title: Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects.
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.
authors.affiliation: Department of Maxillofacial Surgery, AP-HP, Pitié-Salpêtrière University Hospital, Faculty of Medicine, University Paris 6 (Pierre et Marie Curie), Paris, France. poramate.pitakarnnop@gmail.com
authors.forename: P
authors.initials: P
authors.lastname: Pitak-Arnnop
authors.forename: R
authors.initials: R
authors.lastname: Sader
authors.forename: C
authors.initials: C
authors.lastname: Hervé
authors.forename: K
authors.initials: K
authors.lastname: Dhanuthai
authors.forename: J-Ch
authors.initials: JC
authors.lastname: Bertrand
authors.forename: A
authors.initials: A
authors.lastname: Hemprich
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D018865:Dental Research / Q000941:ethics*; D035081:Editorial Policies; D032984:Ethics, Research; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D007598:Journalism, Dental; D010506:Periodicals as Topic; D035842:Research Subjects; D013515:Surgery, Oral / Q000941:ethics*