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A promoter may be a manufacturer in the health sector or a public research organization like Inserm. It assists researchers to ensure the feasibility, quality and correct implementation of their research, that regulatory texts are complied with and research participants are protected.
The law on the protection of participants in clinical and health research defines three main roles:
- participants in the research,
- the researcher who thought up the project, constructs, implements it and then analyses the findings,
- the promoter.
To achieve this, as a promoterInserm:
- evaluates the clinical and health research projects that researchers present to it,
- prepares the necessary documents for submitting the project to the health authorities (Ethical Research Committee and Afssaps),
- takes out civil liability insurance to protect and possibly compensate participants in the research,
- prepares the information documents on the research and consent that all participants in clinical and health research must sign, together with patients’ associations,
- records and possibly declares any adverse events that arise during a research project to the health authorities,
- ensures the proper implementation and quality of the research through regular visits to the investigation sites.