Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond (...) its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials. (shrink)

Models are not adequately evaluated simply by whether they capture the data, after the fact. Other criteria are needed. One criterion is parsimony; but utility and generality are at least as important. Even with respect to parsimony, however, the case against feedback is not as straightforward as Norris et al. present it. We use feedback consistency effects to illustrate these points.

Episodic representations can be entertained either as “remembered” or “imagined”—as outcomes of experience or as simulations of such experience. Here, we argue that this feature is the product of a dedicated cognitive function: the metacognitive capacity to determine the mnemicity of mental event simulations. We argue that mnemicity attribution should be distinguished from other metacognitive operations (such as reality monitoring) and propose that this attribution is a “cognitive gadget”—a distinctively human ability made possible by cultural learning. Cultural learning is a (...) type of social learning in which traits are inherited through social interaction. In the case of mnemicity, one culturally learns to discriminate metacognitive “feelings of remembering” from other perceptual, emotional, action-related, and metacognitive feelings; to interpret feelings of remembering as indicators of memory rather than imagination; and to broadcast the interpreted feelings in culture- and context-specific ways, such as “I was there” or “I witnessed it myself.” We review evidence from the literature on memory development and scaffolding, metacognitive learning and teaching, as well as cross-cultural psychology in support of this view before pointing out various open questions about the nature and development of mnemicity highlighted by our account. (shrink)

The establishment of cooperative links on a voluntary basis did not seem to be adequate for the administration in large urban agglomerations. These links are often lacking in actual administrative power, and they can be reduced to the sum of the municipal interests. Large-scale amalgamation of municipalities does not seem to be a solution when one considers the developments and prevailing attitudes in a few Western European countries. Because of the lack of an integral framework, legally based agglomeration administrations have (...) been created in a number of these countries.They are extra, often complicating administrative levels. The existing administrative levels can often suffice with a balanced redistribution of administrative tasks. Territorial adjustments must be based primarily on functional considerations, but must also be translated in terms of the other administrative levels. A functional redistribution of tasks is, therefore, a condition for a specific solution of the total administrative problem. (shrink)

An increasing number of older patients have to decide on a treatment plan for advanced chronic kidney disease, involving dialysis or conservative care. Shared decision-making is recommended as the model for decision-making in such preference-sensitive decisions. The aim of SDM is to come to decisions that are consistent with the patient’s values and preferences and made by the patient and healthcare professional working together. In clinical practice, however, SDM appears to be not yet routine and needs further implementation. A shift (...) from a biomedical to a person-centered conception might help to make the process more shared. Shared should, therefore, be interpreted as two persons bringing two perspectives to the table, that both need to be explored during the decision-making process. Starting from the patient’s perspective will enable to determine the mutual goals of care first and, subsequently, determine the best way for achieving those goals. To perform such SDM, the healthcare professional needs to become a skilled companion, being part of the patient’s relational context, and start asking the right questions about what matters to the patient as person. In this article, we describe the need for a person-centered conception of SDM for the setting of older patients with advanced CKD. (shrink)

The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy underlying risk-benefit decisions in (...) clinical research, which can be applied to pregnant women. However, the current application is a strong one, leading to the promotion of absolute exclusion or, less often, absolute inclusion of pregnant women. In order to change this paralyzing situation, a shift toward weak precautionary thinking is necessary. Instead of automatic extreme precaution, a balance will be found between harms and potential benefits of including pregnant women in clinical research. (shrink)

Background Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as vulnerable. Our aim was to explore whether and if so to what extent pregnant women are vulnerable as research subjects. Method We performed a conceptual and empirical analysis of vulnerability applied to pregnant women. Analysis A conceptual analysis supports Hurst's definition (...) of vulnerability. Consequently, we argue that pregnant women are vulnerable if they encounter an identifiably increased likelihood of incurring additional or greater wrong. According to the literature, this increased likelihood could exist of four alleged features for pregnant women's vulnerability: informed consent, susceptibility to coercion, higher exposure to risk due to lack of knowledge, vulnerability of the fetus. Discussion Testing the features against Hurst's definition demonstrates that they all concern the same issue: pregnant women are only vulnerable because a higher exposure to risk due to lack of scientific knowledge comprises an increased wrong. Research Ethics Committees have a responsibility to protect the vulnerable, but a higher exposure to risk due to lack of scientific knowledge is a much broader issue and also needs to be addressed by other stakeholders. Conclusions The only reason why pregnant women are potentially vulnerable is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge. Accordingly, the discussion can advance to the development of practical strategies to promote fair inclusion of pregnant women in clinical research. (shrink)

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair inclusion and (...) vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. (shrink)

Drawing on historical inisights, systematic reflections and empirical data, this book offers a substantive understanding of the complex relationship between religion and human rights and of the empirical impact of Christianity and Islam on the attitudes toward human rights, i.e. a human rights culture.

This volume contains four theoretical and four empirical articles that aim at conceptual clarification and descriptive and causal exploration on data from 14 countries about historical and current tensions within and between religions, Christiantity and Islam, and human rights in various contexts.

It is often argued that clinical research should not violate the Kantian principle that people must not be used merely as a means for the purposes of others. At first sight, the practice of clinical research itself, however, seems to violate precisely this principle: clinical research is often beneficial to future people rather than to participants; even if participants benefit, all things considered, they are exposed to discomforts which are absent both in regular care for their diseases and in other (...) areas of daily life. Therefore, in this paper we will consider whether people are used merely as a means by being enrolled in clinical research. On the basis of recent studies of Kantian scholars we will argue that clinical research is compatible with the Kantian principle if the conditions of possible consent and end-sharing have been met. Participants are not used merely as a means if they have sufficient reasons to consent to being enrolled in clinical research and can share the ends of the researchers who use them. Moreover, we will claim that even if people are used merely as a means by participating in clinical research, it may not always be morally wrong to use them in this way. (shrink)

During the past decennium, one of the main issues discussed in research ethics has been focused on the care that should be provided to the control group in a clinical trial. This discussion is also called the standard of care debate . Current international research ethics guidelines contain a wide variety of standards for the standard of care—including the provision of the highest attainable, the best available, the best current, a proven , and an established effective treatment. In this article, (...) we systematically review the currently used standards and argue that none of the current standards is adequate to serve as a universal standard for the standard of care. Alex London has made a substantial proposal for a universal standard, but universally adopting his standard is problematic. In this article, we propose a revised version of London's standard. (shrink)

Protagoras of Abdera, Socrates’ older contemporary, is regarded as one of the most prominent representatives of the so-called sophistic movement. Instead of simply accepting the biased reports given by Plato and Aristotle about this sophist, the contributors to this volume review the complicated doxographical situation and make a case for Protagoras as a philosopher in his own right. Two major themes of this volume are Protagoras’ relativism and his case for a moral and political ideal, both of which are contrasted (...) with the metaphysical idealism of his future opponents in the Academy and the mundane conventionalism typically associated with the sophists. It turns out that rather than a parasitic force of intellectual subversion, Protagoras may have been a prolific and original thinker aiming at a coherent and comprehensive view of man’s place in the world. (shrink)

Transformative and mutually beneficial solutions require decision-makers to reconcile present- and future interests and to align them with those of other decision-makers. Despite the natural co-occurrence of intrapersonal and interpersonal conflicts in the transformation toward sustainability, both types of conflicts have been studied predominantly in isolation. In this conceptual article, we breathe new life into the traditional dialog between individual decision-making and negotiation research and address critical psychological barriers to the transformation toward sustainability. In particular, we argue that research on (...) intrapersonal and interpersonal conflicts should be tightly integrated to provide a richer understanding of the interplay between these conflicts. We propose a novel, unifying framework of interdependent conflicts that systematically structures this interplay, and we analyze how complex interdependencies between the social and temporal dimensions pose fundamental psychological barriers to mutually beneficial solutions. Since challenges to conflict resolution in the transformation toward sustainability emerge not only between individual decision-makers but also frequently between groups of decision-makers, we scale the framework up to the level of social groups and thereby provide an interdependent-conflicts perspective on the interplay between intra- and intergenerational conflicts. Overall, we propose simple, testable propositions, identify intervention approaches, and apply them to transition management. By analyzing the challenges faced by negotiating parties during interdependent conflicts and highlighting potential intervention approaches, we contribute to the transformation toward sustainability. Finally, we discuss implications of the framework and point to avenues for future research. (shrink)

After discussing the so-called Ham myth in South Africa, my focus is on the African church father Augustine (354–430). All texts from his immense oeuvre in which he mentions biblical Ham are reviewed in chronological order. In Against Faustus, the story of Noah and his sons is mainly explained as being Christological: Ham figures as a type of the unbelieving Jews who consented to the murder of Christ, but he is also a type of the Jews because he is ‘the (...) slave of his brothers’ carrying the books by which the Christians may be instructed. Later Augustine corrects his confusion of Ham with the slave Canaan. The story of Ham (and Canaan) is most extensively discussed in the City of God. Neither here nor in the Expositions on the Psalms, Ham is described as being black or a slave. The same goes for a number of his other writings. In Augustine’s late works Against Julian and Unfinished Work against Julian, he thoroughly goes into the question of why (although Ham sinned) ‘vengeance was brought upon Canaan’. Augustine perceives God’s prophecy: from Canaan stems the cursed seed [ semen maledictum ] of the Canaanites. Nowhere, however, he claims that Ham or his descendants would have been cursed to be black or that all of his offspring were condemned to slavery. Contribution: This article demonstrates that the Ham myth does not occur in Augustine. It argues that the ‘ mestizo ’ African Augustine might have been extra sensitive to questions of race and colour. (shrink)

In de oriëntatiefunctie van de journalistiek gaat het om het wegwijs maken van het publiek in een veranderende wereld. In deze oriëntatie is de bewustheid van het eigen wereldbeeld essentieel. Er wordt in het denken over de oriëntatiefunctie bewust gekozen voor een fundamentele doordenking vanuit de ethiek. Journalistiek is namelijk niet alleen een maatschappelijk, maar vooral ook een ethisch gebeuren. Daarom zijn basisgegevens als dat communicatie een scheppingsgave van God is en dat elk mens een roeping heeft, van groot belang. (...) Vanuit diezelfde achtergrond is er aandacht voor de functie van het wereldbeeld van een journalist, de nieuwswaarden en de vraag naar “goed en slecht” nieuws. (shrink)

There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as (...) a case-study. We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment. Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women. (shrink)

BackgroundThe rise of Big Data-driven health research challenges the assumed contribution of medical research to the public good, raising questions about whether the status of such research as a common good should be taken for granted, and how public trust can be preserved. Scandals arising out of sharing data during medical research have pointed out that going beyond the requirements of law may be necessary for sustaining trust in data-intensive health research. We propose building upon the use of a social (...) licence for achieving such ethical governance.Main textWe performed a narrative review of the social licence as presented in the biomedical literature. We used a systematic search and selection process, followed by a critical conceptual analysis. The systematic search resulted in nine publications. Our conceptual analysis aims to clarify how societal permission can be granted to health research projects which rely upon the reuse and/or linkage of health data. These activities may be morally demanding. For these types of activities, a moral legitimation, beyond the limits of law, may need to be sought in order to preserve trust. Our analysis indicates that a social licence encourages us to recognise a broad range of stakeholder interests and perspectives in data-intensive health research. This is especially true for patients contributing data. Incorporating such a practice paves the way towards an ethical governance, based upon trust. Public engagement that involves patients from the start is called for to strengthen this social licence.ConclusionsThere are several merits to using the concept of social licence as a guideline for ethical governance. Firstly, it fits the novel scale of data-related risks; secondly, it focuses attention on trustworthiness; and finally, it offers co-creation as a way forward. Greater trust can be achieved in the governance of data-intensive health research by highlighting strategic dialogue with both patients contributing the data, and the public in general. This should ultimately contribute to a more ethical practice of governance. (shrink)

This article is about developments that are on the rise in response to the global hegemony of the neoliberal approach to life in general and education in particular. After an outline of what neoliberalism entails and how it has impacted education, the discussion moves on to an outline of several of these new developments that are seemingly unrelated but at the deepest level seem to be critical of neoliberalism and its views about education. This is followed by a critical appraisal (...) of these new developments. The appraisal, executed along the guidelines of the social space and ethical function theory, shows that these new developments, although they suggest a number of important corrections regarding neoliberalism and its views on education, are in themselves one-sided and narrow. It is nevertheless important for educators and educationists to take account of such new developments that are in the process of changing our view of the world. (shrink)

The starting point of the present study is to investigate which environmental factors play a role in the media behavior of ethnic minority youth. To what extent do socio-demographic characteristics influence ownership and use of the media? We also address the role of religion, cultural origin and the cultural distance between ethnic minority youth and indigenous Dutch youth. Three numerically important groups of ethnic minority youth are discussed: Turks, Moroccans and Surinamese. In a survey conducted among Turkish, Moroccan and Surinamese (...) youth aged between 12 and 19, residing in the Netherlands, we investigated which environmental factors play a role in the media behavior of ethnic minority youth. A control group of indigenous Dutch youth was established and likewise exposed to the variables under study. (shrink)

IntroductionInternational sharing of health data opens the door to the study of the so-called ‘Big Data’, which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives indicates an urgent need to invest in societal trust in researchers and institutions. Key to an informed understanding of such a ‘social license’ is identifying the views patients and the public may hold with regard to data sharing for health research.MethodsWe performed a narrative review of the empirical evidence addressing patients’ (...) and public views and attitudes towards the use of health data for research purposes. The literature databases PubMed, Embase, Scopus and Google Scholar were searched in April 2019 to identify relevant publications. Patients’ and public attitudes were extracted from selected references and thematically categorised.ResultsTwenty-seven papers were included for review, including both qualitative and quantitative studies and systematic reviews. Results suggest widespread—though conditional—support among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of data research, they expressed concerns about breaches of confidentiality and potential abuses of the data. Studies showed agreement on the following conditions: value, privacy, risk minimisation, data security, transparency, control, information, trust, responsibility and accountability.ConclusionsOur results indicate that a social license for data-intensive health research cannot simply be presumed. To strengthen the social license, identified conditions ought to be operationalised in a governance framework that incorporates the diverse patient and public values, needs and interests. (shrink)

People who work and live in a certain moral practice usually possess a specific form of moral wisdom. If we manage to incorporate their moral intuitions in ethical reasoning, we can arrive at judgements and theories that grasp a moral experience that generally cannot be found outside the said practice. To achieve this goal, we need a legitimate way to balance moral intuitions, ethical principles and general theories. In the present contribution, we describe a version of the model of Reflective (...) Equilibrium, which we call the Normative-Empirical Reflective Equilibrium . RE provides a framework for ethical thinking that includes both moral experience and normative theory.After an outline of the model, we focus on the role of empirical research and illustrate how empirical data on moral intuitions can add to the comprehensiveness of the set of moral beliefs in NE-RE. Subsequently, we describe how coherence among the elements of an NE-RE can be understood and measured. Finally, we address an important question for any method of moral reasoning: what is the status of the outcome of the reasoning process? This is a matter of justification. We argue for a so-called good reasoning-justified outcome strategy in NE-RE. This strategy is built on a reasoning process in which the reason-giving force of each element is tested and weighed. The thinker has to work towards a coherent view in which only the elements with sufficient justificatory power are retained. If the thinker decides that the elements fit together into a coherent view, a reflective equilibrium is reached. NE-RE is an attempt to describe a model for moral reasoning that can profit from the moral wisdom present among experienced agents through the use of empirical research. (shrink)

BackgroundPregnant people have been overlooked or excluded from clinical research, resulting in a lack of scientific knowledge on medication safety and efficacy during pregnancy. Thus far, both the opportunities to generate evidence-based knowledge beyond clinical trials and the role of pregnant people in changing their status quo have not been discussed. Some scholars have argued that for rare disease patients, for whom, just like pregnant people, a poor evidence base exists regarding treatments, solidarity has played an important role in addressing (...) the evidence gap. This paper explores whether and how the enactment of solidarity among pregnant people can be stimulated to help address the poor evidence base on medications used during pregnancy.MethodWe use the concept of solidarity formulated by Prainsack and Buyx and enrich their concept by providing an account for stimulating the enactment of solidarity. Then we apply this account to the case of pregnant people who use medication.ResultsSolidarity means enacted commitment on the part of an individual to assisting others with whom the person recognizes a similarity in a relevant respect. Although solidarity cannot be imposed, we argue that the empowerment of people is a crucial concept in understanding how solidarity can be stimulated. Empowerment in the context of pregnant people means creating awareness about their status quo, explaining how scientific research can help close the knowledge gap, and how pregnant people can themselves contribute. In particular, how pregnant people can contribute to the collection of health data to strengthen the evidence base for medications used during pregnancy.ConclusionsWe conclude that acting in solidarity can help change the status quo for pregnant people. Furthermore, we argue that the empowerment of pregnant people and other relevant stakeholders is a way to stimulate the enactment of solidarity. The process of empowerment starts by raising awareness about the lack of evidence on medications used during prengnacy and by explaining to pregnant people how they can contribute to changing the way knowledge is being generated by, for example, sharing data on the health effects of medications. (shrink)

ABSTRACT Over the past few decades the concept of (human) dignity has deeply pervaded medical ethics. Appeals to dignity, however, are often unclear. As a result some prefer to eliminate the concept from medical ethics, whereas others try to render it useful in this context. We think that appeals to dignity in medical ethics can be clarified by considering the concept from an historical perspective. Firstly, on the basis of historical texts we propose a framework for defining the concept in (...) medical debates. The framework shows that dignity can occur in a relational, an unconditional, a subjective and a Kantian form. Interestingly, all forms relate to one concept since they have four features in common: dignity refers, in a restricted sense, to the ‘special status of human beings’; it is based on essential human characteristics; the subject of dignity should live up to it; and it is a vulnerable concept, it can be lost or violated. We argue that being explicit about the meaning of dignity will prevent dignity from becoming a conversation‐stopper in moral debate. Secondly, an historical perspective on dignity shows that it is not yet time to dispose of dignity in medical ethics. At least Kantian and relational dignity can be made useful in medical ethics. (shrink)

People who work and live in a certain moral practice usually possess a specific form of moral wisdom. If we manage to incorporate their moral intuitions in ethical reasoning, we can arrive at judgements and theories that grasp a moral experience that generally cannot be found outside the said practice. To achieve this goal, we need a legitimate way to balance moral intuitions, ethical principles and general theories. In the present contribution, we describe a version of the model of Reflective (...) Equilibrium, which we call the Normative-Empirical Reflective Equilibrium . RE provides a framework for ethical thinking that includes both moral experience and normative theory.After an outline of the model, we focus on the role of empirical research and illustrate how empirical data on moral intuitions can add to the comprehensiveness of the set of moral beliefs in NE-RE. Subsequently, we describe how coherence among the elements of an NE-RE can be understood and measured. Finally, we address an important question for any method of moral reasoning: what is the status of the outcome of the reasoning process? This is a matter of justification. We argue for a so-called good reasoning-justified outcome strategy in NE-RE. This strategy is built on a reasoning process in which the reason-giving force of each element is tested and weighed. The thinker has to work towards a coherent view in which only the elements with sufficient justificatory power are retained. If the thinker decides that the elements fit together into a coherent view, a reflective equilibrium is reached. NE-RE is an attempt to describe a model for moral reasoning that can profit from the moral wisdom present among experienced agents through the use of empirical research. (shrink)

The display of artefacts always implies an external mediation that influences, and often codifies, the reception of the exhibits. Objects are manipulated, restored, appropriated, staged, in short displayed, through various representational strategies that include pedestals, labels, and showcases. These elements, that we could define as parerga, are often ignored because of their utilitarian function. Yet, they play an important role in the history of the artefacts and define the setting in which the objects can exert their agency. They not only (...) shape their meaning, but also determine the effect that these artefacts have on their viewers. Framing devices create the conditions for interactions between the individual and the object to take place. This publication aims to explore the relation between artefacts and viewers as they are manifested in framing devices, and to develop a new theoretical framework for thinking about the power of objects on display. (shrink)

The essays in this book, by a variety of leading Augustine scholars, examine not only Augustine's multifaceted philosophy and its relation to his epoch-making theology, but also his practice as a philosopher, as well as his relation to other philosophers both before and after him. Thus the collection shows that Augustine's philosophy remains an influence and a provocation in a wide variety of settings today.

Recent developments in biotechnology allow for the generation of increasingly complex products out of human tissues, for example, human stem cell lines, synthetic embryo-like structures and organoids. These developments are coupled with growing commercial interests. Although commercialisation can spark the scientific and clinical promises, profit-making out of human tissues is ethically contentious and known to raise public concern. The traditional bioethical frames of gift versus market are inapt to capture the resulting practical and ethical complexities. Therefore, we propose an alternative (...) approach to identify, evaluate and deal with the ethical challenges that are raised by the increasing commercialisation of the exchange of sophisticated human tissue products. We use organoid technology, a cutting-edge stem cell technology that enables the cultivation of ‘mini-organs’ in a dish, as an example. First, we examine the moral value of organoids and recognise them as hybrids that relate to persons and their bodies as well as to technologies and markets in ambiguous ways. Second, we show that commercialisation of organoids is legitimised by a detachment of the instrumental and commercial value of organoids from their associations with persons and their bodies. This detachment is enacted in steps of disentanglement, among which consent and commodification. Third, we contend that far-reaching disentanglement is ethically challenging: (1) Societal interests could be put under pressure, because the rationale for commercialising organoid technology, that is, to stimulate biomedical innovation for the good of society, may not be fulfilled; (2) The interests of donors are made subordinate to those of third parties and the relational moral value of organoids may be insufficiently recognised. Fourth, we propose a ‘consent for governance’ model that contributes to responsible innovation and clinical translation in this exciting field. (shrink)