PHARE

Descriptif court

RIPH; RNIPH; CODECOH

Objectives

The "Pôle d'Harmonisation & d'Accompagnement en Réglementation et Éthique" (PHARE), is a support and accompaniment structure for research projects carried out in humans by the teams of the Research Center.

Description

PHARE operates along four main areas:

  1. Ethics and regulations
    Application of the Jardé Act and oversight of interventional research involving the human person (RIPH, reviewed by the Committees for the Protection of Persons — CPP) and non-interventional research (RNIPH, reviewed by independent ethics committees: CEEI, CER-UdL, etc.).
  2. Personal data protection
    Compliance with the French Data Protection Act (Loi Informatique et Libertés) and the GDPR: private-sector research authorizations (AIVP), maintenance of the processing register, use of reference methodologies.
  3. Management of biological samples
    Compliance with the French Bioethics Law and monitoring of CODECOH procedures for scientific collections and preparations (blood samples, tissues, etc.).
  4. Legal support
    Assistance in drafting collaboration and valorization agreements.

The "Pôle d'Harmonisation & d'Accompagnement en Réglementation et Éthique" is placed under the direction of the Director, Laurent BEZIN, 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 Information Systems Security Officerw for CNRS.

The PHARE is coordinated by Lydie Merle and Lesly Fornoni and placed under the direction of the Director, Laurent Bezin.

Responsables
lesly.fornoni
lydie.merle