DEBATE ABOUT NOTIONS OF INTERVENTIONAL RESEARCH AND NON-INTERVENTIONAL RESEARCH
DOI:
https://doi.org/10.54695/dss.56.02-03-04.2986Keywords:
Non-interventional study, Clinical trials, Ethical Committee, Regulation (UE) No 536-2014, French law of 5 March 2012, Jardé Law, French Advisory Committee on the treatment of information within health researches (CCTIRS), French Data Protection Authority (CNIL).Abstract
At a time when UE Regulation on clinical trials for
medicines is published, it is appropriate to consider the
need to create a specific regime for non-interventional
researches in the French Code of Public Health and thus
the scope of the French law of 5 March 2012 on research
involving human beings. Was it necessary to create a
separate specific regime from that applicable to personal
data processing? Is this new regime compatible with
European regulations?
