期刊编辑视角下儿童真实世界研究的伦理风险识别与结构化审查框架OA

Owing to physical and mental immaturity,children require special protection in medical research.With the rise of real-world research,ethical issues such as informed consent,privacy protection,and risk-benefit assessment have become particularly prominent in pediatric studies due to diverse data sources and complex study designs.Although institutional review boards constitute the primary safeguard for research ethics,journal editors play an irreplaceable role in pre-publication ethical gatekeeping.From the perspective of journal editors,this paper reviewed common ethical risks in pediatric real-world research,including the lack of scientific value in research topics,unjust control groups,inadequate privacy protection,and other issues.Based on the four principles of biomedical ethics and the three-tier review process,this study constructed a structured ethical review framework.The framework comprised three levels:basic compliance screening at the initial review,substantive risk assessment and grading at the secondary review,and escalated handling of high-risk manuscripts at the final review,and it achieved a transformation from formal compliance verification to substantive ethical assessment led by risk grading.This could provide effective ethical risk assessment tools for journal editors and offer references for medical journals to improve pre-publication ethical governance.