Theological education, spiritual formation and leadership are all contested issues in the Church, especially within the African context. Although these topics are thoroughly discussed, the relation and the interdependence are not always clear. This article discusses these topics in relation to each other and in relation to the One who calls servant leaders to guide his church for her service in the world. The importance of the local church as missional church is emphasised in the article. Thus, what the faith (...) community believes and teaches about God determines our ecclesiology, theological education and leadership. What does God have to do with theological education, spiritual formation and leadership development in Africa? The answer is everything! The article used a literary study to research the relationship between the different topics and the church and concluded that dependence exists between them. CONTRIBUTION: Much is written on theological education in Africa. However, students come into theological education with an already established spirituality formed by other agents. The article contributes to the discussion about the relation between formal theological, spiritual formation and leadership. It emphasises the relation between the theological institution and the local church. (shrink)

In the strategic document of the African Union approved in 2013 and spanning over 50 years, known as Agenda 2063, we find a blueprint for transforming Africa into a global powerhouse of the future. Many of the themes mentioned in Agenda 2063 are also mentioned in the New Testament, such as slavery, unity, poverty, women, children, discrimination and diversity. It is therefore clear that Christianity has something to contribute to Agenda 2063. Another word used throughout the Agenda 2063 document is (...) ‘transformation’. Concepts such as ‘transformative leadership’ and ‘radical transformation at all levels and in all spheres’ are mentioned. This contribution draws on the Agenda 2063 document to engage the missiological themes of unity, reconciliation and justice through the lens of the Belhar Confession. Deeply aware of the pain and disruption colonial Christianity has caused in many instances in Africa, the author contends that the Good News, particularly the New Testament themes of unity, reconciliation and justice, present a potentially transformative approach towards developing Africa. The research question that this article attends to is: how can the churches in Africa contribute to the aspirations of Agenda 2063 from the themes of unity, justice and reconciliation as declared in the Belhar Confession? By interrogating these key concepts of Agenda 2063 through the Confession of Belhar, the author concludes that the Belhar Confession can be regarded as a key African document, which could be explored further to facilitate unity, reconciliation and justice on the continent.Contribution: This article indicates the important relationship between church and state and the need for a partnership for the benefit of both. The need for a transforming state and a transforming church to participate in a transformed Africa is argued. The article promotes multi-, inter- and transdisciplinary aspects of studies as part of a mission praxis and application. (shrink)

Theological education, spiritual formation and leadership are all contested issues in the Church, especially within the African context. Although these topics are thoroughly discussed, the relation and the interdependence are not always clear. This article discusses these topics in relation to each other and in relation to the One who calls servant leaders to guide his church for her service in the world. The importance of the local church as missional church is emphasised in the article. Thus, what the faith (...) community believes and teaches about God determines our ecclesiology, theological education and leadership. What does God have to do with theological education, spiritual formation and leadership development in Africa? The answer is everything! The article used a literary study to research the relationship between the different topics and the church and concluded that dependence exists between them. CONTRIBUTION: Much is written on theological education in Africa. However, students come into theological education with an already established spirituality formed by other agents. The article contributes to the discussion about the relation between formal theological, spiritual formation and leadership. It emphasises the relation between the theological institution and the local church. (shrink)

Transgender people have among the highest rates of suicide attempts of any group in society, driven strongly by the perception that they do not belong in the sex of their physical body. Gender reassignment surgery is a procedure that can change the transgender person’s physical body to accord with their gender identity. The procedure raises important ethical and distributive justice concerns, given the controversy of whether it is a cosmetic or medical procedure and the economic costs associated with performing the (...) procedure. This paper argues that there is a strong case for funding GRS as a matter of clinical necessity and justice. This paper will be divided in four key sections: First, the state of transgender health will be outlined, including the role of GRS and common objections to it. Second, a number of common objections to GRS will be analysed at the outset and shown to be unconvincing. Third, a constructive argument will be advanced, arguing that publicly funded GRS is clinically necessary, cost-effective, and demanded by principles of justice. Fourth, the paper will briefly discuss moralistic biases and why we demand a higher burden of justification for funding GRS compared with other analogous procedures. (shrink)

The Remmelink Committee published its report on medical decisions at the end of life in the Netherlands in September 1991. As a result, the Dutch debate about physician aid‐in‐dying has been broadened to include life‐terminating acts that have not been explicitly requested by the patient.

A transforming spirituality is needed to attend to the ‘third-millennial needs’ of Africa to address issues such as relationships, globalisation, ecology and social issues. It is argued that reformed theology, African spiritualities and a spirituality of creation need to be enriched by each other to bring about transformation in Africa. To discover a transforming spirituality of creation, participants need to listen to the different spiritualities and beliefs, without attempting to create a meta-narrative. Participants need to acknowledge the differences and even (...) tensions, and embrace these. As such, this article attends to the research question, how can a dialogue between reformed theology and spirituality of creation help to establish a transforming spirituality based on common values for the diverse African continent in ‘our third-millennial world’?Contribution: From a multidisplinary theological perspective, the article deals with ‘historical thought’ regarding spirituality and creation. This includes both the textual history from Christianity and oral history from Africa. A missional hermeneutics is used to bring different traditions and beliefs together. (shrink)

In diesem Beitrag sollen zentrale Spielarten und Familienverwandte des Liberalismus vorgestellt sowie auf zentrale Herausforderungen eingegangen werden, die sich dem Liberalismus als politischer Theorie gegenwärtig stellen. In diesem Beitrag sollen zum einen zentrale Spielarten und Familienverwandte von Rawls’ Liberalismus vorgestellt werden. Dabei handelt es sich um den Links- und Rechtslibertarismus, den Neoliberalismus sowie den Nationalliberalismus. Zum anderen sollen mit dem gesellschaftlichen Pluralismus, dem Verhältnis zur Demokratie und der Umweltzerstörung wichtige Herausforderungen thematisiert werden, mit denen sich der politische Liberalismus heutzutage konfrontiert (...) sieht. (shrink)

John Rawls ist im 20. Jahrhundert sicherlich einer der bedeutendsten praktischen Philosophen. Seine Werke und die damit verbundene Begriffs- und Theoriebildung haben viele Traditionslinien philosophischer Klassiker der Moderne aufgegriffen, synthetisiert und neu ausgelegt. Mit seinem Nachdenken über Gerechtigkeit prägt er bis heute viele philosophische Debatten, sei es in positiver Bezugnahme oder negativer Abgrenzung.

This research investigated the impact measures (such as lockdowns) used to combat the spread of the coronavirus disease of 2019 (COVID-19) have on the church’s mission. When people face travel and assembly restrictions, the church as a community of witnesses testifying and participating in Christ’s work risks is being neutralised, and its presence weakened. What then does mission as ‘being with’ look like in these situations? Is faithful presence something one can turn on and off at will depending on the (...) situation? If faithful presence was no more, what then was the impact of such absence on the church’s mission? These questions underscore the relevance of this research which sought to ascertain the impact the COVID-19 pandemic lockdown had on the church’s mission. The crucial area this research sought to explore are the lessons from the COVID-19 lockdown that will help the church prepare for future pandemics which scientists say are inevitable. The research made use of a qualitative interview method to discover the meaning of ‘being with’ in the context of the COVID-19 lockdown. The results revealed six attributes of a missional church. Based on these attributes, the research recommends a seven-step process to prepare the church for possible future pandemics.Contribution: This research has provided the church with an opportunity to shift from being ‘inward-looking’ to a church that is community focused, a church that prepares, trains and equips its adherents for the work of ministry in their own communities such that the work of ministry continues with or without gatherings. (shrink)

In the strategic document of the African Union approved in 2013 and spanning over 50 years, known as Agenda 2063, we find a blueprint for transforming Africa into a global powerhouse of the future. Many of the themes mentioned in Agenda 2063 are also mentioned in the New Testament, such as slavery, unity, poverty, women, children, discrimination and diversity. It is therefore clear that Christianity has something to contribute to Agenda 2063. Another word used throughout the Agenda 2063 document is (...) 'transformation'. Concepts such as 'transformative leadership' and 'radical transformation at all levels and in all spheres' are mentioned. This contribution draws on the Agenda 2063 document to engage the missiological themes of unity, reconciliation and justice through the lens of the Belhar Confession. Deeply aware of the pain and disruption colonial Christianity has caused in many instances in Africa, the author contends that the Good News, particularly the New Testament themes of unity, reconciliation and justice, present a potentially transformative approach towards developing Africa. The research question that this article attends to is: how can the churches in Africa contribute to the aspirations of Agenda 2063 from the themes of unity, justice and reconciliation as declared in the Belhar Confession? By interrogating these key concepts of Agenda 2063 through the Confession of Belhar, the author concludes that the Belhar Confession can be regarded as a key African document, which could be explored further to facilitate unity, reconciliation and justice on the continent. CONTRIBUTION: This article indicates the important relationship between church and state and the need for a partnership for the benefit of both. The need for a transforming state and a transforming church to participate in a transformed Africa is argued. The article promotes multi-, inter- and transdisciplinary aspects of studies as part of a mission praxis and application. (shrink)

This article focuses on the current trends and initiatives in human capacity building in Africa. It takes as it starting point that human capacity development is essential for Africa to become an information and know-ledge society and therefore an equal partner in the global sharing of knowledge. Four knowledge areas are identified and discussed. These are education, research and development, brain drain and information and documentation drain. The paper concludes that there is a clear understanding in Africa that its future (...) lies with education and that most African leaders have a strong political will to invest in human capacity building on the continent. It is also clear that much has been done, particularly primary education. Africa will most defi-nitely benefit from this in the long run. Problem areas remain however. These are in the needed growth of research and development and how to address the brain and information drain phenomena. (shrink)

In a well-known passage from 'The Red Lily', Anatole France retorts ironically: “The law, in its majestic equality, forbids rich and poor alike to sleep under bridges, to beg in the streets, and to steal loaves of bread”. The passage highlights the different burdens experienced by different people when deciding to act or not act in certain ways. This paper critically analyzes this problem; specifically, how we ought to allocate personal responsibility for actions performed by agents who each experience different (...) social, economic, political, and internal and external influences. First, the paper outlines some prevailing conceptions of personal responsibility in the literature. Second, it offers a critique of these views, arguing that they each suffer from a variety of conceptual and practical flaws. Third, a basic framework I call the continuum- threshold account of responsibility is proposed. The account distinguishes between responsibility and blameworthiness, addresses many of our objections against other prevailing conceptions of responsibility, and takes into account background structural conditions while retaining the scope for responsibility and moral agency. (shrink)

This paper discusses the role of age in scientific practice from an ethical perspective. In social perception, people tend to categorise others rather automatically along three major dimensions: race, sex, and age.1 Much empirical and theoretical attention has been devoted to the study of racism and sexism, but comparatively little research in the social and behaviural sciences has been directed at understanding what some refer to as the third ‘-ism’: ageism.2 For a serious understanding of the implications of ageism in (...) science, it is necessary to discuss, first, the conflicting relationships between classical and modern concepts of time and calendar age, and thereafter the concept of ageism. (shrink)

The main premise of the Royal Dutch Medical Association's (RDMA) guideline on palliative sedation is that palliative sedation, contrary to euthanasia, is normal medical practice. Although we do not deny the ethical distinctions between euthanasia and palliative sedation, we will critically analyse the guideline's argumentation strategy with which euthanasia is demarcated from palliative sedation. First, we will analyse the guideline's main premise, which entails that palliative sedation is normal medical treatment. After this, we will critically discuss three crucial propositions of (...) the guideline that are used to support this premise: (1) the patient's life expectancy should not exceed 2 weeks; (2) the aim of the physician should be to relieve suffering and (3) expert consultation is optional. We will conclude that, if inherent problematic aspects of palliative sedation are taken seriously, palliative sedation is less normal than it is now depicted in the guideline. (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)

ABSTRACTThis report on end‐of‐life decision‐making in Canada was produced by an international expert panel and commissioned by the Royal Society of Canada. It consists of five chapters.Chapter 1 reviews what is known about end‐of‐life care and opinions about assisted dying in Canada.Chapter 2 reviews the legal status quo in Canada with regard to various forms of assisted death.Chapter 3 reviews ethical issues pertaining to assisted death. The analysis is grounded in core values central to Canada's constitutional order.Chapter 4 reviews the (...) experiences had in a number of jurisdictions that have decriminalized or recently reviewed assisted dying in some shape or form.Chapter 5 provides recommendations with regard to the provision of palliative care in Canada, as well as recommendations for reform with respect to the various forms of assisted death covered in this document. (shrink)

The Remmelink Committee published its report on medical decisions at the end of life in the Netherlands in September 1991. As a result, the Dutch debate about physician aid‐in‐dying has been broadened to include life‐terminating acts that have not been explicitly requested by the patient.

This paper shall give a review of Elizabeth A. Buchanan : Readings in Virtual Research Ethics. Issues and Controversies. Information Science Pub. , 2003. 350 pages Broschur. 69,00 €.

Modern medicine provides unprecedented opportunities in diagnostics and treatment. However, in some situations at the end of a patient’s life, many physicians refrain from using all possible measures to prolong life. We studied the incidence of different types of treatment withheld or withdrawn in 6 European countries and analyzed the main background characteristics.

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)

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)

We introduce prime products as a generalization of ultraproducts for positive logic. Prime products are shown to satisfy a version of Łoś’s Theorem restricted to positive formulas, as well as the following variant of the Keisler Isomorphism Theorem: under the generalized continuum hypothesis, two models have the same positive theory if and only if they have isomorphic prime powers of ultrapowers.

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)

A quasivariety of algebras has the joint embedding property (JEP) if and only if it is generated by a single algebra A. It is structurally complete if and only if the free ℵ0‐generated algebra in can serve as A. A consequence of this demand, called ‘passive structural completeness’ (PSC), is that the nontrivial members of all satisfy the same existential positive sentences. We prove that if is PSC then it still has the JEP, and if it has the JEP and (...) its nontrivial members lack trivial subalgebras, then its relatively simple members all belong to the universal class generated by one of them. Under these conditions, if is relatively semisimple then it is generated by one ‐simple algebra. We also prove that a quasivariety of finite type, with a finite nontrivial member, is PSC if and only if its nontrivial members have a common retract. The theory is then applied to the variety of De Morgan monoids, where we isolate the sub(quasi)varieties that are PSC and those that have the JEP, while throwing fresh light on those that are structurally complete. The results illuminate the extension lattices of intuitionistic and relevance logics. (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)

Two decades of research on euthanasia in the Netherlands have resulted into clear insights in the frequency and characteristics of euthanasia and other medical end-of-life decisions in the Netherlands. These empirical studies have contributed to the quality of the public debate, and to the regulating and public control of euthanasia and physician-assisted suicide. No slippery slope seems to have occurred. Physicians seem to adhere to the criteria for due care in the large majority of cases. Further, it has been shown (...) that the majority of physicians think that the euthanasia Act has improved their legal certainty and contributes to the carefulness of life-terminating acts. In 2005, eighty percent of the euthanasia cases were reported to the review committees. Thus, the transparency envisaged by the Act still does not extend to all cases. Unreported cases almost all involve the use of opioids, and are not considered to be euthanasia by physicians. More education and debate is needed to disentangle in these situations which acts should be regarded as euthanasia and which should not. Medical end-of-life decision-making is a crucial part of end-of-life care. It should therefore be given continuous attention in health care policy and medical training. Systematic periodic research is crucial for enhancing our understanding of end-of-life care in modern medicine, in which the pursuit of a good quality of dying is nowadays widely recognized as an important goal, in addition to the traditional goals such as curing diseases and prolonging life. (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)

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)

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)

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)

Therapeutic privilege is a defence that may be available to doctors who fail to disclose to the patient relevant information when seeking informed consent for treatment if they have a reasonable belief that providing that information would likely cause the patient concerned serious physical or mental harm. In a landmark judgement, the Singapore Court of Appeal introduced a novel interpretation of TP, identifying circumstances in which it might be used with patients who did not strictly lack capacity but might be (...) inclined to refuse recommended treatments. In this paper, we explore the conceptual and practical challenges of this novel interpretation of TP. We propose that more emphasis should be placed on forms of shared and supported decision-making that foster the autonomy of patients with compromised mental capacity while being mindful of the need to safeguard their well-being. The kind of privilege that doctors might need to invoke is one of time and supportive expertise to ensure a flexible, responsive approach calibrated to the individual patients’ needs. The provision of such service would extinguish the need for the novel TP proposed by the Singapore Court of Appeal. (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)