ReviewEuropean cardiology2026
Ethical and Regulatory Frameworks for Artificial Intelligence in Clinical Research: A European Perspective on the Artificial Intelligence Act for Ethics Committees and Researchers.
Review in European cardiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed.
- Article
- Automated Multi-Label Adverse drug Reaction Extraction from Malaysia's National Pharmacovigilance Narratives.Journal of medical systems · 2026Article
- Exploring the operational challenges of navigating ethical oversight in the era of artificial intelligence: a qualitative study of health research ethics committees in Tanzania.BMC medical ethics · 2026Article
- Review
- Governing medical AI under the EU AI Act: an integrated compliance-by-design framework.Frontiers in digital health · 2026Article
- From Model Lifecycle to Clinical Interaction Lifecycle: Extending the European Artificial Intelligence Act Governance for Foundation Models in Cardiovascular Research.European cardiology · 2026Article
- Research integrity and data ethics in AI-driven integrated healthcare: a critical appraisal.Frontiers in public health · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.