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)

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)

OBJECTIVE: To report and analyse the pattern of end-of-life decision making for terminal Chinese cancer patients. DESIGN: Retrospective descriptive study. SETTING: A cancer clinical trials unit in a large teaching hospital. PATIENTS: From April 1992 to August 1997, 177 consecutive deaths of cancer clinical trial patients were studied. MAIN MEASUREMENT: Basic demographic data, patient status at the time of signing a DNR consent, or at the moment of returning home to die are documented, and circumstances surrounding these events evaluated. RESULTS: (...) DNR orders were written for 64.4% of patients. Patients in pain (odds ratio 0.45, 95% CI 0.22-0.89), especially if requiring opioid analgesia (odds ratio 0.40, 95% CI 0.21-0.77), were factors associated with a higher probability of such an order. Thirty-five patients were taken home to die, a more likely occurrence if the patient was over 75 years (odds ratio 0.12, 95% CI 0.04-0.34), had children (odds ratio 0.14, 95% CI 0.02-0.79), had Taiwanese as a first language (odds ratio 6.74, 95% CI 3.04-14.93), or was unable to intake orally (odds ratio 2.73, 95% CI 1.26-5.92). CPR was performed in 30 patients, none survived to discharge. CONCLUSIONS: DNR orders are instituted in a large proportion of dying Chinese cancer patients in a cancer centre, however, the order is seldom signed by the patient personally. This study also illustrates that as many as 20% of dying patients are taken home to die, in accordance with local custom. (shrink)

Although many studies have revealed the importance of study skills for students' first?year performance and college retention, the extent of the impact of study skills preparation on students' academic achievement is less clear. This paper explores the impact of pre?university study skills preparation on students' first?year study experiences, academic achievement and persistence. The setting for this study is a large law school in the Netherlands which attracts students from more than 100 schools for secondary education. The results show that the (...) perceived study skills preparation concerning time management and learning skills does have a positive impact on college students' first?year study behaviour and academic achievement. However, the study also shows that the impact of perceived college preparation is far less important for college retention than other factors such as satisfaction about the chosen degree programme and tutorial attendance. (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)

Heuristics of evolutionary biology dictate that phylogenetically older processes are inherently more stable and resilient to disruption than younger processes. On the grounds that non-declarative behaviour emerged long before declarative behaviour, Reber argues that implicit learning is supported by neural processes that are evolutionarily older than those supporting explicit learning. Reber suggested that implicit learning thus leads to performance that is more robust than explicit learning. Applying this evolutionary framework to motor performance, we examined whether implicit motor learning, relative to (...) explicit motor learning, conferred motor output that was resilient to physiological fatigue and durable over time. In Part One of the study a fatigued state was induced by a double Wingate Anaerobic test protocol. Fatigue had no affect on performance of participants in the implicit condition; whereas, performance of participants in the explicit condition deteriorated significantly. In Part Two of the study a convenience sample of participants was recalled following a one-year hiatus. In both the implicit and the explicit condition retention of performance was seen and, contrary to the findings in Part One, so was resilience to fatigue. The resilient performance in the explicit condition after one year may have resulted from forgetting or from consolidation of declarative knowledge as implicit memories. In either case, implicit processes were left to more effectively support motor performance. (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)

In their 2007 paper, Swierstra and Rip identify characteristic tropes and patterns of moral argumentation in the debate about the ethics of new and emerging science and technologies (or “NEST-ethics”). Taking their NEST-ethics structure as a starting point, we considered the debate about tissue engineering (TE), and argue what aspects we think ought to be a part of a rich and high-quality debate of TE. The debate surrounding TE seems to be predominantly a debate among experts. When considering the NEST-ethics (...) arguments that deal directly with technology, we can generally conclude that consequentialist arguments are by far the most prominently featured in discussions of TE. In addition, many papers discuss principles, rights and duties relevant to aspects of TE, both in a positive and in a critical sense. Justice arguments are only sporadically made, some “good life” arguments are used, others less so (such as the explicit articulation of perceived limits, or the technology as a technological fix for a social problem). Missing topics in the discussion, at least from the perspective of NEST-ethics, are second “level” arguments—those referring to techno-moral change connected to tissue engineering. Currently, the discussion about tissue engineering mostly focuses on its so-called “hard impacts”—quantifiable risks and benefits of the technology. Its “soft impacts”—effects that cannot easily be quantified, such as changes to experience, habits and perceptions, should receive more attention. (shrink)

In their 2007 paper, Swierstra and Rip identify characteristic tropes and patterns of moral argumentation in the debate about the ethics of new and emerging science and technologies (or “NEST-ethics”). Taking their NEST-ethics structure as a starting point, we considered the debate about tissue engineering (TE), and argue what aspects we think ought to be a part of a rich and high-quality debate of TE. The debate surrounding TE seems to be predominantly a debate among experts. When considering the NEST-ethics (...) arguments that deal directly with technology, we can generally conclude that consequentialist arguments are by far the most prominently featured in discussions of TE. In addition, many papers discuss principles, rights and duties relevant to aspects of TE, both in a positive and in a critical sense. Justice arguments are only sporadically made, some “good life” arguments are used, others less so (such as the explicit articulation of perceived limits, or the technology as a technological fix for a social problem). Missing topics in the discussion, at least from the perspective of NEST-ethics, are second “level” arguments—those referring to techno-moral change connected to tissue engineering. Currently, the discussion about tissue engineering mostly focuses on its so-called “hard impacts”—quantifiable risks and benefits of the technology. Its “soft impacts”—effects that cannot easily be quantified, such as changes to experience, habits and perceptions, should receive more attention. (shrink)

A notion of resource-bounded Baire category is developed for the class PC[0,1] of all polynomial-time computable real-valued functions on the unit interval. The meager subsets of PC[0,1] are characterized in terms of resource-bounded Banach-Mazur games. This characterization is used to prove that, in the sense of Baire category, almost every function in PC[0,1] is nowhere differentiable. This is a complexity-theoretic extension of the analogous classical result that Banach proved for the class C[0, 1] in 1931.

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...