6. Biological specimen

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.

Authorization must be sought from the French Ministry of Research to import and export human organs, cell tissues, and their derivatives which are to be used for scientific purposes. The Ministry of Research is competent only for applications for authorization of import and/or export activities for scientific purposes of human biological samples.

Requests for import/export authorization are only made by email to the generic address: dossiers.import-export@recherche.gouv.fr.

The requestor has to submit a single authorization request by email containing the application form duly completed, accompanied by all the necessary documents depending on the type of application.

The exact documents required to be submitted in order to seek authorization are listed on the Ministry of Research website under “Steps to follow for the application for an import/export permit”.

In France, the collection, storage, transport, and use of biological samples must comply with what is set forth in Articles 1243-3 and 1243-4 of the Public Health Code.

6.2 Does local regulation require any separate consent for biological specimen collection, storage, and future research? If yes, please explain if there are any templates and/or links to be followed.

No, it does not need separate consent (unless it is for a sub-study). Information on biological collection can be included within the main participant information sheet.

The information to be included related to the collection of biological samples includes:

• Objective of the collection
• Nature of the samples preserved
• Place and duration of conservation
• Scientific purpose of the collection
• Methods of obtaining the destruction of the samples
• Possibility of assignment, transfer [It is possible and desirable to refer to a transparency portal to find out about the studies carried out from this collection of samples.]

If biological collection is performed at the participant’s home, this will also need to be indicated within the informed consent.

6.3 Does the local authority require any specific documents for customs clearance?

Yes, it will depend on where the samples will be shipped to.

The European Commission has some information on customs clearance documents and procedures that may be useful.