Follow-up investigation of ethics approvals and regulatory compliance in publications from the IHU-Mi.

backgroundFollowing our previous investigation of 456 articles published by the IHU-Méditerranée Infection (IHU-Mi) institute in Marseille, France, subsequent editorial actions, institutional reviews, and reports from French authorities provided additional evidence relevant to our concerns. We therefore extended our investigation to the broader IHU-Mi bibliography to assess potential breaches of the Declaration of Helsinki, French regulations governing research involving human participants, and the consistency between reported studies and the ethics approvals cited.

methodsWe assessed 2,674 IHU-MI publications identified through PubMed, Google Scholar, PubPeer, and manual searches. We excluded articles not reporting research involving human participants, articles clearly reporting retrospective studies without ethics flaw, and articles for which editorial investigations had clarified our concerns. We compared the remaining articles with the relevant French legal framework and, where available, with ethics approvals obtained through public transparency procedures or other sources.

resultsWe identified ethical or legal concerns in 853 articles from this institute. These included at least 75 articles with retrospective approvals, 194 describing research conducted abroad without mention of local approvals, 343 not mentioning ethics approval, and 426 describing sample collection from healthy volunteers with concerns. Among 374 articles for which we obtained the cited ethics approval documents, at least 304, or 81.3%, described sample collections that were not covered by the corresponding approval. Since our previous investigation, editorial and institutional responses have led to 64 retractions and 270 expressions of concern, and have clarified or substantiated many of the concerns raised. We also found that the local ethics committee issuing most of the approvals may not have been sufficiently independent from the authors.

conclusionInstitutional reports and editorial decisions have substantiated many of the concerns identified in our analysis, although a small subset of cases was attributable to unintentional errors. Our findings indicate widespread and longstanding problems in research ethics compliance within the IHU-Mi bibliography and support the need for continued editorial and institutional review.