Ethical Oversight of First-in-Human Cardiac Procedures for Congenital Heart Disease in Children

Surgical innovation through first-in-human (FIH) procedures, such as partial heart transplantation, plays an important role in advancing clinical care. However, these procedures frequently proceed without formal ethical oversight. We conducted a systematic PubMed search yielding 48 FIH 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 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.