Clinical Trials, Scientific Research, and Liability

The use of artificial intelligence in scientific research and clinical trials raises new questions concerning the protection of individuals and the allocation of liability. AI may operate both as a tool for processing data, discovering medicines, and selecting trial participants, and as the object of clinical experimentation. This chapter examines the regulatory framework introduced by Regulation (EU) 2024/1689, with particular attention to its research exemptions, risk-based approach, transparency requirements, and regulatory gaps. It also considers the European Medicines Agency’s guidance on the use of AI throughout the medicinal product lifecycle. The analysis focuses on the complex network of relationships involving sponsors, research centres, investigators, AI providers, and trial participants. It argues that the use of AI in clinical trials calls for a coordinated system of accountability and civil liability capable of protecting fundamental rights while supporting responsible scientific innovation.