Ethical and legal considerations in non interventional health clinical trials in the French context

Leymarie, Sophie; Bahans, C.; Paltoglou, M.; Demiot, C.

doi:10.1016/j.conctc.2022.100955

Cited by 1 publication

(1 citation statement)

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“…Any experimentation on human beings must be approved by an independent ethics committee and depending on the complexity of the protocol, additional authorizations are required, especially regarding the collection of body fluids such as stool, vaginal secretions or urine). Among the 248 studies identified, we have found at least one that was conducted after the Jardé Law was implemented [13], as well as many more published after 2016 with no dates of patient enrollment identifiable.…”

Section: Fig 1 Various Subjects Samples and Countries For The 248 Stu...mentioning

confidence: 99%

Issues with Ethics in Research – A Case Study of the IHU Mediterranee Infection

FRANK¹,

Florens²,

Barrière³

et al. 2023

Preprint

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The 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 review 456 studies published by the IHU Méditerranée Infection (Marseille, France) and identify a range of issues with the stated authorization of the research, ethically and potentially legally. Of these, 248 were conducted with the same ethics committee reference, even though the subjects, samples and countries were different. Thirty-nine did not even contain a reference to the ethics committee while they contain research on human beings. With this example, we call for stricter control by publishers of the regulatory documentation related to clinical research during the publication process. All supplementary materials are available on https://osf.io/ueqf8/.

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Section: Fig 1 Various Subjects Samples and Countries For The 248 Stu...mentioning

confidence: 99%