CIOMS cited

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.

While medicine regulation in many countries requires prescription drug labels to classify side effects based on their incidence, when eliciting preferences of patients, most discrete choice experiments (DCEs) group side effects by severity. This mismatch between the presentation of side-effect attribute labels in DCEs and real-world choice contexts may impact patients’ choices, bias risk preferences, and threaten external validity. This study investigated whether using incidence compared with severity labels impacts preferences and DCE reliability.

Artificial intelligence-driven paediatric trials pose novel challenges for institutional review boards, as traditional annual continuing review frameworks are often inadequate for evolving algorithmic and data-related risks. International and national regulations provide only limited guidance on how to design proactive, risk-sensitive interim oversight mechanisms for such research. The objective here was to develop and illustrate a risk-sensitive interim review model that strengthens participant protection and procedural fairness in AI-enabled paediatric research.

El uso de inteligencia artificial (IA) en la investigación en salud es cada vez más común y tiene el potencial de transformar la manera como se lleva a cabo la investigación, tanto en sus aspectos científicos como éticos. Esto representa nuevos desafíos para los Comités de Ética de la Investigación (CEI), los cuales cuentan con pocas guías normativas específicas en esta materia. El presente artículo, además de ofrecer una visión general del panorama regulatorio sobre el uso de IA en la investigación biomédica, proporciona a los CEI orientaciones éticas en lo que respecta a (1) la supervisión ética de estudios que emplean aplicaciones de IA en salud, y (2) el uso de IA para la preparación o revisión de los aspectos éticos de un proyecto de investigación. Respecto al primer punto, el artículo propone una aplicación del marco ético tradicional de la ética de la investigación al contexto de estudios que emplean aplicaciones de IA, estructurando el análisis en base a los ocho principios para la investigación ética de Emanuel y cols. En cuanto al segundo punto, se sostiene que el uso de IA por parte de investigadores o los CEI para el análisis ético de los proyectos de investigación resulta éticamente problemático, ya que conlleva el riesgo de despersonalizar y desvirtuar la responsabilidad ética que debe tener toda investigación con seres humanos.

Clinical studies of implantable neural devices raise unique ethical and legal challenges owing to the distinctive nature of these technologies and their research contexts. Persistent issues such as inadequate post-trial arrangements, psychologic risks, and study team roles have been highlighted in the literature. The authors report on a study that aims to address ongoing ethical challenges in clinical studies of implantable neural devices by providing practical recommendations for researchers and research ethics committees.

The study conducted by the authors revealed conflicting perspectives on compensation and benefits among research stakeholders in Malawi. While stakeholders involved in conducting research had a shared understanding of compensation as reimbursement for time and costs, some community members viewed it as redress for harm. The disconnect suggests unequal access to information about research ethics among research stakeholders. Varying compensation based on study procedures also raised concerns over perceived inequalities and feelings of being devalued.

The COVID-19 pandemic posed unprecedented challenges to global research ethics governance. In response to the urgent need for rapid scientific data, ethics review processes were accelerated, informed consent procedures adapted, and new research methods introduced. These changes were guided by the proliferation of research ethics guidelines issued by national, regional and international bodies. However, there has been limited systematic analysis of how these guidelines addressed key ethical challenges during the pandemic and shaped future ethical frameworks. This study aims to map the global network of pandemic related research guidelines, to analyze how they addressed the main pandemic specific ethical challenges.