The PLOS One Editors issue this notice to update the previously published Expression of Concern on this article [1,2].

Following the publication of the article and Expression of Concern [1,2], PLOS investigated concerns pertaining to the reported ethical approval and the article’s adherence to PLOS One’s research ethics policies.

Specifically, the research ethics concerns included that the study involved human participants but did not receive ethics approval from a Comité de Protection des Personnes, and that the ethics approval number #07-026 was also reported in multiple other publications [3–7], and [8,9, retracted in 10], despite differences in the requirements for consent reported in these articles.

Neither the authors nor the institute responded to editorial communications related to this case, but PLOS was previously informed by a representative of the Aix-Marseille Université Ethics Committee that this article [1], and the articles [3–7], and [8,9, retracted in 10] were part of the same retrospective study of samples taken in intensive care units as part of routine patient care, and that the study did not require ethics approval from a Comité de Protection des Personnes according to French law. During these previous editorial communications, PLOS received a copy of ethics approval document #07–026 for editorial review.

Ethics approval document #07–026 was issued by the Comité d#39;Éthique de l#39;Institut Fédératif de Recherché de la Faculté de Médecine de Marseille (IFR48, Marseille, France) on February 19, 2007, for a study titled: “Recherche de nouveaux agents de pneumopathies nosocomiales par une approche métagénomique différentielle.” It allows for the use of blood, urine, and respiratory samples collected for diagnostic purposes, but the document does not clarify where the samples were collected or for how long the approval remained valid.

PLOS reviewed the explanation and documentation provided by the institution and concluded that the documents did not fully resolve the concerns. Specifically,

• If all articles were part of the same larger study, concerns remain about inconsistencies between the reporting of the study design in the articles’ Methods/Materials and Methods sections (no reporting in [3–5] and [6,7] and reported as a prospective study in [1,2] and [8,9, retracted in 10]), and the institute’s reporting of the study design (retrospective).
• If all articles were part of the same larger study, concerns remain about inconsistencies between the reporting of consent obtained for the study in each article (written consent obtained from next-of-kin reported in [1–5], and [6,7], need for written consent waived by the ethics committee [8,9, retracted in 10]), a statement that there are no written consents for this study previously provided by the institute [10], and the information in the ethics document #07-026 stating that patient consent was obtained.
• PLOS identified potential competing interests between multiple members of the approving ethics committee and one or more of the article’s authors.

PLOS has not been able to secure input from an independent official confirming whether or not this study should have been subjected to CPP approval as per French legislation.

In light of the unresolved issues, the Expression of Concern stands.