Kazum, Efi
Martinez‐Catalan, Natalia
Oussama, Rejeb
Eichinger, Josef Karl
Werthel, Jean David
Valenti, Philippe
Article History
Received: 9 May 2021
Accepted: 16 September 2021
First Online: 16 October 2021
Declarations
:
: None.
: This study was classified as observational (non-interventional) by our local ethics committee Statutory and ethical obligations of observational (non-interventional) studies in France: According to the past Huriet law on biomedical research, and to the current regulation that went into effect in August 2006 (law no. 2004-806), such studies do not require prior submission or approval to/from an IRB, and they do not require written consent. There is a current discrepancy on observational studies between the French legal requirements and the editors’ requirements. This observational research on data fulfills current French regulatory and ethical obligations.