The need for a neutral independent and confidential approach

We believe that the organisations representing the various partners in France, notably the public health authorities or national research institutions (for example, INSERM) responsible for clinical research, should establish a "charter" concerning fraud and official guidelines to detect fraud at every step. This could include the bases for procedures not only to prevent fraud by the investigators or the sponsors, but also to manage cases of suspected fraud, including sanctions or penalties for the perpetrator. Each company, sponsor, or institution should also draft its own operating procedures for the monitoring of fraud and misconduct according to its own activity and culture.

Since fraud has several possible origins, it would appear desirable first to develop an administrative structure that would be independent of all parties, but where the scientific community would be represented. This independence is needed to maintain impartiality, and would avoid any party bringing the complaint too early to activate major judicial mechanisms that could eventually harm not only the perpetrator of the fraud but also the innocent party.

Monitoring fraud must take into account various constraints: during the investigation, all persons and companies must be treated with respect and protected from adverse publicity. The French so-called "présomption d'innocence" of the person and confidentiality should be guaranteed. However, within these limits, the investigation must be unconstrained. Once the problem has been dealt with, the information should not be made freely available to the public, but should be limited to the regulatory authorities, if the fraud concerns a medicinal product currently marketed, under development, or under registration, on to the head of public research institutions such as INSERM or the Centre Nationale de la Recherche Scientifique, and when appropriate, to the judicial authorities. Complaints can also be brought by individuals, companies, the health authorities (Afssaps-aps), or public institutions.

The file constituting the elements of proof or presumption should always be provided by the party making the complaint (sponsor, investigator, patient, or individual whistleblowers). This document should be as complete as possible, and it may be necessary to include reports from persons other than those directly involved in the study, as well as external auditors.

Was this article helpful?

0 0

Post a comment