ANSM is publishing the final reports of the inspection conducted at the Institut hospitalo universitaire-Méditerranée Infection de Marseille (IHU) and at the Assistance Publique – Hôpitaux de Marseille (AP-HM), following reports in the context of our whistleblower system. The inspection reveals serious shortcomings and non-compliances with the regulations for research involving the human person (RIPH) , in particular on the ethical level.
ANSM again contacts the public prosecutor of Marseille under article 40 of the code of criminal procedure and initiate administrative proceedings.
At the end of November 2021, ANSM carried out an inspection within the IHU and the AP-HM. The purpose of this was in particular to verify compliance by the IHU and the AP-HM with the legislative and regulatory provisions relating to RIPH by verifying:
- the conditions for implementing the following research with regard to the applicable regulations: “Research for tropheryma whipplei as an agent of gastroenteritis in young children” and “Pathologies associated with travel and acquisition of pathogens and multi-resistant bacteria in medical students doing a practical internship outside France”;
- opinions from the IHU’s internal ethics committee on research projects (over the period October 2018 to 2021);
- information sent by the Institut hospitalo universitaire-Méditerranée Infection de Marseille (IHU) to ANSM regarding the promotion of RIPH;
- medical records of patients treated in 2019 for infectious tuberculosis by the infectious diseases departments of the AP-HM housed within the IHU, due to the possible implementation of interventional research involving an intervention on the person not justified by their usual care in the absence of ANSM authorization and a favorable opinion from a CPP.
The inspection revealed breaches of the RIPH regulations carried out within the IHU , in particular with regard to the methods of implementation, the conditions for taking and using the samples of the people included in research. , as well as the procedures for obtaining consent and informing participants. Ethical rules were not systematically respected, making it impossible to ensure the protection of people at a sufficient level and as required by the regulations.
Given the seriousness of the breaches observed, ANSM has decided to refer the case again to the public prosecutor under article 40 of the code of criminal procedure for the following criminally reprehensible facts:
- the implementation of research in the absence of a prior favorable opinion from a committee for the protection of persons within the IHU and the AP-HM;
- the communication to the ANSM by the IHU prior to the inspection of a falsified document concerning an opinion of the internal ethics committee of the IHU.
At the same time, ANSM is currently initiating a contradictory procedure with the IHU and the AP-HM:
- on the one hand to suspend research carried out without requesting an opinion from a committee for the protection of persons prior to their implementation, by means of a health policy decision;
- on the other hand to enjoin the IHU and the AP-HM to comply with the regulations of the RIPH by corrective and preventive actions, by means of an injunction.
ANSM investigations continue in connection with the IGAS/IGESR mission and on the treatment of patients with infectious tuberculosis.
Indeed, if we have not, at this stage of our investigations, identified elements proving the implementation of an unauthorized clinical trial on the treatment of multi-resistant tuberculosis of patients treated during the year 2019, we nevertheless highlighted the use of combinations of antibiotics different from international recommendations and potentially dangerous for patients. The frequency of serious adverse events over the 2019 period appears high. ANSM is therefore carrying out additional analyses on all the patients treated over the period 2016-2021.
At the same time, ANSM is continuing to review the qualification of several other research projects, in connection with the IGAS/IGERS mission still in progress within the AP-HM and the IHU.
An inspection always concludes with a preliminary inspection report which mentions the deviations observed with regard to the regulations. This preliminary report is transmitted to the inspected operator within the framework of a contradictory procedure which can communicate its answers, its preventive or corrective actions to remedy the observed discrepancies. On the basis of these answers, the final report is drawn up and makes it possible to conclude that the site is compliant or to take appropriate decisions in the event of non-compliance.
We provide the complete inspection report, including the preliminary report, the answers of the inspected and the final reports.