Importance Platform trials have emerged as a novel approach to clinical trials and are often described as a more resource- and cost-efficient design. Despite their growing relevance, the experiences and challenges of teams conducting platform trials remain underexplored. Objectives To examine the experiences and views of platform trial teams regarding the barriers and facilitators raised when conducting platform trials. Design, Setting, and Participants This cross-sectional survey study was carried out from June to August 2023 and was analyzed with a mixed-methods approach. The survey was sent to 127 principal investigators of platform trials and 11 other stakeholders who are experienced in the methodology and conduct of platform trials. The survey could be forwarded to other relevant team members of a platform trial. Main Outcomes and Measures Survey data on barriers and facilitators to conducting platform trials were analyzed using descriptive statistics and standard qualitative content analysis. Results A total of 40 completed surveys were returned. Respondents’ roles in platform trials included trial management (22 respondents [55%]), principal investigator (12 respondents [30%]), statistics and trial methodology (11 respondents [28%]), and data management (11 respondents [28%]). Respondents reported efficacy gains from using a shared coordinating infrastructure for multiple intervention arms as the key advantage of platform trials, although these require more planning time and greater team expertise than traditional randomized clinical trials. There was no consensus on whether the perceived costs and resources needed for adding a comparison within a platform trial were lower or higher compared with setting up a traditional randomized clinical trial. A repeatedly raised challenge was that current regulatory and organizational processes are set up for intervention-specific clinical trials and are incompatible with adaptive and open-ended platform trials. Targeted supports such as guidelines, templates, funding mechanisms, and infrastructure setup for platform trials were identified as facilitators for their conduct. Conclusions and Relevance In this survey study of platform trial experts, it was found that the clinical research landscape is currently not set up for adaptive platform trials, which leads to substantial challenges conducting such trials. These findings suggest that stakeholders need to take concerted action to enable the integration of platform trials.

Conducting a systematic literature review before initiating a new clinical trial can prevent research waste and provide critical justification and valuable insights for designing the trial. Clinical researchers, however, typically lack the resources and experience to conduct systematic reviews. This paper introduces the REVEAL (prior evidence for new trials) guidance-a rigorously developed, user friendly, step-by-step guide for clinical researchers to rapidly, efficiently, and systematically review the literature when planning a trial. REVEAL consists of a detailed guidance document to navigate the process, a structured report form to document the search and findings, and a worked example for practical orientation.

COVID-19 Health Certificates represented a key policy in Europe during the COVID-19 pandemic and were introduced globally by the World Health Organization to strengthen pandemic preparedness. This article undertakes a comparative analysis of COVID-19 Health Certificate policies, and their underlying narratives and framings in nine European countries. Policies differed across European nations in timing, scope, and stringency of the measures entailed and were often subject to major controversies and heated public debates. By tracing their distinct policy narratives (providing emergency response, restoring social and economic activities, and incentivizing vaccination), we suggest that Certificates also served as a proxy for other, highly controversial measures (such as vaccine mandates). When this happened, they were met with intense pushbacks from citizens. Additionally, we show that scientific evidence was differently appropriated in national policy narratives, and that concerns commonly associated with novel digital health technologies (e.g. privacy) did not rise to prominence in public debates.

Meta-research and Trustworthy AI (TAI) share common goals, namely improving evidence, robustness, and transparency, yet there is very little interplay between the two fields. To investigate the potential benefits of closer collaboration between the domains of TAI in healthcare and meta-research, we convened an interdisciplinary workshop funded by the Volkswagen Foundation in February 2025. The workshop aimed to collaboratively examine key challenges in translating AI ethics principles into practice and to identify potential solutions informed by meta-research approaches. A Design Thinking-informed co-creation approach was followed by an inductive descriptive analysis of the outputs. Our results demonstrate how meta-research can offer concrete contributions to address pressing challenges of TAI in healthcare. These challenges include the dynamic and complex nature of TAI ethical requirements and principles, common terminology and understanding of TAI, ensuring robustness, replicability, and reproducibility, choosing adequate evaluation metrics, lack of transparency, advancing preclinical biomedical research, and validation in real-world clinical environments. We present a catalog of ideas and a roadmap for future research, which synthesize existing interconnections and identify concrete next steps and open research gaps, thereby serving as a foundation for future interdisciplinary efforts.

Health inequities arising from social determinants such as income, education, gender, and socioeconomic status profoundly affect disease burden and ageing outcomes. Despite global efforts to promote equitable healthy ageing, substantial gaps remain. This systematic review examined how equity-related factors, defined by the PROGRESS framework: Place of residence, Race/ethnicity, Occupation, Gender/sex, Religion, Education, Socioeconomic status, and Social capital, are incorporated into evaluations of healthy ageing interventions and how outcomes vary across these dimensions. PubMed, Embase, and Scopus were searched from database inception through August 12, 2024, for quantitative evaluations of healthy ageing interventions. Of 5,892 screened studies, 66 met inclusion criteria, most published after 2018 and involving older adults (mean age 71.4 years). The most frequently reported PROGRESS factors were gender/sex (N = 66, 100

BACKGROUND:Efforts to control the global obesity epidemic are increasingly focusing on preventing childhood obesity. A wide range of interventions has been implemented; however, such interventions raise important ethical issues. AIM:This study aims to determine systematically the spectrum of ethical issues that are raised by interventions to prevent or treat childhood obesity. METHODS:A systematic review in PubMed was conducted for publications describing and/or assessing ethical issues raised by childhood obesity interventions. Data were analyzed and synthesized using qualitative content analysis. RESULTS:Our literature search retrieved 4637 publications of which 62 were included in the final analysis. When the ethical issues presented by the 11 different types of childhood obesity interventions were identified, it is clear that the discussion of ethical issues regarding interventions to prevent or treat childhood obesity has important gaps. However, two key overarching themes emerged across the different interventions: a lack of evidence of effectiveness and risk of harmful side effects. CONCLUSION:The obesity epidemic is a growing, yet largely neglected, global public health crisis. Despite there being an ethical obligation to address this crisis, it is ethically problematic that efforts to reduce childhood obesity rates have primarily focused on individual behavior. Evidence demonstrates that these lifestyle interventions are not only largely ineffective but also cause harm. A fundamental shift towards more system-level actions is needed.

Although cardiopulmonary resuscitation (CPR) was initially used very selectively at the discretion of clinicians, the use of CPR rapidly expanded to the point that it was required to be performed on all patients having in-hospital cardiac arrests, regardless of the underlying condition. This created problems with CPR being clearly inadvisable for many patients. Do Not Resuscitate (DNR) orders emerged as a means of providing a transparent process for making decisions in advance regarding resuscitation, initially by patients and later also by clinicians. Under hospital policies in many countries, however, CPR remains the default position for all patients having cardiac arrest in the hospital if there is no DNR order in place, regardless of whether CPR is medically indicated or in the patient's best interests. "Slow Codes" are the delayed or token efforts to provide CPR when clinicians feel CPR is futile or inappropriate. After giving a historical overview of the development and the changing use of CPR, we argue that more attention needs to be given to the cause of slow codes, namely, policies requiring CPR to be performed as the default action while simultaneously lacking implementing interventions such as advance care planning as a routine policy. This is ethically and legally inappropriate, and hospital policies should be modified to allow clinicians to consider whether CPR is appropriate at the time of arrest. Such a change requires a stronger emphasis on early recognition of patients for whom CPR is not in their best interests and to improve hospital emergency planning.

Introduction There is an urgent need to better understand how information from circulating tumour DNA (ctDNA) can be integrated into routine care for patients with advanced solid cancer.Methods and analysis The implementation of liquid biopsies in routine care of patients with advanced solid cancer trial (LIQPLAT) is a single-centre, single-arm trial investigating the implementation of ctDNA in the routine care of patients with advanced solid cancer. We present a mixed-methods process evaluation embedded in the LIQPLAT trial, following Medical Research Council guidance and the Reach, Effectiveness, Adoption, Implementation, Maintenance framework. We show a logic model, which details the causal chain and related assumptions from recruiting patients into the trial to the goal of improving quality of life and survival. Data collection is longitudinal and includes: semistructured interviews with healthcare professionals (pathologists, biologists, oncologists; planned n=20) and patients (planned n=15) to identify implementation barriers and facilitators; recordings of molecular tumour board meetings to analyse clinical decision-making; the 23-item Normalisation MeAsure Development survey for healthcare professionals (planned n=20) at four time points. Quantitative data from hospital records will be used to assess implementation outcomes like patient acceptance rates and ctDNA workflow success. Qualitative data will undergo thematic and content analysis, and quantitative data will be analysed using a Bayesian framework.Ethics and dissemination The LIQPLAT trial was approved by the regional ethics committee of Northwestern and Central Switzerland (BASEC 2024-00358). The qualitative aspects of the process evaluation were exempted from ethics review according to the Swiss Human Research Act. We follow guidelines for data security, confidentiality and information governance. Results will be submitted for publication in peer-reviewed journals and discussed at conferences.Trial registration number NCT06367751, SNCTP000005844.

Abstract Background Imprisonment has a major impact on a person’s psychological well-being. The proportion of older imprisoned persons is dramatically increasing worldwide, and they are likely to have greater physical and mental health needs compared to younger persons in prisons. However, there is currently a lack of research on the psychological stressors and the coping strategies of older imprisoned persons. This study therefore aims to explore the key psychological stressors experienced by older imprisoned persons and their coping strategies. Methods Individual semi-structured qualitative interviews were conducted between April 2017 and December 2018 with a purposive sample of 79 participants from 2 different groups in Switzerland: older imprisoned persons (n = 50) and mental health professionals (n = 29) with experience working in prisons. Transcripts were analysed using conventional content analysis. Results This study has identified various ways in which the prison environment not only undermines older incarcerated persons´ psychological well-being, but also their ability to manage the stress they are experiencing. Two overarching psychological stressors identified were a lack of physical and emotional closeness in social relationships (with prison staff, with other incarcerated persons, and outside of prison), and the loss of autonomy in prison. Participants reported five main ways that older incarcerated persons coped with the psychological stressors in prison: 1) recognising a lack of control over situation, 2) withdrawing and isolating, 3) self-improvement, 4) staying connected to the outside world, and 5) self-expression. Conclusions To improve the psychological well-being of older incarcerated persons, there is a need for: specialised training of prison staff regarding hardships that elderly persons can face in prison relationships, encouragement and enablement of social contacts with the outside world, and increasing possibilities for autonomy, new challenges, and thus stimuli within a limited setting.

Partnerships between public and private organizations in digital health can promote more accessible, affordable, and high-quality care, but they also raise ethical and governance challenges. We searched PubMed, EMBASE, and Web of Science, identifying 46 studies examining ethical aspects of digital health public-private partnerships (PPPs). Three key themes emerged: data privacy and consent, ensuring public benefit and access, and good governance and demonstrating trustworthiness. We provide recommendations for each theme. To foster responsible innovation, we conclude that early and contextual operationalisation of ethics guidelines in PPPs is necessary to balance respect for fundamental values with the pursuit of impactful innovation. If PPPs become more successful as a result, this contributes to reducing the research waste of failed collaborations. Further research should clarify the scope of PPPs and definition of ‘public benefit’, and we call for critical study on the ‘economization’ of digital health promoted by public and private sector organizations.

Many countries around the world do not collect race and ethnicity data in clinical settings. Without such identified data, it is difficult to identify biases in the training data or output of a given artificial intelligence (AI) algorithm, and to work towards medical AI tools that do not exclude or further harm marginalised groups. However, the collection of these data also poses specific risks to racially minoritised populations and other marginalised groups. This Viewpoint weighs the risks of collecting race and ethnicity data in clinical settings against the risks of not collecting those data. The collection of more comprehensive identified data (ie, data that include personal attributes such as race, ethnicity, and sex) has the possibility to benefit racially minoritised populations that have historically faced worse health outcomes and health-care access, and inadequate representation in research. However, the collection of extensive demographic data raises important concerns that include the construction of intersectional social categories (ie, race and its shifting meaning in different sociopolitical contexts), the risks of biological reductionism, and the potential for misuse, particularly in situations of historical exclusion, violence, conflict, genocide, and colonialism. Careful navigation of identified data collection is key to building better AI algorithms and to work towards medicine that does not exclude or harm marginalised groups.

Animals can only be used in research when there is a convincing scientific justification, when the expected benefits of the research outweigh the potential risks in terms of animal suffering and when the scientific objectives cannot be achieved using non-animal alternative methods. Researchers must also apply the 3R principles—replace, reduce and refine—to ensure that animals are used ethically in research. All research involving animals must have been reviewed and approved by an ethics committee prior to commencing the study; the harm–benefit analysis (HBA) is the cornerstone of ethical evaluation, as it will determine if the use of animals is justified. In this paper, we apply the 3R principles (refine, reduce, replace) and HBA used in regulation of animal research to veterinary studies of homeopathy and provide an ethical analysis of such studies. It emerges that proper application of the 3Rs and HBA effectively rules out any homeopathy research in animals.

In this commentary, we would like to ask: what is meant by the feminist turn in German-speaking bioethics? We take this opportunity to reflect on how non-dominant histories in feminist thought and bioethics might offer important starting points for considering the feminist turn in German-speaking bioethics. Any feminist turn in bioethics needs to strengthen an analysis of power, intersectionality, relationality and contextuality, social responsibility, with a specific stake in the socio-political positionalities and commitments of the German-speaking context.

Artificial intelligence (AI) is one of the world's most resource-intensive digital technologies, but the environmental impact of AI on health remains largely unaddressed in both global health and bioethics. Effects on the environment have, thus far, been understood as a subsidiary consideration in AI ethics and rarely considered as a key ethical concern. AI technologies exacerbate climate change and sociopolitical instability due to their intensive use of natural resources and energy resources linked to the training and deployment of algorithmic systems. In global health, this intensive resource use is particularly concerning, given the explicit emphasis on improving health and advancing equity across the world. To address this, we interrogate how the inclusion of AI's environmental impact necessarily reshapes established ethical commitments in AI ethics frameworks and propose concrete strategies for accountability in the area of global health. This approach includes building a culture of intentional AI, for example through improved reporting, auditing, and intranational cooperation, in order to better align AI development and AI ethics with critical climate goals.

Studies on interventions promoting healthy aging often do not address the effect of inequity on their implementation and outcomes. This scoping review aims to identify the equity-related factors explored in healthy aging strategies and interventions. A structured search of multiple electronic databases was conducted using keywords and indexed terms related to healthy aging interventions, with equity aspects including place of residence, race/ethnicity, occupation, religion, education, socioeconomic status, and social capital. A total of 5890 studies were identified and screened, of which 74 met the inclusion criteria. Approximately one-third of the studies (25, 34%) only described equity aspects in demographic characteristics but did analyze results according to these factors; Eleven studies (15%) adjusted for equity aspects; and 38 studies (51%) assessed outcomes by equity factors. Of the 38, 9 studies (24%) examined intervention effects while controlling for equity aspects, and 28 studies (74%) focused on interventions in minority or socioeconomically deprived groups. Of these 28 studies, 20 (71%) reported positive outcomes, primarily in quality of life and functioning. Only 9 studies (12%), explored multiple equity aspects (intersectionality). Equity-related aspects are rarely studied in research in health aging research. Studies examining interventions in minority or socioeconomically deprived groups generally show positive patient-reported outcomes, but none reported effects on healthcare resource use. Future research should prioritize analyzing outcomes by equity dimensions, especially intersectionality, to inform inclusive interventions that may reduce health inequities and promote healthy aging.

Objectives Trials within Cohorts (TwiCs) is a promising design to make randomized trials more efficient. Cohort participants are asked for consent to be randomized into future low-risk interventions tested within the cohort. To enable TwiCs in the Swiss HIV Cohort Study, we added this “randomization consent” to the protocol and approached cohort participants subsequently for written consent. This study describes the TwiCs implementation process. Study Design and Setting We used a mixed methods design to evaluate the implementation process. We used cohort data to characterize participants accepting and declining randomization consent. We conducted a cross-sectional survey with cohort physicians to gather opinions and experiences regarding the TwiCs design. We did semistructured interviews with involved stakeholders (physicians, research personnel, participants, and ethics committee members) to get insights about attitudes, barriers, and facilitators implementing the randomization consent. In addition, we performed observations in cohort visits where the randomization consent was offered. Results Between July 2024 and July 2025, among 5297 cohort participants approached, 3067 (57.9%) accepted and 734 (13.8%) declined the randomization consent. In 1496 (28.2%) cases the decision was postponed to the next visit. Male sex, younger age, higher education, being consulted by a steady physician for at least three visits, and shorter cohort participation time showed higher acceptance rates. Interviewed participants cited fear of additional effort and a lack of interest in research as reasons for declining consent. The overall perception of TwiCs among cohort physicians and research personnel was positive. They recognized the potential to simplify the conduct of trials, especially to test low-risk interventions. Ethical concerns on the TwiCs consent procedure were rare. However, an explicit randomization consent was considered necessary by members of ethical committees while several physicians and participants felt positive about randomizing without explicit consent. The roll-out of the randomization consent was facilitated by well-trained, motivated personnel, and seamless integration into clinical routine. Main barriers for physicians in the consenting process were language barriers, participant difficulty understanding the concept, and time constraints due to tight consultation schedules. Conclusion The implementation of the TwiCs design, including the roll-out of a randomization consent in an existing, large-scale cohort, is feasible. The acceptance rate among participants was high.

Myalgic encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a challenging disease pattern and has gained increasing scientific and public interest in recent years due to the Corona pandemic and Long-Covid. The aim of this study was to investigate (1) medical students’ health-related control beliefs, (2) students’ awareness and views about ME/CFS at the beginning of their medical education, and (3) to examine whether there are correlations between students’ health-related control beliefs and their views about ME/CFS. A cross-sectional online-survey was conducted in October 2020 with all new medical students at the Ludwig Maximilian University of Munich and the Technical University Munich. A total of 251 students completed the survey, representing a response rate of 27.0

The intersection of neuroscience and artificial intelligence (AI) promises important advances, but it also raises important ethical challenges, including data privacy, bias, accountability, and the implications of cognitive enhancement. To help develop AI-enhanced neuroscience technologies that benefit and do not harm individuals and society, it is important that ethical and social considerations are integrated into research and development of AI-enhanced neuroscience, and not left as an afterthought. In this chapter, we explore how the embedded ethics approach can play an important role in helping to identify and address the ethical, legal, and social issues arising from the integration of AI technology into neuroscience in a deeply collaborative and interdisciplinary manner across the entire development process. We outline important elements of the approach and use a hypothetical case study to demonstrate how embedded ethics can potentially aid in the development of more ethically and socially responsible AI-enhanced neuroscience technologies.