2023-04-24 15:47:23
Can research be conducted for more than 20 years in France using medical and judicial records, without obtaining authorization from regulatory authorities or informing the patients involved regarding the use of their data? This question has been raised by a recent, perhaps seemingly trivial, case of article retraction.
On March 9, the journal Child’s Nervous System (Springer Group) withdrew a French research team’s publication, which appeared on October 4, 2021, claiming that “contrary to the statement in the article, the authors have been unable to provide documents confirming that ethics approval was obtained for the study”.
Presented as prospective and observational, the study analyzed the characteristics of head injuries inflicted on infants and, in particular, of Shaken Baby Syndrome (SBS) cases treated at Lille University Hospital between 2001 and 2021. Medical records were matched with reports on the confessions or denial of the presumed perpetrators compiled during the judicial investigation.
Neurosurgeon Matthieu Vinchon, lead author of the paper, and his colleagues concluded that these head injuries are quite often (in 39% of cases) confirmed by a confession, “indicating that the diagnostic criteria are robust”. The publication is in line with the work of Professor Vinchon, who worked as head of the department of pediatric neurosurgery at Lille University Hospital, before moving to Lyon.
SBS, which has been the trigger for several high-profile criminal cases, is at the heart of a raging scientific controversy. Vinchon’s and other neurosurgeons’ studies have been challenged by part of the international scientific community, who believe that diagnostic criteria are weak and lead to wrongful accusations once morest parents and nannies for brain damage due to natural causes.
Before the article was retracted, its relevance had been been called into doubt by two Swedish researchers, co-authors of a 2016 report on SBS for the Swedish Public Health Agency. However, the withdrawal is not connected to these objections, but was rather due to the lack of a green light from an ethics committee.
Vinchon said that the authorization was requested by the journal when the article was submitted, and that he turned to the French Northwest IV Committee for the Protection of Persons (CPP).
In a September 27, 2021, email seen by The worldthe CPP vice-president replied to Vinchon that “since the committee doubts the usefulness of this study and the viability of its conclusion,” he was “not in favor on the ethical side”. However, he continued, “we cannot be expected to give a favorable or unfavorable opinion regarding this project, since it seems that the study has already been carried out”.
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