How to Create a Biological Sample Collection: Requirements and Tips from an Academic Research Example in France

M. Medina Calderon, M. Medina Calderon, C. Viennet, Y. Pellequer, F. Aubin, F. Aubin, P. Guillem, P. Guillem, K. Mouyabi-Nkombo, T. Lihoreau, T. Lihoreau, G. Rolin, G. Rolin

2023

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 labelled “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.

Paper Citation

in Harvard Style

Medina Calderon M., Viennet C., Pellequer Y., Aubin F., Guillem P., Mouyabi-Nkombo K., Lihoreau T. and Rolin G. (2023). How to Create a Biological Sample Collection: Requirements and Tips from an Academic Research Example in France. In Proceedings of the 16th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed, ISBN 978-989-758-631-6, pages 222-228. DOI: 10.5220/0011924500003414

in Bibtex Style

@conference{clinmed23,
author={M. Medina Calderon and C. Viennet and Y. Pellequer and F. Aubin and P. Guillem and K. Mouyabi-Nkombo and T. Lihoreau and G. Rolin},
title={How to Create a Biological Sample Collection: Requirements and Tips from an Academic Research Example in France},
booktitle={Proceedings of the 16th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,},
year={2023},
pages={222-228},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0011924500003414},
isbn={978-989-758-631-6},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 16th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,
TI - How to Create a Biological Sample Collection: Requirements and Tips from an Academic Research Example in France
SN - 978-989-758-631-6
AU - Medina Calderon M.
AU - Viennet C.
AU - Pellequer Y.
AU - Aubin F.
AU - Guillem P.
AU - Mouyabi-Nkombo K.
AU - Lihoreau T.
AU - Rolin G.
PY - 2023
SP - 222
EP - 228
DO - 10.5220/0011924500003414