Artificial intelligence (AI) is rapidly reshaping health research, creating new opportunities to accelerate scientific discovery, strengthen health systems and improve health outcomes. However, without robust ethical safeguards and oversight, AI-related research could also introduce new risks that undermine human rights, equity and public trust.
A new WHO report, Artificial Intelligence-related health research: ethics review and oversight, provides recommendations for researchers, ethics committees, regulators, funders and policy-makers to help ensure that AI-enabled health research is conducted responsibly and for the benefit of all. The report was jointly developed by WHO experts working in research ethics, science and digital health and AI.
AI is already transforming how health data are analyzed, how research is conducted and how new technologies are developed and evaluated. However, the report warns that existing ethics oversight mechanisms may not always be equipped to address the novel risks associated with AI, including issues related to transparency, bias, fairness, accountability, privacy and potential harms arising from the rapid deployment of AI-enabled tools.
The report identifies three broad categories of AI-related health research: health-related research with data that uses AI; research with AI tools and technologies; and health-related research on AI tools and technologies. It also explores how ethical oversight can be strengthened across the research lifecycle, from study design and ethics review to publication, regulation and implementation.
"Artificial intelligence is creating unprecedented opportunities to accelerate health research and improve people's lives,” said Dr Meg Doherty, Director, Department of Science for Health. “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 report notes that research ethics committees (RECs) will continue to play a central role in protecting research participants, but may require additional expertise, training and resources to effectively review increasingly complex AI-related studies. It also emphasizes the responsibility of researchers to identify and mitigate ethical risks early, communicate transparently and consider the broader societal implications of AI technologies.
Beyond ethics committees, the publication highlights the important role of 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 project-by-project review alone.
"Effective governance of AI in health research requires collaboration across disciplines, sectors and institutions,” said Dr Alain Labrique, Director, Department of Data, Digital Health Analytics and Artificial Intelligence. “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 examines challenges and opportunities in low- and middle-income countries. While AI has significant potential to help address persistent health challenges, the publication notes that much of today's AI research and technology development remains concentrated in higher-income settings. Strengthening local leadership, capacity and participation in AI-related health research will therefore be critical to ensuring equitable benefits and avoiding new forms of exclusion or inequity.
Recognizing the rapid pace of technological change, 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.