Correct interpretation of the data from integral laboratory tests, including Thrombin Generation Test, requires biochemistry-based mathematical models of blood coagulation. The purpose of this study is to describe the experimental TGT data from healthy donors and hemophilia A and B patients. We derive a simplified ODE model and apply it to analyze the TGT data from healthy donors and HA/HB patients with in vitro added tissue factor pathway inhibitor antibody. This model allows the characterization of hemophilia patients in the (...) space of three most important model parameters. The proposed approach may provide a new quantitative tool for the analysis of experimental TGT. Also, it gives a reduced model of coagulation verified against clinical data to be used in future theoretical large-scale modeling of thrombosis in flow. (shrink)

Approaches to the analysis of theory choice in science studies often focus either on objective criteria or subjective values for evaluating theories or on critical experiments for testing theories. In the present article a historical case study in the biomedical sciences is reconstructed, in which experimentation was performed to choose between two competing theories of blood coagulation. Analysis of this case study reveals that experimentation exhibits a particular structure, composed of design, execution, and results, and specific characteristics, consisting (...) of controllability, reproducibility, plasticity, and fecundity. Although this structure and these characteristics are not used to replace objective criteria or subjective values of theory evaluation or to define critical experiments, they are instrumental for analyzing and understanding theory choice. (shrink)

As the health care system transitions to a precision medicine approach that tailors clinical care to the genetic profile of the individual patient, there is a potential tension between the clinical uptake of new technologies by providers and the legal system's expectation of the standard of care in applying such technologies. We examine this tension by comparing the type of evidence that physicians and courts are likely to rely on in determining a duty to recommend pharmacogenetic testing of patients (...) prescribed the oral anti-coagulant drug warfarin. There is a large body of inconsistent evidence and factors for and against such testing, but physicians and courts are likely to weigh this evidence differently. The potential implications for medical malpractice risk are evaluated and discussed. (shrink)

Canada has recently published a new Clinical Practice Guideline on the diagnosis and management of brain death. It states that consent is not necessary to carry out the interventions required to make the diagnosis. A supporting article not only sets out the arguments for this but also contends that ‘UK laws similarly carve out an exception, excusing clinicians from a prima facie duty to get consent’. This is supplemented by the claim that recent court decisions in the UK similarly confirm (...) that consent is not required, referencing two judgements in _Battersbee_. We disagree with the authors’ interpretation of the law on consent in the UK and argue that there is nothing in _Battersbee_ to support the conclusion that consent to testing is not necessary. Where there is a disagreement about testing for brain death in the UK, court authorisation is required. (shrink)

We address the ethics of scenarios in which one party entraps, intentionally tempts or intentionally tests the virtue of another. We classify, in a new manner, three distinct types of acts that are of concern, namely acts of entrapment, of intentional temptation and of virtue testing. Our classification is, for each kind of scenario, of itself neutral concerning the question whether the agent acts permissibly. We explain why acts of entrapment are more ethically objectionable than like acts of intentional (...) temptation and why these, in turn, are more ethically objectionable than like acts of virtue testing. Along the way, we scrutinize, and eventually reject, the view that acts of entrapment are ethically unacceptable because intentional temptation is involved in entrapment. (shrink)

The scope of noninvasive prenatal testing (NIPT) could expand in the future to include detailed analysis of the fetal genome. This will allow for the testing for virtually any trait with a genetic contribution, including “non-medical” traits. Here we discuss the potential use of NIPT for these traits. We outline a scenario which highlights possible inconsistencies with ethical decision-making. We then discuss the case against permitting these uses. The objections include practical problems; increasing inequities; increasing the burden of (...) choice; negative impacts on the child, family, and society; and issues with implementation. We then outline the case for permitting the use of NIPT for these traits. These include arguments for reproductive liberty and autonomy; questioning the labeling of traits as “non-medical”; and the principle of procreative beneficence. This summary of the case for and against can serve as a basis for the development of a consistent and coherent ethical framework. (shrink)

Prenatal genetic testing is becoming available for an increasingly broad set of diseases, and it is only a matter of time before parents can choose to test for hundreds, if not thousands, of genetic conditions in their fetuses. Should access to certain kinds of fetal genetic information be limited, and if so, on what basis? We evaluate a range of considerations including reproductive autonomy, parental rights, disability rights, and the rights and interests of the fetus as a potential future (...) child. We conclude that parents should be able to access information that could be useful during pregnancy, but that testing for non-medical information should be limited. Next, we argue that the government lacks a compelling state interest in regulating prenatal genetic testing and propose that regulation should occur through medical professional organizations. Finally, we present a framework for determining what testing physicians should recommend, offer neutrally, or not offer at all. (shrink)

Because physical theories typically predict numerical values, an improvement in experimental precision reduces the tolerance range and hence increases corroborability. In most psychological research, improved power of a statistical design leads to a prior probability approaching 1/2 of finding a significant difference in the theoretically predicted direction. Hence the corroboration yielded by "success" is very weak, and becomes weaker with increased precision. "Statistical significance" plays a logical role in psychology precisely the reverse of its role in physics. This problem is (...) worsened by certain unhealthy tendencies prevalent among psychologists, such as a premium placed on experimental "cuteness" and a free reliance upon ad hoc explanations to avoid refutation. (shrink)

Empowerment, an already central concept in public health, has gained additional relevance through the expansion of mobile health (mHealth). Especially direct-to-consumer self-testing app companies mobilise the term to advertise their products, which allow users to self-test for various medical conditions independent of healthcare professionals. This article first demonstrates the absence of empowerment conceptualisations in the context of self-testing apps by engaging with empowerment literature. It then contrasts the service these apps provide with two widely cited empowerment definitions by (...) the WHO, which describe the term as a process that, broadly, leads to knowledge and control of health decisions. We conclude that self-testing apps can only partly empower their users, as they, we argue, do not provide the type of knowledge and control the WHO definitions describe. More importantly, we observe that this shortcoming stems from the fact that in the literature on mHealth and in self-testing marketing, empowerment is understood as a goal rather than a process. This characterises a shift in the meaning of empowerment in the context of self-testing and mHealth, one that reveals a lack of awareness for relational and contextual factors that contribute to empowerment. We argue that returning to a process-understanding of empowerment helps to identify these apps’ deficits, and we conclude the article by briefly suggesting several strategies to increase self-testing apps’ empowerment function. (shrink)

The development of new methods in the field of prenatal testing leads to an expansion of information that needs to be provided to expectant mothers. The aim of this research is to explore opinions and attitudes of gynecologists in Germany, Poland and Russia towards access to prenatal testing and diagnostics in these countries. Semi-structured interviews were conducted with n = 18 gynecologists in Germany, Poland and Russia. The interviews were analyzed using the methods of content analysis and thematic (...) analysis. Visible in all three countries is a connection of prenatal medicine with the politically and socially contentious issue of pregnancy termination. Respondents in Poland and Russia concentrated on the topic of inadequate resources. Quality of information for expectant mothers is an important point in all three countries. Only in Germany was the issue of language barriers in communication raised. With regard to non-invasive prenatal testing (NIPT) respondents in Germany focused on the ethical issues of routinization of testing; in Poland and Russia they concentrated on fair access to NIPT. Challenges in all three countries arise from structural factors such as imprecise and prohibitive regulations, lack of resources or organization of healthcare services. These should be addressed on a political and medico-ethical level. (shrink)

In recent years, the genetic testing and selection of IVF embryos, known as preimplantation genetic testing (PGT), has gained much traction in clinical assisted reproduction for preventing transmission of genetic defects. However, a more recent ethically and morally controversial development in PGT is its possible use in selecting IVF embryos for optimal intelligence quotient (IQ) and other non–disease-related socially desirable traits, such as tallness, fair complexion, athletic ability, and eye and hair colour, based on polygenic risk scores (PRS), (...) in what is referred to as PGT-P. Artificial intelligence (AI) and machine learning–based analysis of big data sets collated from genome sequencing of specific human ethnic populations can be used to estimate an individual embryo’s likelihood of developing such multifactorial traits by analysing the combination of specific genetic variants within its genome. Superficially, this technique appears compliant with Islamic principles and ethics. Because there is no modification of the human genome, there is no tampering with Allah’s creation (taghyīr khalq Allah). Nevertheless, a more critical analysis based on the five maxims of Islamic jurisprudence (qawa'id fiqhiyyah) that are often utilized in discourses on Islamic bioethics, namely qaṣd (intention), yaqın̄ (certainty), ḍarar (injury), ḍarūra (necessity), and `urf (custom), would instead reveal some major ethical and moral flaws of this new medical technology in the selection of non–disease-related socially desirable traits, and its non-compliance with the spirit and essence of Islamic law (shariah). Muslim scholars, jurists, doctors, and biomedical scientists should debate this further and issue a fatwa on this new medical technology platform. (shrink)

Sripada has recently advanced a new account for asymmetries that have been uncovered in folk judgments of intentionality: the ?Deep Self model,? according to which an action is more likely to be judged as intentional if it matches the agent's central and stable attitudes and values (i.e., the agent's Deep Self). In this paper, we present new experiments that challenge this model in two ways: first, we show that the Deep Self model makes predictions that are falsified, then we present (...) cases that it cannot account for. Finally, we discuss how the Deep Self model could be modified to accommodate these new data. (shrink)

Rich with historical and cultural value, these works are published unaltered from the original University of Minnesota Press editions.

In the past, hypothesis testing in medicine has employed the paradigm of the repeatable experiment. In statistical hypothesis testing, an unbiased sample is drawn from a larger source population, and a calculated statistic is compared to a preassigned critical region, on the assumption that the comparison could be repeated an indefinite number of times. However, repeated experiments often cannot be performed on human beings, due to ethical or economic constraints. We describe a new paradigm for hypothesis testing (...) which uses only rearrangements of data present within the observed data set. The token swap test, based on this new paradigm, is applied to three data sets from cardiovascular pathology, and computational experiments suggest that the token swap test satisfies the Neyman Pearson condition. (shrink)

Unfounded—conspiracy and health—beliefs about COVID-19 have accompanied the pandemic worldwide. Here, we examined cross-nationally the structure and correlates of these beliefs with an 8-item scale, using a multigroup confirmatory factor analysis. We obtained a two-factor model of unfounded (conspiracy and health) beliefs with good internal structure (average CFI = 0.98, RMSEA = 0.05, SRMR = 0.04), but a high correlation between the two factors (average latent factor correlation = 0.57). This model was replicable across 50 countries (total N = 13,579), (...) as evidenced by metric invariance between countries (CFI = 0.96, RMSEA = 0.06, SRMS = 0.07) as well as scalar invariance across genders (CFI = 0.98, RMSEA = 0.04, SRMS = 0.03) and educational levels (CFI = 0.98, RMSEA = 0.04, SRMS = 0.03). Also, lower levels of education, more fear of COVID-19, and more cynicism were weakly associated with stronger conspiracy and health beliefs. The study contributes to knowledge about the structure of unfounded beliefs, and reveals the potential relevance of affective (i.e., fear of COVID-19) and cognitive (i.e., cynicism) factors along with demographics, in endorsing such beliefs. In summary, we obtained cross-cultural evidence for the distinctiveness of unfounded conspiracy and health beliefs about COVID-19 in terms of their structure and correlates. (shrink)

Two first-order logic theories are definitionally equivalent if and only if there is a bijection between their model classes that preserves isomorphisms and ultraproducts (Theorem 2). This is a variant of a prior theorem of van Benthem and Pearce. In Example 2, uncountably many pairs of definitionally inequivalent theories are given such that their model categories are concretely isomorphic via bijections that preserve ultraproducts in the model categories up to isomorphism. Based on these results, we settle several conjectures of Barrett, (...) Glymour and Halvorson. (shrink)

Starting from the ‘Dewey Lectures’, Rawls presents his conception of justice within a contextualist framework, as an elaboration of the basic ideas embedded in the political culture of liberal-democratic societies. But how are these basic ideas to be justified? In this article, I reconstruct and criticize Rawls’s strategy to answer this question. I explore an alternative strategy, consisting of a genealogical argument of a pragmatic kind – the kind of argument provided by authors like Bernard Williams, Edward Craig and Miranda (...) Fricker. I outline this genealogical argument drawing on Rawls’s reconstruction of the origins of liberalism. Then, I clarify the conditions under which this kind of argument maintains vindicatory power. I claim that the argument satisfies these conditions and that pragmatic genealogy can thus partially vindicate the basic ideas of liberal-democratic societies. (shrink)

Abstract: In a previous article in this journal, Daniel Kelly, Stephen Stich, Kevin Haley, Serena Eng and Daniel Fessler report data that, according to them, foster scepticism about an association between harm and morality existent in the Turiel tradition ( Kelly et al. , 2007 ). This article challenges their interpretation of the data. It does so by explicating some methodological problems in the Turiel tradition that Kelly et al. themselves in a way inherit and by drawing on new evidence (...) coming from a partial replication of their research. (shrink)

Background Over the last decades, the neurosciences, behavioral sciences, and the social sciences have all seen a rapid development of innovative research methods. The field of bioethics, however, has trailed behind in methodological innovation. Despite the so-called “empirical turn” in bioethics, research methodology for project development, data collection and analysis, and dissemination has remained largely restricted to surveys, interviews, and research papers. We have previously argued for a “Design Bioethics” approach to empirical bioethics methodology, which develops purpose-built methods for investigation (...) of bioethical concerns. In this paper we compare a research tool created using a design bioethics approach to a “methods-as-usual” approach in empirical bioethics. Methods Our study compared dimensions of engagement with a digital game we created, called “Tracing Tomorrow,” to a standard vignette survey. The two tools investigated the same subject matter, digital phenotyping for mental health, in a sample of 301 UK adolescents. Results Participants who played the game reported a greater sense of presence, emotional engagement, cognitive absorption, and mental health ethics insight, compared to participants who completed the vignette survey. Perceived authenticity and curiosity/motivation to learn more was equivalent for both methods. Conclusion The results of this study highlights the importance of purpose-built methodology for empirical bioethics research. (shrink)

Checklists have been used to improve quality in many industries, including healthcare. The use of checklists, however, has not been extensively evaluated in clinical ethics consultation. This article seeks to fill this gap by exploring the efficacy of using a checklist in ethics consultation, as tested by an empirical investigation of the use of the checklist at a large academic medical system (Cleveland Clinic). The specific aims of this project are as follows: (1) to improve the quality of ethics consultations (...) by providing reminders to ethics consultants about process steps that are important for most patient-centered ethics consultations, (2) to create consistency in the ethics consultation process across the medical system, and (3) to establish an effective educational tool for trainers and trainees in clinical ethics consultation. The checklist was developed after a thorough literature review and an iterative process of revising and testing by a group of experienced ethics consultants. To pilot test the checklist, it was distributed to 46 ethics consultants. After a six-month pilot period in which ethics professionals used the checklist during their clinical activities, a survey was distributed to all of those who used the checklist. The 10-item survey examined consultants’ perceptions regarding the three aims listed above. Of the 25 survey respondents, 11 self-reported as experts in ethics consultation, nine perceived themselves to have mid-level expertise, and five self-reported as novices. The majority (68 percent) of all respondents, regardless of expertise, believed that the checklist could be a “helpful” or “very helpful” tool in the consultation process generally. Novices were more likely than experts to believe that the checklist would be useful in conducting consultations. The limitations of this study include: reduced generalizability given that this project was conducted at one medical system, utilized a small sample size, and used self-reported quality outcome measures. Despite these limitations, to the authors’ knowledge this is the first investigatation of the use of a checklist systematically to improve quality in ethics consultation. Importantly, our findings shed light on ways this checklist can be used to improve ethics consultation, including its use as an educational tool. The authors hope to test the checklist with consultants in other healthcare systems to explore its usefulness in different healthcare environments. (shrink)

Two main types of philosophical arguments have been given in support of the claim that the citizens of affluent societies have stringent moral duties to aid the global poor: “positive duty” arguments based on the notion of beneficence and “negative duty” arguments based on noninterference. Peter Singer’s positive duty argument (Singer 1972) and Thomas Pogge’s negative duty argument (Pogge 2002) are among the most prominent examples. Philosophers have made speculative claims about the relative effectiveness of these arguments in promoting attitudes (...) and behaviors that could lead to the alleviation of poverty. In this article we present the results of two empirical studies that evaluate these claims, and suggest that both arguments have a modest effect on people’s attitudes and behaviors regarding global poverty. In a replication of the second study, the negative duty argument, in particular, had a statistically significant effect on donations. We discuss the theoretical and practical significance of these results and suggest directions for further research on the role that philosophical arguments can play in engendering concern and action on pressing moral problems. (shrink)

Background Noninvasive prenatal testing (NIPT) designed to screen for fetal genetic conditions, is increasingly being implemented as a part of routine prenatal care screening in the United States (US). However, these advances in reproductive genetic technology necessitate empirical research on the ethical and social implications of NIPT among populations underrepresented in genetic research, particularly Black women with sickle cell disease (SCD).Methods Forty (N = 40) semi-structured interviews were conducted virtually with Black women in the US (19 participants with SCD; (...) 21 participants without SCD) from June 2021 to January 2022. We employed a qualitative approach to examine the study participants’ perceptions of the potential advancement of NIPT for screening SCD in the fetus. Data were analyzed using NVivo 12 qualitative software.Results The themes revealed the complexities involving the intersectional lived experiences of SCD, prenatal care, lack of synergy among health providers, and NIPT decision-making. The results further revealed that even when Black women have shared commonalities in their lived experiences while navigating SCD and motherhood, their perceptions of NIPT screening technologies are divergent.Conclusion Expanding the ethical discourse on the social implications of NIPT is critical to fully elucidate how Black women perceive NIPT’s utility, particularly as NIPT advances to screen for SCD in the fetus. Neglecting to include Black women with genetic conditions in empirical studies on NIPT may contribute to ongoing health inequities and limit and constrain reproductive choices among Black women with and without SCD. (shrink)