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.
Type de document :
Article dans une revue
International Journal of Oral and Maxillofacial Surgery, Elsevier, 2009, 38 (7), pp.707-12. 〈10.1016/j.ijom.2009.01.018〉
Liste complète des métadonnées

http://www.hal.inserm.fr/inserm-00415620
Contributeur : Nathalie Duchange <>
Soumis le : jeudi 10 septembre 2009 - 17:19:29
Dernière modification le : mercredi 21 mars 2018 - 18:57:41

Identifiants

Collections

Citation

Poramate Pitak-Arnnop, Robert Sader, Christian Hervé, Kittipong Dhanuthai, Jean-Charles Bertrand, et al.. Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects.. International Journal of Oral and Maxillofacial Surgery, Elsevier, 2009, 38 (7), pp.707-12. 〈10.1016/j.ijom.2009.01.018〉. 〈inserm-00415620〉

Partager

Métriques

Consultations de la notice

150