A major French research centre that produced one of the most widely cited and controversial research papers of the Covid-19 pandemic has been found by an international research team to have used questionable and concerning ethics approval processes across hundreds of studies.
The Institut Hospitalo-Universitaire Méditerranée Infection, or IHU, is a large clinical research centre in the south of France. It was founded by Prof Didier Raoult, who was also director of the centre until August 2022, when he stood down ahead of the release of findings from a government audit that found the institute conducted trials “likely to constitute offences or serious breaches of health or research regulations”.
Raoult was the corresponding author of an IHU-led study published in 2020 which claimed the drugs hydroxychloroquine and azithromycin could in combination treat Covid-19 with “100% viral clearance”, leading to several countries adopting the treatment, and former US president Donald Trump promoting it.
The research was quickly identified as problematic, with the study design and interpretation of data criticised by experts, and the combination treatment also found to be associated with increased risk of heart damage.
More rigorous studies concluded the treatments in combination and alone were ineffective, with major international organisations including the World Health Organisation recommending against the treatments and warning of adverse effects.
Despite this, the drugs are still being prescribed to treat Covid-19 in low and middle-income countries, raising concerns about antimicrobial resistance given azithromycin is an antibiotic. Raoult stands by the study’s findings and hydroxychloroquine.
Given the widespread ramifications caused by one highly promoted study, Lonni Besançon, an assistant prof at Linköping University in Sweden, co-led a review of 456 other studies led by the IHU and published in medical journals.
“Among the studies investigated, 248 were conducted with the same ethics approval number, even though the subjects, samples, and countries of investigation were different,” the review, published in the August edition of the journal Research Integrity and Peer Review, found. “Thirty-nine did not even contain a reference to the ethics approval number while they present research on human beings.”
Raoult’s name was on 415 of the 456 papers that were reviewed, and on 238 of the 248 studies with the same ethics approval number, Besançon told Guardian Australia. While reusing approvals is allowed in some circumstances, this is usually only the case if the research is related to the original approval, the review said.
However, Besançon and his team found ethics approvals were shared across a large variety of research. Some studies, for example, examined samples from stools, urine or organs; some studies were conducted in adults while others examined children, healthy volunteers or obese patients; and study populations even came from different countries.
The authors said medical journals should routinely require researchers to submit their ethics approvals before the work is reviewed and published.
“Although some publishers already require the upload of ethics approval, this practice is not widely adopted,” Besançon said.
“We therefore argue that it should be more widely and rigorously adopted. Ethical approval numbers should be provided as metadata so that post-hoc analysis can be carried out more systematically.”
Guardian Australia contacted Raoult and the IHU for comment but did not receive a response.
A co-author of the review, University of Wollongong epidemiologist Gideon Meyerowitz-Katz, said the IHU “produced by far the most cited and among the most viewed” paper in relation to the pandemic in its hydroxychloroquine study.
“It is genuinely one of the most influential papers of the pandemic and it resulted in a treatment across the world that is still being used, even though we know it does not work,” he said.
“I think it’s hard to overstate how potentially impactful it could be if this research, and other research conducted by the institution, was not conducted ethically.”
This article was amended to reflect Lonni Besançon’s current position at Linköping University in Sweden.
