Document is current
Any future updates will be listed below
-
Authors
Martinez-Catalan, Natalia https://orcid.org/0000-0001-7881-5873
Kazum, Efi
Zampeli, Frantzeska
Cartaya, Marco
Cerlier, Alexandre
Valenti, Philippe
- License Information
-
More Information
Article History
Received: 28 December 2021
Accepted: 14 February 2022
First Online: 28 February 2022
Declarations
:
: The authors report no conflicts of interest or sources of funding.
: 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 fulfils current French regulatory and ethical obligations.
