Raising concerns on questionable ethics approvals – a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection

Research Integrity and Peer Review

Commentary

Véronique Saada¹  Nans Florens²  Fabrice Frank³  Alexander Samuel⁴  Éric Billy⁵  Lonni Besançon⁶  Jérôme Barriere⁷  Gideon Meyerowitz-katz⁸  Jacques Robert⁹ 

[1]Biopathology department, Gustave Roussy Anti-Cancer Center, Villejuif, France

[2]Department of Nephrology, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Strasbourg, France

[3]Independent researcher, Essaouira, Morocco

[4]Independent researcher, Nice, France

[5]Independent researcher, Strasbourg, France

[6]Media and Information Technology, Linköping University, Norrköping, Sweden

[7]Medical Oncology Department, Polyclinique Saint-Jean, Cagnes-sur-Mer, France

[8]School of Health and Society, University of Wollongong, Wollongong, Australia

[9]Université de Bordeaux, INSERM Unité 1312, Bordeaux, France

关键词: Clinical research;    Ethics;    Scientific publications;    Scientific publishing;    IRB (Institutional Review Board);   

DOI  :  10.1186/s41073-023-00134-4

 received in 2023-02-13, accepted in 2023-05-22,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe practice of clinical research is strictly regulated by law. During submission and review processes, compliance of such research with the laws enforced in the country where it was conducted is not always correctly filled in by the authors or verified by the editors. Here, we report a case of a single institution for which one may find hundreds of publications with seemingly relevant ethical concerns, along with 10 months of follow-up through contacts with the editors of these articles. We thus argue for a stricter control of ethical authorization by scientific editors and we call on publishers to cooperate to this end.MethodsWe present an investigation of the ethics and legal aspects of 456 studies published bythe IHU-MI (InstitutHospitalo-Universitaire Méditerranée Infection) in Marseille, France.ResultsWe identified a wide range of issues with the stated research authorization andethics of the published studies with respect to the Institutional Review Boardand the approval presented. Among the studies investigated, 248 were conductedwith the same ethics approval number, even though the subjects, samples, andcountries of investigation were different. Thirty-nine (39) did not evencontain a reference to the ethics approval number while they present researchon human beings. We thus contacted the journals that published these articlesand provide their responses to our concerns. It should be noted that, since ourinvestigation and reporting to journals, PLOS has issued expressions ofconcerns for several publications we analyze here.ConclusionThis case presents an investigation of the veracity of ethical approval,and more than 10 months of follow-up by independent researchers. We call forstricter control and cooperation in handling of these cases, includingeditorial requirement to upload ethical approval documents, guidelines fromCOPE to address such ethical concerns, and transparent editorial policies andtimelines to answer such concerns. All supplementary materials are available.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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