Abstract
Abstract
Background
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 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.
Methods
We present an investigation of the ethics and legal aspects of 456 studies published by
the IHU-MI (Institut
Hospitalo-Universitaire Méditerranée Infection) in Marseille, France.
Results
We identified a wide range of issues with the stated research authorization and
ethics of the published studies with respect to the Institutional Review Board
and the approval presented. Among the studies investigated, 248 were conducted
with the same ethics approval number, even though the subjects, samples, and
countries of investigation were different. Thirty-nine (39) did not even
contain a reference to the ethics approval number while they present research
on human beings. We thus contacted the journals that published these articles
and provide their responses to our concerns. It should be noted that, since our
investigation and reporting to journals, PLOS has issued expressions of
concerns for several publications we analyze here.
Conclusion
This case presents an investigation of the veracity of ethical approval,
and more than 10 months of follow-up by independent researchers. We call for
stricter control and cooperation in handling of these cases, including
editorial requirement to upload ethical approval documents, guidelines from
COPE to address such ethical concerns, and transparent editorial policies and
timelines to answer such concerns. All supplementary materials are available.
Publisher
Springer Science and Business Media LLC
Subject
General Earth and Planetary Sciences,General Environmental Science
Cited by
1 articles.
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