Review of Routine Radiographic Imaging in Children With Craniosynostosis

Background: Seventy-eight years after the Nuremberg Code established informed consent as the foundation of ethical research, craniofacial surgery continues to fall short. Many craniosynostosis studies rely on routine postoperative computed tomography (CT) scans without specifying whether research consent was obtained, raising concerns given the risks of pediatric radiation exposure. Objective: To characterize historical practices surrounding routine postoperative imaging in craniosynostosis research and discuss broader ethical implications. Data Sources: Systematic content analysis was conducted in accordance with PRISMA guidelines across Ovid MEDLINE, Elsevier Embase, and the Cochrane Central Register of Controlled Trials. Study Selection: Studies involving pediatric patients undergoing surgical correction of nonsyndromic craniosynostosis with routine postoperative radiographic imaging. Data Extraction: Data were extracted using a standardized form. Primary outcomes included documented Institutional Review Board (IRB) approval, consent process, and imaging protocol. Results: One Hundred Twenty-four studies met the inclusion criteria. IRB approval was reported in 48%, and imaging consent was documented in 3%. Most (85%) used clinically obtained imaging; 15% used formal research protocols. Research imaging was more common in studies lacking IRB approval ( P =0.04), and evidence ratings were higher among IRB-approved studies ( P =0.009). Conclusions: Serial CT scans in craniosynostosis research are frequently obtained without documented IRB approval or informed consent. Improved documentation is needed to protect pediatric patients and uphold ethical research standards.