_The dynamic development of medical technologies, i.e. the use of medicinal products and medical procedures, requires reflection on the ways to ensure the safety of patients and people using such methods of treatment (medical professionals) in legal and ethical terms. This applies in particular to the currently observed influence of the media on the actions taken in the health care system in Poland as well as individual decisions of patients on the use of the offered drugs and other medical (...) procedures._ _The article presents selected legal provisions defining the conditions for the use of medicinal products (drugs) and experimental medical procedures. The basic element of the considerations is to indicate the legal conditions for this type of use of medical technologies understood in this way, also in a broader context – with the characteristics of ethical conditions for „the media message”, including ensuring its proper quality for the protection of public health._. (shrink)

Polish medical law does not explicitly regulate the possibility of off-label use of medicines. Such procedures therefore raise doubts in medical practice, where medicines are often prescribed beyond the Characteristic of Medicinal Product. This phenomenon particularly affects the treatment of children, as there is a lack of registered medicines in this age group, but they are registered for use in adults. Since such treatment goes beyond the scope of registration, a dilemma arises as to whether it is permissible (...) and, if so, under what conditions and whether sanctions are imposed on the medical professional using the off-label medicine. These issues are addressed in an article by Dr Maria Gutowska-Ibbs, entitled 'Off label - practical consequences of unclear legislation". The present study complements these considerations and is in part an ad vocem statement. The article attempts to differentiate between the use of off-label medicines and medical experiments, following the criterion of the purpose for which a given medical action is performed. The limits of admissibility of such actions under criminal law are also discussed in more detail. Off-label treatment is considered through the prism of the required precautionary rules, compliance with which is the antithesis of inadvertence. It is assumed that if the drug was administered in accordance with current medical knowledge and the treatment is adequate to the patient's condition, there is no violation of these rules, which excludes the imputation of inadvertence. An extensive section of the study is devoted to the issue of the patient's consent to treatment outside the indications. Above all, it emphasises the need to explain in detail to the patient the circumstances of prescribing such a drug and, on this basis, to obtain informed consent. It also stresses the importance of the written form of consent, which can have a significant evidentiary impact in potential litigation. (shrink)

Inflammation is said to be a healthy component of the body's immune system's reaction. Inflammation is characterised by four key symptoms: pain, redness, heat or warmth and swelling. As secondary metabolites, plants may produce a wide range of phytochemical compounds, which possess anti-inflammatory characteristics. Herbal remedies are important therapies for a wide range of ailments all over the world. There are around 7,500 species of medicinal plants, including representatives from over 17,000 flowering plant species. Even though synthetic chemistry (...) has developed its expectations, the use of natural ingredients in the manufacture of drugs used in contemporary medicine is unparalleled. By interfering with the biology of inflammation, anti-inflammatory medications may assist to minimising tissue damage and increase patient comfort. Because of the bulky figure of species reachable for study, the effective development of novel naturally taking place anti-inflammatory drugs is mostly dependent on a multidisciplinary approach to discovering new chemicals. Despite the statistic that many review papers have been produced in this field, the conventional of them simply examined the issue from an area perspective. Several non-steroidal anti-inflammatory drugs have been shown to reduce inflammation and pain by decreasing the isoform of the cyclooxygenase enzyme's digestion of arachidonic acid, hence lowering prostaglandin production. Non-steroidal anti-inflammatory drugs have a host of harmful effects. There are, however, medicinal herbs with anti-inflammatory pharmacological properties that have few or no negative effects. (shrink)

ABSTRACT I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments. INTRODUCTION In contrast to the classic model of randomized-control trials, often with a large number of (...) subjects enrolled, precision medicine attempts to optimize therapeutic outcomes by focusing on the individual.[i] A recent publication highlights the strengths and weakness of both traditional evidence-based medicine and precision medicine.[ii] Plus, it outlines a tension in the shift from evidence-based medicine’s inductive reasoning style (the collection of data to postulate general theories) to precision medicine’s abductive reasoning style (the generation of an idea from the limited data available).[iii] The paper’s main example is the application of precision medicine for the treatment of cancer.[iv] I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. As the name suggests, brain-computer interfaces are a significant advancement in neurotechnology that directly connects someone’s brain to external or implanted devices.[v] Among the various kinds of brain-computer interfaces, adaptive deep brain stimulation devices require numerous personalized adjustments to their settings during the implantation and computation stages in order to provide adequate relief to patients with treatment-resistant disorders. What makes these devices unique is how adaptive deep brain stimulation integrates a sensory component to initiate the stimulation. While not commonly at the level of sophistication as self-supervising or generative large language models,[vi] they currently allow for a semi-autonomous form of neuromodulation. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments.[vii] ANALYSIS I. The State of Precision Medicine in Oncology and the Epistemological Shift While a thorough overview of precision medicine for the treatment of cancer is beyond the scope of this article, its practice can be roughly summarized as identifying clinically significant characteristics a patient possesses (e.g., genetic traits) to land on a specialized treatment option that, theoretically, should benefit the patient the most.[viii] However, in such a practice of stratification patients fall into smaller and smaller populations and the quality of evidence that can be applied to anyone outside these decreases in turn.[ix] As inductive logic helps to articulate, the greater the number of patients that respond to a particular therapy the higher the probability of its efficacy. By straying from this logical framework, precision medicine opens the treatment of cancer to more uncertainty about the validity of these approaches to the resulting disease subcategories.[x] Thus, while contemporary medical practices explicitly describe some treatments as “personalized”, they ought not be viewed as inherently better founded than other therapies.[xi] A relevant contemporary case of precision medicine out of Norway focuses on the care of a patient with cancer between the ventricles of the heart and esophagus, which had failed to respond to the standard regimen of therapies over four years.[xii] In a last-ditch effort, the patient elected to pay out-of-pocket for an experimental immunotherapy (nivolumab) at a private hospital. He experienced marked improvements and a reduction in the size of the tumor. Understandably, the patient tried to pursue further rounds of nivolumab at a public hospital. However, the hospital initially declined to pay for it given the “lack of evidence from randomised clinical trials for this drug relating to this [patient’s] condition.”[xiii] In rebuttal to this claim, the patient countered that he was actually similar to a subpopulation of patients who responded in “open‐label, single arm, phase 2 studies on another immune therapy drug” (pembrolizumab).[xiv] Given this interpretation of the prior studies and the patient’s response, further rounds of nivolumab were approved. Had the patient not had improvements in the tumor’s size following a round of nivolumab, then pembrolizumab’s prior empirical evidence in isolation would have been insufficient, inductively speaking, to justify his continued use of nivolumab.[xv] The case demonstrates a shift in reasoning from the traditional induction to abduction. The phenomenon of ‘cancer improvement’ is considered causally linked to nivolumab and its underlying physiological mechanisms.[xvi] However, “the weakness of abductions is that there may always be some other better, unknown explanation for an effect. The patient may for example belong to a special subgroup that spontaneously improves, or the change may be a placebo effect. This does not mean, however, that abductive inferences cannot be strong or reasonable, in the sense that they can make a conclusion probable.”[xvii] To demonstrate the limitations of relying on the abductive standard in isolation, commentators have pointed out that side effects in precision medicine are hard to rule out as being related to the initial intervention itself unless trends from a group of patients are taken into consideration.[xviii] As artificial intelligence (AI) assists the development of precision medicine for oncology, this uncertainty ought to be taken into consideration. The implementation of AI has been crucial to the development of precision medicine by providing a way to combine large patient datasets or a single patient with a large number of unique variables with machine learning to recommend matches based on statistics and probability of success upon which practitioners can base medical recommendations.[xix] The AI is usually not establishing a causal relationship[xx] – it is predicting. So, as AI bleeds into medical devices, like brain-computer interfaces, the same cautions about using abductive reasoning alone should be carried over. II. Responsive Neurostimulation, AI, and Personalized Medicine Like precision medicine in cancer treatment, computer-brain interface technology similarly focuses on the individual patient through personalized settings. In order to properly expose the intersection of AI, precision medicine, abductive reasoning, and implantable neurotechnologies, the descriptions of adaptive deep brain stimulation systems need to deepen.[xxi] As a broad summary of adaptive deep brain stimulation, to provide a patient with the therapeutic stimulation, a neural signal, typically referred to as a local field potential,[xxii] must first be detected and then interpreted by the device. The main adaptive deep brain stimulation device with premarket approval, the NeuroPace Responsive Neurostimulation system, is used to treat epilepsy by detecting and storing “programmer-defined phenomena.”[xxiii] Providers can optimize the detection settings of the device to align with the patient’s unique electrographic seizures as well as personalize the reacting stimulation’s parameters.[xxiv] The provider adjusts the technology based on trial and error. One day machine learning algorithms will be able to regularly aid this process in myriad ways, such as by identifying the specific stimulation settings a patient may respond to ahead of time based on their electrophysiological signatures.[xxv] Either way, with AI or programmers, adaptive neurostimulation technologies are individualized and therefore operate in line with precision medicine rather than standard treatments based on large clinical trials. Contemporary neurostimulation devices are not usually sophisticated enough to be prominent in AI discussions where the topics of neural networks, deep learning, generative models, and self-attention dominate the conversation. However, implantable high-density electrocorticography arrays (a much more sensitive version than adaptive deep brain stimulation systems use) have been used in combination with neural networks to help patients with neurologic deficits from a prior stroke “speak” through a virtual avatar.[xxvi] In some experimental situations, algorithms are optimizing stimulation parameters with increasing levels of independence.[xxvii] An example of neurostimulation that is analogous to the use of nivolumab in Norway surrounds a patient in the United States who was experiencing both treatment-resistant OCD and temporal lobe epilepsy.[xxviii]Given the refractory nature of her epilepsy, implantation of an adaptive deep brain stimulation system was indicated. As a form of experimental therapy, her treatment-resistant OCD was also indicated for the off-label use of an adaptive deep brain stimulation set-up. Another deep brain stimulation lead, other than the one implanted for epilepsy, was placed in the patient’s right nucleus accumbens and ventral pallidum region given the correlation these nuclei had with OCD symptoms in prior research. Following this, the patient underwent “1) ambulatory, patient-initiated magnet-swipe storage of data during moments of obsessive thoughts; (2) lab-based, naturalistic provocation of OCD-related distress (naturalistic provocation task); and (3) lab-based, VR [virtual reality] provocation of OCD-related distress (VR provocation task).”[xxix] Such signals were used to identify when to deliver the therapeutic stimulation in order to counter the OCD symptoms. Thankfully, following the procedure and calibration the patient exhibited marked improvements in their OCD symptoms and recently shared her results publicly.[xxx] In both cases, there is a similar level of abductive justification for the efficacy of the delivered therapy. In the case study in which the patient was treated with adaptive deep brain stimulation, they at least had their neural activity tested in various settings to determine the optimum parameters for treatment to avoid them being based on guesswork. Additionally, the adaptive deep brain stimulation lead was already placed before the calibration trials were conducted, meaning that the patient had already taken on the bulk of the procedural risk before the efficacy could be determined. Such an efficacy test could have been replicated in the first patient’s cancer treatment, had it been biopsied and tested against the remaining immunotherapies in vitro. Yet, in the case of cancer with few options, one previous dose of a drug that appeared to work on the patient may justify further doses. However, as the Norwegian case presents, corroboration with known responses to a similar drug (from a clinical trial) could be helpful to validate the treatment strategy. (It should be noted that both patients were resigned to these last resort options regardless of the efficacy of treatment.) There are some elements of inductive logic seen with adaptive deep brain stimulation research in general. For example, abductively the focus could be that patient X’s stimulation parameters are different from patient Y’s and patient Z’s. In contrast, when grouped as subjects who obtained personalized stimulation, patients X, Y, and Z demonstrate an inductive aspect to this approach’s safety and/or efficacy. The OCD case holds plenty of abductive characteristics in line with precision medicine’s approach to treating cancer and as more individuals try the method, there will be additional data. With the gradual integration of AI into brain-computer interfaces in the name of efficacy, this reliance on abduction will continue, if not grow, over time. Moving forward, if a responsive deep brain stimulation treatment is novel and individualized (like the dose of nivolumab) and there is some other suggestion of efficacy (like clinical similarities to other patients in the literature), then it may justify insurance coverage for the investigative intervention, absent other unrelated reasons to deny it. III. Ethical Implications and Next Steps While AI’s use in oncology and neurology is not yet as prominent as its use in other fields (e.g., radiology), it appears to be on the horizon for both.[xxxi] AI can be found in both the functioning of the neurotechnologies as well as the implementation of precision medicine. The increasing use of AI may serve to further individualize both oncologic and neurological therapies. Given these implications and the handful of publications cited in this article, it is important to have a nuanced evaluation of how these treatments, which heavily rely on abductive justification, ought to be managed. The just use an abductive approach may be difficult as AI infused precision medicine is further pursued. At baseline, such technology relies on a level of advanced technology literacy among the general public and could exclude populations who lack access to basic technological infrastructure or know-how from participation.[xxxii] Even among nations with adequate infrastructure, as more patients seek out implantable neurotechnologies, which require robust healthcare resources, the market will favor patient populations that can afford this complex care.[xxxiii] If patients already have the means to pay for an initial dose/use of a precision medicine product out of pocket, should insurance providers be required to cover subsequent treatments?[xxxiv] That is, if a first dose of a cancer drug or a deep brain stimulator over its initial battery life is successful, patients may feel justified in having the costs of further treatments covered. The Norwegian patient’s experience implies there is a precedent for the idea that some public insurance companies ought to cover successful cancer therapies, however, insurance companies may not all see themselves as obligated to cover neurotechnologies that rely on personalized settings or that are based on precision/abductive research more than on clinical trials. CONCLUSION The fact that the cases outlined above rely on abductive style of reasoning implies that there may not be as strong a justification for coverage by insurance, as they are both experimental and individualized, when compared to the more traditional large clinical trials in which groups have the same or a standardized protocol (settings/doses). If a study is examining the efficacy of a treatment with a large cohort of patients or with different experimental groups/phases, insurance companies may conclude that the resulting symptom improvements are more likely to be coming from the devices themselves. A preference for inductive justification may take priority when ruling in favor of funding someone’s continued use of an implantable neurostimulator. There are further nuances to this discussion surrounding the classifications of these interventions as research versus clinical care that warrant future exploration, since such a distinction is more of a scale[xxxv] than binary and could have significant impacts on the “right-to-try” approach to experimental therapies in the United States.[xxxvi] Namely, given the inherent limitations of conducting large cohort trials for deep brain stimulation interventions on patients with neuropsychiatric disorders, surgically innovative frameworks that blend abductive and inductive methodologies, like with sham stimulation phases, have traditionally been used.[xxxvii] Similarly, for adaptive brain-computer interface systems, if there are no large clinical trials and instead only publications that demonstrate that something similar worked for someone else, then, in addition to the evidence that the first treatment/dose worked for the patient in question, the balance of reasoning would be valid and arguably justify insurance coverage. As precision approaches to neurotechnology become more common, frameworks for evaluating efficacy will be crucial both for insurance coverage and for clinical decision making. ACKNOWLEDGEMENT This article was originally written as an assignment for Dr. Francis Shen’s “Bioethics & AI” course at Harvard’s Center for Bioethics. I would like to thank Dr. Shen for his comments as well as my colleagues in the Lázaro-Muñoz Lab for their feedback. - [i] Jonathan Kimmelman and Ian Tannock, “The Paradox of Precision Medicine,” Nature Reviews. Clinical Oncology 15, no. 6 (June 2018): 341–42, https://doi.org/10.1038/s41571-018-0016-0. [ii] Henrik Vogt and Bjørn Hofmann, “How Precision Medicine Changes Medical Epistemology: A Formative Case from Norway,” Journal of Evaluation in Clinical Practice 28, no. 6 (December 2022): 1205–12, https://doi.org/10.1111/jep.13649. [iii] David Barrett and Ahtisham Younas, “Induction, Deduction and Abduction,” Evidence-Based Nursing 27, no. 1 (January 1, 2024): 6–7, https://doi.org/10.1136/ebnurs-2023-103873. [iv] Vogt and Hofmann, “How Precision Medicine Changes Medical Epistemology,” 1208. [v] Wireko Andrew Awuah et al., “Bridging Minds and Machines: The Recent Advances of Brain-Computer Interfaces in Neurological and Neurosurgical Applications,” World Neurosurgery, May 22, 2024, S1878-8750(24)00867-2, https://doi.org/10.1016/j.wneu.2024.05.104. [vi] Mark Riedl, “A Very Gentle Introduction to Large Language Models without the Hype,” Medium (blog), May 25, 2023, https://mark-riedl.medium.com/a-very-gentle-introduction-to-large-language-models-without-the-hype-5 f67941fa59e. [vii] David E. Burdette and Barbara E. Swartz, “Chapter 4 - Responsive Neurostimulation,” in Neurostimulation for Epilepsy, ed. Vikram R. Rao (Academic Press, 2023), 97–132, https://doi.org/10.1016/B978-0-323-91702-5.00002-5. [viii] Kimmelman and Tannock, 2018. [ix] Kimmelman and Tannock, 2018. [x] Simon Lohse, “Mapping Uncertainty in Precision Medicine: A Systematic Scoping Review,” Journal of Evaluation in Clinical Practice 29, no. 3 (April 2023): 554–64, https://doi.org/10.1111/jep.13789. [xi] Kimmelman and Tannock, “The Paradox of Precision Medicine.” [xii] Vogt and Hofmann, 1206. [xiii] Vogt and Hofmann, 1206. [xiv] Vogt and Hofmann, 1206. [xv] Vogt and Hofmann, 1207. [xvi] Vogt and Hofmann, 1207. [xvii] Vogt and Hofmann, 1207. [xviii] Vogt and Hofmann, 1210. [xix] Mehar Sahu et al., “Chapter Three - Artificial Intelligence and Machine Learning in Precision Medicine: A Paradigm Shift in Big Data Analysis,” in Progress in Molecular Biology and Translational Science, ed. David B. Teplow, vol. 190, 1 vols., Precision Medicine (Academic Press, 2022), 57–100, https://doi.org/10.1016/bs.pmbts.2022.03.002. [xx] Stefan Feuerriegel et al., “Causal Machine Learning for Predicting Treatment Outcomes,” Nature Medicine 30, no. 4 (April 2024): 958–68, https://doi.org/10.1038/s41591-024-02902-1. [xxi] Sunderland Baker et al., “Ethical Considerations in Closed Loop Deep Brain Stimulation,” Deep Brain Stimulation 3 (October 1, 2023): 8–15, https://doi.org/10.1016/j.jdbs.2023.11.001. [xxii] David Haslacher et al., “AI for Brain-Computer Interfaces,” 2024, 7, https://doi.org/10.1016/bs.dnb.2024.02.003. [xxiii] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 103–4; “Premarket Approval (PMA),” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100026. [xxiv] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 104. [xxv] Burdette and Swartz, 126. [xxvi] Sean L. Metzger et al., “A High-Performance Neuroprosthesis for Speech Decoding and Avatar Control,” Nature 620, no. 7976 (August 2023): 1037–46, https://doi.org/10.1038/s41586-023-06443-4. [xxvii] Hao Fang and Yuxiao Yang, “Predictive Neuromodulation of Cingulo-Frontal Neural Dynamics in Major Depressive Disorder Using a Brain-Computer Interface System: A Simulation Study,” Frontiers in Computational Neuroscience 17 (March 6, 2023), https://doi.org/10.3389/fncom.2023.1119685; Mahsa Malekmohammadi et al., “Kinematic Adaptive Deep Brain Stimulation for Resting Tremor in Parkinson’s Disease,” Movement Disorders 31, no. 3 (2016): 426–28, https://doi.org/10.1002/mds.26482. [xxviii] Young-Hoon Nho et al., “Responsive Deep Brain Stimulation Guided by Ventral Striatal Electrophysiology of Obsession Durably Ameliorates Compulsion,” Neuron 0, no. 0 (October 20, 2023), https://doi.org/10.1016/j.neuron.2023.09.034. [xxix] Nho et al. [xxx] Nho et al.; Erik Robinson, “Brain Implant at OHSU Successfully Controls Both Seizures and OCD,” OHSU News, accessed March 3, 2024, https://news.ohsu.edu/2023/10/25/brain-implant-at-ohsu-successfully-controls-both-seizures-and-ocd. [xxxi] Awuah et al., “Bridging Minds and Machines”; Haslacher et al., “AI for Brain-Computer Interfaces.” [xxxii] Awuah et al., “Bridging Minds and Machines.” [xxxiii] Sara Green, Barbara Prainsack, and Maya Sabatello, “The Roots of (in)Equity in Precision Medicine: Gaps in the Discourse,” Personalized Medicine 21, no. 1 (January 2024): 5–9, https://doi.org/10.2217/pme-2023-0097. [xxxiv] Green, Prainsack, and Sabatello, 7. [xxxv] Robyn Bluhm and Kirstin Borgerson, “An Epistemic Argument for Research-Practice Integration in Medicine,” The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 43, no. 4 (July 9, 2018): 469–84, https://doi.org/10.1093/jmp/jhy009. [xxxvi] Vijay Mahant, “‘Right-to-Try’ Experimental Drugs: An Overview,” Journal of Translational Medicine 18 (June 23, 2020): 253, https://doi.org/10.1186/s12967-020-02427-4. [xxxvii] Michael S. Okun et al., “Deep Brain Stimulation in the Internal Capsule and Nucleus Accumbens Region: Responses Observed during Active and Sham Programming,” Journal of Neurology, Neurosurgery & Psychiatry 78, no. 3 (March 1, 2007): 310–14, https://doi.org/10.1136/jnnp.2006.095315. (shrink)

One of the common characteristics of science, technology, and medicine is their ambition to epistemologically and organizationally move beyond the confines of nation states. In practice, however, they develop differently in countries or regions. Scientists, engineers, and physicians are constrained as well as enabled by national boundaries and specific cultures. The cultural status of such practices in reverse is influenced by a country's history, politics, and the view of the role of science, technology, and medicine in society. It is (...) the relation between a specific region, Scandinavia, and the history of science, technology, and medicine within this region that this issue of Science in Context sets out to explore. But what is this “Scandinavia”? To many, Scandinavia besides being a specific geographical region of three countries (Denmark, Sweden, and Norway) with entwined histories and closely related languages is a way of denoting a specific style or movement. “Scandinavian design” is renowned for three interrelated features; minimalism or simplicity, functionalism, and “design to the people” i.e. functional products for the average citizen (Beer 1975; Glambek 1997; Fallan 2012). -/- . (shrink)

The article analyzes the technological shifts which took place in the second half of the 20th and early 21st centuries and forecasts the main shifts in the next half a century. On the basis of the analysis of the latest achievements in inno-vative technological directions and also on the basis of the opportunities pro-vided by the theory of production revolutions the authors present a detailed analysis of the latest production revolution which is denoted as ‘Сybernetic’. The authors give some forecasts (...) about its development in the nearest five decades and up to the end of the 21st century. It is shown that the development of various self-regulating systems will be the main trend of this revolution. The authors argue that at first the transition to the beginning of the final phase of the Cybernetic Revolution will start in the field of medicine (in its some innovative directions). In future we will deal with the start of convergence of innovative technologies which will form the system of MBNRIC-technologies (i.e. the technological paradigm based on medicine, bio- and nanotechnologies, robotics, IT and cognitive technologies). The article gives a detailed analysis of the future breakthroughs in medicine, bio- and nanotechnologies as well as some other technologies in terms of the development of self-regulating systems with their growing ability to select optimum modes of functioning as well as of other characteristics of the Cybernetic Revolution (resources and energy saving, miniaturization, individualization, etc.). (shrink)

Advanced therapy medicinal products (ATMP) offer hope for health benefits in all situations where traditional methods of therapy fail or cannot be used for various reasons. The main purpose of this article is to analyze the concept of innovation as applied to the biotechnologies employed in ATMP. In the analysis of the concept, five main contexts of meaning that contribute to its understanding will be distinguished: a change in the way of thinking about the available spectrum of medical procedures, (...) the short time of recognition of technologies in the experimental and theoretical models, lack of clinical data in advance of used technologies, increase of technologies’ complexity and diversity of substrates used in them. The conducted analysis indicates the need to adopt an attitude of far-reaching caution in the evaluation of the safety of ATMP therapies in which innovative biotechnologies are used. (shrink)

This article argues that the movement of dogs from pounds to medical laboratories played a critically important role in debates over the use of animals in science and medicine in the United States in the twentieth century, not least by drawing the scientific community into every greater engagement with bureaucratic political governance. If we are to understand the unique characteristics of the American federal legislation that emerges in the 1960s, we need to understand the long and protracted debate over (...) the use of pound animals at the local municipal and state level between antivivisectionists, humane activists, and scientific and medical researchers. We argue that the Laboratory Animal Care Act of 1966 reflects the slow evolution of a strategy that proved most successful in local conflicts, and which would characterize a “new humanitarianism”: not the regulation of experimental practices but of the care and transportation of the animals being provided to the laboratory. Our analysis is consistent with, and draws upon, scholarship which has established the productive power of public agencies and civil society on the periphery of the American state. (shrink)

The practice of medicine involves continual change, driven by a constant stream of developments in the understanding of biological structure and function relevant to human diseases, and the parallel improvements in pharmacologic and other technological interventions. This change is also driven by evolving social philosophies, ethical trends, and lifestyles. As products of society, doctors absorb contemporary values and norms. Indeed, it would appear that the ethical norms and standards of medical practice are flexible, and that the characteristics of medical (...) practice at any particular point in history may reflect the mores of the times rather than any enduring moral imperatives.However, a common perception .. (shrink)

BackgroundThe nursing profession considers conscience as the foundation and cornerstone of clinical practice, which significantly influences professional decision-making and elevates the level of patient care. However, a precise definition of conscience in the nursing field is lacking, making it challenging to measure. To address this issue, this study employed the hybrid approach of Schwartz Barcott and Kim to analyze the concept of conscience-based nursing care.MethodsThis approach involves a three-phase process; theoretical, fieldwork, and analytical. A systematic literature review was conducted using (...) electronic databases during the first phase to find relevant papers. The content of 42 articles that met the inclusion criteria was extracted to determine the attributes, antecedents, and consequences of consciousness care using thematic analysis. Based on the working definition as a product of this phase, the plan of doing the fieldwork phase was designed. During this phase, data were collected through interviews with nurses all of whom were responsible for patient care in hospitals. In this phase, 5 participants were chosen for in-depth interviewing by purposeful sampling. Data were analyzed using directed content analysis. The findings of the theoretical and fieldwork phases were integrated and the final definition was derived.ResultsThe integration of the theoretical and fieldwork phases resulted in identifying four key characteristics of conscience-based nursing care. Firstly, it involves providing professional care with a conscientious approach. Secondly, ethics is at the core of conscience-based care. Thirdly, external spirituality plays a significant role in shaping one's conscience in this context. Finally, conscience-based nursing care is both endogenous and exogenous, with professional commitment being the central focus of care.ConclusionConscience-based nursing care is an essential component of ethical care, which elevates clinical practice to professional care. It requires the integration of individual and social values, influenced by personal beliefs and cultural backgrounds, and supported by professional competence, resources, and a conducive organizational atmosphere in the healthcare field. This approach leads to the provision of responsive care, moral integrity, and individual excellence, ultimately culminating in the development of professionalism in nursing. (shrink)

This paper presents an analysis of the issue that as yet not been extensively researched in the doctrine of Lithuanian and foreign law: the issue of legal distinguishing between medicinal products and food supplements. In order to analyze the problems of theory and practice, the structure of the paper is divided into two parts. The first part concentrates on the main features of medicinal products and food supplements in accordance with the case law of the Court of Justice (...) of the European Union (CJEU). It is established that medicinal products must comply with one of these descriptions: be made and aimed towards healing and preventing sicknesses; cause serious threats to health or have health-hazardous secondary effects; and have very intense effects on physiological features of human organisms. Food supplements in theory should not have these features. However, sometimes in practice preparations identified as food supplements have large doses of certain medicinal substances or other ingredients (e.g. alcohol, plant extracts, vitamins, amino acids, and etc.) that present threats to human health. The practice of the CJEU shows that counterbalancing free movement and public health protection interests is problematic in this area. (shrink)

Intelligent Guided Learning System is a computer system that uses computers to imitate the experience and methods of teaching experts to assist in teaching; ITS provides learners with personalized learning resources and adaptive teaching methods, thus reducing students’ dependence on teachers and realizing independent learning. After years of research and development, and with the help of artificial intelligence technology, ITS has basically formed a stable structure and unified implementation specifications and has given birth to many excellent products in disciplines such (...) as basic computer, language, medicine, and mathematics. Based on the above background, this paper takes the system structure of universal ITS as the basis, combines the characteristics of music sight-singing subject in teaching contents and teaching methods, researches the intelligent guidance system model of music sight-singing, and completes the design of the overall system architecture. The specific strategies and implementation methods of the teaching methods, resource recommendation, and ability assessment components of the teaching model are studied. The research includes the definition of the difficulty characteristics of the score, the design of the score recommendation algorithm, the design of the sight-singing scoring algorithm, and the experimental analysis of each algorithm. It is proposed that the difficulty feature-based score recommendation algorithm is the core component of resource recommendation in the teacher model, and the sight-singing scoring algorithm is the basis for ability assessment and learner model update. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Journal of the History of Ideas 65.2 (2004) 191-211 [Access article in PDF] Oratory and Rhetoric in Renaissance Medicine Nancy G. Siraisi Hunter College In Renaissance medical practice rhetoric had an ambiguous reputation. Many authors warned physicians against use of persuasion or repeated some version of the truism that patients are cured not by eloquence but by medicines. On the other hand, physicians were also reminded that by speaking (...) well they helped patients to have confidence in their advice and to understand directions, which in turn facilitated cure.1 Yet some aspects of medical culture of the period between 1450 and 1600 seem profoundly attentive to rhetoric, at least as regards the use of language, performative elements, and the influence of these features in ancient models (most notably Galen himself).2 One area in which rhetoric had an unambiguous, acknowledged, and essential place was in the medical orations pronounced at university ceremonies. A sample follows: Pursuit of all these different things by study, investigation of obscurities with ingenuity, conquest of difficulties with industry, and—after penetrating into the very fibers of the earth and searching everywhere into the arcana of the whole of nature and from all herbs, fruits, trees, animals, gems, and even poisons—inquiry after remedies and the proper way to use them for all the ills of human life from so many authors, so many disciplines, and even from the very stars: these things, I say, [End Page 191] have uncovered so many hidden cures, been attained with such arduous powers of the mind, completed with so much effort of memory, offer so many things necessary for the health of the entire human race in common, that does not indeed [the entire enterprise of medicine] seem to have been superhuman and really in a certain way divine?3This nicely exuberant example of Renaissance medical rhetoric exemplifies the genre in several respects. The oration to which it belongs was originally delivered to an academic faculty of medicine by a physician; it shows the impact in medical settings of the revival of epideictic rhetoric, and its author drew on learned sources and commonplaces about medicine that belonged to a store of broadly humanistic erudition, shared both in and outside the medical profession. In fact the only truly distinctive feature of this passage is its author. It comes from Erasmus's Encomium medicinae, which he wrote in 1499 for a friend—a physician named Gysbertus—to deliver to the medical faculty of the University of Paris.4If Gysbertus was exceptionally fortunate in his ghost, many other surviving medical orations are internal products of medical faculties, the work of university masters or students of medicine. But whoever their authors, orations delivered in or written for an academic medical setting offer some telling illustrations both of the way in which certain kinds of humanistic interests and requirements came to penetrate medical learning and of the reaction of humanistic rhetoric to medicine. "Medical humanism" is usually understood to encompass both the core enterprise of intensive philological study, editing, and translation of Greek medical texts—never the occupation of more than a handful of hellenist scholars—and also the reception and scientific influence of the fruits of their labors among a wider medical audience. But Renaissance medicine was also a humanistic discipline in a much broader and more inclusive sense; that is, it both fostered and provided ample scope for the development among learned physicians of interests characteristic of humanistic culture in general: rhetoric, history, biography, fascination with remote peoples and places, and antiquarianism. At the same time, as the passage from Erasmus quoted [End Page 192] above demonstrates, humanists outside the medical profession interested themselves in medicine and controlled a stock of rhetorical commonplaces on the subject. To be sure, the penetration of terminology and concepts from medicine into the general culture long antedated the Renaissance.5 But the revival of rhetoric together with attention to ancient sources and commonplaces provided humanist observers with new tools for commenting, sometimes in quite specific and detailed terms, on the contemporary medical scene, a phenomenon... (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

In this paper, the public view of nanotechnology and its applications in medicine, agriculture and industry is evaluated in the mega cities of Iran. Data from 683 individuals in public places provided the first civic perception of nanotechnology in Iran. Quantitative statistical analysis on positive or negative points of view demonstrated that Iranian people had general positive opinions on nanotechnology and its application in medicine. They believed that nanomedicine can significantly improve the current methods used in disease treatments, especially for (...) cancer therapy. In general, the responders believed that they would easily accept the use of nanotechnology products and would like increased financial support of the government on nanomedicine and nanotechnology research fields and they showed little anxiety about the possible risks. According to our statistical analysis, three individual characteristics age, education level and career had a direct correlation with the knowledge level of Iranian people on nanotechnology in the mega cities of Iran. (shrink)

In recent years, animal welfare has become an important element of sustainable production that has evolved along with the transformation of animal production systems. Consumer attitudes towards farm animal welfare are changing around the world, especially at emerging markets of Asia, Africa and Latin America. Survey-based research on consumer attitudes towards farm animal welfare has increased. However, the geographical coverage of studies on consumer attitudes and perceptions about farm animal welfare has mostly been limited to Europe, and North America. Until (...) now, Latin American consumers’ attitudes towards animal welfare have not been well studied. Despite the fact that Mexico, Chile and Brazil belong to the same region, there are marked differences between these countries in terms of their economical and geographical characteristics among other factors. Those differences potentially have an impact on consumer attitudes towards animal welfare and livestock production systems in general. Given the evidence from the literature review, it seems advisable that Latin American producers and food industry who engage in animal welfare-enhancing practices should clearly label their products with information on the type of husbandry system to reach those consumers who want to make an informed choice. Therefore, there are some aspects that need to be studied and cannot be worked separately in order to promote and understand consumer attitudes towards dairy and beef systems, such as geography, economic development, and politics. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

The notion of “responsible luxury” may appear as a contradiction in terms. This article investigates the influence of two defining characteristics of luxury products—scarcity and ephemerality—on consumers’ perception of the fit between luxury and corporate social responsibility (CSR), as well as how this perceived fit affects consumers’ attitudes toward luxury products. A field experiment reveals that ephemerality moderates the positive impact of scarcity on consumers’ perception of fit between luxury and CSR. When luxury products are enduring (e.g., jewelry), a (...) scarce product is perceived as more socially responsible than a more widely available one and provokes positive attitudes. However, this effect does not appear for ephemeral luxury products (e.g., clothing). The perceived fit between luxury and CSR mediates the combined effects of scarcity and ephemerality on consumers’ attitudes toward luxury products. This study provides valuable insights that luxury brand managers can use to design their CSR and marketing strategies. (shrink)

Medicine regulation demands the application of sound medical, scientific, and technical knowledge and skills, and operates within a legal framework. Regulatory functions involve interactions with various stakeholders (e.g., manufacturers, traders, consumers, health professionals, researchers, and governments) whose economic, social, and political motives may differ, making implementation of regulation both politically and technically challenging. This book discusses regulatory landscape globally and the current global regulatory scenario of medicinal products and food products comprehensively.

The purpose of this paper is as follows. First, we can see the ethical problems of biotechnology and characteristic of BT-ICT convergence products in the era of BT-ICT convergence centered on the paradigm shift from IT industry to ICT industry and 4th industrial revolution. Second, as the issue of biotechnology ethics in the era of BT-ICT convergence, we can see the main areas of interest and issues of bioethics, the ethical development process of clinical ethics related to bioethics, and new (...) ethical issues in the era of BT-ICT convergence. Third, the principles and ethics of bioethics - the principles of bioethics of Hood’s P4 Medicine, Robert Merton's CUDOS, M. F. Atiyah’s Responsibility, David B. Resnik - reveal the ethics and social responsibilities that biotechnologists need as professionals. Fourth, as biotechnologists, autonomy and social responsibility of professionalism, and moral literacy and ethical personality to be possessed by biotechnologists. (shrink)

With a few notable exceptions disability studies has not taken account of intersexuality, and it is principally through the lenses of feminist and queer-theory oriented ethical discussions but not through ‘straight’ bioethics that modes valuing intersex difference have been proposed. Meanwhile, the medical presupposition that intersex characteristics are inherently disabling to social viability remains the taken-for-granted truth from which clinical practice proceeds. In this paper I argue against bioethical perspectives that justify extensive and invasive pre- and post-natal medical interference (...) to eradicate intersex. I argue instead that to constitute the necessary conditions for the recognition of the intersexed child as a person, a life valid in its own right, clinicians must refrain from aggressive interference. Clinical specialists presuppose that intersexed children will be socially disabled and unrecognizable as persons; frustrated by the general failure of traditional interventions to assign a sex, clinicians are now pursuing prenatal technologies, including selective termination, to erase intersex. (shrink)

The weaver ant, Oecophylla smaragdina Fabricius (Hymenoptera: Formicidae), has long been known as perhaps the first example of human manipulation of a natural predator population to enhance the natural biological control of insect pests. The practice of ant husbandry in Vietnamese citrus orchards and the knowledge associated with the use of weaver ants in the Mekong delta are described. In contrast to other regions of Asia, where weaver ants are noted for their role in the protection of citrus from insect (...) damage, citrus farmers in the Mekong delta explain the benefits of ant husbandry in terms of an improvement in fruit quality, likened to the influence of fertilizers, that occurs in direct response to excretory products deposited by the weaver ants as they patrol the fruit. A series of tests, carried out in 1993–94, rated the external shine, sweetness, juiciness, and overall appeal, as characteristics of fruit quality, for paired comparisons of sweet orange, mandarin, and pummelo fruit that had been grown in the presence of weaver ants or from which ants had been excluded. The tests indicate a strong influence of the presence of the weaver ant on external shine, juiciness, and overall appeal for each of the citrus fruits, but particularly for mandarin. The significance of these results and ant husbandry practices in the Mekong delta are discussed in relation to the development of citrus production in Vietnam. (shrink)

African American distrust of medicine has consequences for treatment seeking and healthcare behaviour. Much work has been done to examine acute events that have contributed to this phenomenon and a sophisticated bioethics discipline keeps watch on current practices by medicine. But physicians and clinicians are not the only actors in the medical arena, particularly when it comes to health beliefs and distrust of medicine. The purpose of this paper is to call attention not just to ethical shortcomings of the past, (...) but to the structural contexts of those events and the contributions and responsibilities of popular media and academic disciplines in the production of knowledge. We argue that ignoring context and producing inaccurate work has real impacts on health and healthcare, particularly for African Americans, and thus engenders ethical obligations incumbent on disciplines traditionally recognised as purely academic. (shrink)

The rapid growth of human population and associated industrialisation creates strains on resources and climate. One way to understand the impact of human activity is to quantify the total environmental pressures by measuring the ‘footprint’. Footprints account for the total direct and/or indirect effects of a product or a consumption activity, which may be related to e.g. carbon, water or land use, and can be seen as a proxy for environmental responsibility. Footprints shape climate and resource debates, especially concerning (...) environmental strategies. However, in general, footprints hold a dichotomous producer–consumer perspective that is not unanimously accepted. In addition, the current footprinting system transmits a simplistic message about environmental responsibility that taints the justice debate and jeopardises the validity of policies based on them. Consequently, it is crucial to question who is accountable for adverse environmental effects. It is also critical to investigate how the methodological characteristics of footprints shape and affect the efficacy of policies on climate and natural resources. This article examines these challenges, focusing on negative justice and policy implications resulting from assigning environmental responsibility to a sole agent. The article proposes, and morally justifies, the development of a footprinting method that includes justice parameters in an attempt to render fair results that are more meaningful for environmental action. The second objective is to establish the potential of this new framework to promote environmental responsibility and justice while facilitating policymaking. The suggested justice elements aim at turning footprints into a concrete environmental policy instrument framed under the value of environmental fairness. (shrink)

Research and business investment in emerging nanotechnologies is leading to a diverse range of new substances and products. As workers are faced with handling new materials, often with novel properties, the robustness of current workplace health and safety regulatory frameworks is being brought into question. Here, 12 characteristics of the U.S. occupational safety regulatory framework identified by Choi and Ramachandran are considered in the context of emerging nanotechnologies. The assessment suggests that, as the number of new materials entering the (...) workplace continues to increase, OSHA will need to develop flexible approaches to identifying and reducing potential risks. Relying on conventional approaches in the face of unconventional challenges will increase the probability of otherwise avoidable heath impacts. If the potential for engineered nanomaterials to cause harm is to be understood and managed, the agency will need to look at new approaches to generating, sharing, and using information. (shrink)

In addition to obviating the use of synthetic agrochemicals and emphasizing farming in accordance with agro-ecological guidelines, organic farming acknowledges the integrity of plants as an essential element of its natural approaches to crop production. For cultivated plants, integrity refers to their inherent nature, wholeness, completeness, species-specific characteristics, and their being in balance with their (organically farmed) environment, while accomplishing their “natural aim.” We argue that this integrity of plants has ethical value, distinguishing integrity of life, plant-typic integrity, genotypic (...) integrity, and phenotypic integrity. We have developed qualitative criteria to ethically evaluate existing practices and have applied these criteria to assess whether current plant breeding and propagation techniques violate the integrity of crop plants. This process has resulted in a design of a holistic, scientific approach of organic plant breeding and seed production. Our evaluation has met considerable criticism from mainstream (crop) scientists. We respond to the following questions: (1). Can ethics be incorporated into objective crop sciences? (2). What is the nature of the intrinsic value of plants in organic farming? We argue that criteria to take integrity into account can only be assessed from a holistic perspective and we show that a holistic approach is needed to design such ethical notions in a consistent way. The ethical notions have been further elaborated by formulating human responsibility and respect towards crop plants. Responsibility and respect can only be shown by providing crop plants the right to be nurtured and to express natural behavior at all levels of integrity. (shrink)

The concept of moralisation of health behaviours was introduced in social psychology to describe the attribution of moral properties to habits and conditions like smoking or being a vegetarian. Moral properties are powerful motivators for people and institutions, as they may trigger blame, stigma, and appraisal, as well as the polarisation of interest and scientific hype. Here I extend the concept and illustrate how medicines and treatments can be seen as if they had moral properties, too, when they come to (...) be regarded as good or bad in the moral sense, and not just in the instrumental sense of benefiting or harming health. I propose the hydroxychloroquine (HCQ) controversy of 2020 as an example of moralisation of a medicine. HCQ and chloroquine are anti-malarial drugs, whose off-label use for Covid-19 was hotly discussed in the early months of the pandemic, both in the media and within the scientific community, and eventually dismissed when robust evidence came out. The point of the paper is to show that moralisation of health products and treatments may influence individual and institutional decisions in significant ways, and also affect research. For these reasons, it should be carefully monitored and critically assessed. (shrink)

BackgroundThe biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.Main textAny institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that (...) arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context “specification” substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity.ConclusionUnderstanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society. (shrink)

Artykuł przedstawia rozważania oparte na regulacji prawa unijnego oraz polskiego dotyczące wytwarzania oraz stosowania produktów leczniczych terapii zaawansowanej – wyjątków szpitalnych. Autorka omawia unijne źródło regulacji ATMP-HE, jej funkcję oraz cel wprowadzenia do prawa unijnego, a następnie relację tej regulacji do polskiego uregulowania dotyczącego eksperymentu leczniczego. W ocenie autorki na gruncie obowiązującego stanu prawnego nie jest zasadne stanowisko, zgodnie z którym produkt leczniczy terapii zaawansowanej – wyjątek szpitalny jest na tyle legalnie odrębnym pojęciem, a wręcz instytucją prawną, że nie stosuje (...) się do niego regulacji krajowej. Jest to bowiem stanowisko nie tylko niespójne z regulacją unijną oraz krajową, ale również skutkujące przerzuceniem ciężaru ryzyka zastosowania tego produktu bez jakiejkolwiek kontroli oraz odpowiedzialności na pacjenta. Autorka wyraziła stanowisko, zgodnie z którym de lege lata zastosowanie produktu leczniczego terapii zaawansowanej – wyjątku szpitalnego należy kwalifikować jako eksperyment leczniczy, do którego stosuje się także granice dopuszczalności jego przeprowadzenia. Autorka przedstawia skutki uznania zastosowania ATMP-HE za eksperyment leczniczy oraz skutki przyjęcia stanowiska odmiennego. Ponadto w artykule zawarte zostały rozważania na temat niezasadności utożsamiania stosowania ATMP-HE z off-label use oraz compassionate use. Autorka sformułowała również postulaty de lege ferenda. (shrink)

The discourse about traceability in food chains focused on traceability as means towards the end of managing health risks. This discourse witnessed a call to broaden traceability to accommodate consumer concerns about foods that are not related to health. This call envisions the development of ethical traceability. This paper presents a justification of ethical traceability. The argument is couched in liberal distinctions, since the call for ethical traceability is based on intuitions about consumer rights to informed choice. The paper suggests (...) that two versions of ethical traceability find justification. The first version of ethical traceability entails that governments ensure that all consumers are provided with foods that respect some threshold level of, e.g., animal welfare that is supported by an overlapping consensus. The second version of ethical traceability entails that food producers provide consumers with products, and sufficient information about these products, that are relevant for reasonable, non-superficial values that are not supported by an overlapping consensus. Governments should facilitate this in the sense that consumers are not provided with misinformation about characteristics of foods that are relevant for reasonable, non-superficial values that are not supported by an overlapping consensus. (shrink)

The five books of Artemidorus of Ephesus’ Oneirocritica (c. second century CE) constitute the largest collection of divinatory dream-interpretations to survive from Graeco-Roman antiquity. This article examines Artemidorus’ contribution to longstanding medico-philosophical debates over the ontological and epistemic character of such dreams. As with wider Mediterranean traditions concerning premonitory dreams, Greeks and Romans popularly understood them as phenomena with origins exterior to the dreamer (e.g. a visitation of a god). Presocratic and Hippocratic thinkers, however, initiated an effort to bring at (...) least some dream events within the body as interior processes of a physical soul, a bodily turn which ultimately engendered a split in thinking about the possibility and scope of prophetic and diagnostic dreams (e.g. Hippocrates Regimen 4, Aristotle On Prophecy in Dreams, Rufus of Ephesus, and Galen). Here, I examine the way that Artemidorus meant the Oneirocritica to address seriously questions about the origins of dreams and the powers of empirical science in two, related ways. We will see that his defense of oneirocriticism as a techne unfolds along two main axes. First, Artemidorus constructs a necessary veneer of scientific credibility by mobilizing the tropes and organizational strategies characteristic of contemporary technical literature. Secondly, he anchors that authority upon a materialist account of prophetic dreams as “semiotic movements of the soul.” As Price, S. 1986. “The Future of Dreams: From Freud to Artemidorus.” Past & Present 113: 3–36 and Harris-McCoy, D. 2012. Artemidorus’ Oneirocritica: Text, Translation, and Commentary. Oxford: Oxford University Press observed, this explicit commitment to an empirical method of dream-interpretation resembles that of the Hellenistic medical ‘sect’ known as ‘Empiricists,’ who eschewed interest in theoretical etiology in favor of observation, comparison, and compilation of symptoms and outcomes. Pushing beyond similarity, I argue that Artemidorus not only deployed this method to defend empirically grounded accounts of dream-divination (cf. Cicero De div. 1), but endeavored to show that such a scientific method can be used to stabilize and corral productively the potentially infinite number of interpretations any dream-sign might bear without recourse to an underlying, causal theory. (shrink)

The article illustrates the major features of the development of Italian agriculture from the middle of the nineteenth century to the present. It is argued that such development has been characterized by dualism. At the structural level dualism refers to the existence of a large number of small and very small farms, a limited number of medium-sized farms, and the presence of a very small segment of large farms that control the bulk of agricultural production and sales. Structural dualism in (...) Italy is accompanied by regional dualism, which refers to the sharply different characteristics of the agriculture of the north and that of the south. In the northern regions the most productive and advanced farms are concentrated, while in the south smaller and less viable units are present. Dualism has created serious contradictions in Italian society, which have not been resolved with the further integration of the country's agricultural sector into the European Community. (shrink)

Film collectives and collaborative production have evolved into potent vehicles of change, con-verging on themes of gender and representation of marginalised groups, allowing communities to introspect and create their own cultural identity. Community produced short documentaries, shift dialogue from national to local regions. Film Collectives produce short documentaries, reinforc-ing modular over conventional. In this study, the researchers aim to examine short documentaries produced through collaborative production approaches at the grassroots level, specifically those serving or created by communities in India. The (...) research places significant emphasis on investi-gating the advancement of social welfare within the local community through these films. Over-all, the language and structure employed in collaborative filmmaking align more closely with tra-ditional documentary practices. The objective of the study is to achieve a thorough comprehension of the importance of community films and to explore their sustainability over the long term. To achieve this goal, the researchers have chosen to analyse four films produced by SPS Media. Through the creation of their films, SPS Media, captures the real-life experiences and obstacles of marginalised communities. Their films serve to bring attention to and facilitate discussions on issues such as poverty, gender inequality, education, healthcare, and sustainable agriculture. Key characteristics of collaborative production are discussed in the paper. The research methodology adopted is qualitative in the nature, with a case study and narrative and textual analysis of short documentaries. (shrink)

This study appeared in full in the last issue of Research Ethics Review (2009; 5(1): 26). SB, a 21-year-old healthy male, volunteered to take part in a phase I randomized, double-blind, placebo-controlled drug interaction study. The trial compound was a CNS-active drug currently under development for a range of CNS indications. The trial–which was not ‘first in class’ or ‘first in man’ –comprised two residential seven-day study periods with a washout period in between. Three days after the end of the (...) first study period the volunteer developed an acute, severe psychosis that warranted hospitalization. (shrink)

Photo ID 222412412 © US Navy Medicine | Dreamstime.com ABSTRACT In a non-military setting, the answer is clear: it would be unethical to treat someone based on non-medical considerations such as nationality. We argue that Battlefield Triage is a moral tragedy, meaning that it is a situation in which there is no morally blameless decision and that the demands of justice cannot be satisfied. INTRODUCTION Medical resources in an austere environment without quick recourse for resupply or casualty evacuation are often (...) limited. The shortage extends not only to supplies like blood products and drugs, but physicians and other medical personnel. In the midst of a mass casualty scenario, such as a battle that includes intense ground fighting, the medical staff will stretch scarce resources and triage casualties according to specific criteria. Typically, they proceed by providing care for the most severely wounded first, referred to here as conventional triage. At times, though, the staff may reverse the triage so that soldiers with minor wounds can return to the fight. In a mass casualty situation, when medical personnel apply conventional triage and treat casualties from opposing forces, a dilemma may arise. We argue that it can be permissible for military physicians to prioritize their own soldiers over enemy combatants in a mass casualty triage, where reverse triage does not apply. The case we will focus on is as follows: Battlefield Triage: During combat operations on a remote island in the Pacific Ocean, a compatriot soldier and an enemy combatant arrive at the compatriot soldier country’s medical treatment facility. Both have similar gunshot wounds to the abdomen, and they arrive with similar conditions. Both have low oxygen saturation and excessive blood loss. The sole physician only has enough time to stabilize one person. The scenario is brief, and we are aware that medical rules of eligibility will most often dictate how the physician proceeds,[1] but this scenario is useful in setting up the question we focus on in this paper: would it be wrong to favor the stabilization of a soldier just because the soldier is the physician’s compatriot? In other words, can nationality serve as an ethically justified tiebreaker in a situation such as Battlefield Triage?[2] In a non-military setting, the answer is clear: it would be unethical to treat someone based on non-medical considerations such as nationality. The AMA’s Code of Medical Ethics asserts that physicians have “ethical obligations to place patients’ welfare above their self-interest and above obligations to other groups.”[3] The World Medical Association’s Declaration of Tokyo affirms that “no motive, whether personal, collective or political, shall prevail against this higher purpose” of alleviating distress.[4] Physicians are taught early on that triage decisions must be medically indicated and made without consideration of factors such as race, ethnicity, religion, social status, and nationality. They are taught that public trust and obligations of justice grounded in equality demand that only medical indications be considered. But military physicians in a military setting are beholden to obligations, duties, and responsibilities as members of the military, and when these obligations, duties, and responsibilities conflict, as they do in Battlefield Triage, which loyalties win out and why?[5] Critics of partiality on national grounds argue that partiality undermines public trust in medicine and justice because everyone should be treated equally regardless of nationality.[6] Proponents of partiality argue that military obligations supersede equality and that justice requires partiality in such cases.[7] Despite the critics’ disagreement, both agree that there is a morally right, perhaps even blameless, course of action. Drawing on insights from virtue ethics, we argue that Battlefield Triage is a moral tragedy in which justice is unattainable and there is no action without moral cost. The assumption that there is a morally right choice is flawed. We argue that while no decision in this scenario is free from moral blame, there are reasons to favor treating one’s soldiers over enemy combatants. I. The Case Against Partiality There is a common assumption that there is a morally right or just decision in Battlefield Triage. A number of organizations and scholars claim that it is wrong for military physicians to favor their own soldiers on the grounds of nationality or some form of ‘group membership.’ (In a conflict involving service members from multiple nations working as a coalition, a soldier from an allied country may receive the same priority as the US service member due to ‘group membership.’) The World Medical Association’s WMA Declaration of Lisbon on the Rights of the Patient, which was reaffirmed in 2015, posits that, “[i]n circumstances where a choice must be made between potential patients for a particular treatment that is in limited supply, all such patients are entitled to a fair selection procedure for that treatment. That choice must be based on medical criteria and made without discrimination.”[8] This echoes what was set forth in Article 12 of the Geneva Conventions, which states that “[o]nly urgent medical reasons will authorize priority in the order of treatment to be administered.”[9] The argument for impartiality in Battlefield Triage is that every person is morally equal, and equality entails that medical distribution is, “based on a combination of medical need and urgency.”[10] This is in keeping with the bioethical principles that are generally applied.[11] II. The Case for Partiality On the other side, there are arguments that favoritism is the ethically right decision in Battlefield Triage.[12] The argument asserts that members of the military form a morally significant community of friends and participation in these relationships demands partiality. Just as parents have strong ethical duties to their children and not just any children, military personnel have ethical duties to their group, a group that involves an affirmation of mutual aid and support. Some have termed these ‘associative duties. According to Michael Gross, obligations of friendship, care, and solidarity “leave very little room for generally applicable principles of justice that would obligate a medic to treat enemy or non-compatriot wounded ahead of their compatriots.”[13] This is true in Battlefield Triage, but it may also be true even if the enemy’s soldier were more seriously wounded: “the ethics of small group cohesion, largely an ethics of care, mostly replaces the demands of impartial justice.”[14] In a more recent article, Gross explains that preferential treatment is ethically justified based on fighting capability and “the special obligations people owe friends, family, and, no less, comrades-in-arms.”[15] To not show partiality to the US soldier would be morally wrong on the grounds of friendship and mutual care.[16] III. The Moral Tragedy of Battlefield Triage Defenders and critics of Battlefield Triage favoritism based on nationality both frame their position as just or fair. For example, Justin List argues that physicians are “bound to practice medical neutrality,”[17] Marcus Adams denies that physicians “possess special ethical obligations” to enemy combatants because of their profession.[18] These perspectives assume that there is a morally right decision and that justice is attainable. The assumption that there is or can be a morally right Battlefield Triage decision, and we need to put our heads together to figure it out, remains strongly entrenched. However, the facts of the situation should give us pause; there are too many people and too few resources, and this demands a decision-making process that determines who will receive scarce resources. By its very nature, a battlefield triage decision has to be made based on some characteristic or value, a characteristic or value that will inevitably favor some at the expense of others. This is precisely why competing analyses “in the military context struggle to resolve these conflicts satisfactorily.”[19] Drawing on the insights of virtue ethics, we suggest that Battlefield Triage is a moral tragedy. Virtue ethics suggests that morality is about acting virtuously, which is to say that we should do what a virtuous person would do in the situation. Ethics is about figuring out how a just, wise, compassionate, loving, and fair person would act, and then doing that, as one grows in virtue. But life is not always clear cut, and it is possible that virtuous people may find themselves in a moral tragedy, a situation in which, through no fault of one’s own, a person must make a morally objectionable decision. After the action the virtuous person “emerges having done a terrible thing, the very sort of thing that the callous, dishonest, unjust, or in general vicious agent would characteristically do.”[20] Stated differently, a moral tragedy presents a virtuous person with two or more courses of action, all of which have a moral cost.[21] In Battlefield Triage, no matter how the physician goes about deciding, there is going to be defensible concern from those not saved. The fact that there are more people than can be helped fosters competing values in battlefield triage: maximize lives saved, treat people equally, treat the worse off, and support the war effort. Treating people equally may create tension between treating the worse off, maximizing lives saved, and supporting the war effort. Reverse triage is a case in point, as supporting the war effort conflicts with treating the worse off first, as is a fair lottery system since deploying a lottery may not maximize lives saved or support the war effort. There can be reasons why one person is selected over another, to be sure. Yet, there are reasons for making a decision, and that the decision is subject to legitimate moral concern is another. To recognize the moral tragedy of Battlefield Triage is to recognize the impossibility of acting blamelessly in the situation. In this situation, the virtuous military physician is going to have to sacrifice important values such as justice, compassion, and respect for others, even with a defensible criterion in hand. The physician will grieve this sacrifice accordingly. The physician may find her decision difficult or stressful, and rightly so, because of what her circumstances require of her. This kind of moral tragedy results “in actions which betray and violate the rights of persons to whom there may be a strong duty of care. When this happens, it properly triggers an appropriate moral emotion since our moral integrity has been violated and this affects how we think of ourselves and what we have become.”[22] Rather than view her triage decision as the morally superior choice, the virtuous military physician will view her decisions in these circumstances in a different light: it is the least bad option in a terrible situation, and she did something ethically problematic, something that is contrary to her moral character. She deeply regrets the circumstances in which she had to act. IV. Virtue Ethics A virtue ethicist has insight into how one should go about deciding what to do in a moral tragedy, although virtue ethics may not be as helpful as one may hope. The goal of the virtuous military physician in Battlefield Triage is to adopt the best course of action or the action that she feels she ought to do, all things considered. This does not make her choice devoid of serious wrongdoing—a decision must be made, but that does not make it just. The virtuous military physician will approach the situation with courage, responsibility, and insight. She will think about the decision carefully, wisely, and conscientiously; she will weigh the goods and harms of the choices before her, in conjunction with a proper conception of the good life, human worth, and understanding of her obligations to others—including chain of command, fellow soldiers, and the medical community. She is attuned to the value of human life and has a reasonable idea of the various ways her decisions will affect others. She recognizes that she is in this non-ideal situation through no fault of her own: she is not the one fighting in battles; she is serving her country as a physician, whose job it is to save lives, treat everyone justly, and promote military objectives. She regrets the decision she is forced to make in battlefield triage, acting “with immense regret and pain,” Hursthouse explains, “instead of indifferently or gladly.”[23] This is because, no matter what decision is made, the virtuous military physician “does something terrible or horrible,” something she otherwise would not do and is contrary to her values.[24] V. A Resolvable Moral Tragedy Instead of asking whether there is a morally right decision, in which a decision is morally blameless and above reproach, the virtue ethicist asks whether there is a decision with a convincing rationale, knowing that a decision can have a clear rationale but still be morally tragic. It is perfectly reasonable to think that different virtuous persons will arrive at different courses of action: “two virtuous agents, in the same situation,” Hursthouse writes, “may act differently” in irresolvable moral tragedies, in cases in which there is no clear course of action.[25] Because a person must act in a moral tragedy, one goal is to identify reasons for choosing the chosen action. Some decisions are clearly indefensible—treating neither the compatriot soldier nor the enemy combatant in Battlefield Triage would be wrong—and some decisions are more problematic than others. If the military physician selects to treat the soldier because she does not like the enemy combatant’s skin color, such a reason would be deeply problematic. But much of the debate over how to act in a moral tragedy is not over clearly indefensible or problematic criteria. Instead, the literature is largely about different standards or implementations of justice. Some scholars defend nation-impartial triage as right, while others defend nation-aware triage as right, and each argues that the other side is promoting an unjust or otherwise wrong solution to Battlefield Triage. We suggest that Battlefield Triage is a resolvable moral tragedy and that virtue ethics offers convincing reasons to prefer the treatment of the compatriot soldier rather than the enemy combatant on the grounds of national identity. Virtues are integral to living a good life, a flourishing life, but as Aristotle observed long ago, human beings are inherently social, interdependent and interconnected in profound ways.[26] This goes beyond the obvious fact that we need each other to survive day to day (one person makes clothes, another farms, and another makes tools); the claim is that a good or flourishing life depends in large part on one’s social network or community. This is why many of Aristotle’s moral virtues are other facing: justice, friendship, generosity, and magnanimity, to name a few. Courage, a typically self-facing virtue, is understood by Aristotle to be the virtue that regards one’s fear of death in battle, a battle fought on behalf of one’s city.[27] All of this remains true today. Namely, there is an important sense in which our community matters to our lives: it is easier to live a good, flourishing life if one is part of a good, flourishing community. Our community is made up of smaller groups, and it is more accurate to say that we are simultaneous members of different groups within a broader community. A person may be part of a family, friend group, research team, large state university, city, state, and nation. Groups can function well or not, as we all have experienced, and this suggests that there are virtues or excellences that groups can instantiate. Good groups are unified in purpose, with each member doing their duty alongside others for the attainment of that purpose. Good groups manifest solidarity among their members. Although Aristotle does not list solidarity as a virtue, a number of modern-day virtue ethicists have begun examining how group solidarity can be a virtue that contributes to a good or flourishing life.[28] Solidarity is not conceptualized as an individual virtue, a virtue possessed by a person in isolation of others; instead, it is a collective virtue, a virtue that is shared among members of a defined group with particular ends.[29] “A group has solidarity to the extent that its members are disposed to: (1) share values, aims, or goals; (2) care about those values, aims, or goals; (3) act in accordance with those values, aims, or goals; (4) trust the testimony of other group members with respect to those values, aims, and goals; and (5) feel a sense of belonging to the group.”[30] The virtue of collective or group solidarity involves individuals having special concern for each other, shared aims and values, trust, loyalty, and a sense of belonging with these specific others. There is a oneness to the group in the pursuit of a definite goal or purpose, involving mutual support and affirmation of each member. As such, the group has ends and goods above and beyond the good of each individual person. Sometimes solidarity requires personal sacrifice for the collective (for example, a father sacrificing food so his child can eat). The virtue of collective or group solidarity is important to the military and medical community at every level, and for clear reasons. In the military, there is a clear hierarchy of command, unity of purpose and end, mutual trust and support in complex settings, and so on. Soldiers need to know they can count on one another, and solidarity grounds a soldier’s ability to trust others and be assured of mutual aid. In medicine, solidarity maintains self-regulation of the profession, shared values and goals, as well as public support, not to mention that day-to-day operations require physician trust, engagement, and effort toward the ends of clinical care. Physicians need to work together, along with others, in pursuit of health, and disunity is sowed when there is mistrust, selfishness, or disengagement among the healthcare team and organization. Importantly, just as we are all members of various groups and hence may manifest group solidarity in different settings, the virtuous military physician instantiates collective solidarity with both the medical profession and the military. Her dual loyalty contributes to the moral difficulty of acting in Battlefield Triage. The military physician has competing obligations to distinct groups and cannot satisfy all obligations in Battlefield Triage. Solidarity with the military supports the consideration of favoring the soldier for reasons of national identity, whereas solidarity with the medical community does not. Something has to give, which is why it is a moral tragedy. The virtuous military physician, therefore, must weigh the costs of each course of action. To fulfill her obligations to the medical community would require that she does not use nationality and other non-medical considerations in Battlefield Triage. Since the soldier and enemy combatant are equally injured, justice would demand a random process, perhaps a flip of the coin. Although this may satisfy obligations the military physician has to the medical community, this would be costly to the physician’s military group. If word gets out that the physician decides who to treat based on a coin toss, soldiers, families, and citizens may become frustrated and angry. Soldier morale may go down if it becomes known that a coin flip led to the preventable death of a soldier and the saving of an enemy combatant who had killed (or attempted to kill) other soldiers. As Gross highlights, military solidarity involves a mutual aid promise that military personnel promise to help one another.[31] A military physician is part of the military and, as such, is part of the mutual aid promise, which would appear to be violated if the physician flips a coin. Treating a member of one’s own team may be psychologically more beneficial than treating an enemy combatant and may lead to less moral distress.[32] Finally, treating soldiers rather than enemy combatants promotes broader military and social aims, including returning soldiers to health, maintaining unity of purpose, and minimizing community suffering from a soldier’s death. Favoring members of one’s group, that is, triage based on nationality in Battlefield Triage, would fulfill obligations of military group loyalty, which is contrary to the values and duties of medicine. It does not seem as though showing favoritism in this particular situation is very costly to the medical community or general public, but this is because there is recognition that the physician is in the military. Medicine is impartial to non-medical indications partly because of fairness and to promote public trust in medicine. However, Battlefield Triage is unique, as medicine is being practiced in a non-public, wartime setting. In ordinary circumstances, a patient’s identity is irrelevant, and physicians ought not play favorites. Since Battlefield Triage is not an ordinary circumstance, decisions based on patient identity may not undermine public trust in medicine. In addition, it is contestable that fairness in Battlefield Triage requires that no consideration be paid to one’s nationality. Fairness is about giving each person their due, what is owed to them, and the case can be made that soldiers who place themselves in danger for the sake of the common good or a just cause are owed special attention when they suffer harm in the line of duty. In other words, soldiers voluntarily undergo risk to themselves for the greater good, and society owes them for this sacrifice. This plausibly includes preferential treatment in a situation such as Battlefield Triage. So, while the medical community affirms justice demands non-preferential treatment, the military community can affirm the opposite. The demands of fairness are unclear at best or in conflict in this situation: demands of physician justice decry favoritism, while demands of military justice support favoritism. Triage not based on nationality is arguably unfair and triage based on nationality may not undermine public trust, after all. All things considered, there is a clear rationale for favoring nationality-based preferential treatment in Battlefield Triage. Adopting a nationality-based preference in this situation is more defensible than not. This does not make such a decision ethically right or just. Preference based on nationality is the least bad decision, but it is not morally blameless. It involves one in a serious moral wrong, a wrong otherwise avoided and contrary to one’s character. The virtuous military physician is in a situation in which obligations conflict, and we disagree with Gross, who posits that care of fellow soldiers “is important to the near exclusion of all else.”[33] Gross fails to appreciate the collective virtue of solidarity as applied to those in medicine. The military physician has duties to fellow soldiers but also to fellow physicians, to the medical community, and humanity. To favor a soldier on grounds of nationality violates her duties and responsibilities to this latter group. She is involved in a moral tragedy and can only seek the most just action given the circumstances, yet, at least in virtue ethics, the action remains far from blameless. CONCLUSION We argue that Battlefield Triage is a moral tragedy, meaning that it is a situation in which there is no morally blameless decision and that the demands of justice cannot be satisfied. As such, the virtuous military physician incurs a moral cost to acting as she does—there is a moral residue. However, despite being a moral tragedy, there are clear reasons to act in favor of treating one’s own, considering group solidarity. As such, these kinds of tragedies are resolvable: virtuous military physicians should favor treatment of their own, although they would do so with sorrow. - [1] Militaries set forth medical rules of eligibility or guidelines used to determine whether a person qualifies for specific medical interventions or treatments in certain circumstances, and these guidelines are binding for a military physician. For example, despite opposition from medical organizations, militaries have adopted reverse triage guidelines for military physicians to follow. For ethical discussion, see Falzone, Elisabeth, P. Pasquier, C. Hoffmann, O. Barbier, M. Boutonnet, A. Salvadori, A. Jarrassier, J. Renner, B. Malgras, and S. Mérat. "Triage in military settings." Anaesthesia Critical Care & Pain Medicine 36, no. 1 (2017): 43-51. https://doi.org/10.1016/j.accpm.2016.05.004 [2] There are issues that are related to this, including the triage of civilians and allied soldiers. We set related issues aside for purposes of this paper [3] American Medical Association, Code of Medical Ethics: Current Opinions with Annotations, 2004–2005 ed. (Chicago, IL: AMA, 2004), 300. [4] American Medical Association, Code of Medical Ethics: Current Opinions with Annotations, 2004–2005 ed. (Chicago, IL: AMA, 2004), 300. [5] This is termed the “dual loyalty” dilemma in military medicine and has been described at length elsewhere: Institute of Medicine (US) Board on Health Sciences Policy. Military Medical Ethics: Issues regarding Dual Loyalties: Workshop Summary. Washington (DC): National Academies Press (US); 2008. Toward a Framework for Resolving Dual Loyalties. Available from: https://www.ncbi.nlm.nih.gov/books/NBK214853/ [6] See Kenneth G. Swan and K.G. Swan, Jr., “Triage: The Past Revisited,” Military Medicine 161:8 (1996): 448–452. https://doi.org/10.1093/milmed/161.8.448; Jerome A. Singh, “American Physicians and dual loyalty obligations in the ‘war on terror,’” BMC Medical Ethics 4.4 (2003): 1–10. https://doi.org/10.1186/1472-6939-4-4; Beam, Thomas E. "Medical Ethics on the Battlefield." Military Medical Ethics: Sect. IV. Medical ethics in the military. Medical ethics on the battlefield: the crucible of military medical ethics 2 (2003): 369-402; Hereth, Blake. "Health justice for unjust combatants." Journal of Military Ethics 20, no. 1 (2021): 67-81. https://doi.org/10.1080/15027570.2021.1949782. [7] See Adams, Marcus P. "Triage priorities and military physicians." In Physicians at war: The dual-loyalties challenge, pp. 215-236. Dordrecht: Springer Netherlands, 2008. Gross, Michael L. "Comradery, community, and care in military medical ethics." Theoretical medicine and bioethics 32 (2011): 337-350. https://doi.org/10.1007/s11017-011-9189-6. Gross, Michael L. "The limits of impartial medical treatment during armed conflict." In Military medical ethics for the 21st century, pp. 71-84. Routledge, 2016. [8] World Medical Association, WMA Declaration of Lisbon on the Rights of the Patient. 5 December 2022, https://www.wma.net/policies-post/wma-declaration-of-lisbon-on-the-rights-of-the-patient/ [9] Geneva Convention for the Amelioration of the Condition of Wounded, Sick in Armed Forces in the Field. 12 August 1949. https://www.un.org/en/genocideprevention/documents/atrocity-crimes/Doc.30_GC-I-EN.pdf. [10] List, Justin M. "Medical neutrality and political activism: physicians' roles in conflict situations." In Physicians at war: The dual-loyalties challenge, pp. 237-253. Dordrecht: Springer Netherlands, 2008. 240 [11] Beauchamp, T., and J. Childress. 2013. Principles of Biomedical Ethics, 7th ed. Oxford, United Kingdom: Oxford University Press. [12] Adams, Marcus P. "Triage priorities and military physicians." In Physicians at war: The dual-loyalties challenge, pp. 215-236. Dordrecht: Springer Netherlands, 2008. [13] Gross, "Comradery, community, and care in military medical ethics," 347. [14] Gross, “Comradery, community, and care in military medical ethics,” 349. [15] Gross, Michael L. "When medical ethics and military ethics collide." Narrative inquiry in bioethics 13, no. 3 (2023): 199-204. 202 https://dx.doi.org/10.1353/nib.2023.a924191 [16] Our argument draws on virtue ethics, from which care ethics derives, and it is worth clarifying how our argument relates to Gross’s. We do not think that the virtue of friendship grounds triage decisions, for we think it is unlikely that the physician and wounded soldier are friends. Instead, as explained below, we think the collective virtue of group solidarity better captures the moral significance of group loyalty and that Gross would agree with us. But since military physicians are part of distinct groups, with competing obligations, the military physician will be forced to sacrifice a value in battlefield triage cases. In other words, we think Gross downplays the dual group membership of a military physician. [17] List,”Medical neutrality and political activism,” 250. [18] Adams,”Triage priorities and military physicians,” 235. [19] London, Leslie, Leonard S. Rubenstein, Laurel Baldwin-Ragaven, and Adriaan Van Es. "Dual loyalty among military health professionals: human rights and ethics in times of armed conflict." Cambridge Quarterly of Healthcare Ethics 15, no. 4 (2006): 381-391. 383. [20] Hursthouse, R. On Virtue Ethics. OUP 1999. 74 [21] Nussbaum, Martha C. "The costs of tragedy: Some moral limits of cost-benefit analysis." The Journal of Legal Studies 29, no. S2 (2000): 1005-1036, 1007. [22] De Wijze, S. (2005). Tragic-remorse–the anguish of dirty hands. Ethical theory and moral practice, 7(5), 453-471, 457. https://doi.org/10.1007/s10677-005-6836-x [23] Hursthouse, 73 [24] Hursthouse, 81 [25] Hursthouse, 72 [26] Aristotle, Politics 1253a8. Reeve, C. D. C., Indianapolis: Hackett Publishing Co., 2017 [27] Aristotle, Nicomachean Ethics. III.6.114a, 34-35. 2002, Nicomachean Ethics, Christopher Rowe (trans.), Oxford: Oxford University Press [28] Byerly, T. Ryan, and Meghan Byerly. "Collective virtue." The Journal of Value Inquiry 50, no. 1 (2016): 33-50. https://doi.org/10.1007/s10790-015-9484-y; Federico, Veronica. "Conclusion: solidarity as a public virtue." Solidarity as a Public Virtue (2018): 495-542. https://doi.org/10.5771/9783845290058. Rehg, William. "Solidarity and the common good: An analytic framework." Journal of Social Philosophy 38, no. 1 (2007): 7-21. https://doi.org/10.1111/j.1467-9833.2007.00363.x [29] Byerly and Byerly. "Collective virtue." 43 [30] Battaly, Heather. "Solidarity: Virtue or vice?." In Social virtue epistemology, pp. 303-324. Routledge, 2022. 304 [31] Ibid., 2011: 341 [32] It might be thought that displaying altruism by helping an enemy combatant at the expense of one’s fellow soldier may be psychologically satisfiying. For evidence that military physicians find it difficult to treat enemy combatants, see Lundberg, Kristina, Sofia Kjellström, Anders Jonsson, and Lars Sandman. "Experiences of Swedish military medical personnel in combat zones: adapting to competing loyalties." Military medicine 179, no. 8 (2014): 821-826. https://doi.org/10.7205/MILMED-D-14-00038. Lamblin, Antoine, Clément Derkenne, Marion Trousselard, and Marie-Ange Einaudi. "Ethical challenges faced by French military doctors deployed in the Sahel (Operation Barkhane): a qualitative study." BMC Medical Ethics 22 (2021): 1-13. https://doi.org/10.1186/s12910-021-00723-2 [33] Ibid., 2011: 344. (shrink)

Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not been (...) inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (shrink)

Las redes sociales asociadas al conocimiento resultan de interés tanto a los estudios en Ciencia Tecnología y Sociedad, como al desenvolvimiento del pensamiento de la complejidad que se desarrolla en el país. Su análisis explica la naturaleza social de la producción científica y la existencia del capital social, cuyas características se vinculan con la satisfacción y resolución de las necesidades sociales dentro de la población cubana. Se muestra una red, conformada en torno a la Publicación Archivo Médico de Camagüey, durante (...) los años 2003, 2004 y dos bimestres del 2005 sobre el desenvolvimiento de las co autorías dentro de ella. Delineando en qué forma los investigadores se relacionaron entre sí, para valorar algunos de sus resultados. Se describen, los grupos esenciales de investigación y sus principales fortalezas. Constituye una herramienta de trabajo, al exponer los cambios que están ocurriendo en torno a la Universidad Médica Camagüeyana The social networks associated to human knowledge are useful to the studies in Science Technology and Society. Their analysis explains the social nature of the scientific production and the existence of social resources, which link the satisfaction and resolution of the social necessities inside the Cuban population. The characteristics of this networks conformed in Archivo Médico de Camagüey publication on the development of co authorship from 2003 to 2005 were presented in this article. The researchers were related to each other in this work to value in which way they function together and analyze some of their results. The essential groups of investigation and their main strengths were also described. It constitutes a work tool for further research works, to considering the changes that are happening about the scientific knowledge production in Camagüey University of Medicine. (shrink)

Organic crosstalk or intercommunication among different organs is an interesting medical concept based on the biosemiotic perspective which considers the organism as a process maintained by the vital information flow between structural plane and biosemiotic plane, both with their different layers of biological complexity. From this point of view the organ is not merely the structure which produces crosstalk but just as much its product. The crosstalk perspective seeks two main goals: to investigate the characteristic serum biosemiotic patterns of (...) pathogenic organic crosstalk in order to achieve early diseases diagnosis, and to learn how to correct it. These achievements could allow physicians to evolve from a medical practice that focuses on misbiosemiotic effects, diagnosing and treating damaged organs, to a medical practice that focuses on misbiosemiotic processes, in this way diagnosing and treating pathogenic organ crosstalk before it culminates in organ damage. (shrink)

This paper analyzes the data collected about 5,388 videos from the 15 leading channels from Spain, the United Kingdom, and the United States focusing on toys and in which the protagonists are children under 14 years of age. It aims to determine whether there are common patterns of use, production, and activity in videos by kid YouTubers. Specific software was developed to enable information to be gathered from the YouTube platform through the YouTube Data API by analyzing the date on (...) which the video was published, length, number of visits, likes, dislikes, and visits/vote. The main conclusions drawn are that a channel’s success is not dependent on a pattern or specific characteristics, although an impulse pattern has been detected; participation by children who consume content in the United States differs significantly from participation by those in Europe; and certain similarities based on video length and production frequency can be observed between channels. (shrink)

As study of knowledge, epistemology attempts at identifying its necessary and sufficient conditions and defining its sources, structure and limits. From this pointof view, until present, there are no applied approaches to the Romanian archaeology. Consequently, my present paper presents an attempt to explore the structural characteristics of the knowledge creation process through the analysis of the results of a series of interviews conducted on Romanian archaeologists. The interviews followed a qualitative approach built upon a semi-structured frame. Apparent data (...) saturation was reached after four interviews within initial target group (senior researchers with institutional authority). Under these conditions a decision was made to continue the interviews within a secondary control group (young doctoral or post-doc researchers guided by members of the initial target group) in order to both verify the observed data saturation and to assess the impact of the attitude of senior researchers towards scientific research on the younger generation. The preliminary results allow to assert that Romanian archaeology is still caught in a highly conservative and intradisciplinarian manner of knowledge production with a negative effect on both new knowledgeproduction and future specialists’ education. (shrink)

Caplan has argued that the philosophy of medicine does not exist. Although I will not deny the points he makes, I will argue that the philosophy of medicine has characteristics of a developing field with the potential to meet all of Caplan's criteria. The argument is based on Dewey's established views on logical development for a field of inquiry, as well as pointing out how other criteria Caplan imposes can be fulfilled.

This work aims to increase the consumption of online tourism products and promote the development of the tourism economy. Based on this, it first analyses the Internet market under the guidance of consumer psychology. Then, the influencing factors of online product decision-making for the tourism economy are discussed. Finally, based on the above analysis, it discusses and evaluates the main factors affecting the consumption of online travel products. The research method of this work is set based on psychology so (...) that it can analyze the psychological state of consumers more deeply and promote the development of the consumer market. The results show that the main factors affecting the consumption of online travel products include online travel platforms and user characteristics. Specifically, approximately 80% of users consume online travel products based on platform reviews, approximately 10% of users consume online travel products based on platform recommended content, and approximately 5% of users consume online travel products based on platform search content. Users vary mainly by age, gender, and region and have different preferences for different platforms. Among the four major platforms, Ctrip occupies the most consumers. The conclusion is that the main way to develop the tourism economy is to build a better online travel platform. At the same time, it is necessary to promote online tourism according to the characteristics of users and increase the marketing of online tourism products. This work not only provides a reference for promoting online tourism product marketing but also helps to promote the development of the tourism economy. (shrink)

Patients who search for a better treatment, an increased quality of life, or even a chance to preserve life itself may claim to have an interest in accessing investigational medicinal products (IMP), particularly when no validated treatment for their disease or condition exists. For many, awaiting the uncertain and time-consuming process of converting an IMP into an approved drug may not appear a realistic option, as prognoses may be grim and a dramatic outcome may seem hard to avert. Gaining (...) access to an IMP, however, often proves to be a difficult enterprise with a highly uncertain outcome. In addition, the process of seeking access to IMP is surrounded by various ethical issues that will be explored in this article. This paper explores the ethical concerns in two potential tracks of seeking access to IMP for minors: on an individual basis, or collectively, as a patient organisation. In this discourse, several unique ethical and regulatory concerns related to the direct negotiation of access to IMP for minor patients are identified, with a focus on product safety, the recruitment of research subjects, the unnoticed entry of market mechanisms in the recruitment of research subjects, and the sidelining of third parties in the recruitment process. The paper concludes with a concise reflection on the way forward. The quest for access to investigational drugs is particularly relevant to paediatric practice, in which a significant share of the drugs prescribed has never been tested in children or labelled for use in the paediatric population. (shrink)

Psychiatry is a discipline that deals with both the physical and the mental lives of individuals and though it is true that, largely because of this characteristic, different models are used for different disorders, there is still a remnant tendency towards reductionist views in the field. In this paper I argue that the available empirical evidence from psychiatry gives us reasons to question biological reductionism and that in its place we should adopt a pluralistic explanatory model that is more suited (...) to the needs of the discipline and to the needs of the patients it is meant to help. This will allow us to retain psychiatry as an autonomous science that can productively co-exist with neuroscience while also giving patients the kind of attention they need. I further argue that this same evidence supports a view of the mind that is anti-reductive and that allows that causation can be both bottom-up and top-down and that such a view is available in emergentism coupled with an interventionist model of causation. (shrink)

Based on hierarchical classification and logistic regression of early US and French COVID-19 clinical trials we show that despite the registration of a large number of trials, only a minority had characteristics usually associated with providing robust and relevant evidence.

The attention for Moral case deliberation has increased over the past years. Previous research on MCD is often written from the perspective of MCD experts or MCD participants and we lack a more distant view to the role of MCD in Dutch health care institutions in general. The purpose of this paper is to provide an overview of the state of the art concerning MCD in the Netherlands. As part of a larger national study on clinical ethics support in the (...) Netherlands, we will focus on the prevalence and characteristics of MCD in Dutch health. A mixed methods design was used in which we combined two survey questionnaires, two focus groups and 17 individual interviews with top managers or ethics support staff. The findings demonstrate that the prevalence of MCD is relatively high in Dutch health care, especially in mental health care. Institutions with MCD differ from institutions without MCD concerning size, kind of problems and importance of ideological background. Characteristic of MCD is that it often exists for 3 years or more, has a high participation of health professionals and middle managers and is both organized scheduled as unscheduled. As well integration in existing policy as key persons emerge as important issues in relation to the positioning of MCD. We conclude that MCD is a part of an integrated ethics policy and serves as a catalyst for such an integrated ethics policy. (shrink)

This article presents a theory of how the consumption of Islamic products may promote morally consistent behavior over time. We identify and examine three unique meta-characteristics (MCs) of Islamic ethics: ubudiyah (subservience to God), akhirah (focus on the hereafter or the long-term), and tawado (being modest while doing an ethical act). In four experiments, we show that after consumption of an Islamic banking product, MCs produce moral consistency or repeat ethical behavior, which is one major objective of an (...) ethical system. We also show that the absence of MCs results in moral inconsistency, that is, unethical behavior follows earlier consumption of an Islamic banking product due to the mediating psychological mechanism of moral licensing. Hence, it is not only the enactment of general ethical practices, rather the enactment of ethical practices in the specific context set by the MCs through which Islamic ethical system promotes ethical conduct and prevents unethical conduct. The findings have implications for Islamic ethical system and Islamic banking. (shrink)