Artificial intelligence-related health research: ethics review and oversight

Overview

Artificial intelligence (AI) is increasingly used in health-related research to generate knowledge, insights and technologies, but its application may challenge established ethical principles and human rights protections and create novel risks that existing oversight systems do not fully address.

This report examines ethics review and oversight of three categories of AI-related health research: health-related data science using AI; research conducted with AI tools and technologies; and health-related research on AI tools and technologies. It analyses gaps in current ethical standards and oversight, challenges faced by research ethics committees, and measures to strengthen researchers’ adoption of ethical principles.

The report also considers complementary roles for funders, data access mechanisms, scientific journals and publishers, regulatory agencies and other third parties. Particular attention is given to risks and inequities affecting low- and middle-income countries, including fairness, benefit sharing, data colonialism, ethics dumping, power imbalances and capacity-building. It further examines the benefits and risks of using AI in ethics review and provides non-exhaustive considerations for strengthening responsible research conduct and oversight.