CIOMS cited

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.

Randomized controlled trials are central to progress in medicine, but trialists commonly struggle to recruit the required number of participants. Offering financial incentives is one proposed solution, but financial incentives may be problematic when they become irresistible and, thus, undermine the autonomy of potential participants. While some have dismissed this worry about undue inducement and argued that we should be paying participants more to avoid exploitation, the authors argue that this line of argument is based on a too narrow conception of undue inducement and does not fully appreciate the distinction between reimbursement, compensation, and financial incentives.

India's changing PV regulatory framework has been influenced by the incorporation of international standards, including those from the European Medicines Agency (EMA), the World Health Organization Programme for International Drug Monitoring, the Council for International Organizations of Medical Sciences (CIOMS), and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Large-scale public health initiatives, patient populations with a variety of cultural backgrounds, and the existence of ancient medical systems like Ayurveda, Siddha, and Unani are just a few of the distinctive national adaptations that India has made in response to local healthcare circumstances. The convergence of India's PV rules with international norms is examined in this review, which also identifies characteristics specific to India's regulatory framework. Overall, the path towards harmonisation has improved India's standing internationally in the drug-safety ecosystem; but full global equivalency would require continued investment, digital growth, and regulatory modernization.