CIOMS cited

Fluid overload in critically ill patients with acute kidney injury (AKI) is independently associated with increased mortality, prolonged mechanical ventilation and impaired renal recovery. Net ultrafiltration (UFNET) during continuous renal replacement therapy (CRRT) is a cornerstone de- resuscitation strategy; however, tolerance to fluid removal is highly variable and difficult to predict. Ultrafiltration intolerance, encompassing haemodynamic instability, peripheral perfusion deterioration and tissue hypoperfusion during UFNET, lacks a standardised definition and has not been prospectively evaluated using a comprehensive multiparametric monitoring strategy. The Volume removal Intolerance during Net ultrafiltration in acute Kidney injury patients, an Observational study (VINKO) aims to identify clinical, haemodynamic, ultrasound-based, perfusion- related and biochemical factors associated with the development of ultrafiltration intolerance in critically ill patients with AKI undergoing CRRT.

Effective project management is crucial for the successful execution of complex health research initiatives, particularly those involving multiple stakeholders and ethical considerations. This paper illustrates how applying a PMBoK-based framework to the "Active Pregnancy" project enhances planning and coordination, ultimately providing a transferable model for managing similar multidisciplinary health research projects.

Dengue, a mosquito-borne viral disease, is undergoing its largest surge in history, driven by climate and demographic changes. Expanding transmission has highlighted previously under-recognised populations at heightened risk of severe disease, including people with multimorbidity and immunosuppression, for whom live-attenuated vaccines are contraindicated or unlicensed. This evolving epidemiology underscores the urgent need for safe and effective treatments for dengue, particularly for those with complex risk profiles compounded by socioeconomic disadvantage. The authors examined ethical, regulatory, and implementation considerations to support WHO target product profile development for dengue therapeutics. Their analysis highlights the need for better characterisation of groups at risk through approaches such as enhanced surveillance; co-produced approaches for the inclusion of these groups in research prioritisation, trials, and care; and strategies to address key barriers to access for all, such as rapid diagnostics. This framework can potentially inform equitable development and delivery of countermeasures for other infectious disease threats to global health.

Clinical trials are considered as a robust study design to establish which therapeutic interventions including vaccine discovery and developments, and diagnostic tests are most applicable to the public. However, there are many ethical implications of conducting clinical trials in low- and middle-income countries (LMIC). The authors adapted the methodology of an umbrella review to delineate the evidence regarding the ethical considerations on clinical trials in LMIC.

Women make up nearly half of all people living with cardiovascular disease, yet they remain underrepresented in the trials that set diagnostic thresholds, dosing regimens, and treatment algorithms. This narrative review, built on a targeted search of PubMed, the JAMA Network, and regulatory databases through July 2026, examines that gap through a bioethical lens rather than an epidemiological one. Existing state-of-the-art reviews have documented the scale of underrepresentation in detail. What has not been done systematically is testing that evidence against the four principles of biomedical ethics (autonomy, beneficence, nonmaleficence, and justice), and extending the same framework to the algorithmic tools now being trained on decades of sex-imbalanced data. That persistent underrepresentation, where it lacks scientific justification, constitutes a multidimensional bioethical problem rather than a purely methodological one. This article reviews the biological, structural, and regulatory drivers of the gap, the pharmacokinetic and pharmacodynamic consequences of sex-based evidence deficits, the regulatory arc from the FDA’s 1977 exclusion guidance to the 2024 Diversity Action Plans, and the emerging risk that AI-driven cardiovascular tools, trained on that same imbalanced evidence, could encode and scale it further.

The authors identify five areas in which AI tools can improve clinical trial recruitment: generation and optimization of trial eligibility criteria, clinical trial matching, clinical trial enrichment, digital twins and synthetic data, and informed consent. They argue for a sixth domain of AI application, namely the calculation of payment for research participants.

Fluconazole is key for pulmonary cryptococcosis (PC), but its hepatotoxicity (HT) risk is unclear. This study characterized fluconazole-induced liver injury in HIV-neg ative PC patients and explored its mechanism.