This study described the relationships between academic class and student moral sensitivity and reasoning and between curriculum design components for ethics education and student moral sensitivity and reasoning. The data were collected from freshman (n = 506) and senior students (n = 440) in eight baccalaureate nursing programs in South Korea by survey; the survey consisted of the Korean Moral Sensitivity Questionnaire and the Korean Defining Issues Test. The results showed that moral sensitivity scores in patient-oriented care and conflict were (...) higher in senior students than in freshman students. Furthermore, more hours of ethics content were associated with higher principled thinking scores of senior students. Nursing education in South Korea may have an impact on developing student moral sensitivity. Planned ethics content in nursing curricula is necessary to improve moral sensitivity and moral reasoning of students. (shrink)

Assent is an important ethical and legal requirement of paediatric research. Unfortunately, there are significant differences between the guidelines on the details of assent.

This text explores how human beings construe experience: experience as a resource, as a potential for understanding, representing and acting on reality.

When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good Clinical Practice, these irregularities (...) occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed. (shrink)

Application of either the harm principle or the best interest standard to medical decision making conflicts with some types of pediatric research that pose elevated risk without the reasonable prob...

A child’s objection, refusal and dissent regarding participation in non-beneficial biomedical research must be respected, even when the parents or legal representatives have given their permission. There is, however, no consensus on the definition and criteria of a meaningful and valid child’s objection. The aim of this article is to clarify this issue. In the first part we describe the problems of a child’s assent in research. In the second part we distinguish and analyze two models of a child’s objection (...) to research: the capacity-based model and the distress-based model. In the last part we present arguments for a broader and unified understanding of a child’s objection within regulations and practices. This will strengthen children’s rights and facilitate the entire process of assessment of research protocols. (shrink)

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, (...) talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups. (shrink)

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members of the European Union.The (...) most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trialswere the least common ethical policies. Three aspects were significantly morecommon in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation.On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences amongbiomedical journals’ ethical policies calls for further research and active measuresto harmonize policies across journals. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (shrink)

Novel precision oncology trial designs, such as basket and umbrella trials, are designed to test new anticancer agents in more effective and affordable ways. However, they present some ethical concerns referred to scientific validity, risk-benefit balance and informed consent. Our aim is to discuss these issues in basket and umbrella trials, giving examples of two ongoing cancer trials: NCI-MATCH (National Cancer Institute – Molecular Analysis for Therapy Choice) and Lung-MAP (Lung Cancer Master Protocol) study. We discuss three ethical requirements for (...) clinical trials which may be challenged in basket and umbrella trial designs. Firstly, we consider scientific validity. Thanks to the new trial designs, patients with rare malignancies have the opportunity to be enrolled and benefit from the trial, but due to insufficient accrual, the trial may generate clinically insignificant findings. Inadequate sample size in study arms and the use of surrogate endpoints may result in a drug approval without confirmed efficacy. Moreover, complexity, limited quality and availability of tumor samples may not only introduce bias and result in unreliable and unrepresentative findings, but also can potentially harm patients and assign them to an inappropriate therapy arm. Secondly, we refer to benefits and risks. Novel clinical trials can gain important knowledge on the variety of tumors, which can be used in future trials to develop effective therapies. However, they offer limited direct benefits to patients. All potential participants must wait about 2 weeks for the results of the genetic screening, which may be stressful and produce anxiety. The enrollment of patients whose tumors harbor multiple mutations in treatments matching a single mutation may be controversial. As to informed consent – the third requirement we discuss, the excessive use of phrases like “personalized medicine”, “tailored therapy” or “precision oncology” might be misleading and cause personal convictions that the study protocol is designed to fulfill the individual health-related needs of participants. We suggest that further approaches should be implemented to enhance scientific validity, reduce misunderstandings and risks, thus maximizing the benefits to society and to trial participants. (shrink)

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union and South-East European countries that are not members of the European Union. The most common ethical (...) issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trials were the least common ethical policies. Three aspects were significantly more common in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (shrink)

Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society (...) and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects. (shrink)

Occasional reports in the literature suggest that biological samples collected and stored for scientific research are sometimes accessed and used for a variety of forensic purposes. However, donors are almost never informed about this possibility. In this paper we argue that the possibility of forensic access may constitute a relevant consideration at least to some potential research subjects in deciding whether to participate in research. We make the suggestion that if some type of forensic access to research collections is likely (...) to be perceived by the subjects as a reason against donating their biological materials, there are good ethical reasons to make this type of access impossible or at least severely restricted. We also provide an ethical argument for the claim that, if a total ban on this type of forensic access cannot be achieved, potential research subjects should be informed about the extent to which this type of forensic access is possible. (shrink)

In recent literature, panpsychism has been defended by appeal to two main arguments: first, an argument from philosophy of mind, according to which panpsychism is the only view which successfully integrates consciousness into the physical world (Strawson 2006; Chalmers 2013); second, an argument from categorical properties, according to which panpsychism offers the only positive account of the categorical or intrinsic nature of physical reality (Seager 2006; Adams 2007; Alter and Nagasawa 2012). Historically, however, panpsychism has also been defended by appeal (...) to a third argument based on considerations about the nature and observability of causation. This argument has not been much discussed in recent times. Here is a concise version from William James: "… the concrete perceptual flux, taken just as it comes, offers in our own activity-situations perfectly comprehensible instances of causal agency … If we took these experiences as the type of what actual causation is, we should have to ascribe to cases of causation outside of our life, to physical cases also, an inwardly experiential nature. In other words, we should have to espouse a so-called “pan-psychic” philosophy" (James 1911: 218). James here suggests that we have direct experience of causation in our own agency. He thereby directly contradicts David Hume, who famously denied that we have any experience of causation. James goes on to claim that if this experience is representative of causation in general, it follows that all causation is mental, and that panpsychism is true. This kind of argument for panpsychism can be called the argument from (experience of) causation. This chapter offers, first, a history of this argument and arguments closely related to it, and second, an analysis of the argument – is it valid, are its premises in any way defensible, and how does it relate to the other, more popular arguments for panpsychism from philosophy of mind and categorical properties? (shrink)

On 17 July 2012, the European Commission formally adopted a proposal for a new European Union (EU) Directive regarding clinical trials, which will repeal and replace the existing Directive 2001/20/EC. The main reasons for the revision were: (1) the decreasing number of clinical trials in the region and (2) harsh criticism of the present version of the Directive. The proposed regulation could simplify the rules for conducting clinical trials and also rebuild the entire system of clinical trial assessment. However, it (...) seems that we probably have already lost our chance regarding the consistency and quality of functioning of research ethics committees in the EU. (shrink)

The author presents and defends three theses: (1) "the first is that it is not profitable for us at present to do moral philosophy; that should be laid aside at any rate until we have an adequate philosophy of psychology." (2) "the second is that the concepts of obligation, And duty... And of what is morally right and wrong, And of the moral sense of 'ought', Ought to be jettisoned if this is psychologically possible...." (3) "the third thesis is that (...) the differences between the well-Known english writers on moral philosophy from sidgwick to the present day are of little importance." (staff). (shrink)

The aim of this article is to present a critical overview of Jacques Derrida’s objections to the theories of phenomenological experience. I present and analyze Derrida’s principal arguments which show that the primordial character of such experiences is only apparent. I also try to sketch a possible line of defense and to undermine some of the interpretational presuppositions introduced by the author of La voix et le phénomène.

Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are (...) relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs. (shrink)

Epidemiological studies usually do not pose high risk to participants. At the same time they provide valuable knowledge and improve public and individual health. In many countries, studies involving human subjects are subject to ethics review. Research shows that the process of obtaining ethical approval from institutional research boards or research ethics committees is sometimes costly, time-consuming and seriously delays important research projects. In this article we consider arguments against and in favor of ethics review of epidemiological studies. On the (...) one hand, it seems that minimal risk epidemiological studies should not be a subject to ethics review, since any delay of an important study has its death toll and health costs. In this perspective, the calculus of costs and benefits supports rejecting the whole existing approach. Nevertheless, we argue that institutional research boards or ethics research committees protect research participants from wrongs and up till now are the best tools of social and political control over the research enterprise. (shrink)

This is the first comprehensive study of Nietzsche's earliest (and extraordinary) book, The Birth of Tragedy (1872). When he wrote it, Nietzsche was a Greek scholar, a friend and champion of Wagner, and a philosopher in the making. His book has been very influential and widely read, but has always posed great difficulties for readers because of the particular way Nietzsche brings his ancient and modern interests together. The proper appreciation of such a work requires access to ideas that cross (...) the boundaries of conventional specialisms. This is now provided by M. S. Silk and J. P. Stern in their joint study of Nietzsche's book. They examine in detail its content, style and form; its strange genesis and hybrid status; its biographical background and the controversy engendered by its publication; its value as an account of ancient Greek culture and as a theory of tragedy and music; its relation to other theories of tragedy; and its place in the history of German ideas and in Nietzsche's own philosophical career. (shrink)

Traditional Chinese commentators rightly see that understanding Zhuangzi's way with words is the presupposition for understanding Zhuangzi at all. They are not sure, however, if Zhuangzi's words are super-effective or pure nonsense. I consider Zhuangzi's experience with language, and then turn to Heidegger's word of being to see if it may throw light on Zhuangzi's way of saying. I argue that a conversation between Heidegger and Zhuangzi on language is possible, but only by expanding Heidegger's notion of Gestell and through (...) a destruction of the dominant Confucian discourse that obscures Zhuangzi's way of saying. (shrink)

Background. The COVID-19 pandemic necessitated drastic changes to undergraduate medical training at the University of Botswana (UB). To save the academic year when campus was locked down, the Department of Medical Education conducted a needs assessment to determine the readiness for emergency remote teaching (ERT) of the Faculty of Medicine, UB. Objectives. To report on the findings of needs assessment surveys to assess learner and teaching staff preparedness for fair and just ERT, as defined by philosopher John Rawls. Methods. Needs (...) assessment surveys were conducted using Office 365 Forms distributed via WhatsApp, targeting medical students and teaching staff during the 5 undergraduate years. Data were analysed quantitatively and qualitatively. Results. Ninety-two percent (266/289) of students and 73.5% (62/84) of teaching staff responded. Surveys revealed a high penetration of smartphones among students, but poor internet accessibility and affordability in homes. Some teaching staff also reported internet and device insufficiencies. Only WhatsApp was accessible to students and teaching staff. Conclusions. For equitable access to ERT in the future, the surveys revealed infrastructural improvement needs, including wider, stronger, affordable WiFi coverage within Botswana and enhanced digital infrastructures in educational institutions, with increased support for students. (shrink)

In this article I show that although biological and neuropsychological factors enable and constrain the construction of music, culture is implicated on every level at which we can indicate an emotion-music connection. Nevertheless, music encourages an affective sense of human affiliation and security, facilitating feelings of transcultural solidarity.

Drug repurposing is a strategy of identifying new potential uses for already existing drugs. Many researchers adopted this method to identify treatment or prevention during the COVID-19 pandemic. However, despite the considerable number of repurposed drugs that were evaluated, only some of them were labeled for new indications. In this article, we present the case of amantadine, a drug commonly used in neurology that attracted new attention during the COVID-19 outbreak. This example illustrates some of the ethical challenges associated with (...) the launch of clinical trials to evaluate already approved drugs. In our discussion, we follow the ethics framework for prioritization of COVID-19 clinical trials proposed by Michelle N Meyer and colleagues (2021). We focus on four criteria: social value, scientific validity, feasibility, and consolidation/collaboration. We claim that launching amantadine trials was ethically justified. Although the scientific value was anticipated to be low, unusually, the social value was expected to be high. This was because of significant social interest in the drug. In our view, this strongly supports the need for evidence to justify why the drug should not be prescribed or privately accessed by interested parties. Otherwise, a lack of evidence-based argument could enhance its uncontrolled use. With this paper, we join the discussion on the lessons learned from the pandemic. Our findings will help to improve future efforts to decide on the launch of clinical trials on approved drugs when dealing with the widespread off-label use of the drug. (shrink)