Frank Fabrice, Florens Nans, Meyerowitz-Katz Gideon, Barriere Jérôme, Billy Éric, Saada Véronique, Samuel Alexander, Robert Jacques, Besançon Lonni
Independent researcher, Essaouira, Morocco.
Department of Nephrology, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Strasbourg, France.
Res Integr Peer Rev. 2023 Aug 3;8(1):9. doi: 10.1186/s41073-023-00134-4.
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.
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.
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.
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.
临床研究实践受到法律严格监管。在提交和评审过程中，作者不一定能正确填写此类研究在开展所在国所遵循法律的合规情况，编辑也不一定能进行核实。在此，我们报告一个单一机构的案例，该机构有数百篇出版物似乎存在相关伦理问题，我们通过与这些文章的编辑联系进行了10个月的跟进。因此，我们主张科学编辑对伦理授权进行更严格的管控，并呼吁出版商为此进行合作。
我们对法国马赛的地中海感染大学医院研究所（IHU-MI）发表的456项研究的伦理和法律方面进行了调查。
我们在已发表研究的既定研究授权和伦理方面，发现了与机构审查委员会及所提供批准相关的广泛问题。在所调查的研究中，248项研究使用了相同的伦理批准编号，尽管研究对象、样本和调查国家各不相同。39项研究在涉及人体研究时甚至未提及伦理批准编号。因此，我们联系了发表这些文章的期刊，并提供了它们对我们所关注问题的回复。应当指出的是，自我们进行调查并向期刊报告以来，公共科学图书馆（PLOS）已对我们在此分析的几篇出版物发布了关注声明。
本案例展示了对伦理批准真实性的调查，以及独立研究人员超过10个月的跟进。我们呼吁在处理这些案例时进行更严格的管控与合作，包括编辑要求上传伦理批准文件、出版伦理委员会（COPE）解决此类伦理问题的指南，以及应对此类问题的透明编辑政策和时间表。所有补充材料均可供使用。
