The World Health Organization (WHO) has called for tighter ethics oversight of AI health research, warning that existing safeguards may not always be equipped to address novel risks.
The organisation says artificial intelligence is changing how health data are analysed, research is conducted and new technologies are developed and evaluated.
It warns that AI-related research can raise issues around transparency, bias, fairness, accountability, privacy and potential harms from the rapid deployment of AI-enabled tools.
Dr Meg Doherty, director of the Department of Science for Health, said: “Artificial intelligence is creating unprecedented opportunities to accelerate health research and improve people’s lives.
“At the same time, innovation must be guided by strong ethical safeguards that protect human dignity, rights and equity.
“This report provides practical considerations to help researchers, ethics committees and policy-makers navigate the opportunities and risks associated with AI-related health research.”
The new WHO report sets out recommendations for researchers, research ethics committees, regulators, funders and policy-makers to help ensure AI-enabled health research is conducted responsibly and for the benefit of all.
The report was jointly developed by WHO experts working across research ethics, science, digital health and AI.
It identifies three broad categories of AI-related health research: health-related research with data that uses AI, research involving AI tools and technologies, and health-related research on AI tools and technologies.
The guidance looks at how oversight can be strengthened throughout the research lifecycle, from study design and ethics review to publication, regulation and implementation.
WHO says research ethics committees will continue to play a central role in protecting research participants but may need additional expertise, training and resources to effectively review increasingly complex AI-related studies.
The report also places responsibility on researchers to identify and mitigate ethical risks early, communicate transparently and consider the wider societal implications of AI technologies.
It sets out roles for funders, scientific journals, data governance bodies, professional societies and regulatory agencies in promoting responsible AI-related health research and addressing systemic challenges that cannot be managed through individual research reviews alone.
Dr Alain Labrique, director of the Department of Data, Digital Health Analytics and Artificial Intelligence, said: “Effective governance of AI in health research requires collaboration across disciplines, sectors and institutions.
“As AI technologies continue to evolve rapidly, we need oversight mechanisms that are agile, evidence-based and capable of ensuring that innovation remains safe, trustworthy and beneficial for all.”
The report also looks at challenges and opportunities for AI health research in low- and middle-income countries.
WHO says much of today’s AI research and technology development remains concentrated in higher-income settings, despite the technology’s potential to address persistent health challenges.
It says strengthening local leadership, capacity and participation in AI-related health research will be critical to ensuring equitable benefits and avoiding new forms of exclusion or inequity.
WHO describes the report as a starting point for strengthening ethics oversight in the era of AI-related health research and supporting the development of future standards, guidance and governance approaches.
