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The growing use of Big Data and computational methods in health research poses significant challenges for research ethics committees (RECs), whose review frameworks were designed for conventional, hypothesis-driven studies. Empirical evidence on how RECs in continental Europe are responding to these challenges has been largely absent. We conducted a cross-sectional web-based survey of REC members in Germany, Austria, and German-speaking Switzerland (November 2024–March 2025). The structured questionnaire combined closed and open-ended items covering general review practices, prior experience with Big Data proposals, perceived challenges, and the need for additional expertise. Responses from 172 valid cases were analyzed using descriptive statistics and qualitative content analysis. The response rate was approximately 10.1%–12.6%. Review practices were highly heterogeneous: only 59% of participants used any standardized guideline, and a mere 3.5% applied protocols specifically tailored to Big Data studies, despite 48% having reviewed at least one such proposal. Participants identified four clusters of challenges: methodological opacity; regulatory ambiguity regarding the EU Medical Device Regulation and AI Act; data protection concerns including the growing instability of anonymization and inconsistent GDPR interpretations; and the inadequacy of classical informed consent frameworks for exploratory research. While 41% considered Big Data-specific guidance to be lacking and a majority acknowledged expertise gaps, only 8% favored specialized RECs. German-speaking RECs face significant and largely unaddressed challenges in reviewing Big Data health research. The findings point to an urgent need for consensual guidance, deliberate competency development in data science and data protection law, and active REC engagement with emerging European governance frameworks, including the European Health Data Space and the EU AI Act. The challenges identified mirror those in other jurisdictions, suggesting that adapting ethical oversight to data-intensive research requires coordinated responses at the national and European level.
Kassai et al. (Sun,) studied this question.