ArticleEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2026
Bioethics committee approvals in multicentre laryngology research across Europe: the European Laryngological Society's consensus on legal basis and quality assurance.
Article in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo describe European legal foundations, governance structures, and quality assurance mechanisms for bioethics committee approvals in multicenter laryngology research, and present a consensus framework to harmonize practice across Europe.
methodsAn expert panel used the Nominal Group Technique to define scope, review supranational and national regulations (including Regulation (EU) 536/2014 and GDPR considerations), and identify practical barriers in multicenter/multinational laryngology research. Consensus rounds prioritized reproducibility, feasibility, and harmonization of ethics review processes across jurisdictions.
resultsRegulatory context combines EU Regulation 536/2014 and GDPR with substantial national heterogeneity in REC/IRB structure and procedures. Core challenges include: (i) heterogeneity of documentation and approvals; (ii) ambiguity about single vs. multiple REC approvals in multicenter studies; (iii) limited guidance for registry-based and real-world data designs; and (iv) variable integration of data protection and ethics review. Key recommendations: clarify when single-country versus cross-border REC approvals are required; standardize documentation templates and timelines; align consent and data-handling with ethics review; provide governance for emerging study designs and biobanking; and promote EUlevel coordination to harmonize practices.
conclusionsNational variation challenges multicenter laryngology research in Europe. The European Laryngological Society provides a consensus framework to guide legal bases and quality assurance of REC approvals, aiming to improve efficiency, consistency, and ethical compliance.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.