematic, and that ethics scholarship should go beyond the identification of a number of ethical, legal, and social issues. My argument is composed of two strands. First, I argue that we should respond to technological convergence by developing an integrated, patient-centred approach focused on the assessment of individual vulnerabilities. Responding to technological convergence requires that we (i) integrate insights from several areas of ethics, (ii) translate bioethical principles into the mental health context, and (iii) proactively try to anticipate future ethical concerns. Second, I argue that a nuanced understanding of the concept of vulnerability might help us to accomplish this task. I borrow Florencia Luna's notion of 'layers of vulnerability' to show how potential harms or wrongs to individuals who experience psychosis can be conceptualised as stemming from different sources, or layers, of vulnerability. I argue that a layered notion of vulnerability might serve as a common ground to achieve the ethical integration needed to ensure that biomedical innovation can truly benefit, and not harm, individuals who suffer from psychosis.

Progress bias versus status quo bias in the ethics of emerging science and technology.

How should we handle ethical issues related to emerging science and technology in a rational way? This is a crucial issue in our time. On the one hand, there is great optimism with respect to technology. On the other, there is pessimism. As both perspectives are based on scarce evidence, they may appear speculative and irrational. Against the pessimistic perspective to emerging technology, it has been forcefully argued that there is a status quo bias (SQB) fuelling irrational attitudes to emergent science and technology and greatly hampering useful development and implementation. Therefore, this article starts by analysing the SQB using human enhancement as a case study. It reveals that SQB may not be as prominent in restricting the implementation of emergent technologies as claimed in the ethics literature, because SQB (a) is fuelled by other and weaker drivers than those addressed in the literature, (b) is at best one amongst many drivers of attitudes towards emergent science and technology, and (c) may not be a particularly prominent driver of irrational decision-making. While recognizing that SQB can be one driver behind pessimism, this article investigates other and counteracting forces that may be as strong as SQB. Progress bias is suggested as a generic term for the various drivers of unwarranted science and technology optimism. Based on this analysis, a test for avoiding or reducing this progress bias is proposed. Accordingly, we should recognize and avoid a broad range of biases in the assessment of emerging and existing science and technology in order to promote an open and transparent deliberation.

What Are Criteria for Considering Technologies' Uses and Influences in LMICs' Health Care Infrastructures?

A lack of health technology is an obstacle to health system growth in low- and middle-income countries (LMICs). US-based clinicians participating in global health efforts might sometimes wonder about clinical and ethical standards by which they should judge short- and long-term risks and benefits of bringing technological assistance with them to care for patients in LMICs. These countries are heterogeneous and changing, so establishing an evidence base for clinical and ethical decision making about technology use could be an important priority. This article suggests clinically and ethically relevant criteria according to which health technologies' use and influence can be evaluated.

Mitochondrial Replacement Techniques : Examining Collective Representation in Emerging Technologies Governance.

In this article, I draw on research carried out in Europe, primarily in Germany, on patients' and scientists' perspectives on mitochondrial replacement techniques (MRTs) in order to explore some of the complexities related to collective representation in health governance, which includes the translation of emerging technologies into clinical use. Focusing on observations, document analyses, and interviews with eight mitochondrial disease patient organization leaders, this contribution extends our understanding of the logic and meanings behind the ways in which patient participation and collective representation in health governance initiatives take shape. My findings highlight the ways in which a commitment to a global mitochondrial disease patient community and a sense of patient solidarity influence expressions of support with regard to legalizing mitochondrial replacement techniques. My analyses illustrate how normative practices and expectations of participatory governance potentially foreclose opportunities for sustained collective patient engagement with the complex ethical, social, and political dimensions of emerging technologies and may silence diverse and potentially dissenting embodied and lived responses to the prospects of particular technological developments.

From Healthcare to Warfare and Reverse: How Should We Regulate Dual-Use Neurotechnology?

Recent advances in military-funded neurotechnology and novel opportunities for misusing neurodevices show that the problem of dual use is inherent to neuroscience. This paper discusses how the neuroscience community should respond to these dilemmas and delineates a neuroscience-specific biosecurity framework. This neurosecurity framework involves calibrated regulation, (neuro)ethical guidelines, and awareness-raising activities within the scientific community.

Neuroscience Fiction as Eidolá: Social Reflection and Neuroethical Obligations in Depictions of Neuroscience in Film.

Neuroscience and neurotechnology are increasingly being employed to assess and alter cognition, emotions, and behaviors, and the knowledge and implications of neuroscience have the potential to radically affect, if not redefine, notions of what constitutes humanity, the human condition, and the "self." Such capability renders neuroscience a compelling theme that is becoming ubiquitous in literary and cinematic fiction. Such neuro-SciFi (or "NeuroS/F") may be seen as eidolá: a created likeness that can either accurately-or superficially, in a limited way-represent that which it depicts. Such eidolá assume discursive properties implicitly, as emotionally salient references for responding to cultural events and technological objects reminiscent of fictional portrayal; and explicitly, through characters and plots that consider the influence of neurotechnological advances from various perspectives. We argue that in this way, neuroS/F eidolá serve as allegorical discourse on sociopolitical or cultural phenomena, have power to restructure technological constructs, and thereby alter the trajectory of technological development. This fosters neuroethical responsibility for monitoring neuroS/F eidolá and the sociocultural context from which-and into which-the ideas of eidolá are projected. We propose three approaches to this: evaluating reciprocal effects of imaginary depictions on real-world neurotechnological development; tracking changing sociocultural expectations of neuroscience and its uses; and analyzing the actual process of social interpretation of neuroscience to reveal shifts in heuristics, ideas, and attitudes. Neuroethicists are further obliged to engage with other discourse actors about neuroS/F interpretations to ensure that meanings assigned to neuroscientific advances are well communicated and more fully appreciated.

Changing Memories: Between Ethics and Speculation.

Over the past decade, a debate has emerged between those who believe that memory-modulating technologies are inherently dangerous and need to be regulated and those who believe these technologies present minimal risk and thus view concerns about their use as far-fetched and alarmist. This article tackles three questions central to this debate: (1) Do these technologies jeopardize personhood? (2) Are the risks of these technologies acceptable? (3) Do these technologies require special regulation or oversight? Although concerns about the unethical use of memory-modulating technologies are legitimate, these concerns should not override the responsible use of memory-modulating technologies in clinical contexts. Accordingly, we call for careful comparative analysis of their use on a case-by-case basis.

Neurotechnological assessment of consciousness disorders: five ethical imperatives.

Disorders of consciousness (DOCs) cause great human suffering and material costs for society. Understanding of these disorders has advanced remarkably in recent years, but uncertainty remains with respect to the diagnostic criteria and standards of care. One of the most serious problems concerns misdiagnoses, their impact on medical decision-making, and on patients' well-being. Recent studies use neurotechnology to assess residual consciousness in DOC patients that traditional behavioral diagnostic criteria are unable to detect. The results show an urgent need to strengthen the development of new diagnostic tools and more refined diagnostic criteria. If residual consciousness may be inferred from robust and reproducible results from neurotechnological communication with DOC patients, this also raises ethical challenges. With reference to the moral notions of beneficence and fundamental rights, five ethical imperatives are here suggested in terms of diagnosis, communication, interpretation of subjective states, adaptation of living conditions, and care.

Los trastornos de conciencia (TC) provocan grandes sufrimientos humanos y costos materiales para la sociedad. La comprensión de estos trastornos ha avanzado significativamente en los últimos años, pero persiste la incertidumbre respecto a los criterios diagnósticos y estándares de atención. Uno de los problemas más serios se refiere al diagnóstico erróneo, su impacto en la toma de decisiones médicas y en el bienestar de los pacientes. Estudios recientes emplean neurotecnología para evaluar la conciencia residual en los pacientes con TC en que los criterios diagnósticos conductuales tradicionales son incapaces de detectarlos. Los resultados muestran una necesidad urgente de fortalecer el desarrollo de nuevas herramientas diagnósticas y criterios diagnósticos más refinados. Si la conciencia residual se puede inferir de resultados sólidos y reproducibles a partir de la comunicación neurotecnológica con pacientes con TC, esto también plantea desafíos éticos.En relación con las nociones morales de beneficencia y derechos fundamentales, aquí se sugieren cinco imperativos éticos en términos del diagnóstico, comunicación, interpretación de los estados subjetivos, adaptación a las condiciones de vida y atención.

Les troubles de la conscience coûtent en souffrance humaine et en matériel pour la société. Ces dernières années, la compréhension de ces troubles a beaucoup progressé, mais les critères diagnostiques et les standards de soins restent à définir. Un des problèmes les plus importants concerne les erreurs de diagnostic, leur impact sur la prise de décision médicale et sur le bien-être des patients. Des études récentes utilisent la neurotechnologie pour évaluer la conscience résiduelle chez les patients ayant des troubles de la conscience ne pouvant être détectés par les critères de diagnostic comportemental traditionnels. Les résultats montrent un besoin urgent de renforcer le développement de nouveaux outils diagnostiques et de critères diagnostiques plus affinés. Si la conscience résiduelle peut être déduite de résultats solides et reproductibles issus de la communication neurotechnologique avec les patients ayant des troubles de la conscience, cela pose toutefois des problèmes éthiques. En référence aux notions morales de bienfaisance et de droits fondamentaux, cinq impératifs éthiques sont ici proposés en termes de diagnostic, de communication, d'interprétation d'états subjectifs, d'adaptation de condition de vie et de soins.

Beyond the Black Box Approach to Ethics! Comment on "Expanded HTA: Enhancing Fairness and Legitimacy".

In the editorial published in this journal, Daniels and colleagues argue that his and Sabin's accountability for reasonableness (A4R) framework should be used to handle ethical issues in the health technology assessment (HTA)-process, especially concerning fairness. In contrast to this suggestion, it is argued that such an approach risks suffering from the irrrelevance or insufficiency they warn against. This is for a number of reasons: lack of comprehensiveness, lack of guidance for how to assess ethical issues within the "black box" of A4R as to issues covered, competence and legitimate arguments and finally seemingly accepting consensus as the final verdict on ethical issues. We argue that the HTA community is already in a position to move beyond this black box approach.

Epigenetics in the Neoliberal "Regime of Truth": A Biopolitical Perspective on Knowledge Translation.

Recent findings in epigenetics have been attracting much attention from social scientists and bioethicists because they reveal the molecular mechanisms by which exposure to socioenvironmental factors, such as pollutants and social adversity, can influence the expression of genes throughout life. Most surprisingly, some epigenetic modifications may also be heritable via germ cells across generations. Epigenetics may be the missing molecular evidence of the importance of using preventive strategies at the policy level to reduce the incidence and prevalence of common diseases. But while this "policy translation" of epigenetics introduces new arguments in favor of public health strategies and policy-making, a more "clinical translation" of epigenetics is also emerging. It focuses on the biochemical mechanisms and epigenetic variants at the origin of disease, leading to novel biomedical means of assessing epigenetic susceptibility and reversing detrimental epigenetic variants. In this paper, we argue that the impetus to create new biomedical interventions to manipulate and reverse epigenetic variants is likely to garner more attention than effective social and public health interventions and therefore also to garner a greater share of limited public resources. This is likely to happen because of the current biopolitical context in which scientific findings are translated. This contemporary neoliberal "regime of truth," to use a term from Michel Foucault, greatly influences the ways in which knowledge is being interpreted and implemented. Building on sociologist Thomas Lemke's Foucauldian "analytics of biopolitics" and on literature from the field of science and technology studies, we present two sociological trends that may impede the policy translation of epigenetics: molecularization and biomedicalization. These trends, we argue, are likely to favor the clinical translation of epigenetics-in other words, the development of new clinical tools fostering what has been called "personalized" or "precision" medicine. In addition, we argue that an overemphasized clinical translation of epigenetics may further reinforce this biopolitical landscape through four processes closely related to neoliberal pathways of thinking: the internalization and isolation (aspects of liberal individualism) of socioenvironmental determinants of health and increased opportunities for commodification and technologicalization (aspects of economic liberalism) of health care interventions.