Plantation workers have seemingly little opportunities for labour agency, defined as the worker’s ability to act and improve their conditions. In response to a call for a better understanding of the horizontal dimension shaping labour agency, this article questions what local factors determine the worker’s ability to act by analysing the institutional constraints embedded in the national context through a mixed methods approach. A combination of qualitative and quantitative data is used to understand what shapes and constrains the potential for (...) labour agency in the case of plantation workers in the pineapple sector of Costa Rica. We provide new empirical evidence of the relation between the local opportunity structure—proxied by perceived job security and union awareness—and labour agency in terms of a worker’s intention to choose forthright (voice), evasive (exit) or repressed (loyalty) actions. The model results indicate that a lack of job security and a lack of union awareness significantly reduce the likelihood to use forthright actions (such as voicing concerns, striking or joining a union) compared to evasive (such as leaving the job) or repressed actions (such as doing nothing). In addition, the qualitative analysis of the local opportunity structure identifies four institutional constraints: weak employment protection, vulnerability of migrant workers, limited workers’ representation and insufficient labour law enforcement. Besides overcoming these institutional constraints, empowering workers to make their voices heard also requires awareness raising about their collective bargaining rights and more job security. (shrink)

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

BackgroundGene drive technologies (GDTs) promote the rapid spread of a particular genetic element within a population of non-human organisms. Potential applications of GDTs include the control of insect vectors, invasive species and agricultural pests. Whether, and if so, under what conditions, GDTs should be deployed is hotly debated. Although broad stances in this debate have been described, the convictions that inform the moral views of the experts shaping these technologies and related policies have not been examined in depth in the (...) academic literature.MethodsIn this qualitative study, we interviewed GDT experts (n = 33) from different disciplines to identify and better understand their moral views regarding these technologies. The pseudonymized transcripts were analyzed thematically.ResultsThe respondents’ moral views were principally influenced by their attitudes towards (1) the uncertainty related to GDTs; (2) the alternatives to which they should be compared; and (3) the role humans should have in nature. Respondents agreed there is epistemic uncertainty related to GDTs, identified similar knowledge gaps, and stressed the importance of realistic expectations in discussions on GDTs. They disagreed about whether uncertainty provides a rationale to refrain from field trials (‘risks of intervention’ stance) or to proceed with phased testing to obtain more knowledge given the harms of the status quo (‘risks of non-intervention’ stance). With regards to alternatives to tackle vector-borne diseases, invasive species and agricultural pests, respondents disagreed about which alternatives should be considered (un)feasible and (in)sufficiently explored: conventional strategies (‘downstream solutions’ stance) or systematic changes to health care, political and agricultural systems (‘upstream solutions’ stance). Finally, respondents held different views on nature and whether the use of GDTs is compatible with humans’ role in nature (‘interference’ stance) or not (‘non-interference stance’).ConclusionsThis interview study helps to disentangle the debate on GDTs by providing a better understanding of the moral views of GDT experts. The obtained insights provide valuable stepping-stones for a constructive debate about underlying value conflicts and call attention to topics that deserve further (normative) reflection. Further evaluation of these issues can facilitate the debate on and responsible development of GDTs. (shrink)

It may soon become possible not just to replace, but to re-grow healthy tissues after injury or disease, because of innovations in the field of Regenerative Medicine. One particularly promising innovation is a regenerative valve implant to treat people with heart valve disease. These implants are fabricated from so-called ‘smart’, ‘lifelike’ materials. Implanted inside a heart, these implants stimulate re-growth of a healthy, living heart valve. While the technological development advances, the ethical implications of this new technology are still unclear (...) and a clear conceptual understanding of the notions ‘smart' and ‘lifelike' is currently lacking. In this paper, we explore the conceptual and ethical implications of the development of smart lifelike materials for the design of regenerative implants, by analysing heart valve implants as a showcase. In our conceptual analysis, we show that the materials are considered ‘smart’ because they can communicate with human tissues, and ‘lifelike’ because they are structurally similar to these tissues. This shows that regenerative valve implants become intimately integrated in the living tissues of the human body. As such, they manifest the ontological entanglement of body and technology. In our ethical analysis, we argue this is ethically significant in at least two ways: It exacerbates the irreversibility of the implantation procedure, and it might affect the embodied experience of the implant recipient. With our conceptual and ethical analysis, we aim to contribute to responsible development of smart lifelike materials and regenerative implants. (shrink)

Precision medicine research involving human biological material is becoming an increasingly central component of healthcare, and its potential is quickly growing due to rapid technological progress...

The rise of precision medicine has led to an unprecedented focus on human biological material in biomedical research. In addition, rapid advances in stem cell technology, regenerative medicine and synthetic biology are leading to more complex human tissue structures and new applications with tremendous potential for medicine. While promising, these developments also raise several ethical and practical challenges which have been the subject of extensive academic debate. These debates have led to increasing calls for longitudinal governance arrangements between tissue providers (...) and biobanks that go beyond the initial moment of obtaining consent, such as closer involvement of tissue providers in what happens to their tissue, and more active participatory approaches to the governance of biobanks. However, in spite of these calls, such measures are being adopted slowly in practice, and there remains a strong tendency to focus on the consent procedure as the tool for addressing the ethical challenges of contemporary biobanking. In this paper, we argue that one of the barriers to this transition is the dominant language pervading the field of human tissue research, in which the provision of tissue is phrased as a ‘donation’ or ‘gift’, and tissue providers are referred to as ‘donors’. Because of the performative qualities of language, the effect of using ‘donation’ and ‘donor’ shapes a professional culture in which biobank participants are perceived as passive providers of tissue free from further considerations or entitlements. This hampers the kind of participatory approaches to governance that are deemed necessary to adequately address the ethical challenges currently faced in human tissue research. Rather than reinforcing this idea through language, we need to pave the way for the kind of participatory approaches to governance that are being extensively argued for by starting with the appropriate terminology. (shrink)

BackgroundOur human societies and certainly also (bio) medicine are more and more permeated with technology. There seems to be an increasing awareness among bioethicists that an effective and comprehensive approach to ethically guide these emerging biomedical innovations into society is needed. Such an approach has not been spelled out yet for bioethics, while there are frequent calls for ethical guidance of biomedical innovation, also by biomedical researchers themselves. New and emerging biotechnologies require anticipation of possible effects and implications, meaning the (...) scope is not evaluative after a technology has been fully developed or about hypothetical technologies, but real-time for a real biotechnology.Main textIn this paper we aim to substantiate and discuss six ingredients that we increasingly see adopted by ethicists and that together constitute “ethics parallel research”. This approach allows to fulfil two aims: guiding the development process of technologies in biomedicine and providing input for the normative evaluation of such technologies. The six ingredients of ethics parallel research are: (1) disentangling wicked problems, (2) upstream or midstream ethical analysis, (3) ethics from within, (4) inclusion of empirical research, (5) public participation and (6) mapping societal impacts, including hard and soft impacts. We will draw on gene editing, organoid technology and artificial intelligence as examples to illustrate these six ingredients.ConclusionEthics parallel research brings together these ingredients to ethically analyse and proactively or parallel guide technological development. It widens the roles and judgements from the ethicist to a more anticipatory and constructively guiding role. Ethics parallel research is characterised by a constructive, rather than a purely critical perspective, it focusses on developing best-practices rather than outlining worst practice, and draws on insights from social sciences and philosophy of technology. (shrink)

Exposome research is put forward as a major tool for solving the nature-versus-nurture debate because the exposome is said to represent “the nature of nurture.” Against this influential idea, we argue that the adoption of the nature-versus-nurture debate into the exposome research program is a mistake that needs to be undone to allow for a proper bioethical assessment of exposome research. We first argue that this adoption is originally based on an equivocation between the traditional nature-versus-nurture debate and a debate (...) about disease prediction/etiology. Second, due to this mistake, exposome research is pushed to adopt a limited conception of agential control that is harmful to one's thinking about the good that exposome research can do for human health and wellbeing. To fully excise the nature-versus-nurture debate from exposome research, we argue that exposome researchers and bioethicists need to think about the exposome afresh from the perspective of actionability. We define the concept of actionability and related concepts and show how these can be used to analyze the ethical aspects of the exposome. In particular, we focus on refuting the popular “gun analogy” in exposome research, returning results to study participants and risk-taking in the context of a well-lived life. (shrink)

Rousseau was arguably one of the most important and influential of eighteenth-century republican thinkers. However, contemporary republican theorists, most notably Philip Pettit, have written him out of the republican canon by describing Rousseau as a “populist” rather than a republican. I argue that this miscasting of Rousseau is not just historically incorrect but that it has also led to a weakening of contemporary republican political theory. Rousseau was one of the few early modern republican thinkers to take seriously the problem (...) of the tyranny of the majority and to attempt to formulate a cogent answer to that problem. Ignoring his contribution to republican political thought therefore cuts off contemporary republicans from an important resource for thinking about this problem. (shrink)

The basic challenge that readers of the New Testament face is not only about what Jesus Christ teaches but who he is. Functional Christology has developed at the expense of ontological Christology. This challenge centres on Jesus Christ’s relevance, in terms of his identity, not only for Christians in particular but also for creation as a whole. The question ‘who is Jesus Christ in relation to creation?’ is thus of special interest to this study. Various authors such as Gunton, Gregersen, (...) Peacocke and others have approached this question from different perspectives. The PhD study by Rabie-Boshoff was completed to shed light into the context of dialogue between Christian theology and the science of linguistics in an effort to understand the Genesis 1 creation story. This article refers to part of the study in an effort to make sense of who Jesus Christ is in relation to creation. This provides consolation in a time of worldwide lockdown because of the Coronavirus Disease 2019 virus. The human struggle of making sense of the world is brought into sharp focus in times like these, more so in terms of making sense of their creatureliness and mortality. Although science as a valid knowledge base may provide some answers to this human dilemma, Christians in particular appeal to the Bible and their belief in Jesus Christ. This turn to Jesus, and who he is, provides human beings with enduring and satisfying answers to their suffering and pain.Contribution: This article is an attempt to contribute to the ongoing discussion on creation in terms of how human beings make sense of creation, considering who Jesus Christ is in relation to creation. Human beings have always been engaged in a process of making sense of the world they live in. Ancient cultures provide such a window, allowing a glimpse into how those cultures perceived their world. (shrink)

The question of how human beings are to understand their role in creation is of particular interest in our current time of extreme exploitation of the earth and severe environmental degradation. Historically, critiques have been raised against the Judeo-Christian interpretation of the biblical command to subdue the earth and rule over the animals. In all sincerity, the question then needs to be asked what Christian theology has to offer in response to these critiques. Having considered the various interpretations of the (...) meaning of the biblical command to subdue and rule, and with the understanding that the spiritual gifts of wisdom, understanding, knowledge and an ability to perform work have been bestowed by God on human beings, the proposition that this article offers is an alternative understanding of the role of human beings tendered in terms of ‘the justice of the peace’. The Hebrew understanding of peace is used as a basis; shalom does not refer to an absence of war but points to life and maintaining the balance and harmony in creation for life in all its varied forms to prosper. In the context of the imago mundi, it is proposed that human beings have been divinely appointed to uphold justice in creation and rule by keeping the peace.Contribution: The metaphor of ‘the justice of the peace’, used concomitantly with the verbs ‘subdue’ and ‘rule’ within ecotheology, offers a viable alternative to the idea of ‘stewardship’ of creation. This article focuses attention on possible alternative interpretations of the two verbs, contributing to an understanding of our relationship with creation. (shrink)

This article is about the imago Dei, proceeding from an ecotheological perspective. Both the ‘image of God’ and the ‘likeness of God’ are examined based on the understanding that God is a relational God. It approaches the question of the imago Dei in terms of God’s incorporeal nature, and what it is that human beings have in common with God apart from the human being’s capacity for personal and interpersonal relationships. It addresses the question of the imago Dei in terms (...) of God’s spiritual nature and the human being’s ‘earthly’ nature by utilising the metaphor of ‘shadow’. This metaphor was investigated in terms of its meaning in Hebrew (tselem), and Genesis 2:7–8 where the creation of the human being is described in terms of God breathing the breath of life into the human being. A distinction has been drawn between the ‘image of God’ and the ‘likeness of God’, with the ‘likeness of God’ (demuth) that was investigated in the context of Exodus 31:1–5, and the various spiritual gifts conferred to Bezalel by the Spirit of God. Based on this investigation the article posits that the imago Dei as the Shadow of God (life) has been bestowed on all living creatures and not only human beings.Contribution: The suggestion that the imago Dei as the Shadow of God is present in all of the creation urges us to seek further and look deeper into the issue of imago Dei in the sense that such an understanding pointedly has far-reaching implications for the current understanding of the place of human beings in creation. In consideration of this, it bears on our understanding of the meaning of life within the bigger picture of creation and how we respond to the living environment with which we share life. (shrink)

The essays collected here aim to set up a dialogue between the 'historical' and the 'contemporary' Tocqueville. In what ways does a contextualization of Tocqueville throw new light on his relevance as a political thinker today? How can a focus on his embeddedness in the political culture of the nineteenth century contribute to our understanding of his political thought? Or, conversely, how has the usage of Tocqueville's writings in day-to-day political debate influenced the reception of his work both in the (...) past and today? (shrink)

This essay draws attention to the importance of Montesquieu’s earliest and unpublished writings on liberty for our understanding of the famous eleventh book of the Spirit of the Laws. Montesquieu’s investigation of the nature and preconditions of liberty, the author argues, was much more polemical than it is usually assumed. As an analysis of his notebooks shows, Montesquieu set out to wrest control over the concept of liberty from the republican admirers of classical antiquity, a faction that he believed to (...) be dangerously populist and revolutionary. In order to do so, Montesquieu came up with a redefinition of the concept of liberty that allowed him to argue that monarchical subjects could be just as free as republican citizens. This conclusion has important implications not just for our understanding of Montesquieu’s writings but also and more broadly for our understanding of the intellectual history of liberalism. (shrink)

This paper focuses on the reception of Bertrand de Jouvenel’s Du Pouvoir in post-war America. I show how Jouvenel drew on a firmly established tradition of ‘aristocratic liberalism’ in French political thought, which in turn allowed him to develop a pessimistic outlook on modern Western political culture as inherently conducive to totalitarianism. This profound pessimism allowed Du Pouvoir, which fell relatively flat in France itself, to become a critical success in the Anglophone world. Jouvenel’s jeremiad resonated in particular with Cold (...) War warriors such as Friedrich Hayek. (shrink)

This article explores a probable motivation for the insertion of the Pericope Adulterae in the Gospel of John in consideration of the motive of ‘living/life’ used by the gospel writer. Using John 8:12 as the starting point of this investigation, the article focuses on the warning to the Israelites against idolatry with specific attention to the warning against worshiping the sun, the moon, and the stars. It also deals with the Feast of Tabernacles, which is the direct context in which (...) Jesus declared that he is the light of the world. The water ceremony also plays a central role in understanding the bigger picture that unfolds, as well as the Early Church’s struggle against heretical Christological teachings of who Jesus was with regard to his human nature and his divine nature. (shrink)

International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used (...) in numerous ways in the research ethics literature. Because social value justifies involving human participants, especially in early human trials, this is problematic. (shrink)

Opens up new histories of freedom and republicanism by building on Quentin Skinner's ground-breaking Liberty before Liberalism nearly twenty five years after its initial publication. Leading historians and philosophers reveal the neo-Roman conception of liberty that Skinner unearthed as a normative and historical hermeneutic tool of enormous, ongoing power. The volume thinks with neo-Romanism to offer reinterpretations of individual thinkers, such as Montaigne, Grotius and Locke. It probes the role of neo-Roman liberty within hierarchies and structures beyond that of citizen (...) and state – namely, gender, slavery, and democracy. Finally, it reassesses the relationships between neo-Romanism and other languages in the history of political thought: liberalism, conservatism, socialism, and the human rights tradition. The volume concludes with a major reappraisal by Skinner himself. (shrink)

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)

Moral sensitivity and moral reasoning are essential competencies biomedical researchers have to develop to make ethical decisions in their daily practices. Previous research has shown that these competencies can be developed through ethics education. However, it is unclear which underlying mechanisms best support the development of these competencies. In this article we argue that the development of moral sensitivity and moral reasoning can be fostered through teaching strategies that tap into students’ moral imagination. We describe how moral imagination can stimulate (...) the development of these competencies through three different merits of moral imagination. Moral imagination can help students to 1) transfer and apply abstract moral concepts to concrete situations and contexts, 2) explore the perspective of others, 3) explore and foresee the moral consequences of different decisions and actions. We explain these three merits of moral imagination in the context of biomedical research and present a theoretical model for how these merits can be used to stimulate the development of moral sensitivity and moral reasoning. Furthermore, we describe multiple teaching strategies for biomedical curricula that tap into the three merits of moral imagination. These teaching strategies can inspire teachers to design ethics education that activates students’ moral imagination for the development of moral sensitivity and moral reasoning. (shrink)

Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants’ overall protection. A global Task Force (...) was set up to develop model consent clauses specific to rare diseases research, that are comprehensive, harmonized, readily accessible, and internationally applicable, facilitating the recruitment and consent of rare disease research participants around the world. Existing consent forms and notices of consent were analyzed and classified under different consent themes, which were used as background to develop the model consent clauses. The IRDiRC-GA4GH MCC Task Force met in September 2018, to discuss and design model consent clauses. Based on analyzed consent forms, they listed generic core elements and designed the following rare disease research specific core elements; Rare Disease Research Introductory Clause, Familial Participation, Audio/Visual Imaging, Collecting, storing, sharing of rare disease data, Recontact for matching, Data Linkage, Return of Results to Family Members, Incapacity/Death, and Benefits. The model consent clauses presented in this article have been drafted to highlight consent elements that bear in mind the trends in rare disease research, while providing a tool to help foster harmonization and collaborative efforts. (shrink)

Regenerative Medicine promises to develop treatments to regrow healthy tissues and cure the physical body. One of the emerging developments within this field is regenerative implants, such as jawbone or heart valve implants, that can be broken down by the body and are gradually replaced with living tissue. Yet challenges for embodiment are to be expected, given that the implants are designed to integrate deeply into the tissue of the living body, so that implant and body become one. In this (...) paper, we explore how regenerative implants may affect the embodied experience of implant recipients. To this end, we take a phenomenological approach. First, we explore what insights the existing phenomenological and empirical literature on embodiment offers regarding the experience of illness and of living with regular (non-regenerative) implants and organ transplants. Second, we apply these insights to better understand how future implant recipients might experience living with regenerative implants. Third, we conclude that concepts and considerations from the existing phenomenological literature do not sufficiently address what it might be like to live with an implantable technology that, over time, becomes one with the living body. We argue that the interwovenness and intimate relationship of people living with regenerative implants should be understood in terms of ‘entanglement’. Entanglement allows us to explore the complexities of human-technology relations, acknowledging the inseparability of humans and implantable technologies. Our theoretical foundations regarding the role of embodiment may be tested empirically once more people will be living with regenerative implants. (shrink)

Background Massively parallel sequencing techniques, such as whole exome sequencing (WES) and whole genome sequencing (WGS), may reveal unsolicited findings (UFs) unrelated to the diagnostic aim. Such techniques are frequently used for diagnostic purposes in pediatric cases of developmental delay (DD). Yet policy guidelines for informed consent and return of UFs are not well equipped to address specific moral challenges that may arise in these children’s situations. Discussion In previous empirical studies conducted by our research group, we found that it (...) is sometimes uncertain how children with a DD will develop and whether they could come to possess capacities for autonomous decision-making in the future. Parents sometimes felt this brought them into a Catch-22 like situation when confronted with choices about UFs before undergoing WES in trio-analysis (both the parents’ and child’s DNA are sequenced). An important reason for choosing to consent to WES was to gain more insight into how their child might develop. However, to make responsible choices about receiving or declining knowledge of UFs, some idea of their child’s future development of autonomous capacities is needed. This undesirable Catch-22 situation was created by the specific policy configuration in which parents were required to make choices about UFs before being sequencing (trio-analysis). We argue that this finding is relevant for reconfiguring current policies for return of UFs for WES/WGS and propose guidelines that encompass two features. First, the informed consent process ought to be staged. Second, differing guidelines are required for withholding/disclosing a UF in cases of DD appropriate to the level of confidence there is about the child’s future developmental of autonomous capacities. Conclusion When combined with a dynamic consent procedure, these two features of our guidelines could help overcome significant moral challenges that present themselves in the situations of children undergoing genomic sequencing for clarifying a DD. (shrink)

There is a growing consensus that the offer of a reasonable compensation for oocyte donation for reproductive treatment is acceptable if it does not compromise voluntary and altruistically motivated donation. However, how to translate this ‘reasonable compensation’ in practice remains unclear as compensation rates offered to oocyte donors between different European Union countries vary significantly. Clinics involved in oocyte donation, as well as those in other medical contexts, might be encouraged in calculating a more consistent and transparent compensation for donors (...) if the elements that constitute a reasonable compensation are explicated. In doing so, lessons can be learnt from living organ donation and medical research participation. Practices in which the elements of a reasonable compensation for the individuals involved have already been more defined in the literature. By means of analogical reasoning, we will outline the different components of a reasonable compensation and subsequently apply these to the context of oocyte donation. We will argue that oocyte donors should first of all be reasonably reimbursed direct expenses related to the donation, without standard remuneration of lost wages. Second, donating oocytes requests a serious time investment, therefore donors are entitled to suitable compensation for their time spent and efforts made. Finally, we will explain that a reasonable compensation consisting of these two components allows for altruism to remain the key value of oocyte donation for reproductive treatment. However, if we acknowledge that donors’ motives are more complex and often include reasons from self-interest, the reasonable compensation may be complemented with modest (non)monetary benefits. (shrink)

Volume 19, Issue 5, May 2019, Page 43-45.

The introduction of novel diagnostic techniques in clinical domains such as genomics and radiology has led to a rich ethical debate on how to handle unsolicited findings that result from these innovations. Yet while unsolicited findings arise in both genomics and radiology, most of the relevant literature to date has tended to focus on only one of these domains. In this article, we synthesize and critically assess similarities and differences between “scanning the body” and “sequencing the genome” from an ethical (...) perspective. After briefly describing the novel diagnostic contexts leading to unsolicited findings, we synthesize and reflect on six core ethical issues that relate to both specialties: terminology; benefits and risks; autonomy; disclosure of unsolicited findings to children; uncertainty; and filters and routine screening. We identify ethical rationales that pertain to both fields and may contribute to more ethically sound policies. Considerations of preserving public trust and ensuring that people perceive healthcare policies as fair also support the need for a combined debate. (shrink)

In recent years, exposome research has been put forward as the next frontier for the study of human health and disease. Exposome research entails the analysis of the totality of environmental exposures and their corresponding biological responses within the human body. Increasingly, this is operationalized by big-data approaches to map the effects of internal as well as external exposures using smart sensors and multiomics technologies. However, the ethical implications of exposome research are still only rarely discussed in the literature. Therefore, (...) we conducted a systematic review of the academic literature regarding both the exposome and underlying research fields and approaches, to map the ethical aspects that are relevant to exposome research. We identify five ethical themes that are prominent in ethics discussions: the goals of exposome research, its standards, its tools, how it relates to study participants, and the consequences of its products. Furthermore, we provide a number of general principles for how future ethics research can best make use of our comprehensive overview of the ethical aspects of exposome research. Lastly, we highlight three aspects of exposome research that are most in need of ethical reflection: the actionability of its findings, the epidemiological or clinical norms applicable to exposome research, and the meaning and action–implications of bias. (shrink)

Pediatric biobanking is considered important for generating biomedical knowledge and improving health care. However, the inclusion of children’s samples in biobanks involves specific ethical issues. One of the main concerns is how to appropriately engage children in the consent procedure. We suggest that children should be involved through a personalized assent procedure, which means that both the content and the process of assent are adjusted to the individual child. In this paper we provide guidance on how to put personalized assent (...) into pediatric biobanking practice and consider both the content and process of personalized assent. In the discussion we argue that the assent procedure itself is formative. Investing in the procedure should be a requirement for pediatric biobank research. Although personalized assent will require certain efforts, the pediatric community must be aware of its importance. The investment and trust earned can result in ongoing engagement, important longitudinal information, and stability in/for the research infrastructure, as well as increased knowledge among its participants about research activity. Implementing personalized assent will both respect the child and support biobank research. (shrink)

Background A team-based approach has been advocated for advance care planning in nursing homes. While nurses are often put forward to take the lead, it is not clear to what extent other professions could be involved as well. Objectives To examine to what extent engagement in advance care planning practices, knowledge and self-efficacy differ between nurses, care assistants and allied care staff in nursing homes. Design Survey study. Participants/setting The study involved a purposive sample of 14 nursing homes in Flanders, (...) Belgium. Nurses, care assistants and allied care staff completed a survey. Ethical considerations The study was approved by the University Hospital of Brussels, as part of a cluster randomized controlled trial. Results One hundred ninety-six nurses, 319 care assistants and 169 allied staff participated. After adjusting for confounders, nurses were significantly more likely than care assistants to have carried out advance care planning conversations and documented advance care planning ; differences not found between allied staff and care assistants. Advance care planning knowledge total scores differed significantly, with nurses ; 95% confidence interval 0.08–0.17; p < 0.001) and allied staff scoring higher than care assistants. We found no significant differences regarding self-efficacy. Discussion While nursing home nurses conducted more advance care planning conversations and documentation than allied care staff and care assistants, these two professional groups may be a valuable support to nurses in conducting advance care planning, if provided with additional training. Conclusions Allied care staff and care assistants, if trained appropriately, can be involved more strongly in advance care planning to enhance relational and individual autonomy of nursing home residents, alongside nurses. Future research to improve and implement advance care planning should consider this finding at the intervention development stage. (shrink)

The innovative field of Regenerative Medicine (RM) is expected to extend the possibilities of prevention or early treatment in healthcare. Increasingly, clinical trials will be developed for people at risk of disease to investigate these RM interventions. These individuals at risk are characterised by their susceptibility for developing clinically manifest disease in future due to the existence of degenerative abnormalities. So far, there has been little debate about the ethical appropriateness of including such individuals at risk in clinical trials. We (...) discuss three main challenges of selecting this participant model for testing RM interventions: the challenge of achieving a proportional risk–benefit balance; complexities in the trial design in terms of follow-up and sample size; and the difficulty of obtaining informed consent due to the many uncertainties. We conclude that selecting the model is not ethically justifiable for first-in-man trials with RM interventions due to the high risks and uncertainties. However, the model can be ethically appropriate for testing the efficacy of RM interventions under the following conditions: interventions should be low risk; the degenerative abnormalities (and other risk factors) should be strongly related with disease within a short time frame; robust preclinical evidence of efficacy needs to be present; and the informed consent procedure should contain extra safeguards with regard to communication on uncertainties. (shrink)

Sankary et al. (2022) report the results of an empirical study on research participant experiences of exiting research at the end of clinical trials of deep-brain-stimulation (DBS) and responsive n...

Recent advancements in developmental biology enable the creation of embryo-like structures from human stem cells, which we refer to as human embryo-like structures (hELS). These structures provide promising tools to complement—and perhaps ultimately replace—the use of human embryos in clinical and fundamental research. But what if these hELS—when further improved—also have a claim to moral status? What would that imply for their research use? In this paper, we explore these questions in relation to the traditional answer as to why human (...) embryos should be given greater protection than other (non-)human cells: the so-called Argument from Potential (AfP). According to the AfP, human embryos deserve special moral status because they have the unique potential to develop into persons. While some take the development of hELS to challenge the very foundations of the AfP, the ongoing debate suggests that its dismissal would be premature. Since the AfP is a spectrum of views with different moral implications, it does not need to imply that research with human embryos or hELS that (may) have ‘active’ potential should be completely off-limits. However, the problem with determining active potential in hELS is that this depends on development passing through ‘potentiality switches’ about the precise coordinates of which we are still in the dark. As long as this epistemic uncertainty persists, extending embryo research regulations to research with specific types of hELS would amount to a form of regulative precaution that as such would require further justification. (shrink)