Aim: To examine how physicians’ life stances affect their attitudes to end-of-life decisions and their actual end-of-life decision-making.Methods: Practising physicians from various specialties involved in the care of dying patients in Belgium, Denmark, The Netherlands, Sweden, Switzerland and Australia received structured questionnaires on end-of-life care, which included questions about their life stance. Response rates ranged from 53% in Australia to 68% in Denmark. General attitudes, intended behaviour with respect to two hypothetical patients, and actual behaviour were compared between all large (...) life-stance groups in each country.Results: Only small differences in life stance were found in all countries in general attitudes and intended and actual behaviour with regard to various end-of-life decisions. However, with regard to the administration of drugs explicitly intended to hasten the patient’s death , physicians with specific religious affiliations had significantly less accepting attitudes, and less willingness to perform it, than non-religious physicians. They had also actually performed PAD less often. However, in most countries, both Catholics and Protestants reported ever having made such a decision.Discussion: The results suggest that religious teachings influence to some extent end-of-life decision-making, but are certainly not blankly accepted by physicians, especially when dealing with real patients and circumstances. Physicians seem to embrace religious belief in a non-imperative way, allowing adaptation to particular situations. (shrink)

Respect for autonomy is well known as a core element of normative views on good care. Most often it is interpreted in a liberal way, with a focus on independence and self-determination. In this article we argue that this interpretation is too narrow in the context of care in nursing homes. With the aim of developing an alternative view on respect for autonomy in this setting we described four interpretations and investigated the moral intuitions (i.e. moral judgements) of caregivers regarding (...) these approaches. We found that these caregivers seemed to value different notions relating to respect for autonomy under different circumstances. There was no significant difference in moral judgements between men and women or between doctors and nurses. We conclude that a multidimensional understanding of this principle would best fit this context. We end this article with a description of a modest theory of respect for autonomy in nursing homes. (shrink)

Slow euthanasia or a good palliative intervention?There are many ways in which doctors influence the circumstances and/or the timing of a patient’s death. Some of these are accepted as normal medical practice—for instance, when a disproportional treatment is forgone, others are considered tolerable only under strict conditions or even intolerable, such as non-voluntary active euthanasia. A relatively new phenomenon in the ethical discussion on end-of-life decisions is terminal sedation. Terminal sedation is used in patients with terminal illnesses where normal medical (...) treatments cannot relieve severe symptoms such as pain and agitation, and no option is left but to take away the perception of these symptoms. Often, the decision to start terminal sedation is accompanied by the decision to forgo the provision of artificial nutrition and hydration in these patients. In The Netherlands, terminal sedation was estimated to be applied in 4–10% of all deaths in 2001.1 The combination of these two decisions have made the moral status of terminal sedation the subject of fierce ethical debates. Is it slow euthanasia2,3 or is it a good palliative intervention that should be sharply distinguished from euthanasia?4,5 One of the characteristics of this debate is that it is a very confused one: people disagree about the meaning of the term, the appropriateness of it and, of course, about the conditions under which it would be morally justified. As a matter of fact, these three discussions are deeply connected: as is often the case, a discussion about terms is a discussion about norms in disguise.The first observation to be made is that many seemingly descriptive definitions of terminal sedation contain normative claims. Examples of this are definitions of terminal sedation in which only …. (shrink)

In April 2002 a new law regarding euthanasia came into effect in the Netherlands. This law holds that euthanasia remains a criminal offence unless it is performed by a physician who acts according to six specified rules of due care and reports the case to a review committee. The six rules of due care are similar to those of the previous regulation and are largely based on jurisprudence. Completely new, however, is the article concerning a competent patient who has written (...) an advance directive requesting euthanasia under certain circumstances. The law stipulates that a physician may act according to that written request, as long as he or she fulfils all other rules of due care. The author defends the view that these requests are neither feasible nor ethically justifiable, and presents both moral and practical arguments for this, claiming that for consistency reasons one cannot act on the basis of a written statement and fulfil the other rules of due care at the same time. The author also examines a difficult case of a demented, severely depressed woman who had written a living will requesting euthanasia before she became demented. (shrink)

The issue of the allocation of resources in health care is here to stay. The goal of this study was to explore the views of physicians on several topics that have arisen in the debate on the allocation of scarce resources and to compare these with the views of policy makers. We asked physicians and policy makers to participate in an interview about their practices and opinions concerning factors playing a role in decision making for patients in different age groups. (...) Both physicians and policy makers recognised allocation decisions as part of their reality. One of the strong general opinions of both physicians and policy makers was the rejection of age discrimination. Making allocation decisions as such seemed to be regarded as a foreign entity to the practice of medicine. In spite of the reluctance to make allocation decisions, physicians sometimes do. This would seem to be only acceptable if it is justified in terms of the best interests of the patient from whom treatment is withheld. (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 practice of coercive measures in psychiatry is controversial. Although some have suggested that it may be acceptable if patients are a danger to others or to themselves, others committed themselves to eliminate it. Ethical, legal and clinical considerations become more complex when the mental incapacity is temporary and when the coercive measures serve to restore autonomy. We discuss these issues, addressing the conflict between autonomy and beneficence/non-maleficence, human dignity, the experiences of patients and the effects of coercive measures. We (...) argue that an appeal to respect autonomy and/or human dignity cannot be a sufficient reason to reject coercive measures. All together, these ethical aspects can be used both to support and to reject a non-seclusion approach. The total lack of controlled trials about the beneficial effects of coercive measures in different populations however, argues against the use of coercive measures. (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)

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 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)

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)

In response to the paper by Keown and Jochemsen in which the latest empirical data concerning euthanasia and other end-of-life decisions in the Netherlands is discussed, this paper discusses three points. The use of euthanasia in cases in which palliative care was a viable alternative may be taken as proof of a slippery slope. However, it could also be interpreted as an indication of a shift towards more autonomy-based end-of-life decisions. The cases of non-voluntary euthanasia are a serious problem in (...) the Netherlands and they are only rarely justifiable. However, they do not prove the existence of a slippery slope. Persuading the physician to bring euthanasia cases to the knowledge of the authorities is a problem of any euthanasia policy. The Dutch notification procedure has recently been changed to reduce the underreporting of cases. However, many questions remain. (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.

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...

Cette étude analyse la pensée actuelle sur les décisions-fin-de-vie (DfdV) en France d’un point de vue hollandais. Un nombre limité d’interviews avec des ‘opinion-leaders’ français est pris comme base du project. Jusqu’au jour présent, le domaine des DfdV en France a été troublé en l’absence de définitions et de législation plus spécifiques. Les médecins français pourront faire face à un dilemme en soignant un malade mourant, pris en étau entre le caractère illégal officiel de l’euthanasie d’une part et l’obligation professionnelle (...) de traiter chaque cas de façon particulière d’autre part. La conséquence de l’environnement réglementaire incertain est une déresponsabilisation des médecins français vis-à-vis de leurs collègues et des patients. L’adoption de réformes législatives, en ayant la possibilité d’augmenter le nombre de cas d’euthanasie, se heurtait en France à des arguments cartésiens, paternalistes et religieux. En Novembre 2004, l’Assemblée Nationale a adopté une proposition de loi ayant pour but de rendre plus transparente la mise en pratique des limitations et des arrêts de traitement et de reduire la crainte des médecins de poursuites pénales. Cette proposition de loi a été par la suite approuvée par le Sénat. Aux Pays-Bas, l’euthanasie–la terminaison active de la vie–est légale et régulée par des critères précis. L’approche hollandaise fait référence au concept anglo-saxon d’autonomie du patient et correspond à la préférence générale de la société hollandaise pour la révélation et la régulation des activités controversielles plutôt que de tolérer leur existence sub rosa. Depuis l’entrée en vigueur de la régulation sur l’euthanasie aux Pays-Bas le nombre de cas rapportés a augmenté, mais pas le nombre d’euthanasies. Les règles sont respectées et la qualité de la communication entre médecin et patient est élevée. La vigilance Française pour l’autonomie professionnelle offre un exemple de valeur pour les Hollandais. Les Hollandais, de leur part, fournissent des exemples concrets pour la régulation du domaine des DfdV en France dont on a fait un début récemment. (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)

A continuing need for care for elderly, combined with looser family structures prompt the question what filial obligations are. Do adult children of elderly have a duty to care? Several theories of filial obligation are reviewed. The reciprocity argument is not sensitive to the parent–child relationship after childhood. A theory of friendship does not offer a correct parallel for the relationship between adult child and elderly parent. Arguments based on need or vulnerability run the risk of being unjust to those (...) on whom a needs-based claim is laid. To compare filial obligations with promises makes too much of parents’ expectations, however reasonable they may be. The good of being in an unchosen relationship seems the best basis for filial obligations, with an according duty to maintain the relationship when possible. We suggest this relationship should be maintained even if one of the parties is no longer capable of consciously contributing to it. We argue that this entails a duty to care about one’s parents, not for one’s parents. This implies that care for the elderly is not in the first place a task for adult children. (shrink)

The use of do not resuscitate (DNR) orders in Dutch hospitals was studied as part of a nationwide study on medical decisions concerning the end of life. DNR decisions are made in 6 per cent of all admissions, and 61 per cent of all in-hospital deaths were preceded by a DNR decision. We found that in only 14 per cent of the cases had the patients been involved in the DNR decision (32 per cent of competent patients). The concept of (...) futility is analysed as these findings are discussed. We conclude that determining the effectiveness of resuscitation is a medical judgement whereas determining the proportionality (burden/benefit ratio) of it requires a discussion between doctor and patient (or his or her surrogates). Since the respondents in the cases without patient involvement gave many reasons for their decision that went beyond determining effectiveness, we conclude that more patient involvement would have been desirable. (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)

The Dutch law states that a physician may perform euthanasia according to a written advance euthanasia directive when a patient is incompetent as long as all legal criteria of due care are met. This may also hold for patients with advanced dementia. We investigated the differing opinions of physicians and members of the general public on the acceptability of euthanasia in patients with advanced dementia.

Introduction: The Dutch Euthanasia Act states that euthanasia is not punishable if the attending physician acts in accordance with the statutory due care criteria. These criteria hold that: there should be a voluntary and well-considered request, the patient’s suffering should be unbearable and hopeless, the patient should be informed about their situation, there are no reasonable alternatives, an independent physician should be consulted, and the method should be medically and technically appropriate. This study investigates whether physicians experience problems with these (...) criteria in medical practice.Methods: In 2006, questionnaires were sent to a random, stratified sample of 2100 Dutch physicians . Physicians were asked about problems in their decision-making related to requests for euthanasia or assisted suicide after enforcement of the 2002 Euthanasia Act.Results: Of all physicians who had received a request for euthanasia or assisted suicide , 25% had experienced problems in the decision-making with regard to at least one of the criteria of due care. Physicians who had experienced problems mostly indicated to have had problems related to evaluating whether or not the patient’s suffering was unbearable and hopeless and whether or not the patient’s request was voluntary or well considered .Discussion: Physicians in The Netherlands most frequently reported problems related to aspects in which they have to evaluate the patient’s subjective perspective. However, it can be questioned whether placing emphasis on these subjective aspects is an adequate fulfilment of the duties imposed on physicians, as laid down in the Dutch Euthanasia Act. (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)

The possibilities for collecting, storing, and processing of data have increased significantly over the last decades. It has been argued that an increasing demand for health data will de...

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)

Family involvement in healthcare decision-making for competent patients occurs to varying degrees in many communities around the world. There are different attitudes about who should make treatment decisions, how and why. Legal and professional ethics codes in most jurisdictions reflect and support the idea that competent patients should be enabled to make their own treatment decisions, even if others, including their healthcare professionals, disagree with them. This way of thinking contrasts with some cultural norms that put more emphasis on the (...) family as a decision-making entity, in some circumstances to the exclusion of a competent patient. Possible tensions may arise between various combinations of patient, family members and healthcare professionals, and healthcare professionals must tread a careful path in navigating family involvement in the decision-making process. These tensions may be about differences of opinion about which treatment option is best and/or on who should have a say or influence in the decision-making process. While some relevant cultural, legal and policy considerations vary from community to community, there are ethical issues that healthcare professionals need to grapple with in balancing the laws and professional codes on decision-making and the ethical principle of respecting patients and their autonomy. This paper will highlight and propose that a partial resolution to these issues may lie in relational understandings of autonomy, which in principle justify interventions by healthcare professionals and family that support patients in decision-making. (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)

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)

Introduction In 2007, a national review committee was instituted in The Netherlands to review cases of active ending of life for newborns. It was expected that 15–20 cases would be reported. To date, however, only one case has been reported to this committee. Reporting is essential to obtain societal control and transparency; the possible explanations for this lack of reporting were therefore explored. Methods Data on end-of-life decision-making were scrutinised from Dutch nation-wide studies (1995, 2001 and 2005), before institution of (...) the committee. Physicians received a questionnaire about their medical decision-making for stratified samples of deceased infants up to 1 year, drawn from the central death registry. Results In 2005, 58% of all deaths were preceded by an end-of-life decision, compared with 68% in 2001 and 62% in 1995. The use of drugs with a possible life-shortening effect tended to be lower. In 2005, all four cases in the study in which an infants' life was actively ended were preceded by a decision to forego life-prolonging treatment. In three cases, the infant's life expectancy was short; one case involved a longer life expectancy. Discussion The expected number of cases is probably an overestimation due to changes in medical practice such as the tendency to attribute less life-shortening effects to opioids. The lack of reports is probably also associated with requirements in the regulation; it may be difficult to fulfil them due either to time constraints or the nature of the suffering that is addressed. If societal control of active ending of life is considered useful, changes in the regulation may be needed. (shrink)

Although euthanasia and assisted suicide in people with psychiatric disorders is relatively rare, the increasing incidence of EAS requests has given rise to public and political debate. This study aimed to explore support of the public and physicians for euthanasia and assisted suicide in people with psychiatric disorders and examine factors associated with acceptance and conceivability of performing EAS in these patients. A survey was distributed amongst a random sample of Dutch 2641 citizens and 3000 physicians. Acceptance and conceivability of (...) performing EAS, demographics, health status and professional characteristics were measured. Multivariable logistic regression analyses were performed. Of the general public 53% were of the opinion that people with psychiatric disorders should be eligible for EAS, 15% was opposed to this, and 32% remained neutral. Higher educational level, Dutch ethnicity, and higher urbanization level were associated with higher acceptability of EAS whilst a religious life stance and good health were associated with lower acceptability. The percentage of physicians who considered performing EAS in people with psychiatric disorders conceivable ranged between 20% amongst medical specialists and 47% amongst general practitioners. Having received EAS requests from psychiatric patients before was associated with considering performing EAS conceivable. Being female, religious, medical specialist, or psychiatrist were associated with lower conceivability. The majority of the psychiatrists were of the opinion that it is possible to establish whether a psychiatric patient’s suffering is unbearable and without prospect and whether the request is well-considered. The general public shows more support than opposition as to whether patients suffering from a psychiatric disorder should be eligible for EAS, even though one third of the respondents remained neutral. Physicians’ support depends on their specialization; 39% of psychiatrists considered performing EAS in psychiatric patients conceivable. The relatively low conceivability is possibly explained by psychiatric patients often not meeting the eligibility criteria. (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)

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)

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)

Certain organoid subtypes are particularly sensitive. We explore whether moral intuitions about the heartbeat warrant unique moral consideration for newly advanced contracting cardiac organoids. Despite the heartbeat’s moral significance in organ procurement and abortion discussions, we argue that this significance should not translate into moral implications for cardiac organoids.

The authors of the paper ‘Advance euthanasia directives: a controversial case and its ethical implications’ articulate concerns and reasons with regard to the conduct of euthanasia in persons with dementia based on advance directives. While we agree on the conclusion that there needs to be more attention for such directives in the preparation phase, we disagree with the reasons provided by the authors to support their conclusions. We will outline two concerns with their reasoning by drawing on empirical research and (...) by providing reasons that contradict their assumptions about competence of people with dementia and the importance of happiness in reasoning about advance directives of people with dementia. We will draw attention to the important normative questions that have been overstepped in their paper, and we will outline why further research is required. (shrink)

Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international health data sharing. Despite the recent adoption of the EU General Data Protection Regulation, the procedures for how to govern responsible data sharing in such projects are not at all spelled out yet. In search of a first, basic outline of an ethical governance framework, we (...) set out to explore relevant ethical principles and norms. We performed a systematic review of literature and ethical guidelines for principles and norms pertaining to data sharing for international health research. We observed an abundance of principles and norms with considerable convergence at the aggregate level of four overarching themes: societal benefits and value; distribution of risks, benefits and burdens; respect for individuals and groups; and public trust and engagement. However, at the level of principles and norms we identified substantial variation in the phrasing and level of detail, the number and content of norms considered necessary to protect a principle, and the contextual approaches in which principles and norms are used. While providing some helpful leads for further work on a coherent governance framework for data sharing, the current collection of principles and norms prompts important questions about how to streamline terminology regarding de-identification and how to harmonise the identified principles and norms into a coherent governance framework that promotes data sharing while securing public trust. (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)