Search Results (80)

Artificial intelligence (AI) is rapidly transforming healthcare through applications in clinical decision support, diagnostic imaging, population health management, and workflow optimization. Despite these advances, real-world deployment continues to expose critical challenges related to safety, bias, transparency, and integration into clinical workflows. Algorithmic bias can exacerbate health disparities, limited explainability may undermine clinician trust, and insufficient validation and post-deployment monitoring can compromise patient safety. Although the World Health Organization (WHO) has established six ethical principles for AI in health, including autonomy, well-being and safety, transparency, accountability, equity, and sustainability, translating these high-level principles into practical and enforceable governance mechanisms remains a persistent challenge. This narrative review synthesizes insights from bioethics, health policy, computer science, and clinical medicine to identify gaps in current AI governance approaches and proposes a lifecycle-aligned governance-by-design framework that operationalizes WHO ethical principles across key stages of the healthcare AI lifecycle, including data collection, model development, validation, deployment, and post-deployment monitoring. The framework integrates concrete governance mechanisms such as consent governance, fairness evaluation, external validation, explainability, clinician oversight, and continuous performance monitoring. Overall, this work advances a practical, lifecycle-integrated approach to AI governance and provides a structured foundation for developing safe, equitable, and trustworthy AI systems in healthcare. Full article

Background/Objectives: Precision medicine has moved into routine practice, but its evaluation through Health Technology Assessment (HTA) remains ethically underdeveloped. Existing instruments do not address the distinctive ethical demands of genomic profiling, AI-based clinical decision-support, and the equitable distribution of benefits from high-cost targeted therapies. Methods: A modified two-round Delphi study was conducted with a multidisciplinary panel of 18 Greek experts in bioethics, HTA, genomic medicine, nursing, and health policy. In Round 1, 32 candidate ethical statements across seven thematic domains were rated on a three-point scale; retention required a Content Validity Ratio (CVR) ≥ 0.42 and ≥80% agreement. Retained statements were re-evaluated in Round 2 with consensus defined as median ≥ 2.0 and ≥80% agreement. Reporting follows ACCORD guidelines. Results: Fifteen of 32 statements satisfied retention criteria. In Round 2, all 15 achieved consensus with a median of 3.0 and agreement of 94.4–100% (interquartile range, IQR = 0.00). Five domains constituted the final framework: fundamental ethical principles; transparency, stakeholder participation, and institutional accountability; equity and access; digital health and artificial intelligence (AI); and pandemic preparedness and system resilience. Domains addressing environmental sustainability and social acceptability did not meet the threshold. Conclusions: This study presents, to our knowledge, one of the first empirically grounded ethical frameworks for precision medicine HTA developed within an EU Member State through a formal Delphi process. The framework is operationalised through a ready-to-use ethics checklist designed for direct integration into national HTA submission and appraisal processes. Conducted in Greece—a late-aligning EU Member State—the study provides a transferable methodological template for comparable health systems across Europe. Full article

Background/Objectives: Advances in paediatric care have increased the survival of children with severe neurological impairment, often accompanied by complex disability, multimorbidity, and a substantial treatment burden. Determining whether interventions provide meaningful benefit to the child is ethically challenging, particularly when decision-making is shared between parents and clinicians, while the child has limited capacity to participate directly in decision-making. This paper examines the guiding question “what’s in it for the kid?” as a means of strengthening child-centred ethical deliberation alongside established frameworks. Methods: We undertook a conceptual bioethical analysis informed by clinical experience in an inner city tertiary public hospital. The analysis focuses on children with severe neurological impairment and medical complexity. The paper critically examines how the guiding question aligns with and extends key ethical constructs, including shared decision-making, the Zone of Parental Discretion, the Best Interests Standard, and care ethics. Clinical scenarios are used illustratively to demonstrate application in practice. Results: Existing ethical frameworks form an important foundational structure for complex decision-making. The question “what’s in it for the kid” translates ethical principles into a practical moral prompt that centres the child as the subject of decision-making. It facilitates clearer consideration of risks, benefits meaningful to the child and lived experience and helps to distinguish the child’s interests from those of parents and clinicians. Its simplicity enhances accessibility and supports consistent use in complex, high-stakes decisions. Conclusions: “What’s in it for the kid?” is a pragmatic and accessible ethical prompt that complements established frameworks by translating them into clinically usable practice. It promotes explicit, child-focused deliberation and supports a more transparent and child-centred evaluation of benefit and burden, particularly in contexts of uncertainty and medical complexity. Full article

Spirituality and religiosity (S/R) are significant dimensions in mental health care and provide an important foundation for spiritual care, particularly in sociocultural contexts where religious beliefs are deeply embedded in personal and collective life. This study investigates the role of S/R in the treatment of psychiatric patients hospitalized in a private mental health clinic in southern Brazil. Using validated instruments—the Centrality of Religiosity Scale (CRS-10BR), the Brief-RCOPE-14, and the Inventory of Attachment to God (IAD-Br)—the study assessed religious centrality, coping strategies, and attachment styles to God among 100 participants. Based on CRS parameters, the sample was classified as predominantly “religious.” The findings revealed that most patients identified with some form of religion or belief in God, reported moderate to high levels of positive religious coping, and predominantly exhibited secure attachment patterns. Statistically significant correlations were observed between higher religiosity, greater use of positive coping strategies, and lower avoidance in the relationship with God. Despite these findings, spiritual and religious aspects were rarely addressed in clinical interactions. The findings are discussed through the lens of clinical bioethics, emphasizing the ethical relevance of spirituality and religiosity in psychiatric care and highlighting the relevance of developing practical approaches to spiritual care within a whole-person, patient-centered model. Full article

Background: The relationship between AMH (anti-Müllerian hormone) levels, fat distribution, and insulin resistance in women with PCOS has been widely studied, yet findings remain inconsistent. Recent guidelines emphasize the growing role of AMH in PCOS diagnosis and suggest its potential inclusion among diagnostic criteria, highlighting its relevance for guiding therapeutic management. Objectives: This retrospective study aimed to evaluate the association between AMH levels and metabolic parameters in overweight and obese reproductive-age women with PCOS. Ethical approval was obtained from the bioethics committee. Methods: Two groups of 52 women each were selected from PCOS patients treated at our clinic between 2024 and 2025: one with a waist-to-hip ratio (WHR) ≤ 0.85 and the other with a WHR > 0.85. Venous blood samples were collected to measure AMH, fasting glucose, and fasting insulin. Body height and weight were recorded to calculate body mass index (BMI), and insulin resistance was assessed using HOMA-IR. Waist and hip circumferences were measured to determine WHR. Results: The association between central adiposity and AMH in overweight and obese women with PCOS depended on insulin resistance. In insulin-resistant women, higher WHR was linked to lower AMH, whereas in women without insulin resistance, higher WHR corresponded to higher AMH levels. Conclusions: Insulin resistance appears to influence AMH in opposite directions depending on a woman’s WHR, suggesting its potential role in tailoring individualized treatment strategies. Full article

Background: Conducting research in emergency departments and critical care units is crucial for improving patient management through evidence-based practices. Healthcare professionals and researchers in the field of traumatic brain injury (TBI) have a moral and legal obligation to inform patients before conducting any diagnostic test or therapy as part of a clinical study. However, challenges and barriers to conducting research in these high-pressure environments must be acknowledged. Shall the pathway to obtain informed consent in TBI-related research be revisited? We sought to map literature, identify gaps, and clarify the bioethics that should be followed in TBI-related research. Methods: A Scoping review was conducted to identify the obstacles and challenges investigators encounter in clinical and translational TBI research, with a specific emphasis on informed consent and regulatory impediments that often serve as bottlenecks or rate-limiting steps for participant enrollment and overall study success. This review used google scholar and Midline from inception to 2025. Results: Patients with TBI or their surrogates may be unable to provide informed consent within limited therapeutic windows. Despite international regulations and national laws, restrictions on obtaining consent are often criticized as ambiguous in certain situations. Furthermore, the fast-paced, emotionally charged atmosphere in emergency settings poses a risk of delaying crucial research interventions. There are accepted alternatives to informed consent, such as proxy consent, deferred consent, exceptions from consent, and waivers of consent, which are ethically and socially acceptable and compliant with regulations. However, these alternatives are underutilized or may be abused in some cases. Conclusions: This review calls for clarifying and modifying arbitrary regulatory restrictions on research and streamlining the Common Rule. Scientists should also share their innovative solutions to strike a balance between ethical considerations and the minimization of research barriers. Full article

Bioethics education has become established as an essential component for addressing the ethical challenges associated with biomedical development, biotechnology, and decision-making in the healthcare field. Although numerous studies have analyzed the teaching of bioethics among medical students and other health professions, empirical research on bioethics literacy in religious formation contexts remains limited. The objective of this study was to evaluate the level of bioethical knowledge (here operationalized as bioethics literacy) among Catholic seminarians in Colombia and to explore the psychometric properties of a questionnaire designed to measure bioethics literacy in this population. A cross-sectional observational study was conducted through the administration of a structured questionnaire consisting of 32 multiple-choice items with a single correct answer addressing philosophical foundations, personalist bioethics, bioethical principles, clinical bioethics, and issues related to biotechnology. A total of 216 complete questionnaires were analyzed using descriptive statistics and exploratory psychometric analyses, including item difficulty and discrimination, internal consistency, and exploratory factor analysis. The results showed a moderate overall level of bioethics literacy, with better performance in applied domains such as clinical bioethics and bioethical principles, and lower levels of correct responses in philosophical foundations and personalist bioethics. The questionnaire showed moderate internal consistency and a preliminary factorial structure, suggesting its usefulness as an exploratory tool for assessing bioethical knowledge in seminary educational contexts. These results highlight the importance of strengthening the integration between philosophical and theological education and the applied analysis of bioethical problems in seminary educational programs. Full article

Background/Objectives: Necrotizing enterocolitis (NEC) is an inflammatory disease with an incidence of about one in 1000 live births, much higher in premature and low birth weight newborns. Intestinal dysbiosis is an important element in the pathogenesis of NEC, and for this reason, experimental models have been used to administer fecal microbiota transplants (FMTs) for prophylaxis and treatment of NEC with very satisfactory results. The primary endpoint of the study is safety, defined as the incidence of adverse events (AEs) and serious adverse events (SAEs) occurring from the time of intervention until hospital discharge, classified according to severity and assessed for relatedness to the intervention. Methods: This prospective, single-arm, open-label clinical study will include 20 infants born between 24 0/7 and 36 6/7 weeks of gestation. FMTs will be administered twice as a deep rectal infusion via a Foley catheter. The donors of the material from which the FMT will be prepared will be women in the third trimester of pregnancy. The safety of the therapy will be assessed by comparison with a control group, i.e., 20 patients who will meet the same inclusion criteria and will not meet any of the exclusion criteria, subject to the same hospital observation but without undergoing any medical/therapeutic intervention other than the collection of biological material. Discussion: The study will provide data on the safety and initial efficacy of FMT in this group of patients, which will allow for further research into the use of this method in the prevention of infections and NEC. Ethics: The study protocol was approved by the Bioethics Committee of the Medical University of Warsaw, Warsaw, Poland (KB/52/2025). All procedures will follow the principles of the Declaration of Helsinki. The results of the study will be submitted for knowledge translation in peer-reviewed journals and presented at national and international pediatric society conferences. Clinical Trial Registration: The study is registered at ClinicalTrials.gov: ID: NCT06333405. Full article

Intranasal drug delivery represents a transformative “backdoor” to the brain, bypassing the blood–brain barrier (BBB) that bars 98% of small molecules and nearly all large biopharmaceuticals. By harnessing the unique anatomy of the olfactory and trigeminal nerves, therapeutics can travel directly from the nasal cavity to the central nervous system, achieving therapeutic concentrations without the systemic toxicity of traditional routes. Clinical and preclinical evidence highlight the efficacy of intranasal insulin (INI) in treating Alzheimer’s disease (AD) and delirium, with studies showing significant improvements in cognitive scores and reduced hospital stays (7.9 vs. 12.9 days; p = 0.014). Additionally, other peptides can be administered intranasally like oxytocin, neuropeptide Y, and novel metabolic modulators for neuroprotection and affective disorders (AD, autism, Down syndrome). Despite these promises, critical translational gaps remain, including anatomical differences between macrosmatic rodents and microsmatic humans, and significant sex-based dosing dimorphism. The ease of intranasal administration introduces profound bioethical dilemmas regarding neuroenhancement, authenticity, and informed consent in vulnerable populations. The current literature concludes that realizing the full potential of nose-to-brain (N2B) therapy requires a commitment to precision medicine, utilizing specialized delivery devices and objective biomarkers to ensure safe and equitable clinical application. Full article

Background: Clinical Ethics Consultation (CEC) helps healthcare professionals, patients, and families address ethically complex situations in clinical practice. Since 2016, requests for CEC at the Fondazione Policlinico Universitario “A. Gemelli” IRCCS (FPG) have been entered into the hospital IT system like other consulting services. This has increased both the number of requests and the need to monitor and evaluate the service. Aims: This qualitative study investigates how the CEC service at FPG is perceived in terms of its value, role, and impact, and further aims to identify appropriate strategies for evaluating the service. Methods: Semi-structured interviews were conducted with 28 healthcare professionals who had used or taken part in the service within the previous two years. Data were examined using reflective thematic analysis, leading to the development of codes and themes. Results: Five main themes emerged: (1) Role and identity of the clinical ethics consultant the, (2) Benefits of CEC for clinical practice, (3) How to evaluate the CEC Service, (4) HCPs’ Evaluation, and (5) CEC Service Improvement Strategies. Participants saw the consultant as an “active third party” who combines ethical, clinical, and communication skills to mediate conflicts, support teamwork, and guide shared care planning. The service was viewed as strengthening patient-centered care by improving communication with patients and families, clarifying treatment proportionality, and reducing clinicians’ decisional isolation. Interviewees emphasized the need for structured evaluation tools that include both quantitative indicators and qualitative feedback. Satisfaction with the service was consistently high, with recommendations to expand consultant availability, improve timeliness, and enhance training. Conclusions: CEC appears to serve as a clinical, relational, and training resource that fosters ethically grounded, collaborative, and person-centered care. Full article

Genome editing (GE) has transformed medicine by allowing precise changes to DNA, offering potential treatments for a range of inherited and acquired disorders. Several technologies support these advances, including zinc-finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and clustered regularly interspaced short palindromic repeats (CRISPR)-based systems, of which the latter has emerged as the most accessible, versatile, and popular. While GE holds great promise, its clinical use requires careful attention to safety, ethics and regulatory standards. Inadvertent on- and off-target DNA alterations and unintended modification of non-target cells pose major technical challenges, while bioethical considerations and the need for harmonized safety standards create regulatory challenges. The Food and Drug Administration (FDA) and European Medicines Agency (EMA), as regulatory agencies for key advanced therapy markets, provide detailed guidance on these aspects, emphasizing rigorous preclinical testing, patient monitoring, ethical consent, and compliance with legal frameworks. This concise review summarizes what is currently published in the scientific literature and recommended by regulatory agencies, providing an overview of the responsible clinical application of GE, with emphasis on patient safety, adherence to regulatory guidance, and ethical practice. Full article

This review synthetizes experimental evidence on collagen-related bioactivity and the biomaterial potential of plant species native to the Chihuahuan Desert, aiming to identify natural compounds that could enhance next-generation dermal bioinks for 3D bioprinting. A structured search across major databases included studies characterizing plant extracts or metabolites, with reported effects on collagen synthesis, fibroblast activity, inflammation, oxidative balance, or interactions with polymers commonly used in skin-engineering materials being developed. Evidence was organized thematically to reveal mechanistic patterns despite methodological heterogeneity. Several species, among them Larrea tridentata, Opuntia spp., Aloe spp., Matricaria chamomilla, Simmondsia chinensis, Prosopis glandulosa, and Artemisia ludoviciana, repeatedly demonstrated the presence of bioactive metabolites such as lignans, flavonoids, phenolic acids, terpenoids, and polysaccharides. These compounds support pathways central to extracellular matrix repair, including stimulation of fibroblast migration and collagen I/III expression, modulation of inflammatory cascades, antioxidant protection, and stabilization of ECM structures. Notably, several metabolites also influence viscoelastic and crosslinking behaviors, suggesting that they may enhance the printability, mechanical stability, and cell-supportive properties of collagen-, GelMA-, and hyaluronic acid-based bioinks. The review also reflects on the bioethical and sustainability considerations regarding endemic floral resources, highlighting the importance of responsible sourcing, conservation extraction practices, and alignment with international biodiversity and access to benefit/sharing frameworks. Taken together, these findings point to a promising, yet largely unexplored, opportunity: integrating regionally derived phytochemicals into bioinks to create biologically active, environmentally conscious, and clinically relevant materials capable of improving collagen remodeling and regenerative outcomes in 3D-printed skin. Full article

Background/Objectives: Neonatal Intensive Care Units (NICUs) constitute a highly complex clinical environment characterized by patient fragility and frequent ethically sensitive decisions. To date, systematic studies investigating how Italian NICUs address these challenges and what forms of ethics support are effectively available are lacking. The aim of this study is therefore to assess how ethical issues are managed in Italian NICUs, with particular attention to the availability, use, and perceived usefulness of clinical ethics support in everyday practice. Methods: A 25-item questionnaire was developed by adapting an existing tool for investigating clinical ethics activities to the neonatal context. Following expert review by the GIBCE (Gruppo Interdisciplinare di Bioetica Clinica e Consulenza Etica in ambito sanitario), the final instrument covered four areas (general data, experience with ethical dilemmas, tools and procedures, opinions and training needs). A manual web search identified all Italian NICUs and their clinical directors, who were asked to disseminate the survey among staff. Participation was voluntary and anonymous. Data collection was conducted via Google Forms and analyzed through qualitative thematic analysis. Results: A total of 217 questionnaires were collected. The most frequent ethical dilemmas concern quality of life with anticipated multiple or severe disabilities (72.4%) and decisions to withdraw or withhold life-sustaining treatments (64.5%). Major challenges include fear of medico-legal repercussions (57.6%) and communication divergences between physicians and nurses (49.8%). More than half of respondents (52.1%) reported no formal training in clinical ethics, and 68.7% had never developed a Shared Care Plan (Shared Document for healthcare ethics planning) as defined by the Italian Law 219/2017. Conclusions: Findings highlight marked fragmentation in ethical practices across Italian NICUs. On this basis, establishing structured and accessible CEC services could help promote consistency, reinforce shared ethical standards, and support transparent and equitable decision-making in critical neonatal care. Full article

Poor diet is the leading preventable risk factor for death worldwide, associated with over 10 million premature deaths and USD 8 trillion related costs every year. Artificial intelligence or AI is rapidly emerging as the most historically disruptive, innovatively dynamic, rapidly scaled, cost-efficient, and economically productive technology (which is increasingly providing transformative countermeasures to these negative health trends, especially in low- and middle-income countries (LMICs) and underserved communities which bear the greatest burden from them). Yet widespread confusion persists among healthcare systems and policymakers on how to best identify, integrate, and evolve the safe, trusted, effective, affordable, and equitable AI solutions that are right for their communities, especially in public health nutrition. We therefore provide here the first known global, comprehensive, and actionable narrative review of the state of the art of AI-accelerated nutrition assessment and healthy eating for healthcare systems, generated by the first automated end-to-end empirical index for responsible health AI readiness and maturity: the Responsible Health AI readiness and Maturity Index (RHAMI). The index is built and the analysis and review conducted by a multi-national team spanning the Global North and South, consisting of front-line clinicians, ethicists, engineers, executives, administrators, public health practitioners, and policymakers. RHAMI analysis identified the top-performing healthcare systems and their nutrition AI, along with leading use cases including multimodal edge AI nutrition assessments as ambient intelligence, the strategic scaling of practical embedded precision nutrition platforms, and sovereign swarm agentic AI social networks for sustainable healthy diets. This index-based review is meant to facilitate standardized, continuous, automated, and real-time multi-disciplinary and multi-dimensional strategic planning, implementation, and optimization of AI capabilities and functionalities worldwide, aligned with healthcare systems’ strategic objectives, practical constraints, and local cultural values. The ultimate strategic objectives of the RHAMI’s application for AI-accelerated public health nutrition are to improve population health, financial efficiency, and societal equity through the global cooperation of the public and private sectors stretching across the Global North and South. Full article

One Health envisions integrated governance across human, animal, and environmental systems to prevent and respond to complex health threats. Despite its global endorsement, One Health implementation often falters due to institutional fragmentation, power asymmetries, and ethical tensions that erode trust and cooperation. This paper proposes the integration of medical-bioethics mediation within One Health governance as a structured, relational mechanism to manage conflict, foster ethical deliberation, and strengthen trust between sectors and communities. We develop a conceptual framework to apply the mediation principles of neutrality, confidentiality, respect, and shared problem-solving beyond clinical ethics toward multisectoral One Health contexts. The framework is illustrated through domain-specific examples from zoonotic disease control, antimicrobial resistance, and environmental health. Medical bioethics mediation can advance conflict transformation, ethical reflection, participatory decision-making, and policy alignment, thereby supporting transparent negotiation of values and institutionalized dialogue of different One Health actors. Future research should pilot mediation-based governance models and assess their effects on intersectoral trust, collaborative capacity, and integrated health outcomes. Full article