Empirical evidence suggests that while people hold the capacity to control their data in high regard, they increasingly experience a loss of control over their data in the online world. The capacity to exert control over the generation and flow of personal information is a fundamental premise to important values such as autonomy, privacy, and trust. In healthcare and clinical research this capacity is generally achieved indirectly, by agreeing to specific conditions of informational exposure. Such conditions can be openly stated (...) in informed consent documents or be implicit in the norms of confidentiality that govern the relationships of patients and healthcare professionals. However, with medicine becoming a data-intense enterprise, informed consent and medical confidentiality, as mechanisms of control, are put under pressure. In this paper we explore emerging models of informational control in data-intense healthcare and clinical research, which can compensate for the limitations of currently available instruments. More specifically, we discuss three approaches that hold promise in increasing individual control: the emergence of data portability rights as means to control data access, new mechanisms of informed consent as tools to control data use, and finally, new participatory governance schemes that allow individuals to control their data through direct involvement in data governance. We conclude by suggesting that, despite the impression that biomedical big data diminish individual control, the synergistic effect of new data management models can in fact improve it. (shrink)

Precision medicine promises to develop diagnoses and treatments that take individual variability into account. According to most specialists, turning this promise into reality will require adapting the established framework of clinical research ethics, and paying more attention to participants’ attitudes towards sharing genotypic, phenotypic, lifestyle data and health records, and ultimately to their desire to be engaged as active partners in medical research.Notions such as participation, engagement and partnership have been introduced in bioethics debates concerning genetics and large-scale biobanking to (...) broaden the focus of discussion beyond individual choice and individuals’ moral interests. The uptake of those concepts in precision medicine is to be welcomed. However, as data and medical information from research participants in precision medicine cohorts will be collected on an individual basis, translating a participatory approach in this emerging area may prove cumbersome. Therefore, drawing on Joseph Raz’s perfectionism, we propose a principle of respect for autonomous agents that, we reckon, can address many of the concerns driving recent scholarship on partnership and public participation, while avoiding some of the limitations these concept have in the context of precision medicine. Our approach offers a normative clarification to how becoming partners in precision is compatible with retaining autonomy.Realigning the value of autonomy with ideals of direct engagement, we show, can provide adequate normative orientation to precision medicine; it can do justice to the idea of moral pluralism by stressing the value of moral self-determination: and, finally, it can reconcile the notion of autonomy with other more communitarian values such as participation and solidarity. (shrink)

In this paper, I present an emerging explanatory framework about ageing and care. In particular, I focus on how, in contrast to most classical accounts of ageing, biomedicine today construes the ageing process as a modifiable trajectory. This framing turns ageing from a stage of inexorable decline into the focus of preventive strategies, harnessing the functional plasticity of the ageing organism. I illustrate this shift by focusing on studies of the demographic dynamics in human population, observations of ageing as an (...) intraspecifically heterogenous phenotype, and the experimental manipulation of longevity, in both model organisms and humans. I suggest that such an explanatory framework about ageing creates the epistemological conditions for the rise of a peculiar form of prevention that does not aim to address a specific condition. Rather it seeks to stall the age-related accumulation of molecular damage and functional deficits, boosting individual resilience against age-related decline. I call this preventive paradigm “ground-state prevention.” While new, ground-state prevention bears conceptual resemblance to forms of medical wisdom prominent in classic Galenic medicine, as well as in the Renaissance period. (shrink)

This paper explores the epistemology of extrapolation from model organisms to humans in molecular medicine. We take into account two common views on the issue, the homology view and the disanalogy view. In response to both interpretations, we argue that the foundational basis of extrapolations cannot simply be provided by homology and that relevant disanalogies can, thanks to the techniques of molecular biology, be experimentally controlled and exploited to allow useful and reliable extrapolations. The case of "humanised mice" in the (...) context of cancer stem cell research provides evidence of how animal models can be construed to approximate bona fide causal analogue models of human diseases. To supplement this view we show how the epistemology of model organisms needs to take into account the engineering side of molecular medicine. Model organisms are often manipulated to create analogies or remove disanalogies with the target system. We maintain that highlighting this feature is fundamental to explain what warrants extrapolation in the search for the molecular causes of disease. (shrink)

Massive amounts of data are collected and stored on a routine basis in virtually all domains of human activities. Such data are potentially useful to biomedicine. Yet, access to data for research purposes is hindered by the fact that different kinds of individual-patient data reside in disparate, unlinked silos. We propose that data cooperatives can promote much needed data aggregation and consequently accelerate research and its clinical translation. Data cooperatives enable direct control over personal data, as well as more democratic (...) governance of data pools. This model can realize a specific kind of data economy whereby citizens and communities are empowered to steer data use according to their motivations, preferences, and concerns. Policy makers can promote this model by recognizing citizens’ rights to access and to obtain a copy of their own data, and by funding distributed data infrastructures piloting new data aggregation models. (shrink)

What has been called the new mechanistic philosophy conceives of mechanisms as the main providers of biological explanation. We draw on the characterization of the p53 gene in molecular oncology, to show that explaining a biological phenomenon implies instead a dynamic interaction between the mechanistic level—rendered at the appropriate degree of ontological resolution—and far more general explanatory tools that perform a fundamental epistemic role in the provision of biological explanations. We call such tools “explanatory frameworks”. They are called frameworks to (...) stress their higher level of generality with respect to bare mechanisms; on the other hand, they are called explanatory because, as we show in this paper, their importance in explaining biological phenomena is not secondary with respect to mechanisms. We illustrate how explanatory frameworks establish selective and local criteria of causal relevance that drive the search for, characterisation and usage of biological mechanisms. Furthermore, we show that explanatory frameworks allow for changes of scientific perspective on the causal relevance of mechanisms going beyond the account provided by the new mechanistic philosophy. (shrink)

The American Journal of Bioethics, Volume 12, Issue 10, Page 20-22, October 2012.

Some patients tolerate a given drug well, without adverse reactions. For others, though, an identical dose of the same medication can have toxic effects. Moreover, while a drug can be effective at relieving symptoms for some patients, it may fail to do the same for others suffering with the same disease. With such variability in treatment responses, tailoring medical interventions to individual patients has long been an aspiration of medicine. Until recently, however, medicine lacked a clear understanding of the biological (...) reasons for human variation in drug response. Attempting to adjust treatment to the individual patient, physicians have relied primarily on direct observation, trial-and-error, and, ultimately... (shrink)

The online space has become a digital public square, where individuals interact and share ideas on the most trivial to the most serious of matters, including discussions of controversial ethical issues in science, technology and medicine. In the last decade, new disciplines like computational social science and social data science have created methods to collect and analyse such data that have considerably expanded the scope of social science research. Empirical bioethics can benefit from the integration of such digital methods to (...) investigate novel digital phenomena and trace how bioethical issues take shape online.Here, using concrete examples, we demonstrate how novel methods based on digital approaches in the social sciences can be used effectively in the domain of bioethics. We show that a digital turn in bioethics research aligns with the established aims of empirical bioethics, integrating with normative analysis and expanding the scope of the discipline, thus offering ways to reinforce the capacity of bioethics to tackle the increasing complexity of present-day ethical issues in science and technology. We propose to call this domain of research in bioethicsdigital bioethics. (shrink)

To address the ethical challenges in big data health research we propose the concept of systemic oversight. This approach is based on six defining features and aims at creating a common ground across the oversight pipeline of biomedical big data research. Current trends towards enhancing granularity of informed consent and specifying legal provisions to address informational privacy and discrimination concerns in data-driven health research are laudable. However, these solutions alone cannot have the desired impact unless oversight activities by different stakeholders (...) acquire a common substantive orientation. (shrink)

Machine learning heralds highly transformative approaches to the automation of numerous clinical tasks, from diagnosis to risk assessment, and from prognosis to informing treatment decisions....

This paper describes the results of a multi-country survey of governance approaches for the use of digital contact tracing (DCT) in response to the COVID-19 pandemic. We argue that the countries in our survey represent two distinct models of DCT governance, both of which are flawed. The “data protection model” emphasizes privacy protections at the expense of public health benefit, while the “emergency response model” sacrifices transparency and accountability, prompting concerns about excessive governance surveillance. The ethical and effective use of (...) DCT in the future requires a new governance approach that is better suited to this novel use of mobile phone data to promote public health.”. (shrink)

Drugs addressing unmet medical needs can change the lives of millions. Developing and validating new drugs can, however, take many years. To streamline the assessment of new drugs, regulatory agencies have long established shortened review pathways. Among these programs, Accelerated Approval (AA) has recently come under scrutiny due to the U.S. Food and Drug Administration's decision to authorize Aducanumab, the first Alzheimer's disease drug. This decision attracted fierce criticism due to the allegedly insufficient evidence about the safety and efficacy of (...) the drug. While considerable scholarly attention has been devoted to this case, the ethical aspects of the AA regulatory pathway have so far remained relatively unexplored. In this paper, we set out to fill this gap. We illustrate six conditions that should be met for AA to be ethically acceptable: moral solicitude, evidence, risk mitigation, impartiality, sustainability, and transparency. We discuss such conditions and suggest practical steps to implement them in regulatory and oversight processes. Taken together, our six conditions represent a benchmark for assessing the ethical validity of AA processes and decisions. (shrink)

BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map (...) these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large. (shrink)

In this paper, we discuss how access to health-related data by private insurers, other than affecting the interests of prospective policy-holders, can also influence their propensity to make personal data available for research purposes. We take the case of national precision medicine initiatives as an illustrative example of this possible tendency. Precision medicine pools together unprecedented amounts of genetic as well as phenotypic data. The possibility that private insurers could claim access to such rapidly accumulating biomedical Big Data or to (...) health-related information derived from it would discourage people from enrolling in precision medicine studies. Should that be the case, the economic value of personal data for the insurance industry would end up affecting the public value of data as a scientific resource. In what follows we articulate three principles – trustworthiness, openness and evidence – to address this problem and tame its potentially harmful effects on the development of precision medicine and, more generally, on the advancement of medical science. (shrink)

Digital technologies hold promise to modernize healthcare. Such opportunity should be leveraged also to address the needs of rapidly ageing populations. Against this backdrop, this paper examines the use of wearable devices for promoting healthy ageing. Previous work has assessed the prospects of digital technologies for health promotion and disease prevention in older adults. However, to our knowledge, ours is one of the first attempts to specifically address the use of wearables for healthy ageing, and to offer ethical insights for (...) assessing the prospects of leveraging wearable devices in this context. We provide an analysis of the considerable opportunities associated with the use of wearables for healthy ageing, with a focus on the five domains of intrinsic capacity: locomotion, sensory functions, psychological aspects, cognition, and vitality. We then highlight current limitations and ethical challenges of such approach to healthy ageing, including issues related to access, inclusion, privacy, surveillance, autonomy, and regulation. We conclude by discussing the implications of our analysis in light of current debates on the ethics of digital health, and suggest measures to address the identified challenges. (shrink)

Background There are intense discussions about the ethical and societal implications of biomedical engineering, but little data to suggest how scientists think about the ethics of their work. The aim of this study is to describe how scientists frame the ethics of their research, with a focus on the field of molecular systems engineering.Methods Semi-structured qualitative interviews were conducted during 2021–2022, as part of a larger study. This analysis includes a broad question about how participants view ethics as related to (...) their work, with follow up probes about the topics they consider most important. Interviews were transcribed, inductively coded by two researchers to consensus, and analyzed thematically.Results Twenty-four scientists participated in the study. Interviewees hold positions as professors, principal investigators, and senior staff researchers in universities or research institutes in the United States and Europe. Among those scientists who reported reflecting on ethical considerations in their work, many equated ethics with research ethics topics (e.g., safety, replicability), or with regulation and guidelines. Participants expressed the view that ethical issues are primarily relevant for clinical trials of bioengineered products, or for those working with animal or human subjects. Scientists described their research as “too early” or “not examining anything living” with regard to ethical reflection. Finally, many felt that ethics is seen as territory for experts and therefore beyond scientists’ competencies.Conclusions Molecular systems engineering scientists currently focus on regulatory aspects as the framework for their ethical analyses. They describe using a framework to define when life arises, as a means to determine when further ethical engagement is warranted. Further research is needed to investigate how scientists relate to the ethics of their scientific work, and build consensus around concepts of life, autonomous behavior, and physiological relevance of bioengineered systems. (shrink)

Data access and data sharing are vital to advance medicine. A growing number of public private partnerships are set up to facilitate data access and sharing, as private and public actors possess highly complementary health data sets and treatment development resources. However, the priorities and incentives of public and private organizations are frequently in conflict. This has complicated partnerships and sparked public concerns around ethical issues such as trust, justice or privacy—in turn raising an important problem in business and data (...) ethics: how can ethical theory inform the practice of public and private partners to mitigate misaligned incentives, and ensure that they can deliver societally beneficial innovation? In this paper, we report on the development of the Swiss Personalized Health Network’s ethical guidelines for health data sharing in public private partnerships. We describe the process of identifying ethical issues and engaging core stakeholders to incorporate their practical reality on these issues. Our report highlights core ethical issues in health data public private partnerships and provides strategies for how to overcome these in the Swiss health data context. By agreeing on and formalizing ethical principles and practices at the beginning of a partnership, partners and society can benefit from a relationship built around a mutual commitment to ethical principles. We present this summary in the hope that it will contribute to the global data sharing dialogue. (shrink)

Some computational phenomena rely essentially on pragmatic considerations, and seem to undermine the independence of the specification from the implementation. These include software development, deviant uses, esoteric languages and recent data-driven applications. To account for them, the interaction between pragmatics, epistemology and ontology in computational artefacts seems essential, indicating the need to recover the role of the language metaphor. We propose a User Levels (ULs) structure as a pragmatic complement to the Levels of Abstraction (LoAs)-based structure defining the ontology and (...) epistemology of computational artefacts. ULs identify a flexible hierarchy in which users bear their own semantic and normative requirements, possibly competing with the logical specification. We formulate a notion of computational act intended in its pragmatic sense, alongside pragmatic versions of implementation and correctness. (shrink)

The Wealth of Ideas, first published in 2005, traces the history of economic thought, from its prehistory to the present day. In this eloquently written, scientifically rigorous and well documented book, chapters on William Petty, Adam Smith, David Ricardo, Karl Marx, William Stanley Jevons, Carl Menger, Léon Walras, Alfred Marshall, John Maynard Keynes, Joseph Schumpeter and Piero Sraffa alternate with chapters on other important figures and on debates of the period. Economic thought is seen as developing between two opposite poles: (...) a subjective one, based on the ideas of scarcity and utility, and an objective one based on the notions of physical costs and surplus. Professor Roncaglia focuses on the different views of the economy and society and on their evolution over time and critically evaluates the foundations of the scarcity-utility approach in comparison with the Classical/Keynesian approach. (shrink)

Philosophers distinguish between having a property essentially and having it accidentally. The way the distinction has been drawn suggests that it is modal in character, and so that it can be captured in terms of necessity, or cognate notions. The present chapter takes the suggestion at face value by considering a number of modal characterizations of the essential/accidental distinction that have been articulated and discussed since the early 20th century, as well as some of the challenges that they face.

How and to what extent do people take into account the intentions of others? Alessandro Duranti sets out to answer this question, showing that the role of intentions in human interaction is variable across cultures and contexts. Through careful analysis of data collected over three decades in US and Pacific societies, Duranti demonstrates that, in some communities, social actors avoid intentional discourse, focusing on the consequences of actions rather than on their alleged original goals. In other cases, he argues, (...) people do speculate about their own intentions or guess the intentions of others, including in some societies where it was previously assumed they avoid doing so. To account for such variation, Duranti proposes an 'intentional continuum', a concept that draws from phenomenology and the detailed analysis of face-to-face interaction. A combination of new essays and classic re-evaluations, the book draws together findings from anthropology, linguistics and philosophy to offer a penetrating account of the role of intentions in defining human action. (shrink)

Wittgenstein has written a great number of remarks relevant to aesthetical issues: he has questioned the relation between aesthetics and psychology as well as the status of our norms of judgment; he has drawn philosophers attention to such topics as aspect-seeing and aspect-dawning, and has brought insights into the nature of our aesthetic reactions. The examination of this wide range of topics is far from being completed, and the purpose of this book is to contribute to such completion. It gathers (...) both papers discussing some of Wittgenstein s most provocative and intriguing statements on aesthetics, and papers bringing out their implications for art critic and art history, as well as their significance to epistemology and to the study of human mind.". (shrink)

The aim of this paper is to present a system of modal connexive logic based on a situation semantics. In general, modal connexive logics are extensions of standard modal logics that incorporate Aristotle’s and Boethius’ theses, that is the thesis that a sentence cannot imply its negation and the thesis that a sentence cannot imply a pair of contradictory sentences. A key problem in devising a connexive logic is to come up with a system that is both sufficiently strong to (...) fulfill some specific connexive theses and sufficiently well-motivated from a semantical point of view. The approach proposed here tries to address this problem by defining an appropriate connexive relation in terms of more basic notions. The result is a well-motivated system of modal connexive logic that nicely fits in both with the traditional ideas concerning the connexive conditional and with the current developments in connexive logic. (shrink)

L’ambientazione dell’itinerario che qui si propone rinvia ad un’ermeneutica del diritto che concentra l’attenzione non su un settore – costituito da metodologie e principi ai quali attingere per la soluzione di conflitti nella prassi –, ma su una riflessione rigorosa. Tale ordine di pensiero muove dalla filosofia aristotelica del De Interpretatione, sino ai problemi della globalizzazione, trattati interrogandosi se l’ermeneutica occupi o meno un posto prioritario nel complesso universum giuridico. Si prende atto che l’arte dell’interpretazione appare sostituibile con un insieme (...) di teorie argomentative che, con il loro management, rischiano di banalizzare i concetti della responsabilità personale nella vita quotidiana dell’amministrazione della giustizia. (shrink)

This book contains essential contributions to enrich and broaden the application field of pragmatics. It provides an example of how the fruitful reflections and refined conceptual distinctions born in the philosophical field can find a practical application in addressing social, cognitive, clinical, and psychological problems. Its chapters address, from different points of view, the relationship between pragmatic linguistics and philosophy, and outline the possible application of pragmatic theories to different domains. Developed during the third Pragmasophia international conference, whose name is (...) derived from the Greek terms πρᾶγμα (action, fact) and σοφία (knowledge, science), the book aligns itself with its aim to study human actions and activities and how they take shape through language. But ‘Pragma’ and ‘Sophia’ also signal another purpose: highlighting the importance of creating links between empirical investigations on language use, and more traditional philosophical approaches. In this reading, ‘Pragma’ represents the experimental goal devoted to analysing and interpreting language facts. In contrast, the term ‘Sophia’ recalls the original vocation of past philosophers to pursue an ideal of ‘pure knowledge’, disconnected from any practical-economic interest. While maintaining the conference's original purpose of encouraging productive comparisons between different approaches, the book consists of two sections: first, on philosophical approaches, recalls more theoretical aspects (closer to the term ‘Sophia’); the second, ‘Inferential and Cognitive Pragmatics,’ addresses more practical issues affecting domains such as Greek literature, pragmatic disorders, dictionary entries, and speech analysis. The reader, whether in linguists, philosophy or psychology, obtains a complete overview of the most advanced current research lines, both theoretical and empirical, and thus contributes to broadening the scope of pragmatics. (shrink)

Ted Sider has famously argued that existence, in the unrestricted sense of ontology, cannot be vague, as long as vagueness is modeled by means of precisifications. The first section of Chapter 9 exposes some controversial assumptions underlying Sider’s alleged reductio of vague existence. The upshot of the discussion is that, although existence cannot be vague, it can be super-vague, i.e. higher-order vague, for all orders. The second section develops and defends a novel framework, dubbed negative supervaluationary semantics, which makes room (...) for the possibility of super-vague existence. (shrink)

Keenan (1987) observed that trivial determiners built from basic existential determiners (e.g.,either zero or else more than zero) are allowed inthere-insertion contexts, and that trivial determiners built from basic non-existential determiners (e.g.,either all or else not all) are not. This result is unexpected under the analyses ofthere-sentences proposed in Barwise and Cooper (1981), Higginbotham (1987), and Keenan (1987). I argue that the class of NPs barred from the postverbal position ofthere-sentences (strong NPs) is correctly characterized in presuppositional terms, as suggested (...) in de Jong and Verkuyl (1985) and Lumsden (1988). According to this characterization, strong NPs share one of the defining components of definiteness proposed in Heim (1982), namely the Descriptive Content Condition (DCC). How to derive the prohibition against strong NPs inthere-insertion contexts (definiteness effect) from the fact that strong NPs meet the DCC is not obvious, however. I argue that accounting for this prohibition involves regarding the XP-coda in [there be NP XP] as providing the contextual domain for the interpretation of the postverbal NP. (shrink)

Philosophers have rightly condemned lookism—that is, discrimination in favor of attractive people or against unattractive people—in education, the justice system, the workplace and elsewhere. Surprisingly, however, the almost universal preference for attractive romantic and sexual partners has rarely received serious ethical scrutiny. On its face, it’s unclear whether this is a form of discrimination we should reject or tolerate. I consider arguments for both views. On the one hand, a strong case can be made that preferring attractive partners is bad. (...) The idea is that choosing partners based on looks seems essentially similar to other objectionable forms of discrimination. (In particular, the preference for attractive partners is arguably both unfair and harmful to a significant degree.) One can try to resist this conclusion in several ways. I consider three possible replies. The first has to do with the possibility of controlling our partner preferences. The second pertains to attractiveness and “good genes”. The last attempts to link certain aspects of attractiveness to a prospective partner’s personality and values. I argue that the first two replies fail conclusively, while the third only amounts to a limited defense of a particular kind of attractiveness preference. So the idea that we should often avoid preferring attractive partners is compelling. (shrink)