WHO Framework on Ethics and Oversight of AI-Related Health Research:
The World Health Organization (WHO) released a departmental guidance update and global report titled Artificial intelligence-related health research: ethics review and oversight.Jointly developed by WHO experts across research ethics, science, and digital health, the publication provides practical recommendations for researchers, RECs, regulators, research funders, scientific publishers, and policymakers. It aims to establish end-to-end ethical oversight across the research lifecycle—from trial design and data collection to clinical translation, publication, and regulatory post-market monitoring.
The WHO categorizes AI-related health research into three distinct domains:
- Health-related research with data (data science) that uses AI: Machine learning and statistical data science deployed to analyze large datasets to generate new health insights.
- Research with AI tools and technologies: Utilizing AI systems as research instruments—such as large multimodal models (LMMs) for protocol authoring, chatbots for participant recruitment/informed consent, and synthetic data generators.
- Health-related research on AI tools and technologies: Clinical validation studies, prospective randomized controlled trials, and implementation research assessing the safety, efficacy, diagnostic accuracy, and utility of AI systems intended for direct clinical or behavioural intervention.
