Importation / Exportation of Human SamplesHuman samples.jpg

Authorisation must be sought from the French Research Ministry to import and export human organs, cell tissues and their derivatives which are to be used for scientific purposes.  The form is in French because it should be presented to French customs on request, but the sections which must be filled in by the Scientists have been translated into English (in blue).  This regulation is related to Bioethics.

N.B. This dossier must be submitted, by the ESRF, to the Research Ministry at least 2 months before the experiment is due to take place at the ESRF.

This dossier must include :

  • a brief summary of your research project
  • a label which must be placed on all packages carrying human samples or their derivatives. The template can be found here.  The User must complete parts (a), (b) and (c) before including it in their dossier.
  • an accompanying letter from the head of the research department stating the importance of the research project
  • a testimony about innocuousness of the samples related to HBV, HCV and AIDS viruses
  • a letter stating that samples have been collected with prior consent of patients and no money has been exchanged in whatsoever form to collect the samples
  • details are required about the conditioning of the samples for transportation and for handling, once on our beamlines.

It is recommended:

  • to first email the draft of your dossier with all document to the Biosafety Officer,

once completed and the green light given

  • to post one original with signatures and 3 copies to the ESRF Biosafety Officer.  Your dossier will then be sent to the French Ministry of Research, accompanied by a letter from the ESRF Director General.

Specific case for Human Cell Lines

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The regulation also applies for commercial human cell lines.  The supplier certificate should be send to the Safety Group before completing the dossier.  ECACC has agreed to provide a testimony about Bioethical procedures for their cell lines.  The ESRF Safety Officer will add this document to your dossier.

For other suppliers and cell collections bank, either you can get such document directly from the supplier administrative offices or you have to provide their commercial agreement number to supply Human cell lines on the French territory (BRN number).

Do not hesitate to contact the Biosafety officer rapidly to complete the Human Sample dossier and to get help if needed.

What should I provide if the samples are from a French institute?

Several regulation textes came out in 2007 (décret 2007-1220 du 10 août 2007, chapter II) requesting that each French institute declare to the French Ministry of Research all human samples and or derivatives stored on their premises.  Such a declaration, once completed on their specific website, provides a number such as …DC-200X-YZ.  Please refer to this link (in French) for more details.  This Declaration de Conservation number will be requested by the Safety Group in advance, with details about number of samples, nature, type and conditionning, before granting access to the beamlines. 

Do not hesitate to contact the Biosafety officer rapidly for more details and to get help if needed.

French Regulation

Several regulation texts have been published in France for human samples and derivatives.  These texts, in French, are all entered in a database from the link as follow:

or can be viewed from the list below: