Ethical and Regulatory Frameworks for Artificial Intelligence in Clinical Research: A European Perspective on the Artificial Intelligence Act for Ethics Committees and Researchers.

Abstract

The rapid integration of artificial intelligence (AI) into clinical research is transforming the landscape of biomedical innovation, influencing numerous phases of research, with critical ethical and legal implications. Regulation (EU) 2024/1689, commonly referred to as the AI Act and issued in 2024, introduced a new regulatory framework that classifies AI systems used in clinical settings as 'high risk', requiring increased scrutiny by ethics committees and national authorities. This review add