Since the human genome was sequenced in 2003, exploding knowledge and new technologies in the field of genomics have given rise to the new field of precision medicine, whereby treatment is individualized to patients based on their genomic information. However, as with any new scientific advancement and technology, precision medicine has the potential to improve health outcomes but raises ethical questions, particularly in children. Using pediatric precision oncology as an example, this paper focuses on the ethical (...) issues in the integration of genomic information in the management of children with cancer. Pediatric precision oncology encompasses the use of the child’s cancer genomic information and sometimes germline genomic information to aid in diagnosis, risk stratification, and prognostication, as well as “precisely” treating the cancer using genomically guided targeted therapies. The main ethical issues discussed in this paper include the difficulty in obtaining informed consent from parents and assent from the child, due to information overload, emotional overwhelm, cognitive biases, among others; the ambiguity between research and clinical care, leading to therapeutic misconception and mis-estimation; the utility of this novel technology and its impact on scarce resources; and the potential to widen health disparities thus affecting justice. Recognizing and addressing these ethical challenges will help guide the responsible implementation and integration of precision medicine into routine pediatric clinical care. (shrink)

The development of gene expression profiling and next-generation sequencing technologies have steered oncogenomics to the forefront of precision medicine. This created a need for harmonious cooperation between clinicians and researchers to increase access to precision oncology, despite multiple implementation challenges being encountered. The aim is to apply personalised treatment strategies early in cancer management, targeting tumour subtypes and actionable gene variants within the individual’s broader clinical risk profile and wellbeing. A knowledge-generating database linked to the South African (...) Medical Research Council’s Genomic Centre has been created for the application of personalised medicine, using an integrated service and research approach. Insights gained from patient experiences related to tumour heterogeneity, access to targeted therapies and incidental findings of pathogenic germline variants in tumour DNA, provided practice-changing evidence for the implementation of a cost-minimisation pathology-supported genetic testing strategy. Integrating clinical care with genomic research through data sharing advances personalised medicine and maximises precision oncology benefits. (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)

Research question and aim Clinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. This paper describes the development process and the activities performed 20 months from the CEC’s implementation, to increase knowledge about CEC’s implementation strategy. Research design We collected quantitative data related to number and characteristics of (...) CEC activities carried out from October 2020 to June 2022 using the CEC internal database. Data were reported descriptively and compared with data from the literature to provide a complete overview of the CEC’s development and implementation process. Participants and research context The study has been conducted at the local health authority (LHA) of Reggio Emilia. It is a report of the activities provided by the CEC, where no HPs or patients were involved. Ethical Considerations The report is part of a larger study named EVAluating a Clinical Ethics Committee implementation process (EvaCEC), which has been approved by the Local Ethics Committee (AUSLRE Protocollo n° 2022/0026554 of 24/02/2022). EvaCEC is also the first author's PhD project. Findings In total, the CEC performed 7 ethics consultations (EC), published three policies related to particular ethical questions of clinical and organizational practice, provided one educational online course on ethics consultation targeting employed HPs, and promoted a specific dissemination process among the different departments of the LHA. According to our results, the CEC widely fulfilled the standard threefold set of clinical ethics support services tasks (namely, ethics consultation, ethics education, and policy development), but further investigations are needed to evaluate the CEC’s impact on clinical practice. Conclusion Our findings may increase knowledge regarding the composition, role, and tasks of a CEC in an Italian setting, informing future strategies and efforts to regulate these institutions officially. (shrink)

Purpose: This review identifies the prominent topics in the literature pertaining to the ethical, legal, and social issues raised by research investigating personalized genomic medicine. Methods: The abstracts of 953 articles extracted from scholarly databases and published during a 5-year period were reviewed. A total of 299 articles met our research criteria and were organized thematically to assess the representation of ELSI issues for stakeholders, health specialties, journals, and empirical studies. Results: ELSI analyses were published in both scientific (...) and ethics journals. Investigational research comprised 45% of the literature reviewed and the remaining 55% comprised normative analyses. Traditional ELSI concerns dominated the discourse including discussions about disclosure of research results. In fact, there was a dramatic increase in the number of articles focused on the disclosure of research results and incidental findings to research participants. Few papers focused on particular disorders, the use of racial categories in research, international communities, or special populations. Conclusion: Considering that strategies in personalized medicine increasingly target individuals’ unique health conditions, environments, and ancestries, further analysis is needed on how ELSI scholarship can better serve the increasingly global, interdisciplinary, and diverse PGM research community. (shrink)

This book explores the ethical problems of algorithmic bias and its potential impact on populations that experience health disparities by examining the historical underpinnings of explicit and implicit bias, the influence of the social determinants of health, and the inclusion of racial and ethnic minorities in data. Over the last twenty-five years, the diagnosis and treatment of disease have advanced at breakneck speeds. Currently, we have technologies that have revolutionized the practice of medicine, such as telemedicine, precision medicine, big (...) data, and AI. These technologies, especially AI, promise to improve the quality of patient care, lower health care costs, improve patient treatment outcomes, and decrease patient mortality. AI may also be a tool that reduces health disparities; however, algorithmic bias may impede its success. This book explores the risks of using AI in the context of health disparities. It is of interest to health services researchers, ethicists, policy analysts, social scientists, health disparities researchers, and AI policy makers. (shrink)

Recent studies highlight the need for ethical and equitable digital health research that protects the rights and interests of racialized communities. We argue for practices in digital health that promote data self-determination for these communities, especially in data collection and management. We suggest that researchers partner with racialized communities to curate data that reflects their wellness understandings and health priorities, and respects their consent over data use for policy and other outcomes. These data governance approach honors and builds on (...) Indigenous Data Sovereignty (IDS) decolonial scholarship by Indigenous and non-indigenous researchers and its adaptations to health research involving racialized communities from former European colonies in the global South. We discuss strategies to practice equity, diversity, inclusion, accessibility and decolonization (EDIAD) principles in digital health. We draw upon and adapt the concept of Precision Health Equity (PHE) to emphasize models of data sharing that are co-defined by racialized communities and researchers, and stress their shared governance and stewardship of data that is generated from digital health research. This paper contributes to an emerging research on equity issues in digital health and reducing health, institutional, and technological disparities. It also promotes the self-determination of racialized peoples through ethical data management. (shrink)

Cancer has garnered increasing interest among philosophers. This chapter focuses on cancer medicine and precision oncology, an influential approach to cancer which seeks to individualize treatment on the basis of genetic or molecular features of disease. It reviews a range of ontological, epistemic, and ethical questions raised by precision oncology, relating developments in cancer medicine to broader issues in the philosophy of science and medicine.

Biobanks are essential biological database resources for the scientific community, enabling research on the molecular, cellular, and genetic basis of human disease. They are crucial for computational, data‐driven biomedical research, which advances precision medicine and the development of targeted therapies. However, biobanks often lack racial and ethnic diversity, with many data sets predominantly comprising individuals of white, primarily northern European, ancestry. Establishing or enhancing biobanks for the inclusion of historically underrepresented populations requires meticulous ethical and social planning (...) beyond logistical, legal, and economic considerations. This guide provides a roadmap for building and sustaining diverse biobanks, emphasizing ethical guidelines and cultural sensitivity. We highlight the importance of obtaining informed consent from donors, respecting their bodily autonomy, and the economic and research benefits of diverse biobanks to enable precision medicine, drug discovery, and industry‐academic partnerships. Prioritizing key ethical and social considerations allows biobanks to advance scientific knowledge while upholding the rights and autonomy of underrepresented populations. Diversity in biobank sample collection enhances research outcomes by ensuring findings are representative and applicable to various human population groups, fostering trust, promoting inclusivity, and addressing health disparities while informing health policy. This is vital to ensuring biobanking efforts contribute meaningfully to the advancement of health equity. (shrink)

Principles of ethics -- Medical research and clinical trials -- Treatment decision making -- Palliative and end-of-life care -- Patient advocacy -- Communication and ethics -- Genetics and genomics -- The impact of ethical conflict and dilemmas on nurses -- Ethics consultation and education.

This essay introduces this special issue on virtue ethics in relation to military AI. It describes the current situation of military AI ethics as following that of AI ethics in general, caught between consequentialism and deontology. Virtue ethics serves as an alternative that can address some of the weaknesses of these dominant forms of ethics. The essay describes how the articles in the issue exemplify the value of virtue-related approaches for these questions, before ending with thoughts for further research.

Patient-derived xenografts are currently promoted as new translational models in precision oncology. PDXs are immunodeficient mice with human tumors that are used as surrogate models to represent specific types of cancer. By accounting for the genetic heterogeneity of cancer tumors, PDXs are hoped to provide more clinically relevant results in preclinical research. Further, in the function of so-called “mouse avatars”, PDXs are hoped to allow for patient-specific drug testing in real-time. This paper examines the circulation of knowledge (...) and bodily material across the species boundary of human and personalized mouse model, historically as well as in contemporary practices. PDXs raise interesting questions about the relation between animal model and human patient, and about the capacity of hybrid or interspecies models to close existing translational gaps. We highlight that the translational potential of PDXs not only depends on representational matching of model and target, but also on temporal alignment between model development and practical uses. Aside from the importance of ensuring temporal stability of human tumors in a murine body, the mouse avatar concept rests on the possibility of aligning the temporal horizons of the clinic and the lab. We examine strategies to address temporal challenges, including cryopreservation and biobanking, as well as attempts to speed up translation through modification and use of faster developing organisms. We discuss how featured model virtues change with precision oncology, and contend that temporality is a model feature that deserves more philosophical attention. (shrink)

ABSTRACT In ethics, the use of empirical data has become more and more popular, leading to a distinct form of applied ethics, namely empirical ethics. This ‘empirical turn’ is especially visible in bioethics. There are various ways of combining empirical research and ethical reflection. In this paper we discuss the use of empirical data in a special form of Reflective Equilibrium (RE), namely the Network Model with Third Person Moral Experiences. In this model, the empirical data consist of the (...) moral experiences of people in a practice. Although inclusion of these moral experiences in this specific model of RE can be well defended, their use in the application of the model still raises important questions. What precisely are moral experiences? How to determine relevance of experiences, in other words: should there be a selection of the moral experiences that are eventually used in the RE? How much weight should the empirical data have in the RE? And the key question: can the use of RE by empirical ethicists really produce answers to practical moral questions? In this paper we start to answer the above questions by giving examples taken from our research project on understanding the norm of informed consent in the field of pediatric oncology. We especially emphasize that incorporation of empirical data in a network model can reduce the risk of self‐justification and bias and can increase the credibility of the RE reached. (shrink)

Ethical issues in biomedical research are traditionally examined as distinct from those of clinical care. However, this traditional framing may obscure questions of equity and fairness in both rese...

In ethics, the use of empirical data has become more and more popular, leading to a distinct form of applied ethics, namely empirical ethics. This 'empirical turn' is especially visible in bioethics. There are various ways of combining empirical research and ethical reflection. In this paper we discuss the use of empirical data in a special form of Reflective Equilibrium (RE), namely the Network Model with Third Person Moral Experiences. In this model, the empirical data consist of the moral (...) experiences of people in a practice. Although inclusion of these moral experiences in this specific model of RE can be well defended, their use in the application of the model still raises important questions. What precisely are moral experiences? How to determine relevance of experiences, in other words: should there be a selection of the moral experiences that are eventually used in the RE? How much weight should the empirical data have in the RE? And the key question: can the use of RE by empirical ethicists really produce answers to practical moral questions? In this paper we start to answer the above questions by giving examples taken from our research project on understanding the norm of informed consent in the field of pediatric oncology. We especially emphasize that incorporation of empirical data in a network model can reduce the risk of self-justification and bias and can increase the credibility of the RE reached. (shrink)

Psychosocial distress is highly prevalent in cancer patients, approaching rates around 40% across various cancer sites according to multicenter studies. As such, distress screening procedures have been developed and implemented to identify and respond to cancer patients' psychosocial distress and concerns. However, many cancer patients continue to report unmet psychosocial needs suggesting gaps in connecting patients with psychosocial services. Presently, there is a paucity of research examining sex-based disparities in referral rates to behavioral oncology services, particularly for adolescent (...) and young adult cancer patients. Informed by gender role conflict and empirical literature documenting disparities in cancer care and treatment based on a variety of sociocultural variables, this study aimed to examine the presence of sex disparities in referral rates to behavioral oncology services for AYA cancer patients. Data for this study consisted of 1,700 AYA cancer patients who completed a distress screening at a large cancer center of a teaching hospital in the Midwestern United. Results indicated that patient sex significantly predicted the odds of behavioral oncology referral. This finding indicates that female AYA cancer patients are 2.5 times more likely to be referred to behavioral oncology services compared to male AYA cancer patients after controlling for psychosocial distress and emotional, family, and practical problems. Additionally, we found that emotional problems significantly moderated the odds of referral for males and females, however the odds of referral for males who endorsed emotional problems were lower than males who did not endorse emotional problems. This contrasted with female AYA cancer patients where the endorsement of emotional problems increased the odds of referral to behavioral oncology services. Findings are discussed with particular focus on how to enhance equitable care and reduce sex and other sociocultural-based disparities in AYA psychosocial oncology. (shrink)

BackgroundThis study aims to quantitatively and qualitatively evaluate the activities of a Bioethics Unit (BU) 5 years since its implementation (2016–2020). The BU is a research unit providing empirical research on ethical issues related to clinical practice, clinical ethics consultation, and ethical education for health care professionals (HPS).MethodsWe performed an explanatory, sequential, mixed-method, observational study, using the subsequent qualitative data to explain the initial quantitative findings. Quantitative data were collected from an internal database and analyzed by descriptive analysis. (...) Qualitative evaluation was performed by semi-structured interviews with 18 HPs who were differently involved in the BU’s activities and analyzed by framework analysis.ResultsQuantitative results showed an extensive increment of the number of BU research projects over the years and the number of work collaborations with other units and wards. Qualitative findings revealed four main themes, concerning: 1. the reasons for contacting the BU and the type of collaboration; 2. the role of the bioethicist; 3. the impact of BU activities on HPs, in terms of developing deeper and more mature thinking; 4. the need to extend ethics support to other settings. Overall, our results showed that performing both empirical bioethics research and more traditional clinical ethics activities at the same unit would produce an impetus to increase collaboration and spread an 'ethical culture' among local HPs.ConclusionsOur findings contribute to a growing body of literature on the models of clinical ethics support services and the role of empirical research in bioethics internationally. They also prepare the ground for the implementation of a multidisciplinary Clinical Ethics Committee (CEC) that aims to support the BU’s ethics consultation service within the local context. (shrink)

The Defining Issues Test 2 (DIT-2) and Engineering Ethical Reasoning Instrument (EERI) are designed to measure ethical reasoning of general (DIT-2) and engineering-student (EERI) populations. These tools—and the DIT-2 especially—have gained wide usage for assessing the ethical reasoning of undergraduate students. This paper reports on a research study in which the ethical reasoning of first-year undergraduate engineering students at multiple universities was assessed with both of these tools. In addition to these two instruments, students were also asked to create (...) personal concept maps of the phrase “ethical decision-making.” It was hypothesized that students whose instrument scores reflected more postconventional levels of moral development and more sophisticated ethical reasoning skills would likewise have richer, more detailed concept maps of ethical decision-making, reflecting their deeper levels of understanding of this topic and the complex of related concepts. In fact, there was no significant correlation between the instrument scores and concept map scoring, suggesting that the way first-year students _conceptualize_ ethical decision making does not predict the way they behave when _performing_ scenario-based ethical reasoning (perhaps more situated). This disparity indicates a need to more precisely quantify engineering ethical reasoning and decision making, if we wish to inform assessment outcomes using the results of such quantitative analyses. (shrink)

Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and (...) physicians' experiences of the pediatric oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents. Due to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes. (shrink)

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for (...) class='Hi'>research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. (shrink)

Cardiovascular disease is the leading cause of death of women in the United States, yet cardiovascular research is disproportionately conducted using male human subjects and male animal models. This article deploys Katrina Hutchison’s (2019) analysis of gender disparity in clinical trials as a moral aggregation problem to address the problem of underrepresentation of women in cardiovascular research. I identify cost concerns, convenience, pregnancy, and negligence as potential reasons for the underrepresentation of women in CVD research. Finally, I (...) suggest that multilevel strategies will be needed to eliminate sex disparity in CVD research and improve patient care. (shrink)

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

Lee emphasizes the need to better understand the moral relationship between researchers and participants connoted by precision medicine, with the framework of “the gift” offering bioethics a...

Background: Ethical climate and moral distress have been shown to affect nurses’ ethical behaviour. Despite the many ethical issues in paediatric oncology nursing, research is still lacking in the field. Research aim: To investigate paediatric oncology nurses’ perceptions of ethical climate and moral distress. Research design: In this cross-sectional study, data were collected using Finnish translations of the Swedish Hospital Ethical Climate Survey–Shortened and the Swedish Moral Distress Scale–Revised. Data analysis includes descriptive statistics and non-parametric (...) analyses. Respondents and research context: Ninety-three nurses, working at paediatric oncology centres in Finland, completed the survey. Ethical considerations: According to Finnish legislation, no ethical review was needed for this type of questionnaire study. Formal research approvals were obtained from all five hospitals. Return of the questionnaire was interpreted as consent to participate. Results: Ethical climate was perceived as positive. Although morally distressing situations were assessed as highly disturbing, in general they occurred quite rarely. The situations that did appear often reflected performing procedures on school-aged children who resist such treatment, inadequate staffing and lack of time. Perceptions of ethical climate and frequencies of morally distressing situations were inversely correlated. Discussion: Although the results echo the recurrent testimonies of busy work shifts, nurses could most often practise nursing the way they perceived as right. One possible explanation could be the competent and supportive co-workers, as peer support has been described as helpful in mitigating moral distress. Conclusion: Nurturing good collegial relationships and developing manageable workloads could reduce moral distress among nurses. (shrink)

Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of disparate compensation rules violates the ethical principle of fairness. The current paper presents a comparison of the policies of Brazil, Russia, India, China and South Africa. A systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration. The search focused (...) on three main areas namely bibliographic data bases, clinical practice guidelines data bases and a restricted internet search. A manual search of references cited in relevant guideline documents was also conducted. The search terms, Medical Subject Headings and key words were developed for a PubMed platform and then adapted for all other data bases. The search terms were kept constant for each country with the only difference being the country name. The documents so obtained were subjected to systematic content analysis. The study revealed that there is vast panoply of regulations which exist on a continuum. On one extreme is India with comprehensive regulations that are codified into law, and on the other end there is China which does not have specific laws regulating research related injuries. There are a number of differences and similarities such as mandatory insurance requirements, existence of no fault compensation, compensable injuries and the role of research ethics committees. It is imperative to enact legislations that protect participants without stifling the research enterprise. There is need for consistency and ideally harmonization of such regulations at a global level. A model policy on compensation for research related injuries should borrow from the best aspects of the different country policies and should be informed by the cardinal ethics principles of autonomy, justice and beneficence. (shrink)

Implicit biases involve associations outside conscious awareness that lead to a negative evaluation of a person on the basis of irrelevant characteristics such as race or gender. This review examines the evidence that healthcare professionals display implicit biases towards patients. PubMed, PsychINFO, PsychARTICLE and CINAHL were searched for peer-reviewed articles published between 1st March 2003 and 31st March 2013. Two reviewers assessed the eligibility of the identified papers based on precise content and quality criteria. The references of eligible papers were (...) examined to identify further eligible studies. Forty two articles were identified as eligible. Seventeen used an implicit measure, to test the biases of healthcare professionals. Twenty five articles employed a between-subjects design, using vignettes to examine the influence of patient characteristics on healthcare professionals’ attitudes, diagnoses, and treatment decisions. The second method was included although it does not isolate implicit attitudes because it is recognised by psychologists who specialise in implicit cognition as a way of detecting the possible presence of implicit bias. Twenty seven studies examined racial/ethnic biases; ten other biases were investigated, including gender, age and weight. Thirty five articles found evidence of implicit bias in healthcare professionals; all the studies that investigated correlations found a significant positive relationship between level of implicit bias and lower quality of care. The evidence indicates that healthcare professionals exhibit the same levels of implicit bias as the wider population. The interactions between multiple patient characteristics and between healthcare professional and patient characteristics reveal the complexity of the phenomenon of implicit bias and its influence on clinician-patient interaction. The most convincing studies from our review are those that combine the IAT and a method measuring the quality of treatment in the actual world. Correlational evidence indicates that biases are likely to influence diagnosis and treatment decisions and levels of care in some circumstances and need to be further investigated. Our review also indicates that there may sometimes be a gap between the norm of impartiality and the extent to which it is embraced by healthcare professionals for some of the tested characteristics. Our findings highlight the need for the healthcare profession to address the role of implicit biases in disparities in healthcare. More research in actual care settings and a greater homogeneity in methods employed to test implicit biases in healthcare is needed. (shrink)

There is little information about the content of ethics consultations in pediatrics. We sought to describe the reasons for consultation and ethical principles addressed during EC in pediatrics through retrospective review and directed content analysis of EC records at St. Jude Children's Research Hospital. Patient-based EC were highly complex and often involved evaluation of parental decision making, particularly consideration of the risks and benefits of a proposed medical intervention, and the physician's fiduciary responsibility to the patient. Nonpatient consultations provided (...) guidance in the development of institutional policies that would broadly affect patients and families. This is one of the few existing reviews of the content of pediatric EC and indicates that the distribution of ethical issues and reasons for moral distress are different than with adults. Pediatric EC often facilitates complex decision making among multiple stakeholders, and further prospective research is need.. (shrink)

Medication reconciliation for pediatric oncology patientparticipants enrolled in clinical trials often reveals the use of chemical complementary medicine alongside protocol therapeutic agents. Considering the blurry delineation between clinical ethics and research ethics, this paper demonstrates how complementary medicine-related protocol violations introduce ethical questions of who should be included and excluded from clinical trials and offers recommendations on how to manage physician-patient-family interactions around these challenging issues.

The Australian Health Ethics Committee’s National Statement on Ethical Conduct in Research Involving Humans (1999) expanded the health and medical focus of preceding statements by including all disciplines of research. The Statement purports to promote a uniformly high ethical standard for this expanded range of research, and is endorsed by, inter alia, the Australian Academy of the Humanities, the Australian Academy of Science, and the Academy of Social Sciences in Australia.High ethical standards should apply to all (...) class='Hi'>research involving humans. However, uniformity in the review processes of disparate research endeavours is not a necessary condition for uniformly high ethical standards. Bringing the ethical review of all research under a model which has developed within the context of health and medical research ethics for over thirty years may be inappropriate and at times incoherent. The language, methods, nature and products of research in areas such as the Humanities are often very different from those of health, medical and other sciences.The Behavioural and Social Sciences Ethics Review Committee at The University of Queensland (UQ) had, since the mid-1980s, considered that the guidelines of the time did, in fact, cover all aspects of human experimentation. We describe the ways in which this position was implemented, how issues raised by the new wording in the National Statement have been recently managed by UQ’s research ethics committees, and point to outstanding questions. (shrink)

Background Providing care to children with cancer is one of the most challenging areas of ethical care for nurses. Few studies have addressed nurses’ perception of the barriers to giving ethical care in oncology departments. Thus, it is essential that the ethical challenges in caregiving as perceived by oncology nurses be investigated. Objective The present study was conducted to investigate the ethical challenges as perceived by nurses in pediatric oncology units in the south of Iran. Research (...) design The present study is a qualitative work of research with a conventional content analysis design. Data were collected via individual semi-structured interviews. The collected data were analyzed using the qualitative content analysis method. Participants and research context The participants were 21 nurses from pediatric oncology units in state hospitals who were selected by purposeful sampling. Sampling continued until the data were saturated. The study lasted from April to October 2022. Findings Three main themes, promoting psychological safety in the children, respect for the dignity of the children, and expansion of support for families, and nine subthemes were extracted from the data. Ethical considerations The study’s protocol was approved by the Research Ethics Committee of the University of Medical Sciences and ethical principles were followed throughout the study. Discussion and conclusion From the nurses’ perspective, the major ethical challenges in providing ethical care in pediatric oncology units were reducing tension toward promoting the patients’ psychological safety, showing respect for the identity and dignity of the children with cancer, and expanding support of the patients’ families. By creating the right cultural and professional context and establishing proper protocols, healthcare policymakers and administrators can take effective steps toward eliminating the barriers to providing ethical care. (shrink)

Aim: This study was carried out in order to determine ethical decision-making levels of oncology nurses. Ethical Consideration: Research Ethics Committee's approval was obtained prior to the data collection. Permission to use the Turkish version of the Nursing Dilemma Test was received from Birgül Cerit. Written approval was taken from school administrators to conduct the study confirming that there were no invasive procedures planned for human beings during the study period. The study was conducted in accordance with the (...) Helsinki Declaration. Verbal consent was obtained from each of the nurses who agreed to participate after they were informed about the study content. Method: The population of this study conducted in a descriptive way consisted of a total of 96 nurses working at the oncology units and outpatient chemotherapy units of four different hospitals between September 2017 and March 2018. The study sample included 60 nurses who responded to the question form. The data of the study were collected using “Nurses Information Questionnaire” and “Nursing Dilemma Test” developed by Crisham in 1981. Results: Oncology nurses’ mean scores in Principled Thinking (49.00 ± 6.46) and those in Practical Considerations (18.35 ± 4.47) were found to be above the moderate level. It was determined that the oncology nurses participated in the study were familiar with situations similar to the dilemmas included in the Nursing Dilemma Test (15.00 ± 4.20). Conclusion: It was concluded that oncology nurses try to take ethical principles into consideration but are also affected by environmental factors while making decisions concerning ethical dilemmas. The most frequently encountered ethical dilemmas by oncology nurses include the following: deciding not to perform cardiopulmonary resuscitation, telling the truth to the patient, studies being carried out without the patient’s content, and patient’s refusal of treatment. In order to improve oncology nurses’ critical thinking and ethical decision-making skills, it is important to determine ethical dilemmas encountered by oncology nurses, and nurses should be encouraged to be involved in ethical decision-making process through cooperation with the other healthcare personnel. (shrink)

As opposed to a ‘one size fits all’ approach, precision medicine uses relevant biological, medical, behavioural and environmental information about a person to further personalize their healthcare. This could mean better prediction of someone’s disease risk and more effective diagnosis and treatment if they have a condition. Big data allows for far more precision and tailoring than was ever before possible by linking together diverse datasets to reveal hitherto-unknown correlations and causal pathways. But it also raises ethical issues (...) relating to the balancing of interests, viability of anonymization, familial and group implications, as well as genetic discrimination. This article analyses these issues in light of the values of public benefit, justice, harm minimization, transparency, engagement and reflexivity and applies the deliberative balancing approach found in theEthical Framework for Big Data in Health and Research to a case study on clinical genomic data sharing. Please refer to that article for an explanation of how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. Our discussion is meant to be of use to those involved in the practice as well as governance and oversight of precision medicine to address ethical concerns that arise in a coherent and systematic manner. (shrink)

Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research (now called T1 ). Whether or not T1 has these features, (...) translational research beyond approval ( T2 : phase IV, health services, and implementation research) is unlikely to and, when conducted on the global poor, may support development. Therefore, insofar as T1 is morally problematic, and no independent objections to T2 exist, the ethics of translational research is diverse: while some translational research is problematic, some is not. Funding and oversight should reflect this diversity, and T2 should be encouraged, particularly when conducted among the global poor. (shrink)

Background Over the last decade, the return of results (ROR) in precision medicine research (PMR) has become increasingly routine. Calls for individual rights to research results have extended the “duty to report” from clinically useful genetic information to traits and ancestry results. ROR has thus been reframed as inherently beneficial to research participants, without a needed focus on who benefits and how. This paper addresses this gap, particularly in the context of PMR aimed at increasing participant (...) diversity, by providing investigator and researcher perspectives on and questions about the assumed value of ROR in PMR.Methods Semi-structured interviews with a purposive sample of investigators and researchers across federally funded PMR studies in three national consortia, as well as observations of study activities, focused on how PM researchers conceptualize diversity and implement inclusive practices across research stages, including navigating ROR.Results Interviewees (1) validated the value of ROR as a benefit of PMR, while others (2) questioned the benefit of clinically actionable results to individuals in the absence of sufficient resources for translating findings into health care for diverse and disadvantaged populations; (3) expressed uncertainties in applying the presumed value of ROR as a benefit for non-clinical results; and (4) and debated when the promise of the value of ROR may undermine trust in PMR, and divert efforts to return value beyond ROR.Conclusions Conceptualizations of diversity and inclusion among PM researchers and investigators raise unique ethical questions where unexamined assumptions of the value of ROR inform study recruitment efforts to enroll minoritized and under-represented populations. A lack of consideration for resources and infrastructure necessary to translate ROR into actionable information may hinder trustworthy community-research relationships. Thus, we argue for a more intentional interrogation of ROR practices as an offer of benefit and for whom. (shrink)

Background: The nature of children’s cancer comes with lots of ethical issues. Nurses are encouraged to adhere to ethical codes in their practice. Objectives: This study aimed to compare the perspectives of nurses and mothers of children with cancer regarding the adherence of nurses to ethical codes. Research design: In this descriptive-comparative study, a researcher-made questionnaire was used to assess the amount of adherence to Iranian nurses’ code of ethics in perspectives of pediatric oncology nurses and mothers. As (...) a convention, the total scores were categorized as optimal, average, and low adherence. Participants and context: A total of 200 mothers and 60 nurses in pediatric oncology wards of five major hospitals in Tehran, Iran, participated in 2016. Ethical considerations: Organizational approval by the university and informed consent were ensured before conducting the research. The principles of voluntariness, confidentiality, and anonymity were respected during the research process. Findings: Results showed the mean score of the adherence to ethical codes by nurses, as per the nurses is 86.71 (12.57) and as per the mothers is 78.67 (16.09). The highest frequency for “Low adherence” and “Optimal adherence” to code of ethics by nurses were “Respect for individual autonomy and decision-making” (mothers, 72% and nurses, 70%) and “Commitment to confidentiality” (mothers, 64% and nurses, 74%), respectively. This revealed a significant difference between the responses of the nurses and the mothers (p = 0.001). Discussion: The results support the other studies in Iran about the difference between the perspectives of patients and nurses about adherence of nurses to ethical codes. Conclusion: Integration of family-centered and conventional care in addition to more attention to the education of professional ethical principles could be helpful to improve the ethical performance of nurses in oncology pediatric wards. (shrink)

In this paper, I defend an account of the ethics of precision medicine that can explain both its possibilities and limits. Creating a new conceptual and normative model of the ethics of precision health can ensure that good medicine is also excellent and that excellent medicine is also good by providing a resource to scientists and clinicians. First, I propose a new conceptual analysis of precision health. I argue that precision health is defined primarily by targeted (...) medical interventions and not by stratification, as others have asserted. Next, I argue that failure to be adequately responsive to this conceptual analysis explains common ethical abuses in the field. Third, I argue that this conceptual analysis can also pave the way for future research heretofore overlooked. Thus, we can limit abuses in precision health research and care while at the same time opening new avenues to help historically oppressed communities. (shrink)

Personalized medicine with its promise of developing interventions tailored to an individual's health need and genetically related response to treatment might seem a promising antidote to the documented underutilization of standard depression treatments by African Americans. In addition, understanding depression not merely in biochemical terms but also in genetic terms might seem to counter cultural beliefs and stigma that attach to depression when conceived as a mood or behavioral problem under an individual's control. After all, if there is one thing (...) for which a person is not responsible and cannot be blamed, it is her genes. Nevertheless, for multiple reasons, a personalized medical approach to depression treatment, and its attendant conceptualization of depression and treatment response as genetically influenced, present the risk of exacerbating well-documented disparities in access to, and utilization of, treatment for depression among African-American and Caucasian elderly adults. (shrink)

Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents new challenges for protecting human subjects. The extent to which the current “web” of legal protections, including technical data security measures, as well as measures to restrict access or prevent misuse of research data, will protect participants in this context remains largely unknown. Understanding the strength, usefulness, and limitations of this constellation of laws, (...) regulations, and procedures is critical to ensuring not only that participants are protected, but also that their participation decisions are accurately informed. To address these gaps, we conducted in-depth interviews with a diverse group of 60 thought-leaders to explore their perspectives on the protections associated with precision medicine research. (shrink)

Background: Providing oncological care to children is demanding and ethical issues concerning what is best for the child can contribute to moral distress. Objectives: To explore healthcare professionals’ experiences of situations that generate moral distress in Swedish paediatric oncology. Research design: In this national study, data collection was conducted using the Swedish Moral Distress Scale-Revised. The data analysis included descriptive statistics and non-parametric analysis of differences between groups. Participants and research context: Healthcare professionals at all paediatric (...) class='Hi'>oncology centres in Sweden were invited to participate. A total of 278 healthcare professionals participated. The response rate was 89%. Ethical considerations: In its advisory statement, the Regional Ethical Review Board decided that the study was of such a nature that the legislation concerning ethical reviews was not applicable. All participants received written information about the aim of the study and confidentiality. Participants demonstrated their consent by returning the survey. Findings: The two situations with the highest moral distress scores concerned lack of competence and continuity of personnel. All professional groups reported high levels of disturbance. Nurses rated significantly higher frequencies and higher total Moral Distress Scale scores compared to medical doctors and nursing assistants. Discussion: Lack of competence and continuity, as the two most morally distressing situations, confirms the findings of studies from other countries, where inadequate staffing was reported as being among the top five morally distressing situations. The levels of total Moral Distress Scale scores were more similar to those reported in intensive care units than in other paediatric care settings. Conclusion: The two most morally distressing situations, lack of competence and continuity, are both organisational in nature. Thus, clinical ethics support services need to be combined with organisational improvements in order to reduce moral distress, thereby maintaining job satisfaction, preventing a high turnover of staff and ensuring the quality of care. (shrink)

Background and AimPsycho-oncology is a cross-disciplinary and collaborative sub-specialty of oncology that focuses on the psychological, behavioral, ethical, and social aspects of cancer in clinical settings. The aim of this bibliometric study was to analyze and characterize the research productivity and trends in psycho-oncology between 1980 and 2021.MethodologyIn May 2022, the Scopus® database was searched for psycho-oncology-related publications using predetermined search keywords with specific restrictions. Lotka’s law was applied to check the authors’ productivity, while Bradford’s (...) law was used to assess the core journals in this field. The data was analyzed for different bibliometric indicators in the Biblioshiny package, an RStudio tool for bibliometric analysis.ResultsThe initial search resulted in a total of 2,906 publications. Of which, 1,832 publications were included in the final analysis, published between 1980 and 2021. The analyzed publications were written by 7,363 authors from 74 countries and published in 490 journals. There has been a significant increase in psycho-oncology-related publications after 2010. The most productive year was 2021. The annual scientific growth rate was found to be 13.9%. The most relevant leading author in terms of publications was Luigi Grassi from the University of Ferrara, Italy. Lotka’s law found that the number of authors declined as the number of papers written increased. The core journals were Psycho-Oncology, Supportive Care in Cancer, and Journal of Psychosocial Oncology. The most frequently used author’s keywords other than searching keywords were cancer, oncology, quality of life, depression, and anxiety. Recent psycho-oncology-related topics included mental health, COVID-19 infection in humans, people, pandemic, and tumor. The University of Sydney was the top-ranked institution. The leading country in terms of publications, citations, corresponding author country, and international collaboration was the United States of America. The United States had the strongest collaboration with Australia and Canada.ConclusionThe research hotspots include mental health conditions and interventions in cancer patients. We identified international collaboration and research expenditure to be strongly associated with psycho-oncology research productivity. Researchers’ collaboration, which is visible among developed countries, should be extended to low-income countries in order to expand psycho-oncology-related research and understanding. (shrink)

This article presents results from an empirical investigation of the role and importance of ethics in the daily work of Danish oncologyphysicians and Danish molecular biologists. The study is based on 12 semi-structured interviews with three groups of respondents: a group of oncology physicians working in a clinic at a public hospital and two groups of molecular biologists conducting basic research, one group employed at a public university and the other in a private biopharmaceutical company.We found that (...) class='Hi'>oncology physicians consider ethical evaluation as part of their daily work. They discuss how to treat patients in groups and they have interdisciplinary seminars. In contrast, molecular biologists employed at the university do not think that basic research causes significant ethical problems, they do not talk about ethics in their daily work and they do not want to prioritise seminars on ethics. Molecular biologists employed in a private biopharmaceutical company do not think that basic research causes significant ethical problems, but the private company prioritises ethical evaluation. If the company behaves unethical, they will be punished by the consumers and by the investors in the last end. In general, oncology physicians working in the clinic experience a closer relationship between their daily work and ethical problems concerning human beings than molecular biologists conducting basic research. (shrink)

Genomic medicine has the potential to contribute to the development of an array of novel technologies within the clinical armoury, making possible early detection and management of high-risk conditions such as cancer. While significant impact has already been felt in the context of rare inherited single gene disorders, much of the advancement in patient care through genomic medicine more broadly is going to be made possible by research involving large data sets that enable analyses of multiple genetic variants that (...) contribute to risk of common diseases. 1 As well as informing diagnosis and treatment of these diseases, these advances will support prediction and prevention. Considering risk prediction, combining data from multiple variants can produce a polygenic (or integrated) score (PGS/IGS). This will provide more accurate prediction than simply relying on environmental risk factors. While still in their early stages of development and implementation, it is clear that translation... (shrink)

There has been a spurt in both fundamental and translational research that examines the underlying mechanisms of the human microbiome in psychiatric disorders. The personalized and dynamic features of the human microbiome suggest the potential of its manipulation for precision psychiatry in ways to improve mental health and avoid disease. However, findings in the field of microbiome also raise philosophical and ethical questions. From a philosophical point of view, they may yet be another attempt at providing a biological (...) cause for phenomena that ultimately cannot be so easily localized. From an ethical point of view, it is relevant that the human gut microbiome comprises data on the individual’s lifestyle, disease history, previous medications, and mental health. Massive datasets of microbiome sequences are collected to facilitate comparative studies to identify specific links between the microbiome and mental health. Although this emerging research domain may show promise for psychiatric patients, it is surrounded by ethical challenges regarding patient privacy, health risks, effects on personal identity, and concerns about responsibility. This narrative overview displays the roles and advances of microbiome research in psychiatry and discusses the philosophical and ethical implications of microbiome big data and microbiome-based interventions for psychiatric patients. We also investigate whether these issues are really “new,” or “old wine in new bottles.”. (shrink)

This study explored the perceptions of ethics among long-term care employees (N275) in order to test two hypotheses. A cohort cross-sectional survey examined employees’ perceptions of an ethics environment, racial-ethnic, and position disparities (HO1; ANOVA), and, secondarily, ethics in relationship to select, research-grounded work features measured as manage disagreements, effectiveness, work satisfaction, and opinions of care, the latter including intention to remain (HO2; Pearson Correlations). Established questionnaires with robust psychometrics were employed. Response rate was 51%. Non-significant differences between sample (...) and population on key variables supported extrapolation of results. Statistically significant differences between racial–ethnic (p < 0.03; F 2.42) and work positions (p <0.0001; F 6.24) were revealed on ethics (3.16; HO1). Statistically significant relationships (p <0.0001; r = 0.26–0.68; HO2) between ethics and employees’ work features also were found, confirming both hypotheses. Perceptions of ethics based on racial-ethnic and position disparities, as well as the robust links with employee work features, offered potential avenues for decreasing disparities at work and improving the quality of long-term care. Noted further on ethics item scoring were relatively low scores indicating less involvement in, and access to, ethics discussions and decisions. In contrast, the literature review substantiated the importance of empowerment and retention, which were enhanced by employee involvement in work, notably, discussions and decisions. Thus, implications of ethics committees in long-term care sites as ways to potentially enhance employees’ work and quality of care, especially work satisfaction and retention, were explored; relevant concerns raised by the Covid pandemic were, briefly, discussed. (shrink)