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 addresses ethical and regulatory challenges and discusses the application of the AI Act within real-world clinical research. We propose a three-phase lifecycle (training, real-world testing and post-marketing monitoring) to align regulatory burdens with AI maturity. Our recommendations include transparent protocol design with explicit data-use declarations, complementary application of the Medical Device Regulation and the AI Act, with particular attention to the early research phases. This approach provides practical indications for researchers and operational evaluation criteria for ethics committees to ensure patient safety while fostering trustworthy AI deployment in clinical trials.

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