Search Results (27)

The persistence of a binary biomedical framework in healthcare has become increasingly inadequate to address the realities of human diversity. Recent literature highlights how this dichotomous model reinforces inequities for transgender and intersex populations, sustaining barriers to access, stigmatisation, and poorer health outcomes. In this Perspective, I critically reflect on the limitations of the binary paradigm and draw on developments in science, clinical practice, education, and policy to propose a future-oriented approach to health equity. Emerging evidence underscores the complexity of sexual development as a spectrum and the urgent need to move from pathological frameworks toward affirming care based on rights. Key advances include the adoption of affirmative care models, reforms in medical curriculum, and the rise of inclusive research methodologies that capture gender diversity beyond binaries. However, structural barriers—such as rigid clinical protocols, outdated educational content, and insufficient policy alignment—continue to hinder meaningful change. This article advocates for systemic transformation in healthcare education, practice, and research. I outline strategic priorities for the field are the implementation of gender diversity in medical training, the implementation of rights-based clinical guidelines, and the design of inclusive methodologies that remove structural discrimination. These actions are essential to build a more precise, ethical and universally inclusive health system. Ultimately, ensuring sustainable and equitable outcomes requires bridging scientific innovation with human rights principles and focussing on the lived experiences of transgender and intersex individuals. Full article

(1) Background: Data literacy is becoming increasingly important for healthcare professionals in both outpatient care and research. Since healthcare data and the possibilities for its use and misuse are increasing in these areas, healthcare professionals need diverse knowledge regarding the collection, use and evaluation of data. A core component of this is an understanding of the ethical, legal, and social implications (ELSI) of working with health data. (2) Methods: Within the DIM.RUHR project (Data Competence Center for Interprofessional use of Health Data in the Ruhr Metropolis), the challenge of training in data literacy for different healthcare professionals is addressed. Based on a learning objectives matrix for interprofessional data literacy education, an ELSI concept was developed through collaboration with interprofessional project partners. The study was conducted between December 2024 and April 2025. (3) Results: The foundational structure of the ELSI concept was based on the learning objectives matrix and an unstructured literacy search for ELSI concepts in similar contexts. Using an iterative design-based research approach, a group of experts from different fields (didactics, applied ethics, health sciences, law, sociology, informatics, and psychology) developed an ELSI concept for healthcare professionals. The following categories were identified as crucial: 1. philosophy of science: a basic understanding of science and the hurdles and opportunities; 2. ethics: an overview of the biomedical principles and a technological assessment; 3. law: an overview of the reservation of permission and self-determination; 4. social aspects: an overview of health inequalities and different forms of power relations and imbalances. (4) Conclusions: The ELSI concept can be used in the orientation of healthcare professionals in outpatient care and research—regardless of their profession—to develop data competencies, with the aim of providing a holistic view of the challenges and potential in the collection, use, and evaluation of healthcare data. The DIM.RUHR project’s approach is to develop open educational resources that build on the ELSI concept to teach specific skills at different competence levels. Full article

Two-dimensional cell culture systems lack the ability to replicate the complex, three-dimensional (3D) architecture and cellular microenvironments found in vivo. Multicellular spheroids (MCSs) present a promising alternative, with the ability to mimic native cell–cell and cell–matrix interactions and provide 3D architectures similar to in vivo conditions. These factors are critical for various biomedical applications, including cancer research, tissue engineering, and drug discovery and development. Polymeric materials such as hydrogels, solid scaffolds, and ultra-low attachment surfaces serve as versatile platforms for 3D cell culture, offering tailored biochemical and mechanical cues to support cellular organization. This review article focuses on the structure–property relationships of polymeric biomaterials that influence MCS formation, growth, and functionality. Specifically, we highlight their physicochemical properties and their influence on spheroid formation using key natural polymers, including collagen, hyaluronic acid, chitosan, and synthetic polymers like poly(lactic-co-glycolic acid) and poly(N-isopropylacrylamide) as examples. Despite recent advances, several challenges persist, including spheroid loss during media changes, limited viability or function in long-term cultures, and difficulties in scaling for high-throughput applications. Importantly, the development of MCS platforms also supports the 3R principle (Replacement, Reduction, and Refinement) by offering ethical and physiologically relevant alternatives to animal testing. This review emphasizes the need for innovative biomaterials and methodologies to overcome these limitations, ultimately advancing the utility of MCSs in biomedical research. Full article

Background/Objectives: Human pluripotent stem cells (hPSCs) and organoid technologies are transforming pharmaceutical research by providing models that more accurately reflect human physiology, genetic variability, and disease mechanisms. This review aims to assess how these systems improve the predictive power of preclinical drug development while addressing ethical concerns and supporting the advancement of precision medicine. Methods: We conducted a comprehensive review of the recent literature focusing on the biological principles, technological developments, and pharmaceutical applications of hPSC- and organoid-based systems. Particular attention was given to patient-derived models, integration of omics approaches, bioengineering advances, and artificial intelligence applications in drug screening workflows. Results: hPSC- and organoid-based platforms outperform traditional 2D cultures and animal models in replicating human-specific pathophysiology, enabling personalized drug testing and improving predictions of therapeutic efficacy and safety. These technologies also align with the ethical principles of the 3Rs (replacement, reduction, and refinement) by reducing reliance on animal experimentation. However, challenges persist, including standardization of protocols, batch-to-batch variability, and scalability. Promising solutions involve automation, high-throughput screening, and multi-omics integration, which collectively enhance reproducibility and translational relevance. Conclusions: Stem cell- and organoid-based systems offer a more human-relevant, ethical, and individualized approach to biomedical research. Despite current limitations, ongoing interdisciplinary innovations are expected to accelerate their clinical and industrial adoption. Collaborative efforts will be essential to standardize methodologies and fully realize the potential of these models in bridging preclinical and clinical drug development. Full article

This paper examines the ethical frameworks that guide Āyurvedic practices and compares them with those underlying contemporary Western medicine. At the heart of current bioethical debates is the question of whether certain principles can be universally valid across cultures. This paper argues that while the moral vision of Āyurvedic medicine significantly differs from that of Western medicine in various respects, both systems share fundamental ethical principles, notably beneficence and non-maleficence. However, important distinctions arise in their respective conceptions of autonomy and justice, suggesting that these principles may not be as universally applicable as the former two. Drawing on the “four principles” approach of modern Western medical ethics, as outlined in Beauchamp and Childress’s Principles of Biomedical Ethics, this paper challenges the assumption that the principles of autonomy and justice are culturally neutral. Through a comparison with Āyurvedic ethics, we highlight how these principles may not be as universally relevant as commonly assumed, raising important questions about the possibility of a global bioethical framework. Full article

Large language models (LLMs) have emerged as powerful tools for (semi-)automating the initial screening of abstracts in systematic reviews, offering the potential to significantly reduce the manual burden on research teams. This paper provides a broad overview of prompt engineering principles and highlights how traditional PICO (Population, Intervention, Comparison, Outcome) criteria can be converted into actionable instructions for LLMs. We analyze the trade-offs between “soft” prompts, which maximize recall by accepting articles unless they explicitly fail an inclusion requirement, and “strict” prompts, which demand explicit evidence for every criterion. Using a periodontics case study, we illustrate how prompt design affects recall, precision, and overall screening efficiency and discuss metrics (accuracy, precision, recall, F1 score) to evaluate performance. We also examine common pitfalls, such as overly lengthy prompts or ambiguous instructions, and underscore the continuing need for expert oversight to mitigate hallucinations and biases inherent in LLM outputs. Finally, we explore emerging trends, including multi-stage screening pipelines and fine-tuning, while noting ethical considerations related to data privacy and transparency. By applying systematic prompt engineering and rigorous evaluation, researchers can optimize LLM-based screening processes, allowing for faster and more comprehensive evidence synthesis across biomedical disciplines. Full article

Microfluidic technology plays a crucial role in organ-on-a-chip (OoC) systems by replicating human physiological processes and disease states, significantly advancing biomedical research and drug discovery. This article reviews the design and fabrication processes of microfluidic devices. It also explores how these technologies are integrated into OoC platforms to simulate human physiological environments, highlighting key principles, technological advances, and diverse applications. Through case studies involving the simulation of multiple organs such as the heart, liver, and lungs, the article evaluates the impact of OoC systems’ integrated microfluidic technology on drug screening, toxicity assessment, and personalized medicine. In addition, this article considers technical challenges, ethical issues, and future directions, and looks ahead to further optimizing the functionality and biomimetic precision of OoCs through innovation, emphasizing its critical role in promoting personalized medicine and precision treatment strategies. Full article

Foundation Models (FMs) are gaining increasing attention in the biomedical artificial intelligence (AI) ecosystem due to their ability to represent and contextualize multimodal biomedical data. These capabilities make FMs a valuable tool for a variety of tasks, including biomedical reasoning, hypothesis generation, and interpreting complex imaging data. In this review paper, we address the unique challenges associated with establishing an ethical and trustworthy biomedical AI ecosystem, with a particular focus on the development of FMs and their downstream applications. We explore strategies that can be implemented throughout the biomedical AI pipeline to effectively tackle these challenges, ensuring that these FMs are translated responsibly into clinical and translational settings. Additionally, we emphasize the importance of key stewardship and co-design principles that not only ensure robust regulation but also guarantee that the interests of all stakeholders—especially those involved in or affected by these clinical and translational applications—are adequately represented. We aim to empower the biomedical AI community to harness these models responsibly and effectively. As we navigate this exciting frontier, our collective commitment to ethical stewardship, co-design, and responsible translation will be instrumental in ensuring that the evolution of FMs truly enhances patient care and medical decision-making, ultimately leading to a more equitable and trustworthy biomedical AI ecosystem. Full article

Living donor kidney transplantation (LDKT) currently represents the treatment of choice for patients with end-stage renal failure. LDKT is a serious event with profound psychological, interpersonal, familial, and social implications. Over the last few years, there has been an exponential growth in living donation programs involving genetically and emotionally related donors, as well as people who donate to an unrelated and unknown subject. The implementation of paired exchange programs, Samaritan donation, and preemptive transplantation raise further ethical issues, which are inextricably linked to the unique psychosocial context of both the donor and the recipient. The present narrative review aims to provide an update on the main ethical challenges related to LDKT. We conducted a comprehensive literature search in PubMed/Medline. The results of the most relevant studies were narratively synthesized from a psychosocial perspective around the four principles of biomedical ethics: autonomy, beneficence, non-maleficence, and justice. Finally, we discussed the potential future directions to provide an effective, patient-centered, and ethical psychosocial assessment and follow-up of living donors and recipients that underwent LDKT. Full article

Recent advancements in 3D bioprinting and microfluidic lab-on-chip systems offer promising solutions to the limitations of traditional animal models in biomedical research. Three-dimensional bioprinting enables the creation of complex, patient-specific tissue models that mimic human physiology more accurately than animal models. These 3D bioprinted tissues, when integrated with microfluidic systems, can replicate the dynamic environment of the human body, allowing for the development of multi-organ models. This integration facilitates more precise drug screening and personalized therapy development by simulating interactions between different organ systems. Such innovations not only improve predictive accuracy but also address ethical concerns associated with animal testing, aligning with the three Rs principle. Future directions include enhancing bioprinting resolution, developing advanced bioinks, and incorporating AI for optimized system design. These technologies hold the potential to revolutionize drug development, regenerative medicine, and disease modeling, leading to more effective, personalized, and humane treatments. Full article

The meaning of justice can be defined according to a juridical, human, theological, ethical, biomedical, or social perspective. It should guarantee the protection of life and health, personal, civil, political, economic, and religious rights, as well as non-discrimination, inclusion, protection, and access to care. In this review, we deal with three theoretical concepts that define justice in all its aspects. (1) The utilitarian theory, which justifies moral statements on the basis of the evaluation of the consequences that an action produces, elaborating a pragmatic model of medical science. (2) The libertarian theory, which considers freedom as the highest political aim, thus absolutizing the rights of the individual; here, the principle of self-determination, with respect to which the principle of permission/consent is the fundamental presupposition, plays a central role in the definition of the person. (3) The iusnaturalist theory, in which man’s moral freedom is identified with the ability to act by choosing what the intellect indicates to him as good; the natural moral law that drives every conscience to do good is therefore realized in respect for the person in the fullness of his rights. In conclusion, different forms and conceptions of justice correspond to different organizations of society and different ways of addressing ethical issues in the biomedical domain. Full article

Background: Research model selection decisions in basic and preclinical biomedical research have not yet been the subject of an ethical investigation. Therefore, this paper aims, (1) to identify a spectrum of reasons for choosing between animal and alternative research models (e.g., based on in vitro or in silico models) and (2) provides an ethical analysis of the selected reasons. Methods: In total, 13 researchers were interviewed; the interviews were analyzed qualitatively. The ethical analysis was based on the principlism approach and a value judgement model. Results: This paper presents 66 reasons underlying the choice of researchers using animal (27 reasons) or alternative models (39). Most of the reasons were assigned to the work environment (29) and scientific standards (22). Other reasons were assigned to personal attitudes (11) and animal welfare (4). Qualitative relevant normative differences are presented in the ethical analysis. Even if few reasons can be rejected outright from an ethical point of view, there are good reasons to give some more weight than others. Conclusions: The spectrum of reasons and their ethical assessment provide a framework for reflection for researchers who may have to choose between animal models and (investing in) alternatives. This can help to reflect on and ethically justify decisions. Full article

(1) Background: Caring for pregnant cancer patients is clinically and ethically complex. There is no structured ethical guidance for healthcare professionals caring for these patients. (2) Objective: This concept paper proposes a theoretically grounded framework to support ethical and patient-centred care of pregnant cancer patients. (3) Methodological approach: The framework development was based on ethical models applicable to cancer care during pregnancy—namely principle-based approaches (biomedical ethics principles developed by Beauchamp and Childress and the European principles in bioethics and biolaw) and relational, patient-focused approaches (relational ethics, ethics of care and medical maternalism)—and informed by a systematic review of clinical practice guidelines. (4) Results: Five foundational discussion themes, summarising the key ethical considerations that should be taken into account by healthcare professionals while discussing treatment and care options with these patients, were identified. This was further developed into a comprehensive ethics checklist that can be used during clinical appointments and highlights the need for a holistic view to patient treatment, care and counselling while providing ethical, patient-centric care. (5) Conclusion: The proposed framework was further operationalised into an ethics checklist for healthcare professionals that aims to help them anticipate and address ethical concerns that may arise when attending to pregnant cancer patients. Further studies exploring clinicians’ attitudes towards cancer treatment in the course of pregnancy and patient experiences when diagnosed with cancer while pregnant and wider stakeholder engagement are needed to inform the development of further ethical, patient-centred guidance. Full article

Background and objectives: Healthcare organizations have endured significant challenges and relied upon telehealth and related technological advances during the COVID-19 pandemic to allow for the sustainment of care. The purpose of this study was to systematically identify healthcare cybersecurity ethical concerns experienced during the pandemic to assist with the sustainability of the delivery of care going forward. Methods: This study was guided by Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocols for systematic reviews and focused on cybersecurity in healthcare organizations that published articles during the COVID-19 pandemic (March 2020 through October 2022). The articles were accessed using the EBSCOhost and Pub-Med (which queries MEDLINE) platforms, through which the Academic Search Complete, MEDLINE Complete, and Complementary Index databases were accessed. Follow-on supplementary topic modeling allowed for the additional application of ethical principles to the review findings. Results: Among the 22 articles that met the inclusion criteria, three ethical concerns were identified by the rapid review: smart and medical technology concerns (73% of occurrences), at-risk population cybersecurity (55% of occurrences), and legal challenges in data protection (73% of occurrences). The research team also conducted a latent Dirichlet allocation (LDA) analysis, identifying three topics from the review corpus: robotic and biomedical/clinical care outcomes, diagnostic applications, and public health data usage. These were then mapped to primary ethical healthcare principles. Conclusions: The sustainment of healthcare technology interoperability and related telehealth initiatives involves the ongoing assessment of cybersecurity threats and adequate knowledge of related ethical stakeholder concerns to promote ongoing care delivery. Full article

The widespread use of digital technologies that can be worn on our bodies—wearables—is presented as a turning point for various areas of biomedical research and healthcare, such as stress. The ability to constantly measure these parameters, the perceived quality of measurement, and their individual and personal level frame wearable technology as a possibly crucial step in the direction of a more accurate and objective definition and measurement of stress for clinical, research, and personal purposes. In this paper, we discuss the hypothesis that the use of wearables for stress is also beneficial from an ethical viewpoint. We start by situating wearables in the context of existing methods and limitations of stress research. On this basis, we discuss the ethics of wearables for stress by applying ethical principles from bioethics (beneficence, non-maleficence, autonomy, justice), which allows us to identify ethical benefits as well as challenges in this context. As a result, we develop a more balanced view of the ethics of wearables for stress, which we use to present recommendations and indications with a focus on certification, accessibility, and inclusion. This article is, thus, a contribution towards ethically grounded wearable and digital health technology for stress. Full article