Science

Respect ethics and the law, in order to protect confidence in clinical research

Biomedical research is essential for the development of knowledge and the progress of everyone’s health. It would not be acceptable today to offer treatments that have not been tested on humans to guarantee their effectiveness and, above all, their safety. An international consensus has been established since the beginning of the 20th century that research on human beings should only be accepted if it respects certain principles: consent of the subjects, safety, and scientific rigor.

Since 1975, the World Medical Association has made compulsory, within the framework of the Declaration of Helsinki, the preliminary examination of any research project on human beings by an independent committee responsible for verifying, in particular, the scientific justification and the methodology of the study. Because it is not acceptable for a person to suffer any risk or inconvenience by participating in deficient or unnecessary research. French law incorporates these principles accepted by all. It entrusts the personal protection committees (CPP), according to the current terminology resulting from the Jardé law, to carry out this preliminary examination of research projects and to authorize them. According to the risk they pose to the participating subjects, this research involving the human person (RIPH) is classified into three categories. The first requires, in addition to the authorization of the CPP, that of the National Medicines Safety Agency (ANSM).

Certain health research – epidemiological, in particular – does not come under this legal regime because it relates only to data and does not, in itself, involve any act performed on people. They can then receive the prior opinion of a research ethics committee (CER). The REBs, which are formed freely, do not have the power to authorize research that would fall under the legal regime of RIPH. It can be tempting, in a strategy of avoiding the authorization system, to disguise RIPH as research that does not require the examination of the PPC and to submit the projects to a local committee – if necessary, formed ad hoc. An approach that is unethical and that destroys the protection of the law against abusive testing.

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The publication of an investigation in L’Express on July 22, 2021 warns of the existence of abuses of this nature. And this is deeply worrying.

L’Express notably unveils the inclusion, in a study, of young medical students who are asked to perform vaginal swabs on themselves, in order to detect possible sexually transmitted infections. Such research falls within the framework of RIPH and should not be able to escape the prior review of a PPC. L’Express reveals that this was the case, even though this type of study involving students dependent on the researcher who is their teacher poses obvious ethical problems, calling for special measures to protect people. Research on homeless people, such as the Express reports, asks the same type of questions.

The Express investigation shows that the same “authorization” number is found copied and pasted on fifteen scientific articles relating to different research. These anomalies call into question the seriousness with which the rules, ethical and legal, which ensure the protection of people have been treated.

Doubts about compliance with rules and methods are not admissible in clinical research. Preserving the confidence of society in research involving the human person is an ardent obligation of the supervisory, administrative and judicial authorities.

Faced with the seriousness of the facts mentioned, the signatories call on the competent authorities – the ANSM, the prosecution, the National Commission for Informatics and Freedoms (Cnil), but also the General Inspectorate of Social Affairs (Igas) – to a determined reaction in order to establish the extent of these practices and, if necessary, to sanction them.

People participating in medical research must be protected, as well as science, from neglect and abuse.

Signatories

Me Philippe Amiel, health lawyer

Dr Bruno Clément, research director, biology-health

Prof. Bettina Couderc, professor of biotechnologies and biomedical ethics

Prof. Stéphane Gaudry, professor of intensive medicine and intensive care

Prof. Olivier Joannes-Boyau, anesthesiologist

Pr Hervé Maisonneuve, public health doctor

Prof. Patrick Mercié, internal medicine and clinical immunology

Prof. Mathieu Molimard, medical pharmacologist

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Pr Virginie Rage, President of the National Conference of Personal Protection Committees

Jean-Loup Salzmann, former president of the Conference of University Presidents


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