Failure to Report Ethical Approval and Informed Consent in Paediatric Surgical Publications

Abstract

Medical research involving human subjects must follow ethical standards as outlined in the Declaration of Helsinki of the World Medical Association. The 3 journals J Ped Surg, Eur J Pediatr Surg and Pediatr Surg Int all require authors' statements regarding ethical approval and the patient or guardian informed consent for studies involving human subjects. It has previously been reported that ethical approval and informed consent is not documented in a considerable proportion of publications in other journals. The aim of this study was to investigate whether ethical approval and informed consent was documented in a consecutive series of publications involving human subjects in the 3 paediatric surgical journals. All articles involving human subjects or material published in the print and online issues of J Ped Surg, Eur J Pediatr Surg and Pediatr Surg Int in 2010 were systematically reviewed as to whether ethics committee or institutional review board approval and patient or guardian consent to participate in the study was reported. Publications were categorised into prospective studies, retrospective studies, description of new methods and case reports. 579 articles were included in the study (324 J Ped Surg, 103 Eur J Pediatr Surg and 153 Pediatr Surg Int). In case reports (n=142), the lowest level of documentation of ethical approval (1.4%) and informed consent (1%) was observed. The remaining 437 original articles reported ethical approval in 54% of publications (prospective studies 66%, retrospective studies 59%, new methods 27%). Informed consent was documented in 16% of the original articles (prospective studies 50%, retrospective studies 17%, new methods 14%). Detailed investigation of the different journals revealed the highest rate of reporting of ethical approval for J Pediatr Surg (71%), followed by Eur J Pediatr Surg (43%), and Pediatr Surg Int (24%). Patient or guardian informed consent was reported in 15% of the publications in J Pediatr Surg and Pediatr Surg Int, respectively, and in 24% of the papers published in Eur J Pediatr Surg. Adherence to ethical principles in paediatric surgical research should be improved. Information on ethical approval and informed consent should be included in all manuscripts accepted for publication. Editors should consider establishing a specific online template asking authors for the necessary information during the submission process.