BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, (...) RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.ConclusionAs such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task. (shrink)

BackgroundThe Netherlands is one of the few countries where euthanasia is legal under strict conditions. This study investigates whether Dutch newspaper articles use the term ‘euthanasia’ according to the legal definition and determines what arguments for and against euthanasia they contain.MethodsWe did an electronic search of seven Dutch national newspapers between January 2009 and May 2010 and conducted a content analysis.ResultsOf the 284 articles containing the term ‘euthanasia’, 24% referred to practices outside the scope of the law, mostly relating to (...) the forgoing of life-prolonging treatments and assistance in suicide by others than physicians. Of the articles with euthanasia as the main topic, 36% described euthanasia in the context of a terminally ill patient, 24% for older persons, 16% for persons with dementia, and 9% for persons with a psychiatric disorder. The most frequent arguments for euthanasia included the importance of self-determination and the fact that euthanasia contributes to a good death. The most frequent arguments opposing euthanasia were that suffering should instead be alleviated by better care, that providing euthanasia can be disturbing, and that society should protect the vulnerable.ConclusionsOf the newspaper articles, 24% uses the term ‘euthanasia’ for practices that are outside the scope of the euthanasia law. Typically, the more unusual cases are discussed. This might lead to misunderstandings between citizens and physicians. Despite the Dutch legalisation of euthanasia, the debate about its acceptability and boundaries is ongoing and both sides of the debate are clearly represented. (shrink)

BackgroundIn research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus. In this manuscript, we attempted to do just that.MethodsWe extracted (...) the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative.ResultsWe found that there is no consensus on the majority of the imperatives and that in only 8.2 % of the imperatives were there at least moderate consensus. Of the 12 clusters, Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.ConclusionThere was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences. (shrink)

Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. (...) Methods To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications of drugs submitted to the European Medicines Agency from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study. Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37. The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes. (shrink)

BackgroundIn this manuscript, we argue that within the context of phase IV, physician-researchers retain their fiduciary obligation to treat the patient-participants.DiscussionWe first clarify why the perspective that research ethics ought to be differentiated from clinical ethics is not applicable in phase IV, and therefore, why therapeutic orientation is most convivial in this phase. Next, assuming that ethics guidelines may be representative of common morality, we show that ethics guidelines see physician-researchers primarily as physicians and only secondarily as researchers. We then (...) elaborate on what a fiduciary obligation is and how some of the obligations are default duties. Lastly, we look at the fiduciary obligation of the physician-researcher in phase IV interventional trials.ConclusionThe fiduciary obligation to treat is not as easily waived as in earlier trials. Assuming the entwinement of research and practice in phase IV, physician-researchers, in collaboration with other researchers, investigators, and research ethics committees, should ensure that in terms of study design, methodology, and research practice, the therapeutic value of the research to the patient-participants is not diminished. (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)

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)

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)

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...) of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (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.

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)

In the Netherlands, the legalization of assisted suicide for persons with a death wish without severe illness, often referred to as persons with “completed life” or “tiredness of life,” is intensel...

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)

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 recurrent issue in the vast amount of literature on reasoning models in ethics is the role and nature of moral intuitions. In this paper, we start from the view that people who work and live in a certain moral practice usually possess specific moral wisdom. If we manage to incorporate their moral intuitions in ethical reasoning, we can arrive at judgements and (modest) theories that grasp a moral experience that generally cannot be found outside the practice. Reflective equilibrium (RE) (...) provides a framework for balancing moral intuitions, ethical principles and general theories. Nevertheless, persisting problems associated with the use of intuitions need to be addressed. One is the objection that moral intuitions lack the credibility necessary to guide moral reasoning. Ethicists have tried to solve this problem by formulating criteria to separate the “bad” intuitions from the “good” ones at the beginning of the reasoning process. We call this the credible input-justified outcome strategy. An example is the appeal to the common morality by Beauchamp and Childress. We think this approach is unsuccessful. As an alternative, we outline the good reasoning-justified outcome strategy. It connects to a variant of RE in which intuitions from different sources are incorporated. We argue that the elements of RE have different levels of justificatory power at the start of reasoning. In our strategy, each element can gain or lose justificatory power when it is tested in a reasoning process that meets several criteria. (shrink)

Worries about safety of approved drugs have pushed post registration research to become the fastest growing drug research phase. Until recently, phase IV studies were mainly conducted for marketing purposes and run much like a phase III trial—at institutions with experienced investigators and a list of inclusion and exclusion criteria. Innovative phase IV studies involve ordinary physicians in research naïve communities. This brings ethical issues familiar to medical research into clinical practice. As a consequence, individual physicians are challenged to protect (...) scientific integrity and to secure the ethical conduct of research. Several ethical issues need to be addressed in the process of developing a scientifically sound and ethically high principled practice of phase IV research.PHASE IVEssential to phase IV research is the focus on how drugs work in the real world. The research goal may be to explore a specific pharmacological effect, to establish the incidence of adverse reactions, or to determine the effects of long-term administration of a drug. They may also be designed to establish a new clinical indication for a drug.1 Subjects may or may not be randomised, and the studies typically involve large numbers of patient-subjects and physicians.Doubts concerning the scientific rigor and clinical value have put postmarketing research in a poor light. However, high quality phase IV research is badly needed to further pharmaceutical science. First, because it can provide reliable data on the effectiveness, safety and optimal use of a drug in treated populations.2 3 In pre-registration clinical trials , a pharmaceutical product is studied under unrealistic circumstances. Under-representation of women and elderly are common and the concomitant use of medicines is usually extremely restrictive in these trials.4 Second, phase IV can provide much needed data for evidence-based …. (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)

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)

Book Reviews in this Article: Rationing America's Medical Care: The Oregon Plan and Beyond, edited by Martin A. Strosberg, Joshua M. Wiener, Robert Baker and I. Alan Fein. Bad Medicine: The Prescription Drug Industry in the Third World, by Milton Silverman, Mia Lydecker and Philip R. Lee. Stanford Feminist Perspectives in Medical Ethics, edited by Helen Bequaert Holmes and Laura M. Purdy, Bloomington and Indianapolis: Indiana Choices in Health Care: A Report by the Government Committee on Choices in Health Care, (...) The Netherlands, 1992. (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)

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)

In his paper, Fabrice Jotterand clearly illustrates the difficulties of applying the concept of human dignity in the context of emerging enhancement technologies. Unfortunately, however, Jotterand'...

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)

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise (...) in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general. (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)

Current challenges to sustaining public support for health data research have directed attention to the governance of data-intensive health research networks. Accountability is hailed as an important element of trustworthy governance frameworks for data-intensive health research networks. Yet the extent to which adequate accountability regimes in data-intensive health research networks are currently realized is questionable. Current governance of data-intensive health research networks is dominated by the limitations of a drawing board approach. As a way forward, we propose a stronger focus (...) on accountability as learning to achieve accountable governance. As an important step in that direction, we provide two pathways: (1) developing an integrated structure for decision-making and (2) establishing a dialogue in ongoing deliberative processes. Suitable places for learning accountability to thrive are dedicated governing bodies as well as specialized committees, panels or boards which bear and guide the development of governance in data-intensive health research networks. A continuous accountability process which comprises learning and interaction accommodates the diversity of expectations, responsibilities and tasks in data-intensive health research networks to achieve responsible and effective governance. (shrink)

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)

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)

BackgroundFor many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 (...) years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children’s competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives.DiscussionAlthough assessment of children’s competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad.SummaryPrevious research outcomes showed that children’s medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children’s competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated. (shrink)

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

Pragmatic trials aim to directly inform health care decision-making through the collection of so-called ‘real world data’ from observations of comparative treatment effects in clinical practice. In order to ensure the applicability and feasibility of a pragmatic trial, design features may be necessary that deviate from standard research ethics requirements. Examples are traditional requirements to seek written informed consent and to perform extensive data and safety monitoring. Proposals for deviations from standard research ethics practice have resulted in controversy about their (...) ethical acceptability. One of the justifications for altered procedures is the allegedly high social value of pragmatic trials. In order to properly operationalize the concept in the ethical assessment of pragmatic trial designs, specification is warranted. We identified three determinants from common claims about a pragmatic trial's social value: the extent to which the research question has real world relevance, the trial design's ability to generate a real world answer and the probability of direct uptake of the results by decision-makers in practice. Subsequently, we discuss how these determinants should be applied to the practice of pragmatic trials, and to what extent they might be applicable to explanatory trials. (shrink)

The Netherlands is one of the few countries where euthanasia is legal under strict conditions. This study investigates whether Dutch newspaper articles use the term ‘euthanasia’ according to the legal definition and determines what arguments for and against euthanasia they contain. We did an electronic search of seven Dutch national newspapers between January 2009 and May 2010 and conducted a content analysis. Of the 284 articles containing the term ‘euthanasia’, 24% referred to practices outside the scope of the law, mostly (...) relating to the forgoing of life-prolonging treatments and assistance in suicide by others than physicians. Of the articles with euthanasia as the main topic, 36% described euthanasia in the context of a terminally ill patient, 24% for older persons, 16% for persons with dementia, and 9% for persons with a psychiatric disorder. The most frequent arguments for euthanasia included the importance of self-determination and the fact that euthanasia contributes to a good death. The most frequent arguments opposing euthanasia were that suffering should instead be alleviated by better care, that providing euthanasia can be disturbing, and that society should protect the vulnerable. Of the newspaper articles, 24% uses the term ‘euthanasia’ for practices that are outside the scope of the euthanasia law. Typically, the more unusual cases are discussed. This might lead to misunderstandings between citizens and physicians. Despite the Dutch legalisation of euthanasia, the debate about its acceptability and boundaries is ongoing and both sides of the debate are clearly represented. (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)

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)

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.

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)

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)