Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects |
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| Authors: | P Pitak-Arnnop R Sader C Hervé K Dhanuthai J-Ch Bertrand A Hemprich |
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| Institution: | 1. Department of Maxillofacial Surgery, AP-HP, Pitié-Salpêtrière University Hospital, Faculty of Medicine, University Paris 6 (Pierre et Marie Curie), Paris, France;2. Laboratory of Medical Ethics and Legal Medicine, Faculty of Medicine, University Paris 5 (René Descartes), Paris, France;3. Department of Oral, Craniomaxillofacial and Facial Plastic Surgery, Faculty of Medicine, University of Leipzig, Leipzig, Germany;4. Department of Oral, Craniomaxillofacial and Facial Plastic Surgery, Faculty of Medicine, Medical Centre of the Johann Wolfgang Goethe—University Frankfurt am Main, Frankfurt, Germany;5. Department of Oral Pathology, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand;1. Department of Mathematics, Technical University Munich, Munich, Germany;2. Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio, Texas;3. Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, San Antonio, Texas;4. Memorial Sloan Kettering Cancer Center, New York, New York;1. University of Naples Federico II, Department of Advanced Biomedical Science;2. University of Naples Federico II, Department of Reproductive and Odontostomatological Sciences;3. University of Salerno, Department of Medicine and Surgery;1. Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria;2. Department of Neurology, Franz Tappeiner Hospital, Merano, Italy;3. Spinal Cord Injury and Tissue Regeneration Center, Paracelsus Medical University, Salzburg, Austria;4. Department of Neurological, Neuropsychological, Morphological and Movement Sciences, Section of Clinical Neurology, University of Verona, Italy;5. Department of Physiology, Medical University of Graz, Graz, Austria |
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| Abstract: | This retrospective observational study investigated the frequency of reporting ethical approval and informed consent in recently published oral and maxillofacial surgery (OMS) research involving human subjects. All research involving human subjects published in the International Journal of Oral and Maxillofacial Surgery, Journal of Oral and Maxillofacial Surgery, British Journal of Oral and Maxillofacial Surgery, and Journal of Cranio-Maxillofacial Surgery during January to June 2005–2007 were analysed for disclosure of ethical approval by a local ethical committee and obtaining informed consent from the subjects. 534 articles were identified; ethical approval was documented in 118 (22%) and individual patient consent in 135 (25%). 355 reports (67%) did not include a statement on ethical approval or informed consent and only 74 reports (14%) disclosed statements of both. Ethical documentation in retrospective and observational studies was scant; 12% of randomised controlled trials and 38% of non-random trials did not report both of ethical protections. Most recent OMS publications involving humans failed to mention ethical review or subjects’ consent. Authors must adhere to the international research ethics guidelines and journal instructions, while editors should play a gatekeeper role to protect research participants, uphold scientific integrity and maintain public trust in the experimental process and OMS profession. |
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