Failure to report ethical approval in child health research: review of published papers

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Abstract
We reviewed all research reports related to child health (involving patients JAMA, New England Journal of Medicine, Pediatrics, Journal of Pediatrics, Archives of Pediatrics and Adolescent Medicine). Each report was reviewed independently by two research assistants for any statement about informed consent or ethics committee approval; if either statement was present, the report was categorised as having ethical approval. An article that referred to another publication for more details was not reviewed. This approach has been used previously.2 All five journals require studies with human participants to report ethical approval. Reports not describing approval were reviewed again by an investigator to ensure that errors in categorisation of the studies had not been made. Studies were also categorised according to design. The ethics committee at Boston University School of Medicine judged that this project did not represent research involving human subjects and did not require review.