WHO Calls for AI Research Safeguards to Protect Patients and Public Trust

The report, Artificial intelligence-related health research: ethics review and oversight, offers recommendations for researchers, ethics committees, regulators, funders and policy-makers.

Artificial intelligence is changing how researchers analyse health data, conduct studies and develop new technologies, opening possibilities for faster scientific discoveries and better care. The World Health Organization is calling for stronger ethical safeguards to ensure those advances protect the people whose lives and information are involved, warning that gaps in oversight could put human rights, fairness and public trust at risk. Its new report places responsibility across the research community, recognising that the benefits of AI depend on how carefully it is developed, studied and introduced into health systems.

Protecting People Behind the Data

The report, Artificial intelligence-related health research: ethics review and oversight, offers recommendations for researchers, ethics committees, regulators, funders and policy-makers. Developed jointly by WHO experts in research ethics, science, digital health and AI, it examines three broad areas: health research that uses AI to analyse data, research conducted with AI tools and technologies, and research that studies those tools and technologies themselves. Each area raises questions about protecting participants and ensuring that scientific progress produces benefits people can trust.

Existing ethics oversight systems may lack the tools or expertise to address concerns involving transparency, bias, fairness, accountability and privacy, particularly when AI-enabled technologies move quickly into use. WHO calls for attention to these risks throughout the research process, covering study design, ethics review, publication, regulation and implementation. Dr Meg Doherty, Director of WHO's Department of Science for Health, emphasised that AI's potential to accelerate research and improve lives must be supported by safeguards that protect human dignity, rights and equity, making ethical responsibility part of how innovation develops.

Giving Ethics Review the Support It Needs

Research ethics committees remain central to protecting participants, with increasingly complex AI studies creating a need for additional expertise, training and resources. A committee reviewing an AI-related study needs enough understanding to assess its ethical implications and the protections proposed for those involved. Researchers carry responsibility for identifying and reducing risks early, communicating openly about their work and considering the wider effects that a technology could have on society, including people beyond the immediate study.

Funders, scientific journals, data governance bodies, professional societies and regulatory agencies have responsibilities that extend beyond decisions about individual projects. Their involvement can help address wider problems that research ethics committees cannot resolve through separate study reviews alone. Dr Alain Labrique, Director of WHO's Department of Data, Digital Health Analytics and Artificial Intelligence, stressed the need for cooperation across disciplines, sectors and institutions, supported by oversight that can adapt to technological change and use evidence to keep innovation safe, trustworthy and beneficial.

Making Space for Countries at Risk of Being Left Out

Low- and middle-income countries could benefit from AI research that responds to persistent health challenges, although much of the world's research and technology development remains concentrated in higher-income settings. That imbalance raises concerns about who shapes research priorities, whose needs receive attention and who gains from the results. Strengthening local leadership, research capacity and meaningful participation is critical to making benefits more equitable and preventing new forms of exclusion as AI becomes more embedded in health research.

WHO presents the report as a starting point for stronger ethics oversight in a field that continues to change rapidly, providing a foundation for future standards, guidance and governance approaches. Its recommendations connect the promise of faster discovery and stronger health systems with the practical responsibilities required to protect people, sustain public confidence and make improved health outcomes accessible across countries and communities.