Recommendations

Advocating a preventive strategy

The INSERM report stresses the importance of preventive steps by:

• keeping researchers informed (young scientists, recently appointed research unit heads)

• the promotion of good research and clinical practice.

In France, the INSERM units involved in clinical trials on medicinal products, comply with the legal requirements (French law on biomedical research and notification of clinical trials to Afssaps) and conform to good clinical practice, subsequently ensuring not only the protection of study subjects but also the quality and reliability of data.

However, the more fundamental type of biomedical research does not comply sufficiently with good laboratory practice. For this reason, INSERM has introduced the systematic use of research notebooks, that could be replaced in certain cases by a collection of source documents for clinical data or any form particular to a given discipline (human or social sciences).

This approach is crucial to scientific ethics. All research documents and results (research notebooks) are the property of INSERM and must be archived for 10 years or sent to the INSERM main office when a unit is closed. All contracts between INSERM and a partner, institutions, or industry must show compliance with good laboratory practice and use laboratory notebooks.

A further preventative step is the promotion of ethical guidelines for authorship practices and scientific assessment. Too many factors encourage gift authorship in articles:

• pressure to publish

• encouragement by scientific assessors or reviewers from top ranking journals

• irrational request for top scientific publications for selection/ appointment of hospital practitioners.

INSERM has an Ethical Forum, which is the successor of the previous Ethics Committee; this latter has become the "Comité Consultatif National d'Ethique pour les Sciences de la Vie et de la Santé" (National Advisory Ethics Committee for the Life Sciences and Health). INSERM is intending to publish a document on "good authorship and publication practice".

Implementation of a Délégation à l'Intégrité Scientifique to respond to allegations of fraud

The recommendations of the INSERM experts concerning the allegations of fraud/misconduct are inspired by the systems existing in Germany, the UK, and the USA, and are adapted to the INSERM culture and context.

The aim of the Délégation (its head and mediators) is not only to look at the genesis of the problems that could lead to the development of misconduct but also to propose the most suitable steps to prevent it. There are four separate procedures:

• The instruction phases following an allegation of scientific misconduct (instructed by the Délégation, regional mediators, and committees) are separated from the discipline phase, which is driven by the INSERM Director General in case of proven fault.

• The three sequential stages must be confidential and instructors should establish whether there is a real fault, its seriousness, and the person(s) responsible.

• Stage 1 follows an allegation, accepted only in writing, looks at a local solution decided by the Director General after a suggestion of the regional mediator, and after, if necessary, an interview by Délégation head.

• Stage 2 occurs after failure of the previous stage. The Director General appoints experts, with no conflict of interest, in the same field of research, to become the "committee of enquiry". The committee sends its conclusions to the Director General, who decides on the consequences.

• Stage 3 is a formal investigation by an "Investigation Committee" appointed by the Director General and may include foreign experts. Only the Director General is allowed to communicate on the case.

• Enquiry outcome

If a fault is proved, disciplinary or legal measures are taken by the Director General, depending on the importance and the level (individual sanction, closure of the unit). If the fault is not proved, the reputation of the involved person/people needs to be re-established, and necessary sanctions should be taken against the whistleblower in case of defamation.

• Delegation's annual report

The head of the Délégation Générale must provide an annual report to INSERM. This report should contain anonymous statistical data that should help improve good scientific practice guidelines, in order to protect scientific integrity and avoid fraud and misconduct.

Today INSERM has its own good science practice procedures and its own quality assurance system.These procedures against scientific misconduct are adapted from those of other countries. However, the institution would welcome a European initiative to harmonise good scientific practice in order to prevent or handle cases of fraud.The coordinating organisation could be the European Science Foundation (ESF).

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