Mapping national incident reporting systems for high-containment laboratories across Europe and selected North American jurisdictions

Julia Bator
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Julia Bator: University of Oxford

No y3f9q_v2, SocArXiv from Center for Open Science

Abstract: Objective: To map how incident reporting for high-containment laboratories is organised across Europe and selected North American jurisdictions and to assess whether reporting duties function as national reporting-and-learning systems. Methods: Comparative qualitative mapping using the Framework for Assessing Incident Reporting Systems (FAIRS) assessed 31 jurisdictions: the 27 EU member states, Switzerland, the United Kingdom, the United States, and Canada, plus the European Union as a separate supranational layer. Six dimensions covered legal authority, governance, reporting scope, reporting pathway, data infrastructure, analysis and shared learning, assurance and continuous improvement. Data came from official legal and institutional sources collected between January and May 2026, supplemented by targeted expert consultation. Results: Across 32 assessed entities, legal authority for incident reporting was common, but learning functions were much weaker. Mean scores were highest for legal authority (3.0) and assurance (2.5), and lowest for reporting pathway and data infrastructure (1.9) and analysis and shared learning (1.5). Thirty-one entities scored maturity level (ML) 3 on legal authority. Only two scored above ML2 on data infrastructure, and Canada alone reached ML4 on analysis and shared learning. Three system types emerged: one operational exemplar (Canada), 11 coordinated partial systems, and 20 regulated but weakly operationalised systems. The EU layer contributed legal duties without an EU-level reporting-and-learning chain. Conclusions: Formal reporting duties are more widespread than functioning national learning systems. The main governance divide is not legal authority alone, but whether reports are aggregated, analysed, and translated into feedback and system improvement.

Date: 2026-07-14
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Persistent link: https://EconPapers.repec.org/RePEc:osf:socarx:y3f9q_v2

DOI: 10.31219/osf.io/y3f9q_v2

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