Support for Human Experimentation: Ethics and Regulation

Descriptif court

RIPH

Objectives

The "Ethics and Regulations" unit of the CRNL is a support and accompaniment structure for research projects carried out in humans by the teams of the Research Center.

Description

Its missions are to support research protocols involving the human person [RIPH] and all regulatory procedures related to the human person (authorization of a research site, CODECOH procedures); to direct the experimenters to the appropriate and necessary training to carry out the RIPH (training in Good Clinical Practices [GCP], Training in Prevention and Civic Assistance level 1 [PSC1], etc.), to ensure compliance with the regulations, procedures and ethics and to coordinate interactions between the various research actors: investigators, promoters, ethics committees (research ethics committee [CER], Personal Protection Committees [CPP]) and other institutions (National Agency for Medicines and Health Products Safety [ANSM], National Commission for Informatics and Freedoms [CNIL], Biomedicine Agency, Ministry of Research and Innovation [MESRI]).

The Ethics and Regulation unit is placed under the direction of the Director, Olivier Bertrand, and the Deputy Director, Laurent Bezin and coordinated by Lesly FORNONI and Lydie Merle.

The Ethics and Regulation Unit works in close collaboration with the data protection officers (DPO) of the various establishments (INSERM, CNRS, etc.) and relies on the skills by Pierre Emmanuel Aguera, Information Systems Security Officer for CNRS.

The Ethics and Regulations support service for human experimentation is coordinated by Lydie Merle and Lesly Fornoni and placed under the direction of the Director, Olivier Bertrand, and the Deputy Director, Laurent Bezin.

Responsables