The World Health Organization on Monday published a new report calling for stronger ethical safeguards and oversight of artificial intelligence in health research, warning that existing review mechanisms are not always equipped to handle the novel risks that AI introduces into medical science.
The report, titled "Artificial Intelligence-related health research: ethics review and oversight," offers recommendations for researchers, ethics committees, regulators, funders and policy-makers on how to ensure that AI-enabled health research is conducted responsibly. It was jointly developed by WHO experts working across research ethics, science, digital health and artificial intelligence, and was launched alongside a virtual event on Monday. For more context on this story, see our ongoing breaking AI news.
According to the WHO, artificial intelligence is rapidly reshaping how health research is conducted — changing how health data are analyzed, how studies are designed and how new technologies are developed and evaluated. But the organization cautions that without robust safeguards, AI-related research could introduce risks that undermine human rights, equity and public trust.
What the new WHO report covers
The report identifies three broad categories of AI-related health research: health-related research that uses AI to analyze data, research that uses AI tools and technologies, and health-related research conducted on AI tools and technologies themselves.
For each category, the publication examines how ethical oversight can be strengthened across the entire research lifecycle — from study design and ethics review through to publication, regulation and real-world implementation.
The WHO warns that existing ethics oversight mechanisms "may not always be equipped" to address the specific risks AI brings into the research process, including issues related to transparency, bias, fairness, accountability, privacy, and potential harms arising from the rapid deployment of AI-enabled tools.
Why existing review structures are under strain
"Artificial intelligence is creating unprecedented opportunities to accelerate health research and improve people's lives," said Dr Meg Doherty, Director of WHO's Department of Science for Health, in the announcement. "At the same time, innovation must be guided by strong ethical safeguards that protect human dignity, rights and equity."
Doherty described the report as providing "practical considerations" to help researchers, ethics committees and policy-makers navigate both the opportunities and the risks associated with AI-related health research.
The report places research ethics committees — the institutional bodies that review studies involving human participants — at the center of the oversight framework. But it acknowledges that these committees may require additional expertise, training and resources to effectively review increasingly complex AI-related studies, which often involve opaque models, large datasets and techniques that fall outside the traditional training of ethics reviewers.
Responsibility beyond the ethics committee
The publication also emphasizes that responsibility does not stop at the ethics committee door. Researchers themselves, the WHO says, bear the duty of identifying and mitigating ethical risks early, communicating transparently, and considering the broader societal implications of the AI technologies they build and deploy.
Beyond individual researchers and committees, the report highlights the roles of funders, scientific journals, data governance bodies, professional societies and regulatory agencies in promoting responsible AI-related health research. Notably, it argues that some systemic challenges simply cannot be managed through project-by-project review alone — a recognition that AI's impact on the research ecosystem requires structural, institution-level responses.
"Effective governance of AI in health research requires collaboration across disciplines, sectors and institutions," said Dr Alain Labrique, Director of WHO's 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 equity dimension
A significant portion of the report addresses challenges and opportunities in low- and middle-income countries. While AI has significant potential to help address persistent health challenges in these settings, the WHO notes that much of today's AI research and technology development remains concentrated in higher-income countries.
Strengthening local leadership, capacity and participation in AI-related health research will therefore be critical, the organization argues — both to ensure that the benefits of AI are distributed equitably and to avoid creating new forms of exclusion or inequity in global health science.
A starting point, not a final word
Recognizing how quickly the technology is moving, WHO describes the report as a starting point for strengthening ethics oversight in the era of AI-related health research, and as groundwork for the development of future standards, guidance and governance approaches.
The report arrives as health systems worldwide are increasingly experimenting with AI for diagnosis, drug discovery and clinical documentation, placing pressure on research institutions to adapt their review processes. The WHO's message to institutions is that the window to build competent oversight is now — before AI-generated findings, AI-designed trials and AI-analyzed datasets become the norm rather than the exception.
The full report and details of Monday's virtual launch event are available through the World Health Organization's official channels.
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