Raising concerns on questionable ethics approvals - a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection.

Fabrice Frank, Nans Florens, Gideon Meyerowitz-Katz, Jérôme Barriere, Éric Billy, Véronique Saada, Alexander Samuel, Jacques Robert, Lonni Besançon
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引用次数: 1

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.

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对有问题的伦理批准提出关注——一项对来自法国医院-大学(Institut hospital - universitaire)的456项试验的案例研究。
背景:临床研究实践受到法律的严格规范。在提交和审查过程中,作者并不总是正确填写或编辑核实这些研究是否符合进行研究的国家所执行的法律。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篇看似相关的伦理问题的出版物,以及通过与这些文章的编辑联系的10个月的随访。因此,我们主张对科学编辑的伦理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(医院-大学研究所)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提交的批准有关的已发表研究的研究授权和伦理方面的广泛问题。在被调查的研究中,尽管研究对象、样本和调查国家不同,但有248项研究使用了相同的伦理批准号。39项研究在展示人体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,并提供了他们对我们关注的问题的回应。应该指出的是,自从我们的调查和向期刊报告以来,PLOS已经发布了我们在这里分析的几种出版物的担忧表达。结论:本病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10个多月的随访。我们呼吁在处理这些案件时进行更严格的控制和合作,包括编辑要求上传伦理批准文件,COPE的指导方针来解决这些伦理问题,以及透明的编辑政策和时间表来回答这些问题。所有补充材料都准备好了。
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