59 articles – 21 Notices  [english version]
Fiche concise
Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects.
Pitak-Arnnop P., Sader R., Hervé C., Dhanuthai K., Bertrand J.-C., Hemprich A.
International Journal of Oral and Maxillofacial Surgery 38, 7 (2009) 707-12 - http://www.hal.inserm.fr/inserm-00415620
(19264449)
Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects.
Poramate Pitak-Arnnop1, 2, 3, Robert Sader4, Christian Hervé1, Kittipong Dhanuthai5, Jean-Charles Bertrand2, Alexander Hemprich3
1 :  LEM - Laboratoire d'éthique médicale et médecine légale
Réseau Inserm de Recherche en éthique médicale – Université Paris V - Paris Descartes
Faculté de médecine, 45 rue des Saints-Pères, Paris 75006
France
2 :  Stomatologie- Chirurgie maxillo-faciale
Assistance publique - Hôpitaux de Paris (AP-HP) – Hôpital Pitié-Salpêtrière – Université Pierre et Marie Curie [UPMC] - Paris VI
Paris
France
3 :  Department of Oral, Craniomaxillofacial and Facial Plastic Surgery
University Hospital of Leipzig
Faculty of Medicine, Leipzig
Allemagne
4 :  Department of Oral, Craniomaxillofacial and Facial Plastic Surgery
University Frankfurt am Main
Faculty of Medicine, Medical Centre of the Johann Wolfgang Goethe, Frankfurt
Allemagne
5 :  Department of Oral Pathology
Chulalongkorn University
Faculty of Dentistry, Bangkok
Thaïlande
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.
Sciences du Vivant/Ethique
Anglais
1399-0020

Articles dans des revues avec comité de lecture
10.1016/j.ijom.2009.01.018
International Journal of Oral and Maxillofacial Surgery (Int J Oral Maxillofac Surg)
Publisher Elsevier
ISSN 0901-5027 (eISSN : 1399-0020)
internationale
07/2009
04/03/2009
38
7
707-12

Clinical Trials as Topic – Dental Research – Editorial Policies – Ethics – Research – Guidelines as Topic – Humans – Informed Consent – Journalism – Dental – Periodicals as Topic – Research Subjects – Surgery – Oral