Authors:
M. Medina Calderon
1
;
2
;
C. Viennet
3
;
Y. Pellequer
4
;
F. Aubin
3
;
5
;
P. Guillem
6
;
7
;
K. Mouyabi-Nkombo
8
;
T. Lihoreau
1
;
9
and
G. Rolin
1
;
3
Affiliations:
1
Inserm CIC 1431, CHU Besançon, F-25000 Besançon, France
;
2
UFR Sciences de la Santé, Université de Franche-Comté, Besançon, France
;
3
Université de Franche-Comté, UMR 1098 RIGHT INSERM EFS, Besançon, France
;
4
Université de Franche-Comté, EA 4267 PEPITE, Besançon, France
;
5
Department of Dermatology, University Hospital of Besançon, Besançon, France
;
6
Department of Surgery, Clinique du Val d'Ouest, Ecully, France
;
7
RésoVerneuil, Paris, France
;
8
Department of Clinical Research and Innovation, University Hospital of Besançon, Besançon, France
;
9
Tech4Health Network - FCRIN, France
Keyword(s):
Clinical Research, Tissue Collection, Biological Sample, Regulatory Approach.
Abstract:
This short paper examines the regulatory needs behind the creation of a biological sample collection in France. Many research projects, including for medical devices development and evaluation, need biological sample collections, this article’s ambition is to provide a clear view of the requirements to create such collections. Numerous laws from the Public Health Code frame research in the health sector in France, starting with the definition of the research type, and going through the various documents needed, especially securing patient safety (in link with Good Clinical Practices –GCPs) and data protection. To have a better insight into the requirements to create a biological sample collection, the use of an on-going academic research will help illustrate our purpose. This research did not involve human subjects, and therefore had a “simplified” path regarding national competent authority approval, and what is called “reference methodologies”. Even though the procedure was labelle
d “simplified”, numerous interactions are required such as with clinicians, researchers, the clinical investigation center, the hospital research department, and different public administrations including the Hospital, the Minister of Higher Education, Research and Innovation, the National Commission for Data Processing and Liberty (CNIL), and the University of Franche-Comté.
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