Human research at CRNL
CRNL conducts basic and clinical research in humans to decipher the organization of the central nervous system, cognitive functions, mental states and associated brain disorders.
There are many research protocols involving humans carried out at CRNL. In February 2019, the CRNL had 82 working research protocols including healthy subjects (over 3000 adults and nearly 200 children) and patients (over 3800 adults and nearly 500 children).
Regulation and ethics
Human research in France has been framed for the first time in 1988 by the Huriet-Sérusclat law. Today, experimental research in humans and personal data are closely framed by legal rules national (CNIL law of 1978, Jardé law of March 5, 2012), european (EU regulation n ° 536/2014 of April 16, 2014, EU regulation 2016/679 of April 27, 2016) and international (Nuremberg Code). The CRNL benefits from the support of institutional legal experts if necessary.
The CRNL applies the regulations in force and relies on research promoters institutional (HCL, INSERM, CNRS, CH le Vinatier, etc.), industrialists and associative (EDMUS foundation, Avenir foundation, etc.). Many studies are part of the RIPH category (“Research involving the human person”) framed by the Jardé law and are examined by a Committee for the Protection of Persons (CPP).
An "Ethics and Regulations" unit has been created within the CRNL to support research protocols involving humans and ensure compliance with regulations, procedures and ethics.
The Michel Jouvet Neurocampus and the Movement and Handicap and NeuroImmersion Platforms are authorized places for research by Regional Health Agency (decree 2020_17-0486 and decree n ° 2017-1428). They have agreements with the SAMU (to ensure the care and medical transport of volunteers who lend themselves to research in the event of an emergency), clinical research associate and prevention assistants who ensure the safety of the various areas dedicated to human experiments, and experimental staff are trained in first aid.
Useful links:
https://www.crnl.fr/fr/services
https://www.inserm.fr/recherche-inserm/ethique/recherches-conduites-chez-humain