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.

中文翻译：

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引起对可疑伦理审批的担忧——地中海感染大学医院研究所 456 项试验的案例研究

背景

临床研究的实践受到法律的严格监管。在提交和审查过程中，此类研究是否符合进行研究的国家/地区执行的法律并不总是由作者正确填写或由编辑验证。在这里，我们报告了一个单一机构的案例，人们可能会发现数百份出版物似乎存在相关的道德问题，并通过与这些文章的编辑联系进行了 10 个月的跟踪。因此，我们主张对科学编辑的道德授权进行更严格的控制，并呼吁出版商为此进行合作。

方法

我们对法国马赛 IHU-MI（地中海大学感染医院研究所）发表的 456 项研究的伦理和法律方面进行了调查。

结果

我们发现了与机构审查委员会和所提交的批准有关的已发表研究的规定研究授权和道德规范的广泛问题。在所调查的研究中，尽管受试者、样本和调查国家不同，但有 248 项研究具有相同的伦理批准号。三十九 (39) 在介绍人类研究时甚至没有提及伦理批准号。因此，我们联系了发表这些文章的期刊，并就我们的担忧做出了回应。应该指出的是，自从我们进行调查并向期刊报告以来，公共科学图书馆已经对我们在此分析的几篇出版物表达了担忧。

结论

该案例对伦理批准的真实性进行了调查，并由独立研究人员进行了超过 10 个月的跟踪调查。我们呼吁在处理这些案件时进行更严格的控制和合作，包括上传道德批准文件的编辑要求、解决此类道德问题的 COPE 指南，以及回答此类问题的透明的编辑政策和时间表。所有补充材料均可用。