The first of two independent opinions on the ethics screening of research for European Commission funding, written in a personal capacity by a member and co-rapporteur of the panels and submitted to the European Commission on 28 July 2026. It examines the treatment of artificial intelligence in ethics screening: the scope of the definition of an AI system and the research exclusions under Regulation (EU) 2024/1689; the pathways of classification and obligation; testing in real-world conditions under Articles 60 and 61; the effect of the Digital Omnibus on AI, Regulation (EU) 2026/1744, on the timeline and the requirements; the treatment of proposals that fall outside the Act; and the state of the guidance and requirements lists. It closes with proposals for updating the ethics self-assessment guidance. Part I of the collection What the law leaves to ethics.This opinion was submitted to the European Commission on 28 July 2026 and is deposited as delivered. It was prepared under the author's direction; any AI assistance was used as a tool under that direction, and the author takes full responsibility for the work. [Confirm the opinion's own AI statement if it differs from this.] A structured statement is deposited with the record as a machine-readable object.A GCPA-SIDCER community contribution, archived as delivered; not part of the SPEC series.
No takes yet. Share an insight, caveat, or question.
Francis P. Crawley (2026) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: