Brent K Winemiller, Joshua A Daily, Taufiek K Rajab
{"title":"Ethical Oversight of First-in-Human Cardiac Procedures for Congenital Heart Disease in Children.","authors":"Brent K Winemiller, Joshua A Daily, Taufiek K Rajab","doi":"10.1093/icvts/ivaf212","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73406,"journal":{"name":"Interdisciplinary cardiovascular and thoracic surgery","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12500323/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Interdisciplinary cardiovascular and thoracic surgery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/icvts/ivaf212","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"0","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
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.
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