[Legal framework relating to human tissues used for research ends].
Development in cell and tissue engineering needs human tissue samples. If French jurisdiction concerning the human tissue sample collected in a therapeutic goal is well established, the French and European legal context concerning the scientific research is not clear and controversial. In our lab, we aim to conjugate the professional and the moral duty and to impose on our researchers the respect of strictly defined procedures. In order to organize the management of these biological resources, we chose not only to take into account the present legal context concerning the collection of tissues for research purposes, but also to precede the French legal framework by inspiring from good practice, concerning on one hand the conservation, the transformation and the transport of human tissues used to therapeutic ends (decree of December 29, 1998) and on the other hand, from the ethical recommendations of the european directives. It is why, we put some procedures in place to guarantee the donor's information, the staff's security, the confidentiality as well as the tracability.
Pascal
P
P
Banque de tissus et cellules secteur HCL, pavillon I, hôpital Edouard-Herriot, 5, place d'Arsonval 69437 Lyon cedex 03, France. pascale.pascal@chu-lyon.fr
Bensiam
F
F
Auxenfans
C
C
Callu
M-F
MF
Robert
O
O
Damour
O
O
Chapuis
F
F
D001706:Biopsy; D003264:Containment of Biohazards; D005568:Forms and Records Control / Q000331:legislation & jurisprudence; D005602:France; D006801:Humans; D017053:Infection Control / Q000331:legislation & jurisprudence; D007258:Informed Consent / Q000331:legislation & jurisprudence; D012106:Research / Q000331:legislation & jurisprudence*; D014015:Tissue Banks / Q000331:legislation & jurisprudence*; D014019:Tissue Donors / Q000331:legislation & jurisprudence; D020858:Tissue and Organ Harvesting / Q000331:legislation & jurisprudence*; D014186:Transportation / Q000331:legislation & jurisprudence