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Systematic review reveals only 30.6% of first-in-human cardiac procedures documented ethical oversight, highlighting significant governance gaps.
Surgical innovation plays an important role in advancing congenital heart care, often through first-in-human (FIH) procedures introduced to address urgent or complex clinical needs. These procedures frequently proceed without formal ethical oversight. We conducted a systematic PubMed search yielding 48 first-in-human congenital cardiac case reports (1990–2025), then screened each article for 10 predefined oversight-related terms covering regulatory bodies, ethics, and innovation boards. Only 15 procedures (30.6%) documented any form of oversight language. Although recent innovations demonstrate a modest increase in formal oversight, there remains a paucity of structured review for these novel procedures. These findings highlight persistent gaps in the governance and transparency of high-risk surgical innovation.
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Winemiller et al. (2025) studied this question.
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